CN101953953B - Medicinal preparation for preventing and treating prostatic hypertrophy and preparation method thereof - Google Patents
Medicinal preparation for preventing and treating prostatic hypertrophy and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medicinal preparation for preventing and treating prostatic hypertrophy and a preparation method thereof. The medicinal preparation is prepared from the following traditional Chinese medicinal raw materials: giant knotweed rhizome, oldenlandia diffusa, astragalus, oriental waterplantain rhizome, plantain seed, verbena, medicinal cyathula root, Carbopol 940, ethanol, glycerol, polysorbate 80, ethylparaben and sodium carboxymethylcellulose. The medicinal preparation has the functions of clearing heat, detoxifying, regulating vital energy, invigorating the circulation of blood, stimulating the menstrual flow and eliminating stasis and can promote the immunity of body fluid actively. Thus, the medicinal preparation is an effective medicament for treating difficult urination, difficulty and pain in micturition, hematuria and acute non-specific urinary infection prostatitis disease, which are caused by warmheat pathogen of downward flow. The medicinal preparation is different from the conventional tablets, powder and granules and has the characteristics of convenient administration, quick absorption and convenient carrying.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation that prevents and treats prostatic hyperplasia and preparation method thereof, belong to technical field of Chinese medicines.
Background technology
Prostatic hyperplasia is-kind of common disease, also is a kind of frequently-occurring disease in recent years, and is closely related with the raising of people's living standard.Sickness rate is the gesture of rising year by year, and the prostatic hyperplasia pathogenic factor is relevant with estrogenic dysequilibrium with the interior androgen of human body with inherited genetic factors.Show according to World Health Organization's updated statistics, there is prostatic hyperplasia patient nearly 500,000,000 every year in the whole world, only China just reaches 4,000 ten thousand, just there is one family to be subjected to the torment of prostatic hyperplasia disease in per 40 families of China, in today of international medical science fast development, the Chinese traditional Chinese medical science is based on Traditional Chinese medical theory, in conjunction with modern medicine, the utilization modern means of science and technology are being brought into play impayable huge effect controlling in the sick field of prostatic hyperplasia.Along with our country is prosperous and powerful day by day, the raising of people's living standard and the quickening of rhythm of life, numerous and bad life style relevant disease, rapidly increase just with surprising rapidity as diabetes, obesity, prostatic hyperplasia etc., especially prostatic hyperplasia, be considered to for a long time in the past belong to low morbidity in China, 58 examples are just reported in the whole nation altogether before 1958.But the geographic epidemiological survey in Shanghai showed in 1998, and the prevalence of local prostatic hyperplasia is up to 3.4%, and near the sickness rate of the U.S., the prompting prostatic hyperplasia has become one of commonly encountered diseases of China at present.Prostatic hyperplasia also has a lot of new knowledges in recent years to the significant damage of health, finds that this disease prostatic hyperplasia can cause diseases such as hernia, hemorrhoid, so control prostatic hyperplasia disease is very urgent.
Up to the present, prostatic hyperplasia does not still have the method for radical cure, many clinically with Sang Ta, like to live that urine is logical, terazosin, Cefasabal etc., this quasi drugs is alleviating pain rapidly, but also cure the symptoms, not the disease, this quasi drugs toxic and side effects is bigger simultaneously, takes for a long time, and human gastrointestinal tract, hepatic and renal function are had detrimental effect.In order to develop the Chinese medicine of safety, effectively anti-treatment prostatic hyperplasia disease, the applicant has carried out a large amount of explorations and research.
Summary of the invention
Pharmaceutical preparation that provides the safe and effective control prostatic hyperplasia of a kind of energy and preparation method thereof is provided technical problem to be solved by this invention, thereby overcomes the deficiencies in the prior art.
In order to solve the problems of the technologies described above, the present invention adopts following technical scheme: the pharmaceutical preparation of control prostatic hyperplasia, said preparation mainly is to be prepared from by following materials of weight proportions medical material: 1440～1428 parts of Rhizoma Polygoni Cuspidati (monarch drug), 960～970 parts of Herba Hedyotidis Diffusaes (ministerial drug), 720～735 parts of the Radixs Astragali (ministerial drug), 720～740 parts of Rhizoma Alismatis (adjuvant drug), 480～490 parts of Semen Plantaginiss (adjuvant drug), 480～490 parts of Herba Verbenae (adjuvant drug), 480～490 parts of Radix Cyathulaes (messenger drug), 940 10～15 parts of carbopols, 50～55 parts of ethanol, 50～52 parts of glycerol
,2～5 parts of polyoxyethylene sorbitan monoleates, 1～7 part of ethyl hydroxybenzoate, 20～25 parts of sodium carboxymethyl cellulose.
Preferably, it is by 940 10 parts of 1440 parts of Rhizoma Polygoni Cuspidati, 960 parts of Herba Hedyotidis Diffusaes, Radix Astragali 720g part, 720 parts of Rhizoma Alismatis, 480 parts of Semen Plantaginiss, 480 parts of Herba Verbenae, 480 parts of Radix Cyathulaes and carbopols, 50 parts of ethanol, 50 parts of glycerol
,2 parts of polyoxyethylene sorbitan monoleates, 1 part of ethyl hydroxybenzoate, sodium carboxymethyl cellulose is prepared from for 20 parts.
The present invention also provides the preparation method of the pharmaceutical preparation of control prostatic hyperplasia: get Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, the Radix Astragali, Rhizoma Alismatis, Semen Plantaginis, Herba Verbenae, Radix Cyathulae seven flavor medicine material is ground into coarse powder, with 72 hours after-filtration of 80% soak with ethanol, reclaim ethanol, it is 1.00～1.02 clear paste that filtrate is condensed into 80 ℃ of relative densities, be spray dried to dried cream powder, carbopol 940 is mixed with polyoxyethylene sorbitan monoleate and 300ml distilled water, A liquid, the 4g sodium hydroxide is dissolved in joining in the A liquid behind the 100ml water and stirs evenly, get B liquid, again the hydroxyphenyl ethyl ester is dissolved in adding gradually in the B liquid behind the ethanol and stirs evenly, sodium carboxymethyl cellulose and glycerol are added successively stir evenly at last, promptly get transparent suppository matrix; Get above-mentioned Chinese crude drug clear paste, it is an amount of to add water, grinds to form thick paste, joins in the substrate under stirring, and stirs evenly, and moulding promptly gets the drug suppository of preventing and treating prostatic hyperplasia.
In the preparation method of the drug suppository of above-mentioned control prostatic hyperplasia, described drug suppository is an external suppository.
Prescription medicine characteristic of the present invention: Semen Plantaginis, have another name called Herba Plantaginis reality, Rana limnocharis clothing, pig ear tassel, phoenix eyes Semen Plantaginis, be the dry mature seed of Plantago asiatica L. before the Plantaginaceae plant or Plantago depressa Willd Plantago depressa Willd..Sweet, be slightly cold.Return liver, kidney, lung, small intestine meridian.Clearing away heat and promoting diuresis, eliminating dampness by diuresis is treating stranguria, makes eye bright, and eliminates the phlegm.Be used for the edema distension, the puckery pain of pyretic stranguria, diarrhea due to summer heat and dampness, conjunctival congestion and swelling pain, phlegm-heat cough.Herba Hedyotidis Diffusae: be the dry herb of Maguireothamnus speciosus Herba Hedyotidis Diffusae Hedyotis diffusa Willd..Sweet, little hardship, cold.GUIXIN, lung, liver, spleen, large intestine channel.Heat-clearing and toxic substances removing, the dampness removing eliminating carbuncle.Be used for acute appendicitis, laryngopharynx swelling and pain, jaundice due to damp-heat, dysuria, furuncle toxic swelling, venom.Radix Cyathulae: be the dry root of amaranthaceous plant Radix Cyathulae Cyathula officinalis Kuan.Sweet, little hardship, flat.Return liver, kidney channel.。Eliminating blood stasis and inducing menstruation, easing joint movement, inducing diuresis for treating stranguria syndrome.Be used for amenorrhea and mass in the abdomen, retention of placenta, arthralgia, flaccidity of the lower limbs clonic spasm of the muscle, hematuria stranguria with blood, injury from falling down.Rhizoma Polygoni Cuspidati: be dry rhizome and the root of polygonaceae plant Rhizoma Polygoni Cuspidati Polygonum cuspidatum Sieb. et Zucc..Little hardship is slightly cold.Return liver, gallbladder, lung meridian.Expelling wind and removing dampness, dissipating blood stasis analgesic therapy, relieving cough and resolving phlegm.Be used for arthralgia, jaundice due to damp-heat, amenorrhea, { note of the ancient Chinese } abdominal mass, burn due to hot liquid or fire, injury from falling down, carbuncle sore tumefacting virus, cough with copious phlegm.The Radix Astragali: be the dry root of leguminous plant Radix Astagali Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Radix Astragali Astragalus membranaceus (Fisch.) Bge..Sweet, temperature.Return lung, spleen channel.Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.It is weak to be used for the deficiency of vital energy, anorexia and loose stool, and sinking of QI of middle-JIAO, the chronic diarrhea proctoptosis, the metrorrhagia of having blood in stool, the exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle is difficult bursts, and burst for a long time and do not hold back, the blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes.Herba Verbenae: be the dry aerial parts of Verenaceae plant Herba Verbenae Verbena officinalis L..Hardship, cold.Return liver, spleen channel.Promoting blood circulation to remove blood stasis, preventing the attack (or recurrence) of malaria, detoxifcation, inducing diuresis to remove edema.Yong the Yu lumps in the chest and abdomen, amenorrhea dysmenorrhea, malaria, sore throat, carbuncle, edema, pyretic stranguria.Rhizoma Alismatis: be the dry tuber of Alismataceae plant Rhizoma Alismatis Alisma orientalis (Sam.) Juzep..Sweet, cold.Return kidney, urinary bladder channel.Diuresis, clearing away damp-heat.Be used for dysuria, edema distension, the oliguria of having loose bowels, dizziness due to fluid-retention, the puckery pain of pyretic stranguria; Hyperlipidemia.
Side of the present invention separates: according to the result of Epidemiological study, many factors are relevant with the morbidity of prostatic hyperplasia, except that age factor and prostatic hyperplasia incidence rate are closely related, other many factors may be relevant with the generation of prostatic hyperplasia in addition, as race, diet, smoking, sexual life, socioeconomic status, education degree, hypertension and diabetes etc.The main pathogenesis of primary disease is an asthenia of renal qi, disturbance in functioning of QI, so that frequent micturition, urgent micturition, urine twinge, urine be can't help spiritlessness and weakness, soreness of the waist and knees etc.The principle of Chinese traditional treatment prostatic hyperplasia is a heat-clearing and toxic substances removing, vital energy regualting and blood circulation-promoting, and the eliminating stagnation of stimulating the menstrual flow is a method, contained some biotic components in the Chinese medicine promote the drainage of kidney in addition.Acute stage is dialectical to be retention of damp-heat in the interior, and controlling clearing away heat-damp and promoting diuresis to be main; Catabasis is dialectical to be obstruction of collaterals by blood stasis, and controlling promoting blood circulation to remove obstruction in the collateral to be main.
We cure mainly prostatic hyperplasia and see frequent micturition, urgent micturition, urine twinge, urinate and can't help spiritlessness and weakness, soreness of the waist and knees etc.In the side with the Rhizoma Polygoni Cuspidati expelling wind and removing dampness, the dissipating blood stasis analgesic therapy, relieving cough and resolving phlegm is main; With Radix Astragali invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation; With Radix Cyathulae eliminating blood stasis and inducing menstruation, easing joint movement, inducing diuresis for treating stranguria syndrome; With the Herba Verbenae promoting blood circulation to remove blood stasis, preventing the attack (or recurrence) of malaria, detoxifcation, inducing diuresis to remove edema; With the Herba Hedyotidis Diffusae heat-clearing and toxic substances removing, the dampness removing eliminating carbuncle; With Rhizoma Alismatis diuresis, clearing away damp-heat; With the Herba Plantaginis clearing away heat and promoting diuresis, eliminate the phlegm removing heat from blood, detoxifcation; All medicines share, and receive heat-clearing and toxic substances removing altogether, vital energy regualting and blood circulation-promoting, the merit of the eliminating stagnation of stimulating the menstrual flow.
Function of the present invention cures mainly: medicine of the present invention has heat-clearing and toxic substances removing, vital energy regualting and blood circulation-promoting, the effect of the eliminating stagnation of stimulating the menstrual flow.Being mainly used in prostatic hyperplasia sees frequent micturition, urgent micturition, urine twinge, urinates and can't help spiritlessness and weakness, diseases such as soreness of the waist and knees.Trade name of the present invention is: QIANLIE TAI health bolt.
In order to verify that medicine of the present invention has excellent curative, the applicant has carried out series of experimental research, and is specific as follows:
One, preliminary pharmacodynamics test research
1, test material
1.1 animal: 36 domesticated dogs, male, body weight (10-11kg, 2-3 year) is provided by the Guiyang Medical College animal testing center.
1.2 medicine and reagent
QIANLIE TAI health bolt: (high, medium and low dosage),
Drug suppository of the present inventionLot number: 20100204A; 20100204B; 20100204C; Specification: 2g/ grain, character: sepia suppository.(per 1 gram of QIANLIE TAI health bolt high dose is equivalent to 6.28 gram crude drugs; Per 1 gram of dosage is equivalent to 3.14 gram crude drugs in the QIANLIE TAI health bolt; Per 1 gram of QIANLIE TAI health bolt low dosage is equivalent to 1.57 gram crude drugs).
Prostatitis peace bolt: Livzon Pharmaceutical Factory, Livzon Group, lot number: 20090721.
2, experimental technique
2.
1 prostatic hyperplasia animal model manufacture method
36 male domesticated dogs of youth are divided into 6 groups at random, 6 every group, after animal via speed dormancy for animals new II (10 mg/ ml) the 0. 1 ml intramuscular injection anesthesia, model group aseptic injection Herb Gynostemmae Pentaphylli, matched group dissociates but does not inject Herb Gynostemmae Pentaphylli.Second day after operation begins administration, the high, medium and low dosage group of QIANLIE TAI health bolt every every day 1 time, the QIANLIE TAI health bolt of each 1 corresponding dosage; Prostatitis peace bolt group is to prostatitis peace bolt every every day 1 time, each 1; Matched group and model group give QIANLIE TAI health bolt blank suppository, every every day 1 time, each 1; 30 days courses of treatment.
2.2 index detects, put to death and respectively organize all animals after 30 days in administration, leave and take dog prostata tissue specimen, electronic balance claims the dog weight of prostate, and the water method of substitution is measured prostate volume.Get each dog same area prostata tissue, 4 % paraformaldehydes are fixed, the waxdip specimens paraffin embedding slices, the thick 4 μ m of sheet, and dyeing of conventional hematoxylin 2 Yihong and Masson dyeing, light microscopic is observed down.The Masson stained is made half-quantitative detection under MIAS 2000 type image analysis systems.Same specimen in 2. 5 % glutaraldehyde solutions fixing after, with fixing behind the 1 % Osmic acid., the classification ethanol dehydration is embedded in the EPON812, ultramicrotome is made the thick ultrathin section of 50～70 nm, inserts copper mesh with transmission electron microscope observing and take the photograph sheet.
Adopt SPSS 11. 0 statistical softwares to prostate volume and weight statistical disposition as a result, parallel rank test analysis; Image analysis data with
± s represents, adopts the t check to analyze.
3, result
Respectively organize the dog prostate volume after the administration, weight sees Table 1.
Respectively organize the comparison of dog weight of prostate and volume after table 1 administration
The comparison % of three groups of dog prostate of table 2 smooth muscle, connective tissue and substrate area percentage
Hematoxylin 2 Yihong colored light sem observations: matched group dog body of prostate is arranged clear, glandular epithelium is the monolayer column, nuclear is oval, be positioned at basilar part, intracavity does not have or a little secretions is arranged, and body of gland does not have expansion, and a matter does not have hypertrophy, as seen a little basal cell and obvious basement membrane are visible than matter between tangible between body of gland.
QIANLIE TAI health bolt high dose group: prostatic lesion is lighter, and epithelial cell is low post or cubic, and the secretions of a little is arranged, and nuclear is positioned at substrate or central authorities, and the acinus form is normal substantially, substrate pathological changes slight (Fig. 1 1.).Dosage group in the QIANLIE TAI health bolt: epithelial cell is column, high column has concurrently, the visible kernel of nuclear circle, the minority number of plies increases, body of gland is arranged obviously intensive, the part adenomatosis, it is outstanding to intracavity to be mamillary, and the visible powder of intracavity dyes material, secretions increase, lumen of gland obviously diminish (Fig. 1 2.).Model group dog prostate: prostate obviously is the nodositas hypertrophy, and lumen of gland enlarges, and is multiple layer of column or false multiple layer, two-layer at least more than, papillary hyperplasia is fairly obvious, the visible powder of intracavity dyes material.Substrate is abundant on every side, a matter broadening, proliferation of smooth muscle (Fig. 1 3.).
Model group: the nodositas hypertrophy is obvious, and glandular epithelium is false multiple layer, or a large amount of papillary hyperplasia is prominent in lumen of gland, and the visible powder of intracavity dyes material.The substrate hypertrophy increases obviously with smooth muscle especially on every side, little vasodilation hyperemia, local prostate destroyed (Fig. 1 4.).
Masson dyeing and graphical analysis: after the prostata tissue specimen Masson dyeing with the model group after the administration, matched group, the basic, normal, high dosage group of QIANLIE TAI health bolt and positive controls, prostate smooth muscle tissue is dyed redness under the light microscopic, and connective tissue is dyed blueness.Red and blue area is represented smooth muscle and connective tissue area respectively, and both sums are total substrate area.Measure substrate area percentage under each visual field under the same conditions, average.Matched group prostate substrate area percentage and model group prostate substrate area percentage, difference has statistical significance (P＜0. 05) (table 2).
Observe under the Electronic Speculum: can observe glandular cell under the high dose group prostate transmission electron microscope and be high column, metabolism is vigorous, secretory granule increase (Fig. 1 5.) but between in the matter collagen fiber hypertrophy not obvious.Middle dosage glandular epithelium mostly is simple columnar epithelium, but visible pseudostratified columnar epithelium, outgrowth glandular epithelium is arranged closely, basement membrane is complete continuously, existing thickening, and secretory granule further increase, the collagen fiber hypertrophy, the smooth muscle myofilament increases, the destruction of accidental glandular cell.Low dose group ultra micro pathological change is very similar to old group, glandular epithelium is false multiple layer hypertrophy, euchromatin is abundant in the nuclear, heterochromatin is rare, Presentation Function is vigorous, the collagen fiber (Fig. 1 6.) that gather in the matter, still visible in addition more fibroblast, part cell generation degeneration necrosis, and as seen have migration to go into interior lymphocyte.Matched group and positive drug group prostate are not seen significant change.
Two, Study on Preparation
1, preparation technology
1.1 prescription:Rhizoma Polygoni Cuspidati 1440g Herba Hedyotidis Diffusae 960g Radix Astragali 720g Rhizoma Alismatis 720g Semen Plantaginis 480g Herba Verbenae 480g Radix Cyathulae 480g.
1.2 method for making:Above seven flavor medicine material is ground into coarse powder, with 72 hours after-filtration of 80% soak with ethanol, reclaims ethanol, and filtrate is condensed into extractum, is spray dried to dried cream powder.Carbopol is mixed with polyoxyethylene sorbitan monoleate and 300ml distilled water, the last liquid of adding stirred evenly after sodium hydroxide was dissolved in 100ml water, again the hydroxyphenyl ethyl ester is dissolved in adding gradually behind the ethanol and stirs evenly, sodium carboxymethyl cellulose and glycerol are added successively stir evenly at last, promptly get transparent suppository matrix; Get above-mentioned Chinese crude drug clear paste, it is an amount of to add water, grinds to form thick paste, joins in the substrate under stirring, and stirs evenly, and bottling promptly gets the drug suppository of preventing and treating prostatic hyperplasia.
2, Study on Preparation
2.1 process route is determinedThis product prescription is made up of 7 flavor medicines such as Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, Radix Cyathulae, Rhizoma Alismatis, Herba Verbenae, Herba Plantaginis, the Radix Astragali, and the suppository external is made in alcohol extraction.The character of determining on the basis of respecting the clinical usage of former prescription, to take into full account each medical material in the prescription of process route.The character of each medical material is as follows in this project prescription:
(1) Herba Plantaginis
This product is sweet, is slightly cold.Return liver, kidney, lung, small intestine meridian.The tool clearing away heat and promoting diuresis, eliminating dampness by diuresis is treating stranguria, makes eye bright, and eliminates the phlegm.Be used for the edema distension, the puckery pain of pyretic stranguria, diarrhea due to summer heat and dampness, conjunctival congestion and swelling pain, phlegm-heat cough.This product contains galacturonic acid, volume phlegmatic temperament, aucubin, and contains plantenolic acid, choline, adenine, succinic acid, resin etc.
(2) sweet, the little hardship of Herba Hedyotidis Diffusae this product, cold.GUIXIN, lung, liver, spleen, large intestine channel.Heat-clearing and toxic substances removing, the dampness removing eliminating carbuncle.This product mainly contains chemical constituents such as cupreol.
(3) Rhizoma Polygoni Cuspidati
This product mildly bitter flavor is slightly cold.Return liver, gallbladder, lung meridian.Expelling wind and removing dampness, dissipating blood stasis analgesic therapy, relieving cough and resolving phlegm.Be used for arthralgia, jaundice due to damp-heat, amenorrhea, note of the ancient Chinese abdominal mass, burn due to hot liquid or fire, injury from falling down, carbuncle sore tumefacting virus, cough with copious phlegm.This product main component is chemical constituents such as emodin.
(4) sweet, the little hardship of Radix Cyathulae this product, flat.Return liver, kidney channel.Eliminating blood stasis and inducing menstruation, easing joint movement, inducing diuresis for treating stranguria syndrome.Be used for amenorrhea and mass in the abdomen, retention of placenta, arthralgia, flaccidity of the lower limbs clonic spasm of the muscle, hematuria stranguria with blood, injury from falling down.Main leaf contains flavonoids such as lonicerin, luteolin.Stem cyasterone etc.
(5) Herba Verbenae
This product hardship, cold.Return liver, spleen channel.Promoting blood circulation to remove blood stasis, preventing the attack (or recurrence) of malaria, detoxifcation, inducing diuresis to remove edema.Yong the Yu lumps in the chest and abdomen, amenorrhea dysmenorrhea, malaria, sore throat, carbuncle, edema, pyretic stranguria.This product contains oleanolic acid and ursolic acid etc.
(6) Radix Astragali
This product is sweet, temperature.Return lung, spleen channel.Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.It is weak to be used for the deficiency of vital energy, anorexia and loose stool, and sinking of QI of middle-JIAO, the chronic diarrhea proctoptosis, the metrorrhagia of having blood in stool, the exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle is difficult bursts, and burst for a long time and do not hold back, the blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes.This product contains astragaloside etc.
(7) Rhizoma Alismatis this product is sweet, and is cold.Return kidney, urinary bladder channel.Diuresis, clearing away damp-heat.Be used for dysuria, edema distension, the oliguria of having loose bowels, dizziness due to fluid-retention, the puckery pain of pyretic stranguria; Hyperlipidemia.This product stem contains chemical constituents such as volatile oil, α pinene.
In sum, in conjunction with the character characteristics of each medical material in the prescription, alcohol extracting method is adopted in the decision of this bolt, now its experimental result is reported as follows.
2.2 Study on extraction
(1) factor level is establishedThe factor that influences alcohol extraction mainly contains the following aspects: alcohol adding amount, soak time, extraction time etc.Therefore we have carried out the quadrature investigation of 3 factors, 3 levels to these three principal elements, with preferred optimal processing parameter.The factor level table of orthogonal test sees Table 3.
Table 3 alcohol extraction orthogonal test factor level table
(2) extraction processAccording to experimental result, concentration time was at 72 hours, and concentration of alcohol extracts 2 times 80%, it is best extraction process, so our extraction conditions is 72 hours after-filtration of 80% soak with ethanol, reclaim ethanol, it is 1.00～1.02 clear paste that filtrate is condensed into 80 ℃ of relative densities.
2.3 concentration technology is investigatedThe method for concentration that workshop is commonly used has normal pressure to concentrate and concentrating under reduced pressure.Concentrating under reduced pressure have consuming time less, characteristics that thickening temperature is low, therefore heat-sensitive ingredients is destroyed lessly, along with improving constantly of pharmaceutical equipment manufacturing technology, present Chinese medicine workshop has been more, and to adopt concentrating under reduced pressure be main.For with produce actual combining closely, the concentrated mode of this product adopts the concentrating under reduced pressure method.
Get 2 times of recipe quantity medical materials, press optimum extraction process and extract, the alcohol extract concentrating under reduced pressure (0.06～-0.08Mpa, 80 ℃) to clean copy cream, recording at this moment, the extractum relative density is about 1.00-1.02(60 ℃), qinghuo reagent is an amount of.Result of the test shows: adopt pressure reducing mode that this product extracting solution is concentrated, each composition is more stable relatively in the prescription, and illustration method is feasible.
Three, Pharmacodynamic test of active extract research
(1) experiment material
1,36 domesticated dogs of experimental animal are male, body weight (10-15kg, 2-3 year).Provide by the Guiyang Medical College animal center.
2, test drug and reagent QIANLIE TAI health bolt: (high, medium and low dosage), medicine bolt of the present invention, lot number: 20100204A; 20100204B; 20100204C; Specification: 2g/ grain, character: sepia suppository.(per 1 gram of QIANLIE TAI health bolt high dose is equivalent to 6.28 gram crude drugs; Per 1 gram of dosage is equivalent to 3.14 gram crude drugs in the QIANLIE TAI health bolt; Per 1 gram of QIANLIE TAI health bolt low dosage is equivalent to 1.57 gram crude drugs).
Prostatitis peace bolt: Livzon Pharmaceutical Factory, Livzon Group, lot number: 20090721.
(2) QIANLIE TAI health bolt is to the influence of domesticated dog prostatic hyperplasia
1, experimental technique
1.1 laboratory animal: 36 domesticated dogs, male, body weight (10-15kg, 2-3 year).Provide by the Guiyang Medical College animal center.
1.2 test drug: QIANLIE TAI health bolt: (high, medium and low dosage), medicine bolt of the present invention.Lot number: 20100204A; 20100204B; 20100204C; Specification: 2g/ grain, character: sepia suppository.(per 1 gram of QIANLIE TAI health bolt high dose is equivalent to 6.28 gram crude drugs; Per 1 gram of dosage is equivalent to 3.14 gram crude drugs in the QIANLIE TAI health bolt; Per 1 gram of QIANLIE TAI health bolt low dosage is equivalent to 1.57 gram crude drugs).
Prostatitis peace bolt: Livzon Pharmaceutical Factory, Livzon Group, lot number: 20090721.
1.3 test grouping and dosage: 36 male domesticated dogs of youth are divided into 6 groups at random, every group 6, after animal via speed dormancy for animals new II (10 mg/ ml) the 0. 1 ml intramuscular injection anesthesia, model group aseptic injection Herb Gynostemmae Pentaphylli, matched group dissociates but does not inject Herb Gynostemmae Pentaphylli.Second day after operation begins administration, the high, medium and low dosage group of QIANLIE TAI health bolt every every day 1 time, the QIANLIE TAI health bolt of each 1 corresponding dosage; Prostatitis peace bolt group is to prostatitis peace bolt every every day 1 time, each 1; Matched group and model group give QIANLIE TAI health bolt blank suppository, every every day 1 time, each 1; 30 days courses of treatment.
1.4 index was detected on administration after 14 days, put to death and respectively organized all animals, left and took dog prostata tissue specimen, electronic balance claims the dog weight of prostate, and the water method of substitution is measured prostate volume.Get each dog same area prostata tissue, 4 % paraformaldehydes are fixed, the waxdip specimens paraffin embedding slices, the thick 4 μ m of sheet, and dyeing of conventional hematoxylin 2 Yihong and Masson dyeing, light microscopic is observed down.The Masson stained is made half-quantitative detection under MIAS 2000 type image analysis systems.Same specimen in 2. 5 % glutaraldehyde solutions fixing after, with fixing behind the 1 % Osmic acid., the classification ethanol dehydration is embedded in the EPON812, ultramicrotome is made the thick ultrathin section of 50～70 nm, inserts copper mesh with transmission electron microscope observing and take the photograph sheet.
1.5 statistical procedures as a result: adopt SPSS 11. 0 statistical softwares to prostate volume and weight statistical disposition as a result, parallel rank test analysis; Image analysis data with
± s represents, adopts the t check to analyze.
2, experimental result
Respectively organize the dog prostate volume after the administration, weight sees Table 1.
Respectively organize the comparison of dog weight of prostate and volume after table 4 administration
The comparison % of three groups of dog prostate of table 5 smooth muscle, connective tissue and substrate area percentage
Hematoxylin 2 Yihong colored light sem observations: matched group dog body of prostate is arranged clear, glandular epithelium is the monolayer column, nuclear is oval, be positioned at basilar part, intracavity does not have or a little secretions is arranged, and body of gland does not have expansion, and a matter does not have hypertrophy, as seen a little basal cell and obvious basement membrane are visible than matter between tangible between body of gland.
QIANLIE TAI health bolt high dose group: prostatic lesion is lighter, and epithelial cell is low post or cubic, and the secretions of a little is arranged, and nuclear is positioned at substrate or central authorities, and the acinus form is normal substantially, substrate pathological changes slight (Fig. 1 1.).Dosage group in the QIANLIE TAI health bolt: epithelial cell is column, high column has concurrently, the visible kernel of nuclear circle, the minority number of plies increases, body of gland is arranged obviously intensive, the part adenomatosis, it is outstanding to intracavity to be mamillary, and the visible powder of intracavity dyes material, secretions increase, lumen of gland obviously diminish (Fig. 1 2.).Model group dog prostate: prostate obviously is the nodositas hypertrophy, and lumen of gland enlarges, and is multiple layer of column or false multiple layer, two-layer at least more than, papillary hyperplasia is fairly obvious, the visible powder of intracavity dyes material.Substrate is abundant on every side, a matter broadening, proliferation of smooth muscle (Fig. 1 3.).
Model group: the nodositas hypertrophy is obvious, and glandular epithelium is false multiple layer, or a large amount of papillary hyperplasia is prominent in lumen of gland, and the visible powder of intracavity dyes material.The substrate hypertrophy increases obviously with smooth muscle especially on every side, little vasodilation hyperemia, local prostate destroyed (Fig. 1 4.).
Masson dyeing and graphical analysis: after the prostata tissue specimen Masson dyeing with the model group after the administration, matched group, the basic, normal, high dosage group of QIANLIE TAI health bolt and positive controls, prostate smooth muscle tissue is dyed redness under the light microscopic, and connective tissue is dyed blueness.Red and blue area is represented smooth muscle and connective tissue area respectively, and both sums are total substrate area.Measure substrate area percentage under each visual field under the same conditions, average.Matched group prostate substrate area percentage and model group prostate substrate area percentage, difference has statistical significance (P＜0. 05) (table 2).
Observe under the Electronic Speculum: can observe glandular cell under the high dose group prostate transmission electron microscope and be high column, metabolism is vigorous, secretory granule increase (Fig. 1 5.) but between in the matter collagen fiber hypertrophy not obvious.Middle dosage glandular epithelium mostly is simple columnar epithelium, but visible pseudostratified columnar epithelium, outgrowth glandular epithelium is arranged closely, basement membrane is complete continuously, existing thickening, and secretory granule further increase, the collagen fiber hypertrophy, the smooth muscle myofilament increases, the destruction of accidental glandular cell.Low dose group ultra micro pathological change is very similar to old group, glandular epithelium is false multiple layer hypertrophy, euchromatin is abundant in the nuclear, heterochromatin is rare, Presentation Function is vigorous, the collagen fiber (Fig. 1 6.) that gather in the matter, still visible in addition more fibroblast, part cell generation degeneration necrosis, and as seen have migration to go into interior lymphocyte.Matched group and positive drug group prostate are not seen significant change.
Four, toxicity test research
QIANLIE TAI health bolt animal acute toxicity test:Said preparation is a suppository, and according to the trial test situation, the high dose group animal does not see death after the grouping administration, can't find out maximum lethal dose, measures so can't carry out the animal median lethal dose(LD 50).The maximum dosage-feeding that changes the animal oral administration into is measured.
QIANLIE TAI health bolt clinical administration amount is finished medicines 3.6g/ day (being equivalent to crude drug 19.17g), is equivalent to (60 kilograms) per kilogram of body weight 0.06g/kg (amounting to crude drug amount 0.3195g/kg).
This test is chosen and is used the finished product administration.Mice is irritated gastric capacity (40m1/kg body weight) No. 1 (Cmax 40%) administration that gives the Cmax prostatic hyperplasia by maximum in the test, can't increase again because of being subjected to drug level and irritating the long-pending dosage of limitting of body of stomach, so dosage reached maximum dosage, dosage is accumulated as 12g/kg (amounting to the crude drug amount is 63.9g/kg) in the animal subject 24 hours as a result.
The oral maximum dosage-feeding of QIANLIE TAI health bolt mice has been reached 200 times of people's consumption every day (amounting to crude drug amount 0.3195g/kg) as calculated.Observed 14 days continuously after the administration, all are tried mice and there is no unusual performance, none death.
According to statistics Wlrightization rule, can infer that a day maximum dosage-feeding that QIANLIE TAI health bolt oral administration must be greater than 12g/kg (amount to crude drug: amounting to the crude drug amount be 63.9g/kg).
The comparison of table 6 medicine maximum dosage-feeding of the present invention experiment mice body weight
Five, clinical practice
(1) physical data: this organizes 135 examples, male, 50～70 years old age, course of disease 3d～1 year.The patient has urinary tract infection condition of illness, as frequent micturition, and urgent micturition, dysurea, or see hematuria, lumbago, lower abdomen pain, vicious heating.The midstream urine routine examination, leukocyte 〉=10 * 106L-1 or companion's erythrocyte, a small amount of albumen.CCMS is cultivated, and bacteria quantified is cultivated clump count ﹥ 10 * 109L-1.Differential diagnosis in tcm is a stranguria, damp-heat in lower-JIAO, frequent micturition, frequent micturition, and urethra scorching hot, puckery pain, the urine Huang is red or accompany lumbago, lower abdominal pain bitterly, vicious, the yellowish fur that generates heat, wiry and frequent pulse.The midstream urine antibacterial culturing goes out: escherichia coli, Bacillus proteus, klebsiella spp, streptococcus faecalis, staphylococcus.The patient does not all have cardiovascular, serious primary disease such as liver hemopoietic system.Get rid of non-infectious urethral syndrome simultaneously, tuberculosis of urinary system, other urologic diseases such as acute and chronic nephritis.
(2) diagnostic criteria
1.1 Therapeutic Method
The prescription (Rhizoma Polygoni Cuspidati, Semen Plantaginis, Herba Hedyotidis Diffusae, the Radix Astragali, Rhizoma Alismatis, the horsewhip tip, Radix Cyathulae) that the patient uses " prostatitis is safe " bolt is decocted in water for oral dose, every day potion, 7 days is 1 course of treatment, the Chinese medicine and western medicine such as other antipyretic and antidotal type Chinese medicines and antibiotics of stopping using during the treatment.
1.2 curative effect judging standard
Recovery from illness in the recent period; The clinical symptoms complete obiteration, routine urinalysis is normal, and midstream urine is cultivated negative; Produce effects; Clinical symptoms disappears substantially, and symptom integral descends 75%, and routine urinalysis is normal, and midstream urine is cultivated negative; Effectively; Clinical symptoms is improved, and symptom integral descends 50%, and routine urinalysis obviously improves; Invalid; Clinical symptoms does not have improvement, and routine urinalysis does not have improvement.
2 results
Take medicine after 1 course of treatment, cure 43 examples (32%) in the recent period, produce effects 54 examples (40%), effective 27 examples (20%), invalid 11 examples (8%) total effective rate 92%.
Untoward reaction such as heating, erythra, decline of tip blood leukocytes and liver function injury appear in this group patient in therapeutic process.
3 conclusions
" QIANLIE TAI health " bolt is made up of a few flavor medicines such as (Rhizoma Polygoni Cuspidati, Semen Plantaginis, Herba Hedyotidis Diffusae, the Radix Astragali, Rhizoma Alismatis, the horsewhip tip, Radix Cyathulaes).According to the heat-clearing and toxic substances removing of traditional traditional Chinese medical science, vital energy regualting and blood circulation-promoting, diffusing network stimulates the menstrual flow.Theoretical Cheng Fang; Can suppress and kill the various prostatic pathogenic bacterium that cause effectively, have certain antiinflammatory, pain relieving, spasmolysis, and to body fluid exempt from service also can play active promoting function in; Be treatment because effective good medicine of the dysuria of damp-heat in lower-JIAO due to penting up, odynuria, hematuria, acute non-special urinary tract infection prostatitis disease.
This magistral medicines mainly acts on staphylococcus aureus, gram-negative bacteria, gonococcus, chlamydia and mycoplasma etc.This product is expression or the most disappearance of p pili that can cross the expression of the p pili that suppresses pathogenic bacterium property antibacterial and make the p pili, thereby greatly reduce its mutter with the a-D-galactose arsenic of sloping cell surface-β-D-galactose arsenic mutters combining of glucosides receptor and the ability of sticking that produces, homergy excretes pathogenic bacterium and reaches antibacterial action in body.
Tcm clinical practice is thought: " QIANLIE TAI health " bolt prescription has heat-clearing and toxic substances removing, vital energy regualting and blood circulation-promoting, the function of the eliminating stagnation of stimulating the menstrual flow; Be used for chronic prostatitis, prostatic hyperplasia, the burnt damp-heat syndrome person of prostate hyperplasia subordinate, disease is seen: frequent micturition, urgent micturition, urine twinge, urine be can't help spiritlessness and weakness, soreness of the waist and knees etc.
This organizes effective 124 examples of 135 routine patients, total effective rate 92%, and what " QIANLIE TAI health " prescription of suppository was described truly has good heat-clearing and toxic substances removing, vital energy regualting and blood circulation-promoting, antibacterial and anti-inflammation functions.
" QIANLIE TAI health " bolt be the old docter of TCM treat clinical decades prostatosis through proved recipe, in conjunction with the experience for the treatment of nephropathy for many years, change to carry the Chinese patent medicine bolt of development.The function heat-clearing and toxic substances removing, vital energy regualting and blood circulation-promoting is to rush down sharp damp-heat in lower-JIAO.Cure mainly damp invasion of lower energizer, hold and close in bladder or deficiency of kidney-QI, bladder has heat, the water channel hot urination or the difficulty in urination due to obstructed obstructed, umbilicus abdomen shoot, diseases such as the pyretic stranguria that disease appearing at regular intervals, overstrain are promptly sent out, stranguria with blood, stranguria caused by urinary stone, stranguria marked by chyluria, clinical should having decades, curative effect is sure, is widely used.We add flavor Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, the Radix Astragali, Rhizoma Alismatis, Semen Plantaginis, Radix Cyathulae etc. to form.Rhizoma Alismatis, Semen Plantaginis, the clear damp-heat in lower-JIAO of Radix Cyathulae help functioning of bladder; Herba Hedyotidis Diffusae heat-clearing and toxic substances removing activating blood and promoting diuresis; Radix Astragali QI invigorating, the diuresis poison holding.All medicine phases 5 are played heat-clearing and toxic substances removing, vital energy regualting and blood circulation-promoting, the effect of the eliminating stagnation of stimulating the menstrual flow altogether.Modern pharmacological research also proves: medicines such as Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, the Radix Astragali, Rhizoma Alismatis, Semen Plantaginis, Radix Cyathulae have the immune function of human body of raising and broad-spectrum antibacterial action.We are by treating 135 routine prostate and relevant disease, and total effective rate reaches 92%.Diseases such as frequent micturition, dysurea, the urine that the traditional Chinese medical science occurs damp invasion of lower energizer is not smooth not freely, lower abdomen weighs down pain are called damp and hot pouring.Suffer from this sick patient, according to lab testing, what have is diagnosable for urinary system infection, but the no abnormality seen of inspection person is also arranged, and no matter whether check result positive, if dialectical be that damp and hot pouring can be used the treatment of " prostatitis is safe " bolt.Antibiotic is still the main medicine of treatment urinary system infection at present, though effect is strong, rapid-action, but it is mostly via renal metabolism, has increased the burden and the nephrotoxicity of kidney, particularly to impaired kidney, if long-term or heavy dose of the application can produce infringement in various degree.Present antibiotic abuse and resistant rate constantly increase, and are subjected to domestic and international expert's great attention.Curative effect is reliable in the excavation motherland medical science, and the Chinese medicine that toxicity is little, untoward reaction is few has been subjected to the common concern of domestic and international medical circle." prostatitis is safe " bolt has changed traditional tablet, and the powder granule has taking convenience, absorbs soon, and portable characteristics are more suitable for the rhythm of life in the modern.
Description of drawings
Fig. 1 is a prostate pathology slice map
The specific embodiment
The embodiment of the invention 1:
Take by weighing raw material of Chinese medicine Rhizoma Polygoni Cuspidati 1440g, Herba Hedyotidis Diffusae 960g, Radix Astragali 720g, Rhizoma Alismatis 720g, Semen Plantaginis 480g, Herba Verbenae 480g, Radix Cyathulae 480g is ground into coarse powder, get 50ml ethanol, with 72 hours after-filtration of 80% soak with ethanol Chinese medicine coarse powder, reclaim ethanol, it is 1.00～1.02 clear paste that filtrate is condensed into 80 ℃ of relative densities, clear paste is spray dried to dried cream powder, standby; Carbopol 940 10g are mixed with polyoxyethylene sorbitan monoleate 2g and 300ml distilled water, get A liquid, the 4g sodium hydroxide is dissolved in joining in the A liquid behind the 100ml water and stirs evenly, get B liquid, again ethyl hydroxybenzoate 1g is dissolved in adding gradually in the B liquid behind the ethanol and stirs evenly, at last sodium carboxymethyl cellulose 20g and glycerol 50g are added successively and stir evenly, promptly get transparent suppository matrix; Get above-mentioned Chinese crude drug dried cream powder, it is an amount of to add water, grinds to form thick paste, joins in the substrate under stirring, and stirs evenly, and moulding promptly gets the drug suppository of preventing and treating prostatic hyperplasia.This suppository is external suppository.
The embodiment of the invention 2:
Take by weighing raw material of Chinese medicine Rhizoma Polygoni Cuspidati 1428g, Herba Hedyotidis Diffusae 970g, Radix Astragali 735g, Rhizoma Alismatis 740g, Semen Plantaginis 490g, Herba Verbenae 490g, Radix Cyathulae 490g is ground into coarse powder, get 55ml ethanol, with 72 hours after-filtration of 80% soak with ethanol Chinese medicine coarse powder, reclaim ethanol, it is 1.00～1.02 clear paste that filtrate is condensed into 80 ℃ of relative densities, clear paste is spray dried to dried cream powder, standby; Carbopol 940 15g are mixed with polyoxyethylene sorbitan monoleate 5g and 400ml distilled water, get A liquid, the 4g sodium hydroxide is dissolved in joining in the A liquid behind the 100ml water and stirs evenly, get B liquid, again ethyl hydroxybenzoate 7g is dissolved in joining gradually in the B liquid behind the ethanol and stirs evenly, at last sodium carboxymethyl cellulose 25g and glycerol 52g are added successively and stir evenly, promptly get transparent suppository matrix; Get above-mentioned Chinese crude drug dried cream powder, it is an amount of to add water, grinds to form thick paste, joins in the substrate under stirring, and stirs evenly, and moulding promptly gets the drug suppository of preventing and treating prostatic hyperplasia.This suppository is external suppository.
Claims (3)
1. pharmaceutical preparation that prevents and treats prostatic hyperplasia, it is characterized in that: according to listed as parts by weight, it is by 1440～1428 parts of raw material of Chinese medicine Rhizoma Polygoni Cuspidati, 960～970 parts of Herba Hedyotidis Diffusaes, 720～735 parts of the Radixs Astragali, 720～740 parts of Rhizoma Alismatis, 480～490 parts of Semen Plantaginiss, 480～490 parts of Herba Verbenae, 940 10～15 parts of 480～490 parts of Radix Cyathulaes and carbopols, 50～55 parts of ethanol, 50～52 parts of glycerol
,Polyoxyethylene sorbitan monoleate
2～5 parts, 1～7 part of ethyl hydroxybenzoate, sodium carboxymethyl cellulose is prepared from for 20～25 parts.
2. according to the described a kind of pharmaceutical preparation that prevents and treats prostatic hyperplasia of claim 1, it is characterized in that: according to listed as parts by weight, it is by 1440 parts of raw material of Chinese medicine Rhizoma Polygoni Cuspidati, 960 parts of Herba Hedyotidis Diffusaes, 720 parts of the Radixs Astragali, 720 parts of Rhizoma Alismatis, 480 parts of Semen Plantaginiss, 480 parts of Herba Verbenae, 940 10 parts of 480 parts of Radix Cyathulaes and carbopols, 50 parts of ethanol, 50 parts of glycerol
,2 parts of polyoxyethylene sorbitan monoleates, 1 part of ethyl hydroxybenzoate, sodium carboxymethyl cellulose is prepared from for 20 parts.
3. a preparation method of preventing and treating the pharmaceutical preparation of prostatic hyperplasia is characterized in that: take by weighing raw material of Chinese medicine Rhizoma Polygoni Cuspidati 1440g, Herba Hedyotidis Diffusae 960g, Radix Astragali 720g, Rhizoma Alismatis 720g, Semen Plantaginis 480g, Herba Verbenae 480g, Radix Cyathulae 480g is ground into coarse powder, gets 50ml ethanol, with 72 hours after-filtration of 80% soak with ethanol Chinese medicine coarse powder, reclaim ethanol, it is 1.00～1.02 clear paste that filtrate is condensed into 80 ℃ of relative densities, and clear paste is spray dried to dried cream powder, standby; Carbopol 940 10g are mixed with polyoxyethylene sorbitan monoleate 2g and 300ml distilled water, get A liquid, the 4g sodium hydroxide is dissolved in joining in the A liquid behind the 100ml water and stirs evenly, get B liquid, again ethyl hydroxybenzoate 1g is dissolved in adding gradually in the B liquid behind the ethanol and stirs evenly, at last sodium carboxymethyl cellulose 20g and glycerol 50g are added successively and stir evenly, promptly get transparent suppository matrix; Get above-mentioned Chinese crude drug dried cream powder, it is an amount of to add water, grinds to form thick paste, joins in the substrate under stirring, and stirs evenly, and moulding promptly gets the drug suppository of preventing and treating prostatic hyperplasia.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1631433A (en) * | 2004-11-15 | 2005-06-29 | 长春今来药业（集团）有限公司 | Capsule for treating prostate disease and its preparing process |
| CN101152407B (en) * | 2007-10-17 | 2010-07-07 | 通化东宝药业股份有限公司 | Medicament for treating chronic prostatitis and method of preparing the same |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1631433A (en) * | 2004-11-15 | 2005-06-29 | 长春今来药业（集团）有限公司 | Capsule for treating prostate disease and its preparing process |
| CN101152407B (en) * | 2007-10-17 | 2010-07-07 | 通化东宝药业股份有限公司 | Medicament for treating chronic prostatitis and method of preparing the same |
Non-Patent Citations (1)
| Title |
|---|
| 呼永河.慢性前列腺炎的中医药治疗进展.《天津中医学院学报》.2001,第20卷(第04期),45-47. * |
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