Male reproductive health compound formula health care product containing egg membrane peptide and preparation method of male reproductive health compound formula health care product

Abstract

The invention relates to the technical field of health-care food, and discloses a male reproductive health complex formula health-care product containing egg membrane peptide. Comprising the following raw materials in parts by weight: 10-50 parts of egg membrane peptide, 5-20 parts of a zinc compound, 5-15 parts of vitamin E, 1-10 parts of lycopene, 5-25 parts of pachymaran, 3-12 parts of coenzyme Q10, 5-20 parts of a saw palmetto extract, 5-15 parts of L-carnitine, 10-30 parts of vitamin C, 3-10 parts of a ginkgo biloba extract, 5-20 parts of a maca extract, 5-25 parts of lycium barbarum polysaccharide and 1-8 parts of astaxanthin. The egg membrane peptide is a polypeptide composition prepared from an egg shell membrane through an enzymolysis or fermentation method. The zinc compound is one or more of zinc citrate, zinc glycinate and zinc gluconate. The complex formula has a synergistic effect from multiple dimensions of oxidation resistance, inflammation resistance, energy supply and endocrine regulation, and the concentration, activity, normal morphological rate and DNA integrity of sperms are improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of health food, in particular to a compound formula reproductive health care product taking egg membrane peptide as the core and having multiple components synergistically, and a preparation method thereof, which is especially suitable for improving the quality of male semen and regulating the balance of oxidative stress and inflammation of the reproductive system. BACKGROUND

[0002] With the increase of life pressure and the spread of unhealthy living habits, the decline of fertility has become a global public health problem: according to the report of the World Health Organization (WHO, 2024), the average annual decline of global male sperm concentration in the past decade is 1.2%, and the abnormal rate of sperm motility rises to 35%, among which oxidative stress (leading to a 40% increase in sperm DNA damage rate) and chronic inflammation (inducing a 28% increase in the risk of blood-testis barrier destruction) are the core pathogenic factors. Oxidative stress can destroy the structural integrity of the sperm membrane, induce DNA damage and apoptosis, and directly affect sperm motility and fertilization capacity; while inflammatory response can further damage the process of spermatogenesis and maturation through the pathways of destroying the blood-testis barrier, inducing immune abnormalities and interfering with endocrine balance, etc.

[0003] Polypeptides have a broad prospect in the field of functional food and health care products due to their small molecular weight, high bioavailability, good safety, etc., among which egg membrane peptide is a bioactive peptide extracted from chicken eggshell membrane. Studies have shown that it can be directly absorbed through the small intestine, has multiple physiological functions such as scavenging free radicals, inhibiting inflammatory factors, and regulating cellular immunity. For example, experimental studies have shown that egg membrane peptide can effectively scavenge DPPH and hydroxyl radicals (scavenging rate ≥ 85%), protecting cells from oxidative damage; animal experiments have also confirmed that it can inhibit the expression of pro-inflammatory factors such as IL-1β and TNF-α, and increase the level of anti-inflammatory factor IL-10, showing good anti-inflammatory potential. Although egg membrane peptide has been studied more in terms of antioxidant and anti-inflammatory, its direct application in the field of reproductive health is still blank, and there is no study to confirm its direct improvement on sperm or egg quality. The existing related health care products also have obvious deficiencies: CN202110764116.2 discloses a black truffle kidney tonifying formula, which takes black truffle and cordyceps militaris as the main raw materials, but its formula design is only for kidney yang deficiency people, and can only achieve limited efficacy through warming and tonifying kidney yang, and cannot cover the whole functional regulation demand of the reproductive system. The patent uses high-temperature drying process at 60-70°C, resulting in a loss rate of more than 30% of heat-sensitive active ingredients, and further destroys the biological activity of polypeptides by relying on alcohol precipitation process (ethanol concentration 80%).

[0004] CN202410421847.0 discloses a composite plant protein supplement, which contains soybean protein, peanut protein and other ingredients. However, the formula simply mixes 80-100 parts of plant protein with minerals, without considering the nutritional antagonism. The combination rate of zinc element and soybean protein is more than 60%, resulting in a decrease of more than 40% in actual absorption rate.

[0005] CN117285615A discloses a preparation method of eggshell membrane polypeptide, which improves the yield by secondary enzymolysis. However, the process uses 0.05-0.1% NaOH solution for alkaline hydrolysis, resulting in the product containing trace amounts of alkaline substances, which may irritate the reproductive organ mucosa if taken for a long time.

[0006] In summary, the existing technology is difficult to achieve the multi-dimensional synergy of "antioxidation-anti-inflammatory-energy supply-endocrine regulation" due to single ingredient, process defects or poor safety. Therefore, there is an urgent need in the field for a composite formula with excellent ingredient synergy, mild and controllable process, and the ability to comprehensively and safely improve sperm quality. The present application is proposed based on the above technical bottlenecks. SUMMARY

[0007] In view of the above deficiencies in the prior art, the present application provides a male reproductive health composite formula health product containing eggshell membrane peptide and a preparation method thereof. The composite formula takes eggshell membrane peptide as the core and cooperates with multiple active ingredients, and comprehensively improves sperm quality, regulates reproductive immunity and endocrine environment through multi-target and multi-mechanism synergy.

[0008] To achieve the above-mentioned application purposes, the technical scheme adopted by the present application is as follows: a male reproductive health composite formula health product containing eggshell membrane peptide, comprising the following raw materials by weight: 10-50 parts of eggshell membrane peptide, 5-20 parts of zinc compound, 5-15 parts of vitamin E, 1-10 parts of lycopene, 5-25 parts of poria cocos polysaccharide, 3-12 parts of coenzyme Q10, 5-20 parts of saw palmetto extract, 5-15 parts of L-carnitine, 10-30 parts of vitamin C, 3-10 parts of ginkgo biloba extract, 5-20 parts of maca extract, 5-25 parts of wolfberry polysaccharide, and 1-8 parts of astaxanthin; the eggshell membrane peptide is a polypeptide composition prepared by enzymolysis or fermentation of chicken eggshell membrane.

[0009] Further, in the male reproductive health composite formula health product containing eggshell membrane peptide, the zinc compound is one or more of zinc citrate, zinc glycinate and zinc gluconate.

[0010] Further, the male reproductive health composite formula health product containing eggshell membrane peptide further comprises a pharmaceutically or foodologically acceptable excipient, and the excipient comprises one or more of a filler, a binder, a lubricant, a flavoring agent or a preservative.

[0011] Further, the method for preparing the male reproductive health compound formula health care product containing egg membrane peptides comprises the following steps: S1, raw material pretreatment: the egg membrane peptide powder is placed in a fluidized bed dryer, dried at 40-50 DEG C to a moisture content of less than or equal to 5%; the zinc compound, vitamin E, lycopene, coenzyme Q10, L-carnitine, vitamin C, astaxanthin are respectively subjected to ultrafine grinding, and passed through a 200-300 mesh screen; S2, mixing and granulation: all the powder raw materials after pretreatment in S1 are put into a high-efficiency three-dimensional motion mixer, mixed at a speed of 20-30 rpm for 25-35 minutes to obtain a primary mixed powder; the primary mixed powder is transferred into a wet granulator, and the binder is slowly added, and the material temperature is controlled to be less than or equal to 50 DEG C under the conditions of a stirring paddle speed of 200-400 rpm and a cutting knife speed of 1000-2000 rpm; the obtained wet granules are placed in a boiling drying bed and dried at 60-70 DEG C to a moisture content of less than or equal to 3%; S3, whole granulation and total mixing: the dried granules are subjected to whole granulation through a vibrating screen, and the granules between 20-40 meshes are taken; the granules are transferred into a three-dimensional mixer, and magnesium stearate is added as a lubricant, mixed at a speed of 15-25 rpm for 10-20 minutes to obtain total mixed granules; S4, shaping: the total mixed granules are subjected to tabletting by using a rotary tablet press, and the tablet weight difference is ±5%, the hardness is 50-100 N, and the disintegration time is less than or equal to 15 minutes.

[0012] The application has the advantages that the egg membrane peptide is first applied to the field of reproductive health, and is used as a core in cooperation with a plurality of active ingredients such as a zinc compound, vitamin E, lycopene, tremella polysaccharide, coenzyme Q10, saw palmetto extract, L-carnitine, vitamin C, ginkgo extract, maca extract, wolfberry polysaccharide and astaxanthin, so that the sperm quality is comprehensively improved through multi-mechanism and multi-pathway synergistic effect. The egg membrane peptide has antioxidant and anti-inflammatory activities, can scavenge free radicals, inhibit inflammatory factors, protect the sperm cell membrane structure and DNA integrity; the zinc element is a key trace element for sperm generation and maturation, participates in the activity regulation of a plurality of enzymes, and guarantees sperm motility; vitamin E and vitamin C further strengthen the antioxidant defense system as classic antioxidants; lycopene and astaxanthin have strong free radical scavenging capacity, especially in the aspect of lipid peroxidation inhibition; coenzyme Q10 and L-carnitine participate in energy metabolism and improve sperm motility; the saw palmetto extract, maca extract and wolfberry polysaccharide play auxiliary roles in endocrine regulation and immune balance. Therefore, the compound formula is not a simple superposition of the functions of each component, but through multi-target and multi-dimensional synergistic and complementary effects such as antioxidant, anti-inflammatory, energy supply and endocrine regulation, the sperm concentration, motility, normal rate of morphology and DNA integrity are significantly improved, and the technical effect is significantly better than that of a comparative formula lacking any core component (see the experimental data of the comparative formula). DETAILED DESCRIPTION

[0013] The specific embodiments of the present application are described below to enable those skilled in the art to understand the present application, but it should be clear that the present application is not limited to the scope of the specific embodiments, and that all the inventions utilizing the concept of the present application are within the scope of the present application as long as various changes are obvious to those skilled in the art within the spirit and scope of the present application as defined in the appended claims.

[0014] Example 1

[0015] 1. Raw material composition (by weight) Eggshell membrane peptide 10 parts, zinc citrate 5 parts, vitamin E 5 parts, lycopene 1 part, tremella polysaccharide 5 parts, coenzyme Q10 3 parts, saw palmetto extract 5 parts, L-carnitine 5 parts, vitamin C 10 parts, ginkgo biloba extract 3 parts, maca extract 5 parts, wolfberry polysaccharide 5 parts, astaxanthin 1 part, and pharmaceutical excipients are microcrystalline cellulose 20 parts, hydroxypropyl methyl cellulose 3 parts, magnesium stearate 1 part, and sucralose 0.2 parts.

[0016] 2. Health product preparation steps Raw material pretreatment: The eggshell membrane peptide powder was placed in a fluidized bed dryer and dried at 40°C for 2 hours until the moisture content was ≤5%; zinc citrate, vitamin E, lycopene, coenzyme Q10, L-carnitine, vitamin C, and astaxanthin were respectively placed in a super micro grinder and ground for 40 minutes and passed through a 200-mesh sieve; tremella polysaccharide, saw palmetto extract, ginkgo biloba extract, maca extract, and wolfberry polysaccharide were directly passed through a 100-mesh sieve; and microcrystalline cellulose, hydroxypropyl methyl cellulose, magnesium stearate, and sucralose were all passed through an 80-mesh sieve and were ready for use.

[0017] Mixing and granulation: all the pretreated active raw materials and microcrystalline cellulose were put into a high-efficiency three-dimensional motion mixer, the rotation speed was set to 20 rpm, and mixing was carried out for 35 minutes to obtain a preliminary mixed powder; the preliminary mixed powder was transferred into a wet granulator, 5% hydroxypropyl methyl cellulose aqueous solution was slowly added as a binder (the amount of the binder was 15% of the mass of the preliminary mixed powder), the stirring paddle rotation speed was set to 200 rpm, and the cutting knife rotation speed was set to 1000 rpm, and granulation was carried out for 15 minutes, during which the temperature of the material was controlled to ≤50°C through a jacket; the prepared wet granules were placed in a boiling drying bed and dried at 60°C for 3 hours until the moisture content was ≤3%.

[0018] Granulation and total mixing: the dried granules were granulated with a vibrating screen, and the granules between 20-40 meshes were selected; the qualified granules were transferred into a three-dimensional mixer, magnesium stearate and sucralose were added, the rotation speed was set to 15 rpm, and mixing was carried out for 20 minutes to obtain total mixed granules.

[0019] Molding: using a rotary tablet press, set the tablet weight 0.4g / tablet, control the tablet weight difference within ±5%, hardness 50-60N, disintegration time ≤15 minutes, get the compound formula of reproductive health care tablets containing egg membrane peptide.

[0020] 3. Performance test The health care tablets prepared in this example were subjected to performance test. 60 SPF male SD rats were randomly divided into a blank control group (given normal saline) and an example 1 group (given the health care tablets prepared in this example, 100 mg / kg body weight by gavage), 30 rats in each group, continuous gavage for 30 days. 24 hours after the last gavage, the rats were sacrificed and the relevant indicators were detected. The results showed that the sperm concentration of the rats in the example 1 group was increased by 8% compared with the blank control group, the sperm motility was increased by 7%, the normal rate of sperm morphology was increased by 5%, and the DNA integrity was increased by 6%; the activities of antioxidant enzymes (SOD, GSH-Px) in testicular tissue were increased by 10% and 9% respectively, and the contents of inflammatory factors (IL-1β, TNF-α) were decreased by 8% and 7% respectively.

[0021] Example 2

[0022] 1. Raw material composition (by weight) Egg membrane peptide 15 parts, zinc glycinate 8 parts, vitamin E 7 parts, lycopene 3 parts, tremella polysaccharide 10 parts, coenzyme Q10 5 parts, saw palmetto extract 8 parts, L-carnitine 7 parts, vitamin C 15 parts, ginkgo biloba extract 5 parts, maca extract 8 parts, wolfberry polysaccharide 10 parts, astaxanthin 2 parts, pharmaceutical excipients are microcrystalline cellulose 25 parts, hydroxypropyl methyl cellulose 4 parts, magnesium stearate 1.2 parts, sucralose 0.3 parts.

[0023] 2. Health product preparation steps Raw material pretreatment: egg membrane peptide was dried in a fluidized bed dryer at 42°C for 1.8 hours, moisture ≤5%; 7 kinds of raw materials such as zinc glycinate were ultrafine pulverized for 35 minutes and passed through a 250 mesh sieve; the rest of the raw materials were sieved according to the method of example 1.

[0024] Mixing and granulation: active raw materials and microcrystalline cellulose were mixed at a speed of 22 rpm for 32 minutes; the stirring paddle speed was 250 rpm and the cutting knife speed was 1200 rpm during wet granulation, and the granulation was 12 minutes; the boiling drying bed was dried at 62°C for 2.5 hours.

[0025] Granulation and total mixing: after granulation, 20-40 mesh granules were selected, lubricant and flavoring agent were added, and mixed at a speed of 18 rpm for 18 minutes.

[0026] Molding: tabletting was set at 0.45g / tablet, hardness 60-70N, other parameters were the same as example 1.

[0027] 3. Performance test Using the same animal model and test method as in Example 1, the sperm concentration of the rats in Example 2 group was increased by 11% compared with the blank control group, the sperm motility was increased by 10%, the normal rate of sperm morphology was increased by 8%, and the DNA integrity was increased by 9%; the activities of SOD and GSH-Px in testicular tissue were increased by 13% and 12% respectively, and the contents of IL-1β and TNF-α were decreased by 11% and 10% respectively.

[0028] Example 3

[0029] 1, Raw material composition (by weight) Egg membrane peptide 20 parts, zinc gluconate 10 parts, vitamin E 9 parts, lycopene 5 parts, tremella polysaccharide 15 parts, coenzyme Q10 7 parts, saw palmetto extract 12 parts, L-carnitine 9 parts, vitamin C 20 parts, ginkgo biloba extract 7 parts, maca extract 12 parts, wolfberry polysaccharide 15 parts, astaxanthin 4 parts, pharmaceutical excipients are microcrystalline cellulose 30 parts, hydroxypropyl methyl cellulose 5 parts, magnesium stearate 1.5 parts, sucralose 0.4 parts.

[0030] 2, Health product preparation steps Raw material pretreatment: fluidized bed drying of egg membrane peptide at 45℃ for 1.5 hours; ultrafine grinding of 7 kinds of raw materials for 30 minutes, passing through a 300 mesh sieve; other raw materials are conventionally sieved.

[0031] Mixing and granulation: mixing at 25 rpm for 30 minutes; wet granulation stirring paddle 300 rpm, cutting knife 1500 rpm, granulation for 10 minutes; boiling drying at 65℃ for 2 hours.

[0032] Granulation and total mixing: mixing at 20 rpm for 15 minutes.

[0033] Shaping: tablet weight 0.5g / tablet, hardness 70-80N.

[0034] 3, Performance testing The sperm concentration of the rats in Example 3 group was increased by 14% compared with the blank control group, the sperm motility was increased by 13%, the normal rate of sperm morphology was increased by 11%, and the DNA integrity was increased by 12%; the activities of SOD and GSH-Px in testicular tissue were increased by 16% and 15% respectively, and the contents of IL-1β and TNF-α were decreased by 14% and 13% respectively.

[0035] Example 4

[0036] 1, Raw material composition (by weight) Eggshell membrane peptide 25 parts, zinc citrate 12 parts, vitamin E 11 parts, lycopene 7 parts, Pachyman 18 parts, coenzyme Q10 9 parts, saw palmetto extract 15 parts, L-carnitine 11 parts, vitamin C 22 parts, ginkgo biloba extract 8 parts, maca extract 15 parts, wolfberry polysaccharide 18 parts, astaxanthin 5 parts, and medicinal excipients are microcrystalline cellulose 35 parts, hydroxypropyl methyl cellulose 6 parts, magnesium stearate 1.8 parts, and sucralose 0.5 parts.

[0037] 2. Health product preparation steps Raw material pretreatment: fluidized bed drying of eggshell membrane peptide at 43 DEG C for 1.6 hours; supermicro-pulverization of 7 kinds of raw materials for 32 minutes, and passing through a 280-mesh screen.

[0038] Mixing and granulation: mixing at 24 rpm for 28 minutes; wet granulation stirring paddle at 280 rpm, cutting knife at 1400 rpm, and granulation for 11 minutes; boiling drying at 63 DEG C for 2.2 hours.

[0039] Mixing and granulation: mixing at 24 rpm for 28 minutes; wet granulation stirring paddle at 280 rpm, cutting knife at 1400 rpm, and granulation for 11 minutes; boiling drying at 63 DEG C for 2.2 hours.

[0040] Tabletting: tablet weight 0.55 g / tablet, hardness 75-85 N.

[0041] 3. Performance testing In example 4, the sperm concentration of the group of rats is increased by 17% compared with the blank control group, the sperm motility is increased by 16%, the normal rate of sperm morphology is increased by 14%, and the DNA integrity is increased by 15%; the SOD and GSH-Px activities of testicular tissue are increased by 19% and 18% respectively, and the IL-1β and TNF-α contents are reduced by 17% and 16% respectively.

[0042] Example 5

[0043] 1. Raw material composition (by weight) Eggshell membrane peptide 30 parts, zinc glycinate 15 parts, vitamin E 13 parts, lycopene 8 parts, Pachyman 20 parts, coenzyme Q10 10 parts, saw palmetto extract 18 parts, L-carnitine 13 parts, vitamin C 25 parts, ginkgo biloba extract 9 parts, maca extract 18 parts, wolfberry polysaccharide 20 parts, astaxanthin 6 parts, and medicinal excipients are microcrystalline cellulose 40 parts, hydroxypropyl methyl cellulose 7 parts, magnesium stearate 2 parts, and sucralose 0.6 parts.

[0044] 2. Health product preparation steps Raw material pretreatment: fluidized bed drying of eggshell membrane peptide at 44 DEG C for 1.4 hours; supermicro-pulverization of 7 kinds of raw materials for 28 minutes, and passing through a 290-mesh screen.

[0045] Mixing and granulation: mixing at 26 rpm for 26 minutes; wet granulation stirring paddle at 320 rpm, cutting knife at 1600 rpm, and granulation for 9 minutes; boiling drying at 66 DEG C for 1.8 hours.

[0046] Total mixing: 21 rpm for 14 minutes.

[0047] Forming: tablet weight 0.6 g / tablet, hardness 80-90 N.

[0048] 3. Performance testing Example 5 The sperm concentration of the group of rats was increased by 20% compared with the blank control group, the sperm motility was increased by 19%, the normal rate of sperm morphology was increased by 17%, and the DNA integrity was increased by 18%; the activities of SOD and GSH-Px in testicular tissue were increased by 22% and 21%, respectively, and the contents of IL-1β and TNF-α were reduced by 20% and 19%, respectively.

[0049] Example 6

[0050] 1. Raw material composition (by weight) Egg membrane peptide 35 parts, zinc gluconate 16 parts, vitamin E 12 parts, lycopene 6 parts, tremella polysaccharide 22 parts, coenzyme Q10 8 parts, saw palmetto extract 16 parts, L-carnitine 12 parts, vitamin C 23 parts, ginkgo biloba extract 6 parts, maca extract 16 parts, wolfberry polysaccharide 22 parts, astaxanthin 3 parts, and pharmaceutical excipients are microcrystalline cellulose 38 parts, hydroxypropyl methylcellulose 5.5 parts, magnesium stearate 1.6 parts, sucralose 0.45 parts.

[0051] 2. Health product preparation steps Raw material pretreatment: fluidized bed drying of egg membrane peptide at 42°C for 1.7 hours; ultrafine grinding of 7 kinds of raw materials for 31 minutes, and passing through a 270-mesh sieve.

[0052] Mixing and granulation: 23 rpm for 29 minutes; wet granulation stirring paddle 270 rpm, cutting knife 1300 rpm, granulation for 12 minutes; boiling drying at 64°C for 2.1 hours.

[0053] Total mixing: 17 rpm for 17 minutes.

[0054] Forming: tablet weight 0.52 g / tablet, hardness 72-82 N.

[0055] 3. Performance testing Example 6 The sperm concentration of the group of rats was increased by 18% compared with the blank control group, the sperm motility was increased by 17%, the normal rate of sperm morphology was increased by 15%, and the DNA integrity was increased by 16%; the activities of SOD and GSH-Px in testicular tissue were increased by 20% and 19%, respectively, and the contents of IL-1β and TNF-α were reduced by 18% and 17%, respectively.

[0056] Example 7

[0057] 1. Raw material composition (by weight) Eggshell membrane peptide 40 parts, zinc citrate 18 parts, vitamin E 14 parts, lycopene 9 parts, tremella polysaccharide 23 parts, coenzyme Q10 11 parts, saw palmetto extract 19 parts, L-carnitine 14 parts, vitamin C 28 parts, ginkgo biloba extract 10 parts, maca extract 19 parts, wolfberry polysaccharide 23 parts, astaxanthin 7 parts, and medicinal excipients are microcrystalline cellulose 42 parts, hydroxypropyl methyl cellulose 7.5 parts, magnesium stearate 2.2 parts, sucralose 0.7 parts.

[0058] 2. Health product preparation steps Raw material pretreatment: fluidized bed drying of eggshell membrane peptide at 46℃ for 1.3 hours; supermicro-pulverization of the seven raw materials for 27 minutes and passing through a 300-mesh sieve.

[0059] Mixing and granulation: mixing at 27 rpm for 25 minutes; wet granulation with a stirring paddle at 330 rpm and a cutting knife at 1700 rpm for 8 minutes; and boiling drying at 67℃ for 1.7 hours.

[0060] Whole granulation and total mixing: mixing at 22 rpm for 13 minutes.

[0061] Molding: tablet weight 0.65 g / tablet, hardness 85-95 N.

[0062] 3. Performance detection In example 7, the sperm concentration of the group of rats was increased by 23% compared with the blank control group, the sperm motility was increased by 22%, the normal rate of sperm morphology was increased by 20%, and the DNA integrity was increased by 21%; the activities of SOD and GSH-Px in testicular tissue were increased by 25% and 24% respectively, and the contents of IL-1β and TNF-α were reduced by 23% and 22% respectively.

[0063] Example 8

[0064] 1. Raw material composition (by weight) Eggshell membrane peptide 45 parts, zinc glycinate 19 parts, vitamin E 15 parts, lycopene 10 parts, tremella polysaccharide 24 parts, coenzyme Q10 12 parts, saw palmetto extract 20 parts, L-carnitine 15 parts, vitamin C 30 parts, ginkgo biloba extract 8.5 parts, maca extract 20 parts, wolfberry polysaccharide 24 parts, astaxanthin 8 parts, and medicinal excipients are microcrystalline cellulose 45 parts, hydroxypropyl methyl cellulose 8 parts, magnesium stearate 2.5 parts, sucralose 0.8 parts.

[0065] 2. Health product preparation steps Raw material pretreatment: fluidized bed drying of eggshell membrane peptide at 47℃ for 1.2 hours; supermicro-pulverization of the seven raw materials for 25 minutes and passing through a 300-mesh sieve.

[0066] Mixing and granulation: mixing at 28 rpm for 24 minutes; wet granulation with a stirring paddle at 350 rpm and a cutting knife at 1800 rpm for 7 minutes; and boiling drying at 68℃ for 1.5 hours.

[0067] Mixing: 23 rpm for 12 minutes.

[0068] Tabletting: tablet weight 0.7 g / tablet, hardness 90-100 N.

[0069] 3. Performance testing Example 8 The sperm concentration of the group of rats was increased by 30% compared with the blank control group, the sperm motility was increased by 28%, the normal rate of sperm morphology was increased by 20%, and the DNA integrity was increased by 22%; the activities of SOD and GSH-Px in testicular tissue were increased by 28% and 27%, respectively, and the contents of IL-1β and TNF-α were reduced by 26% and 25%, respectively.

[0070] Example 9

[0071] 1. Raw material composition (by weight) Egg membrane peptide 50 parts, zinc gluconate 20 parts, vitamin E 10 parts, lycopene 4 parts, tremella polysaccharide 25 parts, coenzyme Q10 6 parts, saw palmetto extract 10 parts, L-carnitine 8 parts, vitamin C 18 parts, ginkgo biloba extract 5.5 parts, maca extract 10 parts, wolfberry polysaccharide 25 parts, astaxanthin 4.5 parts, and pharmaceutical excipients are microcrystalline cellulose 48 parts, hydroxypropyl methylcellulose 6.5 parts, magnesium stearate 2.3 parts, sucralose 0.55 parts.

[0072] 2. Health product preparation steps Raw material pretreatment: fluidized bed drying of egg membrane peptide at 45°C for 1.5 hours; ultrafine grinding of 7 kinds of raw materials for 29 minutes, and passing through a 290 mesh screen.

[0073] Mixing and granulation: 25 rpm for 27 minutes; wet granulation stirring paddle 310 rpm, cutting knife 1500 rpm, granulation for 10 minutes; boiling drying at 65°C for 2 hours.

[0074] Mixing: 20 rpm for 15 minutes.

[0075] Tabletting: tablet weight 0.68 g / tablet, hardness 88-98 N.

[0076] 3. Performance testing Example 9 The sperm concentration of the group of rats was increased by 24% compared with the blank control group, the sperm motility was increased by 23%, the normal rate of sperm morphology was increased by 21%, and the DNA integrity was increased by 22%; the activities of SOD and GSH-Px in testicular tissue were increased by 26% and 25%, respectively, and the contents of IL-1β and TNF-α were reduced by 24% and 23%, respectively.

[0077] Comparative Example 1 (missing egg membrane peptide) 1. Raw material composition (by weight) Zinc glycinate 19 parts, vitamin E 15 parts, lycopene 10 parts, Pachyman 24 parts, coenzyme Q10 12 parts, saw palmetto extract 20 parts, L-carnitine 15 parts, vitamin C 30 parts, ginkgo extract 8.5 parts, maca extract 20 parts, Lycium barbarum polysaccharide 24 parts, astaxanthin 8 parts, and pharmaceutical excipients are the same as in Example 8.

[0078] 2. Preparation step: the same as in Example 8.

[0079] 3. Performance test The sperm concentration of the rats was increased by 12% compared with the blank control group, the sperm motility was increased by 10%, the normal rate of sperm morphology was increased by 8%, and the DNA integrity was increased by 10%; the activities of SOD and GSH-Px in testicular tissue were increased by 12% and 11%, respectively, and the contents of IL-1β and TNF-α were reduced by 10% and 9%, respectively.

[0080] Comparative Example 2 (lacking zinc compound, vitamin E and lycopene) 1. Raw material composition (by weight) Egg membrane peptide 45 parts, Pachyman 24 parts, coenzyme Q10 12 parts, saw palmetto extract 20 parts, L-carnitine 15 parts, vitamin C 30 parts, ginkgo extract 8.5 parts, maca extract 20 parts, Lycium barbarum polysaccharide 24 parts, astaxanthin 8 parts, and pharmaceutical excipients are the same as in Example 8.

[0081] 2. Preparation step: the same as in Example 8.

[0082] 3. Performance test Animal experiment: the sperm concentration of the rats was increased by 15% compared with the blank control group, the sperm motility was increased by 13%, the normal rate of sperm morphology was increased by 11%, and the DNA integrity was increased by 13%; the activities of SOD and GSH-Px in testicular tissue were increased by 15% and 14%, respectively, and the contents of IL-1β and TNF-α were reduced by 13% and 12%, respectively.

[0083] Comparison and analysis of each example 1. Comparison of raw material dosage From the dosage of egg membrane peptide, Example 1 is 10 parts, and Example 9 is increased to 50 parts, showing an overall increasing trend. The dosage of zinc compound gradually increases from 5 parts in Example 1 to 20 parts and 19 parts in Examples 8 and 9. Other active ingredients such as vitamin E, lycopene, and Pachyman also show an increasing trend in dosage as the examples progress, except for a few ingredients such as vitamin E and lycopene in Example 9, which have a lower dosage than in Example 8. The dosage of pharmaceutical excipients increases as the total amount of active ingredients increases to ensure tablet formation and stability.

[0084] 2. Comparison of health product preparation process parameters The raw material pretreatment stage, egg membrane peptide drying temperature fluctuates between 40-47℃, and the mesh number of the sieved 7 active raw materials is gradually increased from 200 mesh to 300 mesh, which is beneficial to the uniform mixing of the raw materials and the release of the active ingredients. During the mixing and granulation, the stirring paddle speed is increased from 200 rpm to 350 rpm, the cutting knife speed is increased from 1000 rpm to 1800 rpm, and the mixing time and granulation time are shortened with the optimization of parameters. The tablet hardness is increased from 50-60 N to 90-100 N, and the tablet stability is gradually enhanced.

[0085] 3. Performance effect comparison With the increase of the amount of egg membrane peptide and other active ingredients and the optimization of the preparation process, the effect of improving sperm quality of the health care product shows an overall upward trend. The improvement rate of each index in Example 1 is the lowest, and the effect of Example 8 is the best, with a sperm concentration improvement rate of 30%, a sperm motility improvement rate of 28%, a normal sperm morphology rate improvement rate of 20%, and a DNA integrity improvement rate of 22%.

[0086] In Example 9, the amount of egg membrane peptide is 50 parts (the highest among all examples), but the amounts of the following key active ingredients are significantly reduced compared to Example 8 (egg membrane peptide 45 parts) which has the best effect: Vitamin E: from 15 parts to 10 parts (33% reduction); Lycopene: from 10 parts to 4 parts (60% reduction); Coenzyme Q10: from 12 parts to 6 parts (50% reduction); Ginkgo biloba extract: from 20 parts to 10 parts (50% reduction); L-carnitine: from 15 parts to 8 parts (47% reduction); Ginkgo biloba extract: from 8.5 parts to 5.5 parts (35% reduction); Maca extract: from 20 parts to 10 parts (50% reduction).

[0087] The core advantage of the compound formula of the present application is the synergistic effect of "multiple components - multiple dimensions". As the core active ingredient, the full play of the antioxidant and anti-inflammatory effects of egg membrane peptide depends on the functional complementation of other active ingredients: Antioxidant dimension: Vitamin E (lipid peroxidation inhibitor), lycopene (strong lipid-soluble free radical scavenger) and egg membrane peptide (water-soluble free radical scavenger) form a synergistic network. In Example 9, the amounts of the two are significantly reduced, which leads to the inability to effectively inhibit the damage of sperm membrane lipid peroxidation, offsetting the antioxidant gain brought by the increase of egg membrane peptide; Energy supply dimension: the dosage of coenzyme Q10 (a key substance of mitochondrial energy metabolism) and L-carnitine (a sperm energy substrate carrier) is halved, leading to insufficient energy supply for sperm movement. Although eggshell membrane peptide protects the structural integrity of sperm, the sperm motility improvement rate (23%) is still lower than that of Example 8 (28%); Endocrine regulation dimension: the dosage of saw palmetto extract (a testosterone metabolism regulator) and maca extract (a gonadal axis regulator) is reduced, leading to an imbalance in the reproductive endocrine environment, limiting the auxiliary effect of eggshell membrane peptide on sperm production, and the sperm concentration improvement rate (24%) is lower than that of Example 8 (30%).

[0088] To clarify the direct correlation between ingredient reduction and effect decline, a verification group is set up. Verification group formula: eggshell membrane peptide 50 parts + unchanged dosages of all other active ingredients in Example 8, using the same preparation process and detection method. The results show that the sperm concentration of the verification group is improved by 29%, sperm motility by 27%, morphologically normal rate by 21%, and DNA integrity by 23%, all of which are significantly higher than those of Example 9 and close to the level of Example 8. This verification result confirms that the core reason for the effect decline in Example 9 is the insufficient dosage of key synergistic ingredients such as vitamin E and lycopene, rather than the saturation of eggshell membrane peptide, further proving that the formula of the present application needs to meet the synergistic ratio of each active ingredient, and simply increasing the dosage of core ingredients cannot continuously improve the effect.

[0089] Example 8 and Comparative Examples 1-2 are compared and analyzed. The results of the raw material formula comparison are shown in Table 1, and the reproductive effect comparison (based on rat test data) is shown in Table 2.

[0090] Table 1: Comparative dimension Example 8 Comparative Example 1 Comparative Example 2 Core ingredients Egg membrane peptide, zinc compound, vitamin E, lycopene and other 13 active ingredients No egg membrane peptide, the remaining 12 active ingredients are the same as Example 8 No zinc compound, vitamin E, lycopene, the remaining 10 active ingredients are the same as Example 8 Ingredient synergy Multi-component synergy in multiple dimensions such as antioxidant, anti-inflammatory, energy supply, and endocrine regulation Lack of egg membrane peptide, the core role of antioxidant and anti-inflammatory is weakened Lack of zinc (key element for sperm production), vitamin E / lycopene (strong antioxidant), incomplete functional dimension Table 2: Effect index Example 8 Comparative Example 1 Comparative Example 2 Sperm concentration improvement rate 30% 12% 15% Sperm motility improvement rate 28% 10% 13% Sperm morphology normal rate improvement rate 20% 8% 11% DNA integrity improvement rate 22% 10% 13% Adverse reaction rate 0% 0% 0% Based on the above comparative analysis, the formula of Example 8 is the most optimal in terms of completeness and synergy, containing 13 active ingredients such as eggshell membrane peptide, zinc compound, vitamin E, and lycopene, covering key dimensions of reproductive health such as antioxidant, anti-inflammatory, energy metabolism, and endocrine regulation. The synergistic effect of each component is significant, and the absence of any core component (such as eggshell membrane peptide in Comparative Example 1, zinc in Comparative Example 2, and vitamin E and lycopene) will result in a significant decline in effect.

[0091] Example 8 uses low-temperature drying (drying eggshell membrane peptide at 47°C), ultra-fine grinding (300 mesh sieve), and precise temperature control (granulation ≤50°C) processes to maximize the retention of active ingredients and avoid damage to ingredients caused by high temperature and alcohol precipitation.

[0092] In the rat clinical test, the sperm concentration, motility, normal morphology rate, and DNA integrity improvement rate of Example 8 were 30%, 28%, 20%, and 22%, respectively, which were much higher than those of the respective comparative examples; and there was no any adverse reaction, and the safety and effectiveness were both optimal.

[0093] Strong stability and controllability: the physical indexes such as tablet hardness (90-100 N) and disintegration time (≤15 minutes) of Example 8 were stable, the tablet weight difference was within ±5%, the production process was highly controllable, and the industrialized production was facilitated.

Claims

1. A male reproductive health compound formula health product containing egg membrane peptides, characterized in that, The product comprises the following raw materials in parts by weight: 10–50 parts egg membrane peptides, 5–20 parts zinc compounds, 5–15 parts vitamin E, 1–10 parts lycopene, 5–25 parts Poria cocos polysaccharide, 3–12 parts coenzyme Q10, 5–20 parts saw palmetto extract, 5–15 parts L-carnitine, 10–30 parts vitamin C, 3–10 parts ginkgo extract, 5–20 parts maca extract, 5–25 parts wolfberry polysaccharide, and 1–8 parts astaxanthin; wherein the egg membrane peptides are polypeptide compositions prepared from eggshell membranes by enzymatic hydrolysis or fermentation.

2. The male reproductive health compound formula health product containing egg membrane peptides according to claim 1, characterized in that, The zinc compound is one or more of zinc citrate, zinc glycinate, and zinc gluconate.

3. The male reproductive health compound formula health product containing egg membrane peptides according to claim 1, characterized in that, It also includes pharmaceutically or food-grade excipients, which include one or more of fillers, binders, lubricants, flavoring agents, or preservatives.

4. A method for preparing a male reproductive health compound formula health product containing egg membrane peptides as described in any one of claims 1-3, characterized in that, Includes the following steps: S1, Raw material pretreatment: Place the egg membrane peptide powder in a fluidized bed dryer and dry it at 40-50℃ until the moisture content is ≤5%; pulverize the zinc compound, vitamin E, lycopene, coenzyme Q10, L-carnitine, vitamin C and astaxanthin into ultrafine powder and pass them through a 200-300 mesh sieve. S2, Mixing and Granulation: All the pretreated powder raw materials from S1 are put into a high-efficiency three-dimensional motion mixer and mixed at 20-30 rpm for 25-35 minutes to obtain a preliminary mixed powder; the preliminary mixed powder is transferred to a wet granulator, and the binder is slowly added. Granulation is carried out under the conditions of a stirring paddle speed of 200-400 rpm and a cutting blade speed of 1000-2000 rpm, and the material temperature is controlled to be ≤50℃; the resulting wet granules are placed in a fluidized bed dryer and dried at 60-70℃ until the moisture content is ≤3%; S3, Granulation and Mixing: The dried granules are granulated through a vibrating sieve to obtain granules between 20-40 mesh; the granules are then transferred to a three-dimensional mixer, magnesium stearate is added as a lubricant, and the mixture is stirred at 15-25 rpm for 10-20 minutes to obtain the mixed granules. S4, Forming: The total mixed granules are compressed into tablets using a rotary tablet press, with a tablet weight difference of ±5%, a hardness of 50-100N, and a disintegration time of ≤15 minutes.