A traditional Chinese medicine composition and its application in prolonging physical and reproductive lifespan.

Abstract

This application relates to the field of pharmaceutical technology, and more particularly to a traditional Chinese medicine composition and its application in prolonging the lifespan of the body and ovaries, preventing ovarian dysfunction, protecting ovarian reserve, and improving menopausal-related diseases. The pharmaceutical composition includes Rehmannia glutinosa (processed), Gynostemma pentaphyllum, Angelica sinensis, Lycium barbarum, Poria cocos, Ligustrum lucidum, Astragalus membranaceus, Paeonia lactiflora, Bupleurum chinense, Salvia miltiorrhiza, Curcuma longa, Albizia julibrissin, Cuscuta chinensis, Ziziphus jujuba var. spinosa, and Triticum aestivum. This application discovers a traditional Chinese medicine composition that can effectively prolong the lifespan of the body and ovaries, prevent ovarian dysfunction, protect ovarian reserve, and improve menopausal-related diseases. Specifically, by combining the above-mentioned herbs, it is possible to effectively prolong the lifespan of the body and ovaries, improve ovarian function, and alleviate menopausal-related diseases. The traditional Chinese medicine composition provided in this application has significant implications in the fields of aging and ovarian function protection.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine and relates to a Chinese herbal medicine composition and its application in prolonging the lifespan of the body and ovaries, improving ovarian function and alleviating menopausal-related diseases. Background Technology

[0002] With the continuous development of society and the economy, and the increasing demands for quality of life, life expectancy has increased. However, this has also brought about increasingly serious aging and age-related diseases among the elderly. Aging refers to the degenerative changes in the function of the body's tissues and organs as we age, and it is the result of the combined effects of multiple internal and external factors. Aging leads to the cessation of cell growth, impaired tissue function and metabolism, and ultimately affects the body's lifespan.

[0003] The ovary is one of the most important and unique reproductive organs in women. Because it plays a dual role in reproduction and maintaining endocrine homeostasis, it is considered the "pacemaker" of female aging. The decline in ovarian function accelerates aging to some extent, affecting women's lifespan and health. Ovarian aging is a manifestation of shortened ovarian lifespan. Ovarian aging refers to the gradual decline and eventual failure of ovarian reserve / function in women. It is influenced by multiple factors, including genetics, environment, socio-psychological factors, and behavioral patterns. Based on a decrease in the number of follicles and egg quality, it ultimately manifests as sterility and even menopause, affecting various systems throughout the body and leading to the development of related diseases and syndromes. Besides decreased fertility and early menopause, the endocrine dysfunction caused by ovarian aging can increase the risk of age-related diseases such as cardiovascular disease, osteoporosis, Alzheimer's disease, obesity, tumors, and diabetes, affecting multiple systems and organs throughout the body; its harm should not be underestimated. Depending on the stage of ovarian function decline, it can manifest as decreased ovarian reserve (DOR), premature ovarian insufficiency (POI), premature ovarian failure (POF), early menopause, and menopausal syndrome. If left untreated, ovarian function decline can severely impact women's reproductive health and quality of life. However, currently, there is a lack of safe and effective prevention and treatment strategies for ovarian function decline.

[0004] As people's demands for quality of life continue to rise, research on aging and anti-aging strategies has become a hot topic. While aging is inevitable, delaying it is possible. Currently, the mainstream anti-aging methods include stem cell therapy, drug therapy, gene therapy, and calorie restriction, with drug therapy showing particularly prominent advantages. Using drugs for anti-aging offers advantages such as high safety and ease of operation. Drugs that have been found to delay aging and protect ovarian function in various animal models include rapamycin, melatonin, resveratrol, coenzyme Q10, fisetinone, dasatinib, and quercetin. With modern chemical drugs proving ineffective for some diseases, and adverse reactions and drug resistance becoming increasingly prominent, people are beginning to call for a return to nature. Traditional Chinese medicine (TCM) highly embodies the wisdom and practical experience of the nation, representing a treasure of ancient Chinese science and a key to unlocking the treasure trove of Chinese civilization. TCM believes that the kidney is closely related to female ovarian function, governing the development, flourishing, and decline of female reproductive function; the kidney plays a decisive role in the realization of female ovarian physiological function. The *Medical Orthodox Transmission: Gynecology* states, "Menstruation depends entirely on the transformation and production of kidney water. When kidney water is deficient, menstrual blood gradually dries up, eventually leading to cessation of menstruation." *Fu Qingzhu's Gynecology* also states, "Menstrual blood originates from the kidneys," both emphasizing the importance of the kidneys for women's menstruation and fertility. Kidney deficiency is a fundamental pathological change resulting from declining ovarian function, leading to scanty menstruation, amenorrhea, or menopause, and infertility. Menopausal women experience a gradual decline or loss of ovarian function, resulting in decreased estrogen levels and changes in mental and psychological states, neuroendocrine function, and metabolism. The main symptoms include difficulty falling asleep, frequent awakenings, or even insomnia, leading to fatigue, dizziness, headaches, tinnitus, memory loss, depression, and emotional instability, severely impacting work and quality of life. The *Suwen: On the Primordial Innocence of Antiquity* states, "At forty-nine years of age, a woman's Ren meridian becomes deficient, her Chong meridian weakens, her Tiankui (menstrual blood) is exhausted, and her Didao (menstrual flow) becomes blocked, thus her form deteriorates and she becomes infertile." Therefore, it can be seen that aging and ovarian dysfunction are signs of functional disorders caused by imbalance of Qi and blood, deficiency of kidney Qi, malnourishment of the internal organs, decline of the Chong meridian, and imbalance of Yin and Yang.

[0005] my country has a history of using traditional Chinese medicine (TCM) for over 5,000 years, and its medicinal resources are abundant. TCM has demonstrated its effectiveness in delaying aging, treating menstrual disorders, and menopausal syndrome in women, with higher safety profiles and greater acceptance among female patients. However, sufficient evidence is still lacking regarding the efficacy of TCM in prolonging lifespan and preventing ovarian dysfunction, and existing formulas are relatively complex and may have potential side effects. Since lifespan, menstrual disorders, and menopausal syndrome are all symptoms, exploring strategies to prevent and treat these conditions, including addressing the root causes, is more important and urgent. Summary of the Invention

[0006] On one hand, this application provides a traditional Chinese medicine composition comprising the following substances in parts by weight:

[0007] Prepared Rehmannia Root 4-20 parts, Gynostemma pentaphyllum 7-23 parts, Angelica sinensis 1-17 parts, Lycium barbarum 1-17 parts, Poria cocos 4-20 parts, Ligustrum lucidum 1-11 parts, Astragalus membranaceus 1-11 parts, Paeonia lactiflora 1-11 parts, Bupleurum chinense 1-11 parts, Salvia miltiorrhiza 1-17 parts.

[0008] On one hand, this application provides a traditional Chinese medicine composition comprising the following substances in parts by weight:

[0009] Prepared Rehmannia Root 4-20 parts, Gynostemma Pentaphyllum 7-23 parts, Angelica Sinensis 1-17 parts, Lycium barbarum 1-17 parts, Poria 4-20 parts, Ligustrum lucidum 1-11 parts, Astragalus membranaceus 1-11 parts, Paeonia lactiflora 1-11 parts, Bupleurum chinense 1-11 parts, Salvia miltiorrhiza 1-17 parts, Curcuma longa 1-11 parts, Albizia julibrissin 1-11 parts, Cuscuta chinensis 1-11 parts, Ziziphus jujuba var. spinosa 1-11 parts, Triticum aestivum 1-17 parts.

[0010] In some embodiments, the herbal composition comprises the following substances in parts by weight:

[0011] Prepared Rehmannia Root 6-14 parts, Gynostemma Pentaphyllum 9-17 parts, Angelica Sinensis 3-11 parts, Lycium Barbarum 3-11 parts, Poria 6-14 parts, Ligustrum Lucidum 2-8 parts, Astragalus Root 2-8 parts, White Peony Root 2-8 parts, Bupleurum Root 2-8 parts, Salvia Miltiorrhiza 3-11 parts, Curcuma Rhizome 2-8 parts, Albizia Flower 2-8 parts, Cuscuta Seed 2-8 parts, Ziziphus Jujuba Seed 3-10 parts, Triticum Aestivum 3-11 parts;

[0012] In some embodiments, the herbal composition comprises the following substances in parts by weight:

[0013] Prepared Rehmannia Root 8-16 parts, Gynostemma Pentaphyllum 11-19 parts, Angelica Sinensis 5-13 parts, Lycium barbarum 5-13 parts, Poria 8-16 parts, Ligustrum lucidum 3-9 parts, Astragalus membranaceus 3-9 parts, Paeonia lactiflora 3-9 parts, Bupleurum chinense 3-9 parts, Salvia miltiorrhiza 5-13 parts, Curcuma longa 3-9 parts, Albizia julibrissin 3-9 parts, Cuscuta chinensis 3-9 parts, Ziziphus jujuba var. spinosa 5-10 parts, Triticum aestivum 5-13 parts;

[0014] In some embodiments, the herbal composition comprises the following substances in parts by weight:

[0015] Prepared Rehmannia Root 10-18 parts, Gynostemma Pentaphyllum 13-21 parts, Angelica Sinensis 7-15 parts, Lycium barbarum 7-15 parts, Poria cocos 10-18 parts, Ligustrum lucidum 4-10 parts, Astragalus membranaceus 4-10 parts, Paeonia lactiflora 4-10 parts, Bupleurum chinense 4-10 parts, Salvia miltiorrhiza 7-15 parts, Curcuma longa 4-10 parts, Albizia julibrissin 4-10 parts, Cuscuta chinensis 4-10 parts, Ziziphus jujuba var. spinosa 7-10 parts, Triticum aestivum 7-15 parts;

[0016] In some embodiments, the herbal composition comprises the following substances in parts by weight:

[0017] Prepared Rehmannia Root 4-15 parts, Gynostemma Pentaphyllum 9-20 parts, Angelica Sinensis 4-17 parts, Lycium barbarum 4-17 parts, Poria cocos 4-18 parts, Ligustrum lucidum 2-10 parts, Astragalus membranaceus 2-10 parts, Paeonia lactiflora 2-10 parts, Bupleurum chinense 2-10 parts, Salvia miltiorrhiza 2-16 parts, Curcuma longa 2-10 parts, Albizia julibrissin 2-10 parts, Cuscuta chinensis 2-10 parts, Ziziphus jujuba var. spinosa 2-10 parts, Triticum aestivum 2-16 parts.

[0018] In some implementations, the privet fruit of this application is privet fruit (processed).

[0019] In some implementations, the jujube seed in this application is roasted jujube seed.

[0020] In some implementation schemes, this application has repeatedly verified the safety and efficacy of the herbal composition using a fruit fly natural aging model, a mouse ovarian natural aging model, an acute chemotherapy-related ovarian injury animal model, and a mouse tumor-bearing model.

[0021] In some implementations, this application provides a traditional Chinese medicine formula: 15 g of Gynostemma pentaphyllum, 12 g of Rehmannia glutinosa, 9 g of Angelica sinensis, 6 g of Paeonia lactiflora, 9 g of Salvia miltiorrhiza, 6 g of Astragalus membranaceus, 9 g of Lycium barbarum, 6 g of Ligustrum lucidum, 6 g of Bupleurum chinense, and 12 g of Poria cocos.

[0022] In some implementations, this application provides a traditional Chinese medicine formula: 12 g of Rehmannia glutinosa, 15 g of Gynostemma pentaphyllum, 9 g of Angelica sinensis, 9 g of Lycium barbarum, 12 g of Poria cocos, 6 g of Ligustrum lucidum, 6 g of Astragalus membranaceus, 6 g of Paeonia lactiflora, 6 g of Bupleurum chinense, 9 g of Salvia miltiorrhiza, 6 g of Curcuma longa, 6 g of Albizia julibrissin, 6 g of Cuscuta chinensis, 9 g of Ziziphus jujuba var. spinosa, and 9 g of Triticum aestivum.

[0023] In the formula of this application, the principal ingredients are: Gynostemma pentaphyllum and Rehmannia glutinosa; the assistant ingredients are: Angelica sinensis, Paeonia lactiflora, Salvia miltiorrhiza, Astragalus membranaceus, and Cuscuta chinensis; and the adjuvant ingredients are: Lycium barbarum, Ligustrum lucidum, Bupleurum chinense, Poria cocos, Curcuma longa, Albizia julibrissin, Ziziphus jujuba var. spinosa, and Triticum aestivum.

[0024] Menopausal women experience a gradual decline or loss of ovarian function, leading to a decrease in estrogen levels and resulting in psychological, neuroendocrine, and metabolic changes. The main symptoms include difficulty falling asleep, frequent awakenings, or even insomnia, accompanied by fatigue, dizziness, headaches, tinnitus, memory loss, depression, and mood swings, significantly impacting work and quality of life. The *Suwen* (Plain Questions) states, "At forty-nine years of age, a woman's Ren meridian is deficient, her Chong meridian weakens, her Tiankui (menstrual blood) is exhausted, and her Didao (menstrual flow) is blocked, thus her form deteriorates and she becomes infertile." This indicates that menopausal syndrome is a functional disorder caused by kidney deficiency, weakened Chong meridian, imbalance of Qi and blood, malnourishment of the internal organs, and yin-yang imbalance. Therefore, the following herbs are selected: Rehmannia glutinosa, Gynostemma pentaphyllum, Angelica sinensis, Lycium barbarum, Poria cocos, Ligustrum lucidum, Astragalus membranaceus, Paeonia lactiflora, Salvia miltiorrhiza, Bupleurum chinense, Cuscuta chinensis, Ziziphus jujuba var. spinosa, Curcuma longa, Albizia julibrissin, and Triticum aestivum.

[0025] The formula uses Cuscuta chinensis to enhance the liver and kidney tonifying effects, assisting the principal herb in nourishing the kidneys and replenishing essence, benefiting yin and consolidating yang. Ziziphus jujuba var. spinosa, with its red color, enters the heart meridian, thus nourishing the blood of the heart and liver. Roasting it gives it a fragrant aroma that invigorates the spleen; a healthy spleen promotes the generation of qi and blood, further enhancing its blood-nourishing and calming effects. Curcuma longa promotes qi and blood circulation, clears the heart and relieves depression, cooling heart heat and dispersing liver stagnation. Albizia julibrissin flower regulates qi and relieves depression, invigorating the meridians and calming the mind. Triticum aestivum effectively tonifies qi, clears heat, stops sweating, and treats bone steaming fever. When these four herbs are used together, heart blood is nourished, heart qi is opened, and heart fire is reduced, thus harmonizing the heart and kidneys and bringing peace to the five internal organs. Adding Lycium barbarum, Ligustrum lucidum, and Bupleurum chinense further astringes heart qi and raises yang qi, nourishing both liver and heart blood, ensuring sufficient liver blood and alleviating anxiety. The entire formula works synergistically to tonify qi and blood, soothe the liver and relieve depression, and nourish the heart and calm the mind.

[0026] In summary, the above-mentioned traditional Chinese medicine formula has the effects of invigorating qi and nourishing blood, soothing the liver and relieving depression, and nourishing the heart and calming the mind. It is used for restlessness, insomnia, irregular menstruation, spontaneous sweating and night sweats caused by deficiency of qi and blood, stagnation of liver qi, and disharmony between the heart and kidneys; and for women with declining ovarian function and menopausal syndrome with the above symptoms.

[0027] In some embodiments, the herbal composition comprises the following substances in parts by weight: 12 parts Rehmannia glutinosa, 15 parts Gynostemma pentaphyllum, 9 parts Angelica sinensis, 9 parts Lycium barbarum, 12 parts Poria cocos, 6 parts Ligustrum lucidum, 6 parts Astragalus membranaceus, 6 parts Paeonia lactiflora, 6 parts Bupleurum chinense, 9 parts Salvia miltiorrhiza, 6 parts Curcuma longa, 6 parts Albizia julibrissin, 6 parts Cuscuta chinensis, 9 parts Ziziphus jujuba var. spinosa, and 9 parts Triticum aestivum.

[0028] On the one hand, this application also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps:

[0029] 1) Prepare each substance according to its weight proportions;

[0030] 2) Add 5-15 times the amount of water to each of the substances prepared in step 1) and decoct 2 to 3 times, 1 to 2 hours each time, to obtain the decoction;

[0031] 3) Combine the decoctions, let stand, and filter;

[0032] 4) Concentrate the filtrate to an appropriate amount.

[0033] In some implementations, in step 2), the substances prepared in step 1) are boiled with 10 times the amount of water 2 to 3 times, each time for 1.5 hours.

[0034] On the one hand, this application also provides the use of the aforementioned herbal composition in the preparation of medicaments for prolonging lifespan and ovarian lifespan.

[0035] On the one hand, this application also provides the use of the described herbal composition in the preparation of a medicament for treating / alleviating diminished ovarian reserve (DOR).

[0036] On the one hand, this application also provides the use of the aforementioned herbal composition in the preparation of a medicament for treating / alleviating premature ovarian insufficiency (POI).

[0037] On the one hand, this application also provides the use of the aforementioned herbal composition in the preparation of a medicament for treating / alleviating early menopause.

[0038] On the one hand, this application also provides the use of the aforementioned herbal composition in the preparation of a medicament for treating / alleviating menopausal syndrome.

[0039] On the one hand, this application also provides the use of the aforementioned herbal composition in the preparation of a medicament for treating / alleviating premature ovarian failure (POF).

[0040] In some implementations, the dosage form of the drug is an injection, an oral preparation, or a topical preparation.

[0041] In some embodiments, the dosage form is an oral formulation; in some embodiments, the formulation further includes a pharmaceutically acceptable pharmaceutical carrier; in some embodiments, the pharmaceutical carrier includes one or more of a diluent, excipient, filler, binder, disintegrant, surfactant, and lubricant.

[0042] On the one hand, this application also provides a traditional Chinese medicine composition for preventing and treating ovarian dysfunction, comprising the aforementioned traditional Chinese medicine composition and a pharmaceutically acceptable pharmaceutical carrier. Attached Figure Description

[0043] Figure 1 The results of FSH in the human efficacy test of the herbal composition (TJAOA102) in Example 1 of this invention are shown.

[0044] Figure 2 The results of AMH in the human efficacy test of the herbal composition (TJAOA102) in Example 1 of this invention are shown.

[0045] Figure 3 The results of AFC in the human efficacy test of the herbal composition (TJAOA102) in Example 1 of this invention.

[0046] Figure 4 The results of KMI in the human efficacy test of the herbal composition (TJAOA102) in Example 1 of this invention are shown.

[0047] Figure 5This is a comparison of the number of eggs laid (reproductive lifespan) in the female fruit fly treated group (TJAOA102) provided in Example 2 of the present invention with that of the control group (Control), the gypenosides group (GP), and the group without gypenosides (CHC).

[0048] Figure 6 The comparison of the overall lifespan of the female fruit fly treated with the drug (TJAOA102) provided in Example 2 of the present invention with its control group and the control herbal compound group.

[0049] Figure 7 The results of ovarian function detection in mice during the drug administration period provided in Example 3 of this invention are shown below. A represents the HE staining results of mouse ovaries, B represents the percentage of mice with regular estrous cycles, C represents the ovarian index (ovarian weight / mouse body weight), and D represents the estrogen content in mouse serum. In A and B, NC represents the blank control group, CTX represents the simple modeling group, and TJAOA102 represents the group treated with the traditional Chinese medicine composition. Detailed Implementation

[0050] The following specific embodiments further illustrate the technical solution of the present invention. These specific embodiments do not represent a limitation on the scope of protection of the present invention. Non-essential modifications and adjustments made by others based on the concept of the present invention still fall within the scope of protection of the present invention.

[0051] the term:

[0052] Chemotherapy, short for chemical drug therapy, is a treatment that uses chemotherapeutic drugs to kill cancer cells. Clinically, there are different types of chemotherapy drugs, which can be classified according to their mechanisms of action, including alkylating agents, antimetabolites, antibiotics, antitumor drugs, herbal antitumor drugs, hormonal antitumor drugs, and miscellaneous drugs. Most patients require combination therapy with two or more chemotherapy drugs, including oral and intravenous chemotherapy. Additionally, some patients may receive interventional treatment involving arterial infusion of the drugs.

[0053] CTX: Cyclophosphamide is a nitrogen mustard derivative that is hydrolyzed by excess phosphoramidase or phosphatase present in the liver or tumors after entering the human body, and then converted into an activated form of phosphoramidase nitrogen mustard to exert its effect.

[0054] As used in this article, “treatment” refers to any action taken to prevent or delay the onset of a disease, to improve one or more symptoms or complications, to induce or prolong remission, to delay relapse, recurrence or exacerbation, or to otherwise improve or stabilize a subject’s disease state or disease risk. Typically, treatment is preventative and aims to delay or prevent the onset of the disease or any symptoms or complications associated with it.

[0055] Example 1

[0056] A traditional Chinese medicine composition (TJAOA102) wherein the contents of the following ingredients are as follows: Rehmannia glutinosa (processed) 12 g, Gynostemma pentaphyllum 15 g, Angelica sinensis 9 g, Lycium barbarum 9 g, Poria cocos 12 g, Ligustrum lucidum 6 g, Astragalus membranaceus 6 g, Paeonia lactiflora 6 g, Bupleurum chinense 6 g, Salvia miltiorrhiza 9 g, Curcuma longa 6 g, Albizia julibrissin 6 g, Cuscuta chinensis 6 g, Ziziphus jujuba var. spinosa 9 g, and Triticum aestivum 9 g.

[0057] The preparation method of the traditional Chinese medicine composition:

[0058] 1) Prepare all materials according to the specified proportions;

[0059] 2) Add 10 times the amount of water to each of the ingredients prepared in step 1) and boil them 2 to 3 times, 1.5 hours each time;

[0060] 3) Decoction, let stand, and filter;

[0061] 4) Concentrate the filtrate to an appropriate amount.

[0062] Drug efficacy test

[0063] 1) Analyze efficiency indicators: KMI; AMH; FSH; AFC.

[0064] The KMI (Knowledge, Indication, and Scale) refers to a score in which patients rate the severity of ten perimenopausal symptoms based on their own circumstances, multiply the scores by weighting factors, sum the scores item by item, and finally obtain the total score, which is the KMI index.

[0065] AMH refers to anti-Miller hormone, primarily used to assess ovarian reserve function. It can predict the response to controlled ovarian stimulation (COS) and help predict menopause. From infancy, AMH levels are positively correlated with age, gradually increasing with age, peaking around age 16, and then remaining at a stable high level. After age 25, AMH levels are negatively correlated with age, gradually declining until they become undetectable after menopause.

[0066] FSH, follicle-stimulating hormone. FSH is a glycoprotein hormone secreted by the basophilic cells of the anterior pituitary gland. Its main function is to promote the development and maturation of ovarian follicles.

[0067] AFC, or Antral Follicle Count. AFC refers to the total number of follicles with a diameter of 2-9 mm in both ovaries of a woman.

[0068] 2) Judgment criteria for each indicator:

[0069] KMI / AMH / FSH / AFC: The criteria for determining validity are as follows:

[0070] If the FSH result after treatment is less than the minimum threshold for the diagnosis of the above-mentioned disease, it is considered effective; or if the AMH or AFC was less than the minimum threshold for diagnosis before treatment, but is greater than the minimum threshold for diagnosis after medication, it is also considered effective; or if the above indicators improve by more than 50%, it is considered effective.

[0071] 3) Test participants: 18 people. The average age was 38.3 years. All participants were volunteers and all were women with declining ovarian function (DOR, POI, and menopausal syndrome).

[0072] 4) Dosage and administration time: Take two sachets twice a day, half an hour before breakfast in the morning and half an hour before bedtime in the evening, for three consecutive months. It can be added to approximately 200 mL of warm water. Avoid taking this medicine during menstruation.

[0073] 5) Testing Methods

[0074] The subjects underwent fasting serum FSH and AMH tests and bilateral AFC total counts via gynecological ultrasound at Tongji Hospital in Wuhan before treatment and on days 2 to 5 of menstruation after treatment.

[0075] 6) Results

[0076] like Figure 1 As shown, FSH: 4 out of 18 people achieved effectiveness, with an effectiveness rate of 22.2%.

[0077] like Figure 2 As shown, AMH: 2 out of 18 people achieved the effective result, with an effectiveness rate of 11.1%.

[0078] like Figure 3 As shown, AFC: 8 out of 18 people were effective, with an effectiveness rate of 44.4%.

[0079] like Figure 4 As shown, KMI was effective in 7 out of 18 people, with an effectiveness rate of 38.9%.

[0080] Among the aforementioned group, 7 individuals met two or more of the criteria for effectiveness. Assuming any one of the four criteria is met, the overall effectiveness rate is 77.8% (4+2+8+7-7 / 18).

[0081] Currently, there are no mature traditional Chinese medicine (TCM) formulas specifically targeting ovarian aging. Existing TCM formulas mainly target menopausal syndrome, aiming to improve menopausal symptoms. A review of the literature reveals that one study indicated that Kuntai capsules, a formula derived from the *Huangdi Neijing* (Yellow Emperor's Inner Classic), had a 47% efficacy rate in improving premature ovarian failure (DOR) (Clinical study of kidney-tonifying and liver-soothing formula combined with moxibustion at Shenque acupoint for treating kidney deficiency and liver stagnation type premature ovarian failure). Therefore, the efficacy rate of the drug proposed in this application is relatively high.

[0082] 7) Drug safety testing

[0083] The subjects underwent fasting liver and kidney function tests at Tongji Hospital in Wuhan before treatment and on days 2 to 5 of menstruation after treatment, as shown in Table 1.

[0084] Table 1

[0085]

[0086] Example 2

[0087] S1, Prepare food for Drosophila melanogaster w1118 (hereinafter referred to as "Drosophila"):

[0088] Formula: 12 L distilled water, 210 g yeast, 900 g cornmeal, 120 g soybean flour, 100 g agar, 800 mL syrup, 150 mL 10% butylparaben, 30 mL levofloxacin.

[0089] Pour the yeast, cornmeal, soybean flour, and agar dissolved in distilled water into a pot and stir well. While stirring, add 800 mL of syrup, then stir for 30 minutes. Heat at 2300 W for 1.5 hours, then turn off the heat and add 150 mL of butylparaben and 30 mL of levofloxacin. Let stand for 2 minutes, then pour into a tube.

[0090] S2, propagation of Drosophila melanogaster:

[0091] Fruit flies were cultured in a newly prepared diet, with an average of 20 pairs of male and female fruit flies placed in each tube. After the third instar larvae pupated, the adult flies were removed and euthanized. Unmated adult flies that emerged within 8 hours were collected, separated into males and females, 400 each, and randomly divided into 4 groups. They were then cultured in the diet for later use.

[0092] S3, Prepare food containing the corresponding concentration of therapeutic drugs:

[0093] Taking the herbal composition (TJAOA102) as an example: After thoroughly mixing the herbal composition (TJAOA102) solution, take 100 μL and spread it evenly on the surface of the food in the tube, so that it can fully penetrate into the food surface to a depth of about 1 cm, and let it dry.

[0094] S4, rearing conditions:

[0095] The fruit flies were cultured in a constant temperature and humidity incubator with alternating light and dark conditions for 12 hours at a temperature of (25±1)℃ and a humidity of 65%. Fresh food was provided every 2 days and the mortality status of the fruit flies was recorded until all of them died.

[0096] S5, Drug Treatment:

[0097] A total of 5 groups were included: a blank control group (Control), a Gynostemma pentaphyllum group (GP), a Chinese herb compound without GP (CHC), the compound TJAOA102 group (GP+CHC) as applied for in this application, and a control Chinese herb compound group. Each group started the experiment with 100 animals. Fresh food was provided to all groups every other day.

[0098] The blank control group received no medication.

[0099] The GP group consisted of Gynostemma pentaphyllum extract alone.

[0100] Group CHC consists of a combination of Chinese herbal medicines that do not contain Gynostemma pentaphyllum.

[0101] Group TJAOA102 was a single application of this combination of traditional Chinese medicines;

[0102] The components of the control group of traditional Chinese medicine compound prescriptions were: Rehmannia glutinosa 20g, Cuscuta chinensis 15g, Angelica sinensis 10g, Lycium barbarum 15g, Epimedium brevicornu 10g, Morinda officinalis 10g, Dioscorea opposita 15g, Poria cocos 10g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 10g, Bupleurum chinense 10g, Cyperus rotundus 10g, Paeonia suffruticosa 10g, and Glycyrrhiza uralensis 6g.

[0103] S6, Egg Count:

[0104] Each group had 5 tubes, with 20 fruit flies per tube. The control group received no medication. The food concentration was changed every other day. At each time point, 4 female fruit flies from each group were randomly selected to mate with 2 young male fruit flies. The total number of eggs laid by the 4 female fruit flies in each group was counted.

[0105] Get as Figure 5 The results showed that, for female fruit flies, application of TJAOA102 from 1 day after emergence to death could effectively increase the number of eggs laid and improve the ovarian function of female fruit flies at different time periods.

[0106] S7, Lifespan Testing:

[0107] Five tubes were used per group, with 20 fruit flies per tube. The control group received no medication. The food was changed to the appropriate concentration every other day, and the number of surviving fruit flies in each group was counted.

[0108] Get as Figure 6 The results show that, for fruit flies, compared to the control group treated with traditional Chinese medicine compound, application of TJAOA102 from 1 day after emergence to death can more effectively increase the overall lifespan of fruit flies.

[0109] Example 3

[0110] Chemotherapy-induced ovarian damage is a common and widely accepted model of ovarian injury in experimental research. Treatment methods based on this model have reference value for the treatment of various ovarian injury factors. Specifically, chemotherapy-induced ovarian damage was induced in test mammals by administering a certain dose of CTX solution. Test mammals were then given a combination of this traditional Chinese medicine composition (TJAOA102) containing an effective dose, while a control group was given physiological saline. After continuous administration for a period of time, the ovarian function of the test mammals was tested. The results showed that a combination of this traditional Chinese medicine composition (TJAOA102) containing an effective dose was beneficial in alleviating ovarian function decline caused by chemotherapy drugs.

[0111] The application method described in this invention includes the following steps:

[0112] S1, Establishment of a chemotherapy-induced ovarian injury C57BL / 6 mouse model:

[0113] Under light-protected conditions, prepare a CTX solution with a concentration of 10 mg / mL using physiological saline and mix thoroughly to dissolve it; weigh the mice and calculate the injection dose per mouse based on the dosage of 120 mg / kg of CTX;

[0114] The mice were held in place with the left hand, and the appropriate amount of CTX solution was injected into the peritoneum of the mice with the right hand. The blank control group was given the appropriate amount of physiological saline. The rest of the process was the same as that for establishing the model.

[0115] S2, Drug treatment:

[0116] Before chemotherapy, mice in the TJAOA102 group were given 400 mg / kg of this traditional Chinese medicine composition by gavage for 14 days. After chemotherapy, they continued to be given the corresponding dose of this traditional Chinese medicine composition for 14 days. The blank control group and the simple model group were given the same volume of physiological saline.

[0117] S3, Ovarian Reserve Function Test:

[0118] Mouse ovaries were fixed in formalin and sent for serial sectioning. One ovarian section was taken every 80 μm for HE staining, and follicles at each stage were counted under a light microscope. Results are as follows: Figure 7 As shown in Figure A, under an optical microscope, primordial follicles and growing follicles were more commonly seen in ovarian sections of mice in the NC and TJAOA102 groups, while atretic follicles were predominantly seen in ovarian sections of mice in the CTX group. Figure 7 C shows that the ovarian index (ovarian weight / mouse body weight) of mice treated with TJAOA102 increased significantly; D shows that the serum estrogen content of mice in the TJAOA102 group increased significantly.

[0119] S4, Ovarian endocrine testing:

[0120] For ten consecutive days, vaginal secretions from mice were collected with physiological saline to detect estrous cycles. Figure 7 As can be seen from B, the estrous cycle of mice in the TJAOA102 group was more regular, and the proportion of regular estrous cycles obtained from the statistics was higher.

[0121] Comparative Example 1

[0122] S1, Prepare food for Drosophila melanogaster w1118 (hereinafter referred to as "Drosophila"):

[0123] Formula: 12 L distilled water, 210 g yeast, 900 g cornmeal, 120 g soybean flour, 100 g agar, 800 mL syrup, 150 mL 10% butylparaben, 30 mL levofloxacin.

[0124] Pour the yeast, cornmeal, soybean flour, and agar dissolved in distilled water into a pot and stir well. While stirring, add 800 mL of syrup, then stir for 30 minutes. Heat at 2300 W for 1.5 hours, then turn off the heat and add 150 mL of butylparaben and 30 mL of levofloxacin. Let stand for 2 minutes, then pour into a tube.

[0125] S2, propagation of Drosophila melanogaster:

[0126] Fruit flies were cultured in a newly prepared diet, with an average of 20 pairs of male and female fruit flies placed in each tube. After the third instar larvae pupated, the adult flies were removed and euthanized. Unmated adult flies that emerged within 8 hours were collected, separated into males and females, 400 each, and randomly divided into 4 groups. They were then cultured in the diet for later use.

[0127] S3, Prepare food containing the corresponding concentration:

[0128] After thoroughly mixing the herbal solutions from each group, take 100 μL and evenly spread it on the surface of the food in the tube, allowing it to fully penetrate the food surface to a depth of about 1 cm, and then let it dry.

[0129] S4, rearing conditions:

[0130] The fruit flies were cultured in a constant temperature and humidity incubator with alternating light and dark conditions for 12 hours at a temperature of (25±1)℃ and a humidity of 65%. Fresh food was provided every 2 days and the mortality status of the fruit flies was recorded until all of them died.

[0131] S5, Drug Treatment:

[0132] There were a total of 10 groups: Gynostemma pentaphyllum 27 g group, Rehmannia glutinosa 27 g group, Gynostemma pentaphyllum 12 g + Rehmannia glutinosa 15 g group, Gynostemma pentaphyllum 27 g + adjuvant herbs + adjuvant herbs group, Rehmannia glutinosa 27 g + Rehmannia glutinosa 15 g + adjuvant herbs + adjuvant herbs group, Gynostemma pentaphyllum 12 g + Rehmannia glutinosa 15 g + adjuvant herbs + adjuvant herbs group, Gynostemma pentaphyllum 2 g + Rehmannia glutinosa 15 g + adjuvant herbs + adjuvant herbs group, Gynostemma pentaphyllum 18 g + Rehmannia glutinosa 15 g + adjuvant herbs + adjuvant herbs group, Gynostemma pentaphyllum 12 g + Rehmannia glutinosa 7 g + adjuvant herbs + adjuvant herbs group, and Gynostemma pentaphyllum 12 g + Rehmannia glutinosa 22 g + adjuvant herbs + adjuvant herbs group. All groups received fresh food every other day. Each group started with 100 animals.

[0133] In the formula of this application, the principal ingredients are: Gynostemma pentaphyllum and Rehmannia glutinosa; the assistant ingredients are: Angelica sinensis, Paeonia lactiflora, Salvia miltiorrhiza, Astragalus membranaceus, and Cuscuta chinensis; and the adjuvant ingredients are: Lycium barbarum, Ligustrum lucidum, Bupleurum chinense, Poria cocos, Curcuma longa, Albizia julibrissin, Ziziphus jujuba var. spinosa, and Triticum aestivum.

[0134] Unless otherwise specified, the amounts of the components are the same as those in the TJAOA102 described in Example 1.

[0135] S6, Egg Count:

[0136] Each group has 5 tubes, with 20 flies per tube. The food concentration is changed every other day. At each time point, 4 female fruit flies are randomly selected from each group and mated with 2 young male fruit flies. The ovarian lifespan of the 4 female fruit flies in each group is recorded.

[0137] S7, Lifespan Testing:

[0138] Five tubes were placed in each group, with 20 fruit flies per tube. The food concentration was changed every other day, and the number of surviving fruit flies in each group was counted.

[0139] The results shown in Tables 2 and 3 indicate that, as the principal components, the combined use of a certain amount of Gynostemma pentaphyllum and Rehmannia glutinosa is more effective and neither can be omitted. For Drosophila, the TJAOA102 formula can more effectively increase the ovarian lifespan and overall lifespan of Drosophila.

[0140] Table 2

[0141]

[0142] Table 3

[0143]

[0144] Comparative Example 2

[0145] S1, Prepare food for Drosophila melanogaster w1118 (hereinafter referred to as "Drosophila"):

[0146] Formula: 12 L distilled water, 210 g yeast, 900 g cornmeal, 120 g soybean flour, 100 g agar, 800 mL syrup, 150 mL 10% butylparaben, 30 mL levofloxacin.

[0147] Pour the yeast, cornmeal, soybean flour, and agar dissolved in distilled water into a pot and stir well. While stirring, add 800 mL of syrup, then stir for 30 minutes. Heat at 2300 W for 1.5 hours, then turn off the heat and add 150 mL of butylparaben and 30 mL of levofloxacin. Let stand for 2 minutes, then pour into a tube.

[0148] S2, propagation of Drosophila melanogaster:

[0149] Fruit flies were cultured in a newly prepared diet, with an average of 20 pairs of male and female fruit flies placed in each tube. After the third instar larvae pupated, the adult flies were removed and euthanized. Unmated adult flies that emerged within 8 hours were collected, separated into males and females, 400 each, and randomly divided into 4 groups. They were then cultured in the diet for later use.

[0150] S3, Prepare food containing the corresponding concentration:

[0151] After thoroughly mixing the herbal solutions from each group, take 100 μL and evenly spread it on the surface of the food in the tube, allowing it to fully penetrate the food surface to a depth of about 1 cm, and then let it dry.

[0152] S4, rearing conditions:

[0153] The fruit flies were cultured in a constant temperature and humidity incubator with alternating light and dark conditions for 12 hours at a temperature of (25±1)℃ and a humidity of 65%. Fresh food was provided every 2 days and the mortality status of the fruit flies was recorded until all of them died.

[0154] S5, Drug Treatment:

[0155] There were a total of 32 groups, each involving the substitution and adjustment of the dosage of each herb in the formula. Fresh food was provided to all groups every other day. Each group started the experiment with 100 animals.

[0156] In the formula of this application, the principal ingredients are: Gynostemma pentaphyllum and Rehmannia glutinosa; the assistant ingredients are: Angelica sinensis, Paeonia lactiflora, Salvia miltiorrhiza, Astragalus membranaceus, and Cuscuta chinensis; and the adjuvant ingredients are: Lycium barbarum, Ligustrum lucidum, Bupleurum chinense, Poria cocos, Curcuma longa, Albizia julibrissin, Ziziphus jujuba var. spinosa, and Triticum aestivum.

[0157] Unless otherwise specified, the amounts of the components are the same as those in the TJAOA102 described in Example 1.

[0158] S6, Egg Count:

[0159] Each group has 5 tubes, with 20 flies per tube. The food concentration is changed every other day. At each time point, 4 female fruit flies are randomly selected from each group and mated with 2 young male fruit flies. The ovarian lifespan of the 4 female fruit flies in each group is recorded.

[0160] S7, Lifespan Testing:

[0161] Five tubes were placed in each group, with 20 fruit flies per tube. The food concentration was changed every other day, and the number of surviving fruit flies in each group was counted.

[0162] The results shown in Tables 4 and 5 indicate that, as auxiliary medicinal components, the combination of certain dosages of Angelica sinensis, Paeonia lactiflora, Salvia miltiorrhiza, Astragalus membranaceus, and Cuscuta chinensis is more effective and none of them can be omitted. For Drosophila, the TJAOA102 formula can more effectively increase the ovarian lifespan and overall lifespan of Drosophila.

[0163] Table 4

[0164]

[0165] Table 5

[0166]

[0167] Comparative Example 3

[0168] S1, Prepare food for Drosophila melanogaster w1118 (hereinafter referred to as "Drosophila"):

[0169] Formula: 12 L distilled water, 210 g yeast, 900 g cornmeal, 120 g soybean flour, 100 g agar, 800 mL syrup, 150 mL 10% butylparaben, 30 mL levofloxacin.

[0170] Pour the yeast, cornmeal, soybean flour, and agar dissolved in distilled water into a pot and stir well. While stirring, add 800 mL of syrup, then stir for 30 minutes. Heat at 2300 W for 1.5 hours, then turn off the heat and add 150 mL of butylparaben and 30 mL of levofloxacin. Let stand for 2 minutes, then pour into a tube.

[0171] S2, propagation of Drosophila melanogaster:

[0172] Fruit flies were cultured in a newly prepared diet, with an average of 20 pairs of male and female fruit flies placed in each tube. After the third instar larvae pupated, the adult flies were removed and euthanized. Unmated adult flies that emerged within 8 hours were collected, separated into males and females, 400 each, and randomly divided into 4 groups. They were then cultured in the diet for later use.

[0173] S3, Prepare food containing the corresponding concentration:

[0174] After thoroughly mixing the herbal solutions from each group, take 100 μL and evenly spread it on the surface of the food in the tube, allowing it to fully penetrate the food surface to a depth of about 1 cm, and then let it dry.

[0175] S4, rearing conditions:

[0176] The fruit flies were cultured in a constant temperature and humidity incubator with alternating light and dark conditions for 12 hours at a temperature of (25±1)℃ and a humidity of 65%. Fresh food was provided every 2 days and the mortality status of the fruit flies was recorded until all of them died.

[0177] S5, Drug Treatment:

[0178] There were a total of 7 groups: principal drug group, assistant drug group, adjuvant drug group, principal drug + assistant drug group, principal drug + adjuvant drug group, assistant drug + adjuvant drug group, and principal drug + assistant drug + adjuvant drug group. Fresh food was provided to all groups every other day. Each group started with 100 animals.

[0179] In the formula of this application, the principal ingredients are: Gynostemma pentaphyllum and Rehmannia glutinosa; the assistant ingredients are: Angelica sinensis, Paeonia lactiflora, Salvia miltiorrhiza, Astragalus membranaceus, and Cuscuta chinensis; and the adjuvant ingredients are: Lycium barbarum, Ligustrum lucidum, Bupleurum chinense, Poria cocos, Curcuma longa, Albizia julibrissin, Ziziphus jujuba var. spinosa, and Triticum aestivum.

[0180] Unless otherwise specified, the amounts of the components are the same as those in the TJAOA102 described in Example 1.

[0181] S6, Egg Count:

[0182] Each group has 5 tubes, with 20 flies per tube. The food concentration is changed every other day. At each time point, 4 female fruit flies are randomly selected from each group and mated with 2 young male fruit flies. The ovarian lifespan of the 4 female fruit flies in each group is recorded.

[0183] S7, Lifespan Testing:

[0184] Five tubes were placed in each group, with 20 fruit flies per tube. The food concentration was changed every other day, and the number of surviving fruit flies in each group was counted.

[0185] The results shown in Table 6 indicate that the combination of the principal drug, assistant drug, and adjuvant drug is more effective, and all three are indispensable. For fruit flies, the TJAOA102 formula can more effectively increase the ovarian lifespan and overall lifespan of fruit flies.

[0186] Table 6

[0187]

Claims

1. A traditional Chinese medicine composition for prolonging the lifespan of the body and reproductive organs, characterized in that, It is made from the following ingredients in parts by weight: 4-20 parts Rehmannia glutinosa, 7-23 parts Gynostemma pentaphyllum, 1-17 parts Angelica sinensis, 1-17 parts Lycium barbarum, 4-20 parts Poria cocos, 1-11 parts Ligustrum lucidum, 1-11 parts Astragalus membranaceus, 1-11 parts Paeonia lactiflora, 1-11 parts Bupleurum chinense, 1-17 parts Salvia miltiorrhiza, 1-11 parts Curcuma longa, 1-11 parts Albizia julibrissin, 1-11 parts Cuscuta chinensis, 1-11 parts Ziziphus jujuba var. spinosa, and 1-17 parts Triticum aestivum.

2. The herbal composition as described in claim 1, characterized in that, Made from the following substances in parts by weight: Prepared Rehmannia Root 6-14 parts, Gynostemma Pentaphyllum 9-17 parts, Angelica Sinensis 3-11 parts, Lycium Barbarum 3-11 parts, Poria 6-14 parts, Ligustrum Lucidum 2-8 parts, Astragalus Root 2-8 parts, White Peony Root 2-8 parts, Bupleurum Root 2-8 parts, Salvia Miltiorrhiza 3-11 parts, Curcuma Rhizome 2-8 parts, Albizia Flower 2-8 parts, Cuscuta Seed 2-8 parts, Ziziphus Jujuba Seed 3-10 parts, Triticum Aestivum 3-11 parts.

3. The herbal composition as described in claim 1, characterized in that, Made from the following substances in parts by weight: Prepared Rehmannia Root 8-16 parts, Gynostemma Pentaphyllum 11-19 parts, Angelica Sinensis 5-13 parts, Lycium barbarum 5-13 parts, Poria cocos 8-16 parts, Ligustrum lucidum 3-9 parts, Astragalus membranaceus 3-9 parts, Paeonia lactiflora 3-9 parts, Bupleurum chinense 3-9 parts, Salvia miltiorrhiza 5-13 parts, Curcuma longa 3-9 parts, Albizia julibrissin 3-9 parts, Cuscuta chinensis 3-9 parts, Ziziphus jujuba var. spinosa 5-10 parts, Triticum aestivum 5-13 parts.

4. The herbal composition as described in claim 1, characterized in that, Made from the following substances in parts by weight: Prepared Rehmannia Root 10-18 parts, Gynostemma Pentaphyllum 13-21 parts, Angelica Sinensis 7-15 parts, Lycium barbarum 7-15 parts, Poria cocos 10-18 parts, Ligustrum lucidum 4-10 parts, Astragalus membranaceus 4-10 parts, Paeonia lactiflora 4-10 parts, Bupleurum chinense 4-10 parts, Salvia miltiorrhiza 7-15 parts, Curcuma longa 4-10 parts, Albizia julibrissin 4-10 parts, Cuscuta chinensis 4-10 parts, Ziziphus jujuba var. spinosa 7-10 parts, Triticum aestivum 7-15 parts.

5. The herbal composition as described in claim 1, characterized in that, Made from the following substances in parts by weight: Prepared Rehmannia Root 4-15 parts, Gynostemma Pentaphyllum 9-20 parts, Angelica Sinensis 4-17 parts, Lycium barbarum 4-17 parts, Poria cocos 4-18 parts, Ligustrum lucidum 2-10 parts, Astragalus membranaceus 2-10 parts, Paeonia lactiflora 2-10 parts, Bupleurum chinense 2-10 parts, Salvia miltiorrhiza 2-16 parts, Curcuma longa 2-10 parts, Albizia julibrissin 2-10 parts, Cuscuta chinensis 2-10 parts, Ziziphus jujuba var. spinosa 2-10 parts, Triticum aestivum 2-16 parts.

6. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, Includes the following steps: 1) Prepare each substance according to its weight proportions; 2) Add 5-15 times the amount of water to each of the substances prepared in step 1) and decoct 2 to 3 times, 1 to 2 hours each time, to obtain the decoction; 3) Combine the decoctions, let stand, and filter; 4) Concentrate the filtrate to an appropriate amount.

7. The preparation method according to claim 6, characterized in that, In step 2), add 10 times the amount of water to each of the substances prepared in step 1) and boil them 2 to 3 times, 1.5 hours each time.

8. The use of the herbal composition as described in any one of claims 1-5 in the preparation of a medicament for delaying / alleviating aging.

9. The use of the herbal composition according to any one of claims 1-5 in the preparation of a drug for prolonging life.

10. The use of the herbal composition according to any one of claims 1-5 in the preparation of a drug for prolonging reproductive / ovarian lifespan.

11. The use of the herbal composition according to any one of claims 1-5 in the preparation of a medicament for treating / alleviating diminished ovarian reserve (DOR).

12. The use of the herbal composition according to any one of claims 1-5 in the preparation of a medicament for treating / alleviating premature ovarian insufficiency (POI).

13. The use of the herbal composition as described in any one of claims 1-5 in the preparation of a medicament for treating / alleviating early menopause or menopausal syndrome.

14. The use of the herbal composition according to any one of claims 1-5 in the preparation of a medicament for treating / alleviating premature ovarian failure (POF).

15. The application as described in claim 8, characterized in that, The dosage form of the drug is an injection, an oral preparation, or a topical preparation.

16. The application as described in claim 9, characterized in that, The dosage form of the drug is an injection, an oral preparation, or a topical preparation.

17. The application as described in claim 10, characterized in that, The dosage form of the drug is an injection, an oral preparation, or a topical preparation.

18. The application as described in claim 11, characterized in that, The dosage form of the drug is an injection, an oral preparation, or a topical preparation.

19. The application as described in claim 12, characterized in that, The dosage form of the drug is an injection, an oral preparation, or a topical preparation.

20. The application as described in claim 13, characterized in that, The dosage form of the drug is an injection, an oral preparation, or a topical preparation.

21. The application as described in claim 14, characterized in that, The dosage form of the drug is an injection, an oral preparation, or a topical preparation.

22. The application as described in any one of claims 15-21, characterized in that, The dosage form is an oral preparation.

23. The application as described in any one of claims 15-21, characterized in that, The formulation also includes a pharmaceutically acceptable pharmaceutical carrier.

24. The application as described in claim 23, characterized in that, The pharmaceutical carrier includes one or more of the following: diluent, excipient, filler, binder, disintegrant, surfactant, and lubricant.

25. A traditional Chinese medicine composition for preventing and treating ovarian dysfunction, characterized in that, It is made from the herbal composition according to any one of claims 1-5 and a pharmaceutically acceptable pharmaceutical carrier.

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