TW200800242A - Herbal compositions for the prevention or treatment of benign prostatic hyperplasia - Google Patents

Abstract

The present invention relates to herbal compositions for the prevention or treatment of disorders of the prostate, for example, benign prostatic hyperplasia (BPH), prostatitis, and prostatic intraepithelial neoplasia. Specifically, the invention provides compounds that contain C. nurvala and E. arvense and methods of use thereof.

Description

200800242 IX. Description of the invention: [Technical field to which the invention pertains] The present invention relates to a prostate for preventing or treating, for example, expanding prostate or benign prostatic hyperplasia (hereinafter, ???), prostatitis or prostatic intraepithelial neoplasia Herbal composition of the disease. [Prior Art] The prostate is a gland that exists only in the male body and is located just below the bladder and surrounds the urethra. Prostatic hyperplasia (ΒΡΗ) is called a condition of expanding the prostate-system Overgrowth is caused. When the prostate enlarges, : [the fine urethra and reduce the flow of urine, making it more difficult to empty the bladder. DPR is a common condition of aging. For example, the National Health Center (then _1 - 伽如〇 f Health ' According to NIH, BPH affects more than 6 years of age and more than 90% of men over the age of 70. The cause of BpH is unclear. The condition may be related to hormonal changes that occur with male aging. Pills produce hormone 睪 _ 'hormone stagnation _ in some tissues converted to dihydrobiguan (DHT) and estradiol (estrogen). may accumulate high levels of DHT and cause Hyperplasia. However, the cause of the increase in DHT remains the subject of the study. Glandular gland inflammation is a term used to describe the inflammatory condition of the prostate. It is believed that most cases of prostatitis are caused by bacterial infections, but no evidence of noisy has been found. Prostatitis can affect men of any age and an estimated 5% of men experience this condition throughout their lifetime. Among men over 50 years of age, prostatitis is the most common urinary disorder and is less than 5 years old. Among them, the second most common condition. There are 4 types of prostatitis: acute bacterial prostate g (ABP) 'for such as Escherichia coli (heart palpitations (3) ") and gram 118938.doc 200800242 R. brevis (Intestinal (four) // bacterial inflammation caused by bacteria; chronic bacterial prostatitis (CBP), recurrent infection and inflammation of the prostate and urinary tract; non-bacterial prostatitis 'inflammation of the prostate without bacterial infection; and month ί Adenal pain, sometimes called chronic pelvic pain syndrome (CPPS), is an event of prostatitis symptoms without inflammation or bacterial infection. Prostatic intraepithelial neoplasia (PIN) It is determined to be a pro-cancerous lesion of prostate cancer. PIN refers to the morphological spectrum of the pre-cancerous stage, which involves cell proliferation in the prostate duct, tubules, and acinus. Bostwick & (4) introduced the 浯PIN in 1987. In 1989 At international conferences, the term piN replaces various terms (eg, intraductal hyperplasia, hyperpiasia malignant change, large acinar atypical hyperplasia, significant atypia), duct-acinar dysplasia. piN The frequency in men with prostate cancer is significantly higher than in men without cancer. PIN seems to be 10 years earlier than cancer, and the frequency of PIN and cancer increases in parallel with age in the first ten in life. In the middle of the year, pjN was found in 9% of men, PIN was found in 22% of men in the third decade, and ριΝ was found in 40% of men in the fourth decade. When men reach 8 years of age, the incidence rate is 70%. The symptoms of the above prostate disorders are similar. Common symptoms are urinary conditions and dripping after 匕3 excretion; feeling that the bladder has not been completely emptied after urination; frequent urination, especially at night (ie nocturia); urinary hesitation, urinary interruption or urinary flow caused by reduced force Weakness; leakage of urine (ie, overflow incontinence); endeavor or force to start urinating; repeated, sudden 'urgent need to urinate; and hematuria caused by forced excretion (ie hematuria). 118938.doc 200800242 There are two main drugs used to treat prostate disorders: alpha__ agents and 5-alpha-reductase inhibitors. The α-blocker relaxes the smooth muscles of the arteries, prostate, and bladder neck. Relaxation of the smooth muscle around the cyst helps to reduce urinary tract obstruction. Although heart blockers help relieve some of the symptoms, the drug does not cure ΒρΗ. There are several different PU targets, such as alfuzosin ( ), 〇 σ azo azo azo azo C ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( D〇ralese), praz〇sin (Hyp_se), terazosin (Hytrin BpH) and hesulosin (iv) su1〇sin) (F1〇maX MR). Side effects can include headaches, dizziness, hypotension, fatigue, weakness, and difficulty breathing. Long-term risks and benefits have not been studied. 5 α-reductase inhibitor inhibits the production of an enzyme that converts testosterone. Therefore, the 5α-reductase inhibitor can reverse ΒρΗ to some extent and contract the prostate. Side effects include sexual reduction, impotence, ejaculation problems, breast tenderness and: t曰 large and reduced sperm count. Long-term risks and benefits have not been studied. 5 The safety of alpha reductase inhibitors is a concern for pregnant women who may face intermittent capsules, and patients in this therapy should stop for 6 months before donating blood. Surgery is also selected to reduce the symptoms of sputum and prostatitis and is recommended for severe complications and may be associated with urinary incontinence, overactive bladder and urinary symptoms, impotence, retrograde ejaculation (dry orgasm) and Patients who may be the most complication of infertility. Complications of prostatectomy include incontinence and impotence. Natural therapy can be used to treat prostate conditions. Saw Palmetto (Saw 118938.doc 200800242 palmetto; Ser(9) οα) is used as a 5-alpha-reductase inhibitor to reduce DHT production and prevent DHT from binding to the prostate. Schneider et al., Fortschr. Med. 113: 37-40 (1995); Kock and Biber, Urologe 334: 90-95 (1994). Side effects include mild digestive distress and some side effects associated with 5-alpha-reductase inhibitory drug therapy, such as mild itching, headache, high blood pressure, erectile dysfunction, ejaculation disorders, and decreased libido. Pygeum (JPjgewm a/r/ca(10)m) contains three compounds that help the prostate, a pentacyclic triterpenoid compound with diuretic effect; a plant-retaining alcohol with anti-inflammatory activity; and help clear The ferulic acid S of the prostate is associated with any cholesterol deposit of BPH. Andro and Riffaud, Curr. Ther. Res. 56: 796-817 (1995). Castor nettles (t/ri/ca d/o/ca) also reduces BPH symptoms and increases urine volume and maximum urine flow rate in men with early BPH. Kock and Biber, Urologe 334:90-95 (1994). Side effects include digestive distress. All of the treatment options mentioned for prostate conditions have some associated side effects. Medical drug and herbal treatment options often do not completely address the symptoms of urinary incontinence and overactive bladder that may be associated with the condition. There is a need for novel compositions for the prevention and treatment of prostatic disorders and their associated symptoms without undesirable side effects, including overactive bladder (OAB) and urinary incontinence (UI). SUMMARY OF THE INVENTION The present invention provides a method of preventing or treating a prostate disorder. In one embodiment, the prostate disorder can be, for example, an enlarged prostate or benign prostatic hyperplasia 118938.doc 200800242 (hereinafter "ΒΡΗ"), prostatitis, or prostatic intraepithelial neoplasia. In one embodiment, the invention There is provided a method of administering a herb-containing composition to a subject suffering from a prostate condition comprising: sorbus (Οαίβνα(10)rva) present in a concentration of at least about 10.0 mg dry weight equivalent per oral dosage unit. /α; C·(10)rva/a) Stem/skin preparation; concentration of at least about 670 mg dry weight equivalent of Herbs (£· arvww) herbal preparation per oral dosage unit; concentration of at least about 32.5 per oral dosage unit干 dry weight equivalent of 矽; concentration of at least about 24.9 mg dry weight equivalent of phosphorus per oral dosage unit; concentration of at least about 14.5 mg dry weight equivalent of magnesium per oral dosage unit; and concentration per oral dosage unit At least about 16.3 mg dry weight equivalent of calcium. The herb-containing composition of the present invention can be formulated into a dry delivery system, a liquid delivery system, or a controlled release vehicle. The system is formulated into an oral dosage unit comprising a tablet; a dry powder; a capsule; and a caplet. The sorbitan/skin preparation is present at a concentration of at least about 丨, (10) 〇 mg dry weight equivalent per oral dosage unit. The starting material is L000 mg dried pear stem/skin. The starting material is finally concentrated during the manufacturing process to a ratio of 10:1 'which is equal to 100 mg of sapwood. Thus, 100 mg# pear wood stem/skin preparation (its It is equivalent to 1, 〇〇〇mg dry weight of sapwood stem/skin or 1,000 mg of sapwood stem/skin starting material. The medicinal herb preparation is at least about 67 每 per oral dosage unit. The concentration of mg dry weight equivalent is present. That is, the starting material is 670 mg of Herbs. The starting material is finally concentrated during the manufacturing process to a ratio of 4: i or 5:!, which is equal to 167 mg or 134 mg. Herbal preparations. Thus, for example, 167 mg ask 118938.doc 200800242 Jing herbal preparations (which are concentrated) correspond to 670 mg dry weight of herbal medicine or 670 mg of dried herbal medicine starting material. In one embodiment, Standardized Qili herbal preparations obtained from the stem part of the medicinal herbs , also known as the standardized stem extract preparation. In some aspects of the invention, it has been determined that the sputum content of the medicinal herb preparation and/or the batch variation of the yellow _ content expressed by isoquercetin may be The biological activity of the composition of the invention has a negative effect. This problem has been solved by the present invention by providing a medicinal herb preparation having an optimized, standardized hydrazine content and/or flavonoid content expressed by isoquercetin. In an embodiment, the present invention provides a herb-containing composition comprising a sapling stem/skin preparation and a standardized medicinal herb preparation having a strontium content of from about 3% to about 3% by weight based on the total dry weight of the Physalis preparation, Wherein the herb-containing composition is formulated into an oral dosage unit. Therefore, about 3% to about 13% of the 1,500 mg dry weight of the medicinal herb or the 155 mg of the medicinal herb starting material which produces 300 mg of the medicinal herb preparation (which is concentrated) The strontium content will represent about 9 to 39 mg 矽. In a practical example, the sapwood stem/skin preparation is present in the herb-containing composition at a concentration of from about 100 mg to about 4,000 mg dry weight equivalent per oral dosage unit. In one embodiment, the sapwood stem/skin preparation is present in the herb-containing composition at a concentration of from about 500 mg to about 2,000 mg dry weight equivalents per oral dosage unit. In one embodiment, the sapwood stem/skin preparation is present in the herb-containing composition at a concentration of from about 800 mg to about 1,200 mg dry weight equivalent per oral dosage unit. In one embodiment, the standardized wattle formulation is present in the herb-containing composition at a concentration of from about 1 mg to about 3,000 mg dry weight equivalents per oral dosage unit. In one embodiment, the <RTI ID=0.0>>""""""""""""" In one embodiment, the standardized wattle formulation is present in the herb-containing composition at a concentration of from about 500 mg to about 1,000 mg dry weight equivalents per oral dosage unit. In one embodiment, the standardized standard is present in the herb-containing composition at a concentration of from about 600 mg to about 850 mg dry weight equivalents per oral dosage unit. In another embodiment, the herb-containing composition further comprises anhydrous gelatinous cerium oxide, wherein the herbal-containing composition has a total strontium content of from about 3 mg dry weight equivalents to about 71 mg dry weight equivalents per oral dosage unit. In one embodiment, the herb-containing composition further comprises anhydrous colloidal cerium oxide, wherein the total content of the herbal-containing composition is from about 5 mg dry weight equivalents to about 45 mg dry weight equivalents per oral dosage unit. In one embodiment, the herb-containing composition further comprises a water-free colloidal silica dioxide wherein the total composition of the herb-containing composition is from about 9 mg dry weight equivalents per about oral dosage unit to about 34 mg dry weight equivalents. In one embodiment, the standardized medicinal herb preparation further comprises a total flavonoid content of about 0.01% to about 3% of the total flavonoids in a total dry weight of the Physalis preparation, wherein the total flavonoid content is expressed as isoquercetin. . In one embodiment, the standardized medicinal herb formulation further comprises from about 1% to about 2.5% total ketone of the total dry weight of the Physician formulation and the total flavonoid content expressed as isoquercetin. In one embodiment, the standardized medicinal herb preparation further comprises a total flavonoid content of about 5% to about 1.5% total flavonoids based on the total dry weight of the Physalis preparation, wherein the total flavonoid content is expressed as isoquercetin. . In one embodiment, the progress of the standardized medicinal herb preparation comprises a total ketone content of at least about 8% total ketones of the total dry weight of the Physalis preparation, wherein the total flavonoid content is isoquercetin. .doc * 11 - 200800242 Show. In one embodiment, the herb-containing composition further comprises phosphorus, wherein the phosphorus is present at a concentration of from about 5 dry weight equivalents to about 60 mg dry weight equivalents per oral dosage unit. In one embodiment, the herbicidal composition further comprises a lining wherein the filling is present at a concentration of from about 10 mg dry weight equivalents to about 50 mg dry weight equivalents per oral dosage unit. In one embodiment, the herb-containing composition further comprises phosphorus, wherein the phosphorus is present at a concentration of from about 20 mg dry weight equivalents to about 30 mg dry weight equivalents per oral dosage unit.

In one embodiment, the herb-containing composition further comprises about at least about 1 mg dry weight equivalents per about oral dosage unit to about 30 mg dry weight equivalents. In one embodiment, the herb-containing composition of claim 1 further comprises calcium, wherein the calcium is present at a concentration of from about 5 ^ dry weight equivalents to about 25 mg dry weight per oral dosage unit. In one embodiment, the herb-containing composition further comprises calcium, wherein the calcium is present at a concentration of from about 1 mg dry weight equivalents to about 20 mg dry weight equivalents per oral dosage unit. In one embodiment, the herb-containing composition further comprises magnesium, wherein the magnesium is present at a concentration of from about 1 mg dry weight equivalents to about 3 mg dry weight equivalents per oral dosage unit. In an embodiment, the herb-containing composition further comprises a town wherein the town is present at a concentration of from about 5 mg dry weight equivalents per about oral dosage unit to about the dry weight equivalent of the bark. In one embodiment, the herb-containing composition further comprises a town wherein the magnesium is present at a concentration of from about 1 ton dry weight equivalents per about oral dosage unit to about 20 mg dry weight equivalents. In an embodiment, the herb-containing composition further comprises at least one of the following or "down to 4" - co-administered: (4) mining brown pick 118938.doc -12- 200800242

Saw palmetto) a berry preparation wherein Saw Palmetto is present at a concentration of at least about 107 mg of extract per 100 mg of fatty acid and sterol per oral dosage unit; (b) African thorn skin preparation, wherein the African thorn Lithium is present in a concentration per oral dosage unit that is standardized to contain at least about 1 mg dry weight of 2.5 mg of phytosterol; (c) a castor root preparation wherein the ramie is at least about 1 per oral dosage unit. a concentration of 00 mg of extract; (d) a tomato, a tomato, wherein the tomato is present in an oral dose unit at a concentration of at least about 333 mg of 0.1% lycopene (Lycopene); (e) Zucchini (Cwrcz/6/ία (pumpkin seed) seed preparation, wherein the zucchini is present at a concentration of at least about 1 〇g dry weight per oral dosage unit; (f) zinc 'where the lexicon is at least per oral dosage unit A concentration of about 1 mg dry weight equivalent is present; (g) copper, wherein the copper is present at a concentration of at least about 1 mg dry weight per oral dosage unit; (h) sun exposure, wherein the code is at least about every oral dosage unit 5 pg dry weight equivalent The concentration is present; (1) cholecalciferol (vitamin D3) 'where the biliary alcohol is present at a concentration of at least about 2 〇〇 dry weight equivalent per oral dosage unit; (1) vitamin E, wherein vitamin E is at least per oral dosage unit A concentration of about 50 IU dry weight equivalent is present; (k) vitamin B6 'where vitamin B6 is present at a concentration of at least about 25 mg dry weight per oral dosage unit; (1) vitamin C, wherein vitamin C is per oral dose I The unit is present in a concentration of at least about 1 mg dry weight equivalent; (m) a face acid (such as 1-glutamic acid), wherein the glutamic acid is at least about 2 mg dry weight per oral dosage unit. The concentration is present; (n) glycine, wherein the glycine is present at a concentration of at least about 200 meg dry weight equivalents per oral dosage unit; and (〇) 118938.doc -13-200800242 wherein the alanine is per oral The dosage unit is present at a concentration of at least about 200 mg dry weight equivalents. In one embodiment, the present invention provides a herb-containing composition comprising: at least about 15 mg dry weight equivalents per oral dosage unit. • In the sapwood stem 7 Formulations, a stalk extract preparation present at a concentration of at least about 670 mg' dry weight equivalent per oral dosage unit; a total saw palm concentration of at least about 1,070 "mg; normalized to contain at least about 5 〇〇盹 tomato red _ at least about 2.92 § total concentration of tomato; total concentration of at least about 5 mg zinc; total concentration of at least about 8 dry weight equivalent selenium. In one embodiment, the present invention provides a pharmaceutical composition It comprises the herb-containing composition of the invention and a pharmaceutically acceptable carrier. In another aspect, the present invention provides a method of preventing or treating a prostate condition of a subject by administering to the subject an herbal-containing composition of the present invention sufficient to prevent or treat the prostate disorder. Come on. In another aspect, the invention provides a method of preventing or treating a prostate disorder, the method comprising administering a herb-containing composition to a subject suffering from or suffering from a prostate disorder, the herbal composition comprising: at least An i.000 sapling stem/skin preparation and at least about 670 mg of the standardized (5) extract, wherein the administration of the composition reduces the symptoms of a prostate disorder. In one embodiment of the method, the herb-containing composition is formulated in a dry delivery system. In one embodiment of the method, the herb-containing composition is formulated in a liquid delivery system. In one embodiment of the method, the herb-containing composition is formulated in a controlled release vehicle. In one embodiment of the method, oral service? The unit in I! is selected from the group consisting of: a key agent; a dry powder; a glue H8938.doc -14-200800242 and a cap. In some embodiments of the method, the herb-containing composition further comprises at least one compound selected from the group consisting of: (a) at least once per oral dosage unit, containing at least about 85% fatty acid and sterol A saw palm berry preparation in the presence of a concentration of about 107 mg of extract; (b) an African thorn skin that is present in an oral dosage unit, standardized to contain 2.5 mg of phytosterol; and a concentration of about 100 mg dry weight Formulation; (c) a castor root preparation present at a concentration of at least about 1 mg of extract per oral dosage unit; (d) at a concentration of at least about 333 per oral dosage unit that is standardized to contain lycopene lycopene a tomato fruit of mg; (e) a zucchini (squash seed) seed preparation present at a concentration of at least about 10 g dry weight per oral dosage unit, (f) a concentration of at least about 3 gua dry weight equivalents per oral dosage unit (g) a concentration of at least about 1 mg dry weight equivalent of copper per oral dosage unit; (h) a concentration of at least about 5 dry weight equivalents of selenium per oral dosage unit; (1) a concentration of at least about 200 IU per oral dosage unit. Weight equivalent Cholecalciferol (vitamin D3); (1) a concentration of at least about 5 〇ILJ dry weight equivalent of vitamin E per oral dosage unit; (k) a concentration of at least about 0.01 mg dry weight equivalent of vitamin B6 per oral dosage unit; (1) concentration is Each oral dosage unit is at least about 1 〇〇 § dry weight of vitamin C, (m) 丨 度 is at least about 2Q0 mg dry weight equivalent of glutamic acid per oral dosage unit (such as glutamic acid); n) a concentration of at least about 200 mg dry weight equivalent of glycine per oral dosage unit; and (〇) a concentration of at least about 200 mg dry weight equivalent of alanine per oral dosage unit. In some embodiments of the methods, the composition is co-administered with a second composition comprising at least one compound selected from the group consisting of: (a) per oral dosage unit, standardized to contain About 88% fatty acid and sterol at least 118938.doc -15· 200800242 about 107 mg extract concentration present in the saw palmetto berry preparation; (b) in each oral dosage unit, standardized to contain 2. 5 mg phytosterol An African thorn skin preparation present at a concentration of at least about 100 mg dry weight; (c) a ricin root preparation present at a concentration of at least about 100 mg of extract per oral dosage unit; (d) a concentration per oral dosage unit, A tomato fruit that is standardized to contain at least about 333 mg of lycopene 1 mg. lycopene; a zucchini (squash seed) seed preparation in a concentration of at least about 1 gram dry weight per oral dosage unit; (£) concentration At least about 3% dry weight equivalent of zinc per oral dosage unit; (g) at a concentration of at least about i mg dry weight equivalents of copper per oral dosage unit; (h) concentration of at least about 5 dry weight equivalents per oral dosage unit (1) thick At least about 200 IU dry weight equivalents of cholecalciferol (vitamin D3) per oral dosage unit; (1) at a concentration of at least about 5 〇 dry weight equivalents of vitamin E per oral dosage unit; (k) concentration is at least per oral dosage unit Approximately 25 melons dry weight equivalent of vitamin B6; (1) a concentration of at least about 1 mg dry weight per serving of oral vitamin C, (m) concentration of at least about 200 mg dry weight equivalent per oral dosage unit The glutamic acid (e.g., 1-glutamic acid); (8) a concentration of at least about 200 mg dry weight equivalent of glycine per oral dosage unit; and a concentration of at least about 200 mg dry weight equivalent of alanine per oral dosage unit. In one embodiment of the method, the composition is administered to the subject simultaneously with the second composition. In one embodiment of the method, the composition is administered to the subject as the second composition is administered to the subject. In one embodiment of the method, the composition is administered to the subject after the second composition is administered to the subject. In another aspect, the present invention provides a herb-containing composition comprising (a) a concentration of at least about i, 〇〇〇mg dry weight equivalent per oral dosage unit 118938.doc -16-200800242 a pear stem/skin preparation; (b) a standardized stem extract preparation present at a concentration of at least about 1,500 mg dry weight equivalent per oral dosage unit; and (c) at least one selected from the group consisting of: Compound: (i) a saw palmetto berry formulation present at a concentration of at least about 107 mg of extract containing about 85% fatty acid and sterol per oral dosage unit; (ii) standardized per oral dosage unit An African thorn skin preparation present in a concentration of at least about 100 mg dry weight of 2.5 mg phytosterol; (丨丨丨) a ricin root preparation present at a concentration of at least about 100 mg of extract per oral dosage unit; Iv) a concentration of succulent fruit (squash seeds) at a concentration of at least about 333 mg per an oral dose unit, standardized to contain at least about 333 mg of dry saffron; (v) at a concentration of at least about 10 g dry weight per oral dosage unit Seed coat (vi) "Chendu" is a parent oral dose of at least about 1 dry weight equivalent of zinc in the early summer, (vii) concentration of at least about 1 mg dry weight equivalent of copper per oral dosage unit; (viii) concentration per oral dose The unit is at least about 5 dry weight equivalents of selenium; (lx) is at least about 2 IU dry weight equivalent of cholecalciferol (vitamin D3) per oral dosage unit; (X) concentration is at least about 5 per oral dosage unit. 〇 IU dry weight equivalent of vitamin E; (xi) concentration of at least about 25 mg dry weight per oral dosage unit as 1 vitamin B6; (xii) concentration of at least about 100 mg dry weight equivalent of vitamin C per oral dosage unit; ("(1) Concentration is at least about 2 mg dry weight equivalent of glutamic acid per amp of oral administration (eg, 丨-glutamic acid); (hv) concentration is at least about 200 mg dry weight equivalent per oral dosage unit The amine acid; and (xv) concentration is at least about 2 ounces of dry weight equivalent of alanine per oral dosage unit. In another embodiment, the present invention provides a herb-containing composition comprising 118938.doc -17 - 200800242 Included (a) in a concentration of 15 〇 瓜 干 dry weight equivalent per oral dosage unit In the form of sapwood! / skin preparation; (b) standardized stalk extract preparation in the concentration of pi) mg dry weight equivalent per oral dose unit; (c) in the concentration of 107 mg of extract per oral dose unit Saw palmetto berry preparation; (magic concentration is 2.92 g of tomato fruit per oral dose unit, standardized to contain 0.5 mg lycopene; concentration is $ mg dry weight per oral dose unit, and (f) The concentration is 8 dry weight equivalents of selenium per oral dosage unit. [Embodiment]

Therefore, it is to be understood that in the claims In general, the disclosure provides a beneficial herb-containing composition, a combination of the composition with other dietary supplement compositions, and methods of making and using the same. Accordingly, various aspects of the invention are directed to certain therapeutic or prophylactic uses of certain herbal-based compositions for the prevention or treatment of diseases, injuries or conditions associated with enlarged prostate, illustrating such aspects. Various specific embodiments are followed. It should be understood that 'the treatment or prevention of various modes of medical conditions as described is intended to mean "in general, • it contains all treatment or prevention but also contains insufficient treatment or prevention, and which achieves some biological or medical Related results. DEFINITIONS As used herein, "subject" is preferably a mammal' such as a human, but may also be a mobile ', such as a domestic animal (e.g., a dog, a cat, and the like), a farm animal (e.g., a cow, a flat, Pigs, horses and similar animals) and experimental animals (eg large 118938.doc -18- 200800242 mice, mice, guinea pigs and the like). As used herein, an "effective amount" of a composition is an amount sufficient to achieve the desired therapeutic and/or prophylactic effect, for example, an amount that causes prevention or reduction of symptoms associated with the disease being treated. The amount of the composition will depend on the type and severity of the disease and the individual characteristics such as general health, age, sex, weight and drug tolerance. It will also depend on the extent, severity and type of the disease. The skilled artisan will be able to determine the appropriate dosage based on these and other factors. In general, an effective amount of the compositions of the present invention is sufficient to achieve a therapeutic or prophylactic effect. Advantageously, dosages which are readily dosed and uniform in dosage are advantageously achieved. Oral compositions are formulated in unit form. The dosage unit form as used herein refers to a physically discrete unit suitable for use as a single dose for the subject to be treated; each unit contains a calculated basis for producing the desired therapeutic effect. An active composition in a combination with a pharmaceutical carrier. The description of the dosage unit form of the present invention is characterized by the unique characteristics and desire of the dietary supplement. The specific therapeutic effect, and the inherent limitations of the art of making the active composition for treating an individual, are determined and directly dependent thereon. The pharmaceutical composition can be included in a container, package or dispenser along with instructions for administration. The oral dose can be taken daily from 2 to 4 to 4 until the symptoms are significantly alleviated. In one embodiment, the oral dose is taken 3 times a day until the symptoms are significantly alleviated. Usually, the oral dose is taken 3 times a day until the symptoms are significantly alleviated. The compositions may also be administered in combination with one another or in combination with one or more other therapeutic compositions. Shalims is a medium-sized tree that reaches a height of more than 15 meters; it is made of cratevas (Krateuas) 'A 1st century BC Greek naturalist and physician ordered 118938.doc •19-200800242. It is widely spread throughout India, when it blooms from March to May (earlier in the south), the tree with smooth trilobal leaves at the top of the tree looks It is extremely majestic. It has been reported that bark can be used as a demulcent, antipyretic, sedative, metamorphic and tonic.

Question (botanical synonym and common name include (for example) Horsetail; Shave-grass; Bottle-brush; Paddock-pipe; Dutch Rush; Pewterwort; Shavegrass; pewterwort; bottlebrush; horsetail rush; paddock-pipe; Dutch Rush; mare's tail is a European herb that grows throughout the world. It is planted in Yugoslavia in the humid wasteland of the temperate zone. This perennial plant is common to moist loam or sandy soils throughout North America and Eurasia. In the entire plant kingdom, no other herbs are as rich as the horsetail. Equisetum can be used for medicinal purposes. The stems are not harvested in the summer and are dry. The resulting stem, which appears after the stem has withered, can be used as a drug and cut only over the root to use it all. Fresh or dried herbs can be used, but are said to be most effective when fresh. The fluid extract is prepared therefrom. Plant ash is also used. The references cited throughout this application are hereby incorporated by reference in their entirety. The herb-containing composition of the present invention provides the invention for use in the prevention or treatment of sputum A / sputum therapy such as enlargement of prostate or benign prostatic hyperplasia (hereinafter referred to as sputum, sputum, sputum, sputum); A trampoline-free 3 saponin composition for a method of neoplastic disease of neoplasia. Specifically, the present invention is directed to the identification of silk compositions containing the sapwood and the interim period for the prevention and treatment of prostate disorders. In an embodiment of the invention, the herb-containing composition comprises a sapling stem/skin extract and a medicinal herb. In an embodiment of the invention, the herb-containing composition of the invention is an oral supplement contained in a dry delivery system such as a lozenge, a dry powder and a dry meal replacement mixture. In another embodiment, the herb-containing composition of the present invention is an oral supplement contained in a liquid delivery system such as a capsule, caplet or beverage. In another embodiment, the herb-containing iris of the present invention is an oral supplement contained in a controlled release vehicle such as a tablet, a caplet, and a capsule. In another embodiment, the herb-containing compositions of the present invention comprise from about 100 mg to about 6,000 mg dry weight equivalents of sapwood extract per oral dosage unit. In another embodiment, the herb-containing compositions of the present invention comprise from about 500 mg to about 4,000 mg dry weight equivalents of sapwood extract per oral dosage unit. In another embodiment, the herb-containing composition of the present invention contains from about 800 mg to about 1,200 mg dry weight equivalent of sapwood extract per oral dosage unit. To prepare the herb-containing composition of the present invention, the skin and stem of the sapwood are separated from the remaining sapwood plants and dried. The dried skin and stem of the dried pear wood were extracted using 7% (v/v) ethanol/water. The liquid extract was then concentrated to a ratio of 1 :1. Maltodextrin is used as an excipient. The final product of the herb-containing composition of the present invention, i.e., the stalk/skin extract of sapwood, is a brown to dark brown powder. In another embodiment of the present invention, the herbicidal composition of the herb-containing composition of the present invention is obtained from the leaves of the medicinal herb. In one embodiment of the present invention, 118938.doc -21 - 200800242, the herbaceous composition of the herb-containing composition of the present invention is obtained from the stem of the medicinal herb. In another embodiment of the present invention, the herbaceous herbal preparation composition of the herbicidal composition of the present invention is obtained from a mixture of plant parts of the herb. In another embodiment of the present invention, the herb-containing herbal composition of the herb-containing composition of the present invention is derived from all parts of the plant extending above the ground. In one embodiment, the herb-containing composition of the present invention comprises from about 1 mg to about 3 parts per serving of the oral dosage unit. In another embodiment, the herb-containing composition of the present invention contains from about 1 mg to about L500 ^ dry weight equivalent of the herbaceous herbal preparation per oral dosage unit. In another embodiment, the herb-containing composition of the present invention contains from about 600 mg to about 800 mg dry weight equivalents of the herbicide preparation per oral dosage unit. In another embodiment, the herb-containing composition of the present invention contains from about 650 mg to about 700 mg dry weight equivalents of the herbicide preparation per oral dosage unit.矽 has been identified as the provider of the biological activity of the medicinal herbs. Non-standardized formulations of the medicinal herbs typically contain from about 12% to about 6.9% of the total dry weight of the formulation. In one aspect of the invention, it has been determined that the batch variation of the medicinal herb formulation can have a negative effect on the biological activity of the compositions of the present invention. This problem has been solved by the present invention by providing a medicinal herb formulation having an optimized, standardized sputum content. Therefore, in one embodiment of the present invention, the hydrazine content of the medicinal herb preparation in the herb-containing preparation of the present invention is standardized. The use of the standardized formulation of the medicinal herb is advantageous because the variation between batches of mash is reduced' thus the compositions of the invention produce a more consistent prophylactic or therapeutic effect. In the implementation, the drug preparation is standardized to contain about 3% to about 13% of the total dry weight of the herbal preparation. In another embodiment, 118938.doc -22- 200800242, in another embodiment, 'Qi Jing herbal 掣 M ', u, and 軚 軚 以 以 以 以 以 以 含有 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约/. After that. In another embodiment, the interrogated herbal preparation has a standard dry tongue < s + 乂 s s having at least about 6% of the total dry weight of the medicinal herb preparation. In addition to cockroaches, Jing Jing contains about 5% isoquercetin, goat bean bitter and wood = for the thief, and contains, g _, π, several species of flavonoid glycoside (also known as statistic喃糖 l purchase · benzo =, 4 嗣 嗣 〇 〇 〇 葡 葡 葡 葡 葡 葡 葡 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 ) _5,7_ two woven flavonoids can have important pharmacological _ " This helmet is wrong, such as diarrhea, diuretic ketone is a diuretic, one or two is an antispasmodic, anti-inflammatory, disinfectant and even anti-tumor agent However, in general, Lv-like ketone mainly acts on blood sputum, first. The ketoside and saponin may be combined to illustrate the diuretic effect of the sputum. Τ』月匕 is another bear sample in the present invention. , 0 4 A m 人旦" 7 The total flavonoids of the medicinal preparations of 荆 草药 草药 草药 ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( 生物 生物 生物 生物 生物 生物 生物 可 可 生物 生物 可 生物 生物 生物 生物There is a negative effect of ", and, right. I. City by the present invention by providing a chemicalized, standardized total yellow-content (to be treated with an isoquercetin containing a herbal preparation). Therefore, in the present One of the real: Ding invented in the herbal preparations / 歹1, this ^ ^ early 柰 preparation of the total class of Astragalus 詈 ^ octapeptide content expressed as a standardized drug is advantageous, because. Class ~ eight曰,...Chemical preparations, 莉, 颏, heart 颏 _ content (the variation in the amount of isoquercetin is reduced, so the composition of the present invention produces a more consistent therapeutic effect. In an embodiment, ask Preventive or have her dry weight of Herbs Herbs..., w standardized to contain fruit U ~ dry weight 〇. 〇 1% yellow to about 3% 118938, doc -23- 200800242 flavonoids Wherein the total flavonoid is expressed as isoquercetin equivalent. In another embodiment, the medicinal herb preparation is standardized to contain about 0.1% flavonoids to about 2.5% of the total dry weight of the medicinal herb preparation. A flavonoid in which the total flavonoid is expressed in an equivalent amount of isoccalin. In another embodiment, the medicinal preparation is standardized to contain about 5% flavonoids based on the total dry weight of the medicinal herb preparation. 1.5% flavonoids, wherein the total flavonoids are expressed in isoquercetin equivalents. In another embodiment, The pharmaceutical preparations are standardized to contain at least about 8% flavonoids based on the total dry weight of the medicinal herb preparation, wherein the total flavonoids are expressed as iso-bark pigment equivalents. In one embodiment, by solvent extraction, use A raw material having a cerium content satisfying a minimum cerium requirement of, for example, 3%, is standardized to an organic cerium content. In one embodiment, the herb-containing herbal preparation of the herb-containing composition of the present invention is obtained from the medicinal herb The stem is standardized and its cerium oxide is contained, that is, the stalk extract preparation. In short, the stem portion of the medicinal herb is removed from the plant and dried. Then, the minimum is measured by HpLC analysis. After the % content, the extraction process is followed. 65% (v/v) ethanol/water was used: the solvent was taken to obtain an extract. The extract is concentrated to a ratio of about 4:1. Subsequently, the minimum 3% of the extract was again tested by HPLC. The final extractive dry concentrate exhibits a finely plucked powder with a characteristic odor and taste. In another example, the herbicide preparation is standardized by solvent extraction. In short, remove the stem portion of the medicinal herb from the plant and dry it: use a test to ensure the correct biomass morphology of the correct substance (its package a microscopic and read characteristics) (for example, return the evidence sample that has been discerned) Standard storage 118938.doc -24- 200800242 for substance clocking). The extract was obtained using hot water (between about 50 ° C and about 10 ° C) as a solvent. The extract was concentrated to a ratio of about 5: hydrazine. The extract is then dried. The minimum 3% cerium content of the extract was tested by uv-Vis spectrophotometry (cerium oxide was used as a reference material). If the extract exceeds the above-mentioned standard range, it is titrated with the dried extract which has been subjected to the same method as above. The final extracted dry concentrate appeared as a yellow-brown powder. In one embodiment, the herb-containing herbal preparation of the herb-containing composition of the present invention is adapted to the standard of the total flavonoid content, and the stem extract preparation. In another embodiment, the E. arvense herb preparation is standardized to a flavonoid (expressed as isoquercetin) by a solvent extraction method. In short, the stem portion of the medicinal herb is removed from the plant and dried. Subsequently, it was identified by TLC. (isoquercetin is used as a reference substance). Use to ensure that the starting material of the correct substance is in the test (which includes both observations and macroscopic features) (for example, archiving the confirmed evidence samples for material identification). The extract was obtained using hot water (between a pit and about Φ l〇〇C) as a solvent. The extract was concentrated to a ratio of about 54. The extract is then dried. Testing the extract with a minimum of about 1% isoquercetin via uv_vis spectrophotometry (isobartrin as a reference material). If the extract exceeds the above-mentioned standard range, it is used to dry the same method as above. No extract titration. The final extracted dry concentrate appeared as a yellow-brown powder. In the examples, the E. arvense herb preparation was standardized to the organic hydrazine content and the flavonoid content (expressed as isoquercetin) using the method described above. In one aspect of the invention, the herb-containing composition of the present invention contains Shali 118938.doc -25- 200800242 wood! / skin extract and medicinal herbs and anhydrous gelatinous cerium oxide. Additional spleen assisted urogenital tissue to maintain, strengthen and solid. In one embodiment, the herb-containing composition of the present invention contains from about 10 mg dry weight equivalents to about 71 mg dry weight equivalents per oral dosage unit. In another embodiment, the herb-containing composition of the present invention contains from about 15 mg dry weight field to about 45 mg dry weight equivalents per oral dosage unit. In another embodiment, the herb-containing composition of the present invention contains from about 28 mg dry weight equivalents to about 34 mg dry weight equivalents per oral dosage unit. In another aspect of the present invention, the herb-containing composition of the present invention contains phosphorus. In one embodiment, the herb-containing composition of the present invention contains from about 5 mg dry weight equivalents of phosphorus per unit of oral dose to about 6 mg dry weight equivalents of phosphorus per oral dose. In another embodiment, the herb-containing composition of the present invention contains from about 10 mg dry weight equivalents of phosphorus to about 5 mg dry weight equivalents per oral dosage unit. In another embodiment, the herb-containing composition of the present invention contains from about 20 mg dry weight equivalents of phosphorus per oral dosage unit to about 3 mg dry weight equivalents of phosphorus. • In another aspect of the invention, the herb-containing composition of the invention contains calcium. In one embodiment, the herb-containing composition of the present invention contains from about 1 mg dry weight equivalent of calcium per oral dose to about 3 mg dry weight equivalents of calcium per oral dose. In another embodiment, the herb-containing composition of the present invention contains from about 5 mg dry weight equivalents of calcium to about 25 mg dry weight equivalents of calcium per oral dosage unit. In another embodiment, the herb-containing composition of the present invention contains from about 10 mg dry weight equivalents of calcium to about 2 干 ^ dry weight equivalents of calcium per oral dosage unit. In another aspect of the invention, the herb-containing composition of the invention comprises a town. In an embodiment, the herb-containing composition of the present invention contains from about 12,938,388 to about 2,000,000,000,000,000 units of magnesium per unit dose to about 3 mg of dry weight equivalents of magnesium per serving. In another embodiment, the herb-containing composition of the present invention contains from about 5 mg dry weight equivalents of magnesium to about 25 mg dry weight equivalents of magnesium per oral dosage unit. In another embodiment, the herb-containing composition of the present invention contains from about 20 mg dry weight equivalents of magnesium to about 20 mg dry weight equivalents of magnesium per oral dosage unit. In one embodiment, the present invention provides a herb-containing composition comprising: a concentration of at least about 1,000 mg dry weight equivalent per oral dosage unit of φ in a pear/skin preparation; per oral administration a dosage unit having a concentration of at least about 670 mg dry weight equivalent of the stem extract preparation; at least about 1, 〇7〇mg dry weight equivalent of the total saw palm concentration; normalized to contain at least about

The total concentration of Kg lycopene at least about 2.92 g tomato; the total concentration of at least about 5 mg zinc; at least about 8 is the total concentration of dry weight equivalent selenium. In one embodiment, the invention provides a method of treating or preventing a prostatic disorder, wherein an oral dosage unit in an amount sufficient to treat or prevent the prostatic disorder is administered to a subject. In another embodiment, the oral dosage unit is administered to the subject at least once a day. In another embodiment, the oral dosage unit is administered to the subject between 2 and 5 times per day. In one embodiment, the herb-containing composition further comprises Saw Palmetto Berry - #1 ' wherein Saw Palmetto is at least about 107 mg extracted per oral dosage unit, standardized to contain about: 85% fatty acids and sterols. The concentration of the substance exists. In another example, the herb-containing composition is co-administered to a subject in combination with a second composition comprising a saw palmetto berry formulation, the second composition being co-administerable with the herbal-containing composition, or in a herbal-containing combination The substance is administered to the subject before or after the administration of 〇〆118938.doc -27- 200800242 In the case of the shell, the herbal-containing composition further includes the African thorn skin! The non-state thorns are present at a concentration of at least about 1 ounce dry weight per oral dosage unit standardized to contain 2.5 mg of phytosterol. In another embodiment, the 'herbal-containing composition is co-administered to a subject in combination with a second composition comprising an African thorn skin preparation, which may be administered simultaneously with the herbal-containing composition' or in a herbal-containing composition The composition is administered to the subject before or after administration.

In the κ administration, the herbal composition further comprises a castor root formulation wherein the ramie is present at a concentration of at least about 100 mg of extract per oral dose of the single bait. In another embodiment, the herb-containing composition is co-administered to a subject in combination with a second composition comprising a castor root formulation, the second composition being co-administerable with the herbal-containing composition, or in a herbal-containing combination The substance is administered to the subject before or after the administration. In the case of the shellfish, the herb-containing composition further comprises a tomato fruit, wherein the sage is present in a concentration of at least about 333 mg per oral dosage unit that is standardized to contain 〇 番 番 番 。. In another embodiment, the herb-containing composition is administered to the subject in combination with a second composition comprising Fanyou, the second composition can be administered simultaneously with the herbal-containing composition, or administered in a herbal-containing composition. The subject is administered before or after. In an embodiment, the herb-containing composition further comprises the cilantro (squash seed) seed preparation wherein the zucchini is present at a dry weight of at least about 10 g dry weight per oral dosage unit. In one embodiment, the herb-containing composition further comprises a zucchini (pumpkin seed) seed preparation, wherein the zucchini is at least about 100 mg per oral dose (M g dry weight to about ig dry weight per oral dosage unit 118938.doc • 28 - 200800242 + Chen Duo exists. In the embodiment, the herb-containing composition further comprises a Ximeng Dong (squash seed) seed preparation, wherein the Xixianglu system is at least about 0.1 g dry weight per serving unit per serving. A concentration of about 5 g dry weight in an oral dosage unit is present in her case. The herbal-containing composition further includes a zucchini (south: seed) seed preparation, wherein the rhyme is in each oral dosage unit: less, 5 g dry weight to the spoon A concentration of about 1 〇g dry weight per oral dosage unit is present. In another embodiment, the 'herbal-containing composition is co-administered to a subject together with a second composition comprising a squash seed preparation, the second composition being The herb-containing composition is administered simultaneously or before or after the herb-containing composition is administered to the subject. In still another embodiment, the herb-containing composition further comprises zinc, wherein the zinc is per oral dose. A concentration of at least about 3 mg dry weight equivalent is present. In another embodiment, the 'herbal-containing composition is co-administered to a subject in combination with a second composition comprising zinc, the second composition being compatible with the herbal-containing composition Simultaneous administration, or administration prior to or after administration of the herb-containing composition to the subject. In one embodiment, the herb-containing composition further comprises steel, wherein the steel is at least about 丨mg dry weight equivalent per oral dosage unit. The concentration is present in another embodiment - the herbal-containing composition is combined with the second composition comprising copper, and the second composition can be administered simultaneously with the herbal-containing composition, or The herbal composition is administered to the subject before or after administration. In one embodiment, the herb-containing composition further comprises selenium, wherein the selenium is present at a concentration of at least about 5 dry weight equivalents per oral dosage unit. In an embodiment, the herb-containing composition is co-administered to the subject in combination with a second composition comprising selenium, the second composition being co-administerable with the herbal-containing composition, 118938.doc -29-200800242 or in the presence of herbs Composition administered to the subject Pre- or post-administration. In one embodiment, the herb-containing composition further comprises cholecalciferol (vitamin D3) wherein the biliary alcohol is present at a concentration of at least about 2 IU dry weight equivalents per oral dosage unit. In another embodiment, the herb-containing composition is co-administered to a subject in combination with a second composition comprising cholecalciferol, the second composition being co-administerable with the herbal-containing composition, or in a herbal-containing composition In one embodiment, the herb-containing composition further comprises vitamin E, wherein the vitamin E is present at a concentration of at least about 5 〇 dry weight equivalents per oral dosage unit. In an embodiment, the herb-containing composition is administered to the subject together with a second composition comprising vitamin E, the second composition can be administered simultaneously with the herbal-containing composition, or administered to the herb-containing composition. The person is involved before or after. In one embodiment, the herb-containing composition further comprises vitamin B6, wherein the vitamin B6 is present at a concentration of at least about 25 mg dry weight equivalent per oral dosage unit. In another embodiment, the herb-containing composition is administered to a subject in combination with a second composition comprising vitamin B6, which can be administered simultaneously with the herbal-containing composition or in a herbal-containing composition. Submitted to the subject before or after. In the embodiment the herb-containing composition further comprises vitamin C, wherein the vitamin c is present at a concentration of at least about 1 干 dry weight equivalent per oral dosage unit. In another embodiment, the herb-containing composition is co-administered to a subject in combination with a second composition comprising a vitamin: the second composition can be spotted simultaneously with the herbal-containing composition, and the sputum is combined only. And before the 3 Zhuo Le composition is administered to the subject 118938.doc 200800242 or later. In one embodiment, the herb-containing composition further comprises a face acid (e.g., glutamic acid), wherein the face acid is present at a level of at least about 2 ounces per oral dosage unit. In another embodiment, the herb-containing composition is co-administered to a subject in combination with a second composition comprising glutamic acid, the second composition being co-administerable with the herbal-containing composition, or in a herbal-containing composition It is administered before or after being administered to the subject. In one embodiment, the herb-containing composition further comprises glycine, wherein the glycine is present at a concentration of at least about 2 干 dry weight equivalents per oral dosage unit. In another embodiment, the herb-containing composition is co-administered to a subject in combination with a second composition comprising glycine, the second composition being co-administerable with the herbal-containing composition, or in a herbal-containing composition It is administered before or after being administered to the subject. In one embodiment, the herb-containing composition further comprises alanine, wherein the alanine is present in a concentration of at least about 2 〇〇〇 dry weight equivalent per oral dosage unit, in a further embodiment, the herbal-containing composition is included The second composition of alanine is co-administered to the subject, and the second composition can be administered simultaneously with the herb-containing composition or before or after the herb-containing composition is administered to the subject. In another embodiment, the herb-containing composition of the present invention is used in a cream 2. In one embodiment, the "herbal-containing composition" contains from about 1 mg to about 100 mg dry weight equivalents of sapwood stem/skin extract per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about mg to about 60 mg dry weight equivalents of sapwood stem/skin extract per gram of cream. In another embodiment of 118938.doc -31. 200800242, the herb-containing composition of the present invention contains from about 40 mg to about 60 mg dry weight equivalents of sapwood stem/skin extract per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 1 mg to about 60 mg dry weight equivalent of Herbs per gram of cream per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 5 mg to about 40 mg dry weight equivalents of Herbs per gram of cream. In another embodiment, the herbicidal compositions of the present invention comprise from about 10 mg to about 30 mg dry weight equivalents of medicinal herbs per gram of cream. ^ In another embodiment of the invention, the herb-containing composition contains oil. In one embodiment, the herb-containing composition of the present invention contains from about 1 mg to about 30 mg of orange oil per gram of cream. In another embodiment, the herbicidal compositions of the present invention comprise from about 5 mg to about 25 mg of dry orange oil per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 8 mg to about 12 mg of orange oil per gram of cream. In one embodiment of the invention, the herb-containing composition comprises a pencil cypress (J(tetra)/perw vz>gzW(10)?) (Cedarwood) stem essential oil. In one embodiment, the herb-containing composition of the present invention contains from about 1 pg to about 1,000 pg of pencil cypress essential oil per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 250 pg to about 750 pg of lead per gram of cream; pen stalk essential oil. In another embodiment, the herb-containing composition of the present invention contains from about 400 pg to about 600 pg of pencil stalk essential oil per gram of cream. In one embodiment of the invention, the herb-containing composition comprises Myrrh oil. In one embodiment, the herb-containing composition of the present invention contains from about 1 pg to about 1,000 pg of myrrh oil per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 250 to about 750 tons of myrrh oil per gram of cream. In another embodiment, the Zhuo Le composition of the present invention contains from about 400 pg to about 600 pg of myrrh. In one embodiment of the invention, the herb-containing composition comprises neroli oil. In one embodiment, the herb-containing composition of the present invention contains from about 1 pg to about 1,000 pg of neroli oil per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 250 pg to about 750 pg of oil per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 400 jig to about 600 μg of neroli oil per gram of cream. In one embodiment of the invention, the herb-containing composition comprises Cwpreaws Cypress leaf oil. In one embodiment, the herb-containing composition of the present invention contains from about 1 Mg to about 1000 pg of cedar leaf oil per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 50 pg to about 500 pg of cypress oil per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 75 to about 125 pg of cypress oil per gram of cream. In another embodiment of the invention, the herb-containing composition comprises d-α-tocopherol acetate (natural vitamin E). In one embodiment of the invention, the herb-containing composition of the invention contains d-a-tocopheryl acetate. In one embodiment, the herb-containing composition of the present invention contains from about 0.1 mg to about 25 mg of d-a-tocopheryl acetate per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 1 mg to about 10 mg of dry d-a-tocopheryl acetate per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 4 mg to about 6 mg of d-a-tocopheryl acetate per gram of cream. 118938.doc -33· 200800242 In another embodiment of the invention, the herb-containing composition contains diazolidinylurea. In one embodiment of the invention, the herb-containing composition of the invention contains urea aldehyde. In one embodiment, the herb-containing composition of the present invention contains from about 01 mg to about 10 mg of urea aldehyde per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 1 mg to about 5 mg of dry urea per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 3 mg to about 3.5 mg of urea aldehyde per gram of cream. In another embodiment of the invention, the herb-containing composition comprises a hydroxybenzoate. In one embodiment, the herb-containing composition of the present invention contains a hydroxybenzoate. In one embodiment, the herb-containing composition of the present invention contains from about 0.1 mg to about 5 mg of hydroxybenzoate per gram of cream. In another embodiment, the herb-containing composition of the present invention contains from about 0.50 § to about 3 mg of dry hydroxybenzoate per gram of cream. In another embodiment, the herb-containing compositions of the present invention comprise from about 1 mg to about 2 mg of phenyl benzoate per gram of cream. In another embodiment of the present invention, the herb-containing composition comprises extract of Sorbus stalk/skin extract and Phyllostachys pubescens; orange oil; pencil cypress stem; myrrh oil; neroli oil; cypress leaf; -α-tocopheryl acetate; urea aldehyde; and hydroxybenzoic acid 6 purpose. Pharmaceutical Properties and Uses of the Compositions of the Invention The present invention provides a herb-containing composition suitable for use in a method of preventing or treating, for example, a proliferative disorder of prostate or benign prostatic hyperplasia (BPH), prostatitis, and prostatic intraepithelial neoplasia. The main active ingredients believed to be present in Crateva and Equisetum are saponin and phytosterols. 118938.doc -34- 200800242

Fish genus contains flavonoids, glucosinolates and phytosterols, lupinol, while Equisetum contains minerals, sulphur dioxide, flavonoids (isoquercetin, leaf flavonoids and fulvicin) and saponin , Equisetum. Nadkarni Κ·Μ· et al, Indian Materia· Medica· Bombay Popular Prakashan ; British Herbal Pharmacopeia. Publ: British Herbal Medicine Association 1983 J Bone K. Clinical Applications of Ayurvedic and Chinese Herbs· Monographs for the western herbal practitioner· Phytotherapy Press, Warwick, Qld, Australia 1997; The German Commission E Monographs, 1998; D'Agostino M. et al., Boll. Soc. Ital. Biol. Sper. 5 30;60(12):2241-5 (1984); Pengelly A The constituents of medicinal plants: an introduction to the chemistry and therapeutics of herbal medicine. Sunflower Herbal Second Edition, Merriwa, NSW, Australia, 1996; Lakshmi V. et al, Planta Medica, 32: 214-216 (1977). The herb-containing composition of the present invention is useful for the prevention and treatment of incontinence, benign prostatic hyperplasia and urinary incontinence. In men with low-grade bladder caused by benign prostatic hyperplasia, fish genus administration produces a significant reduction in symptoms of frequent urination, urinary incontinence, urinary pain, and urinary retention. Deshpande PJ et al., Indian J. Med. Res” 76 (Suppl): 46-53 (1982). Fish genus is used to increase the elasticity of the bladder and the discharge of urine, thereby helping to effectively empty. Deshpande PJ·etc. Human, Indian J. Med. Res., 76 (Suppl): 46-53 (1982). The bladder manometry study analyzed in this paper also shows that the fish is normalized to the bladder and significantly reduces the amount of residual urine. The present invention contains 118938.doc -35- 200800242 herbal compositions suitable for the prevention and treatment of urinary incontinence. These results are also supported by in vitro animal studies that have demonstrated that the genus Muscles increase the flexibility of smooth muscle and bone musculature. Das Ρ·Κ et al., 1.1^8.111 (1· Med·, 9:49 (1974). Animal studies show that the 40-day treatment with fish wood produces a hypertonic curve of the bladder when compared to the initial curve. Das PK Etc. - Person, J. Res. Ind. Med., 9:49 (1974) ° / Equisetum is rich in tannins and citrates. Antimony is maintained by cerium oxide. ChevaAlier, A·, The Encyclopedia of Medicinal Plants, (Horn V. and Weil, C·, Eds) Dorling Kindersley Ltd., London (1996). Thus, the present invention provides a herbal-containing composition suitable for preventing or treating urogenital disorders such as urinary incontinence, enuresis (such as bedwetting), benign prostatic hyperplasia, urinary calculi, bladder inflammation, and UTI. Different mechanisms produce anti-inflammatory effects, but it is known that isoquercetin found in the genus Equisetum has an anti-inflammatory effect by inhibiting inflammatory prostaglandins. DVAgostino M. et al., Boll Soc. Ital Biol Sper., 30; (12): 2241-5 (1984); Geetha T. et al., Gen·

Pharmacol, 32(4): 495-7 (1999). The positive effect on chronic urinary tract infections is most likely a combination of antibacterial and anti-inflammatory effects. :· Cypress is described as an antispasmodic agent, astringent, disinfectant, deodorant, diuretic; and a tonic that promotes venous circulation in the kidney and bladder area, improves bladder elasticity, and assists incontinence and enuresis. Tisserand and Balacs, Five Oil Safety. A Guide for Health Care Professionals · Churchill Livingstone, U. K., 1995; 28-29, 31, 33-34;

Valnet, J, The Practice of Aromatherapy. Saffron Walden, 118938.doc -36 - 200800242

The CW Daniel Company, Essex, England, 1980; 120-121, Holmes, P. The Energetics of Western Herbs. Artemis Press, Boulder, Colorado, USA, 1989; 567-569, 792 ·, Damian, P & K. Aromatherapy Scent and Psyche· Healing Arts Press, Rochester, Vermont, Canada, 1995; 187-188 ; Price, S. The

Aromatherapy Workbook. Thorsons (Harper Collins), California, USA, 1993; 67 ; Chidell, L. Aromatherapy. A

Definitive Guide to Essential Oils. Hodder and Stoughton Ltd, Kent, UK, 1992; 23-24, 80-81 ί Keller, E. The Compete

H J Kramer, Inc, Tiburon, California, USA, 1991; 178-179 近期 Recent literature describes myrrh as an astringent and disinfectant that produces a palliative effect on the mucosa of the urinary system and promotes tissue healing. Battaglia, S. TTze Complete Guide to Aromatherapy. The Perfect Potion Pty Ltd, Virginia, Brisbane, Qld, Australia, 1995; 110-113, 116, 150-151, 158-159, 182-183, 184-185, 187; Lawless, J. The

Encyclopaedia of Essential Oils. (1992) Element Books for Jacaranda Wiley, Ltd, Australia, 1992; 76-77, 88-89, 135-136. Orange and neroli oil (Neroli) are described as having a antispasmodic effect, a disinfecting effect, and a deodorizing effect. 6,10; Sheppard-Hanger. TTie

Practitioner Manual· Aquarius Publishing, Willetton, Western Australia, 1995; 183 ; Sellar, W. The Directory of

Essential Oils. Saffron Walden, The C.W. Daniel Company, Essex, England, 1992; 50-51, 106-107; Keller, E. The 118938.doc -37- 200800242

Compete Home Guide to Aromatherapy. H J Kramer, Inc, Tiburon, Califomia, USA, 1991; 178-179. The herb-containing composition of the present invention is suitable for the prevention and treatment of a prostate disorder such as benign prostatic hyperplasia. Essential oils are also recommended for male reproductive health and indicate possible effects on the male prostate. Battaglia, S.

Guide to Aromatherapy. The Perfect Potion Pty Ltd, Virginia, Brisbane, Qld, Australia, 1995; 110-113, 116, ISO-151, 158-159, 182-183, 184-185, 187; Price, S. Practical

Aromatherapy. Thorsons, Harper Collins Publishers, California, US, 1983; 157-8, 170-171, 174, 185; Lawless, J. The Encyclopaedia of Essential Oils. (1992) Element Books for Jacaranda Wiley, Ltd, Australia, 1992; 76-77, 88-89, 13 5-136; Valnet, J. The Practice of Aromatherapy.

Saffron Walden, The CW Daniel Company, Essex, England, 1980; 120-121 某些 Some drugs, such as oxybutynin hydrochloride, which are usually designated for urinary incontinence, inhibit acetylcholine on smooth muscle muscarinic The effect is to produce a direct antispasmodic effect, that is, it relaxes the detrusor. Tapp A. J. S. et al., Brit. J. Obstetrics and Gynecology; 97: 521-6 (1990). The anti-cholinergic effect of the drug previously used in patients with urinary incontinence is expected to be greater. Although the antispasmodic effect of these essential oils is not provided in more detail, it can also produce a drug similar to the currently specified drug therapy. Herbal diuretics are documented to increase blood flow through the kidneys, rather than using it. 118938.doc -38 - 200800242

The state of the modern drug diuretic is reabsorbed at the distal tubule of the kidney and associated electrolyte loss (except potassium). Mills and Bone, and Practice of Phytotherapy. Churchill Livingstone, 2000; 35, 220-222. Also, diuresis is often not caused by herbal diuretic use. Mills and Bone, Principles and Practice of Phytotherapy· Churchill Livingstone, 2000; 35, 220-222. It is possible that these herbal essential oils greatly stimulate the blood flow to the kidneys, resulting in increased or more efficient urine production. This effect minimizes the amount of urine lost through continuous leakage when combined with complete emptying of the bladder during excretion. Saw Palmetto is an herbal product used to treat symptoms associated with benign prostatic hyperplasia. The active ingredient is found in the fruit of the American palm tree. Studies have demonstrated the effectiveness of Saw Palmetto in reducing symptoms associated with benign prostatic hyperplasia. Saw Palmetto appears to have multiple modes of action, including inhibition of 5α-reductase and interference with dihydrodecadosterone (DHT) binding to male hormone receptors in prostate cells. See, Plosker G. Serewoa a review of its pharmocology and therapeutic efficacy in benign prostatic hyperplasia. Drugs Aging, 9(5): 379 (1996); Briley M. et al., Inhibitory effect of Permixon on testosterone 5a reductase activity of the rat Ventral prostate, Br. J. Pharmacol 83:401P (1984); Marks LS et al., Tissue effects of saw palmetto and finasteride: use of biopsy cores for in situ quantification of prostatic androgens. Urology, 57:999-1005 (2001) Marks LS· et al. Effects of a saw palmetto herbal blend in men with symptomatic benign 118938.doc -39- 200800242 prostatic hyperplasia. J. Urol·, 163:1451-56 (2000) 〇

African thorns (Pygma) are large evergreens that grow in the plateaus of southern Africa. Pygeum extract has anti-cell division effects on prostate cancer cells and benign prostatic hyperplasia epithelial cells. This effect is associated with inhibition of the cell division of the genus Pythium, which is accompanied by a decrease in cells entering the 8th cycle of the cell cycle. See, Santa Maria Margalef A et al. 'Antimitogenic effect of Pygeum africanum extracts on human prostatic cancer cell lines and explants from benign prostatic hyperplasia. Arch. Esp· Urol·, 56(4): 369-78 (2003). In clinical trials of patients with BPH, pynasum was shown to reduce nighttime urinary frequency and significantly improve urinary flow and urine output. Breza J. Efficacy and accepability of Pygeum africanum extract in the treatment of benign prostatic hyperplasia. Curr. Med. Res. Opin·, 14(3):127 (1998) » Barlet A, Efficacy of Pygeum africanum extract in the medical therapy of Urination disorders due to benign prostatic hyperplasia. Wien. Klim. Woechenschr., 102(22): 667 (1990). Castor is a perennial plant commonly found in the dark and humid areas of forests. Castor contains active sterols, 4-buten-3-one, sterol and rapeseed sterol. Ramie has been found to inhibit BPH-related enzyme activity and subsequently inhibit prostate cell metabolism and growth. Hirano T·, Effects of stinging nettle root extracts and their steroidal components on the Na+, K(+)-ATPase of benign prostatic hyperplasia. Planta. Med., 60(1):30 (1994) 〇118938.doc -40- 200800242 Tomatoes are carotenoids and are present in human serum, liver, adrenal gland, lung, prostate, colon and skin at higher levels than other carotenoids. Lycopene has been found to possess antioxidant and anti-proliferative properties in animal and in vitro studies. Investigations have suggested that high levels of lycopene consumption are associated with long-term protection of prostate health. See, Giovannucci E. and Clinton S.K,, Tomatoes, lycopene, and prostate cancer. Proc. Soc. Exp. Biol. Med. 218(2): 129-139 (1998); Giovannucci, E.,

Tomatoes, tomato-based products, lycopene, and cancer: review of the epidemiologic literature. J. Natl. Cancer Inst.? 91(4):317-331 (1999); Huang HY et al., Prospective study of antioxidant micronutrients in the Blood and the risk of developing prostate cancer. Am. J. Epidemiol., 157(4): 335-44 (2003). Zucchini (Pumpkin Seed) extract contains phytosterols, curcubitin and selenium. Clinical studies have shown that a significant reduction in BPH-related urinary frequency can be achieved during the day and night. It also increases the rate of urine flow and reduces residual urine. See 'Schneider HJ et al., Treatment of benign prostatic hyperplasia. Fortschr. Med. ll 3: 37-40 (1995). It is believed that the plant alcohol in the pumpkin seed acts by inhibiting DHT or by anti-inflammatory action. Stoff JA. and Clouatre D·, The Prostate Miracle: New Natural

Therapies That Can Save Your Life (Kensington Publishing Corp., 2000) 矿物 Minerals Zinc, Copper and Selenium are antioxidants suitable for the treatment of prostate conditions. Studies have shown that zinc deficiency causes prostate enlargement. See, Fair WR· and 118938.doc -41 - 200800242

Heston W., Prostate inflammation linked to zinc shortage. Prevention, June: 113 (1977). The zinc concentration in the prostate was found to be higher than that in other human tissues. However, patients with BPH or prostate cancer have significantly lower levels of zinc than normal healthy men. A total of 50 to 100 mg of zinc supplement per day is often recommended to help contract the enlarged prostate. Zaichick V., Zinc in the human prostate gland. Int. Urol. Nephrol·, 29(5): 5 65 (1997). Copper plays a major role in the antioxidant enzyme system that helps maintain a healthy prostate. Klevay LM·, Lack of a recommended dietary allowance for copper may be hazardous to your health. J. Am. Coll. Nutr. 17(4): 322-6 (1998). In the case of selenium, researchers at the Johns Hopkins School of Hygiene and Public Health found that high levels of selenium and vitamins (alpha-tocopherol and gamma-tocopherol) are effective in preventing prostate disease. cancer. Helzlsouer KJ_ et al., 88 88〇&1^〇11;861\\^^1〇1-Tocopherol, γ-Tocopherol, Selenium, and Subsequent Prostate Cancer, J. Natl· Cancer Inst·, 92:2018 -2023 (2000) Vitamin D3, E, B6 and C are indicated for the treatment of prostate disorders. In men, low blood levels of vitamin D are associated with an increased risk of prostate cancer. Miller GJ, Vitamin D and prostate cancer: biologic interactions and clinical potentials. Cancer Metastasis Rev. 17(4): 353-60 (1998); Corder EH, et al·, Vitamin D and prostate cancer: a prediagnostic study with stored sera Cancer Epidemiol· Biomark· Prev., 2: 467-472 (1993) 〇 Vitamin E is a powerful antioxidant that protects cells from lipid peroxidation. 118938.doc -42- 200800242

Agent. When the antioxidant defense fails, the lipid peroxidation is a fatal factor in the chronic inflammation of the prostate gland. Burton G.,Vitamin E application of the principles of physical organic chemistry to the exploration of its structure and function. Acc. Chem. Res·, 19:194 (1986); Tarasov N·,Correction of abnormal lipid peroxidation in the treatment of Chronic prostatitis. Urol. Nefrol· (Mosk.), Jan-Feb(l): 38 (1998). Supplementation with vitamin E (d α-tocopherol) has been shown to reduce the incidence of BPH inflammation and prostate malignancy. 0 Heinonen 0, Prostate cancer and supplementation with alpha-tocopherol and beta-carotene. J. Natl. Cancer Inst·, 90(6): 40 (1998). Studies have suggested that vitamin B6 reduces the amount of prolactin hormone in men. It reduces the amount of steroid hormone that is converted to dihydrosterolone (DHT). It will be appreciated that it reduces the likelihood of developing a prostate condition such as BPH. Costello LC and Franklin RB, Effect of prolactin on the prostate. Prostate, 24(3): 162-66 (1994). Vitamin C is associated with a 23% reduction in the risk of developing prostate cancer. Kristal AR et al., Vitamin and mineral supplement use is associated with reduced risk of prostate cancer. Cancer Epidemiol. Biomarkers Prev., 8:887-892 (1999). Glucuronic acid, glycine and alanine are amino acids suitable for the treatment of prostate disorders. Studies have shown that after 4 weeks, the formulation of three amino acids helps to reduce swelling of the prostate and relieve symptoms of urinary discomfort. See, Okada S., Clinical application of amino acid preparation for nonspecific prostatitis. Hinyokika Kiyo, 31(1): 179 118938.doc -43- 200800242 (1985). Early studies have found that these amino acids are effective in reducing the symptoms of BPH and help reduce the duration of the condition. See, Cuervo Blanco Ε., Clinical study of a phy to sterol extract of Prunus arborea and 3 amino acids: glycine, alanine and glutamic acid. Arch. Esp· Urol” 31(1): 97 (1978). Formulations The herb-containing compositions of the present invention may be used alone or in addition to a pharmaceutically acceptable composition, vehicle or adjuvant having an advantageous delivery profile, i.e., suitable for delivery to a subject. The invention generally comprises a herb-containing composition of the invention and a pharmaceutically acceptable carrier. As used herein, a "pharmaceutically acceptable carrier" is intended to include any and all solvents and dispersions compatible with pharmaceutical administration. Media, coatings, antibacterial and antifungal compositions, isotonic and absorption delaying compositions, and the like. Suitable carriers are described in the most recent edition of Remington's Pharmaceutical Sciences, which is a standard reference article in the field, Incorporated herein by reference. Preferred examples of such carriers or diluents include, but are not limited to, water, physiological saline, Ringeds solution Dextrose solution and 5% human gold albumin. Such media and compositions for pharmaceutically active substances are well known in the art, except in any conventional medium or composition that is incompatible with the active composition. In addition to the limits, it is desirable to use it in the composition. The supplemental active composition can also be incorporated into the composition. The pharmaceutical compositions of the present invention are formulated to be compatible with the desired route of administration. Examples of routes of administration include, for example, Oral administration; transdermal administration (ie, topical administration) and transmucosal administration. The pH can be adjusted with an acid or a base such as hydrochloric acid or sodium hydroxide 118938.doc -44 - 200800242. Oral compositions usually contain an inert diluent or edible a carrier which can be sealed in a gelatin capsule, a caplet or compressed into a tablet. For the purpose of oral therapeutic administration, the herb-containing composition of the present invention can be combined with an excipient and in the form of a tablet, tablet or capsule. The oral composition can also be prepared using a fluid carrier for use as a mouthwash. The composition of the fluid carrier is administered orally and rinsed and spit or swallowed. The academically compatible combination composition and/or adjuvant material is part of the composition. Tablets, pills, capsules, tablets, and the like may contain any of the following ingredients' or compositions having similar characteristics: a binder such as microcrystalline cellulose, tragacanth or gelatin; an excipient such as starch or lactose, a disintegrating composition such as alginic acid, sodium starch glycolate or corn starch; a lubricant such as magnesium stearate Or Sterotes; a slip agent such as colloidal cerium oxide; a sweetening composition such as sucrose or saccharin; or a perfume composition such as peppermint, methyl salicylate or orange flavor. The herb-containing composition of the present invention can also be formulated into a topical cream for transdermal or transmucosal administration. In one embodiment, the herb-containing composition of the present invention is prepared using a carrier that protects the composition against rapid elimination from the human body, such as a controlled release comprising an implant and an encapsulated delivery system. Formulation. Biodegradable, biocompatible polymers can be used, such as ethylene vinyl acetate, polyanhydrides, polyglycolic acid, collagen, polyorthoesters, and polylactic acid. Methods of preparing oxime and other formulations will be apparent to those skilled in the art. Such materials may also be obtained from Alza Coirporaticm and Nova Pharmaceuticals, Ine Scale 0 118938.doc -45- 200800242 The pharmaceutical composition may be contained in a container, package or dispenser together with instructions for administration. The invention is further defined by reference to the following examples which are not intended to limit the scope of the invention. It will be apparent to those skilled in the art that many modifications of the materials and methods can be carried out without departing from the spirit and scope of the invention. Instance

Example 1 Summary of clinical trials of herbal-containing natural therapeutic creams for urinary incontinence Studies were conducted to investigate the effectiveness of herbal-containing natural therapeutic bladder control creams in reducing urinary incontinence (hereinafter "bladder control cream" Or bladder control cream test preparation). The bladder control cream tested is a natural herbal cream preparation. The test preparation mainly contains essential oil herbal actives, such as the following essential oils · Citrus sinensis (dial) Oil, cypress (Virginia cedarwood) stem oil, Commiphora myrrha (Myrrh) oil, Citrus aurantium (Orange oil or orange blossom) oil and cypress leaves, It is formulated according to the principle of essential oil administration. Battaglia, S., In: The Complete Guide to Aromatherapy. The Perfect Potion Pty Ltd, Virginia, Brisbane, Qld, Australia, pp. 110-113; 116; 150-151; -159; 182-183; 184-185; 187 (1995); Chidell, L., In Aromatherapy. A Definitive Guide to Essential Oils. Hodder and Stoughton Ltd, Kent, UK5 pp. 23-24; 80-81 (1992 ); Keller, E., In: T He Complete Home

Guide to Aromatherapy, H J Kramer, Inc, Tiburon, 118938.do)c -46- 200800242

California, USA, pp. 178-179 (1991) 物质 Substance and method study design according to TGA's 1'Guidelines for Good Clinical Research Practice (GCRP) in. The study was accredited by the Australian College of Natural Medicine Ethics Committee. Visit at the Natural Medicine Clinic (Aaturopathic Clinic) at the Australian College of Natural Medicine in Brisbane. Thirteen (13) women who experienced symptoms of urge incontinence and/or repressive incontinence were recruited through newspaper advertisements. In the first few weeks, three (3) women withdrew from the study for personal reasons. The remaining 10 women completed a three-month study. Women who experience regular urinary incontinence are considered eligible to enter the study if they meet the following criteria: They have not undergone recent surgery, especially hysterectomy or prolapse repair (in the last 12 months); they have not experienced childbirth recently (in In the past 12 months; it has not used any drugs for incontinence symptoms in the past month; it does not have any serious health conditions such as diabetes, heart disease, pancreatic disease, liver disease or chronic inflammatory conditions; There is currently no psychiatric interference therapy; and it does not suffer from skin conditions that are affected by transdermal administration. Allow women to maintain current dietary patterns, but do not give any advice on diet during the study period. The participants' movement patterns were also recorded, and women who participated in some forms of exercise at least three times a week were considered positive. 118938.doc -47 - 200800242 Ask participants to apply 5 grams of cream to the body twice a day for a period of 3 months. Use the short version of the Incontinence Impact Questionnaire (IIQ) and the Genitourinary Distress Survey Form before and after the start of treatment (month 0) and every month (1st, 2nd and 3rd months) (Urogenital Distress Inventory, UDI) assesses the effectiveness of treatment. The short version (6 questions) of IIQ assesses the impact of incontinence on daily activities such as housework, physical activity and social activities. The problem in UDI is especially related to the physical form of incontinence. All questions are rated on a scale of 3 (〇 = no annoyance, 1 = mild annoyance, 2 = moderate annoyance, 3 = extremely annoying). Both questionnaires are standardized disease-specific questionnaires that provide an effective level of detection of incontinence in the elderly. Robinson et al., Obstetrics and Gynecology, 91: 2, 224-8 (1998). The results of these questionnaires were analyzed using a paired check. Test Formulations Bladder control emulsion test formulations were made by TGA approved manufacturing according to GMP guidelines. Each gram of bladder control cream test preparation contains 30 mg of dry extract equivalent of sapwood stem/skin extract; and 2 〇mg of wattle (horsetail) leaves and the following essential oils: 1 〇mg of oil 500 μg of the wrong cypress (cedar wood) stem; 500 called myrrh oil; 5 〇〇 called neroli oil; 1 〇〇 Pg cypress leaf; 5 mg of d-α-tocopherol acetate ( Natural vitamins; 3·3 mg of urea acid; and ι·54 mg of total hydroxybenzoate. The essential oils used in this preparation are not known to be toxic, irritating or allergenic. Results and Discussions Eight (8) The female age is between 6 and 78, while the other two women are significantly 118,938.doc -48 - 200800242 young, 27 years old and 42 years old. Body mass index (BMI) varies from 24.4 to 31.9, mean It was 28.5. During the study period, the weight of these women did not change. All women had at least one child, and the group had an average of 2.0 children. All women had experienced symptoms of repressed incontinence or urge incontinence for at least 10 years. (3) Women have undergone surgery to insert a sling or prolapse repair. No participation Pelvic floor movements were used before or during the study. Before starting treatment, all women reported extreme annoyance due to leakage. The cause of leakage is often a combination of urgency, physical activity, or just continuous leakage. During the period, the results of the monthly effectiveness of the treatment on physical symptoms are presented in Table 1 and Figure 1. Table 1: Urogenital distress surveys: The value of the month: Do you experience the following items, and if experienced, you are considered 7"The degree of trouble after the sputum. The first month of the second month, the third month, the third month of frequent urination 0.098 0.341 0.262 due to the feeling or urgency leakage 0.018 0.007 0.003 due to activity, cough, nozzle leakage 0.012 0.002 0.001 Leakage (drop) 0.222 0.139 0.007 Difficult to empty the bladder 0.254 0.339 0.041 Pain or discomfort in the lower abdomen or genital area 0.500 0.500 0.500 Paired t-test ρ=<0·05 Research results indicate in relation to urgency and activity Significant positive changes in the response to the leak. These effects were observed after the first month of treatment and f continued to improve over 3 months. In continuous leakage and difficulty in emptying the bladder There was also improvement, although the improvement only became significant after all 3 months of treatment. However, it is worth noting that after 3 months, the response to the frequency of urination was not changed 118938.doc -49- 200800242 significant change None of the women experienced pain or discomfort in the lower abdomen or lower (answered "not annoying π throughout the study" and did not suffer from frequent urinary tract infections (which are common in incontinent patients). Compared with the active group (η=5), the non-active group (η=5) had no significant difference in the answers to the questions in IIQ and UDI. Most women report that incontinence has a negative impact on their lifestyle and social activities (answered to η moderate annoyances in the first month " or “serious annoyances"). Compare initial answers with their responses in the third month Shows significant positive changes in household chores, physical activity, and feelings of frustration (see Table 2). Table 2: Incontinence Impact Questionnaires whether urine leakage has affected the following: The first month of the first month of the first month Month household chores 0.039 0.039 0.006 Body entertainment 0.099 0.204 0,026 Recreational activities 0.051 0.500 0.085 Departure from home greater than 30 min 0.302 0.182 0.226 Social activity 0.178 1 0.500 0.098 Emotional health 0.500 0.182 1 0.091 Feeling depressed 0.383 0.023 0.009 Paired t-check ρ = < 〇·〇5

After three months, there was a general, but not significant improvement in the quality of life related to social activities and emotional health due to incontinence. During the study period, there was no significant change in the response to incontinence on recreational activities or the 30-minute trip away from home. Previous studies have confirmed that incontinence has a negative impact on quality of life. Peake et al, Med Anthropol Q, 13(3): 267-85 (1999); Association for Continence Advice, Aust. Continence J.; 6(2): 15-23 (2000); Robinson et al., Obstetrics and Gynecology, 91:2, 224-8 (1998). The study of the present invention indicated a significant improvement in controlling leakage (due to urgency and physical activity) and bladder emptying after 3 months of treatment with the bladder control cream test 118938.doc -50 - 200800242. This effect is independent of diet and exercise patterns. It is also worth noting that this positive answer occurs when there is no specific pelvic motion. These results indicate that improvement in physical symptoms is associated with improved self-confidence and ability to perform on a daily basis. Formulations of essential oils in bladder control cream test formulations appear to target the urinary system and promote better control of urination. The bladder control formulation can act on the muscles of the pelvic floor, the sphincter or its own bladder wall. The astringent essential oil absorption of the bladder control cream test formulation can be minimal' but promotes anti-secretory effects on the mucosa or 'strainability, effect. Mills and Bone, In Pri listens d

Churchill Livingstone, 35, ρρ· 220-222 (2000). At the time of combination, the astringent effect of the bladder control cream test formulation and the diuretic effect can produce urine flow, regulation, or standardization, thereby improving the control of urination without producing polyuria. The value of the value of Table 1 in the case of Zhuangsi is "significantly reduced due to leakage of sensation or urgency. The response to the urge for urgency incontinence ("wet 〇Αβ") is significantly changing the indication that the formulation is generally It can be applied to the treatment of overactive bladder (ΟΑΒ). "Wet ΟΑΒ" and "cognac" are caused by sudden, involuntary contraction of the muscles of the bladder wall, which produces a feeling of sudden urination or urgency. Example 2 Clinical use of herbal natural therapeutic lozenges for urinary incontinence Summary of the trials were conducted to investigate the effectiveness of herbal-containing natural therapeutic bladder control formulations (hereinafter "bladder control formulation" or bladder control test formulation y in reducing urinary incontinence 118938.doc -51- 200800242. Steels, E Seipel, T. and Rao, a., Australian

Continence Journal (2002). The bladder control test preparation is a natural herb-containing preparation formulated into a recording agent: each tablet contains dry extract equivalents: sapwood stem/skin extract (3,000 mg) 3 g, wattle (horsetail) herbs (1, 5 〇〇mg) 1.5 g and magnesium phosphate 70 mg, calcium hydrogen phosphate 70 mg, equivalent to feeding 16 3 mg, magnesium 14.5 mg, phosphorus 24.9 mg. Contains maltodextrin. Materials and Methods Research Design Eight (8) women who experienced symptoms of regular urge incontinence and/or repressed incontinence were recruited through newspaper advertisements. All women meet the following guidelines: (a) have not undergone recent surgery in the last 12 months, especially hysterectomy or prolapse repair, (b) have not had such as diabetes, heart disease, pancreatic disease, liver disease or chronic inflammation Any serious health condition of a sexually transmitted condition, (c) currently not treated for psychotic interference, and (d) did not use any medication for incontinence symptoms in the last month prior to the start of the study. Prior to the study, none of the participants participated in specific pelvic movements to improve muscle flexibility, although participants were aware of these specific pelvic movements. The therapeutic protocol consisted of two tablets per day (equivalent to 12 g of sapwood and 6 g of squid per day) over a 12-week period. The efficacy of treatment was assessed using a short version of the Incontinence Impact Questionnaire (IIQ) and the Urogenital Distress Survey (UDi) before and after the start of treatment (months) and every month (1st, 2nd and 3rd months). . The short version (6 questions) of IIQ assesses the impact of incontinence on daily activities such as household chores, physical activity and social activities. The problem in UDI is particularly related to the physical form of incontinence. 118938.doc -52- 200800242. All questions are rated on a scale of 3 (〇 = no annoyance, i = mild annoyance, 2 = moderate annoyance, 3 = extremely annoying). Both of them are standardized disease-specific questionnaires used to detect incontinence in the elderly. Robinson, D. et al., 〇bstetrics an (i Gynec〇1〇gy, 91:2, 224-8 (1998) 〇' study group consisting of 8 women. 7 participants aged 54 and 6s The age of the participants was 2 years old. The average age of the study group was years. Six participants had given birth to at least 2 children, and 2 participants had no children. Using paired t-tests to analyze these Results of the questionnaire. Test preparations Formulations for bladder control test preparations manufactured by TGA-approved manufacturing according to GMP guidelines. Each tablet contains herbs (salmon stem/skin extract and sage leaves) and minerals (magnesium phosphate and phosphoric acid) Calcium). According to TGA's "Guidelines for

Good Clinical Research Practice (GCRP) in Australia's research. The study was accredited by the Australian Institute of Natural Medicine Ethics Committee. Visit at the Natural Therapy Clinic at the Australian Institute of Natural Medicine in Brisbane. Results and Discussion The effectiveness of bladder control test formulations on physical symptoms is summarized in Table 3 and Figure 2. Prior to treatment, 80% of participants reported that they were affected by activity-related leakage. After 3 months of treatment, it was reduced to 4% (Figure 2). A similar response was observed for the following: leakage due to urgency (6〇% to 35%), frequent urination (70% to 48°/.), difficulty in emptying the bladder (5〇〇/❶ to 25%) ). Before treatment, 50% of participants experienced pain or discomfort before treatment, but none of them reported after 2 118938.doc -53-200800242 months of treatment. After treatment, the number of women who responded to a small amount of leakage decreased by 25% (75% to 50%). Analysis of the data (paired t-test) showed a significant positive change in urinary frequency perception after 1 month of treatment (p = 040.040) and continued in a gradual manner during the duration of the study. (P=0.24 in the second month, p= in the third month; 〇·〇13). After 3 months of treatment, leakage related to urgency (P = * 0.024), leakage due to activity (Ρ = 0. 031), and difficulty in emptying bladder 0 (ρ = 〇 _ 〇 52) Feeling a significant positive change. In addition, positive effects were seen after the first month of treatment. During the study period, there was a positive trend in the answer to a small amount of leakage, but the answers were not significant. After 2 months of treatment, a significant positive response (ρ = 0.025) was observed in relation to pain or discomfort in the lower abdomen or lower. Table 3: Urogenital Distress Survey Form Do you experience the following items, and if experienced, you are affected by the following levels: Frequent urination in the third month of the first month of the first month 0,040 0.024 0.013 Due to feeling or urgency Sexual leakage 0.052 0.024 0.024 Leakage due to activity, cough, sneezing 0.086 0.009 0.031 Small amount of leakage (drop) 0.178 0.145 1 0.091 Difficult to empty the bladder 0.025 0.025 0.052 Pain or discomfort in the lower abdomen or genital area 0.366 0.025 0.025 For t-check ρ = < 0.05

The answers to the incontinence impact questionnaire are presented in Table 6 and Figure 3. The results showed that participants assessed incontinence had a significant negative impact on their quality of life, as assessed by the 50-70% “disturbing score” of the 7 parameters of IIQ (Figure 3). Except for questions about physical entertainment, for all parameters, it is significantly 118938.doc -54- 200800242 lower (to a range of 10-25%, :a: by a town), which is in the month of the sister There was a small change from the third month. Data analysis «Check against the test" shows 'improvement in the perception of the effects of incontinence on lifestyle and social activities, after three months of treatment, social activities (ρ = 0.04), recreational activities (ρ = 〇〇ΐ 7), emotional health (Ρ = 〇. 〇 25) and the departure from home more than 3 minutes (4) 〇 52), feeling (four). _) positive change to indicate. There is no change in the return of household chores or physical entertainment (Table 4). Table 4: Incontinence impact

The results from this study indicate a significant improvement in controlling leakage (due to urgency and physical activity), bladder emptying, and pain or discomfort after 3 months of treatment with the bladder control test formulation (ρ > 〇 〇 5). These results were supported by reports of early studies on the reduction of urinary incontinence, urinary pain and urinary retention in men treated with genus. Deshpande PJ et al., Indian j_ Med. Res., 76 (SuppL): 46-53 (1982). Acetylcholine is the main thorny neurotransmitter involved in bladder emptying. Certain drugs, such as oxybutyrate hydrochloride, which are commonly prescribed for urinary incontinence, inhibit the action of acetylcholine on the muscarinic effects of smooth muscle and produce a direct antispasmodic effect. The 118938.doc -55- 200800242 and other drugs relax the detrusor. Wada Y. et al., Arch. Int. Pharmacodyn.

Ther., 330(1): 76-89 (1995); Tapp A.J.S. fA, Brit. J. Obstetrics Gynecology, 97: 521-6 (1990). These drugs also produce undesirable anticholinergic effects such as dry mouth, blurred vision and constipation. Pathak AS, Aboseif SR. Overactive Bladder: Drug therapy versus nerve stimulation. Nat Clin Pract Urol5 2(7): 3 10-3 11 ? 2005. There are currently no specific drugs that target incontinence symptoms and do not have side effects elsewhere in the body. Although it is interesting to note that side effects from treatment have not been reported as seen with anticholinergic drugs, the mechanisms by which these herbal drugs exert these effects are not known. Example 3 Herbal Natural Therapeutic Lozenges with Standardized Antimony Content (Formulation 2) Clinical Trial Summary for Prevention and Treatment of Urinary Incontinence and Overactive Bladder (〇ab) Studies to investigate the natural use of herbs for oral administration Therapeutic bladder control formulations (i.e., bladder control test formulations) are effective in reducing urinary incontinence and overactive bladder. These studies were designed and performed as outlined in Example 2 above and are further detailed below. The bladder control test formulation is a natural herbal preparation formulated into a tablet.矽 has been identified as the provider of the biological activity of the medicinal herbs. The non-private quasi-chemical formulation of the medicinal herb usually contains from about 12% to about 6.9 〇/% based on the total dry weight of the formulation.矽之矽. In one aspect of the invention, it has been determined that batch variations in the guanidine content of the medicinal herb formulation can have a negative effect on the biological activity of the compositions of the present invention. This problem has been solved by the present invention by providing an optimized and standardized herbaceous herbal preparation. Therefore, in one embodiment of the present invention, 118938.doc-56-200800242, the hydrazine content of the medicinal herb preparation in the herb-containing preparation of the present invention is standardized. It is advantageous to use the standardized formulation of the herb, because the variation between batches is reduced, so that the composition of the invention produces a more consistent prophylactic or therapeutic effect. Materials and Methods Test Formulations Bladder control test formulation tablets were manufactured by TGA approved manufacturing according to GMP guidelines. Each tablet contains herbs (salmon stem/skin extract and stem extract) and minerals (i.e., magnesium phosphate and calcium phosphate and barium). For example, each tablet contains the following dry weight equivalents: Sorbus stem/skin extract (3, 〇〇〇mg), with a standardized diarrhea content of 3% based on the total dry weight of the stalk extract preparation Physician (Ponytail) stem extract preparation (1,5〇〇mg), anhydrous colloidal cerium oxide (50 · 3 mg), magnesium silicate 70 mg, calcium arsenate 7 〇mg, equivalent to calcium 16.3 mg , magnesium 14.5 mg, phosphorus 24.9 mg. Each tablet contained 41.6 mg dry weight equivalents of total hydrazine per tablet. Each tablet contains some maltodextrin. Study Design Human subjects (male and female) who experienced symptoms of regular overactive bladder, urge incontinence, and/or repressive incontinence were recruited via newspaper advertisements. All human subjects met the following criteria: (a) had not undergone recent surgery in the last 12 months, especially hysterectomy or prolapse repair, (b) did not have such symptoms as diabetes, heart disease, pancreatic disease or Any serious health condition of liver disease, (c) No medication for incontinence symptoms 118938.doc -57-200800242 was used in the last month prior to the start of the study. Prior to the study, none of the participants participated in specific pelvic movements to improve muscle flexibility. The therapeutic protocol consisted of a human test subject who took two tablets of bladder control test formulation twice daily for a period of 12 weeks. Before the start of treatment - (the third month) and every month (the first, second and third months), the incontinence impact questionnaire (IIQ) was recorded by recording the daily and weekly urination frequency and short version of the flat V. And the urogenital distress questionnaire (UDI) to assess the efficacy of treatment. As detailed in Table 5 below, the problems in UDI are particularly relevant to the physical form of incontinence. Table 5: Urogenital Distress Survey Form Do you experience the following items, and if experienced, you are affected by the following levels: _ Frequent urination ^ Leakage due to feeling or urgency due to activity, cough, sneezing Leakage __ a small amount of leakage (drop) 'It is difficult to empty the pain or discomfort of the lower abdomen or genital area of the bladder

As outlined in Table 6 below, the short version (6 questions) IIQ assesses the impact of incontinence on daily activities such as household chores, physical activity, and social activities. Table 6: Incontinence Impact Questionnaire Whether the leakage of urine has affected the following items: Housework chores < Body and Recreation II Recreational Activities" Departures greater than 30 minutes away from social activities Emotional health _ Feeling of depression All questions are rated on a scale of 0 to 3 ( 0 = no annoyance, 1 = mild annoyance, I18938.doc -58 - 200800242 2 = moderate annoyance, 3 = extremely disturbed). Both questionnaires were standardized disease-specific questionnaires used to detect incontinence in the elderly. R〇bins〇n, D. et al., Obstetrics and Gynec〇l〇gy, 91:2, 224_8 (1998). The average frequency of urination during the day and night at months 0, 1, 2 and 3 was also analyzed, and the results were also compared using the paired 1> check. The results of these questionnaires were analyzed using paired t-tests. Positive improvement is defined as the measurement of the physical condition of the incontinence or the acceptance of the bladder control test formulation when compared to the same parameters in the human test subject prior to receiving the bladder control test formulation: Body or Society of the examiner A statistically significant difference in the parameters of the activity, ie a household value of $0.05. Any of the physical or social activities associated with the physical condition of the incontinence or the human test subject receiving the bladder control test formulation when compared to the same parameters in the human test examiner prior to receiving the bladder control test formulation The parameters are improving, confirming that the bladder control test preparation is suitable for preventing or treating the progenitor systemic diseases of human subjects, such as urinary incontinence; overactive bladder; enuresis; benign prostatic hyperplasia; urinary stones; cystitis; Road infection. Results and Discussion Demographics 9 participants completed the study, 3 males and 6 females, with an average age of 52 years (range 41-72 years). The frequency of urination during the day shows that during the three months of treatment, the frequency of urination during the day is steadily decreasing. The number of participants who need to empty the bladder is reduced from 14 times per day (before treatment) to 10 times a day (after 1 month), 8.3 times a day (after 2 months) and at I18938.doc -59 - 200800242 3 months The step-by-step is reduced to 6.6 times per day. It showed a significant decrease between the first and subsequent months (the second month of calving 2; the third month of calving 1). The frequency of nocturnal palsy is not shown. This treatment effectively reduces the number of times the participants need to empty the bladder at night. The awakening gradually decreased from 2.7 times per night to 2 times per night, 1.4 times per night and 2 times per night (in the i, 2 and 3 months respectively). The results of the verification showed a significant decrease in frequency between the second and second months (;7 = 〇 〇 47) and the third month 〇 = 0.024). Participants in the study of Nine Miles reported that nocturia was the main symptom and one of the reasons for participating in the study. The overall improvement in sputum, (described below) seems to be directly linked to the long-term uninterrupted sleep (recorded from the personal file). Urogenital Distress Survey The symptoms experienced by most participants are (Figure 4): Frequent urination (about 89%). Because of the leakage of the fan, 78% of the participants were affected, and the leakage of the eve I affected 67% of the participants. Other symptoms included leakage due to activity (56%), difficulty emptying the bladder (44%), and pain or discomfort (33%). The results presented in Figure 5 (as a mean annoyance answer) indicate that after a month of treatment, all categories of symptoms decreased and continued to decrease over the next 2 months. The results of the questionnaire were analyzed using paired t-tests. After 2 months, there was a significant positive change in the #居癀季 and was still significant at the 3rd month of treatment (Ρ = 〇·〇〇9, 0.011, respectively). Other significant symptoms that occurred in the second month and continued to be significant in the third month were due to urgency leakage (both corpses 0·〇28, 0·016) and difficulty in emptying the bladder (total 〇〇35, howling) 118938.doc -60- 200800242 and a small amount of leakage (respectively =0 022, 〇〇 43). Incontinence affects the volume display as the most incontinent and GAB material to live away from home for more than 30 minutes (w } Qing enjoys (about). 78% of participants experience home chores, social activities, emotional redness and feeling depressed The cost of the safari is affected. The results in Figure 7 (as an average annoyance answer) clearly show the life of the mouth (via difficult to carry out the day. ^ ^ 吊 day hanging activities and social activities as well as emotional health and feelings Frustration assessment) and right _) and eight have the adverse effects of symptoms. On average, Lv, within 4 weeks of treatment, Shen Xueyi # is less annoyed (and most) in the special activity 'during the remainder of the study' reported as continuous improvement. The results of the questionnaire were analyzed using a paired t-test. Incontinence has an improvement in the perception of lifestyle and social effects, which is indicated by a positive change in the mouth of all questions at the end of the study. In the second month, all problems improved significantly (see Table 7). The positive effect of the problem of emotional health and feelings of depression should be related to the improvement of the quality of life of the infertility/4-^ σ jiff. Visited in the third month, and asked participants whether treatment has improved their quality of life. Overall, & 叩=67/. Reported that Q〇L improved. These results clearly indicate a significant improvement in QOL for participants experiencing a reduction or reduction in the severity of symptoms including urinary frequency, nocturnal urgency, urgency, and bladder disability.成 疋 疋 疋 P 及 及 及 及 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 938 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 118 Leakage leakage (drip) Bladder 0 month relative to the first month 0.051 0.050 0.347 0.104 0.035 0.169 0 month relative to the second month 0.009 0.028 0.104 0.022 0.035 0.081 0 month relative to the third month 0.011 0.016 0.139 0,043 0.081 0.225 Incontinence Impact Questionnaire T-test results Housework Physical entertainment is more than 30 minutes away from home Social sentimental feelings chores Entertainment activities Trip activity Health frustration 0 month relative to first month 0.195 0.195 0.051 0.272 0.051 0.104 0.195 0 Month relative to the second month, 0.050 0.043 0.023 0.023 0.023 0.013 0,028 0 month relative to the third month 0.052 0.052 0.023 0.021 0.023 0.007 0.016 Conclusion The results of this study indicate that the use of strontium content is standardized for men and women. Jingzhi Formula 2 preparation is a suitable and effective treatment, which effectively reduces urinary frequency, nocturia Symptoms, urgency, and bladder discomfort in urinary incontinence and symptoms of OAB. Symptoms were relieved after 4 weeks of treatment, especially during the 8-12 weeks of treatment with this treatment, the severity of the symptoms was further reduced. This treatment is not associated with major adverse reactions. Formulation 2 with standardized cerium oxide content, showing results comparable to the original tablet formulation, however results usually occur more quickly, with a more consistent reduction in symptom severity (disturbance level) after 1 month of treatment . Also at 3 months of treatment, fewer participants experienced urinary distress symptoms compared to the 3 month outcome of Formula 1. The study showed that Formulation 2, which contained a standardized amount of cerium oxide, was more effective than a similar formulation with 矽 unstandardized. Example 4 Herbal Natural Treatment with Standardized Antimony Content and Flavonoid Content 118938.doc •62- 200800242 Lozenges (Formulation 3) Summary of Clinical Trials for Prevention and Treatment of Urinary Incontinence and Overactive Abdominal Disease (〇ab) The study investigated the effectiveness of herbal-containing natural therapeutic bladder control formulations (i.e., bladder control test formulations) for reducing urinary incontinence and sputum beta. The studies were designed and executed as outlined in Example 2 and Example 3 above and are further detailed below. The bladder control test preparation is a natural herbal preparation formulated into a bond: a dose. ® 矽 has been identified as a provider of biological activity of the medicinal herbs. In addition to cockroaches, Phyllostachys pubescens contains about 5% of the saponins of the squid, and several kinds of flavonoid glycosides (also known as flavonoids), isoquercetin (also known as quercetin). Also known as isoquercetin; quercetin 3-〇_P_D_glucopyranoside; 4H-1_benzopiperone, 2_(3,4-dihydroxy-phenyl)_3 (b d_grape Furanosyloxy)-5,7-dihydroxy-). For example, flavonoids of isoquercetin may have important pharmacological properties. In some aspects of the invention, it has been determined that the herb is medicinal The batch variation of the flavonoid content expressed by Shixi and/or isoquercetin may have a negative effect on the biological activity of the composition of the present invention. This problem has been solved by the present invention by providing an optimized, standardized hydrazine content and It is solved by the herbicide preparation of ketone content, such as isoquercetin. The study evaluates the efficacy of modified formulations in the prevention and treatment of symptoms of urinary incontinence and sputum. Substance and method test preparation, according to GMP guidelines, Tuga approved manufacturer's bladder control test preparation lozenges. Each lozenge contains herbs (salmon stems/skins) Extract and Physician H8938.doc -63- 200800242 stem extract) and minerals (magnesium phosphate and calcium phosphate and strontium). For example, each key contains the following dry weight equivalents: sapwood stem/skin extract ( 3, 〇〇〇mg), with a standardized diarrhea content of 3% of the total dry weight of the stalk extract preparation and a standardized flavonoid content of 0.8% (expressed as isoquercetin) Stem extract preparation (1,5〇0 mg), anhydrous colloidal bismuth dioxide (5〇3 mg), magnesium phosphate 70 mg, calcium hydrogen phosphate 70 mg, equivalent to calcium 6.3 mg, magnesium 14 5 mg, Phosphorus 24·9 mg. Each tablet contains 6 〇·8 mg dry weight equivalent of each tablet. Each tablet contains some maltodextrin. The research design is recruited through newspaper advertisements to experience regular urge incontinence and / A human subject with symptoms of repressive incontinence. All human subjects meet the following criteria: (a) have not experienced recent surgery, especially hysterectomy or prolapse repair, in the last 12 months, (b) Have any serious health condition such as diabetes, heart disease, pancreatic disease or liver disease, < (c) open No drugs were used for incontinence symptoms in the last month before the study. Prior to the study, none of the participants participated in specific pelvic movements to improve muscle flexibility. Therapeutic protocols were tested by humans over a 12-week period, daily. Two lozenges of two bladder control test preparations were taken twice before starting treatment (month 0) and every month thereafter (days 1, 2 and 3), by recording the average daily and nightly The frequency of urination was assessed using a short version of the Incontinence Impact Questionnaire 118938.doc -64-200800242 (IIQ) and the Urogenital Distress Survey (UDI). As detailed in Table 8 below, the problem in UDI is particularly related to the physical form of incontinence. Table 8: Urogenital Distress Survey

Do you experience the following, and if experienced, you are affected by the following: _ Frequent urination due to sensation or urgency leaks - leakage due to activity, cough, sneezing _ a small amount of leakage (drops )_ Difficulty in emptying the lower abdomen or genital area of the bladder. Pain or discomfort as outlined in Table 9 below. The short version (6 questions) of the IIQ assesses the effects of incontinence on daily activities such as housework, physical activity and social activities. Table 9: Incontinence Impact Questionnaire

Whether the fart has affected the following items: Housework _ Body entertainment _ Entertainment activities _ Fence home greater than 30 min trip social activities _ 愔 健康 health _ feeling depressed _ all questions are rated on a scale of 0 to 3 (0 = No annoyance, 1 = mild annoyance, 2 = moderate annoyance, 3 = extremely annoying). Both questionnaires were standardized disease-specific questionnaires used to detect incontinence in the elderly. Robinson, D. et al., Obstetrics and Gynecology, 91: 2, 224-8 (1998). The average frequency of urination during day and night at months 0, 1, 2 and 3 was also analyzed and the results were compared using paired t-tests. The results of these questionnaires were analyzed using paired t-tests. Positive improvement is defined as the physical condition of the test (4) or the test of the bladder control test preparation when compared with the parameters of the human test subject 118938.doc -65-200800242 before receiving the bladder control test preparation. The statistically significant difference in the parameters of the body or society of the examiner, that is, the P value ^).05. When comparing with the same parameters in the human test subject before receiving the bladder control test preparation, the body with the incontinence Positive improvement of any parameter related to the physical or social activity of the human test subject of the human or test bladder control test formulation, confirming that the bladder control test formulation is suitable for the prevention or treatment of a urogenital disorder in a human subject' eg 7 cases of urinary loss, overactive disorder, this urinary tract; benign prostatic hyperplasia; urinary stones; cystitis; and urinary tract infection. Results and discussion Demographics 10 participants (2 males and 8 females) completed the study The average age was 65.9 years (range 49-71 years). The frequency of urination during the day confirmed the average urination during the day during the 3 months of treatment. The rate was significantly reduced (ρ < 0·05). The number of times the participants needed to empty the bladder decreased from 11.5 times per day (before treatment) to 8.5 times a day (after 1 month), 6.6 times per day (after 2 months) and Further reduced to 6 〇 per day in the third month. These results were significant in the first month 〇 = 〇 · 〇 17) and remained significant during the study period (in the 2nd and 3rd months ρ = 〇·〇2) The nocturia frequency results confirmed that the treatment effectively reduced the number of times the participants needed to empty the bladder at night. The arousal was reduced from 2.5 per night to 1.5 per night, 0.5 per night and 0.5 per night. Times (in months 1, 2 and 3 respectively). This was a significant difference (p<〇〇5) at the second treatment of 118938.doc -66-200800242 and the third month of treatment. Many participants were After 2 months of treatment, they were able to fall asleep all night. These results were significant at the i-month (ρ = 0.063) and remained significant during the study period (in the second month, at the 3rd month of the corpse) = 0.03). Urogenital distress survey

The symptoms experienced by most participants were (Figure 8): frequent urination (78%), urgency (78%), small leakage (67%), and emptying of the bladder (67%). Other symptoms were reported as smaller _, which was: #活(四) leakage affecting 44% of participants, while only 33% reported pain in the new area. The results presented in Figure $ (expressed as mean annoyance level) indicate that i months of treatment reduced symptoms in all categories and symptoms continued to decrease over the next 2 months. The results of the questionnaire were analyzed using paired t-tests. After 2 months of treatment, there was a significant positive change in the following symptoms, which was sustained in the third month: less due to leakage due to urgency (p=()()11, 〇()17), A small amount of leakage (respectively corpse 011, G.G15) and heart-to-heart (respectively (four) times, 0.045) annoyed feeling. The third month of De Gong A #后^生# The significant change in the exhibition season (ρ = 0·009) The incontinence effect questionnaire was shown as the most incontinence and reduction ig # (80%) in 30 minutes of the trip, 褚Jian Yan is affected. And the activities affected by the OAB are (Figure 1〇): Participants in the 75% of the competitions experience the rituals of the rituals and the chores of the chores and the participation of the participants in the meeting and 60% of the participants are shown in Figure 11. In the midst of the sheep, the cockroaches... The results of the answer to the thousand average annoyance clearly show the life of the mouth (via the difficulty of day Φ activities and social activities and emotional health 118,938.doc • 67 · 200800242 = assessment of depression) with incontinence In the case of unfavorable treatment of symptoms, 'participants are less annoyed in most of these activities, except for the (four) sample (which is in the fourth (fourth) annoyance level).

The results of the questionnaire were analyzed using paired t-tests (Table 1). The effect of incontinence on lifestyle and social activity (4)# is indicated by a positive change in the answer to all questions (except household chores) at the end of the study. After the first month of treatment, a significant improvement was reported in (4) Heart (4), and other positives were observed in the 2nd and 3rd months (seed, 〇37, 〇〇1〇 and 〇〇15 respectively) effect. After 2 and 3 months of treatment, Yu Jianyan (Ρ〇·081 and 0.029, respectively) and minus f# (both corpses 1 and 〇〇〇1 respectively), recreational (respectively household = 〇· 〇15 and 〇·〇〇4) and the invitation to the match (both households = 〇〇 22 and 0·012) have significantly improved their heart's indication that treatment is associated with improved quality of life. During the third month of the visit, participants were also asked if treatment had improved their quality of life. Overall, 70% reported an improvement in q〇l. These results clearly indicate a significant improvement in QOL for participants experiencing a reduction or reduction in the severity of symptoms of urinary incontinence, urinary urgency, and bladder discomfort. Table 10 - Results of paired t-test (p-value) urinary distress questionnaire and incontinence impact questionnaire 118938.doc -68 - 200800242 Urinary distress survey T-test results frequent urination due to urgency and activity, a small amount of leakage is difficult to empty Leakage of pain or discomfort (drip) Bladder 0 month relative to first month 0.591 0.096 0.168 0.015 0.168 0.081 0 month relative to 2nd month 0.051 0.011 0.081 0.011 0.024 0.096 0 month relative The third month 0.0099 0.017 0.269 0.015 0.045 0.089 Incontinence Impact Questionnaire T-test results household chores physical entertainment entertainment activities away from home more than social sentiment sensation 30 min activities healthy frustration journey 0 months relative to the first month 0.726 0.081 0.104 0.037 0.193 0.509 0.104 0 month relative to the second month 0.343 0.022 0.015 0.010 0.052 0.081 0.001 0 month phase 0.132 0.012 0.004 0.015 0.011 0.029 0.001 Conclusion of the third month The results of the study indicate that the content of cerium oxide and flavonoids Formulated with standardized formula 3 to effectively reduce urinary frequency, nocturia, urgency and bladder discomfort All the symptoms of OAB and urinary incontinence. Symptoms were relieved after 4 weeks of treatment, especially during the 4-8 week period of treatment, the severity of the symptoms was further reduced. Formulation 3 is a suitable and effective treatment for men and women and is not associated with major adverse reactions. Therefore, Formulation 3 used in this study proved superior to Formulation 1 and Formulation 2. Formulation 3 demonstrated an increase in efficacy in reducing all symptoms of urinary incontinence and OAB and experienced results in a shorter period of time. This study confirmed that Formulation 3 containing standardized amounts of cerium oxide and flavonoids was more effective than Formulation 1 and Formulation 2. 118938.doc -69- 200800242 Example 5 Comparison of the effectiveness of different lozenge formulations (Formulations 1, 2 and 3) for the prevention and treatment of urinary incontinence and overactive bladder (OAB) Summary The objective of the study was to Comparing the results of the Incontinence Impact Questionnaire (IIQ) and the Urogenital Distress Survey (UDI) from various studies, comparing the three lozenge formulations of the present invention, formula 丨, formula 2 and formula 3 in the treatment of urinary incontinence and OAB The effect of the symptoms. Formulation j is a non-standardized formulation evaluated in Clinical Study Example 2; Formulation 2 is standardized in Quercus sinensis and evaluated in Clinical Study Example 3; and Formulation 3 is standardized using Quercetin and flavonoids. And evaluated in Clinical Study Example 4. Study Design To compare the effectiveness of three different lozenge formulations directly, compare the percent reduction (%) of the annoyance levels of the two questionnaires. This analytical method was used to compare the change in the 0th month (baseline) value of each study. Urinary frequency and nocturia were evaluated directly in Formulation 2 and Formulation 3. RESULTS AND DISCUSSION The results from the Urinary Distress Survey (UDI) indicated that Formulation 2 was compared to Formulation 1, especially in frequent urination, leakage due to urgency, small leakage (drops), and difficulty in emptying the bladder. The strontium content is standardized to be more effective. By showing a higher percentage of symptom severity (Table U), it is shown that Formulation 3 (standardized in sputum and flavonoid content) is most effective in reducing urinary distress (UDI), especially in reducing frequent urination due to sensation or urgency. Leakage, due to leakage of activity, cough, sneezing, a small amount of leakage (drop) and difficulty in emptying 118938.doc -70- 200800242 bladder. All formulations are shown to be effective in reducing at least 75% of abdominal pain. However, because participants with less than 4 〇〇/0 experienced the condition at month 0, the results were not considered significant. Table U. Percentage reduction in UDI annoyance levels for Formulas 1, 2 and 3 in the third month Formula 1 Formula 2 Formula 3 Frequent urination ~~ -- 56 70 71 Leakage due to urgency 55 72 74 Leakage 64 50 68 A small amount of leakage (drops) ~~ 61 64 66 Difficult to empty the bladder 57 60 63 The Comparative Incontinence Impact Questionnaire (IIQ) also shows that Formulation 3 has a better response to Formulations 1 and 2 for all QOL problems ( Shown by symptom relief). The number of people experiencing symptoms per month (%) is also assessed. Formulation 3 showed increased efficacy' because fewer participants experienced symptoms in the third month compared to the previous formulation (Figure 12). Urinary frequency and nocturia were evaluated only in Formulation 2 and Formulation 3. A comparison of these results indicated that both formulations were effective in reducing the frequency of urination during the day (approximately 50% reduction) and the effect was visible at the end of the first 8 weeks of treatment. However, Formulation 3 was better than Formulation 2 in reducing nocturia, with a 96% reduction in symptoms observed in the second month and a greater overall frequency (in the third month, 96% vs. 63%) (Table 12). . Table 12 - Percentage reduction in urination frequency Daytime night formula 2 Formulation 3 Formulation 2 Formulation 3 0 month relative to the first month 28 26 35 40 0 month relative to the 2nd month 41 45 48 96 0 month relative 3 months 53 48 63 96 118938.doc -71· 200800242 Conclusion The results of this study indicate that all formulations are safe and not associated with major adverse reactions. All formulations are effective in reducing all symptoms of urinary incontinence and sputum AB, including frequent urination, nocturia, urgency, and bladder discomfort. All formulations were shown to have reduced symptoms and reduced severity of symptoms, usually faster and more pronounced with Formulation 2 and Formulation 3. Formulation 3 is most effective in reducing nocturia compared to Formulation 2. In summary, all formulations are shown to be effective in treating urinary incontinence and the symptoms of OAB. Standardized Qili 7 (Formulation 2) improves the effectiveness of the original formulation

And it is further optimized by standardizing the scorpion and flavonoids (Formulation 3). Example 6: Formulations for Incontinence and Overactive Bladder Tests Summary of Tests Expected Batches of Antimony in therapeutic Formulations The change is because many excipients contain diterpenoids, which are considered to be in a non-absorbable form. Inter-batch k-ings that have been combined with a formulation for incontinence and overactive bladder testing can result in an amount of strontium falling below the therapeutically active strontium content per tablet. Formulation 1 for Clinical Study Example 2 produced therapeutic efficacy in the reduction of symptoms of urinary incontinence. Because the formulation uses non-standardized extracts, batch-to-batch variations in the strontium content of the formulation may and may result in inconsistent effectiveness. Inventive Formulation 2 (for Clinical Study Example 3) and Formulation 3 (for Clinical Study Example 4) were developed to address the potential for batch-to-batch variation and subsequent inconsistency. It contains a standard amount of quiz extract and a consistent amount of anhydrous gelatinous cerium oxide. Test the bismuth content of all three formulations 118938.doc -72- 200800242 to determine the formula! The extent of possible batch-to-batch variation and confirmation of the maintenance of therapeutic content when used with formulations containing standardization (#). Various test methods for measuring the content of Shi Xi are available and can be used to produce variable society: | / this 'for each sample, the same as the carrier ^ currently used in the Chinese Pharmacopeia (Bp) I (: pMs test method. This method completely destroys all other molecules in the composition, leaving only ruthenium, which can then be measured relative to the SK) 2 (dioxotomy) control group. The amount of the method _ # has a distinction between the stone-free and the non-absorbable form of the stone eve. Results Formulation 1 contained a non-standardized lily extract. After the test, the batch of Formulation i exhibited a strontium content of 34.0 mg per tablet (about mg per tablet). The bismuth content of the subsequent batches of Formulation 1 was tested and displayed at 4.7 mg per tablet (again, each tablet was about 15 00 mg). This is a batch-to-batch variation of about 6% and the focus is on the significant inter-assay variation of the Shixi content when using Shihua's unstandardized horsetail extract. It is expected that the amount of strontium in the batch will change, and the therapeutic effectiveness will be reduced when the content falls below the content that is not effective. This was observed in subsequent batches of Formulation i containing 14.5 mg per tablet. The batch produced worse and inconsistent results when compared to the original production batch containing 34.0 mg of strontium per tablet. (data not shown) Both Formulation 2 and Formulation 3 used standardized Quercetin extract and a consistent amount of anhydrous colloidal cerium oxide. In the test, Formulations 2 and 3 respectively showed a content of 41. 6 mg per tablet and a content of 60.8 mg per tablet (again, each tablet was 1,000 mg). These levels are all above the per-component granules, which are shown to be therapeutically effective in Clinical Study Example 2. Similarly, the change in the strontium content between the two batches of the 118938.doc -73-200800242 formulation was only 3%, which is a 50% reduction in the batch-to-batch variation of Formulation 1. It is expected that batch-to-batch variations (when using the same formulation (Formulation 2 or Formulation 3)) will be minimized even when further use of such standardized formulations. Table 13 - Results of the 矽 test using the ICPMS BP method Formulation Description Total 矽 (亳克/旋旋) Total 矽% (1000 mg tablets) 1 Original formulation · Tested in the clinical study described in Example 2 Original production batch 34.0 3.40 1 Original formulation, subsequent batch 14.5 1.45 2 Modified formulation with standardized strontium content tested in the clinical study described in Example 3 41.6 4.16 3 Tested in the clinical study in Example 4 An improved formula with a normalized bismuth content of 60.8 6.08 It should be noted that the total 石 % % described in Table 13 contains from the standardization

The bioavailability of the extract formulation comes from the majority of non-bioavailable excipients. The composition of the lozenge of Formulation 2 is summarized in the table "According to the present invention, the results obtained with a formulation having a standardized Quercetin extract preparation containing at least about 3% of hydrazine are obtained. In the preferred embodiment Wherein, the formulation package 3 has at least about 3% to about 13% bismuth of the standardized sputum extract preparation. In another preferred embodiment {column, the physique contains a standardized phoenix having at least about to about (4) An extract preparation. In still another preferred embodiment, the formulation comprises a standardization extract preparation having an ancient, /, at least about 6% 00

118938.doc 74- 200800242 Magnesium Phosphate 70 Nil Anhydrous Gelatin 50.32 23.5 Filler __ 209.68 9 (minimum) Total: 15000 4L5 Conclusion If the amount of mash in the test formulation is minimized, consistent prevention: Sexual or therapeutic effects are more likely. The test results for different batches of non-standardized Shishi formula (ie formula i)] show 60°/. The batch changes. These batch changes are expected to cause inconsistencies and reduce the effectiveness of prevention and treatment effectiveness. φ Formulation 2 and Formulation 3 used a quiz extract with a standardized hydrazine content and a consistent amount of anhydrous colloidal cerium oxide, thus obtaining a uniform strontium content per tablet for each formulation. The change in the strontium content between the batches of the two formulations was only 30%, that is, the variation between batches of Formulation 1 was reduced by 5%. Batch-to-batch variations that wish to use the same formulation (2 or 3) will be minimized even in further use. The bioavailable bismuth content of the present invention per tablet can be standardized by using a consistent optimum amount of normalized hydrazine content. This avoids the negative issues associated with batch changes in bioavailability 矽 content. _ Formulation 2 and Formulation 3 of the present invention having an optimized, standardized hydrazine content minimizes the problem of batch-to-batch variation in the cerium content of the formulation. Subsequently, as shown in Clinical Studies 3, 4 and 5, a more consistent prophylactic or therapeutic effect is produced. Example 7 Summary of clinical trials of herbal-containing natural therapeutic lozenges for the prevention and treatment of benign prostatic hyperplasia: investigation of natural herbal-containing therapeutic preparations for oral administration (ie, sputum control test preparations) Among the benign prostatic hyperplasias is H8938.doc -75- 200800242 efficiencies ° Prostate control test preparations are natural herbal preparations formulated into capsules. Materials and Methods Test Formulations Prostate control test formulation capsules were made according to GMP guidelines by TGA-approved manufacturing facilities (TGA"Guidelines for Good Clinical Research Practices (GCRP) in Australia"). Each capsule contains herbs, namely stalks/skin extracts of saplings and extracts of stalks. For example, each capsule contains the following dry weight equivalents: sapwood stem/skin extract (1, 〇〇〇 mg) and stalk stem extract preparation (670 mg). Study Design A male human subject who experienced regular BPH symptoms was recruited via a newspaper advertisement. All male human subjects met the following criteria: (a) did not experience recent prostate surgery in the last 12 months, (b) did not have any serious symptoms such as diabetes, heart disease, pancreatic disease, liver disease or chronic inflammatory conditions Health conditions, (c) no current psychiatric intervention therapy, (4) no medications used to observe symptoms in the last month prior to the start of the study, and (4) no specific pelvic motion to improve muscle flexibility prior to the study. The therapeutic protocol consisted of a human test subject who took a capsule of a prostate control test formulation three times a day for 12 weeks. At the beginning of treatment (before the 〇 month y and i straight; lead and subsequent mother months (1st, 2nd and 3rd 118938.doc -76- 200800242 months), use frequency of urination and nocturia, international prostate symptom meter The International Prostate Symptom Score (IPSS) and the Urogenital Distress Survey (UDI) assess the efficacy of treatment. IPSS gives the level of impact of BPH. The two questionnaires are standardized disease-specific questionnaires. The problems in UDI are especially in incontinence and paralysis. Physical aspects and their effects on quality of life. All questions are rated on a scale of 3 (no = no annoyance, 1 = mild annoyance, 2 = moderate annoyance, 3 = extremely annoying).

As detailed in Table 15 below, the problem in UDI is particularly relevant to the physical form of the symptoms of delirium. Table 15: Urogenital Distress Survey

Do you experience the following items, and if experienced, you are affected by the following annoyances: Drip after excretion 'feeling the bladder is not completely empty after urinating' Frequent urination, especially at night " Reduce the amount of leakage caused by force (letter '- to force or force to start urination - hematuria caused by forced excretion _ a "-" IPSS consists of seven (7) questions about the specific symptoms associated with sputum

...has weak urine flow?

The maximum IPSS is 35 (the maximum level of all problems is 5). Level: No, 118938.doc •77· 200800242 1 Less than 1/5, 2 less than half, 3 about half, 4 more than half, 5 Almost always IPSS uses the following rating system: °-8 Mild Symptoms; 9-19 Moderate symptoms; 2G_35 Severe symptoms. The results of these questionnaires were analyzed using paired t-tests. Positive improvement is defined as the physical condition of the BPH, or the physical or social activity of the test subject receiving the prostate control vehicle, in the human test subject before the preparation of the prostate control test preparation: The statistically significant difference in the parameters' is also the household value; ^〇.〇5. Results and Discussion Demographics There were 10 authors who completed the study for 3 months. His age is 42-76 years old and his average age is 59 years old. Daytime frequency At baseline, the mean daytime urinary frequency varies between 7-12. A significant decrease (ρ < 0.05) was confirmed in the second month and continued to change in the third month. At the end of the study, the frequency was significantly reduced. This value appeals to the frequency of secretion of healthy people. Nocturia (night urinary frequency) 118938.doc -78- 200800242 Nocturia is significantly reduced (P<5) and this is the average number of toilets per night at 1.5 after one (1) month of treatment, continued during the study period . In the third month or less. IPSS total scores Subjects with a total IPSS greater than 9 (moderate/severe symptoms) were eligible for the study. The study included 10 subjects who all had a (s) ss symptom score within the baseline at baseline.

After (1) months of treatment, the mean total IPSS score decreased slightly and further decreased significantly in the 2nd and 3rd months (Table 16). Table 16: Total IPPS Score: Mean Symptoms and % Reduction from Baseline

After 3 months of treatment, the subjects were reclassified according to ipss: 8 participants were fe degrees, 11 were moderate and 3 were severe. Urinary distress survey

UDI is a standardized disease-specific questionnaire used to detect incontinence in the elderly. The quality of life is assessed according to the symptoms of “You are influenced by the “Guangqing Zhiyan”. This is different from the IPSS that asks for specific quantitative information (this symptom is more than one time). As assessed by UDI, the quality of life is significantly improved. UDI The average annoyance level of each of the six questions decreased in the first month and further decreased in the second month, showing significant results in the third month. Conclusion In summary, in the third month, prostate-related symptoms due to prostate formulation 118938.doc -79- 200800242 and significantly reduced, confirming that the formula is suitable for prostate conditions, such as BPH. "The human subject's bladder (from the frequency of days and (4)) should be positive and It happened in the middle of the month. The symptoms of urinary flow gradually changed and were assessed by ipss. Urine ~ strength has a change in household weight (such as Example 8 for the prevention and treatment of benign anterior 厶 ♦ human body - hyperplasia and other composition groups α grass natural therapeutic tablets clinical trial summary

A study was conducted to investigate the effectiveness of the herbal natural medicinal preparation (i.e., the prostate control test preparation) for the oral administration of the sputum for the treatment of oral administration. The prostate control test formulation is a natural herbal preparation formulated into a capsule. Materials and Methods Test Formulations Prostate Control Test Formulation Capsules were made according to GMP guidelines by TGA2"Guidelh^s for Good Clinical Research Practices (GCRP) in Australia". Each capsule contains herbs, namely stalks/skin extracts of saplings and extracts of stalks. For example, each capsule contains the following dry weight equivalents: sapwood stem/skin extract (1,000 mg) and stalk stem extract preparation (670 mg). Each of the prostate control test formulation capsules is administered in combination with at least one of the following 15 compositions: (1) 107 mg extract of Saw Palmetto standardized to contain about 85% fatty acids and sterols; (2) standardized to contain 2.5 mg phytosterols of African thorn bark 100 mg; (3) ramie root 100 mg; (4) standardized to 118938.doi-80-200800242 tomato fruit containing 0.25 mg lycopene 2.92 g; (5) Zucchini (squash seed) seeds 10 g, (6) zinc 5 mg; (7) copper 1 mg; (8) Shixi 8; (9) biliary I bowel alcohol (vitamin 〇 3) 200 m; 1〇) Each oral dose unit 5 〇叩 dry weight of vitamin E; (11) vitamin B6 25 mg; (12) vitamin C concentration 1 〇〇: mg; (13) glutamic acid (such as glutamic acid ) 200 mg; (14) glycine 200 mg; - and (15) 2 mg of alanine. For example, one or more of the 15 compositions are combined in a cohort control test formulation capsule or co-administered with a prostate control test capsule. In the case of co-administration, the 15 compositions are administered to the subject before or after the administration of the test capsule of the gland control test. Study Design A male human subject who experienced regular BPH symptoms was recruited via a newspaper advertisement. All male human subjects met the following criteria: (a) had not experienced recent prostate surgery in the last 12 months, (b) did not have symptoms such as diabetes, heart disease, pancreatic disease, liver disease or slow-inflammatory inflammatory conditions (c) when no psychiatric intervention has been treated, (d) did not use any drug for BpH symptoms in the last month prior to the start of the study, and; (4) before participating in the sacral plate Exercise to improve muscle flexibility. The therapeutic protocol consisted of a capsule of a human prostate control test formulation taken three times a day by a human test subject over a period of 12 weeks, in any other combination as set forth above. Before starting treatment (Gth month) and thereafter every month 118938.doc δ1 200800242 (1st, 2nd and 3rd months), using urination frequency and nocturia, international prostate symptom score (IPSS) and genitourinary distress The questionnaire (UDI) assesses the efficacy of the treatment. IPSS gives the impact level of BPH. As detailed in Table 17 below, the problems in UDI are particularly relevant to the physical aspects of BPH symptoms. Table 17: Urogenital Distress Survey Form Do you experience the following items, and if experienced, you are affected by the following annoyance: Drip after excretion '

After urinating, the bladder is not completely emptied~ Frequent urination, especially at night, leakage of urine caused by a small amount of leakage (drop) - exerting force or force to start urination by forced excretion of hematuria using paired t-test analysis The results of the questionnaire. Positive improvement is defined as a statistically significant difference, ie p-value cut.05. Results and Discussion A summary of other compositions taken by study participants is shown in Table 18 below. Table 18: Summary of other compositions taken by participants. Serenoa Lycopene Amino Acid * Vit B6 Vit. A Vit. C VitD Number of people taking other compositions in Zinc Stone 10 10 1 7 2 4 3 10 10 N=10 (Number of participants in the study) Note: Some participants take more than one other composition Note that the *amino acid formulation contains any of the following: L-glutamic acid, glycine, alanine. 118938.doc -82- 200800242 Demographics Ten subjects completed a three-month study using capsules of prostate control test formulations with any of the other combinations specified above. His age is 47_7°3 years old and his average age is 64 years old. The body weight varied from 64_11 〇 kg and the average body weight was 89·7 kg. The median body mass index (BMI) was 28.4. Most (8) subjects were classified as overweight or obese (BMI > 25), and only 2 subjects were within normal body weight (BMI 19.5-24.5). Urinary frequency At baseline, the average daytime urinary frequency was 7.3 times (range 12 times). After one (1) month of treatment, the frequency was significantly reduced from 7.3 times per day to 6.0 times per day (19% reduction). (It is significant at p<〇〇5). After two (2) months of treatment, this trend persisted with an average of 5 urinations (or a 21% reduction in daytime frequency). After 3 months of treatment, subjects recorded an average daily frequency of 5 ( (equivalent to a 32% reduction in frequency compared to baseline). Overall, the frequency is significantly reduced. Nocturia (night urinary frequency) At baseline, the mean nocturnal urinary frequency was 34 (range). After one (1) month of treatment, nocturia was significantly reduced (p < 0.05) and it persisted during the study. The frequency is reduced to 2·2 times per night (reduced by 35%, and the range is 15 hours longer than the mother). The results were similar to those recorded at two (2) months of treatment, with an average of 2.4 urinations (or a reduction in nocturia of 29.4%, ranging from w per night). After 3 months of treatment, there was a further significant improvement, with the subject recording an average nightly frequency of I·1 times/night (equivalent to a 68% reduction in nocturia compared to baseline, and a range of only 0-3 urination/ late). 118938.doc -83· 200800242 Five subjects (50%) reported a frequency greater than 3 times per night. At the end of the study, 'all subjects reported less than 3 urinations per night. International Prostate Symptom Score (IPSS) Issues and Levels

IPSS consists of seven (7) questions about specific symptoms associated with BPH. ...have the feeling of not completely emptying your bladder after you have finished urinating? ...after you have finished urinating, you must urinate again within 2 hours? ...when you urinate, stop and start again several times? ... found it difficult to delay urination? 5·...has weak urine flow? 6···· Must try hard or force to start urinating? 7. In the past month, how many times do you usually get up and urinate from the time you go to bed at night until the time you get up in the morning? The maximum IPSS is 35 (the maximum level of all problems is 5). Level: 〇 No, 1 is less than 1/5, 2 is less than half, 3 is about half, 4 is greater than half, 5 Almost always IPSS uses the following rating system: 0-8 mild symptoms; 9-19 Symptoms; 118938.doc -84 - 200800242 20-35 Severe symptoms. IPSS total score _ average, average reduction ❶ Subjects who reported total moxibustion (moderate/severe symptoms) were eligible for the study. The study included H) subjects who scored a total score of 12-33 at baseline with an average grade of 21.

Among them, the four subjects with symptoms were classified as having mild symptoms (deleted 9-19) and the six subjects were classified as having severe symptoms (11 > 882 〇 _35). After 3 months of treatment, subjects were reclassified according to IPSS, and now only 5 X subjects experienced mild symptoms, 3 experienced moderate symptoms and only 2 had severe symptoms. After 3 months of treatment, all subjects experienced a reduction in the severity of the symptoms. The average total IPSS score at baseline was 21. After one (1) month of treatment, it decreased slightly to 15.3, which is equivalent to a 2.6% reduction in ipSS. After two months of treatment, the average IPSS was further reduced to 13.5, which is equivalent to (7) “reduced by 35.1%. After three (3) months of treatment, the total ipss results were recorded as iO.7, which is equivalent to a reduction in IPSS. 49%. These changes were significant (p<0.05) at months 1, 2, and 3 months. Urinary Distress Survey UDI is a standardized disease-specific questionnaire used to detect incontinence in the elderly. "You are assessed by the question of the 蘧 蘧 & & & " This is different from the IPSS that asks for specific quantitative data. H8938.doc -85- 200800242 Table 19: Urinary Distress Survey Form Do you experience the following items, and if experienced, you are affected by the following: 1. Frequent urination 2. Leakage due to feeling or urgency 3 · Leakage due to activity, cough, sneezing 4 · Small amount of leakage (drop) — 5, difficult to empty the bladder 6. Pain or discomfort in the lower abdomen or genital area: 0, no; 1, slight; 2, moderate ; 3, the symptom of the very highest score is the problem 1 (······frequency.............). It is completely related to the frequency log and IPSS (which indicates that the urinary frequency during the day and night is the most commonly observed and most distressed symptom). As the average annoyance score of frequency is reduced from 2.4 to (K8 (from moderate/severe annoyance to mild annoyance), there is a general improvement. Q5(..........It is difficult to empty the bladder. .........) The average annoyance is also determined to be a distress symptom that affects quality of life. After treatment in the third month, it is significantly reduced to 0.5 in the third month. Other symptoms (Q2, 3, 4, 6) were assessed by their (>1.5 scoring) as less annoyance, although these symptoms were improved after 3 months of study. However, IPSS and UDI show up Significant positive trends in symptom reduction and quality of life. Use a single question to assess quality of life. “How do you feel if you spend the rest of your life according to your current urinary condition?" 0. Happy 1. Happy 2. Very Satisfaction 118938.doc -86- 200800242 3 · Mixing - about quite satisfactory and dissatisfied 4. Very dissatisfied 5 · not bothering 6. bad average level before treatment is very dissatisfied (level 44, range 2_ 6 At the first month, it was slightly lower (still very unsatisfactory, with an average of 3.9). At the second month, it Further reduced to mixed (average of 32). However, at the third month, the subject recorded an average of 24, which indicated that in the third month, the self-reported change was satisfied. Before the preparation, when comparing the same parameters in the human test subject, the positive parameters related to the physical condition of the BPH and the physical or social activities of the human test subject receiving the prostate control test preparation are improved. It is confirmed that the prostate control test preparation is suitable for preventing or treating prostate diseases of human subjects, such as ΒρΗ, prostatitis and prostatic intraepithelial neoplasia. Example 9 is for treating benign prostatic hypertrophy (ΒρΗ) and for treating ΒρΗ Summary of clinical trials of herbal hypertrophy (ΟΑΒ) and urinary incontinence (IJI) containing herbal preparations of genus, horsetail and saw palmetto. Studies were conducted to investigate herbal-containing therapeutic preparations (hereinafter referred to as BpH preparations or BPH test preparations). Effectiveness in the treatment of urinary symptoms associated with BPH in men between the ages of 35 and 8 years. The BpH test formulation is formulated into capsules. Contains herbal preparations. Each capsule contains dry extract equivalents: 1.0 g of stalk stem/skin extract, 67 〇mg of wattle (horsetail), saw palmetto 118938.doc -87- 200800242 实1〇7§, % fruit 2.92g, 5mg and 砸8μ§. Material and Methodology Design Designed in Brisbane, Australia's male (age between 35 and 8 years old) with the secret symptoms of newspaper advertisements:, ::: = With the following criteria: Everyone is (4) It: Life: A person who is severely restricted due to a pre-existing malignant disease or other disease. (b) No recent genitourinary surgery (<3 months). (c) Patients not registered in another study. w no bladder biopsy / cystoscopy + biopsy (d) days), no chronic persistent local lesions (eg, > intersex cystitis, bladder stones) (e) currently no psychotic interference treatment, and (7) On: No drugs for incontinence symptoms were used in the last month before the study. The therapeutic protocol consisted of 3 capsules per day, 3 capsules per day (three times a day, pear wood, 2.01g Jingjing, 32ig mine palm, 8 heartplant, 15mg words and 24 selenium). Before and after the start of treatment (the third month) and every month (the first, second and third months), the frequency of urination and nocturia, the international prostat symptom score (4) s) and the urogenital distress questionnaire (UDI) assessment The efficacy of treatment. Give the level of influence of BPH. The two questionnaires are standardized money-specific questionnaires. The problem in UDI is especially related to the physical form of incontinence and 〇ab and its life.

Il8938.doc -88- 200800242 The effect of quality is related. All questions are rated on a scale of 3 (〇 = no annoyance, 丨 = mild annoyance, 2 = moderate annoyance, 3 = extremely disturbed). The results of these questionnaires were analyzed using paired t-tests. Positive improvement is defined as the physical or social activity of the test subject in which the body condition of the BPH is measured by the prostate control test sample when compared to the human test subject before receiving the prostate control test formulation: The statistical difference between the parameters' is also the household value $〇.〇5. Test Formulations BPH test formulation capsules were manufactured by TGA-approved manufacturing according to the Go〇d Manufacturing Practice (GMp) guidelines. Each capsule contains herbs (Salmwood, Jingjing, Mine Standard Palm, Fanzhuang) and minerals (zinc and selenium). According to TGA"Guidelines f0r Go〇d Clinical Re bribe

Practic^GCRP) in Australia. The study was accredited by the Australian Institute of Natural Medicine Ethics Committee. The visit was conducted at the Natural Therapy Clinic of the Australian Institute of Natural Medicine in Brisbane. Results and Discussion Demographics were completed by 23 subjects. The 3-month study was 39-79 years old with an average age of 63 years. The body weight varied from 60 to 104 kg with an average body weight of 83.7 kg. The median body mass index (3)^) was 26.7. The patients were classified as overweight or obese (BMI>25), and 9 subjects were within the normal body weight limit (BMI 19.5-24.5). Statistically, there was no correlation between age and symptom severity (total IPS using severity level) Statistically, there was no association between BMI and symptom severity (to make U8938.doc •89·200800242 use the total IPSS of severity). At baseline, the average urination frequency of this group was 32 times per night. In the first month, it was significantly reduced to 2.4 times, and in the second month, it was 2 times and 1.3 times. At the baseline, the average daytime urinary frequency was 8 7 times (range 3_丨8 times). (1) After the month of treatment The frequency was significantly reduced from 8 72 times a day to a daily rate (a decrease of 18.4%). (It is significant at p<0 05). In two

After (7) months of treatment, this trend persisted with an average of 62 urinations (or a daytime frequency reduction of 3G/.). After 3 months of treatment, the subjects recorded an average of 56 times, the frequency of the day (equivalent to a 35 percent decrease in frequency compared to baseline). Overall, the frequency is significantly reduced. This value is comparable to the urinary tract of healthy people. 20) 〇

Table 2〇 · Average and decrease in urinary frequency during the day,

At baseline, the mean nocturnal urinary frequency was 3.3 (range 1-9). After () months of treatment, nocturia was significantly reduced (ρ < 0. 05) and it was held between the two, κ. The frequency was reduced to 24 times per night (decreased π%, and the range was 1_5 illusion for maternal night. The result was similar to that recorded at the time of treatment for two (7) months. 2 〇 _ urination of people (or nocturia decreased by 29%, range For the nightly ^4 - person L after 3 months of treatment, further significant improvement, the subject recorded an average frequency of 1 / 3 times / night (equivalent to a reduction in nocturia compared with baseline II8938.doc 200800242 61 %, and the range is only 0-3 urination/night.) Five subjects (50%) reported a frequency greater than 3 times per night. At baseline, the average frequency of the group was 4.5 times per night. Significantly reduced to 2.8 in the first month, 2.5 in the second month, and 1.5 in the third month (Table 21). Table 21: Mean and decrease in nocturnal urinary frequency (nocturia). ❹,n==33 Night frequency baseline 1st month 2nd month 3rd month average 3.3 2.4 2.0 1.3 Reduction % (from baseline) 27% 29% 61% International Prostate Symptom Score (IPSS) Issues and Levels IPSS consists of seven (7) questions about specific symptoms associated with BPH. 1... After you have finished urinating, have your bladder not completely emptied Feeling? 2.... After you have finished urinating, you must urinate again within 2 hours? 3... When you urinate, stop and start again several times? 4... Found it difficult to delay urination? 5 •...has weak urine flow? 6 .... Must try hard or force to start urinating? 7. In the past month, how many times do you usually get up and urinate from the time you go to bed at night until you get up in the morning? Lida IPSS is 3 5 (the biggest level of all problems) For $) Level: 0 Not at all '1 less than 1/5 times, 2 half times, 118938.doc 200800242 3 About half the number of times, 4 More than half the number of times, 5 Almost always IPSS uses the following rating system: 0-8 Light Symptoms; 9-19 Moderate Symptoms; 20-35 Severe Symptoms. IPSS Total Score - Mean, Mean Reduction % - Reported > 9% of total IPSS (moderate / severe symptoms) for the study Qualified. The study included 23 subjects with a total IPSS symptom score at baseline ranging from 11-33, with an average of 19.1. Among them, 14 subjects with symptoms were classified as moderate. Symptoms (IPSS 9-19) and classification of 9 subjects For a severe symptom (IPSS 20-35), the average total IPSS score at baseline was 19.1. After one (1) month of treatment, it was slightly reduced to 15_8, which is equivalent to a 17.3% reduction in IPSS. After 2 months of treatment, the average IPSS was further reduced to 13.9, which is equivalent to a 27.2% reduction in IPSS. After three (3) months of treatment, the total IPSS results were recorded as 5 12.2, which is equivalent to a 36.1% reduction in IPSS. These were changed during the first, second and third months: significant (p < 0.05) (Table 22). Table 22: Total IPPS Score: Mean Symptoms and Reduction from Baseline % Baseline of the first month of the first month of the first month of the subject. 19.1 15.8 13.9 12.2 % reduction (from baseline) 17.3% 27.2% Ί 36.1% I18938.doc -92- 200800242 After 3 months of treatment, subjects were reclassified according to IPSS: 8 participants were now classified as mild, 11 were moderate and 3 were severe. Urine flow problems 1-4 and 6 are particularly relevant to the pattern of urinary flow. The results in this study show that '50% of the subjects reported that the symptoms occurred at least 5% of the time. In the first month, for Q1-4 and Q6, the average reduction in IPSS was about 20°/. . A greater improvement was observed after 2 months of treatment and the mean reduction (compared to baseline) was reported to be 29-36%. After the third month, a further significant improvement was observed (average reduction of about 45-49%). Weak urinary flow In this study, at baseline, 30% of the group reported a level of q5 of 5 (almost always). (···” weak urine flow"···). Another 43% gives level 3_4 (half to more than half the number). This show, most men experience the show name. After the first month of treatment, Slightly reduced (i 〇 0 / 〇), no further improvement in the second month (11%) and in the third month, the symptoms decreased by an average of 15 〇 / 〇.

Urinary Distress Survey Form The quality of life has improved significantly as assessed by UDI. In the quality of life problem, there is self-satisfaction to the satisfaction of the t-satisfaction / report full # into the research period 29 of the 33 subjects (88%) hope to continue treatment. u is a standardized disease-specific questionnaire for detecting incontinence of the elderly's troubles. The quality of life is assessed based on the symptom" This is different from asking for specific quantitative information (IPSS 〇H8938.doc -93- 200800242) Table 23: Urinary distress survey table Muir experienced the following items, and if experienced, you are subject to the following The degree of annoyance: ~~ 1. Frequent urination 2. Leakage due to feeling or urgency 3. Leakage due to activity, cough, sneezing _ 4. Small amount of leakage (drop) — 5. Difficult to empty bladder 6 • Pain or discomfort level in the lower abdomen or genital area: 〇, none; 1, slight; 2, moderate; 3, the symptom of the highest scoring is question 1 (...frequency.......... .....). It is completely related to frequency and IPSS (which indicates that urinary frequency during the day and night is the most commonly observed and most distressed symptom). A significant improvement is shown by a 32% reduction in average annoyance scores (from moderate/severe annoyance to mild annoyance). Q5 (.·............It is difficult to empty the bladder............) It is also determined to be a distressing symptom that affects the quality of life, and the average annoyance is divided into 1 · 6. After the third month of treatment, it decreased significantly to 0.48 in the third month (indicating a 70% reduction). The subject assessed that other symptoms (Q2, 3, 4, 6) were less annoyed by their (score 1 or less), although the symptoms were improved after 3 months of study. However, IPSS and UDI are showing a significant positive trend in reducing symptoms and increasing quality of life. Use a single question to assess quality of life. ‘1 How do you feel if you spend the rest of your life according to your current urinary condition? " 0. Happy 1. Happy 2. Very satisfied 118938.doc -94- 200800242 3. Mixed - about quite satisfactory and dissatisfied 4. Very dissatisfied 5. Unhappy 6. Oops before the treatment average level is 3.95 ( The range is 2-5). In the first month, it was slightly reduced (average 3.4, range 1-5). In the second month, it did not change significantly (mean 3.2, range 0-5). However, in the third month, the subject recorded an average of 2.9 with a range of 0-5. Overall, this represents a change from very dissatisfied to quite satisfactory/very satisfied in the 3rd month. Conclusion In summary, at the 3rd month, symptoms were significantly reduced due to the prostate formulation. The effect on the bladder (the frequency of day and night) is most positive and occurs within the first month. The symptoms of urinary flow gradually improve and the intensity of urinary flow changes. Equivalents; , , : The invention has been described in connection with its specific embodiments, but it should be understood that it can be further modified. In addition, the application is intended to cover any variations of the invention, which are included in the scope of the invention, Use or modify. [Simplified Schematic] Figure 1 is a histogram showing the percentage of "very annoying" in the clinical evaluation of herbal-based creams for urinary incontinence. Figure 2 is a histogram showing the percentage of the answer to the extreme annoyance during the clinical evaluation of herbal-based lozenges for urinary incontinence. 118938.doc -95- 200800242 Figure 3 is a histogram showing the percentage of "very annoying" responses during the clinical evaluation of herbal-based lozenges for urinary incontinence. Figure 4-11 shows the clinical evaluation of herbs The histogram of the percentage of the answer to the "annoyance" during the treatment of urinary incontinence and overactive bladder. Figure 12 shows the experience of urinary incontinence and bladder after 3 months of treatment with various herbal-based suspects. A histogram of the percentage reduction in people with symptoms of hyperactivity. 118938.doc -96-

Claims (1)

200800242 X. Patent application scope: 1 · The use of a herbal composition as a medicament, the herbal composition comprising: at least about 1, 〇〇〇mg of sapwood (CraievG stem/skin preparation and at least about 670 mg of standardization (^心心状茎提取物' wherein the agent is suitable for treating a symptom of a prostate condition in an individual. 2. 2. The use of claim 1, wherein the herb-containing composition is formulated in a dry delivery system: 3. The use of claim 1, wherein the herb-containing composition is formulated in a liquid φ delivery system. 4. The use of claim 1, wherein the herb-containing composition is formulated in a controlled release vehicle. The use of item 1, wherein the herbal composition is formulated as an oral dosage unit selected from the group consisting of: a lozenge; a dry powder; a capsule; and a caplet. 6. The claim 1-5 Use, wherein the herb-containing composition further comprises at least one compound selected from the group consisting of: _ (a) at least 85% of the fatty acid and sterol are normalized per oral dosage unit. Saw palmetto present in the concentration of 1〇7 mg extract: repens/serrw/aia; Saw palmetto) berry preparation; (b) at least about 1 含有 containing 2.5 mg of phytosterol in each oral dosage unit. Pygeum africanum (%) in the presence of a dry weight of mg is present in a concentration of at least about 100 mg of extract per oral dosage unit. 118938.doc 200800242 (4) of castor dzWea; stinging nettles) root preparation; The concentration is at least about 333 mg of tomato (Lycopersicon esculentum, tomato), which is standardized to contain 0.1 mg of Lycopene per gram of dosage unit, and (4) at least about 10 g dry weight per oral dosage unit. A concentration of zucchini (CwrewHiap India 6) (pumpkin seed) seed preparation; (1) a concentration of at least about 3 mg dry weight equivalent of zinc per oral dosage unit; (g) a concentration of at least about 1 mg dry weight equivalent per oral dosage unit Copper; • (h) a concentration of at least about 5 dry weight equivalents of selenium per oral dosage unit; (i) a concentration of at least about 200 IU dry weight equivalent of cholecalciferol (vitamin D3) per oral dosage unit; (j) a concentration of at least about 50 IU dry weight equivalent of vitamin E per oral dosage unit; (k) a concentration of at least about 25 mg dry weight equivalent of vitamin B6 per oral dosage unit; (1) • concentration per oral dosage unit At least about 100 mg dry weight equivalent of vitamin C; (m) a concentration of at least about 200 mg dry weight equivalent of bran per oral dosage unit: (8) aminic acid (eg, 1-glutamic acid); concentration of at least about about every oral dosage unit 200 mg dry weight equivalent of glycine; and (〇) concentration of at least about 200 mg dry weight equivalent of alanine per oral dosage unit. The use of any one of claims 1 to 5, wherein the composition is co-administered with a second composition comprising a compound selected from the group consisting of: II8938.doc 200800242, selected from the group consisting of: (4) per A saw palmetto fruit preparation in a concentration of at least about 107 mg of an extract containing about 85% fatty acid and sterol in an oral dosage unit; (b) 2.5 standard phytochemicals per oral dosage unit An African thorn skin preparation present at a concentration of at least about 100 mg dry weight; (C) a ricin root preparation in a concentration of at least about 1 〇〇 of the extract in a parent oral dosage unit; (4) a concentration per oral dosage unit a tomato fruit standardized to contain at least about 333 mg of 01 mg lycopene; k) 2 a zucchini (pumpkin seed) seed preparation present at a concentration of at least about 1 g dry weight per oral dosage unit; (0 concentration per oral dosage unit) At least about 3 mg dry weight equivalent, (g) a concentration of at least about 1 mg dry weight equivalent of copper per oral dosage unit; (8) a concentration of at least about 5 dry weight equivalents per oral dosage unit; The degree is at least about 200 IU dry weight equivalent of cholecalciferol (vitamin D3) per oral dosage unit; (1) at a concentration of at least about 50111 dry weight equivalents of vitamin 每 per oral dosage unit; 〇〇 concentration is at least about 25111 per oral dosage unit § dry weight equivalent of vitamin Β6; (1) concentration of at least about 100 mg dry weight equivalent per oral dosage unit 118938.doc 200800242 biotin c; (m) concentration of at least about 200 mg dry weight equivalent of bran per oral dosage unit Aminic acid (such as 1-glutamic acid); (n) > Chen is at least about 20 mg dry weight equivalent of glycine per oral dosage unit; and (〇) > At least about 2 mg dry weight equivalents of propylamine according to the use of claim 7, wherein the composition is administered to the subject when the second composition is the same as the second composition. 7. The use of the composition, wherein the composition is administered to the subject before the second composition is administered to the subject. 1) The use of the item 7, wherein the composition is in the second combination The subject is administered to the examinee and then administered to the subject. And comprising: (a) a concentration of at least about ιοοο mg dry weight equivalent per oral dosage unit _ existing sorbitol stem/skin preparation; (b) at least about 1,500 mg dry weight equivalent per oral dosage unit a standardized stem extract preparation in the presence of a concentration; • (c) at least one compound selected from the group consisting of: " (1) normalized to about 85% fatty acid and sterol per oral dosage unit a mineral palm berry preparation at a concentration of at least about mg07 mg of the extract; (11) Africa at a concentration of at least about 100 § dry weight of each of the orally administered dosage units containing 2.5 mg of phytosterol. Doc 200800242 thorn skin preparation; (iii) ramie root preparation in the concentration of at least about 1 〇〇 mg of extract per oral dosage unit; (iv) concentration is standardized for each oral dosage unit containing 〇. i mg Tomato fruit of at least about 333 mg of lycopene; (v) zucchini (squash seed) seed preparation in a concentration of at least about 10 g dry weight per oral dosage unit; (vi) concentration per oral dose At least about 1 mg dry weight equivalent of 10 zinc; (vii) a concentration of at least about 1 mg dry weight equivalent of copper per oral dosage unit; (viii) a concentration of at least about 5 pg dry weight equivalent per oral dosage unit; (ix) a concentration of at least about 200 IU dry weight equivalent of cholecalciferol (vitamin D3) per oral dosage unit; (X) a concentration of at least about 50 IU dry weight per oral dosage unit when | φ of vitamin E; (xi) The concentration is at least about 25 mg dry weight equivalent per oral dosage unit: vitamin B6; (χϋ) concentration is at least about 100 mg dry weight equivalent of vitamin C per oral dosage unit; (xiii) concentration is at least about every oral dosage unit 200 mg dry weight equivalent of glutamic acid (eg 1-prostine); (xiv) concentration of at least about 200 mg dry weight equivalent per oral dosage unit 118938.doc 200800242 of glycine; and (XV) concentration per The oral dosage unit is at least about 2 〇〇❿ dry weight equivalent of alanine. 12. A herb-containing composition comprising: (a) a stalk/skin preparation of sorbet present at a concentration of 1,000 ^ dry weight equivalent per oral dosage unit; : (b) 670 mg per oral dosage unit Standardized stem extract preparation in the presence of dry weight equivalent; • (〇) saw palmetto berry preparation in the concentration of 107 mg of extract per oral dose; (4) Concentration is standardized for each oral dosage unit 5 2. 2g of tomato fruit; (e) Spread is 5 mg dry weight equivalent per oral dose unit; and (0 concentration is 8 dry weight equivalents per oral dose unit. 118938.doc