A phytoestrogen composition for conditioning female health and methods of making and using the same

Abstract

The present application relates to a kind of phytoestrogen composition for conditioning female health and its preparation method and application, the composition of the phytoestrogen composition includes: pueraria extract, yam extract, astragalus extract, mulberry extract, medlar extract, red pomegranate extract, flaxseed extract.The present application provides a kind of multi-source composite phytoestrogen composition with the core of homology of medicine and food ingredient, by the synergistic effect of different sources phytoestrogen, realize the " two-way regulation " of estrogen level: pueraria, red pomegranate, flaxseed three raw materials cover three different types of phytoestrogen, realize more extensive estrogen receptor coverage;Yam, astragalus, medlar and mulberry are nourishing body and mind from four aspects of spleen, kidney, liver and blood-Yam spleen and kidney, astragalus, medlar and mulberry are nourishing body and mind from four aspects of spleen, kidney, liver and blood-Yam spleen and kidney, astragalus, medlar and mulberry are nourishing body and mind from four aspects of spleen, kidney, liver and blood-Yam spleen and kidney, astragalus, medlar and mulberry are nourishing body and mind from four aspects of spleen, kidney, liver and blood-Yam spleen and kidney, astragalus, medlar and mulberry are helpful to the recovery of healthy state of organism.

Description

Technical Field

[0001] This invention belongs to the field of functional foods and relates to a phytoestrogen composition for regulating women's health, its preparation method, and its application. Background Technology

[0002] Women go through four main physiological stages in their lives: puberty, reproductive age, perimenopause, and old age. Each stage may present different challenges. Modern women often devote double energy to family and work, and the health problems they face are becoming increasingly common. These include menstrual disorders, premenstrual syndrome, ovarian insufficiency, breast hyperplasia, menopausal syndrome, gynecological inflammation, depression, and anxiety, which seriously affect the quality of life of women.

[0003] Due to women's physiological characteristics, hormonal fluctuations occur cyclically throughout life, and many women's health problems are related to hormonal changes. Estrogen promotes organ development and the establishment of the menstrual cycle during puberty; it ensures ovarian health and maintains fertility during reproductive years; and it helps prevent osteoporosis and cardiovascular disease during menopause and old age. Therefore, regulating the balance of estrogen secretion in women is crucial for women's health at all ages. Currently, hormone replacement therapy is a commonly used clinical treatment, but it may have side effects such as increased risk of cancer and blood clots.

[0004] Phytoestrogens are a class of active ingredients in plants that possess estrogen-like or anti-estrogenic effects. Their heterocyclic polyphenol structures are similar to endogenous estrogens, allowing them to bind to estrogen receptors (ER) and exert estrogen-like or anti-estrogenic effects. They do not directly increase hormone levels in the body but maintain endocrine balance through this bidirectional regulatory mechanism. Commercially available estrogen products primarily focus on specific cycles or stages such as menstruation and menopause, and are mostly single-ingredient health foods, such as soy isoflavones. These products suffer from issues such as limited target action and low bioavailability. Furthermore, they do not meet the requirements of ordinary functional foods, such as being "mild, safe, and suitable for daily consumption." Therefore, exploring effective methods for regulating hormone balance has become a crucial technological need in the field of women's health. Summary of the Invention

[0005] In view of the shortcomings of the prior art, the purpose of this invention is to provide a phytoestrogen composition for regulating women's health, its preparation method and application.

[0006] To achieve this objective, the present invention adopts the following technical solution: In a first aspect, the present invention provides a phytoestrogen composition for regulating women's health, wherein the components of the phytoestrogen composition include: kudzu root extract, yam extract, astragalus extract, mulberry extract, wolfberry extract, pomegranate extract, and flaxseed extract.

[0007] This invention creatively provides a multi-source compound phytoestrogen composition with medicinal and edible homologous ingredients as its core. Through the synergistic effect of phytoestrogens from different sources, it achieves "bidirectional regulation" of estrogen levels: kudzu root, pomegranate, and flaxseed, three raw materials, cover three different types of phytoestrogens, achieving broader estrogen receptor coverage; yam, astragalus, wolfberry, and mulberry nourish the body and mind from four aspects: spleen, kidney, liver, and blood—yam strengthens the spleen and kidneys, astragalus replenishes qi and promotes blood circulation, wolfberry nourishes the kidneys and liver, and mulberry nourishes yin, replenishes kidneys, and generates fluids, helping the body restore a healthy state. The composition of this invention has high safety and is suitable for women throughout their life cycle. It can be prepared into various dosage forms such as solid beverages, liquid beverages, tablets, and capsules.

[0008] Preferably, the phytoestrogens composition comprises, by weight, 15-25 parts of kudzu root extract (e.g., 15, 17, 19, 21, 23, 25, etc.), 20-30 parts of yam extract (e.g., 20, 22, 24, 26, 28, 30, etc.), 8-15 parts of astragalus extract (e.g., 8, 10, 12, 14, 15, etc.), and 10-20 parts of... 10-20 parts of mulberry extract (e.g., 10, 12, 14, 16, 18, 20, etc.), 10-20 parts of wolfberry extract (e.g., 10, 12, 14, 16, 18, 20, etc.), 8-15 parts of pomegranate extract (e.g., 8, 10, 12, 14, 15, etc.), and 8-15 parts of flaxseed extract (e.g., 8, 10, 12, 14, 15, etc.).

[0009] Preferably, the puerarin content in the kudzu root extract is not less than 5%.

[0010] Preferably, the kudzu root extract is obtained by a preparation method comprising the following steps: Using water as a solvent, the kudzu root raw material was subjected to ultrasonic-microwave-assisted enzymatic hydrolysis and filtration. The filter residue was then subjected to water extraction to obtain the kudzu root extract.

[0011] Preferably, the enzyme used in the enzymatic hydrolysis is any one or a combination of at least two of cellulase, hemicellulase, and β-glucosidase.

[0012] Preferably, the enzyme used in the enzymatic hydrolysis is a combination of cellulase and hemicellulase in a mass ratio of 1:(0.2-3) (for example, it can be 1:0.2, 1:0.5, 1:1, 1:1.5, 1:2, 1:2.5, 1:3, etc.).

[0013] Preferably, the amount of enzyme added for enzymatic hydrolysis is 0.2-0.8% of the mass of the kudzu root raw material (e.g., 0.2%, 0.4%, 0.6%, 0.8%, etc.).

[0014] Preferably, the power of the ultrasound is 100-300 W (e.g., 100 W, 200 W, 300 W, etc.), and the power of the microwave is 100-300 W (e.g., 100 W, 200 W, 300 W, etc.).

[0015] Preferably, the temperature of the ultrasound-microwave assisted enzymatic hydrolysis is 40-60℃ (e.g., 40℃, 45℃, 50℃, 55℃, 60℃, etc.), and the time is 20-40 min (e.g., 20 min, 25 min, 30 min, 35 min, 40 min, etc.).

[0016] Preferably, the enzymatic hydrolysis includes a step of inactivating the enzyme.

[0017] Preferably, during the water extraction, the ratio of filter residue to water is 1:(8-15) g / mL (e.g., it can be 1:8 g / mL, 1:10 g / mL, 1:12 g / mL, 1:14 g / mL, 1:15 g / mL, etc.).

[0018] Preferably, the water extraction temperature is 40-60℃, for example, 40℃, 45℃, 50℃, 55℃, 60℃, etc., the time is 1-2 h (for example, 1 h, 1.2 h, 1.4 h, 1.6 h, 1.8 h, 2 h, etc.), and the pH is 5-6 (for example, 5, 5.2, 5.4, 5.6, 5.8, 6, etc.).

[0019] Preferably, the water extraction is performed 1-3 times (e.g., 1 time, 2 times, 3 times, etc.).

[0020] Preferably, the water extraction further includes a step of mixing the enzymatically hydrolyzed filtrate and the water extract.

[0021] Preferably, the flaxseed extract contains no less than 40% linolenic acid.

[0022] Preferably, the flaxseed extract is obtained by a preparation method comprising the following steps: flaxseed is subjected to aerobic fermentation and extraction with an alkaline aqueous solution to obtain the flaxseed extract.

[0023] Preferably, the microorganisms used in the aerobic fermentation are a combination of yeast and Bacillus.

[0024] In a second aspect, the present invention provides a method for preparing the phytoestrogen composition as described in the first aspect, the method comprising: The phytoestrogens composition was obtained by mixing kudzu root extract, yam extract, astragalus extract, mulberry extract, wolfberry extract, pomegranate extract, and flaxseed extract.

[0025] Preferably, the mixing temperature is 20-30℃ (e.g., 20℃, 22℃, 24℃, 26℃, 28℃, 30℃, etc.).

[0026] All other specific point values ​​not listed above within the numerical ranges mentioned above can be selected and are all within the protection scope of this invention. For the sake of brevity, they will not be described in detail here.

[0027] Thirdly, the present invention provides the use of the phytoestrogens composition as described in the first aspect in the preparation of products for regulating female estrogen levels.

[0028] Preferably, the product also includes excipients acceptable in the functional food field.

[0029] Preferably, the excipients include any one or a combination of at least two of the following: flavoring agents, flow aids, and fillers.

[0030] Preferably, the flavoring agent comprises any one or a combination of at least two of the following: erythritol, sucralose, steviol glycosides, xylitol, fructooligosaccharides, galactooligosaccharides, citric acid, malic acid, and ascorbic acid.

[0031] Compared with the prior art, the present invention has the following beneficial effects: This invention creatively provides a multi-source compound phytoestrogen composition with medicinal and edible homologous ingredients as its core. Through the synergistic effect of phytoestrogens from different sources, it achieves "bidirectional regulation" of estrogen levels: kudzu root, pomegranate, and flaxseed, three raw materials, cover three different types of phytoestrogens, achieving broader estrogen receptor coverage; yam, astragalus, wolfberry, and mulberry nourish the body and mind from four aspects: spleen, kidney, liver, and blood—yam strengthens the spleen and kidneys, astragalus replenishes qi and promotes blood circulation, wolfberry nourishes the kidneys and liver, and mulberry nourishes yin, replenishes kidneys, and generates fluids, helping the body restore a healthy state. The composition of this invention has high safety and is suitable for women throughout their life cycle. It can be prepared into various dosage forms such as solid beverages, liquid beverages, tablets, and capsules. Detailed Implementation

[0032] To further illustrate the technical means and effects of the present invention, the following describes the technical solution of the present invention in conjunction with preferred embodiments of the present invention. However, the present invention is not limited to the scope of the embodiments.

[0033] The flaxseed extract used in this invention was purchased from Shanghai Haoyun Biotechnology Co., Ltd., and its flax lignan SDG content is ≥40%; the pomegranate extract was purchased from Shanghai Yuanyi Biotechnology. Yam extract source: Guangdong Qingyunshan Pharmaceutical Co., Ltd.; Astragalus extract source: Guangdong Qingyunshan Pharmaceutical Co., Ltd.; Mulberry extract source: Guangdong Qingyunshan Pharmaceutical Co., Ltd.; Goji berry extract source: Guangdong Qingyunshan Pharmaceutical Co., Ltd.; Cellulase source: Cangzhou Xiasheng Enzyme Biotechnology Co., Ltd.; Pectinase source: Cangzhou Xiasheng Enzyme Biotechnology Co., Ltd.

[0034] Preparation Example 1 This preparation example provides a kudzu root extract, prepared by the following method: (1) Crush the kudzu root raw material, mix it with water at a material-to-liquid ratio of 1:10 g / mL, and add a compound enzyme preparation of cellulase and hemicellulase at a mass ratio of 1:0.5. The total mass of the enzyme accounts for 0.5% of the mass of the kudzu root raw material. Ultrasonic-microwave assisted enzymatic hydrolysis was performed with an ultrasonic power of 300 W and a microwave power of 200 W. The enzymatic hydrolysis was carried out at 55℃ for 40 min, followed by heating to 100℃ and maintaining the temperature for 10 min to inactivate the enzyme. The mixture was then filtered to obtain the enzymatic hydrolysis filtrate and filter residue. (2) The filter residue from step (1) and water are mixed at a material-to-liquid ratio of 1:12 g / mL and extracted at 60℃ for 2 h. After extraction, the first extract and filter residue are obtained by filtration. The aforementioned filter residue and water were mixed at a material-to-liquid ratio of 1:10 g / mL and extracted at 60℃ for 1.5 h. After extraction, the mixture was filtered to obtain the second extract and filter residue. The aforementioned filter residue and water were mixed at a material-to-liquid ratio of 1:8 g / mL and extracted at 60℃ for 1 h. After extraction, the mixture was filtered to obtain the third extract and filter residue. (3) Mix the enzymatic hydrolysis filtrate, the first extract, the second extract, and the third extract, and concentrate them under reduced pressure at 60°C to one-third of the original volume to obtain the kudzu root extract.

[0035] Preparation Example 2 This preparation example provides a kudzu root extract, prepared by the following method: (1) Crush the kudzu root raw material and mix it with water at a material-to-liquid ratio of 1:8 g / mL. Add a compound enzyme preparation of cellulase and hemicellulase at a mass ratio of 1:1. The total mass of the enzyme accounts for 0.4% of the mass of the kudzu root raw material. Ultrasonic-microwave assisted enzymatic hydrolysis was performed with an ultrasonic power of 200 W and a microwave power of 300 W. The enzymatic hydrolysis was carried out at 55℃ for 30 min, followed by heating to 100℃ and maintaining the temperature for 10 min to inactivate the enzyme. The mixture was then filtered to obtain the enzymatic hydrolysis filtrate and filter residue. (2) The filter residue from step (1) and water were mixed at a ratio of 1:10 g / mL and extracted at 55°C for 1.5 h. After extraction, the first extract and filter residue were obtained by filtration. The aforementioned filter residue and water were mixed at a material-to-liquid ratio of 1:8 g / mL and extracted at 55℃ for 1 h. After extraction, the mixture was filtered to obtain the second extract and filter residue. The aforementioned filter residue and water were mixed at a material-to-liquid ratio of 1:8 g / mL and extracted at 55℃ for 1 h. After extraction, the mixture was filtered to obtain the third extract and filter residue. (3) Mix the enzymatic hydrolysis filtrate, the first extract, the second extract, and the third extract, and concentrate them under reduced pressure at 60°C to one-third of the original volume to obtain the kudzu root extract.

[0036] Preparation Example 3 This preparation example provides a kudzu root extract, prepared by the following method: (1) Crush the kudzu root raw material, mix it with water at a material-to-liquid ratio of 1:8 g / mL, and add a compound enzyme preparation of cellulase and hemicellulase at a mass ratio of 1:2. The total mass of the enzyme accounts for 0.6% of the mass of the kudzu root raw material. Ultrasonic-microwave assisted enzymatic hydrolysis was performed with an ultrasonic power of 200 W and a microwave power of 200 W. The enzymatic hydrolysis was carried out at 55℃ for 35 min, followed by heating to 100℃ and maintaining the temperature for 10 min to inactivate the enzyme. The mixture was then filtered to obtain the enzymatic hydrolysis filtrate and filter residue. (2) The filter residue from step (1) and water are mixed at a ratio of 1:10 g / mL and extracted at 60℃ for 1.5 h. After extraction, the first extract and filter residue are obtained by filtration. The aforementioned filter residue and water were mixed at a material-to-liquid ratio of 1:10 g / mL and extracted at 60℃ for 1 h. After extraction, the mixture was filtered to obtain the second extract and filter residue. The aforementioned filter residue and water were mixed at a material-to-liquid ratio of 1:8 g / mL and extracted at 60℃ for 1 h. After extraction, the mixture was filtered to obtain the third extract and filter residue. (3) Mix the enzymatic hydrolysis filtrate, the first extract, the second extract, and the third extract, and concentrate them under reduced pressure at 60°C to one-third of the original volume to obtain the kudzu root extract.

[0037] Preparation Example 4 This preparation example provides a kudzu root extract. The difference between the preparation method and Preparation Example 1 is that step (1) is as follows: the kudzu root raw material is crushed and mixed with water at a material-to-liquid ratio of 1:10 g / mL. A complex enzyme preparation of cellulase and hemicellulase with a mass ratio of 1:0.5 is added, and the total mass of the enzyme accounts for 0.5% of the mass of the kudzu root raw material. Ultrasonic-assisted enzymatic hydrolysis was performed at a power of 500 W at 60°C for 45 min. The temperature was then raised to 100°C and maintained for 10 min to inactivate the enzyme. The mixture was then filtered to obtain the enzymatic hydrolysate and the filter residue. With other conditions remaining unchanged, the kudzu root extract was obtained.

[0038] Preparation Example 5 This preparation example provides a kudzu root extract. The difference between the preparation method and Preparation Example 1 is that step (1) is as follows: the kudzu root raw material is crushed and mixed with water at a material-to-liquid ratio of 1:10 g / mL. A complex enzyme preparation of cellulase and hemicellulase with a mass ratio of 1:0.5 is added, and the total mass of the enzyme accounts for 0.5% of the mass of the kudzu root raw material. Microwave-assisted enzymatic hydrolysis was performed at a microwave power of 500 W at 60°C for 40 min, followed by heating to 100°C and maintaining the temperature for 10 min to inactivate the enzyme. The mixture was then filtered to obtain the enzymatic hydrolysis filtrate and filter residue. With other conditions remaining unchanged, the kudzu root extract was obtained.

[0039] Preparation Example 6 This preparation example provides a kudzu root extract. The difference between the preparation method and that of Preparation Example 1 is that cellulase is not added in step (1), and the reduced mass of cellulase is proportionally allocated to hemicellulase. All other conditions remain unchanged.

[0040] Preparation Example 7 This preparation example provides a kudzu root extract. The only difference between this preparation method and that of Preparation Example 1 is that hemicellulase is not added in step (1), and the reduced mass of hemicellulase is proportionally allocated to cellulase. All other conditions remain unchanged.

[0041] Example 1 This embodiment provides a phytoestrogen composition, the preparation method of which is as follows: At 25°C, 20 parts of kudzu root extract, 25 parts of yam extract, 12 parts of astragalus extract, 15 parts of mulberry extract, 12 parts of wolfberry extract, 10 parts of pomegranate extract, 12 parts of flaxseed extract, and 20 parts of erythritol obtained in Preparation Example 1 were added to a three-dimensional mixer and mixed evenly to obtain the phytoestrogens composition.

[0042] Example 2 This embodiment provides a phytoestrogen composition, the preparation method of which is as follows: At 25°C, 18 parts of kudzu root extract, 20 parts of yam extract, 10 parts of astragalus extract, 10 parts of mulberry extract, 15 parts of wolfberry extract, 15 parts of pomegranate extract, 8 parts of flaxseed extract, and 20 parts of erythritol obtained in Preparation Example 2 were added to a three-dimensional mixer and mixed evenly to obtain the phytoestrogens composition.

[0043] Example 3 This embodiment provides a phytoestrogen composition, the preparation method of which is as follows: At 25°C, 15 parts of kudzu root extract, 30 parts of yam extract, 8 parts of astragalus extract, 10 parts of mulberry extract, 8 parts of wolfberry extract, 8 parts of pomegranate extract, 15 parts of flaxseed extract, and 20 parts of erythritol obtained in Preparation Example 3 were added to a three-dimensional mixer and mixed evenly to obtain the phytoestrogens composition.

[0044] Examples 4-7 Examples 4-7 each provide a phytoestrogen composition. The only difference between the preparation method and Example 1 is that the kudzu root extract obtained in Example 1 is replaced with the kudzu root extract obtained in Examples 4-7, while all other conditions remain unchanged.

[0045] Comparative Example 1 This comparative example provides a phytoestrogen composition. The only difference between this preparation method and Example 1 is that the kudzu root extract obtained in Example 1 is not added. Instead, the reduced amount of kudzu root extract is proportionally allocated to yam extract, astragalus extract, mulberry extract, wolfberry extract, pomegranate extract, and flaxseed extract, while all other conditions remain unchanged.

[0046] Comparative Example 2 This comparative example provides a phytoestrogen composition. The only difference between this preparation method and Example 1 is that yam extract is not added, and the reduced proportion of yam extract is proportionally allocated to kudzu root extract, astragalus extract, mulberry extract, wolfberry extract, pomegranate extract, and flaxseed extract, while all other conditions remain unchanged.

[0047] Comparative Example 3 This comparative example provides a phytoestrogen composition. The preparation method differs from that of Example 1 only in that Astragalus extract is not added, and the reduced amount of Astragalus extract is proportionally allocated to Pueraria lobata extract, Dioscorea opposita extract, Morus alba extract, Lycium barbarum extract, Pomegranate extract, and Flaxseed extract, while all other conditions remain unchanged.

[0048] Comparative Example 4 This comparative example provides a phytoestrogen composition. The preparation method differs from that of Example 1 only in that mulberry extract is not added, and the reduced amount of mulberry extract is proportionally allocated to kudzu root extract, yam extract, astragalus extract, wolfberry extract, pomegranate extract, and flaxseed extract, while all other conditions remain unchanged.

[0049] Comparative Example 5 This comparative example provides a phytoestrogen composition. The preparation method differs from that of Example 1 only in that the wolfberry extract is not added, and the reduced amount of wolfberry extract is proportionally allocated to kudzu root extract, yam extract, astragalus extract, mulberry extract, pomegranate extract, and flaxseed extract, while all other conditions remain unchanged.

[0050] Comparative Example 6 This comparative example provides a phytoestrogen composition. The only difference between this preparation method and Example 1 is that pomegranate extract is not added, and the reduced amount of pomegranate extract is proportionally allocated to kudzu root extract, yam extract, astragalus extract, mulberry extract, wolfberry extract, and flaxseed extract, while all other conditions remain unchanged.

[0051] Comparative Example 7 This comparative example provides a phytoestrogen composition. The preparation method differs from that of Example 1 only in that flaxseed extract is not added, and the reduced amount of flaxseed extract is proportionally allocated to kudzu root extract, yam extract, astragalus extract, mulberry extract, wolfberry extract, and pomegranate extract, while all other conditions remain unchanged.

[0052] Comparative Example 8 This comparative example provides a phytoestrogen composition. The only difference between this preparation method and that of Example 1 is that the equal proportions of the kudzu root extract obtained in Example 1 are replaced with commercially available kudzu root extract (manufacturer: Shaanxi Tianxingjian Biochemical Technology Co., Ltd.), while all other conditions remain unchanged.

[0053] Test Example 1 This test case examines the ovarian maintenance effects of the phytoestrogens compositions of Examples 1-7 and Comparative Examples 1-8.

[0054] (1) Animal culture One hundred and twenty female SPF-grade ICR mice, aged 6-8 weeks and weighing 18-22 g, were housed in an SPF-grade animal room at a temperature of (22±2)℃ and a humidity of (50±10)%, with a 12-hour light / 12-hour dark cycle. They had free access to food and water and were kept in an acclimatization room for one week before the experiment began.

[0055] (2) Experimental grouping and drug administration Mice were randomly divided into 17 groups, with 6 mice in each group: normal control group, model control group, Example 1-7 groups and Comparative Example 1-8 groups.

[0056] Except for the normal control group, mice in the other groups were injected intraperitoneally with cyclophosphamide (50 mg / kg) for 3 consecutive days to induce a premature ovarian failure model; the normal control group was injected intraperitoneally with an equal volume of physiological saline.

[0057] After modeling, the respective example groups and comparative groups were administered the phytoestrogens compositions prepared in the corresponding examples and comparative examples by gavage (the dosage was 0.5 g / kg based on the crude drug amount, suspended in 0.5% sodium carboxymethyl cellulose); the normal control group and the model control group were administered an equal volume of distilled water by gavage. Administration was once daily for 4 consecutive weeks.

[0058] (3) Detection indicators and methods Mice were fasted for 12 hours after the last administration, and blood was collected by enucleation. Serum was separated, and serum estradiol (E2), follicle-stimulating hormone (FSH), and anti-Müllerian hormone (AMH) levels were measured by ELISA. Mice were euthanized after blood collection, and both ovaries were dissected and weighed to calculate the ovarian index (ovarian weight / body weight).

[0059] The test results are shown in Table 1. The results showed that the E2, AMH, and ovarian index of the model control group were significantly lower than those of the normal control group, while FSH was significantly elevated, indicating successful modeling. After administration to each example group, the above indicators all showed significant regression. Changing the preparation method of the kudzu root extract would lead to a decrease in efficacy. After administration to each comparative group, the efficacy was significantly lower than in Example 1 due to the lack of one component in the composition.

[0060] Test Example 2 This test case examines the efficacy of the phytoestrogens compositions of Example 1 and Comparative Examples 1-8 in regulating female menstrual cycles.

[0061] (1) Subject information We are recruiting female volunteers who meet the following criteria: age 25-50, with a regular menstrual cycle (21-35 days) in the past 6 months, and at least two of the following menstrual-related symptoms: dysmenorrhea, cold limbs, mood swings, and decreased sleep quality; and who are willing to participate and sign an informed consent form.

[0062] Exclusion criteria: pregnant or breastfeeding women; those who have taken hormonal drugs or contraceptives within the past 3 months; those with gynecological organic diseases such as uterine fibroids, endometriosis, or polycystic ovary syndrome; those with severe cardiovascular, cerebrovascular, liver, kidney, or mental illnesses; and those who are allergic to any component of the composition of this invention.

[0063] One hundred eligible participants were selected, with an age of (35.6±6.8) years, and were randomly assigned to either the experimental group or the placebo group, with 10 participants in each group. There were no statistically significant differences between the groups in terms of age, weight, and symptom severity, making them comparable.

[0064] (2) Administration method The test group received oral administration of the phytoestrogens composition of Example 1 and Comparative Examples 1-8 of this invention (5 g / dose based on crude drug amount) twice daily for two menstrual cycles (i.e., 2 months). The placebo group received an equal amount of a placebo (made from excipients such as starch dextrin and containing no active ingredient) with identical appearance, administered in the same manner as the test group. During the medication period, both groups maintained normal diet and lifestyle, and did not take any other medications or health supplements related to menstrual regulation.

[0065] (3) Evaluation indicators and methods Questionnaires were administered to both groups of participants before the trial (0 months) and after the trial (2 months). The survey included four indicators: dysmenorrhea severity, cold limbs, mood swings, and sleep quality. Each indicator was scored on a 10-point scale, and participants self-evaluated based on their own feelings.

[0066] The scoring criteria are as follows: (1) Significant improvement: 7-10 points, symptoms are significantly reduced after taking the medicine, and the patient feels that the effect is obvious; (2) Some improvement: 4-6 points, symptoms are reduced after taking the medicine, but the patient still feels that some symptoms remain; (3) No improvement: 0-3 points, the patient feels that the symptoms have basically not changed after taking the medicine. The more obvious the improvement, the higher the score.

[0067] The test results are shown in Table 2 (results are rounded to the nearest integer). The results showed that after using the phytoestrogens composition of the present invention, the subjects' dysmenorrhea, cold limbs, mood fluctuations, and sleep quality were significantly improved, indicating that the phytoestrogens composition prepared by the present invention has an excellent effect in relieving menstrual discomfort. If any component of the present invention is missing or the kudzu root extract obtained by the specific preparation method is replaced, the relief effect will be significantly reduced.

[0068] Test Example 3 This test case examines the improvement of perimenopausal syndrome in women using the phytoestrogens compositions of Example 1 and Comparative Examples 1-8.

[0069] (1) Subject information We are recruiting female volunteers who meet the following criteria: age 45-60, meet the clinical diagnostic criteria for menopausal syndrome, have a modified Kupperman score (KMI, a tool widely used in medicine to quantitatively assess the severity of perimenopausal syndrome in women) ≥15, and have at least two menopausal symptoms such as hot flashes, night sweats, sleep disturbances, and mood swings; and are willing to participate and sign an informed consent form.

[0070] Exclusion criteria: pregnant or breastfeeding women; those who have taken hormonal drugs or contraceptives within the past 3 months; those with gynecological organic diseases such as uterine fibroids, endometriosis, or ovarian tumors; those with severe cardiovascular, cerebrovascular, liver, kidney, or mental illnesses; and those who are allergic to any component of the composition of this invention.

[0071] One hundred eligible participants, aged (51.2±5.6) years, were selected and randomly assigned to either the experimental group or the placebo group, with 10 participants in each group. There were no statistically significant differences between the groups in terms of age, weight, and modified Kupperman score, making them comparable.

[0072] (2) Administration method The test group received oral administration of the phytoestrogens composition prepared in Example 1 and Comparative Examples 1-8 of this invention (5 g / dose based on crude drug amount) twice daily for 2 months. The placebo group received oral administration of an equivalent amount of a placebo (made from excipients such as starch dextrin and containing no active ingredient), with the same administration method as the test group. During the medication period, both groups maintained normal diet and lifestyle, and did not take any other medications or health supplements related to menopause management.

[0073] (3) Evaluation indicators and methods Questionnaires were administered to two groups of subjects before the trial (0 months) and after the trial (2 months). The survey included four indicators: hot flashes, night sweats, sleep quality, and mood fluctuations. Each indicator was scored on a 10-point scale, and subjects evaluated themselves based on their own feelings. The scoring criteria were as follows: (1) Significant improvement: 7-10 points, symptoms were significantly reduced after taking the medication, and the subjects felt a significant effect; (2) Some improvement: 4-6 points, symptoms were reduced after taking the medication, but the subjects felt that some symptoms were still present; (3) No improvement: 0-3 points, the subjects felt that there was basically no change in symptoms after taking the medication. The more significant the improvement, the higher the score.

[0074] The test results are shown in Table 3 (results are rounded to the nearest integer). The results showed that after using the phytoestrogens composition of the present invention, subjects with obvious perimenopausal syndrome experienced significant improvements in hot flashes, night sweats, mood swings, and sleep quality, indicating that the phytoestrogens composition prepared by the present invention has excellent effects in relieving perimenopausal syndrome. If any component of the present invention is missing or if the kudzu root extract obtained by the specific preparation method is replaced, the relieving effect will be significantly reduced.

[0075] The applicant declares that the technical solution of this invention is illustrated by the above embodiments, but this invention is not limited to the above embodiments, that is, it does not mean that this invention must rely on the above embodiments to be implemented. Those skilled in the art should understand that any improvements to this invention, equivalent substitutions of raw materials for the products of this invention, addition of auxiliary components, selection of specific methods, etc., all fall within the protection scope and disclosure scope of this invention.

[0076] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solution of the present invention, and these simple modifications all fall within the protection scope of the present invention.

[0077] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not describe the various possible combinations separately.

Claims

1. A phytoestrogen composition for regulating women's health, characterized in that, The components of the phytoestrogens composition include: kudzu root extract, yam extract, astragalus extract, mulberry extract, wolfberry extract, pomegranate extract, and flaxseed extract.

2. The phytoestrogen composition according to claim 1, characterized in that, The phytoestrogens composition comprises, by weight, 15-25 parts kudzu root extract, 20-30 parts yam extract, 8-15 parts astragalus extract, 10-20 parts mulberry extract, 10-20 parts wolfberry extract, 8-15 parts pomegranate extract, and 8-15 parts flaxseed extract.

3. The phytoestrogen composition according to claim 1 or 2, characterized in that, The puerarin content in the kudzu root extract is not less than 5%; Preferably, the kudzu root extract is obtained by a preparation method comprising the following steps: Using water as a solvent, the kudzu root raw material was subjected to ultrasonic-microwave-assisted enzymatic hydrolysis and filtration. The filter residue was then subjected to water extraction to obtain the kudzu root extract.

4. The phytoestrogen composition according to claim 3, characterized in that, The enzyme used in the enzymatic hydrolysis is any one or a combination of at least two of cellulase, hemicellulase, and β-glucosidase. Preferably, the enzyme used in the enzymatic hydrolysis is a combination of cellulase and hemicellulase in a mass ratio of 1:(0.2-3); Preferably, the amount of enzyme added for the enzymatic hydrolysis is 0.2-0.8% of the mass of the kudzu root raw material; Preferably, the power of the ultrasound is 100-300 W, and the power of the microwave is 100-300 W; Preferably, the temperature of the ultrasound-microwave assisted enzymatic hydrolysis is 40-60℃, and the time is 20-40 min; Preferably, the enzymatic hydrolysis includes a step of inactivating the enzyme.

5. The phytoestrogen composition according to claim 3 or 4, characterized in that, During the water extraction, the ratio of filter residue to water is 1:(8-15)g / mL; Preferably, the water extraction temperature is 40-60℃, the time is 1-2 h, and the pH is 5-6; Preferably, the water extraction is performed 1-3 times; Preferably, the water extraction further includes a step of mixing the enzymatically hydrolyzed filtrate and the water extract.

6. The phytoestrogen composition according to any one of claims 1-5, characterized in that, The flaxseed extract contains no less than 40% linolenic acid; Preferably, the flaxseed extract is obtained by a preparation method comprising the following steps: flaxseed is subjected to aerobic fermentation and extraction with an alkaline aqueous solution to obtain the flaxseed extract; Preferably, the microorganisms used in the aerobic fermentation are a combination of yeast and Bacillus.

7. The method for preparing the phytoestrogen composition according to any one of claims 1-6, characterized in that, The preparation method includes: The phytoestrogens composition was obtained by mixing kudzu root extract, yam extract, astragalus extract, mulberry extract, wolfberry extract, pomegranate extract, and flaxseed extract.

8. The preparation method according to claim 7, characterized in that, The mixing temperature is 20-30℃.

9. The use of the phytoestrogens composition according to any one of claims 1-6 in the preparation of products for regulating female estrogen levels.

10. The application according to claim 9, characterized in that, The product also includes excipients acceptable in the functional food sector; Preferably, the excipients include any one or a combination of at least two of the following: flavoring agents, flow aids, and fillers.

Images