Composition for maintaining female ovary and preparation method thereof

Abstract

The invention discloses a composition for female ovary maintenance and a preparation method thereof, and relates to the field of health-care compositions.The preparation method comprises the following steps that pectin and a sweetening agent are evenly mixed and dissolved with water, and a material A is obtained; uniformly mixing the traditional Chinese medicine formula, the material A, the active ingredients, the resistant dextrin, the vitamins, the flavoring agent and the edible essence in sequence; the preparation method comprises the following steps: fixing the volume with purified water, stirring, filtering, filling, sterilizing and packaging to obtain the composition for maintaining the female ovary. Through immobilization of fructo-oligosaccharide and beta-glucosidase and lac enteric targeting, the utilization rate of functional components is increased; pachymaran-raphanin-resveratrol covers immunity, antioxidation and metabolic regulation pathways, and directly strikes the premature ovarian failure core mechanism; in general, through full-chain optimization of delivery-conversion-absorption-metabolism, the efficacy is remarkably improved on the premise of safety.

Description

Technical Field

[0001] The present invention relates to the field of health care compositions, and in particular to a composition for maintaining female ovaries and a preparation method thereof. Background Art

[0002] The ovaries are crucial organs in the female reproductive system. They not only produce and release eggs, maintaining female fertility, but are also important endocrine glands in the female body. The ovaries secrete a variety of hormones, including estrogen and progesterone, which profoundly influence the development of secondary sexual characteristics, menstrual cycle regulation, bone health, cardiovascular function, and skin condition. The health of the ovaries is directly linked to a woman's physical and mental health and quality of life, serving as the "source of life" that helps maintain youthful vitality and physiological balance.

[0003] As women age, their ovarian function gradually declines. However, in addition to physiological decline, ovarian aging and pathology are also affected by bad living habits, unreasonable diet, tremendous mental stress and mood swings. In addition, environmental pollution, exposure to chemicals, genetic factors and some disease factors may also lead to ovarian pathology and premature aging, which in turn cause a series of physical discomforts, such as irregular menstruation, insomnia, irritability, sagging skin, etc., which seriously reduce women's quality of life. Therefore, more attention needs to be paid to ovarian maintenance.

[0004] While the importance of ovarian maintenance is widely recognized, and a number of ovarian maintenance products have appeared on the market, these products have numerous shortcomings. Some products, seeking short-term effects, contain synthetic hormones or other synthetic chemical ingredients. While some initial benefits, such as improved skin and menstrual regulation, may be apparent, long-term use can cause numerous side effects, including endocrine disorders, breast tenderness, enlarged uterine fibroids, and even an increased risk of cancer. Some products also have complex ingredients, making their nutrients and active ingredients difficult to absorb, resulting in low bioavailability and an inability to truly maintain ovarian health. Therefore, developing a safe, effective, side-effect-free product with simple, easily absorbed ingredients that truly maintains ovarian health has important practical significance and social value for maintaining women's health and improving their quality of life. Summary of the Invention

[0005] In order to solve the above technical problems, the present invention provides a composition for female ovary maintenance and a preparation method thereof.

[0006] The purpose of the present invention can be achieved through the following technical solutions:

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

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

[0009] (1) Weigh wolfberry fruit, cassia seed, raspberry, jujube seed, and lotus seed raw materials by weight, mix the raw materials, and then grind and beat to obtain a slurry; heat the extraction tank to 90-100°C, add the slurry, extract, filter, centrifuge and concentrate to obtain a liquid;

[0010] (2) Mixing sodium alginate solution and β-glucosidase solution, adding glutaraldehyde solution, mixing well, and cross-linking for 3-5 hours; dropping the cross-linked solution into calcium chloride solution and hardening for 2-5 hours; filtering and washing with citric acid-sodium citrate buffer solution with a pH of 3.4-4.8, and drying to obtain microcapsules;

[0011] (3) The feed liquid is mixed with the microcapsules, adsorbed under vacuum conditions for 20-40 minutes, and the coating liquid is added. The microcapsules are coated in a fluidized bed to obtain the Chinese medicine formula.

[0012] Furthermore, in step (1), the weight ratio of wolfberry fruit, 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 minutes.

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

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

[0016] Furthermore, the cross-linking and hardening temperature is controlled at 3-5°C.

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

[0018] Furthermore, the coating solution in step (3) is obtained by dissolving oligofructose, hydroxypropyl methylcellulose and shellac in a mixed solution of ethanol and water; in terms of weight percentage, oligofructose accounts for 4-6%, hydroxypropyl methylcellulose accounts for 5-15%, shellac accounts for 2-5%, and the remainder is the 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 pachymaran, sulforaphane and resveratrol, wherein the mass ratio of pachymaran, 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 ovary maintenance comprises the following steps:

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

[0025] A2. The Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, flavorings, and edible flavors are mixed in sequence; the mixture is adjusted to volume with the remaining purified water and stirred for 3-5 minutes, and then filtered, filled, sterilized, and packaged to obtain a composition for female ovarian maintenance.

[0026] Beneficial effects of the present invention:

[0027] (1) Fructooligosaccharides (FOS) are added to the coating solution to proliferate intestinal bifidobacteria through its prebiotic properties, enhance intestinal barrier permeability, and lay the foundation for subsequent glycoside absorption. The FOS is fermented and degraded into butyric acid by the bacterial flora to enhance the transmembrane absorption of the active ingredients. At the same time, the bacterial flora is activated to produce more β-glucosidase, which continuously hydrolyzes the macromolecular glycosides of traditional Chinese medicine (such as hydrolyzing Cassia anthraquinone glycosides into chrysophanol, etc.), thereby increasing the absorption rate. FOS is made into an enteric coating with shellac / hydroxypropyl methylcellulose (HPMC), which protects the active ingredients and enzymes of traditional Chinese medicine in the gastric acid environment, ensures colon-targeted release, and improves bioavailability.

[0028] (2) All active ingredients are plant extracts, without the risk of synthetic hormones. Poria polysaccharide inhibits chronic inflammation by regulating the function of macrophages and T cells, reduces the disorder of the immune microenvironment of ovarian tissue, and indirectly protects follicle development; sulforaphane activates antioxidant pathways, enhances cell detoxification ability, inhibits the NF-κB pathway, and can be combined with resveratrol to amplify the anti-inflammatory effect and reduce ovarian inflammatory damage; resveratrol, as a powerful antioxidant, scavenges free radicals, reduces oxidative damage to ovarian granulosa cells, and significantly improves the proliferation ability of damaged cells; sulforaphane, Poria polysaccharide and resveratrol work synergistically to form a multi-dimensional protection mechanism. The immunomodulatory effect of Poria polysaccharide provides a more favorable microenvironment for resveratrol and sulforaphane, while sulforaphane enhances the bioavailability of resveratrol to ensure that it can better exert its anti-inflammatory effect. The combined use of the three can more effectively cope with the complexity of ovarian dysfunction, thereby improving the effect of ovarian maintenance. DETAILED DESCRIPTION

[0029] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0030] Some of the raw materials used in the examples of the present invention and the comparative examples are as follows: Poria 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 Intelligent Manufacturing 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%), the cherry concentrate is Montmorency tart cherry concentrate (Bendley Trading (Qingdao) Co., Ltd., 5 times concentrated, 68° Brix), resistant dextrin (Shaanxi Chenming Biotechnology Co., Ltd., purity>99.9%), pectin (Shandong Pingju Biotechnology Co., Ltd., purity 99%), and the edible flavor is cherry powder flavor (Hebei Jijie Biotechnology Co., Ltd., purity 99%).

[0031] Example 1

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

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

[0034] (1) Weigh 3 parts of wolfberry, 3 parts of cassia seed, 0.2 parts of raspberry, 0.1 parts of jujube kernel and 1.8 parts of lotus seed according to weight, crush to 70 mesh, add water to make pulp (solid-liquid mass ratio is 1:5) to obtain slurry; heat the extraction tank to 90℃, add slurry, extract for 120 minutes (intermittent extraction: stir once every 30 minutes, each time for 5 minutes), filter with 300 mesh filter bag to remove residue and obtain extract, transfer the extract to horizontal centrifuge (2000r / min, 30s) and tubular high-speed centrifuge (10000r / min, 5s) in turn to obtain centrifuge liquid, concentrate through polyamide reverse osmosis membrane (1.5MPa, 40℃) to Brix of 10%, and then enter low-temperature double-effect concentration (first effect: 0.045MPa, 80℃; second effect: 0.075MPa, 55℃) to Brix of 20% to obtain feed 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% volume concentration of glutaraldehyde solution, mix well, and cross-link at 3°C ​​for 3 hours; drop the cross-linked solution into a 1.0% mass concentration of calcium chloride solution and harden at 3°C ​​for 2 hours; filter and rinse with a citric acid-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, 4% oligofructose, 5% hydroxypropyl methylcellulose, and 2% shellac were dissolved in 89% of 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 was 1:3), adsorbed under vacuum conditions for 20 minutes, and the coating solution was added (the mass ratio of the coating solution to the microcapsules was 3:1). The Chinese medicine formula was obtained by fluidized bed coating (inlet air temperature 45°C, atomization pressure 0.3 MPa, flow rate 5 mL / min).

[0037] The active ingredient is a composition of pachymaran, sulforaphane and resveratrol, wherein the mass ratio of pachymaran, 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 ovary maintenance comprises the following steps:

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

[0041] A2. The Chinese herbal formula, material A, active ingredients, resistant dextrin, vitamins, cherry concentrate, and edible flavoring are mixed in sequence; the mixture is adjusted to volume with the remaining purified water and stirred for 3 minutes. The mixture is then filtered, filled, sterilized (105°C, 30 minutes), and packaged to obtain a composition for female ovarian maintenance.

[0042] Example 2

[0043] A composition for female ovarian maintenance comprises the following components, calculated by weight: 20 parts of a traditional Chinese medicine formula, 1 part of an active ingredient, 0.01 parts of vitamins, 11 parts of erythritol, 1 part of sucralose, 8 parts of cherry juice 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 Chinese medicine formula is:

[0045] (1) Weigh 6 parts of wolfberry, 6 parts of cassia seed, 1 part of raspberry, 1 part of jujube kernel and 3 parts of lotus seed according to weight, crush to 70 mesh, add water to make pulp (solid-liquid mass ratio is 1:5) to obtain slurry; heat the extraction tank to 100℃, add slurry, extract for 120min (intermittent extraction: stir once every 30min, each time for 5min), filter with 300-mesh filter bag to remove residue and obtain extract, transfer the extract to horizontal centrifuge (2000r / min, 30s) and tubular high-speed centrifuge (10000r / min, 5s) in turn to obtain centrifuge liquid, concentrate by polyamide reverse osmosis membrane (1.5MPa, 40℃), concentrate to Brix of 10%, and then enter low-temperature double-effect concentration (first effect: 0.045MPa, 80℃; second effect: 0.075MPa, 55℃) to Brix of 20% to obtain feed 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% volume concentration of glutaraldehyde solution, mix well, and cross-link at 5°C for 5 hours; drop the cross-linked solution into a 2.5% mass concentration of calcium chloride solution and harden at 5°C for 5 hours; filter and rinse with a citric acid-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, 6% oligofructose, 15% hydroxypropyl methylcellulose, and 5% shellac were dissolved in 74% of 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 was 1.5:1), adsorbed under vacuum conditions for 40 minutes, and the coating solution was added (the mass ratio of the coating solution to the microcapsules was 3:1). The Chinese medicine formula was obtained by fluidized bed coating (inlet air temperature 45°C, atomization pressure 0.3 MPa, flow rate 5 mL / min).

[0048] The active ingredient is a composition of pachymaran, sulforaphane and resveratrol, wherein the mass ratio of pachymaran, 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 ovary maintenance comprises the following steps:

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

[0052] A2. The Chinese herbal formula, material A, active ingredients, resistant dextrin, vitamins, cherry juice concentrate, and edible flavoring are mixed in sequence; the mixture is adjusted to volume with the remaining purified water and stirred for 5 minutes. The mixture is then filtered, filled, sterilized (105°C, 30 minutes), and packaged to obtain a composition for female ovarian maintenance.

[0053] Example 3

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

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

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

[0057] (2) Take a sodium alginate solution with a mass concentration of 4% and a β-glucosidase solution with an enzyme activity of 450 U / mL, mix them thoroughly, add a glutaraldehyde solution with a volume concentration of 25%, mix them evenly, and cross-link them at 4°C for 4 hours; drop the cross-linked solution into a calcium chloride solution with a mass concentration of 1.75%, and harden it at 4°C for 4 hours; filter it and rinse it with a citric acid-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, 5% oligofructose, 10% hydroxypropyl methylcellulose, and 3% shellac were dissolved in 82% of 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 was 1.25:2), adsorbed under vacuum conditions for 30 minutes, and the coating solution was added (the mass ratio of the coating solution to the microcapsules was 3:1). The Chinese medicine formula was obtained by fluidized bed coating (inlet air temperature 45°C, atomization pressure 0.3 MPa, flow rate 5 mL / min).

[0059] The active ingredient is a composition of pachymaran, sulforaphane and resveratrol, wherein the mass ratio of pachymaran, 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 ovary maintenance comprises the following steps:

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

[0063] A2. The Chinese herbal formula, material A, active ingredients, resistant dextrin, vitamins, cherry juice concentrate, and edible flavoring are mixed in sequence; the mixture is adjusted to volume with the remaining purified water and stirred for 4 minutes. The mixture is then filtered, filled, sterilized (105°C, 30 minutes), and packaged to obtain a composition for female ovarian maintenance.

[0064] Comparative Example 1

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

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

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

[0068] (2) Take a sodium alginate solution with a mass concentration of 4% and a β-glucosidase solution with an enzyme activity of 450 U / mL, mix them thoroughly, add a glutaraldehyde solution with a volume concentration of 25%, mix them evenly, and cross-link them at 4°C for 4 hours; drop the cross-linked solution into a calcium chloride solution with a mass concentration of 1.75%, and harden it at 4°C for 4 hours; filter it and rinse it with a citric acid-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, 5% sucrose, 10% hydroxypropyl methylcellulose, and 3% shellac were dissolved in 82% of 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 was 1.25:2), adsorbed under vacuum conditions for 30 minutes, and the coating solution was added (the mass ratio of the coating solution to the microcapsules was 3:1). The Chinese medicine formula was obtained by fluidized bed coating (inlet air temperature 45°C, atomization pressure 0.3 MPa, flow rate 5 mL / min).

[0070] The active ingredient is a composition of pachymaran, sulforaphane and resveratrol, wherein the mass ratio of pachymaran, 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 ovary maintenance comprises the following steps:

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

[0074] A2. The Chinese herbal formula, material A, active ingredients, resistant dextrin, vitamins, cherry juice concentrate, and edible flavoring are mixed in sequence; the mixture is adjusted to volume with the remaining purified water and stirred for 4 minutes. The mixture is then filtered, filled, sterilized (105°C, 30 minutes), and packaged to obtain a composition for female ovarian maintenance.

[0075] Comparative Example 2

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

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

[0078] (1) Weigh 4.5 parts of wolfberry, 4.5 parts of cassia seed, 0.6 parts of raspberry, 0.55 parts of jujube kernel and 2.4 parts of lotus seed according to weight, crush to 70 mesh, add water to make pulp (solid-liquid mass ratio is 1:5) to obtain slurry; heat the extraction tank to 95℃, add slurry, extract for 120 minutes (intermittent extraction: stir once every 30 minutes, each time for 5 minutes), filter with 300 mesh filter bag to remove residue and obtain extract, transfer the extract to horizontal centrifuge (2000r / min, 30s) and tubular high-speed centrifuge (10000r / min, 5s) in turn to obtain centrifuge liquid, concentrate through polyamide reverse osmosis membrane (1.5MPa, 40℃) to Brix of 10%, and then enter low-temperature double-effect concentration (first effect: 0.045MPa, 80℃; second effect: 0.075MPa, 55℃) to Brix of 20% to obtain feed 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% volume concentration of glutaraldehyde solution, mix well, and cross-link at 4°C for 4 hours; drop the cross-linked solution into a 1.75% mass concentration of calcium chloride solution and harden at 4°C for 4 hours; filter and rinse with a citric acid-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, 5% oligofructose, 10% hydroxypropyl methylcellulose, and 3% shellac were dissolved in 82% of 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 was 1.25:2), adsorbed under vacuum conditions for 30 minutes, and the coating solution was added (the mass ratio of the coating solution to the microcapsules was 3:1). The Chinese medicine formula was obtained by fluidized bed coating (inlet air temperature 45°C, atomization pressure 0.3 MPa, flow rate 5 mL / min).

[0081] The active ingredient is a composition of pachymaran, sulforaphane and resveratrol, wherein the mass ratio of pachymaran, 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 ovary maintenance comprises the following steps:

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

[0085] A2. The Chinese herbal formula, material A, active ingredients, resistant dextrin, vitamins, cherry juice concentrate, and edible flavoring are mixed in sequence; the mixture is adjusted to volume with the remaining purified water and stirred for 4 minutes. The mixture is then filtered, filled, sterilized (105°C, 30 minutes), and packaged to obtain a composition for female ovarian maintenance.

[0086] Comparative Example 3

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

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

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

[0090] (2) Take a sodium alginate solution with a mass concentration of 4% and a β-glucosidase solution with an enzyme activity of 450 U / mL, mix them thoroughly, add a glutaraldehyde solution with a volume concentration of 25%, mix them evenly, and cross-link them at 4°C for 4 hours; drop the cross-linked solution into a calcium chloride solution with a mass concentration of 1.75%, and harden it at 4°C for 4 hours; filter it and rinse it with a citric acid-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, 5% oligofructose, 10% hydroxypropyl methylcellulose, and 3% shellac were dissolved in 82% of 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 was 1.25:2), adsorbed under vacuum conditions for 30 minutes, and the coating solution was added (the mass ratio of the coating solution to the microcapsules was 3:1). The Chinese medicine formula was obtained by fluidized bed coating (inlet air temperature 45°C, atomization pressure 0.3 MPa, flow rate 5 mL / min).

[0092] The active ingredient is 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 ovary maintenance comprises the following steps:

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

[0096] A2. The Chinese herbal formula, material A, active ingredients, resistant dextrin, vitamins, cherry juice concentrate, and edible flavoring are mixed in sequence; the mixture is adjusted to volume with the remaining purified water and stirred for 4 minutes. The mixture is then filtered, filled, sterilized (105°C, 30 minutes), and packaged to obtain a composition for female ovarian maintenance.

[0097] Comparative Example 4

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

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

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

[0101] (2) Take a sodium alginate solution with a mass concentration of 4% and a β-glucosidase solution with an enzyme activity of 450 U / mL, mix them thoroughly, add a glutaraldehyde solution with a volume concentration of 25%, mix them evenly, and cross-link them at 4°C for 4 hours; drop the cross-linked solution into a calcium chloride solution with a mass concentration of 1.75%, and harden it at 4°C for 4 hours; filter it and rinse it with a citric acid-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, 5% oligofructose, 10% hydroxypropyl methylcellulose, and 3% shellac were dissolved in 82% of 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 was 1.25:2), adsorbed under vacuum conditions for 30 minutes, and the coating solution was added (the mass ratio of the coating solution to the microcapsules was 3:1). The Chinese medicine formula was obtained by fluidized bed coating (inlet air temperature 45°C, atomization pressure 0.3 MPa, flow rate 5 mL / min).

[0103] The active ingredient is a composition of pachymaran and resveratrol, wherein the mass ratio of pachymaran 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 ovary maintenance comprises the following steps:

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

[0107] A2. The Chinese herbal formula, material A, active ingredients, resistant dextrin, vitamins, cherry juice concentrate, and edible flavoring are mixed in sequence; the mixture is adjusted to volume with the remaining purified water and stirred for 4 minutes. The mixture is then filtered, filled, sterilized (105°C, 30 minutes), and packaged to obtain a composition for female ovarian maintenance.

[0108] Comparative Example 5

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

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

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

[0112] (2) Take a sodium alginate solution with a mass concentration of 4% and a β-glucosidase solution with an enzyme activity of 450 U / mL, mix them thoroughly, add a glutaraldehyde solution with a volume concentration of 25%, mix them evenly, and cross-link them at 4°C for 4 hours; drop the cross-linked solution into a calcium chloride solution with a mass concentration of 1.75%, and harden it at 4°C for 4 hours; filter it and rinse it with a citric acid-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, 5% oligofructose, 10% hydroxypropyl methylcellulose, and 3% shellac were dissolved in 82% of 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 was 1.25:2), adsorbed under vacuum conditions for 30 minutes, and the coating solution was added (the mass ratio of the coating solution to the microcapsules was 3:1). The Chinese medicine formula was obtained by fluidized bed coating (inlet air temperature 45°C, atomization pressure 0.3 MPa, flow rate 5 mL / min).

[0114] The active ingredient is a combination of pachymaran and sulforaphane, wherein the mass ratio of pachymaran 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 ovary maintenance comprises the following steps:

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

[0118] A2. The Chinese herbal formula, material A, active ingredients, resistant dextrin, vitamins, cherry juice concentrate, and edible flavoring are mixed in sequence; the mixture is adjusted to volume with the remaining purified water and stirred for 4 minutes. The mixture is then filtered, filled, sterilized (105°C, 30 minutes), and packaged to obtain a composition for female ovarian maintenance.

[0119] The following is a further test on the effect of the composition for female ovary maintenance prepared by the present invention, and the test results are described as follows.

[0120] 1. Test subjects:

[0121] Sixty sexually mature female Sprague-Dawley rats (non-pregnant and non-parous), SPF grade, weighing 200-240g, and aged 8-9 weeks, were purchased from Guangzhou Yancheng Biotechnology Co., Ltd. The rats were quarantined for three days prior to the experiment and inspected daily. Unhealthy rats were immediately removed and healthy rats were selected for the experiment. Housing conditions: 5 rats per box, housed at a temperature of 25°C, a relative humidity of 55%, and a 10:14 hour daylight cycle. Food and water were available ad libitum during the housing period.

[0122] 2. Test method:

[0123] 2.1 Grouping, Modeling, and Drug Administration

[0124] After three days of adaptive feeding, 50 rats were randomly divided into a blank group, a model group, and a test group (Example 1-3 and Comparative Examples 1-5), with 5 rats in each group. Except for the blank group, all other groups received a single intramuscular injection of hydrocortisone (32 mg / kg) into the lower limbs daily in the morning for 12 consecutive days to induce a premature ovarian failure (POF) model. After modeling, the blank and model groups were fed purified water, while the Example 1-3 and Comparative Examples 1-5 groups were fed the respective compositions (1 g / kg) once daily in the morning and afternoon for 28 consecutive days.

[0125] 2.2 Detection of serum reproductive hormone levels and organ indices

[0126] 24 hours after the last dose, blood was collected from the abdominal aorta of the rats and centrifuged. Serum was then assayed for E2, FSH, and LH levels using radioimmunoassay according to the respective kit instructions. 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 for wet weight. 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 laparotomized, and a duodenal cannulation was established to establish a circulation circuit. Krebs-Ringer solution (containing phenol red 2 mg / mL) containing rhubarb extract (0.1 mg / mL) was perfused. Samples were collected once every 15 minutes for a total of 2 hours, and the drug concentration (HPLC method) and phenol red concentration (corrected for water absorption) were determined. The absorption rate constant (Ka) was calculated. The colon contents of the rats were collected after sacrifice, and the detection methods were 16S rRNA sequencing: Bifidobacterium / Lactobacillus abundance; GC-MS: short-chain fatty acid (butyrate) concentration.

[0129] 2.4 Statistical methods

[0130] SPSS 21.0 statistical software was used for analysis. Measurement data were expressed as x ± s. If the data conformed to normal grouping or, after transformation, conformed to the test of homogeneity of variance, one-way analysis of variance was used for comparisons between groups. If the data still did not conform to normal distribution and homogeneity of variance after transformation, the rank sum test was used for comparisons between groups. Enumeration data were analyzed using the chi-square test. P < 0.05 indicated statistical significance.

[0131] 3. Results

[0132] 3.1 Serum reproductive hormone levels

[0133] Compared with the blank group, the serum E2 level of rats in the model group decreased, while the FSH and LH levels and the FSH / LH ratio increased (P < 0.05). Compared with the model group, the serum E2 level of rats in each example group and each comparative example group increased, while the FSH and LH levels and the FSH / LH ratio decreased (P < 0.05 or P < 0.01). However, the serum E2 levels of rats in each example group increased more significantly, while the FSH and LH levels and the FSH / LH ratio decreased more significantly (P < 0.05 or P < 0.01) than those in the comparative example groups. The results of the serum reproductive hormone levels of rats in each group are shown in Table 1.

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

[0135] 3.2 Ovarian Index and Uterine Index

[0136] The ovarian and uterine indices of rats in the model group were lower than those in the blank group, with the difference in ovarian index being statistically significant (P < 0.01). The ovarian index of rats in each example group and the comparative example group was higher than that in the model group (P < 0.01); the uterine index was lower than that in the model group, but the difference was not statistically significant (P > 0.05). However, the ovarian index of each example group was higher and the uterine index was lower than that in each comparative example group. The results of the ovarian and uterine indices of rats in each group are shown in Table 2.

[0137] Table 2. Ovarian and uterine index results of rats in each group (unit: mg / 100g)

[0138] 3.3 Absorption rate constant, butyrate concentration, and Bifidobacterium abundance

[0139] The absorption rate constant, butyric acid concentration and bifidobacterium abundance of the rats in the model group were lower than those in the blank group. The absorption rate constant, butyric acid concentration and bifidobacterium abundance of the rats in each experimental group were higher than those in the model group. However, the absorption rate constant, butyric acid concentration and bifidobacterium abundance of each embodiment group in the experimental group were higher than those of each comparative example group. The measurement results are shown in Table 3.

[0140] Table 3. Absorption rate constant, butyrate concentration and Bifidobacterium abundance in rats of each group

[0141] Result Analysis: According to the data analysis of Tables 1, 2, and 3, it can be seen that the FSH / LH ratio was significantly higher in the absence of fructooligosaccharides and β-glucosidase (Comparative Examples 1-2) than in Example 3, confirming that the two synergistically promote the hydrolysis of glycosides and improve the utilization rate of active ingredients in traditional Chinese medicine. The Ka value, colonic butyrate concentration, and bifidobacterium abundance were increased, confirming that fructooligosaccharides promote bacterial metabolism and glycoside conversion, improving absorption rate and bioavailability. The active ingredient was missing (Comparative Examples 3-5). The synergistic effect of sulforaphane, poria polysaccharide, and resveratrol can form a multi-dimensional protective mechanism. The immunomodulatory effect of poria 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 and thereby improve the effect of ovarian maintenance.

[0142] The above content is merely an example and explanation of the concept of the present invention. Those skilled in the art may make various modifications or additions to the described specific embodiments or replace them in a similar manner. As long as they do not deviate from the concept of the invention or exceed the scope defined by the claims, they should all fall within the scope of protection of the present invention.

Claims

1. A composition for female ovarian maintenance, characterized in that: The invention comprises 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, 2-4 parts of resistant dextrin, 0.2-0.3 part of pectin, 0.1-0.2 part of edible flavor and 60-80 parts of purified water.

2. A composition for female ovary maintenance according to claim 1, characterized in that: The preparation method of the Chinese medicine formula is: (1) Weigh wolfberry fruit, cassia seed, raspberry, jujube seed, and lotus seed raw materials by weight, mix the raw materials, and then grind and beat to obtain a slurry; heat the extraction tank to 90-100°C, add the slurry, extract, filter, centrifuge and concentrate to obtain a liquid; (2) Mixing sodium alginate solution and β-glucosidase solution, adding glutaraldehyde solution, mixing well, and cross-linking for 3-5 hours; dropping the cross-linked solution into calcium chloride solution and hardening for 2-5 hours; filtering and washing with citric acid-sodium citrate buffer solution with a pH of 3.4-4.8, and drying to obtain microcapsules; (3) The feed liquid is mixed with the microcapsules, adsorbed under vacuum conditions for 20-40 minutes, and the coating liquid is added. The microcapsules are coated in a fluidized bed to obtain the Chinese medicine formula.

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

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

5. The composition for female ovary maintenance according to claim 2, characterized in that: The mass ratio of the feed liquid to the microcapsules in step (3) is 1-1.5:1-3.

6. The composition for female ovary maintenance according to claim 2, characterized in that: The coating solution in step (3) is obtained by dissolving oligofructose, hydroxypropyl methylcellulose and shellac in a mixed solution of ethanol and water; in terms of weight percentage, oligofructose accounts for 4-6%, hydroxypropyl methylcellulose accounts for 5-15%, shellac accounts for 2-5%, and the remainder is the mixed solution.

7. The composition for female ovary maintenance according to claim 1, characterized in that: The active ingredient is a composition of pachymaran, sulforaphane and resveratrol, wherein the mass ratio of pachymaran, sulforaphane and resveratrol is 2-3:1-3:4-6.

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

9. The composition for female ovary maintenance according to claim 1, characterized in that: The sweeteners are at least two of erythritol, stevia, maltitol and sucralose.

10. The method for preparing the composition for female ovary maintenance according to any one of claims 1 to 9, characterized in that: The following steps are involved: A1. Mix pectin and sweetener, and dissolve in 20-26 parts of purified water to obtain material A. A2. The Chinese medicine formula, material A, active ingredients, resistant dextrin, vitamins, flavorings, and edible flavors are mixed in sequence; the mixture is adjusted to volume with the remaining purified water and stirred for 3-5 minutes, and then filtered, filled, sterilized, and packaged to obtain a composition for female ovarian maintenance.

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