Method and composition for protecting or improving ovarian function in mammals

Abstract

A method and composition for protecting or improving ovarian function in mammals, and the related use of the composition in the preparation of a food, beverage, nutritional supplement and animal feed for the improvement of ovarian function in mammals. The method and composition can increase the number of follicles, improve the quality of follicles, improve the ovarian function, and delay aging.

Description

Methods and compositions for protecting or improving ovarian function in mammals Technical Field

[0001] The present invention belongs to the technical field of dietary or nutritional supplements, and specifically relates to methods and compositions for protecting or improving ovarian function in mammals, as well as related applications thereof in preparing foods, beverages, nutritional supplements, and animal feed for protecting or improving ovarian function in mammals. Background Art

[0002] The female ovaries contain tens of thousands of follicles. Their primary function is to release eggs and secrete female hormones. Starting at puberty, the ovaries ovulate periodically. Ovarian aging refers to the gradual decline and eventual exhaustion of a woman's ovarian reserve with aging. This decline is primarily due to a decrease in follicle count and egg quality, ultimately leading to sterility and even menopause. This can affect multiple systems and organs, leading to the development of related diseases and syndromes.

[0003] Around the age of 45-50, women's ovarian function begins to decline, estrogen levels drop, and they enter perimenopause. However, some women before the age of 40 may experience premature ovarian failure due to environmental, dietary, unhealthy lifestyle habits, psychological, or pathological factors. Ovarian aging can cause physical and physiological changes in women, such as menstrual changes, osteoporosis, increased blood pressure, increased skin wrinkling, and menopausal symptoms such as hot flashes, mood swings, and irritability. It can also weaken the body's immune system, accelerate aging, and seriously affect women's quality of life.

[0004] Ovarian aging is a complex biological process characterized by the interaction of multiple factors and a gradual accumulation of factors. With age, follicles are consumed, and a decrease in follicle number is the primary cause of ovarian aging. This is further compounded by the accumulation of metabolic products, altering the ovarian microenvironment. Factors such as free radicals and advanced glycation end products damage the follicles, while the accumulation of mitochondrial DNA mutations and telomere shortening also reduces the quality of remaining follicles. With the accelerated pace of life and dramatic economic and demographic shifts in today's society, the incidence of ovarian failure-related diseases in women has increased significantly, and the social implications of ovarian aging have become increasingly prominent. Consequently, the diseases and issues associated with ovarian aging have become a matter of widespread social concern.

[0005] Currently, the main approaches to improving and treating ovarian aging and its related symptoms and diseases include hormone replacement therapy (HRT). However, existing research clearly demonstrates its numerous side effects and long-term carcinogenicity, significantly limiting its clinical application. Traditional Chinese Medicine advocates delaying ovarian aging by "tonifying the kidneys and replenishing yin, soothing the liver and nourishing blood." However, in the absence of a clear understanding of its etiology and pathology, TCM prescriptions may be prone to misuse and indiscriminate treatment. Furthermore, there are relatively few commercially available foods or health supplements for improving polycystic ovary syndrome or delaying ovarian aging, most of which primarily contain soy isoflavones, which are simple in composition and have limited therapeutic effects.

[0006] Ergothioneine (EGT) is a safe, naturally occurring compound with excellent anti-inflammatory and antioxidant properties. Pyrroloquinoline quinone (PQQ) is a water-soluble, heat-stable small molecule. Mammals cannot synthesize PQQ themselves, but they can obtain it from foods such as vegetables and meat. PQQ is an essential nutrient for maintaining mammalian health and is considered a longevity factor. It is crucial to study the relationship between ergothioneine (EGT) and PQQ and ovarian function.

[0007] Summary of the Invention

[0008] To achieve the above object, in one aspect, the present invention provides a method for protecting or improving mammal ovarian function, the method comprising administering a composition to a mammal, the composition comprising an effective amount of ergothioneine or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof. In some embodiments, the composition may also comprise a pharmaceutically acceptable carrier.

[0009] In some embodiments, the composition further comprises an effective amount of pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog, or derivative thereof.

[0010] In some embodiments, the composition further comprises an effective amount of evening primrose extract. The evening primrose extract can be, for example, evening primrose oil.

[0011] In some embodiments, the composition further comprises an effective amount of inositol.

[0012] In some embodiments, protecting or improving ovarian function in a mammal comprises promoting follicle development, increasing the number of follicles, or improving the quality of follicles.

[0013] In some embodiments, the method is used to delay or improve premature ovarian failure or aging, improve polycystic ovary syndrome, relieve dysfunctional uterine bleeding, delay menopause and / or alleviate menopausal symptoms.

[0014] In some embodiments, the composition is formulated in the form of a suppository, tablet, pill, granule, powder, film, injection, capsule, aerosol, elixir, tincture, tonic, solution, liquid suspension, or syrup.

[0015] In some embodiments, the composition is prepared as a food, a beverage, a nutritional supplement, or an animal feed.

[0016] In some embodiments, the composition is administered orally, intravenously, intramuscularly, intraperitoneally, or sublingually.

[0017] In some embodiments, thioneine or its pharmaceutically acceptable salt, acid, ester, analog or derivative is formulated to be used in an amount of 1-1500 mg per day. In some embodiments, thioneine or its pharmaceutically acceptable salt, acid, ester, analog or derivative can be formulated to be used in an amount of 1-1000 mg, 2-500 mg, 3-200 mg, 4-100 mg, 5-50 mg, 10-30 mg per day.

[0018] In some embodiments, pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof is formulated for administration in an amount of 1-1000 mg per day. In some embodiments, pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof can be formulated for administration in an amount of 2-500 mg, 3-200 mg, 5-100 mg, 10-50 mg, 15-40 mg per day.

[0019] In some embodiments, evening primrose extract is formulated for administration in an amount of 10-2000 mg per day. In some embodiments, evening primrose extract can be formulated for administration in an amount of 15-1500 mg, 20-1000 mg, 50-800 mg, 100-600 mg, 200-500 mg per day.

[0020] In some embodiments, inositol is formulated for administration in an amount of 10-3000 mg per day. In some embodiments, inositol can be formulated for administration in an amount of 15-2000 mg, 20-1500 mg, 50-1000 mg, 80-500 mg, 100-400 mg per day.

[0021] In some embodiments, the weight ratio of ergothioneine, pyrroloquinoline quinone, evening primrose extract and inositol of the present invention is (1-10):(1-10):(10-100):(80-400). In some embodiments, the weight ratio of ergothioneine, pyrroloquinoline quinone, evening primrose extract and inositol can be (1-5):(1-4):(20-80):(80-400), 1:1:20:80, 1:1:40:100, 1:1:40:160, 1:1:60:200, 5:4:80:400, 5:4:20:100, 5:4:20:80.

[0022] On the other hand, the present invention provides a composition comprising ergothioneine or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof for use in protecting or improving mammalian ovarian function. In some embodiments, the composition may further comprise a pharmaceutically acceptable carrier.

[0023] In some embodiments, the composition further comprises an effective amount of pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog, or derivative thereof.

[0024] In some embodiments, the composition further comprises an effective amount of evening primrose extract. The evening primrose extract can be, for example, evening primrose oil.

[0025] In some embodiments, the composition further comprises an effective amount of inositol.

[0026] In some embodiments, protecting or improving ovarian function in a mammal comprises promoting follicle development, increasing the number of follicles, or improving the quality of follicles.

[0027] In some embodiments, the composition is used to delay or improve premature ovarian failure or aging, improve polycystic ovary syndrome, relieve dysfunctional uterine bleeding, delay menopause and / or alleviate menopausal symptoms.

[0028] In some embodiments, the composition is formulated in the form of a suppository, tablet, pill, granule, powder, film, injection, capsule, aerosol, elixir, tincture, tonic, solution, liquid suspension, or syrup.

[0029] In some embodiments, the composition is prepared as a food, a beverage, a nutritional supplement, or an animal feed.

[0030] In some embodiments, thioneine or its pharmaceutically acceptable salt, acid, ester, analog or derivative is formulated to be used in an amount of 1-1500 mg per day. In some embodiments, thioneine or its pharmaceutically acceptable salt, acid, ester, analog or derivative can be formulated to be used in an amount of 1-1000 mg, 2-500 mg, 3-200 mg, 4-100 mg, 5-50 mg, 10-30 mg per day.

[0031] In some embodiments, pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof is formulated for administration in an amount of 1-1000 mg per day. In some embodiments, pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof can be formulated for administration in an amount of 2-500 mg, 3-200 mg, 5-100 mg, 10-50 mg, 15-40 mg per day.

[0032] In some embodiments, evening primrose extract is formulated for administration in an amount of 10-2000 mg per day. In some embodiments, evening primrose extract can be formulated for administration in an amount of 15-1500 mg, 20-1000 mg, 50-800 mg, 100-600 mg, 200-500 mg per day.

[0033] In some embodiments, inositol is formulated for administration in an amount of 10-3000 mg per day. In some embodiments, inositol can be formulated for administration in an amount of 15-2000 mg, 20-1500 mg, 50-1000 mg, 80-500 mg, 100-400 mg per day.

[0034] In another aspect, the present invention provides the use of ergothioneine or its physiologically acceptable salt, acid, ester, analog or derivative in the preparation of a composition for protecting or improving mammalian ovarian function. In some embodiments, the composition may further comprise a pharmaceutically acceptable carrier.

[0035] In some embodiments, the composition further comprises an effective amount of pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog, or derivative thereof.

[0036] In some embodiments, the composition further comprises an effective amount of evening primrose extract. The evening primrose extract can be, for example, evening primrose oil.

[0037] In some embodiments, the composition further comprises an effective amount of inositol.

[0038] In some embodiments, protecting or improving ovarian function in a mammal comprises promoting follicle development, increasing the number of follicles, or improving the quality of follicles.

[0039] In some embodiments, the composition is used to delay or improve premature ovarian failure or aging, improve polycystic ovary syndrome, relieve dysfunctional uterine bleeding, delay menopause and / or alleviate menopausal symptoms.

[0040] In some embodiments, the composition is formulated in the form of a suppository, tablet, pill, granule, powder, film, injection, capsule, aerosol, elixir, tincture, tonic, solution, liquid suspension, or syrup.

[0041] In some embodiments, thioneine or its pharmaceutically acceptable salt, acid, ester, analog or derivative is formulated to be used in an amount of 1-1500 mg per day. In some embodiments, thioneine or its pharmaceutically acceptable salt, acid, ester, analog or derivative can be formulated to be used in an amount of 1-1000 mg, 2-500 mg, 3-200 mg, 4-100 mg, 5-50 mg, 10-30 mg per day.

[0042] In some embodiments, pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof is formulated for administration in an amount of 1-1000 mg per day. In some embodiments, pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof can be formulated for administration in an amount of 2-500 mg, 3-200 mg, 5-100 mg, 10-50 mg, 15-40 mg per day.

[0043] In some embodiments, evening primrose extract is formulated for administration in an amount of 10-2000 mg per day. In some embodiments, evening primrose extract can be formulated for administration in an amount of 15-1500 mg, 20-1000 mg, 50-800 mg, 100-600 mg, 200-500 mg per day.

[0044] In some embodiments, inositol is formulated for administration in an amount of 10-3000 mg per day. In some embodiments, inositol can be formulated for administration in an amount of 15-2000 mg, 20-1500 mg, 50-1000 mg, 80-500 mg, 100-400 mg per day.

[0045] In another aspect, the present invention provides a method of managing glucose tolerance or reducing fasting blood glucose levels in an individual, the method comprising administering to a mammal a composition comprising an effective amount of ergothioneine or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof.

[0046] In some embodiments, the composition further comprises an effective amount of pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog, or derivative thereof.

[0047] In some embodiments, the composition further comprises an effective amount of evening primrose extract. The evening primrose extract can be evening primrose oil.

[0048] In some embodiments, the composition further comprises an effective amount of inositol.

[0049] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] FIG1 is a graph showing changes in total testosterone T in each experimental group of the present invention.

[0051] FIG2 is a graph showing changes in estradiol E2 in various experimental groups of the present invention.

[0052] FIG3 is a graph showing changes in luteinizing hormone (LH) in each experimental group of the present invention.

[0053] FIG4 is a graph showing changes in follicle stimulating hormone (FSH) in each experimental group of the present invention.

[0054] FIG5 is a graph showing changes in blood sugar in each experimental group of the present invention.

[0055] FIG6 is a graph showing changes in HMOA-IR in each experimental group of the present invention.

[0056] FIG7 is a graph showing changes in total cholesterol TC in each experimental group of the present invention.

[0057] FIG8 is a graph showing changes in triglyceride TG in each experimental group of the present invention. DETAILED DESCRIPTION

[0058] The preferred embodiments of the present invention will now be described in detail with reference to the embodiments thereof. Although the present invention will be described in conjunction with the preferred embodiments, it should be understood that they are not intended to limit the present invention to these embodiments. On the contrary, the present invention is intended to cover substitutions, modifications and equivalents, which may be included within the spirit and scope of the present invention as defined in the claims.

[0059] As used herein, the term "or" is intended to include "and" and "or." In other words, the term "or" can also be replaced with "and / or."

[0060] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0061] As used herein, the term "comprises" or "includes" or variations thereof refers to instances where the term is used in its non-limiting sense, meaning that items following the term are included, but items not specifically mentioned are not excluded. It also includes the more restrictive verbs 'consisting essentially of' and 'consisting of.'

[0062] As used herein, the terms "mammal" or "subject" are used interchangeably to refer to any animal to which the methods and compositions of the present disclosure can be applied or administered. The animal may be suffering from an illness or other disease, but the animal does not need to be sick to benefit from the methods and compositions of the present disclosure. Thus, any animal can utilize the disclosed compositions or be a recipient of the disclosed methods. Although the animal subject is preferably a human, the methods and compositions of the present invention are also suitable for veterinary medicine, for example, for treating domesticated species such as canines, felines, murines, and various other pets; farm animals, such as cattle, horses, sheep, goats, pigs, etc.; and wild animals, such as non-human primates in the wild or in zoos, etc.

[0063] As used herein, the term "administer" refers to the process of delivering the disclosed composition or active ingredient to a subject. The composition of the present invention is preferably administered orally, intravenously, intramuscularly, intraperitoneally, or sublingually, but may also be administered by other conventional routes to achieve the desired effect.

[0064] As used herein, the term "effective amount" refers to the amount required to achieve the effects taught herein. The effective amount herein includes, but is not limited to, the amount necessary to protect or improve ovarian function in mammals, and / or promote follicular development, increase the number of follicles, improve follicle quality, and / or delay or improve premature ovarian failure or aging, improve polycystic ovary syndrome, alleviate dysfunctional uterine bleeding, delay menopause, and / or alleviate menopausal symptoms. According to the present disclosure, a suitable single dose size is a dose that can achieve the above-mentioned effects when administered once or multiple times within an appropriate time period.

[0065] As used herein, the term "pharmaceutically acceptable" refers to pharmaceutically, physiologically, dietary acceptable, and refers to those compositions or agents, materials or combinations of compositions and / or dosage forms thereof that are within the scope of sound medical judgment, suitable for contact with the tissues of humans and animals, compatible with the other ingredients of the composition, without excessive toxicity, irritation, allergic response or other problems or complications, and commensurate with a reasonable benefit / risk ratio.

[0066] In some embodiments, the ergothioneine of the present invention or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof and / or a composition comprising the same can be prepared as a composition together with a dietary or pharmaceutically acceptable carrier. Such carriers include those non-toxic compatible substances commonly used in health foods and dietary supplements and pharmaceutical preparations, such as sugars, starches, cellulose and its derivatives, powdered tragacanth, malt, gelatin, talc, oils, glycols, polyols, esters, agar, alginic acid, pyrogen-free water, isotonic saline, etc.

[0067] In some embodiments, ergothioneine or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof of the present invention and / or compositions comprising the same can be administered with other supplements, such as vitamins, minerals, nootropics, and other supplements known in the art.

[0068] Method of the present invention comprises and uses at least 1mg every day, typically 1-1500mg, preferably 1-1000mg, 2-500mg, 3-200mg, 4-100mg, 5-50mg, 10-30mg ergothioneine or its pharmaceutically acceptable salt, acid, ester, analogue or derivative, this depends on concrete preparation and form.Amount to be used can also change according to factors such as experimenter's sensitivity, age, sex and body weight, idiosyncratic reaction.One or more dosages can be used once or repeatedly every day or with applicable frequency in any time period.For example, effective dose can be used every day, continue one day, several days, many days or use every day indefinitely.

[0069] The composition of the present invention is simple and convenient to prepare and can be prepared by simply mixing the raw materials evenly. In some embodiments, the preparation method of the composition of the present invention may include the following steps: first, after uniformly mixing some of the raw materials, mixing them with other raw materials; more preferably, the raw materials are mixed in a three-dimensional mixing manner for 20-30 minutes. In some embodiments, the components in the composition of the present invention can be dissolved in a suitable solvent to form a corresponding solution and / or suspension, and then the solutions and / or suspensions of the components are mixed to form a mixed form in which the composition of the present invention is dissolved in a solvent. In the preparation method of the composition, the components can be reasonably added using a mixing method well known in the art depending on the properties of the raw materials.

[0070] The following examples are provided to illustrate selected embodiments of the present invention and are not intended to limit the scope of the present invention. Unless otherwise specified, the materials and reagents described in the following examples are all commercially available products and can be purchased on the market.

[0071] Example 1

[0072] 20 parts of ergothioneine and 20 parts of PQQ were mixed evenly in a three-dimensional double cone mixer, and then evenly mixed with 400 parts of inositol and 1600 parts of evening primrose extract to obtain the composition of Example 1.

[0073] Example 2

[0074] Take 20 parts of ergothioneine and 20 parts of PQQ, mix them evenly in a three-dimensional double cone mixer, and then evenly mix them with 800 parts of inositol and 2000 parts of evening primrose extract to obtain the composition of Example 2.

[0075] Example 3

[0076] 20 parts of ergothioneine and 20 parts of PQQ were mixed evenly in a three-dimensional double cone mixer, and then evenly mixed with 1200 parts of inositol and 4000 parts of evening primrose extract to obtain the composition of Example 3.

[0077] Example 4

[0078] 25 parts of ergothioneine and 20 parts of PQQ were mixed evenly in a three-dimensional double cone mixer, and then evenly mixed with 400 parts of inositol and 2000 parts of evening primrose extract to obtain the composition of Example 4.

[0079] Example 5

[0080] 25 parts of ergothioneine and 20 parts of PQQ were mixed evenly in a three-dimensional double cone mixer, and then evenly mixed with 100 parts of inositol and 400 parts of evening primrose extract to obtain the composition of Example 5.

[0081] Example 6

[0082] Female Wistar rats weighing 220-230 g were selected and fed ad libitum. After one week without any intervention, the rats were randomly divided into a control group (CK) (n=10; placebo); a model group (MD) (n=10; placebo); an experimental group A (n=10; ergothioneine 2.25 mg / kg / d); an experimental group B (n=10; ergothioneine 2.25 mg / kg / d + pyrroloquinoline quinone 1.8 mg / kg / d); and an experimental group C (n=10; ergothioneine 2.25 mg / kg / d + pyrroloquinoline quinone 1.8 mg / kg / d + evening primrose 18 mg / kg / d + inositol 9 mg / kg / d). All four groups received continuous intraperitoneal injections of testosterone propionate (10 mg / kg, once daily for 6 weeks) and olive oil. Administration was by gavage.

[0083] Each group received oral gavage for 8 consecutive weeks. Finally, the rats were anesthetized with 1% sodium pentobarbital and fasted for 16 hours before being killed at estrus. Blood was collected via the abdominal aorta and centrifuged at 1000g for 15 minutes at 4°C to obtain serum.

[0084] Hormone determination: Serum levels of total testosterone (T), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2) were determined using ELISA. All procedures using the ELISA kits were performed strictly according to the manufacturer's instructions.

[0085] During the final week of oral gavage, each group underwent OGTT, insulin, HOMA-IR, and lipid profile measurements. After a 16-hour fast, fasting blood glucose (0 min) was measured; subsequently, rats were intraperitoneally injected with 50% glucose solution (2 g / kg). Blood glucose was measured using the glucose oxidase method at various time points (0 min, 30 min, 60 min, and 120 min); tail tip blood was collected during the OGTT. HOMA-IR was calculated using an ELISA kit and the formula [HOMA-IR = fasting insulin (mIU / L) × fasting blood glucose (mmol / L) / 22.5]. Serum total cholesterol (TC) and total triglycerides (TG) were measured using a total cholesterol assay kit and a triglyceride assay kit.

[0086] Graphpad 8.0 software was used for data analysis. The results were expressed as standard deviation (x±s), and significance was analyzed using one-way ANOVA test.

[0087] As shown in Figures 1-4, after 6 weeks of testosterone propionate administration, the serum E2 and T levels of rats increased significantly, the LH level decreased significantly, and the FSH level did not change significantly. After 8 consecutive weeks of intervention, compared with the model group, the serum E2 and T levels of rats in experimental groups A, B, and C were significantly reduced, and experimental group C showed the greatest decrease, 22.9% and 47.3%, respectively; in terms of serum T levels, experimental group C also showed a significant difference that was better than experimental groups A and B. In terms of serum LH levels, compared with the model group, only experimental group C showed a significant difference in the recovery, which was 10%, and there was no significant difference in statistical terms from the serum LH levels of normal rats. According to the results, it can be found that the administration of composition C (ergothioneine + pyrroloquinoline quinone + evening primrose + inositol) has a positive regulatory effect on the hormone levels of rats.

[0088] Glucose tolerance and blood lipid results: In the final week, an oral glucose tolerance test (OGTT) was performed. Glucose gavage had no significant effect on the normal control group, resulting in normal glucose tolerance. However, the model group animals showed improved glucose tolerance compared to the normal control group. As shown in Figures 5-8, the model group had higher blood glucose levels at 30, 60, and 120 minutes compared to the control group. Furthermore, compared to the model group, blood glucose levels in experimental groups A, B, and C were significantly lower at various time points over the 120-minute period. Initial blood glucose levels in experimental group C were 30 mg / dL lower than those in the model group, and peak blood glucose levels at 60 minutes were 20 mg / dL lower. These results indicate that experimental group C had the greatest effect in improving glucose tolerance. The HMOA-IR index was calculated based on fasting blood glucose and fasting insulin. The HMOA-IR index of the model group was 12.5, the HMOA-IR index of the experimental group A was 11.3, the HMOA-IR index of the experimental group B was 10.1, and the HMOA-IR index of the experimental group C was 9.6. The data showed that the HMOA-IR index of the experimental group C was reduced by 30.2% compared with the model group. We detected the total cholesterol TC and triglyceride TG content in the serum by ELISA. According to the results, we found that compared with the model group, the experimental groups A, B and C were able to significantly reduce the content of TC and TG in the serum, among which the experimental group C had the largest reduction, indicating that the application of composition C (ergothioneine + pyrroloquinoline quinone + evening primrose + inositol) had the best effect.

[0089] This example demonstrates that the composition comprising EGT and the method of the present invention have a positive regulatory effect on the sex hormone levels of female rats, are beneficial to improving polycystic ovary syndrome, and protect the normal function of the ovary.

[0090] The inventors have discovered that the composition containing EGT of the present invention and the method of the present invention have a positive regulatory effect on ovarian health, can significantly promote follicle development, increase the number of follicles, improve follicle quality, increase AMH levels, protect or improve ovarian function in mammals, for example, can delay or improve premature ovarian failure or aging, improve polycystic ovary syndrome, relieve dysfunctional uterine bleeding, delay menopause and / or alleviate menopausal symptoms.

[0091] Although specific embodiments and examples of the present invention have been described herein, it will be understood by those skilled in the art that any modifications and variations may be made without departing from the principles of the present invention. The above examples and descriptions do not limit the scope of the present invention. Any combination of the embodiments of the present invention, as well as any obvious extensions or analogs thereof, are within the scope of the present invention. Furthermore, the present invention encompasses any arrangement intended to achieve the same purpose, as well as all such variations and modifications that fall within the scope of the appended claims.

Claims

1. A method for protecting or improving ovarian function in mammals, characterized in that: The method comprises administering to the mammal a composition comprising an effective amount of ergothioneine or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof.

2. The method according to claim 1, characterized in that The composition also comprises an effective amount of pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof.

3. The method according to claim 1 or 2, characterized in that: The composition also includes an effective amount of evening primrose extract.

4. The method according to any one of claims 1 to 3, characterized in that The composition also includes an effective amount of inositol.

5. The method according to any one of claims 1 to 4, characterized in that The protection or improvement of mammalian ovarian function includes promoting follicle development, increasing the number of follicles or improving the quality of follicles.

6. The method according to any one of claims 1 to 5, characterized in that The method is used for delaying or improving premature ovarian failure or aging, improving polycystic ovary syndrome, relieving dysfunctional uterine bleeding, delaying menopause and / or alleviating menopausal symptoms.

7. The method according to any one of claims 1 to 6, characterized in that The composition is formulated into the form of suppositories, tablets, pills, granules, powders, films, injections, capsules, aerosols, elixirs, tinctures, tonics, solutions, liquid suspensions or syrups.

8. The method according to any one of claims 1 to 7, characterized in that The composition is prepared as food, beverage, nutritional supplement and animal feed.

9. The method according to any one of claims 1 to 8, characterized in that The composition is administered orally, intravenously, intramuscularly, intraperitoneally or sublingually.

10. The method according to any one of claims 1 to 9, characterized in that The ergothioneine or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof is formulated for administration in an amount of 1-1500 mg per day.

11. The method according to any one of claims 2 to 10, characterized in that The pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof is formulated for administration in an amount of 1-1000 mg per day.

12. The method according to any one of claims 3 to 11, characterized in that The evening primrose extract is formulated to be administered in an amount of 10-2000 mg per day.

13. The method according to any one of claims 4 to 12, characterized in that The inositol is formulated for administration in an amount of 10-3000 mg per day.

14. A composition comprising ergothioneine or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof, characterized in that, The composition is used for protecting or improving the ovarian function of mammals.

15. The composition according to claim 14, characterized in that The composition also comprises an effective amount of pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof.

16. The composition according to claim 14 or 15, characterized in that The composition also includes an effective amount of evening primrose extract.

17. The composition according to any one of claims 14 to 16, characterized in that The composition also includes an effective amount of inositol.

18. The composition according to any one of claims 14 to 17, characterized in that The protection or improvement of mammalian ovarian function includes promoting follicle development, increasing the number of follicles or improving the quality of follicles.

19. The composition according to any one of claims 14 to 18, characterized in that The composition is used for delaying or improving premature ovarian failure or aging, improving polycystic ovary syndrome, relieving dysfunctional uterine bleeding, delaying menopause and / or alleviating menopausal symptoms.

20. The composition according to any one of claims 14 to 19, characterized in that The composition is formulated into the form of suppositories, tablets, pills, granules, powders, films, injections, capsules, aerosols, elixirs, tinctures, tonics, solutions, liquid suspensions or syrups.

21. The composition according to any one of claims 14 to 20, characterized in that The composition is prepared as food, beverage, nutritional supplement and animal feed.

22. The composition according to any one of claims 14 to 21, characterized in that The ergothioneine or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof is formulated for administration in an amount of 1-1500 mg per day.

23. The composition according to any one of claims 15 to 22, characterized in that The pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof is formulated for administration in an amount of 1-1000 mg per day.

24. The composition according to any one of claims 16 to 23, characterized in that The evening primrose extract is formulated to be administered in an amount of 10-2000 mg per day.

25. The composition according to any one of claims 17 to 24, characterized in that The inositol is formulated for administration in an amount of 10-3000 mg per day.

26. Use of ergothioneine or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof in the preparation of a composition for protecting or improving ovarian function in a mammal.

27. The use according to claim 26, characterized in that The composition also comprises an effective amount of pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof.

28. The use according to claim 26 or 27, characterized in that The composition also includes an effective amount of evening primrose extract.

29. The use according to any one of claims 26 to 28, characterized in that The composition also includes an effective amount of inositol.

30. The use according to any one of claims 26 to 29, characterized in that The protection or improvement of mammalian ovarian function includes promoting follicle development, increasing the number of follicles or improving the quality of follicles.

31. The use according to any one of claims 26 to 30, characterized in that The composition is used for delaying or improving premature ovarian failure or aging, improving polycystic ovary syndrome, relieving dysfunctional uterine bleeding, delaying menopause and / or alleviating menopausal symptoms.

32. The use according to any one of claims 26 to 31, characterized in that The composition is formulated into the form of suppositories, tablets, pills, granules, powders, films, injections, capsules, aerosols, elixirs, tinctures, tonics, solutions, liquid suspensions or syrups.

33. The use according to any one of claims 26 to 32, characterized in that The ergothioneine or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof is formulated for administration in an amount of 1-1500 mg per day.

34. The use according to any one of claims 27 to 33, characterized in that The pyrroloquinoline quinone or a pharmaceutically acceptable salt, acid, ester, analog or derivative thereof is formulated for administration in an amount of 1-1000 mg per day.

35. The use according to any one of claims 28 to 34, characterized in that The evening primrose extract is formulated to be administered in an amount of 10-2000 mg per day.

36. The use according to any one of claims 29 to 35, characterized in that The inositol is formulated for administration in an amount of 10-3000 mg per day.

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