Traditional Chinese medicine composition for treating decrease of ovarian reserve function

Abstract

The invention provides a traditional Chinese medicine composition for treating ovarian reserve function decline. The traditional Chinese medicine composition is prepared from the following medicines in parts by mass: 9-30 parts of radix astragali preparata, 6-20 parts of roasted rhizoma atractylodis macrocephalae, 10-15 parts of poria cocos, 2-10 parts of radix glycyrrhizae preparata, 6-20 parts of semen cuscutae, 9-20 parts of radix dipsaci (dipsacus root), 6-12 parts of herba lycopi and 6-15 parts of lily. Experimental results show that the traditional Chinese medicine composition is suitable for improving the ovarian function of a patient suffering from spleen-kidney deficiency type ovarian reserve function decline.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating diminished ovarian reserve, and more particularly relates to a traditional Chinese medicine composition for improving the ovarian reserve function of patients with diminished ovarian reserve of the type of deficiency of both the spleen and the kidney. BACKGROUND

[0002] Diminished ovarian reserve (DOR) is a common gynecological reproductive endocrine disease that causes female fertility to decline and sex hormone deficiency. According to research reports, women with diminished ovarian reserve have a significantly increased risk of miscarriage, and about 35% to 75% of spontaneous abortions are related to embryo chromosomal abnormalities caused by decreased oocyte quality. The ovarian reserve function of patients with recurrent spontaneous abortion (RSA) tends to decrease, and there is a clear correlation between the two. Low AMH and AFC levels can predict a higher probability of pregnancy failure. With the increase in the number of abortions, the AMH level and AFC decrease, and the proportion of DOR patients significantly increases. If RSA patients also have DOR, on the one hand, the number of oocytes decreases, making it difficult for RSA patients to become pregnant again; on the other hand, the quality of oocytes decreases, and the quality of embryos is poor, increasing the probability of spontaneous abortion after pregnancy. Therefore, RSA combined with DOR can affect the pregnancy rate of patients again and the survival rate of embryos after pregnancy again.

[0003] At present, modern medical treatment mainly belongs to causal treatment or empirical treatment. For the decline of ovarian reserve function in RSA patients, hormone replacement therapy is mainly used. Hormone replacement therapy can quickly improve the symptoms of low estrogen caused by DOR by exogenous supplementation of estrogen and progesterone, but it cannot fundamentally restore ovarian function. Long-term use increases the risk of endometrial hyperplasia, endometrial cancer, breast cancer and other diseases, and the recurrence rate is high after drug withdrawal. Therefore, it is of positive clinical and social significance to explore an effective method of traditional Chinese medicine for treating RSA combined with DOR and propose a traditional Chinese medicine composition that can improve the ovarian reserve function of RSA patients combined with DOR. SUMMARY

[0004] The inventors have found in long-term clinical practice that patients with recurrent miscarriage combined with decreased ovarian reserve are mostly seen with deficiency of both the spleen and the kidney. The kidney is the origin of congenital constitution, stores essence, and governs reproduction. Adequate kidney essence can help to fix the fetus, and deficiency of the kidney can not help to fix and support the fetus. The spleen is the origin of acquired constitution and the source of qi and blood. The fetus relies on the qi and blood of the mother for nourishment, and deficiency of the spleen can not help to support and nourish the fetus. The follicle, as the essence of reproduction, needs the qi and blood essence transformed by the spleen and the kidney for nourishment. If the spleen and the kidney are deficient, the follicle lacks the material basis for growth and development, leading to poor embryo quality, and various reasons can cause repeated pregnancy and repeated miscarriage. Therefore, the inventors take the principle of tonifying the kidney and invigorating the spleen to create the present drug combination invention.

[0005] The present application aims to provide a traditional Chinese medicine composition.

[0006] The traditional Chinese medicine composition is prepared from the following drugs by mass: 9-30 parts of prepared radix astragali, 6-20 parts of fried radix atractylodis, 10-15 parts of poria, 2-10 parts of prepared licorice, 6-20 parts of semen cuscutae, 9-20 parts of rhizoma drynariae, 6-12 parts of lonicera, and 6-15 parts of flos lilii. Specifically, the traditional Chinese medicine composition is prepared from the following drugs by mass: 12 parts of prepared radix astragali, 12 parts of fried radix atractylodis, 12 parts of poria, 6 parts of prepared licorice, 15 parts of semen cuscutae, 15 parts of rhizoma drynariae, 10 parts of lonicera, and 12 parts of flos lilii.

[0007] The application of the above traditional Chinese medicine composition in the preparation of a drug for treating decreased ovarian reserve in a subject also belongs to the protection scope of the present application.

[0008] In the application, the subject is also combined with recurrent miscarriage.

[0009] The subject has the manifestations of deficiency of both the spleen and the kidney.

[0010] The drug has the following therapeutic effects: improving the serum anti-Mullerian hormone level of the subject, reducing the serum basal follicle-stimulating hormone level of the subject, improving the serum basal estradiol level of the subject, improving the pregnancy rate of the subject, improving the 12-week embryo survival rate of the subject, and reducing the TCM syndrome score of the subject in terms of deficiency of both the spleen and the kidney.

[0011] The drug is superior to fentanyl in the following aspects: improving the serum anti-Mullerian hormone level of the subject, improving the pregnancy rate of the subject, improving the 12-week embryo survival rate of the subject, and reducing the TCM syndrome score of the subject in terms of deficiency of both the spleen and the kidney.

[0012] The drug is a water decoction of the traditional Chinese medicine composition.

[0013] The present application also provides a drug for treating decreased ovarian reserve, which contains the above traditional Chinese medicine composition.

[0014] The medicine is a water decoction of the traditional Chinese medicine composition.

[0015] The application also provides a medicine for improving the ovarian function of patients with spleen and kidney deficiency type of decreased ovarian reserve, and the medicine contains the traditional Chinese medicine composition.

[0016] In the prescription, the prepared Astragalus membranaceus strengthens the spleen and replenishes qi, and nourishes the source of blood and body fluid, so that the kidney essence is nourished; the Semen Taxilli supplements the kidney and essence, and consolidates the Chong and Ren channels, so that the ovarian follicle develops well when the kidney essence is sufficient, and the fetus is protected when the kidney qi is sufficient, and the two are the monarch herbs; the fried Atractylodes macrocephala strengthens the spleen and removes dampness, and aims to "assist the transformation and transportation of the spleen"; the Dipsacus asper (Cibotium valgare) is used with Semen Taxilli, so as to increase the function of tonifying the liver and kidney, and the fried Atractylodes macrocephala and the Dipsacus asper (Cibotium valgare) are the ministerial herbs; the Poria cocos strengthens the spleen and removes dampness, and the Lonicera japonica activates blood and regulates menstruation, and removes pathological products, so that the blood circulation is normal; the Lilium brownii pacifies the heart and tranquilizes the mind, and improves the bad mood, and are the auxiliary herbs; the prepared Glycyrrhiza uralensis harmonizes all the herbs. The combination of all the herbs can strengthen the spleen and the kidney, regulate the menstruation and assist the pregnancy.

[0017] The experimental results show that the traditional Chinese medicine composition of the application can improve the serum AMH level of the patient more than the treatment of fentanyl; the application and fentanyl can both reduce the serum basic FSH level, can both reduce the serum basic FSH / LH value level, and can both improve the serum basic E2 value level, and have the equivalent effect of fentanyl; the application can improve the pregnancy rate of the patient more than the treatment of fentanyl, and the embryo survival rate of the patient after being treated by the application for 12 weeks is higher than that of fentanyl; the application and fentanyl can both reduce the TCM syndrome score of the patient, and improve the clinical symptoms of the patient, and the improvement effect of the application on the symptoms is better than that of fentanyl; and the liver and kidney functions, blood routine, urine routine and electrocardiogram of all the patients before and after the treatment of the application are not obviously abnormal, and no adverse events occur in all the patients, so the application has high safety. DETAILED DESCRIPTION

[0018] The application will be further described in detail below in combination with specific embodiments, and the examples given are only for illustrating the application, rather than limiting the scope of the application. The examples provided below can serve as a guide for further improvement by those skilled in the art, and do not constitute any limitation on the application in any way.

[0019] In the following examples, the experimental methods are conventional methods, and are carried out according to the techniques or conditions described in the literature in the field or according to the product instructions, unless otherwise specified. The materials, reagents and the like used in the following examples can be obtained from commercial channels, unless otherwise specified.

[0020] Example 1: Curative effect observation test of the traditional Chinese medicine composition on RSA combined with DOR 1. Data and methods 1.1General information: The case data came from patients with recurrent miscarriage combined with decreased ovarian reserve of spleen and kidney deficiency type treated in the gynecology department of Guang'anmen Hospital of China Academy of Chinese Medical Sciences from June 2022 to September 2023. A total of 58 cases were included. This study used a randomized controlled study, divided into a treatment group of 29 cases, with an average age of (34.45±3.22) years, and a miscarriage frequency of 2.7±1.02 times; a control group of 29 cases, with an average age of (33.31±3.63) years, and a miscarriage frequency of 2.6±1.00 times. There was no significant difference in age, body mass index, and natural miscarriage frequency between the two groups (P>0.05), and they were comparable. P

[0021] 1.2 Diagnostic criteria 1.2.1 Western diagnostic criteria for recurrent miscarriage Refer to the diagnostic criteria for recurrent miscarriage in the Expert Consensus on Diagnosis and Treatment of Recurrent Miscarriage and the 8th edition of Obstetrics and Gynecology published by People's Medical Publishing House: 2 or more consecutive natural miscarriages with the same sexual partner.

[0022] 1.2.2 Western diagnostic criteria for decreased ovarian reserve Refer to the Expert Consensus on Clinical Diagnosis and Treatment of Decreased Ovarian Reserve and Cao Zeyi's Obstetrics and Gynecology, combined with clinical practice: ① AMH (anti-Mullerian hormone) <1.1 ng / mL; ② Bilateral ovarian AFC <5; ③ Basal serum hormone (at least 2 consecutive menstrual 2-4 days, 4 weeks apart): 10 IU / L < bFSH < 40 IU / L or bFSH / bLH > 2-3.6 or bE2 > 80 pg / ml (293.8 pmol / L). For patients under 40 years of age, any one of the above laboratory indicators can be diagnosed as decreased ovarian reserve.

[0023] 1.2.3 TCM syndrome differentiation criteria for spleen and kidney deficiency Refer to the National Administration of Traditional Chinese Medicine's “TCM Syndrome Diagnosis and Treatment Criteria”, “Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine (Trial)” (2002 Edition) and Zhang Yuzhen's Obstetrics and Gynecology for relevant content on spleen and kidney deficiency and spontaneous abortion: ① Frequent pregnancy and miscarriage (2 or more consecutive natural miscarriages); ② Lumbosacral weakness, dizziness and tinnitus; ③ Fatigue, shortness of breath, and lazy speech.

[0024] Secondary symptoms: ① Poor appetite, abdominal distension, loose and watery stools; ② Dizziness and forgetfulness, frequent nocturia; ③ Pale complexion, dark eye sockets, or dark spots on the face; ④ Diminished sexual desire, chills, and cold limbs.

[0025] Tongue and pulse: pale tongue, white fur, and slow or weak pulse.

[0026] ​​With all the above main symptoms, secondary symptoms with 1 or more, in line with the tongue and pulse manifestations, can be diagnosed as spleen and kidney deficiency syndrome.

[0027] 1.3 Inclusion criteria (1) Married women aged 20-40 years old; (2) Meet the western medicine diagnostic criteria for recurrent miscarriage and ovarian reserve function decline; (3) Meet the TCM syndrome differentiation criteria of spleen and kidney deficiency syndrome; (4) Voluntarily participate in this clinical study and sign the informed consent form.

[0028] All the above 4 criteria can be included.

[0029] 1.4 Exclusion criteria (1) Both or one of the couple has chromosomal abnormalities or serious genetic diseases; (2) Existence of reproductive anatomical factors affecting pregnancy; (3) Combined with serious autoimmune diseases or serious endocrine diseases; (4) Combined with prethrombotic state or abnormal semen examination of the male; (5) Acute stage of toxoplasma infection or acute stage of gynecological inflammation or combined with sexually transmitted diseases; (6) Combined with serious internal medicine diseases or mental diseases; (7) Used artificial cycle hormone drug treatment within the last 3 months; (8) Allergic to the study drug or have contraindications for fenmetozole.

[0030] Any of the above shall be excluded.

[0031] 1.5 Treatment method Treatment group: Take the drug combination of the application, roasted astragalus 12g, fried atractylodes 12g, tuckahoe 12g, fried licorice 6g, cuscuta 15g, continue to break (chuan broken) 15g, lonicera 10g, lily 12g. The pharmacy department of Guang'anmen Hospital uniformly prepares water decoction with controllable quality. Morning and evening each time, 28 days for a course of treatment, 3 courses of continuous administration, no drug during menstruation, strict contraception during drug administration, and preparation after treatment.

[0032] Control group: take Femoston treatment, manufacturer: Abbott Biologicals B.V., approval number: H20150346. Take method: take 1 tablet orally per day, 28 days as a course of treatment, take 3 courses of treatment in a row, strictly use contraception during the medication period, and prepare for pregnancy after the treatment. Take Femoston from the first day of menstruation. Take 1 white tablet (containing estradiol 1 mg) per day for the first 14 days; take 1 gray tablet (containing estradiol 1 mg and dydrogesterone 10 mg) per day for the last 14 days. After a cycle of 28 days, the next cycle should be started on the 29th day.

[0033] 1.6 Observation index (1) Observe the levels of AMH, FSH, E2 and LH in the peripheral blood of patients in both groups on the 2nd-4th day of menstruation before and after treatment. (2) Observe the re-pregnancy rate of patients in both groups within half a year after treatment, follow up to 12 weeks of pregnancy, and count the embryo survival rate at 12 weeks of pregnancy in both groups.

[0034] (3) Observe the TCM syndrome efficacy of patients in both groups after treatment. The TCM syndrome score includes the scores of symptoms such as soreness of waist and knees, dizziness and tinnitus, fatigue, shortness of breath, loss of appetite, abdominal distension, loose stool, forgetfulness, frequent nocturia, dark complexion, decreased sexual desire, cold limbs, etc. Patients in both groups fill in the TCM syndrome score table before treatment and after 3 courses of treatment, count and analyze the changes in TCM symptom scores, and record 2 times in total. Efficacy index (N) = [(pre-treatment score - post-treatment score) / pre-treatment score] x 100%; recovery: N ≥ 95%, clinical symptoms and signs disappear; marked effect: 70% ≤ N < 95%, clinical symptoms and signs are significantly reduced; effective: 30% ≤ N < 70%, clinical symptoms and signs are improved; ineffective: N < 30%, clinical symptoms and signs are not improved or worsened.

[0035] (4) Safety observation: check the liver and kidney function, blood routine, and urine routine of patients in both groups before and after treatment. Record whether there are adverse reactions such as allergy, headache, nausea and vomiting, breast pain, etc. during the medication period, and record the adverse reaction events and measures taken.

[0036] 1.7 Statistical method SPSS 26.0 software was used for statistical analysis of the research data. Count data was expressed as rate (%); chi-square test was used for four-table data; non-parametric test was used for rank data. Test level α = 0.05, P < 0.05 indicates that the difference is statistically significant. When comparing measurement data, those conforming to normal distribution were expressed as mean ± standard deviation, and those not conforming were expressed as median (interquartile range). When data conforms to normal distribution, independent samples t test was used between groups, and paired samples test was used within groups.t Test; when not obeying normal distribution, Mann-Whitney test is used between groups, and Wilcoxon test is used within groups.

[0037] 2. Results 2.1 Comparison of serum AMH levels Before treatment, the serum AMH levels of the patients in the two groups had no statistically significant difference (P>0.05), and were comparable. After treatment, the serum AMH level of the patients in the treatment group was obviously increased (P<0.001) compared with that before treatment, and the serum AMH level of the patients in the control group had no obvious change (P>0.05). After treatment, the serum AMH level of the patients in the treatment group was obviously higher than that in the control group (P<0.001), indicating that the application can improve the serum AMH level of the patients more than fentanyl, and Table 1 can be referred to. P P P P

[0038] Table 1 Comparison of serum AMH levels of the patients in the two groups M P 25 , P 75

[0039] Note: Before treatment, serum AMH does not obey normal distribution, and Mann-Whitney test is used; after treatment, serum AMH obeys normal distribution, and independent sample t test is used; before and after treatment, paired sample t test is used.

[0040] 2.2 Serum basal FSH (follicle-stimulating hormone) level Before treatment, the serum basal FSH levels of the patients in the two groups had no statistically significant difference (P>0.05), and were comparable. After treatment, the serum basal FSH levels of the patients in the two groups were both decreased compared with those before treatment, and the difference had statistical significance (P<0.001). After treatment, the serum basal FSH levels of the patients in the treatment group and the control group had no statistically significant difference (P>0.05), indicating that the application and fentanyl can both reduce the serum basal FSH level, and the application has the equivalent effect of fentanyl, and Table 2 can be referred to. P P P

[0041] Table 2 Comparison of serum basal FSH levels M P 25 , P 75 ​​​​​​​​​​​

[0042] Note: Serum basal FSH before treatment does not obey normal distribution, Mann-Whitney test is used between groups; serum basal FSH after treatment obeys normal distribution, independent sample test is used; Wilcoxon test is used before and after treatment within groups. t

[0043] 2.3 Serum basal FSH / LH value There was no statistically significant difference in serum basal FSH / LH value between the two groups of patients before treatment (P>0.05), which was comparable. After treatment, the serum basal FSH / LH value of the patients in the two groups decreased compared with before, and the difference was statistically significant (P<0.05); the serum basal FSH / LH value after treatment between the treatment group and the control group had no statistically significant difference (P>0.05), which indicated that the application and fenobam could both reduce the serum basal FSH / LH value level, the application had the equivalent effect of fenobam, and Table 3 was seen. P P P

[0044] Table 3 Difference comparison of serum basal FSH / LH value M P 25 , P 75

[0045] Note: Serum basal FSH / LH value before treatment and after treatment does not obey normal distribution, Mann-Whitney test is used between groups; paired sample t test is used for comparison before and after treatment within groups.

[0046] 2.4 Serum basal E2 (estradiol) level There was no statistically significant difference in serum basal E2 value between the two groups of patients before treatment (P>0.05), which was comparable. After treatment, the serum basal E2 value of the patients in the two groups increased compared with before, and the difference was statistically significant (P<0.05); the serum basal E2 value after treatment between the treatment group and the control group had no statistically significant difference (P>0.05), which indicated that the application and fenobam could both improve the serum basal E2 value level, the application had the equivalent effect of fenobam, and Table 4 was seen. P P P

[0047] Table 4 Difference comparison of serum basal E2 M P 25 , P 75 ​​​​​​​​​​​​​

[0048] Note: Serum basal E2 levels before treatment do not conform to normal distribution, Mann-Whitney test is used between groups; after treatment, normal distribution is met, independent sample t test is used; paired sample t test is used for comparison before and after treatment in group.

[0049] 2.5 Pregnancy rate The patients in both groups are followed up for half a year after treatment, 13 cases in the treatment group are pregnant, the pregnancy rate is 44.8%; 6 cases in the control group are pregnant, the re-pregnancy rate is 20.7%, the difference is statistically significant (P<0.05), which indicates that the application can improve the pregnancy rate of patients more than fentanyl treatment, as shown in Table 5. P

[0050] Table 5 Comparison of re-pregnancy rates of patients in two groups

[0051] Note: Pregnancy is count data, chi-square test is used.

[0052] 2.6 Embryo survival rate at 12 weeks of pregnancy The patients who are pregnant after treatment are continuously followed up to 12 weeks of pregnancy, and the embryo survival rate at 12 weeks of pregnancy is observed. There are 13 cases of pregnancy in the treatment group, 12 cases of embryo survival at 12 weeks of pregnancy, and the embryo survival rate is 92.3%; there are 6 cases of pregnancy in the control group, 4 cases of embryo survival at 12 weeks of pregnancy, and the embryo survival rate is 66.7%, the difference between the two groups is not statistically significant (P>0.05), which indicates that the embryo survival rate at 12 weeks of pregnancy of patients after treatment of the application is higher than that of fentanyl treatment, but the difference between the two groups is not statistically significant, as shown in Table 6. P

[0053] Table 6 Comparison of embryo survival rates at 12 weeks of pregnancy of patients in two groups

[0054] Note: Sample size = 19 (n<40), minimum expected value is 0.56 (T<1), Fisher's exact probability method is used for test.

[0055] 2.7 TCM syndrome score and curative effect Before treatment, the TCM syndrome scores of patients in two groups are compared, and the difference is not statistically significant (P>0.05), which is comparable. After treatment, the TCM syndrome scores of patients in two groups are decreased compared with before, and the difference is statistically significant (P<0.05), and the improvement of the treatment group is better than that of the control group, and the difference is statistically significant (P<0.05), which indicates that the application and fentanyl can both reduce the TCM syndrome score of patients and improve the clinical symptoms of patients, but the improvement effect of the application on symptoms is better than that of fentanyl, as shown in Table 7. P P P ​​​​​

[0056] Table 7 Comparison of differences in TCM syndrome scores

[0057] Note: The TCM syndrome scores before treatment did not comply with normal distribution, and the Mann-Whitney test was used for comparison between groups; the TCM syndrome scores after treatment complied with normal distribution, and the independent sample test was used; the Wilcoxon test was used for comparison within groups. t

[0058] After treatment, 1 person (3.4%) in the treatment group was cured, 18 people (62.1%) were markedly effective, 8 people (27.6%) were effective, and 2 people (6.9%) were ineffective; in the control group, 0 person (0%) was cured, 8 people (27.6%) were markedly effective, 16 people (55.2%) were effective, and 5 people (17.2%) were ineffective. It can be seen that both treatment regimens have high total efficacy, with the treatment group reaching 93.1% and the control group reaching 82.8%. However, as can be seen from the data, 19 patients in the treatment group were cured or markedly effective, accounting for 65.5%; while in the control group, only 8 patients were cured or markedly effective, accounting for 27.6%. It can be seen that the number of patients in the treatment group is significantly more than that in the control group. Non-parametric test shows that Z = 2.846, P = 0.004 (<0.05), and the difference is statistically significant. Therefore, both treatment regimens have good total efficacy of TCM syndromes, but the treatment of the present application is more effective than that of fentanyl. P

[0059] Table 8 Comparison of differences in total efficacy of TCM syndromes

[0060] Note: This table is a single-item ordered RxC table, and non-parametric test is used to compare the differences between the two groups.

[0061] 2.8 Safety observation Before and after treatment, all patients had no obvious abnormalities in liver and kidney function, blood routine, urine routine, and electrocardiogram examination, and no adverse events occurred in all patients.

[0062] The above describes the present application in detail. For those skilled in the art, without departing from the purpose and scope of the present application, and without unnecessary experiments, the present application can be implemented in a wide range of equivalent parameters, concentrations and conditions. Although the present application gives a special example, it should be understood that further improvements can be made to the present application. In general, according to the principle of the present application, this application intends to include any change, use or improvement of the present application, including changes made by conventional techniques known in the art, which deviates from the scope disclosed in the present application.​​

Claims

1. A traditional Chinese medicine composition, made from the following ingredients in parts by weight: 9-30 parts of roasted Astragalus membranaceus, 6-20 parts of stir-fried Atractylodes macrocephala, 10-15 parts of Poria cocos, 2-10 parts of roasted Glycyrrhiza uralensis, 6-20 parts of Cuscuta chinensis, 9-20 parts of Dipsacus asper (Sichuan Dipsacus), 6-12 parts of Lycopus lucidus, and 6-15 parts of Lilium brownii.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following ingredients in parts by weight: 12 parts of roasted Astragalus membranaceus, 12 parts of stir-fried Atractylodes macrocephala, 12 parts of Poria cocos, 6 parts of roasted Glycyrrhiza uralensis, 15 parts of Cuscuta chinensis, 15 parts of Dipsacus asper (Sichuan Dipsacus), 10 parts of Lycopus lucidus, and 12 parts of Lilium brownii.

3. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating decreased ovarian reserve in subjects.

4. The application according to claim 3, characterized in that, The subjects also had recurrent miscarriages.

5. The application according to claim 3 or 4, characterized in that, The subjects exhibited symptoms of spleen and kidney deficiency.

6. The application according to any one of claims 3-5, characterized in that, The drug has the following therapeutic effects: increasing the subject's serum anti-Müllerian hormone level, decreasing the subject's serum basal follicle-stimulating hormone level, increasing the subject's serum basal estradiol level, increasing the subject's pregnancy rate, increasing the subject's embryo survival rate at 12 weeks of gestation, and decreasing the subject's TCM syndrome score for spleen and kidney deficiency.

7. The application according to claim 6, characterized in that, The drug is superior to Femoston in the following aspects: increasing serum anti-Müllerian hormone levels in subjects, increasing pregnancy rates in subjects, increasing embryo survival rates at 12 weeks of gestation in subjects, and reducing the TCM syndrome score of subjects with spleen and kidney deficiency.

8. The application according to any one of claims 3-7, characterized in that, The drug is an aqueous decoction of the traditional Chinese medicine composition.

9. A medicine for treating decreased ovarian reserve, said medicine comprising the traditional Chinese medicine composition according to claim 1 or 2.

10. The medicament according to claim 9, characterized in that, The drug is an aqueous decoction of the traditional Chinese medicine composition.

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