Composition for preventing and treating premature ovarian failure and regulating endocrine and preparation method thereof

Abstract

The invention discloses a composition for preventing and treating premature ovarian failure and regulating endocrine and a preparation method thereof. The composition comprises the following raw materials: dioscin, ergothioneine, PQQ, glutathione, angelica sinensis, peach kernels, mulberries, black fungus and broccoli. The traditional Chinese medicine and modern medicine concepts of treatment based on evidence are fused, the raw materials are scientific in compatibility and synergistic in effect, the effects of regulating reproductive endocrine, improving ovarian functions, resisting oxidative stress, enhancing organism immunity and the like are achieved together, premature ovarian failure can be prevented and treated, uncomfortable symptoms caused by ovarian function decline can be relieved, and the traditional Chinese medicine composition is safe and efficient.

Description

Technical Field

[0001] This invention relates to the field of compositions, specifically to a composition for preventing premature ovarian failure and regulating endocrine function, and a method for preparing the same. Background Technology

[0002] Premature ovarian failure (POF) refers to the ovarian failure and subsequent amenorrhea in women before the age of 40. It is accompanied by a decline in estrogen levels and an increase in gonadotropin levels, and often manifests as menstrual disorders, hot flashes and night sweats, dull skin, osteoporosis, mood swings, and other symptoms, which seriously affect women's reproductive health and quality of life.

[0003] Currently, hormone replacement therapy is the most common clinical treatment for premature ovarian failure. While it can alleviate some symptoms, long-term use may increase the risk of diseases such as breast cancer and endometrial cancer, and it also has certain side effects. Traditional Chinese medicine has unique advantages in the treatment of premature ovarian failure. Traditional medicine considers premature ovarian failure to fall under the categories of "amenorrhea" and "infertility," and its pathogenesis is closely related to liver and kidney deficiency, insufficient qi and blood, and phlegm-dampness obstruction. Treatment mainly focuses on tonifying the kidneys and replenishing essence, nourishing the liver and kidneys, and replenishing qi and blood.

[0004] However, traditional Chinese medicine suffers from slow efficacy and limited targeted formulation. With the development of modern medicine, research has revealed that factors such as oxidative stress and immune dysfunction play a significant role in the development of premature ovarian failure. Therefore, developing a safe and effective combination for the prevention and treatment of premature ovarian failure, combining traditional Chinese medicine theory with modern medical research findings, is of great importance. Summary of the Invention

[0005] To overcome the shortcomings of existing technologies, this invention develops a composition for preventing and treating premature ovarian failure and regulating endocrine function. This composition integrates traditional medicine and modern medical concepts, acting on multiple targets and at multiple stages. It can effectively regulate reproductive endocrine function, improve ovarian function, alleviate the discomfort symptoms caused by premature ovarian failure, and has a high safety profile.

[0006] The composition comprises the following raw materials in parts by weight: 10-30 parts diosgenin, 5-20 parts ergothionein, 5-20 parts PQQ, 3-15 parts glutathione, 10-25 parts angelica, 5-15 parts peach kernel, 5-20 parts mulberry, 5-15 parts black fungus, and 5-20 parts broccoli.

[0007] Furthermore, the composition comprises the following raw materials in parts by weight: 12-25 parts diosgenin, 8-15 parts ergothionein, 8-15 parts PQQ, 5-12 parts glutathione, 15-20 parts angelica, 8-12 parts peach kernel, 10-18 parts mulberry, 8-12 parts black fungus, and 8-15 parts broccoli.

[0008] More preferably, the composition consists of the following raw materials in parts by weight: 15 parts diosgenin, 10 parts ergothionein, 12 parts PQQ, 6 parts glutathione, 16 parts angelica, 10 parts peach kernel, 15 parts mulberry, 10 parts black fungus, and 10 parts broccoli.

[0009] More preferably, the composition consists of the following raw materials in parts by weight: 10 parts diosgenin, 5 parts ergothionein, 5 parts PQQ, 3 parts glutathione, 10 parts angelica, 5 parts peach kernel, 5 parts mulberry, 5 parts black fungus, and 5 parts broccoli.

[0010] Further preferably, the composition comprises the following raw materials in parts by weight: 30 parts diosgenin, 20 parts ergothionein, 20 parts PQQ, 15 parts glutathione, 25 parts angelica, 15 parts peach kernel, 20 parts mulberry, 15 parts black fungus, and 20 parts broccoli.

[0011] To further enhance the effectiveness of the composition, vitamins may be added to the composition, including one or more of the following: vitamin A, vitamin B, vitamin C, and vitamin D.

[0012] This invention also provides a compound preparation for preventing premature ovarian failure and regulating endocrine function. The raw materials include the above-mentioned composition, and may also include excipients or carriers that are conventionally acceptable in food science or pharmaceutical science, including one or more of the following: diluents, wetting agents, lubricants, binders, disintegrants, encapsulating agents, flavoring agents, sustained-release agents, dispersants, plasticizers, and light-blocking agents.

[0013] Compound preparations can be made into any one or more forms such as powders, granules, tablets, pills, capsules, ointments, gels, oral liquid preparations, tea bags, hard candies, and soft candies.

[0014] The preparation method of the composition of the present invention includes the following steps: Select mulberries without rot, wash and drain them; take the florets of broccoli, wash and cut them into small pieces; freeze-dry the mulberries and broccoli under vacuum, and then grind them into powder A. Remove the fibrous roots and impurities from the angelica root and crush it; remove the seed coat from the peach kernel and crush it; soak the black fungus until it is fully expanded, remove the hard roots, and chop it; add the processed angelica root, peach kernel, and black fungus to 10-20 times the amount of water, add yeast extract and glucose, adjust the pH to 6.5-7.0, sterilize with high-pressure steam at 121℃ for 20 minutes, cool to obtain the culture medium, and put it into a fermenter; A compound bacterial strain was selected, activated under constant temperature conditions, and prepared into a compound bacterial suspension, which was then inoculated into a culture medium. The fermentation was carried out in a sealed fermenter with low-speed stirring for 12-36 hours. After stirring was stopped, the fermentation was continued in a sealed environment for 36-72 hours to obtain the fermentation broth. The fermentation broth was heated to 90°C and maintained for 30 minutes to inactivate the bacteria and terminate the fermentation. The fermentation broth was separated into supernatants using a centrifuge. The supernatants were concentrated under reduced pressure and spray-dried to obtain the fermentation extract.

[0015] Diosgenin, ergothioneine, PQQ, glutathione, powder A, and fermentation extract were mixed, pulverized, and sieved to obtain the composition.

[0016] The composite microbial strain is Bacillus subtilis and Lactobacillus plantarum, with a live bacteria ratio of (1-5):(1-5). Preferably, the live bacteria ratio is 1:1, 2:1, 3:1, 4:1, 5:1, 1:2, 1:3, 1:4, or 1:5.

[0017] Preferably, the amount of yeast extract added is 0.2%-0.5%, and the amount of glucose added is 0.1%-0.5%.

[0018] Preferably, the fermentation temperature is 28℃-37℃.

[0019] Preferably, the supernatant is concentrated under reduced pressure to 1 / 5 to 1 / 2 of its original volume; the inlet temperature of the spray dryer is 150℃-200℃, and the outlet temperature is 60℃-90℃.

[0020] Preferably, the sieve mesh size is 80-200 mesh.

[0021] Diosgenin includes, but is not limited to, extracts from yam. Yam, a traditional Chinese medicine, functions to invigorate the spleen and replenish qi, and to aid in the production of kidney essence.

[0022] Ergothioneine includes, but is not limited to, extracts derived from button mushroom powder.

[0023] PQQ stands for pyrroloquinoline quinone, which includes, but is not limited to, extracts derived from natto powder.

[0024] Glutathione includes, but is not limited to, glutathione-derived yeast powder.

[0025] The effects and functions of this invention: Diosgenin: Diosgenin can bind to estrogen receptors (ERα / ERβ), activate downstream signaling pathways, promote the expression of estrogen-related genes, and support ovarian hormone synthesis. It also possesses strong antioxidant stress-reducing capabilities, reducing damage to the ovaries from reactive oxygen species (ROS) and protecting follicle health.

[0026] Ergothioneine (EGT): Ergothioneine (EGT) is a natural sulfur-containing amino acid antioxidant that effectively eliminates free radicals in the ovaries, protects cell membranes from damage, and penetrates deep into mitochondria to reduce oxidative stress, maintain normal ATP synthesis, and delay ovarian cell aging. It efficiently enters cells via its dedicated transporter protein (OCTN1), providing deep antioxidant protection to the ovaries and slowing cell aging. Simultaneously, it inhibits tyrosinase activity, reduces melanin production, fades dark spots, brightens skin tone, and allows beauty to radiate naturally from within.

[0027] PQQ: PQQ can regulate the immune system, enhance the ovaries' disease resistance, promote metabolism, eliminate toxins from the body, promote nerve cell growth and repair, improve sleep quality, alleviate mood fluctuations, and relax and restore the body and mind.

[0028] Glutathione: Glutathione is a natural antioxidant in the human body and an important anti-aging molecule. It can neutralize free radicals, reduce the damage of oxidative stress to reproductive cells, improve the survival rate and development potential of eggs, and improve the discomfort symptoms caused by declining ovarian function, such as irregular menstruation and dull skin. It can also delay the aging process of ovarian cells and delay menopause.

[0029] Angelica sinensis: Sweet, pungent, and warm in nature, it enters the liver, heart, and spleen meridians; it has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain. It is used for blood deficiency and chlorosis, dizziness and palpitations, amenorrhea and dysmenorrhea, and abdominal pain due to deficiency and cold. It can improve ovarian blood circulation, increase estrogen synthesis, promote follicle development, provide sufficient nutrition to the ovaries, and relieve dysmenorrhea and menstrual disorders.

[0030] Peach kernel: Bitter, sweet, and neutral in nature; enters the heart, liver, and large intestine meridians; functions to invigorate blood and remove blood stasis; used for amenorrhea, dysmenorrhea, and abdominal masses. It can improve ovarian blood stasis, improve follicle blood supply, promote blood circulation, and help regulate endocrine balance.

[0031] Mulberry: Sweet and sour in taste, cold in nature, and enters the heart, liver, and kidney meridians; it nourishes yin and blood, generates fluids and moistens dryness, and is used for liver and kidney yin deficiency, dizziness, tinnitus, palpitations, and insomnia. It nourishes liver and kidney yin, improving ovarian function decline caused by liver and kidney deficiency. It is also rich in anthocyanins, vitamin C, and other natural antioxidants, reducing ovarian oxidative stress and protecting egg cells.

[0032] Black fungus: Black fungus polysaccharides have immune-enhancing and antioxidant effects, helping to maintain the stability of the ovarian microenvironment. It is also rich in iron and vitamin E. Iron can prevent anemia and provide nutritional support for maintaining ovarian function, while vitamin E has antioxidant properties, synergistically protecting ovarian cells.

[0033] Broccoli: Rich in various vitamins, minerals, and dietary fiber, it can replenish the body's nutrients, enhance immunity, and help improve the ovarian microenvironment. Glucosinolates can induce the expression of antioxidant enzymes in the body, enhancing overall antioxidant defense.

[0034] In this invention's formulation, ergothioneine, PQQ, glutathione, mulberry, broccoli, and other multi-source antioxidants work synergistically to significantly reduce free radical levels in ovarian tissue and prevent premature follicle apoptosis. Angelica sinensis, peach kernel, and black fungus work together to improve ovarian blood supply and promote estrogen synthesis. Dioscorea saponins and mulberry work together to nourish kidney essence, providing the ovaries with sufficient "innate essence." By increasing estrogen synthesis, lowering FSH, and increasing E2, this formula helps restore ovarian function and delays the progression of premature ovarian failure.

[0035] This invention integrates the concepts of traditional Chinese medicine in tonifying the kidneys and replenishing essence, nourishing the liver and kidneys, and replenishing qi and blood with the evidence-based treatment principles of modern medicine. Through multi-level anti-oxidation, blood circulation promotion, kidney tonification and immune regulation, it forms a comprehensive protective network against premature ovarian failure. It can play a synergistic role in improving ovarian microcirculation, reducing oxidative damage and regulating estrogen levels, providing a scientific basis for the prevention and treatment of premature ovarian failure and the regulation of endocrine function.

[0036] Compared with the prior art, the present invention has the following beneficial effects: I. Precise protection of the ovaries and prevention of premature aging: Dioscorea saponins activate the estrogen pathway and resist ROS damage; Ergothioneine and glutathione provide antioxidant protection and deep cell protection against aging; PQQ enhances immunity; Angelica sinensis, peach kernel, mulberry, black fungus, and broccoli nourish the liver and kidneys, replenish qi and blood, and provide nutrition.

[0037] II. Regulates endocrine function to relieve discomfort, harmonizes mind and body, improves menstrual irregularities and dysmenorrhea, alleviates menopausal symptoms and slows down the process. Ergothioneine and glutathione rejuvenate the skin and fade spots, while PQQ strengthens immunity, boosts energy, and improves sleep and mood.

[0038] Third, the raw materials are natural and mild, with high safety. The raw materials produce a synergistic effect after fermentation, with good and unpredictable results, and high application value. Attached Figure Description

[0039] Figure 1 Serum estradiol (E2) levels in each group of rats Figure 2 Serum follicle-stimulating hormone (FSH) levels in each group of rats Figure 3 Serum luteinizing hormone (LH) levels in each group of rats Figure 4 Serum superoxide dismutase (SOD) levels in each group of rats Figure 5 Serum malondialdehyde (MDA) levels in each group of rats Detailed Implementation

[0040] To better illustrate the purpose, technical solution, and advantages of the present invention, the present invention will be further described below in conjunction with specific embodiments.

[0041] Example 1 A composition for preventing premature ovarian failure, comprising the following raw materials in parts by weight: 15 parts diosgenin, 10 parts ergothionein, 12 parts PQQ, 6 parts glutathione, 16 parts angelica, 10 parts peach kernel, 15 parts mulberry, 10 parts black fungus, and 10 parts broccoli.

[0042] The preparation method includes the following steps: Select mulberries without rot, wash and drain them; take the florets of broccoli, wash and cut them into small pieces; freeze-dry the mulberries and broccoli under vacuum, and then grind them into powder A. Remove the fibrous roots and impurities from the angelica root and crush it; remove the seed coat from the peach kernel and crush it; soak the black fungus until it is fully expanded, remove the hard roots, and chop it; add the processed angelica root, peach kernel, and black fungus to 15 times the amount of water, add 0.2% yeast extract and 0.5% glucose, adjust the pH to 6.8, sterilize with high pressure steam at 121℃ for 20 minutes, cool to obtain the culture medium, and put it into a fermenter; A compound bacterial strain, with a live Bacillus subtilis and Lactobacillus plantarum ratio of 1:2, was selected and activated under constant temperature conditions to prepare a compound bacterial suspension, which was then inoculated into a culture medium. The suspension was then placed in a sealed fermentation tank and fermented at 35°C with low-speed stirring for 24 hours. After stirring was stopped, fermentation continued for another 48 hours in a sealed tank to obtain the fermentation broth. The fermentation broth was then heated to 90°C and maintained for 30 minutes to inactivate the bacteria, thus terminating the fermentation. The fermentation broth was separated into supernatants using a centrifuge. The supernatants were concentrated under reduced pressure to 1 / 4 of their original volume and then spray-dried at an inlet temperature of 180°C and an outlet temperature of 70°C to obtain the fermentation extract.

[0043] Diosgenin, ergothionein, PQQ, glutathione, powder A, and fermentation extract were mixed, pulverized, and passed through a 100-mesh sieve to obtain the composition.

[0044] Example 2 A composition for preventing premature ovarian failure, comprising the following raw materials in parts by weight: 10 parts diosgenin, 5 parts ergothionein, 5 parts PQQ, 3 parts glutathione, 10 parts angelica, 5 parts peach kernel, 5 parts mulberry, 5 parts black fungus, and 5 parts broccoli.

[0045] The preparation method includes the following steps: Select mulberries without rot, wash and drain them; take the florets of broccoli, wash and cut them into small pieces; freeze-dry the mulberries and broccoli under vacuum, and then grind them into powder A. Remove the fibrous roots and impurities from the angelica root and crush it; remove the seed coat from the peach kernel and crush it; soak the black fungus until it is fully expanded, remove the hard roots, and chop it; add the processed angelica root, peach kernel, and black fungus to 10 times the amount of water, add 0.2% yeast extract and 0.5% glucose, adjust the pH to 6.7, sterilize with high pressure steam at 121℃ for 20 minutes, cool to obtain the culture medium, and put it into a fermenter; A compound bacterial strain, with a live Bacillus subtilis and Lactobacillus plantarum ratio of 1:1, was selected and activated under constant temperature conditions to prepare a compound bacterial suspension, which was then inoculated into a culture medium. The suspension was then placed in a sealed fermentation tank and fermented at 34°C with low-speed stirring for 24 hours. After stirring was stopped, fermentation continued for another 48 hours in a sealed environment to obtain the fermentation broth. The fermentation broth was heated to 85°C and maintained for 30 minutes to inactivate the bacteria, thus terminating the fermentation. The fermentation broth was separated into supernatants using a centrifuge. The supernatants were concentrated under reduced pressure to 1 / 4 of their original volume and then spray-dried at an inlet temperature of 180°C and an outlet temperature of 70°C to obtain the fermentation extract.

[0046] Diosgenin, ergothionein, PQQ, glutathione, powder A, and fermentation extract were mixed, pulverized, and passed through a 100-mesh sieve to obtain the composition.

[0047] Example 3 A composition for preventing premature ovarian failure, comprising the following raw materials in parts by weight: 30 parts diosgenin, 20 parts ergothionein, 20 parts PQQ, 15 parts glutathione, 25 parts angelica, 15 parts peach kernel, 20 parts mulberry, 15 parts black fungus, and 20 parts broccoli.

[0048] Preparation method: The preparation method includes the following steps: Select mulberries without rot, wash and drain them; take the florets of broccoli, wash and cut them into small pieces; freeze-dry the mulberries and broccoli under vacuum, and then grind them into powder A. Remove the fibrous roots and impurities from the angelica root and crush it; remove the seed coat from the peach kernel and crush it; soak the black fungus until it is fully expanded, remove the hard roots, and chop it; add the processed angelica root, peach kernel, and black fungus to 20 times the amount of water, add 0.2% yeast extract and 0.5% glucose, adjust the pH to 6.6, sterilize with high pressure steam at 121℃ for 20 minutes, cool to obtain the culture medium, and put it into a fermenter; A compound bacterial strain, with a live Bacillus subtilis and Lactobacillus plantarum ratio of 2:1, was selected and activated under constant temperature conditions to prepare a compound bacterial suspension, which was then inoculated into a culture medium. The suspension was then placed in a sealed fermentation tank and fermented at 36°C with low-speed stirring for 24 hours. After stirring was stopped, fermentation continued for another 48 hours in a sealed environment to obtain the fermentation broth. The fermentation broth was then heated to 95°C and maintained for 30 minutes to inactivate the bacteria, thus terminating the fermentation. The fermentation broth was separated into supernatants using a centrifuge. The supernatants were concentrated under reduced pressure to 1 / 4 of their original volume and then spray-dried at an inlet temperature of 180°C and an outlet temperature of 70°C to obtain the fermentation extract.

[0049] Diosgenin, ergothionein, PQQ, glutathione, powder A, and fermentation extract were mixed, pulverized, and passed through a 100-mesh sieve to obtain the composition.

[0050] [Pharmacological Efficacy Experiment] (a) Experimental materials 1. Experimental animals: SPF-grade female SD rats, weighing 200-220g, with free access to food and water, were subjected to experiments after 1 week of acclimatization.

[0051] 2. Reagents and instruments: cyclophosphamide, physiological saline, ELISA test kits (E2, FSH, LH), superoxide dismutase (SOD) kit, malondialdehyde (MDA) kit; electronic balance, multi-functional microplate reader, high-speed refrigerated centrifuge, pipettes.

[0052] (II) Experimental Methods 1. Grouping: Ten rats were randomly assigned to the control group, and the rest were used to establish the rat model.

[0053] Preparation of a rat model of premature ovarian failure: Rats in the model group were injected intraperitoneally with 50 mg / kg cyclophosphamide solution once a week for two consecutive weeks to establish a premature ovarian failure model. Rats with successful model establishment were randomly divided into four groups: model group, Example 1 group, Example 2 group, and Example 3 group, with 10 rats in each group.

[0054] The control group rats were injected intraperitoneally with an equal dose of physiological saline.

[0055] 2. Administration: The example group was administered 10g / kg / day by gavage, while the blank group and model group were administered the same dose of physiological saline by gavage for 28 consecutive days.

[0056] 3. Detection indicators: (1) Serum hormone level detection: After administration, rats were anesthetized with pentobarbital, blood was collected from the abdominal aorta, and serum was separated by centrifugation. The levels of estradiol (E2), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) in the serum were detected by ELISA.

[0057] (2) Detection of ovarian oxidative stress indicators: Rat ovarian tissue was taken, tissue homogenate was prepared, and superoxide dismutase (SOD) activity and malondialdehyde (MDA) content were detected.

[0058] (3) Ovarian tissue morphology observation: The bilateral ovaries were separated, the ovarian tissue was fixed, embedded, sectioned, stained with HE, and the ovarian morphology and number of follicles were observed under a microscope.

[0059] (III) Experimental Results 1. Comparison of serum hormone levels: Compared with the blank group, the E2 level of rats in the model group was significantly decreased, and the FSH and LH levels were significantly increased (P<0.01); compared with the model group, the E2 level of groups 1-3 was significantly increased, and the FSH and LH levels were significantly decreased (P<0.05), indicating that the composition can effectively regulate the endocrine function of rats with premature ovarian failure.

[0060] Table 1. Effects of each group on serum hormone levels in rats (n=10) Group E2 (pmol / L) FSH (mIU / mL) LH (mIU / mL) Blank group 45.23±5.12 15.36±2.14 12.45±1.87 Model group 18.56±3.28△△ 42.68±4.35△△ 35.72±3.69△△ Example 1 Group 35.68±4.52* 22.15±2.87** 22.36±2.54* Example 2 Group 32.15±4.26* 25.42±3.18* 20.87±2.31* Example 3 Group 30.24±3.98* 27.53±3.42* 24.12±2.68* Note: Compared with the control group, ΔP < 0.01; compared with the model group, *P < 0.05. 2. Comparison of ovarian oxidative stress indicators: Compared with the blank group, the SOD activity of rat ovarian tissue in the model group was significantly reduced and the MDA content was significantly increased (P<0.01); compared with the model group, the SOD activity of groups 1-3 was significantly increased and the MDA content was significantly reduced (P<0.05), indicating that the composition has a good antioxidant stress effect.

[0061] Table 2. Effects of each group on oxidative stress indices in rat ovaries (n=10) Group SOD (mIU / ml) MDA (pg / ml) Blank group 125.36±10.24 3.25±0.42 Model group 65.42±8.15△△ 8.76±1.05△△ Example 1 Group 98.72±9.58** 4.85±0.56* Example 2 Group 92.15±9.36* 5.32±0.68* Example 3 Group 88.34±8.92* 5.68±0.72* Note: Compared with the blank control group, △△P<0.01; compared with the model control group, *P<0.05 3. Ovarian tissue morphology observation: The ovaries of rats in the blank group had intact structure, a large number of follicles, and normal development of follicles at all stages; the ovaries of rats in the model group had disordered structure, a significantly reduced number of follicles, and most of them were atretic follicles; the ovarian structure of rats in the groups of Examples 1-3 was improved, the number of follicles was significantly increased compared with the model group, and mature follicles were visible, indicating that the composition can improve the morphology of ovarian tissue and promote follicle development.

[0062] (iv) Experimental Conclusions The composition of this invention can effectively regulate serum hormone levels in rats with premature ovarian failure, improve antioxidant capacity, reduce oxidative damage, and improve ovarian tissue morphology and function. It has a good preventive and therapeutic effect on premature ovarian failure, and the effect of Example 1 is the best among all examples.

[0063] This invention's composition is based on traditional Chinese medicine theory and combined with modern medical research findings. The formula is scientifically sound, and the ingredients work synergistically. It regulates estrogen receptor expression and scavenges free radicals through components such as diosgenin and ergothioneine, while improving ovarian blood circulation and nourishing the liver and kidneys through traditional Chinese medicine components such as angelica and peach kernel. This multi-target, multi-dimensional approach improves ovarian function. Animal experiments show that this composition significantly increases E2 levels, decreases FSH and LH levels, improves oxidative stress, increases follicle count, and effectively alleviates symptoms of premature ovarian failure, demonstrating a definite therapeutic effect. All ingredients in the composition are either food-grade or natural, with minimal toxicity and high safety, making it suitable for long-term use.

Claims

1. A composition for preventing and treating premature ovarian failure and regulating endocrine function, characterized in that, The raw material composition of the composition is as follows: 10-30 parts of diosgenin, 5-20 parts of ergothionein, 5-20 parts of PQQ, 3-15 parts of glutathione, 10-25 parts of angelica, 5-15 parts of peach kernel, 5-20 parts of mulberry, 5-15 parts of black fungus, and 5-20 parts of broccoli.

2. The composition according to claim 1, characterized in that, The raw material composition of the composition is as follows: 12-25 parts of diosgenin, 8-15 parts of ergothionein, 8-15 parts of PQQ, 5-12 parts of glutathione, 15-20 parts of angelica, 8-12 parts of peach kernel, 10-18 parts of mulberry, 8-12 parts of black fungus, and 8-15 parts of broccoli.

3. The composition according to claim 1 or 2, characterized in that, The raw material composition of the composition is as follows: 15 parts diosgenin, 10 parts ergothionein, 12 parts PQQ, 6 parts glutathione, 16 parts angelica, 10 parts peach kernel, 15 parts mulberry, 10 parts black fungus, and 10 parts broccoli.

4. A compound preparation for preventing premature ovarian failure and regulating endocrine function, characterized in that, The raw materials include the composition according to any one of claims 1-3.

5. The compound formulation according to claim 4, characterized in that, The compound formulation also includes conventionally acceptable excipients or carriers.

6. The compound formulation according to claim 5, characterized in that, The compound preparation is any one or more of the following: powder, granule, tablet, pill, capsule, ointment, gel, oral liquid preparation, tea bag, hard candy, and soft candy.

7. A method for preparing the composition according to any one of claims 1-3, characterized in that, Includes the following steps: Select mulberries without rot, wash and drain them; take the florets of broccoli, wash and cut them into small pieces; freeze-dry the mulberries and broccoli under vacuum, and then grind them into powder A. Remove the fibrous roots and impurities from the angelica root and crush it; remove the seed coat from the peach kernel and break it. Soak the black fungus until it is fully expanded, remove the hard roots, and chop it. Add the processed angelica, peach kernels, and black fungus to 10-20 times the amount of water, add yeast extract and glucose, adjust the pH to 6.5-7.0, sterilize with high-pressure steam at 121℃ for 20 minutes, cool to obtain the culture medium, and put it into a fermenter. A compound bacterial strain was selected, activated under constant temperature conditions, and prepared into a compound bacterial suspension, which was then inoculated into a culture medium. A sealed fermentation tank was used with low-speed stirring. After fermentation for 12-36 hours, stirring was stopped, and fermentation continued for another 36-72 hours to obtain the fermentation broth. The fermentation broth was heated to 90℃ and maintained for 30 minutes to inactivate the bacteria and terminate the fermentation. The fermentation broth was separated into supernatants using a centrifuge. The supernatants were concentrated under reduced pressure and spray-dried to obtain the fermentation extract. Diosgenin, ergothioneine, PQQ, glutathione, powder A, and fermentation extract were mixed, pulverized, and sieved to obtain the composition.

8. The preparation method according to claim 7, characterized in that, The compound microbial strain is Bacillus subtilis and Lactobacillus plantarum, with a live bacteria ratio of (1-5):(1-5).

9. The preparation method according to claim 7 or 8, characterized in that, The amount of yeast extract added is 0.2%-0.5%, and the amount of glucose added is 0.1%-0.5%.

10. The use of the composition according to any one of claims 1-3 or the compound preparation according to any one of claims 4-6 in the preparation of a preparation for preventing premature ovarian failure, regulating endocrine function, and improving ovarian function.

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