External biological preparation for reproductive maintenance and male function improvement and preparation method thereof

Abstract

The invention discloses an external biological preparation for reproductive maintenance and male function improvement and a preparation method thereof. The external biological preparation is mainly prepared from clerodendranthus spicatus extract, cistanche deserticola extract, herba epimedii extract, maca extract, fructus lycii extract, salvia officinalis oil and functional polypeptide. The composition further comprises arginine, oyster peptide, hippocampus peptide, a yam root extract, a coleus forskohlii root extract, a tea leaf extract, a cynomorium songaricum extract and a tribulus terrestris extract. The external biological preparation breaks through the limitations of a first pass effect, gastrointestinal tract dependence, low bioavailability and the like of a traditional oral product, realizes accurate intervention aiming at the sub-health problem of men, is beneficial to improving testosterone concentration and NO level, improving inflammation, activating cell energy to promote repair and regeneration, promoting sperm formation and enhancing body microcirculation, and has a good application prospect. Therefore, the aims of protecting the gonad axis and improving the male function are fulfilled.

Description

Technical Field

[0001] The present invention relates to the field of biological preparations, and in particular to an external biological preparation for reproductive care and male function enhancement and a preparation method thereof. Background Art

[0002] As the living environment of human beings continues to change, people's living habits are also constantly changing. These deteriorating habits and environments also affect the health status of modern humans. According to statistics, about 35% of people in the world are in a sub-healthy state, of which male sub-healthy people account for as high as 75%. In addition, a large number of social surveys and medical statistics at home and abroad show that more and more diseases are rapidly approaching men, and continue to seriously threaten the physical and mental health of male comrades, such as prostatitis (the incidence rate of men aged 20-50 is as high as 20-40% or more), sexual dysfunction, prostate hyperplasia, hypertension, diabetes, fatigue syndrome, obesity syndrome, hair loss, baldness, etc. Men's health is showing a clear downward trend, which has attracted more and more social attention.

[0003] Aging is one of the main causes of male sub-health problems. Men, like women, also experience menopause. Male menopause, also known as age-related testosterone deficiency syndrome (TDS), refers to a syndrome in which the testosterone level of middle-aged and elderly men decreases with age, the serum testosterone level is lower than the normal range of healthy young men, and a series of clinical symptoms and signs of partial androgen deficiency appear. The main characteristics are: ① Decreased libido and erectile dysfunction; ② Mood changes accompanied by decreased mental and spatial orientation abilities, easy fatigue, irritability and depression; ③ Weight loss accompanied by decreased muscle volume and strength; ④ Sparse hair and loose skin; ⑤ Decreased bone density and osteoporosis; ⑥ Fat deposition, which can easily cause obesity, etc.

[0004] In addition to the above symptoms, as men age, frequent prostate problems are another major "male problem" in society. The prostate is an asymmetric solid organ unique to men. The prostate fluid it secretes is the main component of semen. It can also secrete 5-α reductase to convert testosterone into more active dihydrotestosterone, and has the function of urination and sperm transportation. However, as people age, the occurrence of diseases such as prostatitis, prostatic hyperplasia, prostatic stones, prostatic cysts, and prostate cancer can cause men to experience symptoms such as urination discomfort and sexual dysfunction, seriously affecting their quality of life. At the same time, prostatitis can lead to a decrease in semen quality and decreased sperm motility, which will affect sperm transportation and fertilization ability; prostatic hyperplasia can compress the vas deferens and ejaculatory ducts, resulting in obstruction of normal semen discharge, which in turn affects sperm count and fertility.

[0005] In addition, modern people are generally under great social pressure, and being in a state of excessive fatigue, anxiety, depression and stress for a long time can induce erectile dysfunction. This state not only makes men fall into negative emotions such as inferiority, which in turn profoundly affects their daily rhythm and work efficiency, but also the long-term accumulated psychological pressure may induce a series of mental illnesses. More seriously, this state will also have an adverse effect on the sex life between couples. The disharmony of sexual life will lead to a significant decline in the satisfaction of both parties with each other. If this dissatisfaction is not properly handled, it is very likely to intensify family conflicts and even trigger a marriage crisis. At the same time, erectile dysfunction means that it is difficult for men to complete their sex life normally, which poses a direct threat to their fertility. For those couples who are eager to have children, this is undoubtedly a heavy blow. It not only affects their confidence in social occasions, but also casts a shadow on their work performance, reducing their quality of life in all aspects.

[0006] As the backbone of the family and society, the health status of men is not only a personal issue, but also directly affects the happiness and future of the family. In the face of increasingly severe men's health problems, in order to better help men solve the above health problems, a series of solutions and products have emerged on the market, such as lifestyle adjustments such as exercise and diet, health products, medicines, medicinal liquor, food tonics and other oral products, aiming to help men return to a healthier physical state and enjoy life better. However, these solutions have certain limitations. For example, although exercise and diet can help improve the overall health level, the effect is slow and the effect varies from person to person; the quality of health products and nutritional supplements varies, and some even contain unknown ingredients, and long-term use has unforeseen safety risks; medicines need to be taken under the guidance of a doctor, and long-term use will also cause physical burden; for severe prostate hyperplasia or cancer, surgical treatment is usually required, and the surgery itself has risks, and postoperative recovery takes a long time, which is not suitable for all people.

[0007] In contrast, topical products act directly on the skin or specific parts without going through the digestive system. They can act more directly and quickly on the target area, and significantly reduce the risk of systemic side effects that may be caused by oral administration. In terms of effectiveness, many modern topical care products combine advanced technology with natural ingredients, which can improve local discomfort faster and better. The significant advantages of topical products also provide new solutions to men's sub-health problems.

[0008] The present invention aims to develop a safe and effective external care product for men, which can help prevent or improve common male sub-health problems, improve men's quality of life, enhance male fertility, and solve their unspeakable problems. Based on this, this application is proposed. Summary of the invention

[0009] The purpose of the present invention is to provide an external biological preparation for reproductive maintenance and improving male function and a preparation method thereof.

[0010] According to one aspect of the present application, the present invention discloses an external biological preparation for reproductive maintenance and improving male function, which comprises the following components by weight percentage:

[0011]

[0012] In some embodiments, the following components are also included by weight percentage:

[0013]

[0014] In some embodiments, the following components are also included by weight percentage:

[0015]

[0016]

[0017] In some embodiments, the functional polypeptide is collagen amino acid, oligopeptide, heptapeptide. The present application also has the following better technical solutions based on the above components: In some embodiments, the following components are included by weight percentage:

[0018]

[0019] In some embodiments, the following components are included by weight percentage:

[0020]

[0021] In some embodiments, the following components are included by weight percentage:

[0022]

[0023]

[0024] The present invention also provides a method for preparing an external biological preparation for reproductive maintenance and improving male function, comprising the following steps:

[0025] (1) Weigh each material according to weight percentage;

[0026] (2) Add butylene glycol, magnesium sulfate, caffeine, glycerin and water into the water phase pot, heat to 85-95°C, keep warm for 30 minutes, and set aside;

[0027] (3) Add stearyl glycyrrhetinate, isononanoic acid, polydimethylsiloxane and tocopherol into an emulsifier, stir and homogenize evenly, heat to 65-85° C., keep warm for 10 minutes, and set aside;

[0028] (4) slowly adding the material obtained in step 2 to the material obtained in step 3, and homogenizing after addition;

[0029] (5) cooling the material obtained in step 4 to 50-60° C., adding tetrahydropiperine dissolved in glycerol, and stirring evenly;

[0030] (6) Cooling the material obtained in step 5 to 35-45° C., sequentially adding phenoxyethanol, Herba Cynomorii Extract, Herba Cistanches Extract, Herba Epimedii Extract, Herba Maca Extract, Herba Lycii Extract, Herba Sage Oil, functional polypeptides, arginine, oyster peptides, hippocampal peptides, Dioscorea zingiberensis Root Extract, Herba Coleus Forskohlii Root Extract, Tea Extract, Herba Cynomorii Extract, and Herba Tribulus Terrestris Extract, and stirring evenly;

[0031] (7) Cooling the material obtained in step 6 to 25-30° C., sampling and testing the material and discharging the material after passing the test to obtain the biological preparation of the present application.

[0032] The biological preparation obtained by the above materials and steps is administered through the skin in the form of solution, emulsion, gel or cream.

[0033] Prescription explanation:

[0034] Coleus forskohlii root extract: rich in forskolin, it can activate 3β-HSD reaction enzyme, increase the synthesis of androdienone, and promote the secretion of testosterone.

[0035] Tea extract: Contains polyphenol theaflavins, which can reduce the activity of 5α-reductase, thereby reducing the metabolic decomposition of androstenone, causing its accumulation and increasing its content.

[0036] Epimedium extract: Contains substances such as icariin, flavonoids and alkaloids, which can effectively stimulate the hypothalamus-pituitary-gonadal axis, promote the synthesis and secretion of sex hormones such as testosterone, and increase male sexual desire and sexual impulse; in addition, epimedium extract can inhibit the activity of type 5 phosphodiesterase, thereby increasing the activity and content of nitric oxide in the penile blood vessels, dilating blood vessels to make the penis congested, thereby enhancing the hardness and duration of erection.

[0037] Dioscorea root extract: Rich in active ingredients such as diosgenin, it can regulate the secretion of male hormones and help maintain male hormone balance by affecting the hypothalamus-pituitary-testis axis.

[0038] Arginine: It is the main component of the sperm head. Supplementing arginine is beneficial to promote sperm production, improve sperm quality and activity; at the same time, arginine can stimulate the body to secrete dopamine and other excitatory substances, act on the nervous system, bring pleasure, and thus enhance sexual desire. In addition, arginine is a direct precursor of nitric oxide, which can generate NO under the action of eNOS and increase the level of NO in the body. At the same time, activating nitric oxide synthase (eNOS) to increase the production of NO, its antioxidant effect can also reduce the oxidative decomposition of NO, enhance the stability and bioavailability of NO, and help improve erectile dysfunction.

[0039] Cynomorium songaricum extract: contains alkaloids, polysaccharides, flavonoid compounds and other ingredients. Modern medical research shows that Cynomorium songaricum can improve sexual and reproductive functions, increase testosterone content, and promote the secretion of follicle stimulating hormone (FSH) in the HPG axis, thereby promoting the proliferation of spermatogonial stem cells and promoting spermatogenesis-related genes such as Thy1, GFRα and PLZF in testicular tissue, protecting the survival of spermatogenic cells, promoting the development and differentiation of spermatogenic cells, thereby improving male spermatogenesis, improving sperm quality, and improving sexual maturity.

[0040] Oyster peptide: As a biological product extracted from oysters, it retains a variety of nutrients in oysters, such as zinc and taurine. These ingredients play an important role in male sexual function. Among them, zinc is a key mineral for promoting sperm production and improving sperm motility, and the zinc in oyster peptides can effectively supplement this nutrient, thereby improving male sexual function. In addition, oyster peptides can also increase male serum testosterone levels and further enhance male sexual function. It can promote metabolism and improve the body's immunity.

[0041] Hippocampal peptide: rich in various amino acids and trace elements, it helps to improve the quality and quantity of sperm.

[0042] Tribulus extract: Rich in tribulus saponins, new zinc elements and other ingredients, it can increase sperm count, improve sperm motility, promote testosterone secretion in the testicles, and thus improve male function. It can also increase blood testosterone levels, increase muscle strength, and enhance explosive power and endurance.

[0043] Kidney tea extract: It can enhance the metabolism and excretion function of the kidneys, thereby improving various discomfort symptoms caused by kidney deficiency. It is rich in amino acids and can enhance physical strength. Kidney tea has the effects of clearing away heat and dampness, removing stones and promoting diuresis, and can improve the phenomenon of urinary incontinence caused by prostatitis.

[0044] Cistanche deserticola extract: It has a strong antioxidant effect, can remove free radicals in the body, protect cells from oxidative damage, and regulate the male endocrine system, balance the hormone level in the body, and reduce sexual dysfunction caused by secretion disorders. It is rich in amino acids, cystine, vitamins and minerals, improves sperm quality and quantity, and enhances male fertility.

[0045] Maca extract: contains macaene, macaamide, glucosinolate, alkaloids, volatile oils and other ingredients. It is absorbed through the skin and circulated into the hypothalamus, pituitary gland and testicles of the brain, regulating the secretion of sex hormones, maintaining and restoring the sex hormones secreted by the human body to normal levels, increasing sperm count and sperm motility, thereby improving sexual function and fertility. At the same time, it also has antioxidant capacity, can relieve stress, enhance immunity, improve sleep quality, improve menopausal syndrome, and delay aging. In addition, the L-arginine component contained in maca also helps to increase the level of NO, thereby helping to improve erectile dysfunction.

[0046] Lycium barbarum extract: The Compendium of Materia Medica records its effects of "tonifying the kidney and producing essence, nourishing the liver and improving eyesight". It is rich in calcium, potassium, iron, zinc, selenium, vitamin B and vitamin C, and Lycium barbarum polysaccharides can significantly reduce the degree of lipid peroxidation in tissues, maintain the dynamic balance of the body's oxidation and antioxidant systems, protect tissue cells from free radicals, and improve the body's internal conditions and overall health level; at the same time, Lycium barbarum polysaccharides and other ingredients in Lycium barbarum can increase the content of liver glycogen and muscle glycogen in the body, thereby increasing the body's vitality, relieving fatigue and refreshing the mind.

[0047] Medicinal sage oil: It can promote the flow of lymph, help restore abnormal glandular function, and has a purifying function on the circulatory system. It can remove the accumulation of excess waste in the body, promote blood circulation, and activate blood circulation and disperse blood stasis.

[0048] Functional peptides: Peptides are bioactive substances that regulate the physiological functions of various systems and cells in the body. Collagen amino acids are the basic units of collagen, which promote collagen synthesis, anti-aging and immune support; oligopeptides can promote cell growth and repair, and improve skin elasticity; heptapeptides have high cell penetration ability and good pharmacokinetic properties, and can be used as drug carriers to accurately deliver drugs to target sites.

[0049] Compared with the prior art, the present invention has the following beneficial effects:

[0050] (1) Increase testosterone concentration levels: The main active ingredients are Coleus forskohlii root extract, tea extract, Epimedium extract, and Dioscorea zingiberensis root extract, which inhibit the activity of 5α-reductase, promote the synthesis and secretion of testosterone, and increase testosterone levels.

[0051] (2) Increase NO levels and improve erectile dysfunction: With epimedium extract, maca extract and arginine as the main ingredients, it activates nitric oxide synthase (eNOS), promotes the synthesis of NO, reduces NO degradation, enhances NO stability, and improves bioavailability. NO is an important signal molecule for vasodilation, which can dilate blood vessels and increase blood flow, thereby promoting the improvement of erectile dysfunction.

[0052] (3) Promote sperm formation and improve sperm motility: With arginine, Cynomorium songaricum extract, oyster peptide, hippocampal peptide, Tribulus terrestris extract, etc. as the main active ingredients, it supplements amino acids and minerals, promotes sperm production, and improves sperm motility.

[0053] (4) Improve inflammation, protect the gonad axis, and promote excretion: Mainly based on kidney tea extract, Cistanche extract, and Epimedium extract, they can reduce the level of inflammation, prevent urinary tract infections, activate the gonad axis, and promote the further synthesis of testosterone.

[0054] (5) Nourishing the kidneys and improving fatigue: Mainly composed of maca extract and wolfberry extract, it can provide rich nutrients, enhance muscle endurance, resist sports fatigue, promote the excretion of urea nitrogen from the body, and improve fatigue.

[0055] (6) Unblocking microcirculation and promoting the discharge of metabolic waste: With sage oil as the main active ingredient, it can promote the flow of lymph, help restore the dysfunctional glands, and purify the circulatory system. It can remove the accumulation of excess waste in the body, promote blood circulation, and activate blood circulation and relieve blood stasis.

[0056] (7) Activate cells and promote repair and regeneration: With functional peptides as the main active ingredients, such as collagen amino acids, oligopeptides, heptapeptides, etc., it promotes cell growth, differentiation and repair, improves cell vitality, and promotes cell absorption of active substances.

[0057] (8) Improve sexual function and enhance fertility: With oyster peptide, Tribulus terrestris extract, Cistanche deserticola extract, Maca extract, and Lycium barbarum extract as the main active ingredients, it can promote the secretion of testosterone in the testicles, regulate the secretion of male sex hormones and the endocrine system, balance the hormone levels in the body, thereby improving male sexual function and enhancing fertility.

[0058] The topical biological preparation of this application uses transdermal technology to achieve direct drug action on key parts, breaking through the first-pass effect, gastrointestinal dependence, low bioavailability and other problems of traditional oral products, achieving precise intervention for men's sub-health problems and avoiding the metabolic burden on the liver and kidneys. By increasing testosterone concentration and NO levels, improving inflammation, activating cell energy, promoting repair and regeneration, promoting sperm formation and vitality, and enhancing microcirculation, it can protect the gonad axis, help excrete metabolic waste from the body, improve body fatigue, improve fertility, and enhance male function, and comprehensively improve men's sub-health problems. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] Figure 1 Figure 1 is the result of the mouse behavior test; a is the behavior trajectory of the blank group; b is the swimming trajectory of the experimental group; c is the statistical diagram of the weighted swimming time of mice; d is the statistical diagram of the average speed; e is the statistical diagram of the swimming trajectory of mice;

[0060] Figure 2 This is a statistical chart of mouse sperm count;

[0061] Figure 3 It is a statistical chart of sex hormone indicators of mice; among them, a is the testosterone concentration; b is the NO concentration; c is the gonadotropin-releasing hormone concentration;

[0062] Figure 4 The above is a statistical chart of the antioxidant index results of mice; a is SOD activity; b is MDA content; c is LDH concentration. DETAILED DESCRIPTION

[0063] The present invention is further described in detail below:

[0064] Example: An external biological preparation for reproductive maintenance and improving male function, prepared according to the following requirements in terms of weight percentage:

[0065]

[0066] Among them, the functional polypeptides are collagen amino acids, oligopeptides, and heptapeptides.

[0067] The following components are also included by weight percentage:

[0068]

[0069]

[0070] The following components are also included by weight percentage:

[0071]

[0072] A method for preparing an external biological preparation for reproductive maintenance and improving male function comprises the following steps:

[0073] (1) Weigh each material according to weight percentage;

[0074] (2) Add butylene glycol, magnesium sulfate, caffeine, glycerin and water into the water phase pot, heat to 85-95°C, keep warm for 30 minutes, and set aside;

[0075] (3) Add stearyl glycyrrhetinate, isononanoic acid isononanoate, polydimethylsiloxane, and tocopherol into an emulsifier, stir and homogenize evenly, heat to 65-85° C., keep warm for 10 minutes, and set aside;

[0076] (4) slowly adding the material obtained in step 2 to the material obtained in step 3, and homogenizing after addition;

[0077] (5) cooling the material obtained in step 4 to 50-60° C., adding tetrahydropiperine dissolved in glycerol, and stirring evenly;

[0078] (6) Cooling the material obtained in step 5 to 35-45° C., sequentially adding phenoxyethanol, Herba Cynomorii Extract, Herba Cistanches Extract, Herba Epimedii Extract, Herba Maca Extract, Herba Lycii Extract, Herba Sage Oil, functional polypeptides, arginine, oyster peptides, hippocampal peptides, Dioscorea zingiberensis Root Extract, Herba Coleus Forskohlii Root Extract, Tea Extract, Herba Cynomorii Extract, and Herba Tribulus Terrestris Extract, and stirring evenly;

[0079] (7) Cooling the material obtained in step 6 to 25-30° C., sampling and testing the material and discharging the material after passing the test to obtain the biological preparation of the present application.

[0080] The biological preparation obtained by the above materials and steps is administered through the skin in the form of solution, emulsion, gel or cream. The effect examples and clinical examples of the present application adopt cream.

[0081] The specific operation method is as follows:

[0082] 1. Take an appropriate amount of the cream prepared in this application and apply it on the back of the body in the shape of Bagua, clockwise for 5 times.

[0083] 2. Open the acupoints, rub the Mingmen acupoint with your palms together, and press the Shenshu acupoint and Qihai acupoint with the tips of your thumbs for 5 seconds. Rub the Mingmen acupoint, Shenshu acupoint, and press the Qihai acupoint.

[0084] 3. Loosen the longissimus lumborum and splenius muscles, push the splenius muscles from bottom to top with the thumbs of both hands, push from the long and strong point to the gate of life, and then push the longissimus lumborum. Push the long point 3 times, and rub the inch point 5-10 times.

[0085] 4. Press the quadratus lumborum and latissimus dorsi horizontally from outside to inside, using the thumbs of both hands to press 5-8 times.

[0086] 5. Push the Baliao and move the iliac sutures horizontally. Push the upper end of the sacrum with the thumbs of both hands, and then push the sacral sutures on both sides from the inside to the outside. Push the Baliao in a fan shape with Changqiang as the center. Move the iliac sutures on both sides horizontally from the outside to the inside 3-5 times with the thumbs of both hands. Press the Huantiao acupoint for 3 seconds. Rub the Baliao to warm it up. Rub the Baliao coccyx with the hypothenar of both hands 50-60 times alternately.

[0087] 6. Open the acupoints. Press the Shenque acupoint with your thumbs, and then press the Qihai, Guanyuan, and Zhongji acupoints with your thumbs. Press each acupoint for 20 seconds, and do it 3 times. Press the Qihai, Guanyuan, and Zhongji acupoints.

[0088] 7. Rub the lower abdomen with your palms together, starting from Shenque to Qugu, and rub the lower abdomen downwards with four fingers in three vertical lines. First, rub with four fingers together for 5-10 times, then rub with the thumbs downwards for 5-10 times.

[0089] 8. Stroke the groin. Use both hands to divide the hip joint into two lines and move along the bone gap to the groin. Rub one side with your fingers 10 times.

[0090] 9. Press the urgent pulse with your palm, and press the urgent pulse on the inner thigh with the hypothenar eminence.

[0091] 10. Press the acupoints with your fist. Use the flat of your fist to press the Qihai, Guanyuan and Zhongji points for 30 seconds to 1 minute.

[0092] 11. Soothe your lower abdomen, rub your hands together to warm them up, and apply a massage to your lower abdomen.

[0093] Effect embodiment:

[0094] 1. Frosting treatment

[0095] Ten adult male mice were taken and divided into a blank group (CTR) and an experimental group, with 5 mice in each group. The abdominal hair of the experimental group was removed, and no other treatment was performed on the blank group. Each mouse in the experimental group was smeared with 500 mg of the cream prepared in the present application, once a day, 5 days a week, and continuously applied for 8 weeks.

[0096] 2. Improve fatigue effect evaluation

[0097] Improvement in exercise endurance is the most powerful macroscopic manifestation of enhanced anti-fatigue ability. The length of time for weighted swimming can reflect the degree of animal exercise fatigue. Swimming weighted experiments are conducted every two weeks. No cream is applied on the day of the experiment. Lead is attached to the middle of the mouse's tail (the weight of the lead is 7% of the mouse's body weight). Each mouse is then placed in a swimming bucket (the volume of the swimming bucket is 30cm×30cm×60cm), the water depth in the swimming bucket is 40cm, and the temperature is 25±1°C. The exhaustive swimming time of each mouse is recorded, that is, the time is started when the mouse is placed in the bucket, and the mice maintain swimming activities until they sink to the bottom of the swimming bucket and fail to rise to the surface of the water to breathe within 10s. A weighted swimming experiment is conducted before the end of the experiment, and the average swimming speed and movement trajectory of the mice in the first two minutes are recorded.

[0098] Depend on Figure 1 It can be seen that after using the cream prepared in the present application for 8 weeks, the swimming time, speed and total distance of the mice in the experimental group increased by 27.5%, 86.4% and 21.7% respectively compared with the blank group.

[0099] 3. Fertility index assessment: sperm count measurement

[0100] After 8 weeks, the two groups of mice were killed, and the bilateral epididymis was separated, washed with saline, dried with filter paper, weighed, and placed in a test tube containing 0.5 mL of saline, cut into pieces, blown into a suspension, and the volume was fixed to 1 mL with saline to prepare the sperm suspension. 10 μl of sperm suspension was dropped onto the cell counting plate, and the number of sperm in the four squares was counted under a 10x microscope. When counting, the left side of the sperm head on the line was counted but not the right side, and the top was counted but not the bottom. The number of sperm per milliliter is: total number of sperm in the cell counting plate / 4×104×dilution factor.

[0101] Depend on Figure 2 It can be seen that the sperm count statistics showed that the sperm count of mice in the experimental group increased by 74.1% compared with the blank group.

[0102] 4. Sex hormone index assessment: testosterone, NO, gonadotropin-releasing hormone level detection

[0103] After 8 weeks, the mice in both groups were killed, their eyeballs were removed and blood was collected, and the blood was kept at room temperature for 30 minutes, placed at 4°C for 1 hour, and centrifuged at 3000r / min for 15 minutes. The upper serum (50μL, undiluted) was taken for testosterone and NO kit detection.

[0104] Depend on Figure 3 It can be seen that after continuous application of the cream prepared by the present application for 8 weeks, the concentrations of testosterone and NO in the serum of the experimental group mice were significantly higher than those of the blank group, and there was a significant difference. At the same time, the level of gonadotropin-releasing hormone in the experimental group was also lower, indicating that the preparation of the present application can regulate hormone levels through the hypothalamus-pituitary-gonadal axis.

[0105] 5. Testis maintenance effect evaluation: Antioxidant index SOD, malondialdehyde (MDA), lactate dehydrogenase (LDH) content determination

[0106] At the 8th week, the two groups of mice were killed, and the testicular tissues of the mice were ground and mixed with lysis buffer (RIPA) and protease inhibitor (PMSF) (RIPA:PMSF=100:1) and then ultrasonically broken (ultrasonication for 5s, stop for 10s, and this cycle for 1min), vortexed for 1min, and ice bathed for 3min. After the above operation was repeated 10 times, centrifuged at 3000r / min for 10min (4℃), and the supernatant was aspirated to obtain tissue homogenate. The total protein concentration was quantified using the BCA kit, and the SOD activity, MDA and LDH concentrations were detected respectively.

[0107] In order to evaluate the protective effect of the preparation of the present application on mouse testicular tissue, the contents of SOD, MDA and LDH in mouse testicular tissue were detected and analyzed. Figure 4 It can be seen that the preparation of the present application can increase the SOD enzyme activity and reduce the MDA content in the testis to varying degrees. Compared with the blank group, the SOD enzyme activity of the experimental group increased by 24.5%, and the MDA content decreased by 24.5%. Thus, the antioxidant activity of the testis is significantly enhanced, the spermatogenic ability of spermatogenic cells is enhanced, and the LDH concentration is increased.

[0108] In summary, the biological preparation of the present application can increase the testosterone concentration level and NO level; can promote sperm formation and increase sperm count; improve the antioxidant level of testosterone tissue and help protect the gonad axis; and also has a good effect on improving fatigue, etc. By improving the above multi-dimensional indicators, it helps to improve sexual function and fertility.

[0109] Clinical Examples:

[0110] 1. Mr. Tang, 36 years old, office worker, clerical work. He often felt tired and had sore waist and hip muscles. He used the biological preparation of the present application 3 times, 50g each time, to massage the waist, hips and groin area. After using it for 3 times in a row, he felt a significant sense of relaxation in the lower body, the pigmentation of the waist was reduced, and the muscle soreness was reduced.

[0111] 2. Mr. Li, 60 years old, is preparing to retire. He often feels heavy and weak, and has a sense of fatigue. He uses the biological preparation of this application to massage the waist, hips and groin area once a week, 50g each time. After using it 7 times, his body feels much lighter and he feels more energetic.

[0112] 3. Mr. Tang, 28 years old, engaged in research and development. He said that he was under great pressure at work, started to lose hair, had low energy, and was prone to insomnia. He insisted on massaging the waist, hips and lower abdomen with the biological preparation of this application once a week, 50g each time. After using it for 4 times in a row, he felt that his fatigue was much reduced, he was not so tired, and his spirit was much better than before. He currently has no sex life and no comparison was made in this regard.

[0113] 4. Mr. Huang, 55 years old, works as a factory security guard. He reported white urine, urethral discomfort, urinary retention, burning sensation, dull pain in the lower abdomen, frequent nighttime waking up, which seriously affected his sleep and quality of life. He used 100g of the biological preparation of this application to massage the waist, buttocks, lower abdomen, groin and other parts. After one massage, the impact of urination on the next day was enhanced, and the discomfort in the urethra and lower abdomen was reduced. After using it 3 times, the white urine dripping situation disappeared. After using it 6 times, the number of nighttime waking up decreased, and the mental state was better. The frequency of use is now 1-2 times a week.

[0114] 5. Mr. Zhang, 48 years old, works in factory management. He suffers from prostate hypertrophy, prostatitis and prostate calcification. He usually needs to go to the toilet every half an hour and his urination is not smooth. After using 100g of the biological preparation of the present application and massaging once according to the instructions, he only needs to go to the toilet once every 2 hours, and his urination becomes clear and smooth.

[0115] 6. Mr. Li, 50 years old, works in sales. He suffers from prostatitis and usually feels pain when urinating. After using 80g of the biological preparation of the present application and massaging the waist, hips, lower abdomen, groin and other parts twice, he urinates more smoothly and easily, and the discomfort is significantly improved.

[0116] 7. Mr. Liang, 36 years old, engaged in research and development. He has a sore waist due to long-term sitting, and has gradually shown signs of baldness. He has sex 1-2 times a week but feels powerless. He insists on using the biological preparation of this application and massaging the buttocks and lower abdomen with manual massage, once a day for the first 3 days, once for the next 5 days, 50g each time, and after using it for 1 month, he said that he felt much more relaxed after sex and the time was extended by about 3 minutes. He felt very good, and the fatigue after sex was reduced, and the whole person felt full of energy. Now he has sex 2-3 times a week.

[0117] 8. Mr. Gao, 30 years old, works in IT and often works overtime. He has sex, but his wife did not get pregnant 2 years after marriage. After examination, he was diagnosed with premature ejaculation and mild asthenozoospermia and oligospermia. He used the biological preparation of this application and massaged the buttocks, lower abdomen and groin, 50g each time, once every 5 days. After 2 months of use, the symptoms of premature ejaculation disappeared, and he continued to use it for several months. At the follow-up, his wife was pregnant.

[0118] In summary, the biological preparation of the present application breaks through the limitations of traditional oral products such as first-pass effect, gastrointestinal dependence, and low bioavailability through transdermal application, and achieves precise intervention for men's sub-health problems. It can increase testosterone concentration levels and NO levels, which helps to improve male function; it can enhance the antioxidant level of testosterone tissue, protect the gonad axis, and promote excretion; it can improve energy and improve fatigue; at the same time, it can promote sperm formation and improve sperm motility, which is expected to improve fertility.

[0119] In clinical trials, the biological preparation of the present application can improve physical fatigue, enhance energy and improve mental state, stimulate sexual desire and improve erectile dysfunction; at the same time, it can help regulate prostate problems and improve problems such as frequent urination, painful urination and urinary discomfort caused by prostate hyperplasia, prostatitis and prostate hypertrophy. At the same time, the preparation of the present invention is easy to use, can achieve the desired effect through transdermal use, reduces the metabolic burden of the human liver, and can be used for a long time.

[0120] The above are only some embodiments of the present invention. For those skilled in the art, several modifications and improvements can be made without departing from the creative concept of the present invention, which all belong to the protection scope of the present invention.

Claims

1. A topical biological preparation for reproductive maintenance and male function enhancement, characterized in that: By weight percentage, it includes the following components:

2. The external biological preparation for reproductive maintenance and male function enhancement according to claim 1, characterized in that: The following components are also included by weight percentage:

3. The external biological preparation for reproductive maintenance and male function enhancement according to claim 2, characterized in that: The following components are also included by weight percentage:

4. The external biological preparation for reproductive maintenance and male function enhancement according to claim 1, characterized in that: The functional polypeptides are collagen amino acids, oligopeptides and heptapeptides.

5. The external biological preparation for reproductive maintenance and male function enhancement according to claim 1, characterized in that: By weight percentage, it includes the following components:

6. The external biological preparation for reproductive maintenance and male function enhancement according to claim 2, characterized in that: By weight percentage, it includes the following components:

7. The external biological preparation for reproductive maintenance and male function enhancement according to claim 3, characterized in that: The following components are also included by weight percentage:

8. The method for preparing the external biological preparation for reproductive maintenance and male function enhancement according to any one of claims 1 to 7, characterized in that: The following steps are involved: (1) Weigh each material according to weight percentage; (2) Add butylene glycol, magnesium sulfate, caffeine, glycerin and water into the water phase pot, heat to 85-95°C, keep warm for 30 minutes, and set aside; (3) Add stearyl glycyrrhetinate, isononanoic acid, polydimethylsiloxane and tocopherol into an emulsifier, stir and homogenize evenly, heat to 65-85° C., keep warm for 10 minutes, and set aside; (4) slowly adding the material obtained in step 2 to the material obtained in step 3, and homogenizing after addition; (5) cooling the material obtained in step 4 to 50-60° C., adding tetrahydropiperine dissolved in glycerol, and stirring evenly; (6) Cooling the material obtained in step 5 to 35-45° C., sequentially adding phenoxyethanol, Herba Cynomorii Extract, Herba Cistanches Extract, Herba Epimedii Extract, Herba Maca Extract, Herba Lycii Extract, Herba Sage Oil, functional polypeptides, arginine, oyster peptides, hippocampal peptides, Dioscorea zingiberensis Root Extract, Herba Coleus Forskohlii Root Extract, Tea Extract, Herba Cynomorii Extract, and Herba Tribulus Terrestris Extract, and stirring evenly; (7) Cooling the material obtained in step 6 to 25-30° C., sampling and testing the material and discharging the material after passing the test to obtain the biological preparation of the present application.

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