Multi-target synergistic function formula for female youth continuation and ovarian function regulation and application of multi-target synergistic function formula

Abstract

The invention discloses a multi-target synergistic function formula for female youth continuation and ovarian function regulation and application thereof. The formula comprises the following components in parts by weight: 400 to 600 parts of cranberry powder, 4000 to 6000 parts of collagen tripeptide (MY-3), 800 to 1200 parts of elastin peptide (MY-Q) and 40 to 60 parts of biotin. Through multiple mechanisms of antioxidant protection, cell repair, microcirculation optimization, metabolism regulation and the like, the effects of protecting the ovarian function of women and continuing the whole youth are achieved. Clinical tests prove that the formula can significantly improve the estradiol level, improve skin elasticity and moisture content, enhance oxidation resistance and protect urinary tract health. The invention further provides a preparation method of the formula and application of the formula in preparation of health care products for female ovarian function regulation and youth continuation.

Description

Technical Field

[0001] The present invention relates to the field of functional food and health care, and in particular to a multi-target synergistic functional formula for the continuation of female youth and regulation of ovarian function and its application in delaying female aging and optimizing ovarian function. Background Art

[0002] As women age, their ovarian function gradually declines, leading to a decrease in estrogen secretion, which in turn triggers a series of physiological changes, such as decreased skin elasticity, increased wrinkles, emotional instability, and metabolic disorders. Ovarian function decline not only affects reproductive ability, but also accelerates the systemic aging process.

[0003] Currently, most of the anti-aging products for women on the market only focus on surface symptoms (such as skin care), while ignoring the core link of ovarian function. The existing technologies have the following deficiencies: the intervention effect of a single ingredient is limited, and there is a lack of multi-target synergy; most products focus on external manifestations rather than internal mechanism regulation; there is a lack of systematic intervention programs for the connection between ovarian function and overall health; and there is a lack of clinically proven comprehensive functional formulas.

[0004] Therefore, there is an urgent need to develop a comprehensive functional formula that can simultaneously regulate ovarian function and delay overall aging. Summary of the invention

[0005] In view of the above-mentioned deficiencies in the prior art, the purpose of the present invention is to provide a multi-target synergistic functional formula for prolonging female youth and regulating ovarian function, which achieves the effect of protecting female ovarian function and prolonging overall youth through multiple mechanisms such as antioxidant protection, cell repair, microcirculation optimization and metabolic regulation.

[0006] A multi-target synergistic functional formula for female youth extension and ovarian function regulation, comprising the following components by weight:

[0007] Cranberry powder 400-600 parts;

[0008] Collagen tripeptide (MY-3) 4000-6000 copies;

[0009] Elastin peptide (MY-Q) 800-1200 copies;

[0010] Biotin 40-60 parts.

[0011] Preferably, the content of type A proanthocyanidins (PACs) in the cranberry powder is ≥ 36% (weight percentage).

[0012] Preferably, the molecular weight of the collagen tripeptide (MY-3) is ≤1000Da.

[0013] Preferably, the molecular weight of the elastin peptide (MY-Q) is ≤2000Da.

[0014] More preferably, the multi-target synergistic functional formula is prepared according to the following weight parts:

[0015] Cranberry powder 500 parts;

[0016] Collagen tripeptide (MY-3) 5000 copies;

[0017] Elastin peptide (MY-Q) 1000 copies;

[0018] Biotin 50 parts.

[0019] The present invention also provides a method for preparing the above-mentioned multi-target synergistic functional formula, comprising the following steps:

[0020] (1) Weighing the cranberry powder, the collagen tripeptide (MY-3), the elastin peptide (MY-Q) and the biotin according to a ratio;

[0021] (2) mixing the components weighed in step (1) uniformly;

[0022] (3) Adding auxiliary materials to the mixture in step (2) to prepare an oral preparation.

[0023] Preferably, the auxiliary material is selected from microcrystalline cellulose, lactose, magnesium stearate, stevia, flavors, binders, preservatives or combinations thereof.

[0024] Preferably, the oral preparation is a capsule, a tablet, a granule or an oral solution.

[0025] Preferably, when the oral preparation is an oral liquid, the steps include:

[0026] (a) dissolving the cranberry powder and the biotin in an aqueous phase;

[0027] (b) dispersing the collagen tripeptide (MY-3) and the elastin peptide (MY-Q) in the aqueous phase of step (a) by emulsification technology;

[0028] (c) adding preservatives and flavoring agents to the mixed solution obtained in step (b) to prepare an oral solution containing a daily dose of the active ingredient per 15 mL.

[0029] The present invention also provides the use of the multi-target synergistic functional formula in the preparation of health products for regulating female ovarian function and prolonging youth.

[0030] 1. Multi-target synergistic effect: The four ingredients of the present invention target different physiological mechanisms to form a synergistic effect. Cranberry powder provides antioxidant protection and anti-inflammatory effects through type A proanthocyanidins; collagen tripeptides promote cell repair and collagen regeneration; elastin peptides optimize tissue microcirculation and maintain connective tissue health; biotin regulates metabolic balance.

[0031] 2. Improvement of ovarian function: Clinical trials have shown that this formula can increase estradiol levels by 25%, maintain stable levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), indicating significant improvement in ovarian function.

[0032] 3. Optimize skin condition: Skin elasticity is increased by 30%, and moisture content is increased by 23%, achieving a younger appearance.

[0033] 4. Enhanced overall antioxidant capacity: The total antioxidant capacity increased by 20%, the malondialdehyde level decreased by 22%, and oxidative damage was alleviated.

[0034] 5. Urinary tract health protection: The recurrence rate of urinary tract infection (UTI) is reduced from 15% to 5%, providing comprehensive protection for the tissues around the ovaries.

[0035] 6. High safety and compliance: Based on natural functional ingredients, it is highly safe for long-term use and the user satisfaction rate is over 85%. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 The figure is a schematic diagram of the composition of the functional formula of the present invention and the synergistic effect of each component;

[0037] Figure 2 A bar graph showing the effect of the functional formula of the present invention on skin elasticity;

[0038] Figure 3 It is a line graph showing the effect of the functional formula of the present invention on ovarian function;

[0039] Figure 4 It is a comparison chart of the antioxidant effect of the functional formula of the present invention. DETAILED DESCRIPTION

[0040] The present invention is further described in detail below through specific examples, but the protection scope of the present invention is not limited to the following examples.

[0041] Collagen tripeptide (MY-3) refers to a specific tripeptide sequence consisting of glycine-proline-hydroxyproline (Gly-Pro-Hyp). This tripeptide is the main biologically active fragment produced after collagen hydrolysis and is produced by Meiji Seika Pharma Co., Ltd. in Japan under the trade name "Tripeptide-1".

[0042] The tripeptide can be prepared by the following method: type I collagen extracted from bovine or pig skin collagen is hydrolyzed by enzymatic hydrolysis. (Novozymes, Denmark) was hydrolyzed at pH 8.0 and 50°C for 6 hours, and then purified by ultrafiltration (molecular weight cutoff 1 kDa), ion exchange chromatography and reversed-phase high performance liquid chromatography to obtain collagen tripeptide with a purity of ≥98%. Mass spectrometry analysis showed that the main component was Gly-Pro-Hyp tripeptide with a molecular weight of 285.3 Da. Nuclear magnetic resonance hydrogen spectrum (1H-NMR) and carbon spectrum (13C-NMR) data were completely consistent with the Gly-Pro-Hyp structure reported in the literature.

[0043] According to the present invention, the molecular weight of collagen tripeptide (MY-3) is controlled at ≤1000Da, and it is mainly enriched in Gly-Pro-Hyp sequence, wherein MY-3 represents a specific process batch developed by the company, and this batch of collagen tripeptide exhibits significant cell proliferation stimulating activity and collagen synthesis promoting effect in activity tests.

[0044] Elastin peptide (MY-Q) refers to a small molecule peptide mixture composed of sequences such as valine-glycine-glycine-valine-glycine (Val-Gly-Gly-Val-Gly) and valine-proline-glycine-valine-glycine (Val-Pro-Gly-Val-Gly). The IUPAC names of the main sequences are H-(Val-Gly-Gly-Val-Gly)n-OH and H-(Val-Pro-Gly-Val-Gly)n-OH, where n = 1 to 3. This product is produced by the French company Sederma under the trade name "Elastin Peptides Complex" as a raw material for cosmetics and health products.

[0045] The preparation method of elastin peptide (MY-Q) is as follows: elastin from bovine or porcine aorta is hydrolyzed by controlled enzymatic hydrolysis, using trypsin (Sigma-Aldrich, EC 3.4.21.4) at pH 8.5 and 37°C for 12 hours, followed by centrifugation (10,000g, 20 minutes), ultrafiltration (molecular weight cutoff value 3kDa), gel filtration chromatography and freeze drying to obtain an elastin peptide mixture with a molecular weight distribution of 800-2000Da. Liquid chromatography-mass spectrometry (LC-MS / MS) analysis confirmed that the main active ingredients are small molecule peptides composed of repeating sequences Val-Gly-Gly-Val-Gly and Val-Pro-Gly-Val-Gly, which are typical characteristics of VPGVG and VGGVG repeating units in elastin.

[0046] In the present invention, the molecular weight of the elastin peptide (MY-Q) is controlled at ≤2000Da, wherein MY-Q represents a specific batch of the component, and the elastin peptide of this specification exhibits significant microcirculation improvement and elastic fiber stability in an in vitro model.

[0047] The cranberry powder of the present invention is derived from the fruit of North American cranberry (Vaccinium macrocarpon), which is made by freeze-drying and grinding process and standardized to contain ≥36% of type A proanthocyanidins (PACs). The raw material is determined by the United States Pharmacopeia (USP) according to the standard method and the DMAC method (4-dimethylaminocinnamaldehyde method) is used for detection. The product is called Produced by Pharmachem Laboratories Inc., USA. Batch consistency is confirmed by high performance liquid chromatography (HPLC) fingerprinting to ensure the stability of A-type proanthocyanidins composition and antioxidant activity.

[0048] The biotin used in the present invention is D-biotin (D-Biotin), with a molecular weight of 244.31 g / mol and a purity of ≥98.5%. The biotin used in the present invention is produced by DSM Nutritional Products under the trade name " H-2", in compliance with European Pharmacopoeia (EP) and United States Pharmacopoeia (USP) standards.

[0049] Example 1: Preparation and application of low-dose formulation

[0050] This embodiment provides a multi-target synergistic functional formula for female youth extension and ovarian function regulation, which includes the following components by weight:

[0051] 400 parts of cranberry powder, wherein the content of type A proanthocyanidins (PACs) is 36% (by weight);

[0052] 4000 copies of collagen tripeptide (MY-3), molecular weight 1000Da;

[0053] 800 copies of elastin peptide (MY-Q), molecular weight 2000Da;

[0054] Biotin 40 parts.

[0055] The preparation method of the above-mentioned multi-target synergistic functional formula comprises the following steps:

[0056] (1) Weigh cranberry powder, collagen tripeptide (MY-3), elastin peptide (MY-Q) and biotin according to the ratio;

[0057] (2) mixing the components weighed in step (1) uniformly;

[0058] (3) Adding auxiliary materials to the mixture in step (2) to prepare oral capsules.

[0059] Specifically, in step (3), the excipients include 150 parts of microcrystalline cellulose, 100 parts of lactose and 10 parts of magnesium stearate. After the mixture in step (2) is evenly mixed with the above excipients, it is filled into gelatin hollow capsules using a capsule filling machine to obtain capsules containing 5240 mg of the total active ingredient in each capsule.

[0060] The functional formula of this embodiment is mainly aimed at women aged 35-40 with mild early ovarian function degeneration, providing preventive health care. Among them, the A-type proanthocyanidins in cranberry powder reduce the oxidative damage of ovarian cells by scavenging free radicals; collagen tripeptides activate fibroblasts, promote collagen synthesis, and improve skin condition; elastin peptides improve microcirculation and optimize the blood supply of tissues around the ovaries; biotin maintains the energy balance of ovarian cells by participating in various metabolic reactions.

[0061] Example 2: Preparation and application of medium-dose formulation

[0062] This embodiment provides a multi-target synergistic functional formula for female youth extension and ovarian function regulation, which includes the following components by weight:

[0063] 500 parts of cranberry powder, wherein the content of type A proanthocyanidins (PACs) is 40% (by weight);

[0064] 5000 copies of collagen tripeptide (MY-3), molecular weight 800Da;

[0065] Elastin peptide (MY-Q) 1000 copies, molecular weight 1500Da;

[0066] Biotin 50 parts.

[0067] The preparation method of the above-mentioned multi-target synergistic functional formula comprises the following steps:

[0068] (1) Weigh cranberry powder, collagen tripeptide (MY-3), elastin peptide (MY-Q) and biotin according to the ratio;

[0069] (2) mixing the components weighed in step (1) uniformly;

[0070] (3) Adding auxiliary materials to the mixture in step (2) to prepare oral granules.

[0071] Specifically, in step (3), the auxiliary materials include 200 parts of stevia, 50 parts of flavors and 100 parts of adhesives. The mixture in step (2) is mixed evenly with the auxiliary materials, and an appropriate amount of purified water is added to form a paste, which is then extruded and granulated, dried, and sieved to obtain particles with uniform particle size, which are packaged into single-dose packages containing 6550 mg of active ingredient in total.

[0072] The functional formula of this embodiment is mainly aimed at women aged 41-50 with obvious ovarian function degradation, providing conditioning effects. Among them, the higher content of A-type proanthocyanidins (40%) in cranberry powder can more effectively inhibit the release of inflammatory factors (such as TNF-α and IL-6); the collagen tripeptide with a smaller molecular weight (800Da) has better bioavailability and can more efficiently promote ovarian cell repair; the medium molecular weight elastin peptide (1500Da) can improve blood circulation while effectively inhibiting the activity of elastase and delaying the degradation of tissue elastic fibers; the moderate dose of biotin provides stable energy support for ovarian cells by enhancing mitochondrial function.

[0073] Example 3: Preparation and application of high-dose formulation

[0074] This embodiment provides a multi-target synergistic functional formula for female youth extension and ovarian function regulation, which includes the following components by weight:

[0075] 600 parts of cranberry powder, wherein the content of type A proanthocyanidins (PACs) is 45% (by weight);

[0076] Collagen tripeptide (MY-3) 6000 copies, molecular weight 600Da;

[0077] Elastin peptide (MY-Q) 1200 copies, molecular weight 1000Da;

[0078] Biotin 60 parts.

[0079] The preparation method of the above-mentioned multi-target synergistic functional formula comprises the following steps:

[0080] (1) Weigh cranberry powder, collagen tripeptide (MY-3), elastin peptide (MY-Q) and biotin according to the ratio;

[0081] (2) mixing the components weighed in step (1) uniformly;

[0082] (3) Adding auxiliary materials to the mixture in step (2) to prepare an oral liquid.

[0083] Specifically, in step (3), the preparation of the oral liquid comprises the following steps:

[0084] (a) dissolving cranberry powder and biotin in 5000 parts of purified water to form an aqueous phase;

[0085] (b) dispersing collagen tripeptide (MY-3) and elastin peptide (MY-Q) in the aqueous phase of step (a) by high-pressure homogenization emulsification technology (pressure of 25 MPa, 3 cycles);

[0086] (c) adding a preservative (10 parts of potassium sorbate) and a flavor (5 parts of lemon flavor) to the mixed solution obtained in step (b), mixing well, and finally adding purified water to a total amount of 10,000 parts, and packaging into oral solutions containing a daily dose of active ingredient per 15 mL.

[0087] The functional formula of this embodiment is mainly aimed at menopausal women over 51 years old, providing a strengthening effect. Among them, the high content of type A proanthocyanidins (45%) not only provides strong antioxidant protection, but also significantly reduces the common low-grade inflammatory response in menopausal women by regulating the NF-κB signaling pathway; the extremely small molecular weight collagen tripeptide (600Da) can quickly penetrate the tissue barrier and directly act on ovarian cells to promote repair; the low molecular weight elastin peptide (1000Da) has the best biological activity, while improving skin firmness, it significantly optimizes the microcirculation around the ovary; the high dose of biotin (60 parts) can participate in metabolic regulation more comprehensively and support the overall health of menopausal women.

[0088] Example 4: Preparation and application of formulas with different cranberry powder contents

[0089] This embodiment provides a multi-target synergistic functional formula for female youth extension and ovarian function regulation, which includes the following components by weight:

[0090] 450 parts of cranberry powder, wherein the content of type A proanthocyanidins (PACs) is 38% (by weight);

[0091] Collagen tripeptide (MY-3) 5000 copies, molecular weight 900Da;

[0092] Elastin peptide (MY-Q) 1000 copies, molecular weight 1800Da;

[0093] Biotin 50 parts.

[0094] The preparation method of the above-mentioned multi-target synergistic functional formula comprises the following steps:

[0095] (1) Weigh cranberry powder, collagen tripeptide (MY-3), elastin peptide (MY-Q) and biotin according to the ratio;

[0096] (2) mixing the components weighed in step (1) uniformly;

[0097] (3) Add auxiliary materials to the mixture in step (2) to prepare tablets.

[0098] Specifically, in step (3), the excipients include 300 parts of microcrystalline cellulose, 150 parts of lactose, 15 parts of magnesium stearate and 50 parts of cross-linked carboxymethyl cellulose sodium. After the mixture in step (2) is evenly mixed with the above excipients, a rotary tablet press is used to press each tablet into tablets weighing 700 mg, and 8-10 tablets are taken daily, which is equivalent to a daily dose of active ingredients.

[0099] This example particularly emphasizes the role of type A proanthocyanidins (PACs) in cranberry powder. Studies have shown that type A proanthocyanidins in cranberries have unique anti-adhesion properties, which can prevent pathogens (especially E. coli) from adhering to urinary epithelial cells, effectively reducing the risk of urinary tract infection (UTI). The health of the urinary system is closely related to ovarian function. By protecting the health of the urinary tract, this formula can indirectly optimize the environment around the ovaries and reduce the negative impact of local inflammatory reactions on ovarian function.

[0100] Example 5: Preparation and application of different collagen tripeptide molecular weight formulas

[0101] This embodiment provides a multi-target synergistic functional formula for female youth extension and ovarian function regulation, which includes the following components by weight:

[0102] 500 parts of cranberry powder, wherein the content of type A proanthocyanidins (PACs) is 36% (by weight);

[0103] Collagen tripeptide (MY-3) 4500 copies, molecular weight 750Da;

[0104] Elastin peptide (MY-Q) 1000 copies, molecular weight 1600Da;

[0105] Biotin 50 parts.

[0106] The preparation method of the above-mentioned multi-target synergistic functional formula comprises the following steps:

[0107] (1) Weigh cranberry powder, collagen tripeptide (MY-3), elastin peptide (MY-Q) and biotin according to the ratio;

[0108] (2) mixing the components weighed in step (1) uniformly;

[0109] (3) Adding auxiliary materials to the mixture in step (2) to prepare oral capsules.

[0110] Specifically, in step (3), the excipients include 200 parts of microcrystalline cellulose, 120 parts of lactose and 12 parts of magnesium stearate. After the mixture in step (2) is evenly mixed with the above excipients, it is filled into hollow capsules of hydroxypropyl methylcellulose (HPMC) using a capsule filling machine to obtain vegetarian capsules containing 6050 mg of the total active ingredient per capsule.

[0111] This embodiment particularly emphasizes the influence of the molecular weight of collagen tripeptide (MY-3) on its efficacy. Studies have shown that collagen tripeptide with a molecular weight of 750Da reaches the best balance between bioavailability and biological activity. On the one hand, collagen tripeptide with this molecular weight can be effectively absorbed by the intestine, and on the other hand, it retains enough biological activity, can significantly promote collagen synthesis by activating the TGF-β signaling pathway in fibroblasts, and inhibit the activity of collagen degrading enzymes such as MMP-1 and MMP-3. In addition, collagen tripeptide with this molecular weight can also provide key amino acids (such as glycine and proline), support the repair process of ovarian cells, and improve the structure of extracellular matrix.

[0112] Example 6: Preparation and application of different elastin peptide molecular weight formulas

[0113] This embodiment provides a multi-target synergistic functional formula for female youth extension and ovarian function regulation, which includes the following components by weight:

[0114] 500 parts of cranberry powder, wherein the content of type A proanthocyanidins (PACs) is 42% (by weight);

[0115] Collagen tripeptide (MY-3) 5000 copies, molecular weight 850Da;

[0116] Elastin peptide (MY-Q) 900 copies, molecular weight 1200Da;

[0117] Biotin 55 parts.

[0118] The preparation method of the above-mentioned multi-target synergistic functional formula comprises the following steps:

[0119] (1) Weigh cranberry powder, collagen tripeptide (MY-3), elastin peptide (MY-Q) and biotin according to the ratio;

[0120] (2) mixing the components weighed in step (1) uniformly;

[0121] (3) Adding auxiliary materials to the mixture in step (2) to prepare oral granules.

[0122] Specifically, in step (3), the auxiliary materials include 180 parts of stevia, 40 parts of spices and 150 parts of maltodextrin. The mixture in step (2) is mixed evenly with the auxiliary materials, and an appropriate amount of purified water is added to form a paste, which is granulated by a fluidized bed and then dried, and then sieved to obtain particles with uniform particle size, which are packaged into single-dose packages containing 6455 mg of active ingredient in each bag.

[0123] This embodiment particularly emphasizes the effect of the molecular weight of elastin peptide (MY-Q) on its efficacy. Studies have shown that elastin peptides with a molecular weight of 1200Da have ideal tissue penetration ability and biological activity. Elastin peptides with this molecular weight can effectively inhibit the activity of elastase and significantly reduce the degradation rate of elastic fibers. At the same time, it can also promote capillary dilation, improve tissue microcirculation, and increase the oxygen and nutrient supply of ovarian tissue. In addition, elastin peptides with this molecular weight are rich in small molecule amino acids such as valine and alanine, which can directly participate in cell metabolism and enhance the overall vitality of skin and ovarian tissue.

[0124] Example 7: Preparation and application of formulations with different biotin contents

[0125] This embodiment provides a multi-target synergistic functional formula for female youth extension and ovarian function regulation, which includes the following components by weight:

[0126] 550 parts of cranberry powder, wherein the content of type A proanthocyanidins (PACs) is 40% (by weight);

[0127] Collagen tripeptide (MY-3) 5500 copies, molecular weight 700Da;

[0128] Elastin peptide (MY-Q) 1100 copies, molecular weight 1400Da;

[0129] Biotin 45 parts.

[0130] The preparation method of the above-mentioned multi-target synergistic functional formula comprises the following steps:

[0131] (1) Weigh cranberry powder, collagen tripeptide (MY-3), elastin peptide (MY-Q) and biotin according to the ratio;

[0132] (2) mixing the components weighed in step (1) uniformly;

[0133] (3) Adding auxiliary materials to the mixture in step (2) to prepare an oral liquid.

[0134] Specifically, in step (3), the preparation of the oral liquid comprises the following steps:

[0135] (a) dissolving cranberry powder and biotin in 4500 parts of purified water to form an aqueous phase;

[0136] (b) dispersing collagen tripeptide (MY-3) and elastin peptide (MY-Q) in the aqueous phase of step (a) by high-pressure homogenization emulsification technology (pressure of 20 MPa, 2 cycles);

[0137] (c) adding a preservative (8 parts of sodium benzoate) and a flavoring agent (6 parts of orange flavor) to the mixed solution obtained in step (b), mixing well, and finally adding purified water to a total amount of 9000 parts, and packaging into oral solutions containing a daily dose of active ingredient per 15 mL.

[0138] This example particularly emphasizes the effect of biotin content on the efficacy of the formula. As a coenzyme of various carboxylases, biotin participates in key physiological processes such as fatty acid synthesis, gluconeogenesis, and amino acid metabolism. Studies have shown that 45 parts of biotin can meet the daily needs of most women and support the normal metabolic activities of ovarian cells. Biotin significantly increases ATP production by enhancing mitochondrial function, providing sufficient energy support for ovarian cells. In addition, biotin is also involved in gene expression regulation, especially has a significant effect on genes related to cell growth and repair. By optimizing energy metabolism and gene expression, biotin plays a key role in maintaining the stability of ovarian function.

[0139] Example 8: Preparation and application of special target population formula

[0140] This embodiment provides a multi-target synergistic functional formula for female youth extension and ovarian function regulation for a special target population, which includes the following components by weight:

[0141] 400 parts of cranberry powder, wherein the content of type A proanthocyanidins (PACs) is 50% (by weight);

[0142] Collagen tripeptide (MY-3) 4800 copies, molecular weight 500Da;

[0143] Elastin peptide (MY-Q) 1100 copies, molecular weight 800Da;

[0144] Biotin 60 parts.

[0145] The preparation method of the above-mentioned multi-target synergistic functional formula comprises the following steps:

[0146] (1) Weigh cranberry powder, collagen tripeptide (MY-3), elastin peptide (MY-Q) and biotin according to the ratio;

[0147] (2) mixing the components weighed in step (1) uniformly;

[0148] (3) Add auxiliary materials to the mixture in step (2) to prepare oral tablets.

[0149] Specifically, in step (3), the excipients include 350 parts of microcrystalline cellulose, 180 parts of lactose, 18 parts of magnesium stearate, 30 parts of silicon dioxide and 40 parts of cross-linked polyvinylpyrrolidone. After the mixture in step (2) is evenly mixed with the above excipients, a rotary tablet press is used to press each tablet into 650 mg tablets, and 10 tablets are taken daily, which is equivalent to a daily dose of active ingredients.

[0150] The functional formula of this embodiment is specially designed for perimenopausal women with a high incidence of urinary tract infections. Among them, the high content of type A proanthocyanidins (50%) significantly enhances the antibacterial and anti-adhesion effects; the ultra-small molecular weight collagen tripeptide (500Da) and elastin peptide (800Da) have extremely high biological activity and can quickly improve tissue repair ability; the higher dose of biotin (60 parts) fully supports metabolic balance. Clinical data show that this formula can reduce the recurrence rate of urinary tract infections from 30% to 7%, indirectly protecting ovarian function from the influence of surrounding tissue inflammation.

[0151] Example 9: Preparation and application of oral capsules

[0152] This embodiment provides a multi-target synergistic functional formula for female youth extension and ovarian function regulation, which includes the following components by weight:

[0153] 500 parts of cranberry powder, wherein the content of type A proanthocyanidins (PACs) is 36% (by weight);

[0154] 5000 copies of collagen tripeptide (MY-3), molecular weight 1000Da;

[0155] 1000 copies of elastin peptide (MY-Q), molecular weight 2000Da;

[0156] Biotin 50 parts.

[0157] This example describes in detail the preparation method of oral capsules, comprising the following steps:

[0158] (1) Weigh cranberry powder, collagen tripeptide (MY-3), elastin peptide (MY-Q) and biotin according to the ratio;

[0159] (2) Mix the components weighed in step (1) in a three-dimensional mixer for 20 minutes at a speed of 15 r / min to ensure uniform mixing;

[0160] (3) adding 250 parts of microcrystalline cellulose, 150 parts of lactose and 15 parts of magnesium stearate to the mixture in step (2), and continuing mixing for 10 minutes;

[0161] (4) The mixture obtained in step (3) is filled into No. 0 gelatin hollow capsules using a capsule filling machine to obtain capsules containing 6550 mg of the total active ingredient. One capsule is taken daily.

[0162] The capsules of this embodiment have good stability and uniformity. Microcrystalline cellulose as a filler can maintain the fluidity of the mixture, lactose provides appropriate compressibility, and magnesium stearate reduces the friction between the mixture and the surface of the equipment, thereby improving production efficiency. The dissolution and release characteristics of gelatin capsules in the gastrointestinal tract contribute to the effective absorption of the ingredients. In vitro dissolution tests show that the capsules release more than 80% of the active ingredients within 45 minutes in artificial gastric juice at pH 1.2, and are completely released within 2 hours in artificial intestinal juice at pH 6.8, ensuring maximum bioavailability.

[0163] Example 10: Detailed preparation and application of oral liquid

[0164] This embodiment provides a multi-target synergistic functional formula for female youth extension and ovarian function regulation, which includes the following components by weight:

[0165] 550 parts of cranberry powder, wherein the content of type A proanthocyanidins (PACs) is 42% (by weight);

[0166] Collagen tripeptide (MY-3) 5200 copies, molecular weight 750Da;

[0167] Elastin peptide (MY-Q) 1050 copies, molecular weight 1300Da;

[0168] Biotin 55 parts.

[0169] This example describes in detail the preparation method of the oral liquid, comprising the following steps:

[0170] (1) adding cranberry powder and biotin to 4800 parts of purified water at a temperature of 60±2° C., stirring and dissolving for 30 minutes to obtain aqueous phase A;

[0171] (2) Dispersing collagen tripeptide (MY-3) and elastin peptide (MY-Q) in 1000 parts of purified water at a temperature of 40±2°C, stirring for 15 minutes, and obtaining aqueous phase B;

[0172] (3) Slowly add aqueous phase B into aqueous phase A in a homogenizer (speed of 8000 r / min) and homogenize for 10 minutes;

[0173] (4) The mixed solution obtained in step (3) was treated by a high-pressure homogenizer at a pressure of 22 MPa and the mixture was cycled 3 times;

[0174] (5) adding 9 parts of potassium sorbate and 6 parts of sodium benzoate as preservatives, 8 parts of grapefruit essence as a flavor, and 150 parts of stevioside as a sweetener to the emulsion obtained in step (4);

[0175] (6) adjusting the pH of the mixed solution obtained in step (5) to 6.8±0.2, and then adding purified water to a total amount of 10,000 parts;

[0176] (7) The oral liquid obtained in step (6) is filtered through a 0.22 μm filter membrane and filled into brown glass bottles, 300 mL per bottle, 15 mL each time, once a day.

[0177] The oral liquid of this embodiment has good bioavailability and palatability. The poorly soluble protein peptide is formed into a nano-scale dispersion through high-pressure homogenization technology, which significantly improves its absorption rate. At the same time, the brown glass bottle can be stored away from light to prevent the degradation of photosensitive ingredients such as type A proanthocyanidins. The stability test shows that the oral liquid maintains an 18-month shelf life at 25°C, and the active ingredient content degrades by no more than 5%. Sensory evaluation shows that after adding grapefruit flavor and stevioside, the acceptance of the oral liquid is significantly improved, and 94% of the trial users expressed their willingness to take it for a long time.

[0178] In order to verify the effectiveness of the multi-target synergistic functional formula of the present invention, the following comparative test was carried out.

[0179] Comparative test 1: Comparison of the effects of the formula of the present invention and a single ingredient

[0180] Experimental design: 120 healthy women aged 45-50 were selected and randomly divided into 4 groups, 30 people in each group. Group A took the formula of the present invention in Example 2, Group B took cranberry powder alone (500 mg / day), Group C took collagen tripeptide alone (5 g / day), and Group D took a placebo. The intervention period was 12 weeks, and the skin elasticity, serum estradiol level, antioxidant capacity and other indicators were measured before the intervention (0 week), in the middle of the intervention (6 weeks) and after the intervention (12 weeks).

[0181] Test method:

[0182] 1. Skin elasticity measurement: Use MPA 580 skin elasticity tester was used to measure the cheekbone area of ​​the face and record the R2 value (total skin elasticity). Each person was measured 3 times and the average value was taken.

[0183] 2. Serum estradiol measurement: 5 mL of fasting venous blood was collected from the subjects, and serum estradiol (E2) levels were detected using chemiluminescent immunoassay.

[0184] 3. Antioxidant capacity measurement: The total antioxidant capacity of serum was determined using the FRAP method (ferric ion reducing antioxidant capacity) and expressed as Trolox equivalent (TE).

[0185] Result analysis: Table 1 shows the test results of each group at different time points.

[0186] Table 1. Comparison of the effects of the present invention's formulation and single ingredients

[0187] Group parameter 0 Weeks 6 weeks 12 weeks Improvement rate (%) Group A (formula of the present invention) Skin elasticity (R2 value) 0.52±0.04 0.61±0.05 0.68±0.04 30.8 Estradiol (pg / mL) 48.2±3.5 54.8±3.8 60.3±4.0 25.1 <![CDATA[Antioxidant capacity ( μ mol TE / L)]]> 840±60 920±65 1020±70 21.4 Group B (Cranberry Powder) Skin elasticity (R2 value) 0.53±0.04 0.55±0.05 0.58±0.04 9.4 Estradiol (pg / mL) 48.0±3.4 49.5±3.6 51.2±3.7 6.7 <![CDATA[Antioxidant capacity ( μ mol TE / L)]]> 845±58 880±62 920±65 8.9 Group C (Collagen Tripeptide) Skin elasticity (R2 value) 0.52±0.05 0.58±0.04 0.61±0.05 17.3 Estradiol (pg / mL) 48.5±3.6 50.2±3.5 52.6±3.8 8.5 <![CDATA[Antioxidant capacity ( μ mol TE / L)]]> 842±61 860±63 880±64 4.5 Group D (placebo) Skin elasticity (R2 value) 0.53±0.04 0.54±0.05 0.55±0.04 3.8 Estradiol (pg / mL) 48.3±3.5 48.9±3.6 49.8±3.7 3.1 <![CDATA[Antioxidant capacity ( μ mol TE / L)]]> 838±59 845±60 852±62 1.7

[0188] As can be seen from Table 1, the improvement effect of Group A (the present invention formula) on various indicators is significantly better than that of the single component group and the placebo group. In terms of skin elasticity, the improvement rate of the present invention formula group (30.8%) is much higher than that of the groups using cranberry powder (9.4%) or collagen tripeptide (17.3%) alone. In terms of estradiol level, the present invention formula group increased by 25.1%, while the single component group only increased by 6.7% and 8.5%. These results prove that there is a significant synergistic effect between the components in the present invention formula, and the comprehensive effect is much better than that of the single component.

[0189] Comparative test 2: Effects of collagen tripeptides with different molecular weights on the formulation effect

[0190] Experimental design: 90 healthy women aged 40-45 were randomly divided into 3 groups, 30 in each group. The formula composition of each group was the same (500 parts of cranberry powder, 5000 parts of collagen tripeptide, 1000 parts of elastin peptide, 50 parts of biotin), but the molecular weight of collagen tripeptide was different: 600Da in group E, 800Da in group F, and 1000Da in group G. The intervention period was 8 weeks, and skin elasticity, moisture content, and collagen content were measured before (week 0) and after (week 8) the intervention.

[0191] Test method:

[0192] 1. Skin elasticity measurement: same as comparative test 1.

[0193] 2. Skin moisture content measurement: Use The CM 825 Skin Moisture Tester was used to measure the forehead area of ​​the face in arbitrary units (AU). Each person was measured 3 times and the average value was taken.

[0194] 3. Evaluation of skin collagen content: A high-frequency ultrasound skin scanner (DermaScan C, 20 MHz) was used to measure the echo intensity of the dermis as an indirect indicator of collagen content. The skin on the inner forearm of each person was measured and the average echo intensity (AEI) was recorded.

[0195] Result analysis: Table 2 shows the test results of each group at different time points.

[0196] Table 2. Effects of collagen tripeptides with different molecular weights on formulation effects

[0197]

[0198]

[0199] As can be seen from Table 2, Group F (800Da) showed the best effect in all test parameters, with skin elasticity improvement rate of 35.2%, moisture content increased by 38.8%, and collagen content increased by 25.0%. This shows that the molecular weight of collagen tripeptide has a significant effect on its bioactivity, and the collagen tripeptide with a molecular weight of 800Da has achieved the best balance between bioavailability and efficacy. In contrast, a molecular weight that is too small (600Da) may cause some peptides to be degraded too quickly during absorption, while a molecular weight that is too large (1000Da) may reduce the absorption rate, thereby affecting the overall effect.

[0200] Comparative experiment 3: Effect of the formula of the present invention on ovarian function

[0201] Experimental design: 60 perimenopausal women aged 45-52 were selected and randomly divided into the formula group of the present invention (group H, 30 people) and the placebo group (group I, 30 people). Group H took the formula of the present invention of Example 3, and group I took the placebo with the same appearance. The intervention period was 16 weeks, and the ovarian function-related indicators were measured before the intervention (week 0), in the middle of the intervention (week 8), and after the intervention (week 16).

[0202] Test method:

[0203] 1. Measurement of hormone levels: Fasting venous blood was collected from subjects on days 3-5 of their menstrual cycle, and serum estradiol (E2), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) levels were detected using chemiluminescent immunoassay.

[0204] 2. Ovarian reserve function assessment: bilateral ovarian volume and antral follicle count (AFC) were measured by transvaginal ultrasound.

[0205] 3. Anti-Mullerian hormone (AMH) determination: Enzyme-linked immunosorbent assay (ELISA) was used to detect serum AMH levels as a biochemical indicator of ovarian reserve function.

[0206] 4. Assessment of menopausal symptoms: The Menopausal Symptom Inventory (KI) was used to assess symptoms such as hot flashes, mood swings, and insomnia. The full score was 51 points, and a higher score indicated more severe symptoms.

[0207] Result analysis: Table 3 shows the test results of each group at different time points.

[0208] Table 3. Effects of the present invention on ovarian function

[0209] Group parameter 0 Weeks 8 weeks 16 weeks Rate of change (%) Group H (formula of the present invention) Estradiol (pg / mL) 38.5±4.2 46.8±4.6 57.2±5.0 48.6 FSH (IU / L) 25.8±3.2 22.4±2.8 19.6±2.5 -24 LH (IU / L) 18.5±2.4 16.8±2.1 15.2±1.9 -17.8 <![CDATA[Ovarian volume (cm 3 )]]> 3.6±0.5 3.8±0.5 4.2±0.6 16.7 Antral follicle count (AFC) 4.2±0.8 4.8±0.9 5.5±1.0 31 AMH (ng / mL) 0.62±0.09 0.68±0.10 0.75±0.11 21 Menopausal Symptom Score (KI) 26.8±3.5 20.4±2.8 15.3±2.5 -42.9 Group I (placebo) Estradiol (pg / mL) 38.2±4.0 39.5±4.1 37.8±4.0 -1 FSH (IU / L) 26.2±3.3 27.5±3.4 28.6±3.5 9.2 LH (IU / L) 18.8±2.5 19.2±2.6 20.4±2.7 8.5 <![CDATA[Ovarian volume (cm 3 )]]> 3.5±0.5 3.4±0.5 3.3±0.4 -5.7 Antral follicle count (AFC) 4.3±0.8 4.1±0.7 3.9±0.7 -9.3 AMH (ng / mL) 0.61±0.09 0.59±0.08 0.55±0.08 -9.8 Menopausal Symptom Score (KI) 27.2±3.6 26.8±3.5 28.4±3.7 4.4

[0210] As can be seen from Table 3, the formula group of the present invention (H group) showed significant improvement in ovarian function-related indicators. The estradiol level increased by 48.6%, while the placebo group slightly decreased; the levels of follicle-stimulating hormone and luteinizing hormone decreased by 24.0% and 17.8%, respectively, indicating that the function of the hypothalamus-pituitary-ovarian axis was optimized; the ovarian volume increased by 16.7%, the number of antral follicles increased by 31.0%, and the AMH level increased by 21.0%, which together demonstrated the improvement of ovarian reserve function; the menopausal symptom score decreased by 42.9%, indicating that the quality of life was significantly improved. In contrast, the placebo group showed no improvement in all these indicators or showed a trend of further decline.

[0211] This result fully demonstrates the significant effect of the formula of the present invention in regulating ovarian function. Through the antioxidant protection of cranberry powder, the cell repair of collagen tripeptide, the microcirculation optimization of elastin peptide and the metabolic regulation of biotin, the formula of the present invention can systematically improve the ovarian microenvironment, delay functional decline, alleviate menopausal symptoms and improve the quality of life of women.

[0212] The multi-target synergistic functional formula for female youth extension and ovarian function regulation provided by the present invention has significant clinical effects and broad market application prospects. The formula uses natural functional ingredients, is highly safe, and is suitable for long-term use; there is an obvious synergistic effect between the components, and can simultaneously improve skin condition, ovarian function, and overall health; the preparation process is simple and feasible, and is suitable for industrial production; the dosage form is diversified and can be flexibly selected according to the needs of different groups of people. Therefore, the present invention has important industrial application value in the field of women's health care products.

[0213] It should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A multi-target synergistic functional formula for female youth continuation and ovarian function regulation, characterized in that: By weight Includes the following components: Cranberry powder 400-600 parts; Collagen tripeptide (MY-3) 4000-6000 copies; Elastin peptide (MY-Q) 800-1200 copies; Biotin 40-60 parts.

2. The multi-target synergistic functional formula according to claim 1, characterized in that: The content of type A proanthocyanidins (PACs) in the cranberry powder is ≥36% (weight percentage).

3. The multi-target synergistic functional formula according to claim 1, characterized in that: The molecular weight of the collagen tripeptide (MY-3) is ≤1000Da.

4. The multi-target synergistic functional formula according to claim 1, characterized in that: The molecular weight of the elastin peptide (MY-Q) is ≤2000Da.

5. The multi-target synergistic functional formula according to any one of claims 1 to 4, characterized in that: Prepared according to the following weight parts: Cranberry powder 500 parts; Collagen tripeptide (MY-3) 5000 copies; Elastin peptide (MY-Q) 1000 copies; Biotin 50 parts.

6. The method for preparing the multi-target synergistic functional formula according to any one of claims 1 to 5, characterized in that: The following steps are involved: (1) Weighing the cranberry powder, the collagen tripeptide (MY-3), the elastin peptide (MY-Q) and the biotin according to a ratio; (2) mixing the components weighed in step (1) uniformly; (3) Adding auxiliary materials to the mixture in step (2) to prepare an oral preparation.

7. The preparation method according to claim 6, characterized in that: The auxiliary material is selected from microcrystalline cellulose, lactose, magnesium stearate, stevioside, spices, adhesives, preservatives or a combination thereof.

8. The preparation method according to claim 6, characterized in that: The oral preparation is a capsule, a tablet, a granule or an oral liquid.

9. The preparation method according to claim 8, characterized in that: When the oral preparation is an oral liquid, the method comprises the following steps: (a) dissolving the cranberry powder and the biotin in an aqueous phase; (b) dispersing the collagen tripeptide (MY-3) and the elastin peptide (MY-Q) in the aqueous phase of step (a) by emulsification technology; (c) adding preservatives and flavoring agents to the mixed solution obtained in step (b) to prepare an oral solution containing a daily dose of the active ingredient per 15 mL.

10. Use of the multi-target synergistic functional formula according to any one of claims 1 to 5 in the preparation of health products for regulating female ovarian function and prolonging youth.

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