A composition for female ovarian maintenance and its preparation method

Abstract

This invention discloses a composition for female ovarian maintenance and its preparation method, relating to the field of health care compositions, including the following steps: mixing pectin and sweetener, dissolving in water to obtain material A; then mixing the traditional Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, flavoring agents, and edible flavorings in sequence; stirring after adjusting the volume with purified water, then filtering, filling, sterilizing, and packaging to obtain a composition for female ovarian maintenance; this invention improves the utilization rate of functional components through the immobilization of fructooligosaccharides and β-glucosidase and the enteric coating targeting of shellac; Poria cocos polysaccharide-sulforaphane-resveratrol covers immune, antioxidant, and metabolic regulation pathways, directly targeting the core mechanism of premature ovarian failure; in summary, through the optimization of the entire chain of delivery-conversion-absorption-metabolism, the efficacy is significantly improved under the premise of safety.

Description

Technical Field

[0001] This invention relates to the field of health care compositions, and more specifically to a composition for female ovarian maintenance and its preparation method. Background Technology

[0002] The ovary is a vital organ in the female reproductive system. It not only plays a crucial role in producing and releasing eggs, maintaining female fertility, but also functions as an important endocrine gland. The ovary secretes various hormones, including estrogen and progesterone, which have a profound impact on the development of secondary sexual characteristics, menstrual cycle regulation, bone health, cardiovascular stability, and skin condition. In short, the health of the ovary directly affects a woman's physical and mental health and quality of life; it is the "source of life" for maintaining youthful vitality and physiological balance.

[0003] As women age, ovarian function gradually declines. However, in addition to physiological decline, ovarian aging and disease are also affected by unhealthy lifestyle habits, an unbalanced diet, and significant mental stress and emotional fluctuations. Furthermore, environmental pollution, exposure to chemicals, genetic factors, and certain diseases can also lead to ovarian diseases and premature aging, resulting in a series of physical discomforts such as irregular menstruation, insomnia, irritability, and sagging skin, which seriously reduce women's quality of life. Therefore, it is necessary to pay more attention to ovarian health.

[0004] Although the importance of ovarian maintenance has been recognized, and some ovarian maintenance products have appeared on the market, these products have many shortcomings. Some products, in pursuit of short-term effects, add synthetic hormones or other synthetic chemicals. While they may show some effects in the initial stages, such as improved skin condition and menstrual regulation, long-term use can lead to numerous side effects, potentially causing endocrine disorders, breast tenderness, enlarged uterine fibroids, and even increasing the risk of cancer. Other products have complex ingredients, and the nutrients and active substances are difficult for the body to absorb, resulting in low bioavailability and failing to truly exert their effect on ovarian maintenance. Therefore, developing a safe, effective, side-effect-free product with simple, easily absorbed ingredients that can truly maintain ovarian health is of significant practical and social value for protecting women's health and improving their quality of life. Summary of the Invention

[0005] To address the aforementioned technical problems, this invention provides a composition for female ovarian maintenance and a method for preparing the same.

[0006] The objective of this invention can be achieved through the following technical solutions:

[0007] A composition for female ovarian maintenance, comprising the following components by weight: 10-20 parts of traditional Chinese medicine formula, 0.5-1 part of active ingredient, 0.005-0.01 part of vitamin, 8-12 parts of sweetener, 5-8 parts of flavoring agent, 2-4 parts of resistant dextrin, 0.2-0.3 parts of pectin, 0.1-0.2 parts of edible flavoring, and 60-80 parts of purified water.

[0008] Furthermore, the preparation method of the traditional Chinese medicine formula is as follows:

[0009] (1) Weigh out the raw medicinal materials of wolfberry, cassia seed, raspberry, jujube seed and lotus seed according to the weight parts. Mix the above raw medicinal materials and crush them into a pulp to obtain a slurry. Heat the extraction tank to 90-100℃, add the slurry, extract, filter, centrifuge and concentrate to obtain the liquid.

[0010] (2) Take sodium alginate solution and β-glucosidase solution, mix them, add glutaraldehyde solution, mix well, and crosslink for 3-5 hours; add the crosslinked solution to calcium chloride solution and harden for 2-5 hours; filter and wash with citrate-sodium citrate buffer solution with pH 3.4-4.8, and dry to obtain microcapsules;

[0011] (3) Mix the liquid with the microcapsules, adsorb under vacuum for 20-40 minutes, add coating solution, and coat with fluidized bed to obtain the traditional Chinese medicine formula.

[0012] Furthermore, in step (1), the weight ratio of wolfberry, cassia seed, raspberry, jujube seed and lotus seed is 3-6:3-6:0.2-1:0.1-1:1.8-3.

[0013] Furthermore, the extraction time in step (1) is 100-140 min.

[0014] Furthermore, in step (2), the volume ratio of sodium alginate solution, β-glucosidase solution, glutaraldehyde solution, and calcium chloride solution is 8-12:1-3:0.5-1.2:10-15.

[0015] Furthermore, the sodium alginate has a mass concentration of 3-5%, the β-glucosidase solution has an enzyme activity of 350-500 U / mL, and the glutaraldehyde solution has a volume concentration of 20-30%.

[0016] Furthermore, the crosslinking and hardening temperature is controlled at 3-5℃.

[0017] Furthermore, in step (3), the mass ratio of the liquid to the microcapsules is 1-1.5:1-3.

[0018] Furthermore, in step (3), the coating solution is obtained by dissolving fructooligosaccharides, hydroxypropyl methylcellulose and shellac in a mixed solution of ethanol and water; by weight percentage, fructooligosaccharides account for 4-6%, hydroxypropyl methylcellulose accounts for 5-15%, shellac accounts for 2-5%, and the remainder is a mixed solution.

[0019] Furthermore, the volume ratio of ethanol to water in the mixed solution is 1-2:1-2.

[0020] Furthermore, the active ingredient is a composition of Poria cocos polysaccharide, sulforaphane and resveratrol, wherein the mass ratio of Poria cocos polysaccharide, sulforaphane and resveratrol is 2-3:1-3:4-6.

[0021] Furthermore, the vitamins are vitamin B1 and vitamin B2 in a mass ratio of 4-6:2-4.

[0022] Furthermore, the sweetener is at least two of erythritol, stevia, maltitol, and sucralose.

[0023] A method for preparing a composition for female ovarian maintenance includes the following steps:

[0024] A1. Mix pectin and sweetener evenly, dissolve in 20-26 parts purified water to obtain material A;

[0025] A2. Mix the traditional Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, flavoring agents, and edible flavorings in sequence; after adjusting the volume with the remaining purified water, stir for 3-5 minutes, then filter, fill, sterilize, and package to obtain a composition for female ovarian maintenance.

[0026] The beneficial effects of this invention are:

[0027] (1) Fructooligosaccharides (FOS) are added to the coating solution. Through its prebiotic properties, FOS can proliferate Bifidobacteria in the intestine, enhance the permeability of the intestinal barrier, and lay the foundation for the subsequent absorption of glycosides. FOS is fermented and degraded into butyric acid by the microbial community to enhance the transmembrane absorption of active ingredients. At the same time, FOS can activate the microbial community to produce more β-glucosidase, continuously hydrolyze the large molecular glycosides of traditional Chinese medicine (such as hydrolyzing cassia seed anthraquinone glycosides into rhein), and improve the absorption rate. FOS is made into an enteric coating with shellac / hydroxypropyl methylcellulose (HPMC) to protect the active ingredients and enzymes of traditional Chinese medicine in the gastric acid environment, ensure targeted release in the colon, and improve bioavailability.

[0028] (2) All active ingredients are plant extracts, with no risk of synthetic hormones. Poria cocos polysaccharide inhibits chronic inflammation by regulating the function of macrophages and T cells, reducing the disorder of the immune microenvironment of ovarian tissue, and indirectly protecting follicle development. Sulforaphane activates the antioxidant pathway, enhances the cell detoxification ability, and inhibits the NF-κB pathway. When combined with resveratrol, it can amplify the anti-inflammatory effect and reduce ovarian inflammatory damage. As a powerful antioxidant, resveratrol scavenge free radicals, reduce oxidative damage to ovarian granulosa cells, and significantly enhance the proliferation ability of damaged cells. The synergistic effect of sulforaphane, Poria cocos polysaccharide and resveratrol can form a multi-dimensional protection mechanism. The immunomodulatory effect of Poria cocos polysaccharide provides a more favorable microenvironment for resveratrol and sulforaphane, while sulforaphane enhances the bioavailability of resveratrol, ensuring that it can better exert its anti-inflammatory effect. The combined use of the three can more effectively address the complexity of ovarian dysfunction, thereby improving the effect of ovarian maintenance. Detailed Implementation

[0029] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0030] The following are some of the raw materials used in the embodiments and comparative examples of this invention: Poria cocos polysaccharide (Shanghai Ronghe Pharmaceutical Technology Development Co., Ltd., purity >95%), sulforaphane (Chongqing Botao Biotechnology Co., Ltd., purity 98%), resveratrol (Shenzhen Jianyuan Biotechnology Co., Ltd., purity ≥99%), vitamin B2 (Wuhan Lihe Zhizao Biotechnology Co., Ltd., purity 98%), vitamin B1 (Shandong Luxiang Pharmaceutical Co., Ltd., purity 99%), erythritol (Hefei Tianjian Chemical Co., Ltd., purity 99%), sucralose (Jiangsu Duoyang Bioengineering Technology Co., Ltd., purity 99%), cherry concentrate (Montmorenci acid cherry concentrate, Bindeli Trading (Qingdao) Co., Ltd., 5x concentration, 68°Brix), resistant dextrin (Shaanxi Chenming Biotechnology Co., Ltd., purity >99.9%), pectin (Shandong Pingju Biotechnology Co., Ltd., purity 99%), and edible flavoring (cherry powder flavoring, Hebei Jijie Biotechnology Co., Ltd., purity 99%).

[0031] Example 1

[0032] A composition for female ovarian maintenance, comprising the following components by weight: 10 parts of traditional Chinese medicine formula, 0.5 parts of active ingredient, 0.005 parts of vitamin, 7 parts of erythritol, 1 part of sucralose, 5 parts of cherry concentrate, 2 parts of resistant dextrin, 0.2 parts of pectin, 0.1 parts of edible flavoring, and 60 parts of purified water.

[0033] The preparation method of the traditional Chinese medicine formula is as follows:

[0034] (1) Weigh out 3 parts of wolfberry, 3 parts of cassia seed, 0.2 parts of raspberry, 0.1 parts of jujube seed, and 1.8 parts of lotus seed according to the weight ratio. Grind the raw materials to 70 mesh, add water and slurry (solid-liquid mass ratio is 1:5) to obtain slurry. Heat the extraction tank to 90℃, add the slurry, and extract for 120 min (intermittent extraction: stir once every 30 min, 5 min each time). Filter the slurry with a 300 mesh filter bag to remove the residue and obtain the extract. Transfer the extract to a horizontal centrifuge (2000 r / min, 30 s) and a tubular high-speed centrifuge (10000 r / min, 5 s) to obtain the centrifuged liquid. Concentrate the liquid through a polyamide reverse osmosis membrane (1.5 MPa, 40℃) to Brix 10%, and then enter a low-temperature double-effect concentration (first effect: 0.045 MPa, 80℃; second effect: 0.075 MPa, 55℃) to Brix 20% to obtain the liquid.

[0035] (2) Take a 3% sodium alginate solution and a β-glucosidase solution with an enzyme activity of 350 U / mL, mix them thoroughly, add a 20% glutaraldehyde solution, mix well, and crosslink at 3℃ for 3h; add the crosslinked solution to a 1.0% calcium chloride solution and harden at 3℃ for 2h; after filtration, wash with a citrate-sodium citrate buffer solution with a pH of 3.4 to obtain microcapsules; the volume ratio of sodium alginate solution, β-glucosidase solution, glutaraldehyde solution and calcium chloride solution is 8:1:0.5:10.

[0036] (3) By weight fraction, 4% fructooligosaccharide, 5% hydroxypropyl methylcellulose, and 2% shellac were dissolved in a mixed solution (the volume ratio of ethanol to water was 1:1) to obtain a coating solution. The solution was mixed with microcapsules (mass ratio of 1:3), and adsorbed under vacuum for 20 min. The coating solution was then added (the mass ratio of coating solution to microcapsules was 3:1), and the mixture was coated in a fluidized bed to obtain the traditional Chinese medicine formula (inlet air temperature 45℃, atomization pressure 0.3MPa, flow rate 5mL / min).

[0037] The active ingredients are a composition of Poria cocos polysaccharide, sulforaphane and resveratrol, wherein the mass ratio of Poria cocos polysaccharide, sulforaphane and resveratrol is 2:1:4.

[0038] The vitamins are vitamin B1 and vitamin B2 in a mass ratio of 4:2.

[0039] A method for preparing a composition for female ovarian maintenance includes the following steps:

[0040] A1. Mix pectin, erythritol and sucralose, and dissolve them completely in 20 parts of purified water at 50℃ to obtain material A;

[0041] A2. Mix the traditional Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, cherry concentrate, and edible flavoring in sequence; after adjusting the volume with the remaining purified water, stir for 3 minutes, then filter, fill, sterilize (105℃, 30 minutes), and package to obtain a composition for female ovarian maintenance.

[0042] Example 2

[0043] A composition for female ovarian maintenance, comprising the following components by weight: 20 parts of traditional Chinese medicine formula, 1 part of active ingredient, 0.01 parts of vitamin, 11 parts of erythritol, 1 part of sucralose, 8 parts of cherry concentrate, 4 parts of resistant dextrin, 0.3 parts of pectin, 0.2 parts of edible flavoring, and 80 parts of purified water.

[0044] The preparation method of the traditional Chinese medicine formula is as follows:

[0045] (1) Weigh out 6 parts of wolfberry, 6 parts of cassia seed, 1 part of raspberry, 1 part of jujube seed, and 3 parts of lotus seed according to the weight ratio. Crush them to 70 mesh and add water to make a slurry (solid-liquid mass ratio of 1:5). Heat the extraction tank to 100℃, add the slurry, and extract for 120 min (intermittent extraction: stir once every 30 min, 5 min each time). Filter the slurry through a 300 mesh filter bag to remove the residue and obtain the extract. Transfer the extract to a horizontal centrifuge (2000 r / min, 30 s) and a tubular high-speed centrifuge (10000 r / min, 5 s) to obtain the centrifuged liquid. Concentrate it through a polyamide reverse osmosis membrane (1.5 MPa, 40℃) to Brix 10%, and then enter a low-temperature double-effect concentration (first effect: 0.045 MPa, 80℃; second effect: 0.075 MPa, 55℃) to Brix 20% to obtain the material liquid.

[0046] (2) Take a 5% sodium alginate solution and a β-glucosidase solution with an enzyme activity of 500 U / mL, mix them thoroughly, add a 30% glutaraldehyde solution, mix well, and crosslink at 5℃ for 5h; add the crosslinked solution to a 2.5% calcium chloride solution, and harden at 5℃ for 5h; after filtration, wash with a citrate-sodium citrate buffer solution with a pH of 4.8 to obtain microcapsules; the volume ratio of sodium alginate solution, β-glucosidase solution, glutaraldehyde solution, and calcium chloride solution is 12:3:1.2:15.

[0047] (3) By weight fraction, 6% fructooligosaccharide, 15% hydroxypropyl methylcellulose and 5% shellac were dissolved in a mixed solution (the volume ratio of ethanol and water was 1:1) 74% to obtain a coating solution. The solution was mixed with microcapsules (mass ratio of 1.5:1) and adsorbed under vacuum for 40 min. The coating solution was then added (the mass ratio of coating solution to microcapsules was 3:1). The mixture was coated in a fluidized bed to obtain the traditional Chinese medicine formula (inlet air temperature 45℃, atomization pressure 0.3MPa, flow rate 5mL / min).

[0048] The active ingredients are a combination of Poria cocos polysaccharide, sulforaphane and resveratrol, wherein the mass ratio of Poria cocos polysaccharide, sulforaphane and resveratrol is 3:3:6.

[0049] The vitamins are vitamin B1 and vitamin B2 in a mass ratio of 6:4.

[0050] A method for preparing a composition for female ovarian maintenance includes the following steps:

[0051] A1. Mix pectin, sucralose and erythritol, and dissolve them completely in 26 parts of purified water at 70℃ to obtain material A;

[0052] A2. Mix the traditional Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, cherry concentrate, and edible flavoring in sequence; after adjusting the volume with the remaining purified water, stir for 5 minutes, then filter, fill, sterilize (105℃, 30 minutes), and package to obtain a composition for female ovarian maintenance.

[0053] Example 3

[0054] A composition for female ovarian maintenance, comprising the following components by weight: 15 parts of traditional Chinese medicine formula, 0.75 parts of active ingredient, 0.0075 parts of vitamin, 9 parts of erythritol, 1 part of sucralose, 6.5 parts of cherry concentrate, 3 parts of resistant dextrin, 0.25 parts of pectin, 0.15 parts of edible flavoring, and 70 parts of purified water.

[0055] The preparation method of the traditional Chinese medicine formula is as follows:

[0056] (1) Weigh out 4.5 parts of wolfberry, 4.5 parts of cassia seed, 0.6 parts of raspberry, 0.55 parts of jujube seed, and 2.4 parts of lotus seed according to the weight ratio. Grind the raw medicinal materials to 70 mesh, add water and slurry (solid-liquid mass ratio is 1:5) to obtain slurry. Heat the extraction tank to 95℃, add the slurry, and extract for 120 min (intermittent extraction: stir once every 30 min, 5 min each time). Filter the slurry with a 300 mesh filter bag to remove the residue and obtain the extract. Transfer the extract to a horizontal centrifuge (2000 r / min, 30 s) and a tubular high-speed centrifuge (10000 r / min, 5 s) to obtain centrifuged liquid. Concentrate the liquid through a polyamide reverse osmosis membrane (1.5 MPa, 40℃) to Brix 10%, and then enter a low-temperature double-effect concentration (first effect: 0.045 MPa, 80℃; second effect: 0.075 MPa, 55℃) to Brix 20% to obtain the liquid.

[0057] (2) Take a 4% sodium alginate solution and a β-glucosidase solution with an enzyme activity of 450 U / mL, mix them thoroughly, add a 25% glutaraldehyde solution, mix well, and crosslink at 4℃ for 4h; add the crosslinked solution dropwise into a 1.75% calcium chloride solution and harden at 4℃ for 4h; after filtration, wash with a citrate-sodium citrate buffer solution with a pH of 4.1 to obtain microcapsules; the volume ratio of sodium alginate solution, β-glucosidase solution, glutaraldehyde solution, and calcium chloride solution is 10:2:0.85:12.5.

[0058] (3) By weight fraction, 5% fructooligosaccharide, 10% hydroxypropyl methylcellulose and 3% shellac were dissolved in a mixed solution (the volume ratio of ethanol and water was 1:1) 82% to obtain a coating solution. The solution was mixed with microcapsules (mass ratio of 1.25:2) and adsorbed under vacuum for 30 min. The coating solution was then added (the mass ratio of coating solution to microcapsules was 3:1). The solution was coated in a fluidized bed to obtain the traditional Chinese medicine formula (inlet air temperature 45℃, atomization pressure 0.3MPa, flow rate 5mL / min).

[0059] The active ingredients are a composition of Poria cocos polysaccharide, sulforaphane and resveratrol, wherein the mass ratio of Poria cocos polysaccharide, sulforaphane and resveratrol is 2.5:2:5.

[0060] The vitamins are vitamin B1 and vitamin B2 in a mass ratio of 5:3.

[0061] A method for preparing a composition for female ovarian maintenance includes the following steps:

[0062] A1. Mix pectin, sucralose and erythritol, and dissolve them completely in 23 parts of purified water at 60℃ to obtain material A;

[0063] A2. Mix the traditional Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, cherry concentrate, and edible flavoring in sequence; after adjusting the volume with the remaining purified water, stir for 4 minutes, then filter, fill, sterilize (105℃, 30 minutes), and package to obtain a composition for female ovarian maintenance.

[0064] Comparative Example 1

[0065] A composition for female ovarian maintenance, comprising the following components by weight: 15 parts of traditional Chinese medicine formula, 0.75 parts of active ingredient, 0.0075 parts of vitamin, 9 parts of erythritol, 1 part of sucralose, 6.5 parts of cherry concentrate, 3 parts of resistant dextrin, 0.25 parts of pectin, 0.15 parts of edible flavoring, and 70 parts of purified water.

[0066] The preparation method of the traditional Chinese medicine formula is as follows:

[0067] (1) Weigh out 4.5 parts of wolfberry, 4.5 parts of cassia seed, 0.6 parts of raspberry, 0.55 parts of jujube seed, and 2.4 parts of lotus seed according to the weight ratio. Grind the raw medicinal materials to 70 mesh, add water and slurry (solid-liquid mass ratio is 1:5) to obtain slurry. Heat the extraction tank to 95℃, add the slurry, and extract for 120 min (intermittent extraction: stir once every 30 min, 5 min each time). Filter the slurry with a 300 mesh filter bag to remove the residue and obtain the extract. Transfer the extract to a horizontal centrifuge (2000 r / min, 30 s) and a tubular high-speed centrifuge (10000 r / min, 5 s) to obtain centrifuged liquid. Concentrate the liquid through a polyamide reverse osmosis membrane (1.5 MPa, 40℃) to Brix 10%, and then enter a low-temperature double-effect concentration (first effect: 0.045 MPa, 80℃; second effect: 0.075 MPa, 55℃) to Brix 20% to obtain the liquid.

[0068] (2) Take a 4% sodium alginate solution and a β-glucosidase solution with an enzyme activity of 450 U / mL, mix them thoroughly, add a 25% glutaraldehyde solution, mix well, and crosslink at 4℃ for 4h; add the crosslinked solution dropwise into a 1.75% calcium chloride solution and harden at 4℃ for 4h; after filtration, wash with a citrate-sodium citrate buffer solution with a pH of 4.1 to obtain microcapsules; the volume ratio of sodium alginate solution, β-glucosidase solution, glutaraldehyde solution, and calcium chloride solution is 10:2:0.85:12.5.

[0069] (3) By weight fraction, 5% sucrose, 10% hydroxypropyl methylcellulose and 3% shellac were dissolved in a mixed solution (the volume ratio of ethanol and water was 1:1) 82% to obtain a coating solution. The solution was mixed with microcapsules (mass ratio of 1.25:2) and adsorbed under vacuum for 30 min. The coating solution was then added (the mass ratio of coating solution to microcapsules was 3:1). The solution was coated in a fluidized bed to obtain the traditional Chinese medicine formula (inlet air temperature 45℃, atomization pressure 0.3MPa, flow rate 5mL / min).

[0070] The active ingredients are a composition of Poria cocos polysaccharide, sulforaphane and resveratrol, wherein the mass ratio of Poria cocos polysaccharide, sulforaphane and resveratrol is 2.5:2:5.

[0071] The vitamins are vitamin B1 and vitamin B2 in a mass ratio of 5:3.

[0072] A method for preparing a composition for female ovarian maintenance includes the following steps:

[0073] A1. Mix pectin, sucralose and erythritol, and dissolve them completely in 23 parts of purified water at 60℃ to obtain material A;

[0074] A2. Mix the traditional Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, cherry concentrate, and edible flavoring in sequence; after adjusting the volume with the remaining purified water, stir for 4 minutes, then filter, fill, sterilize (105℃, 30 minutes), and package to obtain a composition for female ovarian maintenance.

[0075] Comparative Example 2

[0076] A composition for female ovarian maintenance, comprising the following components by weight: 15 parts of traditional Chinese medicine formula, 0.75 parts of active ingredient, 0.0075 parts of vitamin, 9 parts of erythritol, 1 part of sucralose, 6.5 parts of cherry concentrate, 3 parts of resistant dextrin, 0.25 parts of pectin, 0.15 parts of edible flavoring, and 70 parts of purified water.

[0077] The preparation method of the traditional Chinese medicine formula is as follows:

[0078] (1) Weigh out 4.5 parts of wolfberry, 4.5 parts of cassia seed, 0.6 parts of raspberry, 0.55 parts of jujube seed, and 2.4 parts of lotus seed according to the weight ratio. Grind the raw medicinal materials to 70 mesh, add water and slurry (solid-liquid mass ratio is 1:5) to obtain slurry. Heat the extraction tank to 95℃, add the slurry, and extract for 120 min (intermittent extraction: stir once every 30 min, 5 min each time). Filter the slurry with a 300 mesh filter bag to remove the residue and obtain the extract. Transfer the extract to a horizontal centrifuge (2000 r / min, 30 s) and a tubular high-speed centrifuge (10000 r / min, 5 s) to obtain centrifuged liquid. Concentrate the liquid through a polyamide reverse osmosis membrane (1.5 MPa, 40℃) to Brix 10%, and then enter a low-temperature double-effect concentration (first effect: 0.045 MPa, 80℃; second effect: 0.075 MPa, 55℃) to Brix 20% to obtain the liquid.

[0079] (2) Take a 4% sodium alginate solution and an α-glucosidase solution with an enzyme activity of 450 U / mL, mix them thoroughly, add a 25% glutaraldehyde solution, mix well, and crosslink at 4℃ for 4h; add the crosslinked solution dropwise into a 1.75% calcium chloride solution and harden at 4℃ for 4h; after filtration, wash with a citrate-sodium citrate buffer solution with a pH of 4.1 to obtain microcapsules; the volume ratio of sodium alginate solution, α-glucosidase solution, glutaraldehyde solution, and calcium chloride solution is 10:2:0.85:12.5.

[0080] (3) By weight fraction, 5% fructooligosaccharide, 10% hydroxypropyl methylcellulose and 3% shellac were dissolved in a mixed solution (the volume ratio of ethanol and water was 1:1) 82% to obtain a coating solution. The solution was mixed with microcapsules (mass ratio of 1.25:2) and adsorbed under vacuum for 30 min. The coating solution was then added (the mass ratio of coating solution to microcapsules was 3:1). The solution was coated in a fluidized bed to obtain the traditional Chinese medicine formula (inlet air temperature 45℃, atomization pressure 0.3MPa, flow rate 5mL / min).

[0081] The active ingredients are a composition of Poria cocos polysaccharide, sulforaphane and resveratrol, wherein the mass ratio of Poria cocos polysaccharide, sulforaphane and resveratrol is 2.5:2:5.

[0082] The vitamins are vitamin B1 and vitamin B2 in a mass ratio of 5:3.

[0083] A method for preparing a composition for female ovarian maintenance includes the following steps:

[0084] A1. Mix pectin, sucralose and erythritol, and dissolve them completely in 23 parts of purified water at 60℃ to obtain material A;

[0085] A2. Mix the traditional Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, cherry concentrate, and edible flavoring in sequence; after adjusting the volume with the remaining purified water, stir for 4 minutes, then filter, fill, sterilize (105℃, 30 minutes), and package to obtain a composition for female ovarian maintenance.

[0086] Comparative Example 3

[0087] A composition for female ovarian maintenance, comprising the following components by weight: 15 parts of traditional Chinese medicine formula, 0.75 parts of active ingredient, 0.0075 parts of vitamin, 9 parts of erythritol, 1 part of sucralose, 6.5 parts of cherry concentrate, 3 parts of resistant dextrin, 0.25 parts of pectin, 0.15 parts of edible flavoring, and 70 parts of purified water.

[0088] The preparation method of the traditional Chinese medicine formula is as follows:

[0089] (1) Weigh out 4.5 parts of wolfberry, 4.5 parts of cassia seed, 0.6 parts of raspberry, 0.55 parts of jujube seed, and 2.4 parts of lotus seed according to the weight ratio. Grind the raw medicinal materials to 70 mesh, add water and slurry (solid-liquid mass ratio is 1:5) to obtain slurry. Heat the extraction tank to 95℃, add the slurry, and extract for 120 min (intermittent extraction: stir once every 30 min, 5 min each time). Filter the slurry with a 300 mesh filter bag to remove the residue and obtain the extract. Transfer the extract to a horizontal centrifuge (2000 r / min, 30 s) and a tubular high-speed centrifuge (10000 r / min, 5 s) to obtain centrifuged liquid. Concentrate the liquid through a polyamide reverse osmosis membrane (1.5 MPa, 40℃) to Brix 10%, and then enter a low-temperature double-effect concentration (first effect: 0.045 MPa, 80℃; second effect: 0.075 MPa, 55℃) to Brix 20% to obtain the liquid.

[0090] (2) Take a 4% sodium alginate solution and a β-glucosidase solution with an enzyme activity of 450 U / mL, mix them thoroughly, add a 25% glutaraldehyde solution, mix well, and crosslink at 4℃ for 4h; add the crosslinked solution dropwise into a 1.75% calcium chloride solution and harden at 4℃ for 4h; after filtration, wash with a citrate-sodium citrate buffer solution with a pH of 4.1 to obtain microcapsules; the volume ratio of sodium alginate solution, β-glucosidase solution, glutaraldehyde solution, and calcium chloride solution is 10:2:0.85:12.5.

[0091] (3) By weight fraction, 5% fructooligosaccharide, 10% hydroxypropyl methylcellulose and 3% shellac were dissolved in a mixed solution (the volume ratio of ethanol and water was 1:1) 82% to obtain a coating solution. The solution was mixed with microcapsules (mass ratio of 1.25:2) and adsorbed under vacuum for 30 min. The coating solution was then added (the mass ratio of coating solution to microcapsules was 3:1). The solution was coated in a fluidized bed to obtain the traditional Chinese medicine formula (inlet air temperature 45℃, atomization pressure 0.3MPa, flow rate 5mL / min).

[0092] The active ingredients are a combination of sulforaphane and resveratrol, wherein the mass ratio of sulforaphane to resveratrol is 2:5.

[0093] The vitamins are vitamin B1 and vitamin B2 in a mass ratio of 5:3.

[0094] A method for preparing a composition for female ovarian maintenance includes the following steps:

[0095] A1. Mix pectin, sucralose and erythritol, and dissolve them completely in 23 parts of purified water at 60℃ to obtain material A;

[0096] A2. Mix the traditional Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, cherry concentrate, and edible flavoring in sequence; after adjusting the volume with the remaining purified water, stir for 4 minutes, then filter, fill, sterilize (105℃, 30 minutes), and package to obtain a composition for female ovarian maintenance.

[0097] Comparative Example 4

[0098] A composition for female ovarian maintenance, comprising the following components by weight: 15 parts of traditional Chinese medicine formula, 0.75 parts of active ingredient, 0.0075 parts of vitamin, 9 parts of erythritol, 1 part of sucralose, 6.5 parts of cherry concentrate, 3 parts of resistant dextrin, 0.25 parts of pectin, 0.15 parts of edible flavoring, and 70 parts of purified water.

[0099] The preparation method of the traditional Chinese medicine formula is as follows:

[0100] (1) Weigh out 4.5 parts of wolfberry, 4.5 parts of cassia seed, 0.6 parts of raspberry, 0.55 parts of jujube seed, and 2.4 parts of lotus seed according to the weight ratio. Grind the raw medicinal materials to 70 mesh, add water and slurry (solid-liquid mass ratio is 1:5) to obtain slurry. Heat the extraction tank to 95℃, add the slurry, and extract for 120 min (intermittent extraction: stir once every 30 min, 5 min each time). Filter the slurry with a 300 mesh filter bag to remove the residue and obtain the extract. Transfer the extract to a horizontal centrifuge (2000 r / min, 30 s) and a tubular high-speed centrifuge (10000 r / min, 5 s) to obtain centrifuged liquid. Concentrate the liquid through a polyamide reverse osmosis membrane (1.5 MPa, 40℃) to Brix 10%, and then enter a low-temperature double-effect concentration (first effect: 0.045 MPa, 80℃; second effect: 0.075 MPa, 55℃) to Brix 20% to obtain the liquid.

[0101] (2) Take a 4% sodium alginate solution and a β-glucosidase solution with an enzyme activity of 450 U / mL, mix them thoroughly, add a 25% glutaraldehyde solution, mix well, and crosslink at 4℃ for 4h; add the crosslinked solution dropwise into a 1.75% calcium chloride solution and harden at 4℃ for 4h; after filtration, wash with a citrate-sodium citrate buffer solution with a pH of 4.1 to obtain microcapsules; the volume ratio of sodium alginate solution, β-glucosidase solution, glutaraldehyde solution, and calcium chloride solution is 10:2:0.85:12.5.

[0102] (3) By weight fraction, 5% fructooligosaccharide, 10% hydroxypropyl methylcellulose and 3% shellac were dissolved in a mixed solution (the volume ratio of ethanol and water was 1:1) 82% to obtain a coating solution. The solution was mixed with microcapsules (mass ratio of 1.25:2) and adsorbed under vacuum for 30 min. The coating solution was then added (the mass ratio of coating solution to microcapsules was 3:1). The solution was coated in a fluidized bed to obtain the traditional Chinese medicine formula (inlet air temperature 45℃, atomization pressure 0.3MPa, flow rate 5mL / min).

[0103] The active ingredients are a combination of Poria cocos polysaccharide and resveratrol, wherein the mass ratio of Poria cocos polysaccharide to resveratrol is 2.5:5.

[0104] The vitamins are vitamin B1 and vitamin B2 in a mass ratio of 5:3.

[0105] A method for preparing a composition for female ovarian maintenance includes the following steps:

[0106] A1. Mix pectin, sucralose and erythritol, and dissolve them completely in 23 parts of purified water at 60℃ to obtain material A;

[0107] A2. Mix the traditional Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, cherry concentrate, and edible flavoring in sequence; after adjusting the volume with the remaining purified water, stir for 4 minutes, then filter, fill, sterilize (105℃, 30 minutes), and package to obtain a composition for female ovarian maintenance.

[0108] Comparative Example 5

[0109] A composition for female ovarian maintenance, comprising the following components by weight: 15 parts of traditional Chinese medicine formula, 0.75 parts of active ingredient, 0.0075 parts of vitamin, 9 parts of erythritol, 1 part of sucralose, 6.5 parts of cherry concentrate, 3 parts of resistant dextrin, 0.25 parts of pectin, 0.15 parts of edible flavoring, and 70 parts of purified water.

[0110] The preparation method of the traditional Chinese medicine formula is as follows:

[0111] (1) Weigh out 4.5 parts of wolfberry, 4.5 parts of cassia seed, 0.6 parts of raspberry, 0.55 parts of jujube seed, and 2.4 parts of lotus seed according to the weight ratio. Grind the raw medicinal materials to 70 mesh, add water and slurry (solid-liquid mass ratio is 1:5) to obtain slurry. Heat the extraction tank to 95℃, add the slurry, and extract for 120 min (intermittent extraction: stir once every 30 min, 5 min each time). Filter the slurry with a 300 mesh filter bag to remove the residue and obtain the extract. Transfer the extract to a horizontal centrifuge (2000 r / min, 30 s) and a tubular high-speed centrifuge (10000 r / min, 5 s) to obtain centrifuged liquid. Concentrate the liquid through a polyamide reverse osmosis membrane (1.5 MPa, 40℃) to Brix 10%, and then enter a low-temperature double-effect concentration (first effect: 0.045 MPa, 80℃; second effect: 0.075 MPa, 55℃) to Brix 20% to obtain the liquid.

[0112] (2) Take a 4% sodium alginate solution and a β-glucosidase solution with an enzyme activity of 450 U / mL, mix them thoroughly, add a 25% glutaraldehyde solution, mix well, and crosslink at 4℃ for 4h; add the crosslinked solution dropwise into a 1.75% calcium chloride solution and harden at 4℃ for 4h; after filtration, wash with a citrate-sodium citrate buffer solution with a pH of 4.1 to obtain microcapsules; the volume ratio of sodium alginate solution, β-glucosidase solution, glutaraldehyde solution, and calcium chloride solution is 10:2:0.85:12.5.

[0113] (3) By weight fraction, 5% fructooligosaccharide, 10% hydroxypropyl methylcellulose and 3% shellac were dissolved in a mixed solution (the volume ratio of ethanol and water was 1:1) 82% to obtain a coating solution. The solution was mixed with microcapsules (mass ratio of 1.25:2) and adsorbed under vacuum for 30 min. The coating solution was then added (the mass ratio of coating solution to microcapsules was 3:1). The solution was coated in a fluidized bed to obtain the traditional Chinese medicine formula (inlet air temperature 45℃, atomization pressure 0.3MPa, flow rate 5mL / min).

[0114] The active ingredients are a combination of Poria cocos polysaccharide and sulforaphane, wherein the mass ratio of Poria cocos polysaccharide to sulforaphane is 2.5:2.

[0115] The vitamins are vitamin B1 and vitamin B2 in a mass ratio of 5:3.

[0116] A method for preparing a composition for female ovarian maintenance includes the following steps:

[0117] A1. Mix pectin, sucralose and erythritol, and dissolve them completely in 23 parts of purified water at 60℃ to obtain material A;

[0118] A2. Mix the traditional Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, cherry concentrate, and edible flavoring in sequence; after adjusting the volume with the remaining purified water, stir for 4 minutes, then filter, fill, sterilize (105℃, 30 minutes), and package to obtain a composition for female ovarian maintenance.

[0119] The following is a further efficacy test of the composition for female ovarian maintenance prepared according to the present invention, and the test results are as follows.

[0120] 1. Test subjects:

[0121] Sixty sexually mature female SD rats (non-pregnant and nulliparous), SPF grade, weighing 200-240g, 8-9 weeks old, were purchased from Guangzhou Yancheng Biotechnology Co., Ltd. The rats were quarantined 3 days prior to the experiment, and checked daily during this period. Any unhealthy rats were immediately culled, and only healthy rats were used for the experiment. Housing conditions: 5 rats per enclosure, housing temperature of 25℃, relative humidity of 55%, using a 10h:14h day / night cycle with intermittent lighting. Free access to food and water was provided during the rearing period.

[0122] 2. Test methods:

[0123] 2.1 Grouping, Modeling, and Drug Administration

[0124] After 3 days of acclimatization, 50 rats were randomly divided into three groups: a control group, a model group, and an experimental group (Examples 1-3 and Comparative Examples 1-5), with 5 rats in each group. Except for the control group, all other groups received an intramuscular injection of hydrocortisone (32 mg / kg) into their hind limbs once daily for 12 consecutive days to establish the premature ovarian failure (POF) model. After successful model establishment, the control and model groups were fed purified water, while the Examples 1-3 and Comparative Examples 1-5 groups were fed their respective prepared compositions (1 g / kg) twice daily, once in the morning and once in the afternoon, for 28 consecutive days.

[0125] 2.2 Detection of serum levels of reproductive-related hormones and organ indices

[0126] Twenty-four hours after the last administration, blood was collected from the abdominal aorta of rats and centrifuged. Serum was collected, and the levels of E2, FSH, and LH in the serum were measured using radioimmunoassay according to the instructions of the corresponding kit. The percentage of FSH to LH was calculated (FSH / LH × 100%). After blood collection, the rats were sacrificed, and the uterus and bilateral ovaries were removed, washed, and weighed. The organ index was calculated using the formula: Organ Index = Organ Wet Weight (mg) / Body Weight (100g).

[0127] 2.3 Digestion and Absorption Efficiency Verification Experiment

[0128] Intestinal circulation absorption experiment: After anesthesia, rats were dissected and a duodenal cannula was inserted to establish a circulation loop. Krebs-Ringer solution containing rhubarb extract (0.1 mg / mL) (containing phenol red 2 mg / mL) was infused. Samples were taken every 15 min for 2 h to determine the drug concentration (HPLC method) and phenol red concentration (corrected for water absorption). The absorption rate constant (Ka) was calculated. After the rats were sacrificed, the contents of the colon were analyzed using 16S rRNA sequencing to detect Bifidobacterium / Lactobacillus abundance and GC-MS to detect short-chain fatty acid (butyric acid) concentration.

[0129] 2.4 Statistical Methods

[0130] SPSS 21.0 statistical software was used for results analysis. Quantitative data are expressed as mean ± standard deviation (x±s). If the data conformed to normality and homogeneity of variance after transformation, one-way ANOVA was used for comparisons between groups. If the data still did not conform to normality and homogeneity of variance after transformation, the rank-sum test was used for comparisons between groups. Chi-square test was used for categorical data. P < 0.05 was considered statistically significant.

[0131] 3. Results

[0132] 3.1 Serum reproductive hormone levels

[0133] Compared with the control group, the serum E2 level in the model group was decreased, while the FSH, LH levels and FSH / LH ratio were increased (P<0.05). Compared with the model group, the serum E2 level in each example group and each comparative group was increased, while the FSH, LH levels and FSH / LH ratio were decreased (P<0.05 or P<0.01). However, the increase in serum E2 level and the decrease in FSH, LH level and FSH / LH ratio were more significant in each example group compared with the comparative groups (P<0.05 or P<0.01). The results of serum reproductive hormone level measurements in each group of rats are shown in Table 1.

[0134] Table 1: Serum reproductive hormone levels in rats of each group

[0135]

[0136] 3.2 Ovarian index and uterine index

[0137] The ovarian and uterine indices of the model group rats were lower than those of the control group, with a statistically significant difference in the ovarian index (P<0.01). The ovarian indices of all example groups and the comparative group were higher than those of the model group (P<0.01); the uterine indices were lower than those of the model group, but the differences were not statistically significant (P>0.05). However, the ovarian index was higher and the uterine index was lower in each example group compared to the comparative group. The results of the ovarian and uterine index measurements for each group are shown in Table 2.

[0138] Table 2. Results of ovarian and uterine indices in rats of each group (unit: mg / 100g)

[0139]

[0140] 3.3 Absorption rate constant, butyric acid concentration, and Bifidobacterium abundance

[0141] The absorption rate constant, butyric acid concentration, and Bifidobacterium abundance of the model group rats were all lower than those of the blank group. The absorption rate constant, butyric acid concentration, and Bifidobacterium abundance of the rats in each experimental group were all higher than those of the model group. However, the absorption rate constant, butyric acid concentration, and Bifidobacterium abundance of each example group in the experimental group were higher than those of each comparative group. The measurement results are shown in Table 3.

[0142] Table 3. Absorption rate constants, butyrate concentrations, and Bifidobacterium abundance in each group of rats.

[0143]

[0144] Results Analysis: According to the data analysis in Tables 1, 2, and 3, the absence of fructooligosaccharides and β-glucosidase (Comparative Examples 1-2) resulted in a significantly higher FSH / LH ratio than in Example 3, confirming that the two synergistically promote glycoside hydrolysis and improve the utilization rate of active ingredients in traditional Chinese medicine. The increased Ka value, colonic butyrate concentration, and Bifidobacterium abundance further confirm that fructooligosaccharides promote gut microbiota metabolism and glycoside transformation, thereby improving absorption and bioavailability. In the absence of active ingredients (Comparative Examples 3-5), sulforaphane, Poria cocos polysaccharide, and resveratrol work synergistically to form a multi-dimensional protective mechanism. The immunomodulatory effect of Poria cocos polysaccharide provides a more favorable microenvironment for resveratrol and sulforaphane, while sulforaphane enhances the bioavailability of resveratrol, ensuring that it can better exert its anti-inflammatory effect. The combined use of the three can more effectively address the complexity of ovarian dysfunction, thereby improving the effect of ovarian maintenance.

[0145] The above description is merely an example and illustration of the concept of the present invention. Those skilled in the art can make various modifications or additions to the specific embodiments described or use similar methods to replace them, as long as they do not deviate from the concept of the invention or exceed the scope defined in the claims, they should all fall within the protection scope of the present invention.

Claims

1. A composition for female ovarian maintenance, characterized in that, By weight, it includes the following components: 10-20 parts of traditional Chinese medicine formula, 0.5-1 part of active ingredients, 0.005-0.01 parts of vitamins, 8-12 parts of sweetener, 5-8 parts of flavoring agent, 2-4 parts of resistant dextrin, 0.2-0.3 parts of pectin, 0.1-0.2 parts of edible flavoring, and 60-80 parts of purified water; The preparation method of the traditional Chinese medicine formula is as follows: (1) Weigh out the raw medicinal materials of wolfberry, cassia seed, raspberry, jujube seed and lotus seed according to the weight parts. Mix the above raw medicinal materials and crush them into a pulp to obtain a slurry. Heat the extraction tank to 90-100℃, add the slurry, extract, filter, centrifuge and concentrate to obtain the liquid. (2) Take sodium alginate solution and β-glucosidase solution, mix them, add glutaraldehyde solution, mix well, and crosslink for 3-5 hours; add the crosslinked solution to calcium chloride solution and harden for 2-5 hours; filter and wash with citrate-sodium citrate buffer solution with pH 3.4-4.8, and dry to obtain microcapsules; (3) Mix the liquid with the microcapsules, adsorb under vacuum for 20-40 min, add coating solution, and coat in a fluidized bed to obtain the traditional Chinese medicine formula; In step (3), the coating solution is obtained by dissolving fructooligosaccharides, hydroxypropyl methylcellulose and shellac in a mixed solution of ethanol and water; by weight percentage, fructooligosaccharides account for 4-6%, hydroxypropyl methylcellulose accounts for 5-15%, shellac accounts for 2-5%, and the remainder is a mixed solution; The active ingredient is a composition of Poria cocos polysaccharide, sulforaphane and resveratrol, wherein the mass ratio of Poria cocos polysaccharide, sulforaphane and resveratrol is 2-3:1-3:4-6.

2. The composition for female ovarian maintenance according to claim 1, characterized in that, In step (1), the weight ratio of wolfberry, cassia seed, raspberry, jujube seed and lotus seed is 3-6:3-6:0.2-1:0.1-1:1.8-3.

3. The composition for female ovarian maintenance according to claim 1, characterized in that, In step (2), the volume ratio of sodium alginate solution, β-glucosidase solution, glutaraldehyde solution and calcium chloride solution is 8-12:1-3:0.5-1.2:10-15.

4. The composition for female ovarian maintenance according to claim 1, characterized in that, In step (3), the mass ratio of the liquid to the microcapsules is 1-1.5:1-3.

5. A composition for female ovarian maintenance according to claim 1, characterized in that, The vitamins mentioned are vitamin B1 and vitamin B2 in a mass ratio of 4-6:2-4.

6. The composition for female ovarian maintenance according to claim 1, characterized in that, The sweetener is at least two of erythritol, stevia, maltitol and sucralose.

7. A method for preparing a composition for female ovarian maintenance according to any one of claims 1-6, characterized in that, Includes the following steps: A1. Mix pectin and sweetener evenly, dissolve in 20-26 parts purified water to obtain material A; A2. Mix the traditional Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, flavoring agents, and edible flavorings in sequence; after adjusting the volume with the remaining purified water, stir for 3-5 minutes, then filter, fill, sterilize, and package to obtain a composition for female ovarian maintenance.

Images