KR20050004950A - Composition comprising the herbal complex extract for prevention and treatment of menorrhalgia and dysmenorrhea - Google Patents

Abstract

PURPOSE: Provided is a composition comprising the extract of mixed herbs for prevention and treatment of menorrhalgia and dysmenorrhea as well as constipation, dermatitis, back pain and sensibility of cold. The mixed herbs include Cyperus rotundu, Angelica gigas Nakai, Curcuma zedoaria Roscoe, Moutan Cortex Radicis, Artemisiae Argyi Folium, Linderae Radix, Ligustici Rhizoma, Corydlais Tuber, Scirpi Rhizoma, Cartami Flos and Mume Fructus. CONSTITUTION: The composition for prevention and treatment of menorrhalgia and dysmenorrhea as well as constipation, dermatitis, back pain and sensibility of cold is characterized by containing the extract of mixed herbs which is obtained by the steps of: drying the herbs and finely cutting and mixing them; extracting the mixture at 20-120 deg.C for 1 hour to 15 days using water, C1-C4 lower alcohol or the mixture thereof; and filtering the extract, followed by concentration under reduced pressure and drying to give the crude extract.

Description

Composition comprising the herbal complex extract for prevention and treatment of menorrhalgia and dysmenorrhea}

The present invention relates to a composition effective for the prevention and treatment of gynecological diseases containing a complex herbal, more specifically, hyangbuja, Angelica, Bulgogi, bark skin, love leaf, oak, cheongung, Hyunhosaeng, Samreung, Shiho, safflower, omega It relates to a composition for preventing and treating dysmenorrhea and dysmenorrhea of a woman mainly comprising the combined herbal extract.

Menstrual pain refers to lower abdominal pain or low back pain that occurs lightly or severely during or after menstruation in women of childbearing age. Abdominal distension, diarrhea, constipation, etc. appear incidentally. Menstrual pain is one of the most common gynecological disorders in about 50% of women of childbearing age. Menstrual pain is usually experienced by young women, usually within one to two years after menarche, but severe cases can last up to the age of 40. About 10% of them complain of pain that they cannot do what they normally do for one to three days every month.

A survey by Kyunghee Medical Center Oriental Medicine Hospital found 47% of women complaining of menstrual cramps, backaches and even headaches, 13% of gastrointestinal disorders such as anorexia and indigestion, and 8% of women with discomfort. In particular, 70% of the 632 high school girls complained of dysmenorrhea and 50% complained of severe pain. More pain in female students was attributed to excessive academic and test fears. However, 66% of them just refer to 28% of painkillers, and more than 90% of them do not have a basic treatment.

The exact cause of dysmenorrhea has been studied by many scholars for a considerable period of time, but the exact cause is still unknown. However, the fact that menstrual cramps are associated with the menstrual cycle suggests a deep link to the imbalance of endocrine hormones.

There are several theories regarding the pathogenesis of dysmenorrhea, including the theory that progesterone deficiency is the cause, the theory that it is caused by excessive secretion of estrogens and androgens, the theory that it is caused by excessive secretion of prostaglandins, a pain-causing substance, and vitamins There is a theory that nutritional deficiency such as B complex or essential fatty acid is the cause, and it is generally considered that the above factors work in combination.

Among the theories, the most prominent theory is that menstrual cramps are caused by excessive secretion of prostaglandins. In the secretion of female hormones along the menstrual cycle, prostaglandins, which are pain-causing substances, stop when the luteinizing hormone (progesterone) is released. It is secreted and the muscles of the uterus are severely reduced and ischemia can cause pain. Therefore, the following method is used to suppress such pain.

The most common method is pain relief by inhibiting the production of prostaglandins using aspirin, acetaminophen, ibuprofen and the like, and another method is administering progesterone in the corpus luteum formation phase of the menstrual cycle.

Further known treatments include the method of administering melatonin (N-acetyl-5-methoxytrytamine) disclosed in Korean Patent No. 0171408, and serotonin (5) disclosed in Korean Patent Application Laid-Open No. 2001-0024462. Hydroxytryptamine).

Acetaminophen, the most commonly used analgesic drug, causes side effects of liver or kidney damage when taken over the recommended amount, and side effects may occur even when other drugs containing acetaminophen are used simultaneously. It is becoming.

In addition, methods of administering hormones or neurotransmitters such as progesterone, melatonin, and serotonin during the corpus luteum formation phase are known to improve not only menstrual pain but also general pain relief and chronic fatigue, depression, and the like. However, since the above methods directly administer hormones, melatonin, and serotonin, they cannot be 100% convinced of their safety, and have high manufacturing costs, so they cannot be easily taken at all times.

Meanwhile, Cyperus rotundus L. is a perennial herb of Cyperaceae, and the roots of Hyangbu are beta-pinene, camphene, cyperone, cyperol and cy. It contains 1% of essential oils such as Cyperene and patchoulenone, as well as kobusone and eugenol. It has analgesic and antibacterial effects. It is used for neuralgia, indigestion and headache and is a summary of gynecological diseases (Jung Bo-seop and Shin Min-kyo).

Angelica gigas is a perennial herb belonging to the genus Umbelliferae. The root of the Angelica gigas contains decursin, decursinol, and the root contains imperatorin. Wind, blood, blood, gut blood, tonic, landscaping, soothing, etc. Menstruation, postpartum abdominal pain, It is applied to menopause, arthralgia, low back pain, bruise pain, anemia, etc. (Bo Bo-seop and Shin Min-kyo).

Curcuma zedoaria is a perennial herbaceous herb belonging to the family Zingiberaceae. The roots of the Ahu are the buds, and the sesquiterpenes are the main components of the essential oils of the root. Contains zederone, zedoarone, furanodiene, etc., and has pharmacological effects such as antibacterial and anti-tumor effects. There are cardiovascular pain, indigestion, blood clots, bruise pain. It is applied to gastric cancer and uterine cancer (Bo Bo-seop and Shin Min-kyo);

Bark peel is the root of Paeonia suffruticosa , which belongs to the Paeoniaceae family, and its root contains paeonol, paeonoside, paeonolide, essential oil, phytosterol, etc. have. It is effective in antipyretic, septic blood, gore blood, and pain relief. It cures bleeding, non-bleeding, menopause, and bruises. (Bo Bo-seop and Shin Min-kyo; Hyang-Yaksa Dictionary, Young-lim History.

The leaves are dried leaves of Artemisia argyi and its related plant, Artemisia princeps , which belong to the compositae. It contains artermisia alcohol, camphor and borneol. Treats blood donations and treats pain caused by cold abdominal pain, bleeding, menstrual irregularities, hemorrhage, nasal bleeding, and chronic haemorrhage (Jung Bo-seop and Shin, Min-Kyo; Hyangjedae, Yeonglimsa. Pp1014-1015, 1998).

Lindica strychnifolia belongs to the family Lauraceae, and its root contains linderan, linderene, and linderol as main components. I use it as a medicine for the urination,

Ligusticum chuanxiong Hort. Is a perennial herb belonging to the umbelliferae, and in oriental medicine, its root stem (Cnidii Rhizoma) is dried, such as headaches, infertility, menstrual irregularities, anemia, tonicity, coldness, and postpartum pain. It is mainly used for gynecological diseases. Ligustilide, Butylidenphthalide, Butyphthalide, Neocnidilide, Cinidilide, Sedanolide, Sencunole It contains essential oils mainly made of reed (Senkyunolide), etc., and it has the effect of an active blood circulation, a painful pain in the stomach, painful, antibacterial, vasodilatation and soothing.鎭 靜), lowering blood pressure, antifungal action.

Corydalis (Corydalis turtschaninovii) may have a round tuber with perennial plant belonging to Corydalis and (Fumariaceae), the tuber (塊莖) of Corydalis and dongsok closely related plant is called era color, stiffness with (corydaline), dl - tetrahydro It contains alkaloids such as tetrahydropalmatine, conadine, etc., acts on the central nervous system, shows analgesic and sedative effects, acts on the endocrine system, promotes ACTH secretion, and promotes散瘀), Igi, and pain relief (Bo Bo-seop and Shin Min-kyo); Hyangjedae Dictionary, Yeonglimsa. Pp596-598, 1998).

Samneung is the root of Scipus yagara, a perennial herb, belonging to the cyperaceae, and it has the effects of bleeding, lichen pain , droplets, and swelling. Iii), menstrual irregularity, postpartum abdominal pain, bruise pain, etc. (Bo Bo-seop and Shin Min-kyo);

Bupleurum scorzoneraefolium is a perennial herb of Umbelliferae, which uses the roots of shiho and cognate root plants as herbal medicines. , Saponin and the like. It has pharmacological effects such as fever, sedation, analgesic, and anti-inflammatory, and it treats headache, neck, harital port, menstrual irregularity, uterine sewage, and malaria (Jung Bo-seop and Shin Min-kyo) ; Hyangjeomsa Dictionary, Yeonglimsa Temple (pp412-414, 1998).

Safflower is a flower of Carthamus tinctorius , belonging to Compositae, and contains safflower yellow and carthamin. Treats stillbirth, postpartum urinary tract insufficiency, pain caused by fish blood, and bruise (Jung Bo-seop and Shin Min-kyo; Hyang-Yaksa Dictionary, Yeonglimsa. Pp1054-1055, 1998).

Plums are dried immature fruits of Prunus mume belonging to the family Amygdalaceae. Fruits contain substances such as citric acid, malic acid, brine, cytosterol and olenolic acid, and have antibacterial and antifungal effects. It has the efficacy of jinjin, astringent, hookworm, and branch, and is used for chronic hari, dysentery, hematopoiesis, urinary blood, vomiting, repellent remedy, and dry mouth. And Shin, Min-Kyo;

In Korean Patent Laid-Open No. 2002-87572, yeast extract is used as the main raw material, and mixed with herbal medicines such as chitosan, donkey, sweet ginseng, turmeric, licorice, extract, peppermint, cinnamon, ginger, ginseng, cheonma, cheongung, and baekchul. Disclosed is a composition having a function of relieving electric syndrome and dysmenorrhea, and Korean Patent Registration No. 232671 discloses Cheongmongseok, Hapjang, Dried Chil, Frankincense, Myrrh, Samneung, Sesame, Small Fennel, Osuyu, Dongguk, Cheongung, Neckache, Crust, Essence, rhubarb, green skin, dermis, baekbokyeong, Hyunho color, oak, motherwort, casualty, cheoncho, hyangbuja, cedar, gyeji, gallant, bark skin, deceased, safflower, joiner, lingji, huang, hwangyeon, golden, half, ume, fast Disclosed is a method for preparing a composition for the treatment of gynecological diseases and female obesity.

In order to prevent, alleviate and treat dysmenorrhea and menstrual irregularities with the combination of the herbal medicines, the present inventors have pharmacologically observed the effects and treatment mechanisms of the combined herbal medicines, and studied whether there is a possibility to treat the disease.

As a result, the complex herbal extract according to the present invention confirmed the fact that it has a therapeutic effect on menstrual cramps and menstrual irregularities, thereby completing the present invention.

It is an object of the present invention to provide a composition for preventing, alleviating and treating menstrual cramps and menstrual irregularities containing a complex herbal medicine.

In order to achieve the above object, the present invention is for preventing, alleviating and treating dysmenorrhea and dysmenorrhea containing a complex herbal medicine consisting of hyangbuja, Angelica, sesame, bark skin, love leaf, oak, cheonggung, Hyunho color, Samreung, Shiho, safflower and ume To provide a composition.

The composition is effective for women with severe menstrual cramps, menstrual irregularities, cold belly or cold hands and feet, women before menopause but without menstruation, women with very low menstruation, female constipation caused by the same cause as the above symptoms, It can be used very effectively for skin urticaria, skin diseases such as acne, cold hands and feet and back pain.

Hereinafter, the present invention will be described in detail.

Complex herbal extract of the present invention, each of the dried herbal medicines are finely mixed at a constant ratio, about 1 to 20 times the weight (kg), preferably about 5 to 10 times the water, C ₁ to Lower alcohols of C ₄ or mixed solvents thereof, at 20 to 120 ° C., preferably at 90 to 110 ° C. for about 1 hour to 15 days, preferably about 1 hour to 1 day, cold extraction, hot water extraction, ultrasonic extraction or The extract obtained using reflux cooling extraction can be filtered, concentrated under reduced pressure or dried to obtain a crude extract.

In addition, for example, the complex herbal extract of the present invention, each dried herbal medicines are chopped and mixed at a constant ratio, about 1 to 20 times the weight (kg), preferably about 5 to 10 times the water, 10 to 30% (v / v) vinegar water, 1 to 20% (w / v) brine, unsweetened juice, shochu or a mixed solvent thereof at 20 to 50 ° C., preferably at 20 to 30 ° C. extraction temperature. Crude extracts may be obtained by chilling for about 1 to 15 days, preferably about 3 to 10 days.

Such herbal medicines include homogeneous herbal medicines that are obvious in the art and can be used for the same or similar purposes as the prophylactic and therapeutic purposes of the present invention.

The unseasoned juice means rice water, and preferably, after washing the brown rice in distilled water once or three times, the supernatant obtained by placing it in distilled water for 1 to 3 hours is used. In addition, the liquor may be a commercial alcohol distilled alcohol 10% or more, the higher the alcohol concentration is preferred.

The extract of each herbal medicine obtained as described above is mixed to prepare a complex herbal medicine, and in addition, it can be filtered, concentrated or dried.

The final mixing ratio of the herbal medicines in the mixed herbal medicines is Hyangbuja: Dongguk: Bulgogi: Oak: Peony: Cheongung: Hyunho Colour: Shiho: Safflower: Amaryllis: Samreung: Ome = 20-1: 3-1: 3-1: 3-1: 2 to 1: 2 to 1: 2 to 1: 2 to 1: 2 to 1: 2 to 1: 2 to 1: 2 to 1, preferably 14: 2: 2: 2: 1: 1: 1: 1: 1: 1: 1: 1.

The medicinal herb extract increases the motility of the muscles of the uterus and causes rhythmic contractions or relaxation, and increases blood flow in the lower abdomen and uterus.

Therefore, the composition of the present invention can be effectively used for the treatment of dysmenorrhea, dysmenorrhea, constipation, skin diseases, cold hands and feet, and low back pain caused by dysfunction of the uterine muscles and decreased blood flow in the lower abdomen.

Symptoms improved in more than 70% of patients with dysmenorrhea in the clinical trial of the combined herbal medicine.

The present invention also provides a pharmaceutical composition for preventing, alleviating and treating dysmenorrhea, including a complex herbal extract obtained by the above method as an active ingredient and a pharmaceutically acceptable carrier.

The pharmaceutical composition of the present invention comprises 0.1 to 90% by weight of the complex herbal extract based on the total weight of the composition.

Pharmaceutical dosage forms of the extracts of the present invention may be used in the form of their pharmaceutically acceptable salts, or may be used alone or in combination with other pharmaceutically active compounds, as well as in any suitable collection. Compositions comprising the multi-drug of the invention may further comprise a suitable carrier, excipient and diluent according to conventional methods.

Carriers, excipients and diluents that may be included in the composition comprising the complex herbal of the present invention include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, Gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.

Compositions comprising extracts according to the invention are in the form of powders, granules, tablets, pills, capsules, suspensions, emulsions, syrups, aerosols and the like, external preparations, suppositories and sterile injectable solutions, respectively, according to conventional methods. Can be formulated and used.

Preferred dosages of the extracts of the present invention vary depending on the condition and weight of the patient, the extent of the disease, the form of the drug, the route of administration and the duration, and may be appropriately selected by those skilled in the art. However, for the desired effect, the extract of the present invention is preferably administered at 0.1 to 10 g / kg, preferably 1 to 3 g / kg per day. Administration may be administered once a day or may be divided several times.

The pharmaceutical composition of the present invention can be administered to mammals such as rats, mice, livestock, humans by various routes. All modes of administration can be expected, for example by oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine dural or intracerebroventricular injection.

The present invention provides a health functional food comprising a compound herbal extract and a food acceptable food supplement additive exhibiting a preventive and alleviating effect of menstrual pain. Examples of the food to which the complex herbal extract can be added include various foods, beverages, gums, teas, vitamin complexes, and health functional foods.

It may also be added to foods or beverages for the purpose of preventing, alleviating and treating dysmenorrhea. At this time, the amount of the extract in the food or beverage, in general, in the case of the health functional food composition of the present invention can be added to 0.1 to 20% by weight, preferably 1 to 15% by weight of the total food weight, the health beverage composition It can be added at a ratio of 1 to 30 g, preferably 3 to 10 g based on 100 ml.

The health beverage composition of the present invention has no special limitation in the liquid component except for containing the complex herbal extract as an essential ingredient in the indicated ratio, and may contain various flavors or natural carbohydrates as additional ingredients, such as ordinary drinks. . Examples of the above-mentioned natural carbohydrates include monosaccharides such as glucose, fructose and the like; Disaccharides such as maltose, sucrose and the like; And conventional sugars such as polysaccharides such as dextrin, cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As flavoring agents other than those mentioned above, natural flavoring agents (tauumatin, stevia extract (e.g., rebaudioside A, glycyrrhizin, etc.), and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. The proportion of natural carbohydrates is generally about 1-20g, preferably about 5-12g per 100ml of the composition of the present invention.

In addition to the above, the composition of the present invention includes various nutrients, vitamins, minerals (electrolytes), flavors such as synthetic flavors and natural flavors, coloring and neutralizing agents (such as cheese and chocolate), pectic acid and salts thereof, alginic acid and its Salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages, and the like. In addition, the compositions of the present invention may contain fruit flesh for the production of natural fruit juices and fruit juice drinks and vegetable drinks. These components can be used independently or in combination. The proportion of such additives is not so critical but is generally selected from the range of 0 to about 20 parts by weight per 100 parts by weight of the composition of the present invention.

'Geun' which is a unit used in the following examples may be converted into 600 g of one root according to the conversion standard of the metrological form described in the Chinese medicine.

Hereinafter, the present invention will be described in detail by Examples and Test Examples.

However, the following Examples and Test Examples are only illustrative of the present invention, and the content of the present invention is not limited to the following Examples and Test Examples.

Example 1 Compound Herbal Extract Preparation Example 1

Hyangbuja, Danggui, Bongbu, Barkpi, Love Leaf, Yakjang, Cheongung, Hyeonhosaek, Samreung, Siho, Honghwa and Omae dried herbs purchased from Gyeongdong Market were pulverized and powdered.

After mixing the herbal medicines at the same weight ratio, 1.2 kg of the mixed herbal medicines were immersed in 5 liters of methanol and left for 3 days. The extract was filtered, the filtrate was concentrated under reduced pressure and dried to prepare 700 g of a composite herbal extract.

Example 2. Compound Herbal Extract Preparation Example 2

Raw materials were selected and adjusted according to the theft and powder degree in the Pharmacopoeia, then Hyangbuja 5kg, Angelica 714.3g, Bulge 714.3g, Yak 714.3g, Peony skin 357.1g, Cheongung 357.1g, Hyunho Saek 357.1g, Siho 357.1g, Safflower 357.1g, young leaf 357.1g, Samreung 357.1g, oak 357.1g were mixed in an extractor, 133 liters of purified water was added, extracted at 104 ° C for 4 hours, left for 2 hours, and extracted again for 2 hours and left for 16 hours.

The extract was filtered and the filtrate was concentrated under reduced pressure at 60 ° C. or lower to obtain water immersion drying x 1.2 kg (yield: 12%) to prepare 10,000 rings according to the preparation of the Pharmacopoeia General Formula Pill below.

Example 3 Complex Herbal Extract Preparation Example 3

Hyangbuja and Dongguk dried herbal medicines purchased at Gyeongdong Market were washed and dried in the sun and then sliced.

After mixing 6 roots of Hyangbuja and 4 roots of Angelica, 10 roots of mixed herbal medicines were immersed in 2.8 liters of soju and sealed, and then left for 3 days. After 3 days, the saengbuja was taken out and dried, and the extract was filtered. The filtrate was used mixed or concentrated with other herbal extracts.

Example 4. Compound Herbal Extract Preparation Example 4

The Hyangbuja and the dried dried herb purchased from Kyungdong Market were washed, dried in the sun, and then chopped.

After mixing 6 roots of Hyangbuja and 4 roots of sediment, 10 roots of mixed herbal medicines were immersed in 2.8 liters of unseasoned juice in which 114 g of salt was dissolved, and then left for 3 days. After 3 days, the saengbuja was taken out and dried, and the extract was filtered. The filtrate was used mixed or concentrated with other herbal extracts.

Example 5 Complex Herbal Extract Preparation Example 5

Hyangbuja, bark skin and leaf dried herbal medicines purchased at Gyeongdong Market were washed, dried in the sun, and then chopped.

After mixing 6 roots of Hyangbuja, 2 roots of neck bark and 2 roots of lobe, 10 roots of mixed herbal medicines were immersed in 2.8 liters of unsweetened juice and sealed, and left for 3 days. After 3 days, the saengbuja was taken out and dried, and the extract was filtered. The filtrate was used mixed or concentrated with other herbal extracts.

Example 6 Combination Herbal Extract Preparation Example 6

Hyangbuja and oak dried herbal medicines purchased at Gyeongdong Market were washed and dried in the sun and then sliced.

After mixing six roots of Hyangbuja and four roots of five drops, 10 roots of mixed herbal medicines were immersed in 2.8 liters of unsweetened juice and sealed, and left for 3 days. After 3 days, the saengbuja was taken out and dried, and the extract was filtered. The filtrate was used mixed or concentrated with other herbal extracts.

Example 7. Compound Herbal Extract Preparation Example 7

Hyangbuja, Cheonggung, and Hyunho-colored dried herb purchased from Gyeongdong Market were washed, dried completely in the sun, and then chopped.

After mixing 6 roots of Hyangbuja, 2 roots of Cheongung and 2 roots of Hyunho-saeng, 10 roots of mixed herbal medicines were immersed in 14.7 liters of distilled water and sealed, and left for 3 days. After 3 days, the saengbuja was taken out and dried, and the extract was filtered. The filtrate was used mixed or concentrated with other herbal extracts.

Example 8. Compound Herbal Extract Preparation Example 8

Hyangbuja, Samneung, and Siho dry herbs purchased from Gyeongdong Market were washed, dried in the sun, and then chopped.

After mixing 6 roots of Hyangbuja, 2 roots of Samreung and 2 roots of Shiho, 10 roots of mixed herbal medicines were immersed in 14.7 liters of distilled water mixed with vinegar at 1-fold vinegar concentration, and left for 3 days. After 3 days, the saengbuja was taken out and dried, and the extract was filtered. The filtrate was used mixed or concentrated with other herbal extracts.

Example 9 Combination Herbal Extract Preparation Example 9

Hyangbuja, safflower and omega dried herbal medicines purchased at Gyeongdong Market were washed, dried in the sun, and then chopped.

Six roots of Hyangbuja, two roots of safflower and two roots of ume were mixed, and 10 roots of mixed herbal medicines were immersed in 1 liter of vinegar and 114 liters of brine, and then left for 3 days. After 3 days, the saengbuja was taken out and dried, and the extract was filtered. The filtrate was used mixed or concentrated with other herbal extracts.

Example 10. Compound 10 extract preparation example 10

The herbal extracts of Examples 3 to 9 were mixed in equal amounts of 5 liters, 30 liters of which were mixed, heated and concentrated to prepare about 10 liters, thereby preparing a complex herbal extract concentrate.

Example 11 Artemis Preparation as a Pill for Treating Menstrual Pain

100 g of corn starch was added to 500 ml of purified water and boiled to complete mixing. Then, the mixture was cooled to a semi-solid. After mixing with 120 g of the mixed herbal medicine of Example 10, the mixture was completely mixed and kneaded. It was prepared by drying, and this pill was named Artemis.

In order to confirm the physiological pain relief and other effects on the composition for treating menstrual pain of the present invention, women of childbearing potential were investigated for symptoms before and after taking.

Clinical trial example.

To ten women in their twenties, thirties, forties, and fifties among the patients who visited the pill prepared in Example 11 to Anyang Grandfather Oriental Medical Center (President Nouijun), especially, premenstrual syndrome, menstrual pain, coldness, etc. Women were given orally at 40 doses per day before menstruation or during menstrual cramps before bedtime. The trial period ranged from March 21, 2002 to April 17, 2002. As a result of the application, the questionnaire and VAS were used to directly indicate changes before and after taking the drug. The results are shown in Table 1 below.

Symptom Cured Ease / shrink No change worse Menstrual pain 14/40 35% 14/40 35% 11/40 27.5% 1/40 2.5% Period of menstrual pain 15/40 37.5% 12/40 30% 13/40 32.5% 0/40 0% Coldly 10/40 25% 20/40 50% 10/40 25% 0/40 0% Cold hands and feet 4/40 10% 23/40 57.5% 13/40 32.5% 0/40 0%

In the treatment of dysmenorrhea, the clinical trials of Artemis administered in Example 11 of the present invention showed good clinical and response results in the treatment of dysmenorrhea, dysmenorrhea, low back pain, and the lower abdomen. Increasing the body temperature of the result showed good results in the cold caused by menstrual irregularities. Adverse events were reported in 3 patients (0.75%). The symptoms were skin rash and lethargy, and skin rash incidence (0.05%). There were no serious adverse events.

The complex herbal extract of the present invention can be administered in the following formulations, the following formulation examples are merely to illustrate the invention, whereby the content of the invention is not limited.

Formulation Example 1 Preparation of Pills

Complex herbal extract of Example 10..120 mg

Corn starch ............... 100 mg

Sterilized Distilled Water ...

The above components are mixed and refilled in a 0.3 cm diameter by a conventional pill manufacturing method to prepare pills.

Formulation Example 2 Preparation of Tablet

Dry herbal extract of Example 10 ......... 200 mg

Lactose ......................................... 100 mg

Starch ......................................... 100 mg

Magnesium stearate proper amount

The above components are mixed and tableted according to a conventional method for producing tablets to produce tablets.

Formulation Example 3 Preparation of Capsule

Complex herbal extract of Example 10 ............ 100 mg

Lactose 50 mg

Starch .................................. 50mg

Talc ........................................ 2mg

Magnesium Stearate .........

The capsules are prepared by mixing the above components and filling the gelatin capsules according to a conventional method for preparing capsules.

Formulation Example 4 Preparation of Liquid

Complex herbal extract of Example 10 ............ 1000 mg

Sugar ... 20g

Isomerized sugar ............... 20g

Lemon flavor ......................

Purified water was added to make a total of 1000 ml. According to the conventional method for preparing a liquid, the above components are mixed, and then filled into a brown bottle and sterilized to prepare a liquid.

Formulation Example 5 Preparation of Healthy Food

Combined herbal dry extract of Example 10 ....... 1000 mg

Vitamin Blend ...............

Vitamin A Acetate ............... 70 μg

Vitamin E ........... 1.0 mg

Vitamin B1 ......... 0.13 mg

Vitamin B2 ........... 0.15 mg

Vitamin B6 ............ 0.5 mg

Vitamin B12 ........................ 0.2 μg

Vitamin C ......................................... 10 mg

Biotin ............... 10 μg

Nicotinic Acid Amide ... 1.7 mg

Folic acid ............... 50 ㎍

Calcium Pantothenate ..................... 0.5 mg

Inorganic Mixture ...

Ferrous Sulfate ............... 1.75 mg

Zinc Oxide ........... 0.82 mg

Magnesium Carbonate ......... 25.3 mg

Potassium monophosphate ......................................... 15 mg

Dicalcium Phosphate ............... 55 mg

Potassium citrate ... 90 mg

Calcium Carbonate ... 100 mg

Magnesium Chloride ............... 24.8 mg

Although the composition ratio of the above-mentioned vitamin and mineral mixtures is mixed with a component suitable for a health food in a preferred embodiment, the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional health food manufacturing method. The granules may be prepared and used for preparing a health food composition according to a conventional method.

Formulation Example 6 Preparation of Healthy Drink

Combined herbal extract of Example 10 ..... 1000 mg

Citric Acid ........................................ 1000 mg

Oligosaccharide ......................... 100 g

Plum concentrate ........................... 2 g

Taurine ......................................... 1 g

Purified water is added ............................................. 900 ml

After mixing the above components in accordance with the conventional healthy beverage preparation method, and stirred and heated at 85 ℃ for about 1 hour, the resulting solution is filtered and obtained in a sterilized 2 liter container, sealed sterilized and then refrigerated Used to prepare the healthy beverage composition of the invention.

Although the composition ratio is a composition suitable for a preferred beverage in a preferred embodiment, the composition ratio may be arbitrarily modified according to regional and ethnic preferences such as demand hierarchy, demand country, use purpose.

As described above, the complex herbal extract of the present invention is a herbal drug that has been widely used in conventional medicine as a pharmaceutical agent, and there is no toxicity problem, and when oral administration of the composition of the present invention confirms that menstrual pain is alleviated and menstrual irregularities are treated. It can be used as a medicine and health functional food to prevent and treat pain caused by menstrual pain and to cure menstrual irregularities.

Claims (3)

Composition for preventing, alleviating and treating dysmenorrhea, comprising a complex herbal medicine consisting of hyangbuja, Angelica, sesame, bark skin, love leaf, oak, cheongung, Hyunho color, samreung, shiho, safflower, and ume. Composition for the prevention and treatment of menstrual irregularities containing complex herbal medicine consisting of hyangbuja, Angelica, sesame, bark skin, love leaf, oak, cheongung, Hyunho color, samreung, shiho, safflower and omae. Health functional foods for preventing or alleviating menstrual cramps and menstrual irregularities containing complex herbal medicine consisting of Hyangbuja, Angelica, Sesame, Bark skin, apple leaf, Yak, Cheongung, Hyunho Saeng, Samneung, Shiho, Safflower and Ome and food acceptable food additives.