Traditional Chinese medicine composition for treating polycystic ovarian syndrome and preparation thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating polycystic ovarian syndrome and a preparation thereof. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: semen cuscutae, fructus lycii, glossy privet fruit, herba ecliptae, radix bupleuri, codonopsis pilosula, ligusticum wallichii, radix paeoniae alba, prepared rehmannia root, vinegar-processed rhizoma cyperi, angelica sinensis, fructus aurantii, pericarpium citri reticulatae and honey-fried licorice root. Pharmacological experiments and clinical tests prove that the traditional Chinese medicine composition can effectively reduce the androgen level, promote follicle growth and provide a good fertilization environment for the polycystic ovarian syndrome, and meanwhile has high safety and high application and popularization value.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition and preparation for treating polycystic ovary syndrome and a preparation method thereof. Background Art

[0002] Polycystic ovary syndrome (PCOS) is a complex endocrine and metabolic disorder characterized by hyperandrogenism, ovulation disorders, and polycystic ovarian changes. Clinical manifestations include oligomenorrhea or even amenorrhea, infertility, hirsutism and acne, obesity, emotional disorders, etc. According to statistics, the incidence of PCOS in women of childbearing age worldwide is as high as 6% to 20%, of which about 85% of PCOS patients have hyperandrogenism or related clinical symptoms.

[0003] At present, the cause of PCOS is not completely clear. It is generally believed that the pathogenesis of PCOS is due to persistent anovulation and metabolic dysfunction. The main problems are hyperandrogenism and insulin resistance. In addition, environmental factors such as intrauterine environmental pollution, intrauterine high androgen levels, overnutrition and unhealthy lifestyles accelerate the occurrence and development of PCOS.

[0004] In Western medicine treatment, progestins are often used cyclically to adjust PCOS patients in adolescence and perimenopause, and short-acting combined oral contraceptives are used to prevent endometrial hyperplasia and relieve symptoms of hyperandrogenism. In addition, for PCOS patients with insulin resistance, metformin is used in combination with clomiphene, letrozole, and gonadotropin to induce ovulation. Although the above treatment methods can promote ovulation rates of 76.6-88.5%, the pregnancy rate is only 21.5-31.3%, and the treatment course is long and prone to relapse. How to improve the pregnancy rate of PCOS patients still needs to be solved urgently.

[0005] Traditional Chinese medicine has a unique advantage in treating PCOS. It classifies it as a disease category including late menstruation, scanty menstruation, amenorrhea, metrorrhagia, infertility, etc., and adopts the method of syndrome differentiation and treatment based on the diversity of its clinical manifestations. The main etiology and pathogenesis can be summarized as liver depression and kidney deficiency, damp-heat in the liver meridian, and phlegm-dampness in spleen deficiency. Traditional Chinese medicine that nourishes the kidney and regulates menstruation, soothes the liver and clears heat, resolves phlegm and dredges the meridians, and activates blood circulation and removes blood stasis is commonly used for treatment, such as Chuanxiong, Angelica dahurica, peach kernel, safflower, red peony root, and aconite. Good results have been achieved, and because of few side effects and the ability to regulate body functions and improve sub-health conditions at the same time, it has gradually become a new choice for most patients.

[0006] Therefore, in view of the poor efficacy of PCOS in the prior art and the inability to completely cure it, which affects the quality of life, fertility and long-term health of patients, the present invention seeks a drug for improving or treating PCOS, which is of great significance. Summary of the invention

[0007] In the present application, the inventors of the present application attempt to provide a new Chinese medicine composition for improving or treating polycystic ovary syndrome, and provide a method for preparing the oral preparation of the above-mentioned Chinese medicine composition, which may help to clinically solve the problems of polycystic ovary syndrome such as oligomenorrhea or even amenorrhea, infertility, hirsutism and acne, obesity, emotional disorders, etc. in adolescent girls, women of childbearing age and perimenopausal women.

[0008] Specifically, the present invention relates to the following contents:

[0009] First, a Chinese medicine composition for improving or treating polycystic ovary syndrome is provided, which specifically comprises the following components in parts by weight:

[0010] Cuscuta 8-18 weight parts Lycium barbarum 8-18 weight parts Ligustrum lucidum 8-18 weight parts

[0011] 8-18 parts by weight of Eclipta prostrata 8-18 parts by weight of Bupleurum 8-18 parts by weight of Codonopsis pilosula 8-18 parts by weight

[0012] 10-15 weight parts of Chuanxiong, 10-15 weight parts of White Peony Root, 10-15 weight parts of Rehmannia Glutinosa, 10-15 weight parts of

[0013] Cyperus rotundus 10-15 weight parts Angelica sinensis 10-15 weight parts Citrus aurantium 10-15 weight parts

[0014] 6-12 parts by weight of dried tangerine peel and 3-7 parts by weight of liquorice.

[0015] During the prescription formulation process, the inventors found that when the Rehmannia root in the prescription is cooked Rehmannia root, the Cyperus rotundus is vinegar-cured Cyperus rotundus, and the Licorice root is roasted Licorice root, the overall efficacy of the drug is more stable and the therapeutic effect obtained is more satisfactory.

[0016] Furthermore, the inventors found that in one embodiment, when the Chinese medicine composition includes the following components in parts by weight, a better therapeutic effect is achieved:

[0017] Cuscuta chinensis 15 parts by weight Lycium barbarum 15 parts by weight Ligustrum lucidum 15 parts by weight

[0018] 15 parts by weight of Eclipta prostrata 15 parts by weight of Radix Bupleuri 15 parts by weight of Codonopsis pilosula 15 parts by weight

[0019] 12 parts by weight of Chuanxiong, 12 parts by weight of White Peony Root, 12 parts by weight of Rehmannia Glutinosa, 12 parts by weight

[0020] 12 parts by weight of vinegar-scented cyperus rotundus 12 parts by weight of Chinese angelica sinensis 12 parts by weight of fructus aurantii

[0021] 9 parts by weight of dried tangerine peel and 6 parts by weight of roasted licorice root.

[0022] The second purpose of the present invention is to provide a Chinese medicine composition for improving or treating polycystic ovary syndrome, which has high bioavailability, stable and reliable quality, is easy to carry and easy to take. Specifically, the Chinese medicine composition is prepared into an oral preparation according to conventional processes and excipients of Chinese medicine pharmaceutics. Preferably, the Chinese medicine composition can be prepared into one of capsules, granules and tablets.

[0023] The third object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition, comprising:

[0024] (1) Sieve and crush the above Chinese medicinal materials;

[0025] (2) Extracting the upper layer of volatile oil from Chuanxiong, white peony root, Chinese angelica root and liquorice by steam distillation, enclosing the volatile oil with cyclodextrin and drying it to obtain a cyclodextrin inclusion compound, and filtering the lower layer of residue for later use;

[0026] (3) extracting other Chinese medicinal materials and the filter residue in step (2) with ethanol, filtering, concentrating, drying, and crushing to obtain an extract powder for later use;

[0027] (4) The powders obtained in steps (2) and (3) are mixed to prepare a commonly used pharmaceutical preparation according to a conventional preparation method.

[0028] It is found through experiments that the volatile oil component in the present invention has a certain influence on the efficacy stability of the final drug. After the inventor creatively uses cyclodextrin for inclusion, it is found that the efficacy is better.

[0029] Preferably, in order to enhance the inclusion effect, after experiments, the inventors believe that the inclusion effect is better when β-cyclodextrin is used, and the mass ratio of the cyclodextrin to the volatile oil is preferably 4 to 8:1.

[0030] Furthermore, the cyclodextrin inclusion step in step (2) is as follows: separating the upper volatile oil, adding 1 to 4 times 85% ethanol and stirring, slowly dropping β-cyclodextrin aqueous solution into the above solution, stirring for 2-4 hours, filtering, washing and drying to obtain the inclusion compound.

[0031] Furthermore, except for the Chinese medicinal materials in step (2), the remaining Chinese medicinal materials and the residues in step (1) are added with 65-85% ethanol and heated under reflux for extraction 1-3 times, each time for 2-3 hours, the extracts are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.17-1.23 (65° C.), and then freeze-dried at low temperature.

[0032] In addition, the inventors also found that after being prepared into conventional oral preparations, the stability of the drug preparations was insufficient. This may be due to the poor stability of the active ingredients contained in the volatile oil and alcohol extract of the Chinese medicine composition of the present invention, thereby reducing the efficacy. In response to this phenomenon, the inventors tried to add stabilizers and finally determined that the stabilizers added were pyrosulfite and glycine.

[0033] Further, the preparation method of the Chinese medicine composition of the present invention is determined as follows:

[0034] (1) Sieve and crush the above Chinese medicinal materials;

[0035] (2) Extracting the upper volatile oil from Chuanxiong, white peony root, Chinese angelica root and liquorice by steam distillation, separating the upper volatile oil, adding 1 to 4 times 85% ethanol and stirring, slowly adding a β-cyclodextrin aqueous solution to the above solution, stirring for 2 to 4 hours, filtering, washing and drying to obtain an inclusion compound; the cyclodextrin used for the cyclodextrin inclusion compound is β-cyclodextrin, and the mass ratio of the cyclodextrin to the volatile oil is 4 to 8:1.

[0036] (3) Except for the Chinese medicinal materials in step (2), the remaining Chinese medicinal materials and the residues in step (1) are subjected to 65-85% ethanol heating and reflux extraction for 1-3 times, each time for 2-3 hours, the extracts are combined, filtered, and the filtrate is concentrated to an extract with a relative density of 1.17-1.23 (65° C.), sodium pyrosulfite and glycine are added to the extract, wherein the mass ratio of the extract, sodium pyrosulfite, and glycine is 1:0.5-0.8:0.6-1.0, and after stirring evenly, freeze-drying at low temperature to obtain a dry powder;

[0037] (4) The powders obtained in steps (2) and (3) are mixed to prepare a commonly used pharmaceutical preparation according to a conventional preparation method.

[0038] The fourth object of the present invention is to provide pharmaceutical uses of the above-mentioned Chinese medicine composition. The Chinese medicine composition of the present invention is cleverly combined and combined by the inventor according to the etiology of the disease. The whole prescription has both tonifying and purging, opening and closing properly, nourishing blood, promoting blood circulation without hurting blood, and warming without being dry and greasy. Pharmacological experiments have confirmed that the above-mentioned composition has the effects of tonifying the kidney and regulating menstruation, soothing the liver and regulating qi, and shows significant therapeutic effects on polycystic ovary syndrome, especially polycystic ovary syndrome with liver depression and kidney deficiency, which can significantly improve the development of follicles, improve irregular menstruation, and greatly improve the pregnancy rate.

[0039] Compared with the prior art, the Chinese medicine composition of the present invention has a reasonable formula and compatibility, the Chinese medicinal materials are cheap and easily available, the side effects are small, the preparation method is practical, it is convenient for clinical promotion and Chinese medicine research and development, and has a high promotion and application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 The results of the effect of the Chinese medicine composition of the present invention on the serum hormone level of rats (compared with the blank control group: P < 0.01 ## Compared with the model group, P < 0.01 is indicated by **);

[0041] Figure 2The results of the effect of the Chinese medicine composition of the present invention on the ovarian coefficient of rats (compared with the blank control group: P < 0.01 ## Compared with the model group, P<0.01 is indicated by **). DETAILED DESCRIPTION

[0042] The above contents of the present invention are further described in detail below through specific implementation methods in the form of embodiments. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following examples. All technologies realized based on the above contents of the present invention belong to the scope of the present invention.

[0043] Similar modifications, replacements or changes made to the technical solution of the present invention based on the routine selection and industry experience of those skilled in the art are all within the protection scope of the present invention.

[0044] Example 1 Preparation of granules

[0045] Formula:

[0046]

[0047] The preparation method is:

[0048] (1) Sieve and crush the above Chinese medicinal materials;

[0049] (2) Extract the upper volatile oil from Chuanxiong, white peony root, Chinese angelica root and liquorice by steam distillation, separate the upper volatile oil, add 2 times 85% ethanol and stir, slowly add β-cyclodextrin aqueous solution to the above solution, stir for 2 hours, filter, wash and dry to obtain inclusion compound; the cyclodextrin used for the cyclodextrin inclusion is β-cyclodextrin, and the mass ratio of the cyclodextrin to the volatile oil is 4:1.

[0050] (3) Except for the Chinese medicinal materials in step (2), the remaining Chinese medicinal materials and the residues in step (1) are subjected to 85% ethanol heating and reflux extraction for 3 times, each time for 3 hours, the extracts are combined, filtered, and the filtrate is concentrated to an extract with a relative density of 1.17 (65° C.), sodium pyrosulfite and glycine are added to the extract, wherein the mass ratio of the extract, sodium pyrosulfite, and glycine is 1:0.5:0.6, and after stirring evenly, freeze-drying at low temperature to obtain a dry powder;

[0051] (4) The powders obtained in steps (2) and (3) are mixed to prepare granules according to a conventional preparation method.

[0052] Example 2 Preparation of granules

[0053] Formula:

[0054]

[0055] The preparation method is:

[0056] (1) Sieve and crush the above Chinese medicinal materials;

[0057] (2) Extract the upper volatile oil from Chuanxiong, white peony root, Chinese angelica root and liquorice by steam distillation, separate the upper volatile oil, add 4 times 85% ethanol and stir, slowly add β-cyclodextrin aqueous solution to the above solution, stir for 4 hours, filter, wash and dry to obtain inclusion compound; the cyclodextrin used for the cyclodextrin inclusion is β-cyclodextrin, and the mass ratio of the cyclodextrin to the volatile oil is 8:1.

[0058] (3) Except for the Chinese medicinal materials in step (2), the remaining Chinese medicinal materials and the residues in step (1) are subjected to 65% ethanol heating and reflux extraction once, each time for 2 hours, the extracts are combined, filtered, and the filtrate is concentrated to an extract with a relative density of 1.23 (65° C.), sodium metabisulfite and glycine are added to the extract respectively, wherein the mass ratio of the extract, sodium metabisulfite, and glycine is 1:0.5:1.0, and after stirring evenly, freeze-drying at low temperature to obtain a dry powder;

[0059] (4) The powders obtained in steps (2) and (3) are mixed to prepare granules according to a conventional preparation method.

[0060] Example 3 Preparation of granules

[0061] Formula:

[0062]

[0063]

[0064] The preparation method is the same as that of Example 1.

[0065] Example 4 Preparation of granules

[0066] Formula:

[0067]

[0068] The preparation method is the same as that of Example 1.

[0069] Example 5 Preparation of granules

[0070] Formula:

[0071]

[0072] The preparation method is the same as that of Example 2.

[0073] Preparation of Comparative Example 1 Granules

[0074] Formula:

[0075]

[0076] The preparation method is the same as Example 2.

[0077] Preparation of Comparative Example 2 Granules

[0078] Formula:

[0079]

[0080] The preparation method is the same as Example 1.

[0081] Preparation of Comparative Example 3 Granules

[0082] Formula:

[0083]

[0084] Weigh the above-mentioned Chinese medicinal materials by weight and mix them evenly; add water to cover all the raw materials, soak for 30 minutes, boil over high heat until boiling, then turn to low heat and boil for 40 minutes, add water and boil for 30 minutes for the second time, collect the decoction and concentrate it, add conventional pharmaceutical excipients, and prepare it into granules according to conventional methods.

[0085] Preparation of Comparative Example 4 Granules

[0086] Formula:

[0087]

[0088] (1) Sieve and crush the above Chinese medicinal materials;

[0089] (2) Extract the upper volatile oil from Chuanxiong, white peony root, Chinese angelica root and liquorice by steam distillation, separate the upper volatile oil, add 4 times 85% ethanol and stir, slowly add β-cyclodextrin aqueous solution to the above solution, stir for 4 hours, filter, wash and dry to obtain inclusion compound; the cyclodextrin used for the cyclodextrin inclusion is β-cyclodextrin, and the mass ratio of the cyclodextrin to the volatile oil is 8:1.

[0090] (3) Except for the Chinese medicinal materials in step (2), the remaining Chinese medicinal materials and the residues in step (1) are subjected to 65% ethanol heating and reflux extraction once, each time for 2 hours, the extracts are combined, filtered, and the filtrate is concentrated to an extract with a relative density of 1.23 (65° C.), and freeze-dried at low temperature to obtain a dry powder;

[0091] (4) The powders obtained in steps (2) and (3) are mixed to prepare granules according to a conventional preparation method.

[0092] Preparation of Comparative Example 5 Granules

[0093] Formula:

[0094]

[0095] Weigh the above-mentioned Chinese medicinal materials by weight and mix them evenly; add water to cover all the raw materials, soak for 30 minutes, boil over high heat until boiling, then turn to low heat and boil for 40 minutes, add water and boil for 30 minutes for the second time, collect the decoction and concentrate it, add conventional pharmaceutical excipients, and prepare it into granules according to conventional methods.

[0096] Verification Example (I) Effect of the pharmaceutical composition of the present invention on PCOS model rats

[0097] 1 Materials and methods

[0098] 1.1 Experimental animals and husbandry

[0099] Healthy SPF female SD rats, 6-8 weeks old, weight: 180±20g. Experimental animal license number: SYXK(Lu)2018-0008. The experiment started after 1 week of routine adaptation under laboratory conditions.

[0100] 1.2 Modeling method

[0101] Healthy SD female rats were given letrozole 1mg / kg + 1% sodium carboxymethylcellulose by gavage at 4ml / kg·d for 21 days to establish the model. Vaginal smears were performed on the rats on the 10th to 20th day after the start of the model. The model was considered successful if the rats had persistent leukocytes in the vaginal epithelium and lost the estrous cycle. Another 10 rats were taken as the blank control group and given 1% sodium carboxymethylcellulose by gavage at 4ml / kg·d for 21 days.

[0102] 1.3 Experimental drug administration

[0103] The rats with successful modeling were divided into 7 groups, namely, model group, positive control group, Example 1 low-dose group, Example 1 high-dose group, Example 2 group, Comparative Example 2 group, and Comparative Example 5 group, with 10 rats in each group.

[0104] The low-dose group of Example 1 and the high-dose group of Example 1 were orally administered with the Chinese medicine composition, with a total raw drug content of 12.5 g / kg / d and 25 g / kg / d, respectively, the Example 2 group, the Comparative Example 2 group, and the Comparative Example 5 group were orally administered with a total raw drug content of 12.5 g / kg / d, and the positive control group was orally administered with clomiphene citrate 4.5 mg / kg / d. The rats in the drug administration group were orally administered with the drug composition solution, and the blank control group and the model group were orally administered with an equal amount of normal saline, once a day, for 10 consecutive days.

[0105] 2. Detection indicators and methods

[0106] 2.1 Effects on serum hormone levels in rats:

[0107] After the administration on the 10th day, blood was collected from the carotid artery and centrifuged at 3000 r / min and 4°C to obtain serum. The FSH, LH, T, and SHBG levels of rats in each group were determined.

[0108] 2.2 Effects on rat ovarian weight and ovarian coefficient:

[0109] At the end of the experiment, the rats were killed, and the ovaries were removed and weighed.

[0110] Coefficient = ovarian wet weight (g) / body weight (g) × 100%

[0111] 3 Experimental results

[0112] 3.1 Results of serum hormone levels in rats in each group:

[0113] The test results confirmed that after administration, compared with the model group, the serum hormone levels of rats in each example group and the positive control group were significantly different (P < 0.01; P < 0.05), while the comparative example group showed no significant difference (P > 0.05); indicating that the Chinese medicine composition of the present invention can effectively regulate the hormone levels of PCOS rats. The specific results are as follows Figure 1 3.2 Results of ovaries and ovarian coefficients of rats in each group:

[0114] At the end of the experiment, the ovaries were taken out, and it was observed that the ovaries of the rats in the normal control group were bright in color, plump and smooth in surface, small in size, with multiple corpora lutea and follicles of different developmental stages, complete in shape and neatly arranged. The ovaries of the rats in the model group were whitish in color, enlarged in volume, thickened in capsule, cystic dilation of follicles, and reduced in number of corpora lutea; the ovaries of each drug-administered group were brighter in color than those in the model group, the number of cystically dilated follicles was reduced, the number of follicles and corpora lutea increased, and the arrangement was more neat, among which the ovaries of the high-dose group in Example 1 and the positive control drug group were closest in appearance to the normal group, while the appearance of the comparative example group was not much different from that of the model group.

[0115] Further, the ovarian coefficient was calculated, and the results were as follows Figure 2 As shown in the figure, it can be found that the ovarian coefficient of the rats in the model group increased significantly compared with other groups (P < 0.01; P < 0.05); and after administration, compared with the model group, the ovarian coefficient of the rats decreased, among which the decrease in each embodiment group was significant (P < 0.01; P < 0.05), indicating that the Chinese medicine composition group of the present invention has a therapeutic effect on polycystic ovary syndrome, and its effect is not significantly different from that of the positive control drug group (P > 0.05), and compared with the model group, each comparative embodiment group is not significant (P > 0.05).

[0116] Verification Example (II) Effect of the pharmaceutical composition of the present invention on PCOS patients with liver depression and kidney deficiency

[0117] 1. Materials and methods

[0118] 1.1 Research subjects

[0119] 16 patients with PCOS infertility.

[0120] 1.2 Western medicine diagnostic criteria:

[0121] ① According to the industry standards of the Gynecological Endocrinology Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association, the patient meets the diagnostic criteria for polycystic ovary syndrome and has not become pregnant after more than one year of trying to conceive; ② Age 23 to 35 years old.

[0122] 1.3 TCM diagnostic criteria:

[0123] With reference to the Symptoms of the National Standard of the People's Republic of China on Clinical Diagnosis and Treatment Terminology, the diagnostic criteria are as follows: (1) Main symptoms: amenorrhea, or late menstruation, scanty menstruation, light or dark color or purple-black, with blood clots; soreness of waist and knees; (2) Secondary symptoms: abdominal distension and pain during menstruation that refuses to be pressed, which is relieved after the blood clots are discharged; dizziness and tinnitus; depression or fatigue; (3) Typical tongue and pulse: pale or dark tongue or dark purple or dark old tongue, deep and thin pulse or stringy and slow pulse; (4) The above main symptoms are required, and 1-2 secondary symptoms are present. Combined with the tongue and pulse, it can be identified as liver depression and kidney deficiency.

[0124] 1.3 Exclusion criteria:

[0125] ① The male has reproductive abnormalities; ② Infertility caused by other reasons, such as fallopian tube obstruction, abnormal development of reproductive organs, etc.

[0126] 1.4 Grouping:

[0127] They were randomly divided into a control group and an experimental group, with 8 people in each group.

[0128] 1.5 Treatment

[0129] (1) Control group: Placebo granules were taken orally once daily starting from the third day of the menstrual cycle for 21 consecutive days.

[0130] (2) Experimental group: 10 g of the granules prepared in Example 1 were taken three times a day for 21 consecutive days.

[0131] 2. Observation indicators

[0132] 2.1 TCM symptom score

[0133] Table 1 TCM symptom scores

[0134]

[0135]

[0136] 2.2 Comparison of follicle development:

[0137] The days of follicle maturation, ovulation rate and pregnancy rate in the menstrual cycle were compared between the two groups after treatment.

[0138] 3. Results

[0139] 3.1 TCM syndrome score results:

[0140] Before and after treatment, the two groups of patients were scored according to the contents of Table 1, and the results are shown in Table 2. From the data in Table 2, it can be seen that after treatment, both the control group and the experimental group had significant improvements to varying degrees (P < 0.05). Furthermore, compared with the control group, the TCM syndrome score of the experimental group was lower than that of the control group (P < 0.05).

[0141] Table 2 Results of TCM syndrome scores

[0142]

[0143] Note: Compared with before treatment, * P<0.05; compared with the control group, ％ P<0.05.

[0144] 3.2 Follicular development:

[0145] After treatment, the comparison of follicular development of patients is shown in Table 3. From the data in the table, it can be seen that the ovulation rate of the control group is only 47.2%, and the ovulation rate of the experimental group is 79.1%, and the data of the two groups are statistically different (P < 0.05); after treatment, the pregnancy rate results are: the pregnancy rate of the control group is 33.4%, and the pregnancy rate of the experimental group is 73.8%, and the data of the two groups are statistically different (P < 0.05).

[0146] Table 3 Follicular development

[0147] Grouping Follicle maturation days / day Ovulation rate / % Pregnancy rate / % Control group 19.53±3.02 27.2％ 23.4％ Experimental Group 12.03±2.58* 79.1％ 63.8％

[0148] Note: Compared with the control group, *P<0.05.

Claims

1. A Chinese medicine composition for improving or treating polycystic ovary syndrome, characterized in that: The Chinese medicine composition comprises the following components in parts by weight:

2. The Chinese medicine composition according to claim 1, characterized in that In the traditional Chinese medicine composition, the rehmannia root is prepared rehmannia root, the cyperus rotundus is vinegar cyperus rotundus, and the liquorice root is roasted liquorice root.

3. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition comprises the following components in parts by weight:

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared into an oral preparation according to conventional processes and auxiliary materials of Chinese medicine pharmaceutics. Preferably, the Chinese medicine composition can be prepared into one of capsules, granules and tablets.

5. The Chinese medicine composition according to claim 1, characterized in that: The preparation method of the Chinese medicine composition comprises: (1) Sieve and crush the above Chinese medicinal materials; (2) Extracting the upper layer of volatile oil from Chuanxiong, white peony root, Chinese angelica root and liquorice by steam distillation, enclosing the volatile oil with cyclodextrin and drying it to obtain a cyclodextrin inclusion compound, and filtering the lower layer of residue for later use; (3) extracting other Chinese medicinal materials and the filter residue in step (2) with ethanol, filtering, concentrating, drying, and crushing to obtain an extract powder for later use; (4) The powders obtained in steps (2) and (3) are mixed to prepare a commonly used pharmaceutical preparation according to a conventional preparation method.

6. The Chinese medicine composition according to claim 5, characterized in that: The cyclodextrin used in the cyclodextrin inclusion in step (2) is β-cyclodextrin. Preferably, the mass ratio of the cyclodextrin to the volatile oil is 4-8:

1. Preferably, the cyclodextrin inclusion step in step (2) is: separating the upper volatile oil, adding 1-4 times 85% ethanol and stirring, slowly dropping β-cyclodextrin aqueous solution into the above solution, stirring for 2-4 hours, filtering, washing and drying to obtain the inclusion compound.

7. The Chinese medicine composition according to claim 5, characterized in that: The step (3) comprises the following steps: except for the Chinese medicinal materials in step (2), the remaining Chinese medicinal materials and the residues in step (1) are added with 65-85% ethanol, heated and refluxed for extraction for 1-3 times, each time for 2-3 hours, the extracts are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.17-1.23 (65° C.), and then freeze-dried at low temperature to obtain the paste.

8. The Chinese medicine composition according to claim 1, characterized in that: The step (3) comprises: except for the Chinese medicinal materials in step (2), the remaining Chinese medicinal materials and the residues in step (1) are added with 65-85% ethanol, heated and refluxed for extraction for 1-3 times, each time for 2-3 hours, the extracts are combined, filtered, and the filtrate is concentrated to an extract with a relative density of 1.17-1.23 (65° C.), sodium pyrosulfite and glycine are added to the extract respectively, wherein the mass ratio of the extract, sodium pyrosulfite and glycine is 1:0.5-0.8:0.6-1.0, after being stirred evenly, freeze-dried at low temperature to obtain a dry powder.

9. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is used in preparing a medicine for treating polycystic ovary syndrome with liver depression and kidney deficiency syndrome.

10. The use according to claim 9, characterized in that: The Chinese medicine composition is used in preparing a drug for treating polycystic ovary syndrome hyperandrogenism.

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