CN111388497B - Pharmaceutical composition for treating polycystic ovarian syndrome - Google Patents

Pharmaceutical composition for treating polycystic ovarian syndrome Download PDF

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CN111388497B
CN111388497B CN202010442913.4A CN202010442913A CN111388497B CN 111388497 B CN111388497 B CN 111388497B CN 202010442913 A CN202010442913 A CN 202010442913A CN 111388497 B CN111388497 B CN 111388497B
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pharmaceutical composition
alisol
aucubin
icariin
quercetin
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CN111388497A (en
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郝松莉
陈强
徐芳
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Heilongjiang University of Chinese Medicine
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin

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  • Health & Medical Sciences (AREA)
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  • Pregnancy & Childbirth (AREA)
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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention provides a pharmaceutical composition for treating polycystic ovarian syndrome. The pharmaceutical composition is prepared by taking quercetin, icariin, aucubin and alisol A as raw materials according to a certain weight percentage. Can be prepared into various clinically common oral preparations. The pharmaceutical composition has good treatment effect on a rat model with polycystic ovarian syndrome, can obviously reverse insulin resistance, has no toxic or side effect, and has good clinical application prospect.

Description

Pharmaceutical composition for treating polycystic ovarian syndrome
Technical Field
The invention belongs to the field of medicines, and particularly relates to a pharmaceutical composition for treating polycystic ovarian syndrome, a preparation method thereof, an oral pharmaceutical preparation and application thereof.
Background
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in gynecological clinics. It is mainly characterized by menstrual disorder (such as amenorrhea, infrequent menstruation, functional uterine bleeding, etc.), hyperandrogenism clinical manifestations (such as hirsutism, acne, etc.) and/or hyperandrogenism, ovarian polycystic changes. Anovulatory hemorrhage or infrequent menstruation caused by polycystic ovarian syndrome, and ovulation failure in the birth period are important reasons for infertility. PCOS patients are also associated with complications that severely affect female health, such as obesity, hyperinsulinemia, glycolipid metabolism disorders, type 2 diabetes, cardiovascular disease, and the like.
Clinically, hyperandrogenism and insulin resistance are two of the major features of polycystic ovary syndrome. Statistically, between 50% and 70% of patients have insulin resistance at the same time. Currently, there is a lack of curative treatment for PCOS. Western medicine mainly uses hormone regulating drugs for treatment. For example, ethinylestradiol cyproterone tablets (darlingn-35) are suitable for patients with hyperandrogenism or hyperandrogenism, and periodic withdrawal of progestin or other short-acting oral contraceptives are commonly used to regulate the menstrual cycle. However, hormone therapy is limited in its clinical application to some extent due to its large side effects and many clinical contraindications. In addition, some insulin-lowering drugs (such as metformin and the like) are used for adjuvant treatment.
The traditional Chinese medicine has the unique advantage in conditioning gynecological endocrine, the ancient books of traditional Chinese medicine have no names of polycystic ovarian syndrome, and the traditional Chinese medicine belongs to the categories of later menstruation, amenorrhea, infertility, metrorrhagia and metrostaxis and the like according to clinical manifestations, and the pathogenesis is complex. For example, according to years of clinical experience, the famous old traditional Chinese medicine chaihong rock is considered to be mostly caused by insufficiency of spleen and kidney and phlegm dampness blocking, and the empirical prescription (containing the traditional Chinese medicines such as the dodder, the plantain seed, the epimedium, the eucommia bark, the angelica and the like) has the effects of obviously improving the menstrual condition of a PCOS patient and promoting ovulation and pregnancy (see Chinese tuckahoe, etc., the clinical observation of treating polycystic ovary syndrome by the kidney-tonifying spleen-tonifying blood-nourishing diuresis method, China journal of combination of traditional Chinese and western medicines, volume 23, phase 11, month 11 in 2003, page 819. 822). However, the traditional Chinese medicine decoction has heavy taste, may stimulate the gastrointestinal tract, and is inconvenient to carry, so that the patient has poor medication compliance, and the patient is difficult to insist on using the decoction for a long time. Meanwhile, the traditional Chinese medicine prescription has more traditional Chinese medicines, so that the cost and the potential safety hazard are higher, and the effective quality control and the large-scale production are not facilitated.
In view of the above, it is imperative to develop a pharmaceutical composition for treating polycystic ovarian syndrome, which has good therapeutic effect, little side effect and convenient administration, by deeply researching and screening natural product active ingredient monomers in the classical Chinese medicine formulation by a modern pharmacological research method.
Disclosure of Invention
The invention aims to provide a safe, effective, convenient and economic pharmaceutical composition for patients with polycystic ovarian syndrome, and provides a new idea for clinically treating polycystic ovarian syndrome and modernization of traditional Chinese medicine.
The technical scheme for realizing the purpose of the invention is as follows:
the first aspect of the invention provides a pharmaceutical composition for treating polycystic ovary syndrome, which comprises quercetin, icariin, aucubin and alisol A.
In one embodiment, the pharmaceutical composition comprises the following active ingredients in weight percent: 20-40% of quercetin, 20-40% of icariin, 5-20% of aucubin and 10-25% of alisol A.
In a more preferred embodiment, the pharmaceutical composition comprises the following active ingredients in weight percent: quercetin 30-40%, icariin 30-40%, aucubin 5-15% and alisol A15-25%.
In a most preferred embodiment, the pharmaceutical composition consists of the following active ingredients in weight percent: 35% of quercetin, 35% of icariin, 10% of aucubin and 20% of alisol A.
In addition, the pharmaceutical composition may further comprise metformin. In a preferred embodiment, the total weight percentage of quercetin, icariin, aucubin, and alisol and the weight percentage of metformin are both 50%.
Alternatively, the pharmaceutical compositions of the present invention may be used in combination with a suitable dose of metformin. Both may be administered simultaneously, or metformin may be administered before or after administration of the pharmaceutical composition of the invention.
In a second aspect of the present invention, there is provided a process for the preparation of the above pharmaceutical composition by mixing the above active ingredients.
The third aspect of the invention provides an oral pharmaceutical preparation for treating polycystic ovary syndrome, which is prepared by mixing the pharmaceutical composition with a pharmaceutically acceptable carrier.
The pharmaceutical preparation is tablets, capsules, granules or oral liquid. Preferably tablets or capsules.
The pharmaceutically acceptable carrier refers to conventional pharmaceutical carriers in the field of pharmaceutical preparations, and is selected from one or more of fillers, binders, disintegrants, lubricants, suspending agents, wetting agents, pigments, flavoring agents, solvents and surfactants.
In a fourth aspect, the invention provides the use of the pharmaceutical composition or the oral pharmaceutical preparation for preparing a medicament for treating polycystic ovarian syndrome.
In a specific embodiment, the pharmaceutical composition or oral pharmaceutical preparation further has an effect of improving insulin resistance.
The active ingredients quercetin, icariin, aucubin and alisol A used in the pharmaceutical composition can be extracted and separated from flowers, leaves and fruits of Chinese medicinal materials containing the active ingredients, such as dodder, epimedium, alisma orientale and the like, by adopting a biological purification method, and can also be purchased from commercially available products.
At present, many scholars consider that, in addition to sex hormone disorders, insulin resistance and hyperinsulinemia are closely related to the onset of polycystic ovary syndrome. The pharmaceutical composition containing quercetin, icariin, aucubin and alisol A can directly and comprehensively regulate hormone balance in a subject, also has the effects of improving insulin resistance and hyperinsulinemia and reducing local androgen generation, and can restore the functions of hypothalamus-pituitary-ovarian axis through mutual promotion and restriction of various hormones and factors, and restore normal local regulation and control of the ovary by changing the internal environment of the ovary, so that the PCOS clinical symptoms and related biochemical indexes are improved synergistically.
Compared with the prior art, the invention has the following beneficial effects:
(1) on the basis of treating the classic prescription of polycystic ovarian syndrome, four natural product monomers are selected through a large number of pharmacological experimental screens, and are combined according to a specific proportion to prepare the pharmaceutical composition capable of treating the polycystic ovarian syndrome, so that a new thought is provided for modernization of traditional Chinese medicine.
(2) Pharmacological experiments prove that the pharmaceutical composition has good treatment effect on a rat model with polycystic ovarian syndrome, can reverse the disordered sexual cycle of experimental animals, can also obviously reverse insulin resistance, has no toxic or side effect, and has good clinical application prospect.
(3) The natural product monomers used in the pharmaceutical composition have wide sources and can be produced by a mature method, so that the pharmaceutical composition is convenient for industrial large-scale production. In addition, the medicinal composition is prepared into a conventional oral preparation by adding a medicinal carrier, so that the medicament is stable in treatment, the effect is improved, and the administration is convenient.
(4) Surprisingly, the addition of metformin to the pharmaceutical composition of the present invention, or the combination of metformin and the pharmaceutical composition of the present invention, shows even stronger synergistic effect in the treatment of polycystic ovarian syndrome than the single use of the pharmaceutical composition of the present invention, and provides more treatment options for clinically treating polycystic ovarian syndrome.
Detailed Description
The following description of the preferred embodiments of the present invention is provided for the purpose of illustration and description, and is in no way intended to limit the invention. The examples do not show the specific techniques or conditions, according to the technical or conditions described in the literature in the field, or according to the product specifications. The reagents or instruments used are conventional products which are not known to manufacturers and are available from normal sources.
Example 1: preparation of oral preparation of pharmaceutical composition of the invention
1. An exemplary recipe is as follows:
prescription 1: 35g of quercetin, 35g of icariin, 10g of aucubin and 20g of alisol A, and the total amount is 100 g.
Prescription 2: 40g of quercetin, 40g of icariin, 5g of aucubin and 15g of alisol, and the total amount is 100 g.
Prescription 3: 30g of quercetin, 40g of icariin, 15g of aucubin and 15g of alisol A, and the total amount is 100 g.
Prescription 4: 17.5g of quercetin, 17.5g of icariin, 5g of aucubin, 10g of alisol A and 50g of metformin, wherein the total amount is 100 g.
2. Exemplary dosage forms are as follows:
and (3) tablet preparation: 1-3100 g of prescription, 50g of lactose, 15g of compressible starch, 10g of hydroxypropyl cellulose, 5g of magnesium stearate and a proper amount of 70% ethanol are respectively taken and prepared into 1000 tablets.
And (3) capsule preparation: 1-3100 g of the prescription, 80g of starch, 25g of sodium carboxymethyl starch, 20g of dextrin and a proper amount of 70% ethanol are respectively taken to prepare 1000 granules.
Example 2: pharmacodynamic experiment
1. Purpose of the experiment:
investigating the effect of the pharmaceutical composition of the invention on a rat model of polycystic ovarian syndrome insulin resistance
2. Experimental materials:
2.1 animals: SPF-grade Wister female rat with weight of 250 + -20 g was purchased from Beijing Huafukang Biotechnology GmbH with license number SCXK (Jing) 2018-.
2.2 Instrument: 1mL injector, gavage needle, animal cage, picric acid, capillary glass tube, high-precision zoom optical microscope, low-temperature centrifuge, glucometer, enzyme-linked immunosorbent assay.
2.3 main drugs and reagents: quercetin, icariin, aucubin and alisol A, dehydroepiandrosterone, sesame oil for injection (Sigma company, USA), extract of Tongliang for invigorating spleen, tonifying kidney and nourishing blood were prepared according to literature method (see Polyporus, etc., as described above), and single medicinal materials were purchased from Beijing Hojingtang drugstore, Daying-35 (Bayer medicine health promotion Co., Ltd.), metformin (Heizinghengtai pharmaceutical industry Co., Ltd.), serum insulin, testosterone (T), Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) detection kit (Novertaine company, USA).
3. Experimental methods
3.1 establishment and administration of insulin resistance rat model of polycystic ovarian syndrome
Female Wister rats are injected with 6mg/100g of dehydroepiandrosterone (dissolved in 0.09mL of sesame oil and 0.01mL of 95% ethanol solution) subcutaneously at the neck every day, after 20 days of continuous injection, the vaginal exfoliative cytology is observed for 10 days, and the rats with vaginal epithelial cells continuously in a keratinized state are used as rat polycystic ovary syndrome animal models successfully induced by the dehydroepiandrosterone, and follow-up experiments are continued.
Rats successfully modeled were fasted overnight, and fasting blood glucose and insulin were measured the next morning after retrobulbar venous blood sampling. The insulin resistance index is calculated according to the following formula: the insulin resistance index of the rat is fasting blood glucose x fasting insulin/22.5, wherein the rat with the insulin resistance index of more than 2 is taken as a model animal for successfully inducing the insulin resistance of the polycystic ovary syndrome, and the subsequent experiments are continued.
The grouping and dosing schedule was as follows:
(1) blank group: gavage, 0.9% physiological saline
(2) Model group: gavage, 0.9% physiological saline
(3) Experimental groups: intragastric administration, prescription 1 (calculated by weight percentage, quercetin 35%, icariin 35%, aucubin 10%, alisol A20%), 100mg/kg
(4) The prescription control group: 2g/kg of extract (calculated according to actual extract) of formula for stomach irrigation, spleen strengthening, kidney tonifying, blood nourishing and diuresis promoting
(5) Hormone control group: gavage to achieve Ying-35, 2mg/kg
(6) Metformin control group: gavage, metformin, 100mg/kg
(7) A combination of drugs: and (3) intragastric administration, wherein the ratio of the experimental group (3) to the metformin control group (7) is 1: 1 ratio combination, i.e. 50mg/kg of each administration
The above groups are fed under the same feeding conditions once a day for two weeks.
3.2 evaluation index
3.2.1 hormone level detection: after the last administration, rats in each group were fasted overnight, anesthetized with 2% sodium pentobarbital, and blood was collected in 3mL abdominal aorta, and serum was centrifuged, one part was directly measured for T, LH and FSH levels, and the other part was stored at-80 ℃ for further use.
3.2.2 blood glucose level, insulin level and insulin resistance index measurements: serum samples frozen at-80 ℃ were taken, and after returning to room temperature, fasting plasma glucose (FBG) and Fasting Insulin (FINS) levels were determined in each group of rats, and the insulin resistance index (HOMA-IR) was calculated using the formula described above.
3.3 statistical methods
Results were analyzed using SPSS 19.0 statistical software and data are presented as mean ± standard deviation. The comparison among groups was performed by one-way anova, and p <0.05 indicated that the difference was statistically significant.
4. Results of the experiment
4.1 Effect of the pharmaceutical composition of the present invention on the insulin resistance level of polycystic ovary syndrome in rats
As shown in Table 1, the serum T, LH level in the model group rats was significantly higher (p <0.001, p <0.01) than that in the blank group rats, and the FSH level was significantly lower (p <0.01) than that in the blank group, indicating that the model group animals had already developed hyperandrogenism and sex hormone disorder. As can be seen from the data in table 1, T and LH levels were very significantly decreased (p <0.001, p <0.01) and FSH levels were significantly increased (p <0.01) compared to the model group after administration of the control hormone to the experimental animals by da-35. The animals of the experimental group given the pharmaceutical composition of the present invention showed a trend consistent with that of the hormone control group, only to a statistically significant extent slightly lower than that of the hormone control group (p <0.01, p < 0.05). The formulation control group also showed similar trend, but the effect intensity was less than that of the pharmaceutical composition of the present invention, and only the T value was statistically significant (p <0.05), and the changes in LH and FSH were not statistically significant. Metformin administration to experimental animals had only a weak effect on T, LH and FSH levels during the study, suggesting that metformin has a weak direct effect on hormone levels. Surprisingly, however, although metformin alone had a weaker effect on hormone levels, the combination showed a stronger effect than the experimental group, with a consistent trend of change from the hormone control group, only to a statistically significant extent slightly lower than the hormone control group (p <0.01, p < 0.05).
The results show that the pharmaceutical composition provided by the invention can generate significant effects similar to hormone control Dauin-35 on T, LH and FSH hormone levels of a polycystic ovarian syndrome model rat when being administered to experimental animals, and the action effect of the pharmaceutical composition is significantly better than that of a prescription control group. In addition, the effect on the hormone level of the pharmaceutical composition of the invention shows stronger synergistic effect after being combined with metformin.
Table 1: comparison of hormone levels in rats of each group
Figure BDA0002504807260000081
Note: comparison with blank control: p<0.01，***P<0.001; comparison with model groups:#P<0.05，##P<0.01，###P<0.001
4.2 Effect of pharmaceutical composition of the present invention on blood glucose level, insulin level and insulin resistance index in polycystic ovary syndrome insulin resistant rats
As shown in Table 2, the serum FBG, FINS levels and HOMA-IR values of the model group rats were significantly increased (p <0.05, p <0.01) compared with those of the blank group rats, indicating that the model group animals had developed insulin resistance symptoms. As can be seen from the data in table 2, after administration of metformin to the experimental animals, insulin resistance was significantly reduced (p <0.05, p <0.01) in the experimental animals, and serum FBG, FINS levels and HOMA-IR values were closer to those of the blank animals. However, the hormone control of daruin-35 given to the experimental animals did not appear to have a significant effect on their serum FBG, FINS levels and HOMA-IR values, indicating that administration of animal hormone alone did not improve insulin resistance in the experimental animals at the same time. As shown by the data in table 2, the administration of the pharmaceutical composition of the present invention to experimental animals significantly reduced serum FBG, FINS levels and HOMA-IR values (p <0.05) during the study period, although the effect was less intense than that of metformin. In contrast, the control group of formulations had weaker effects on the blood glucose and insulin related indicators, had no statistical significance on the effects of serum FBG and FINS levels, and was only able to significantly reduce the HOMA-IR value (p < 0.05). However, the combination group showed a stronger effect in improving insulin resistance than the experimental group, which had a consistent trend with the metformin control group, only to a statistically significant extent slightly lower than the metformin control group (p < 0.05).
The results show that the pharmaceutical composition provided by the invention can produce significant reduction effects on serum FBG (fiber bragg grating) and FINS (fiber optic protein) levels and HOMA-IR (highest occupied molecular weight) values of rat in a polycystic ovarian syndrome model after being administered to experimental animals, and although the effect is not as good as that of a special antidiabetic drug metformin, the effect is significantly better than that of a prescription control group. In addition, the pharmaceutical composition of the invention shows stronger synergistic effect in improving insulin resistance after being combined with metformin.
Table 2: blood glucose level, insulin level and insulin resistance index in rats of each group
Figure BDA0002504807260000091
Note: comparison with blank control: p<0.05，**P<0.01; comparison with model groups:#P<0.05，##P<0.01
5. conclusion of the experiment
The pharmaceutical composition provided by the invention has a significant improvement effect on the hormone level and the insulin resistance of a polycystic ovary syndrome insulin resistant rat, and the effect is obviously better than that of a classic formula which is capable of tonifying spleen, tonifying kidney, nourishing blood and promoting diuresis. In addition, compared with the unilateral action effect of hormone drugs and metformin on hormone and insulin resistance, the pharmaceutical composition has good effects on regulating hormone level and improving insulin resistance. The pharmaceutical composition of the present invention shows stronger synergistic effect than the pharmaceutical composition of the present invention in both regulation of hormone level and improvement of insulin resistance when used in combination with metformin.
In addition, during the administration of the animal experiment for up to two weeks, no obvious adverse reaction of the pharmaceutical composition is observed, and the experimental animals have good tolerance to the pharmaceutical composition.
It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims (10)

1. A pharmaceutical composition for treating polycystic ovarian syndrome, which is characterized by comprising quercetin, icariin, aucubin and alisol A.
2. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises the following active ingredients in weight percent: 20-40% of quercetin, 20-40% of icariin, 5-20% of aucubin and 25% of alisol A10.
3. The pharmaceutical composition according to claim 1 or 2, wherein the pharmaceutical composition comprises the following active ingredients in weight percent: quercetin 30-40%, icariin 30-40%, aucubin 5-15% and alisol A15-25%.
4. The pharmaceutical composition of claim 3, wherein the pharmaceutical composition consists of the following active ingredients in weight percent: 35% of quercetin, 35% of icariin, 10% of aucubin and 20% of alisol A.
5. The pharmaceutical composition of claim 1, further comprising metformin.
6. A process for the preparation of a pharmaceutical composition according to claim 1, characterized in that the active ingredients according to claim 1 are mixed.
7. An oral pharmaceutical formulation for treating polycystic ovary syndrome, wherein the pharmaceutical formulation is prepared by mixing the pharmaceutical composition of claim 1 with a pharmaceutically acceptable carrier.
8. The oral pharmaceutical formulation of claim 7, wherein the pharmaceutical formulation is a tablet, capsule, granule or oral liquid.
9. Use of the pharmaceutical composition of claim 1 in the manufacture of a medicament for the treatment of polycystic ovary syndrome.
10. The use according to claim 9, wherein the pharmaceutical composition or oral pharmaceutical preparation further has an effect of improving insulin resistance.
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CN103285022B (en) * 2013-04-19 2016-06-08 中国人民解放军第二军医大学 For preparing the Chinese medicine monomer composition and method of making the same for the treatment of polycystic ovarian syndrome
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