A composition for improving male sexual function and resisting fatigue, and a preparation method and application thereof

Abstract

The application discloses a composition for improving male sexual function and resisting fatigue, a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The composition provided by the application can promote testosterone synthesis and secretion, maintain normal testosterone level of the body, improve blood perfusion of gonadal tissue, enhance mitochondrial function of gonadal cells, delay testicular aging, and further achieve the effects of enhancing sexual desire, erectile function, improving premature ejaculation and spermatorrhea; the composition also has the effects of protecting nerves and cell tissues from oxidative damage, repairing damaged tissues, reducing penile sensitivity, and effectively improving or curing premature ejaculation; and the composition can improve sleep and psychological barriers / stress, and improve the anti-fatigue capacity by providing sufficient kidney essence and blood and qi for the body.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, and in particular to a composition for improving male sexual function and relieving fatigue, its preparation method and application. Background Technology

[0002] Male sexual function refers to the comprehensive ability of the male reproductive system to play a role in sexual behavior, reproduction, and hormonal regulation. It mainly includes libido, erection, ejaculation, sexual pleasure, and fertility. Abnormalities in sexual arousal, erection, ejaculation, or sexual satisfaction caused by physiological factors, psychological factors, or lifestyle habits, leading to difficulties or inability to complete sexual intercourse, are called male sexual dysfunction. Common types include: 1) Erectile dysfunction (ED); 2) Premature ejaculation; 3) Decreased libido; and 4) Delayed ejaculation / anejaculation.

[0003] Long-term sexual dysfunction can easily lead to psychological problems such as anxiety, depression, and low self-esteem, seriously interfering with normal social and work performance. Psychological stress and sexual dysfunction form a vicious cycle, further aggravating the condition. Long-term psychological stress can also interfere with sleep quality, reduce daily energy levels, and exacerbate physical and mental fatigue. Low self-esteem can also weaken workplace confidence and work efficiency, and even lead to social avoidance. Sexual imbalance can also cause sexual apathy in partners, affecting the relationship, reducing family satisfaction, and disrupting the harmonious family atmosphere.

[0004] Currently, medications for treating male sexual dysfunction often suffer from the problem of treating only the symptoms, not the root cause. For example, medications for erectile dysfunction (ED) often use PDE5 inhibitors (such as sildenafil and tadalafil), medications for premature ejaculation use local anesthetics (such as lidocaine gel), and medications for decreased libido use androgen replacement therapy (such as testosterone undecanoate). Furthermore, these medications can cause side effects such as facial flushing, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rashes, and even polycythemia.

[0005] Therefore, it is of great significance to develop traditional Chinese medicine compositions that can fundamentally treat or alleviate male sexual dysfunction, have few toxic side effects on the body, or be beneficial to health. Summary of the Invention

[0006] The purpose of this invention is to provide a composition for improving male sexual function and relieving fatigue, as well as its preparation method and application, so as to provide a traditional Chinese medicine composition that fundamentally treats or alleviates male sexual dysfunction, has few toxic side effects on the body, and is beneficial to health.

[0007] To achieve the above objectives, the present invention provides a composition for improving male sexual function and relieving fatigue, comprising Cistanche deserticola, Polygonatum sibiricum, Cornus officinalis, Lycium barbarum, Cordyceps militaris fruiting body, fish maw polypeptide, deer skin glue, Rehmannia glutinosa, Dioscorea opposita, Eucommia ulmoides leaf, and Grifola frondosa.

[0008] Preferably, the components include the following parts by weight: 15-20 parts Cistanche deserticola, 5-10 parts Polygonatum sibiricum, 10-15 parts Cornus officinalis, 3-8 parts Lycium barbarum, 3-8 parts Cordyceps militaris fruiting body, 10-15 parts fish maw polypeptide, 15-20 parts deer skin glue, 3-8 parts Rehmannia glutinosa, 10-15 parts Dioscorea opposita, 5-10 parts turtle shell edge, 3-8 parts Eucommia ulmoides leaf, and 10-15 parts Grifola frondosa.

[0009] Preferably, the components include the following parts by weight: 15 parts Cistanche deserticola, 5 parts Polygonatum sibiricum, 10 parts Cornus officinalis, 3 parts Lycium barbarum, 3 parts Cordyceps militaris fruiting body, 10 parts fish maw polypeptide, 15 parts deer skin glue, 3 parts Rehmannia glutinosa, 10 parts Dioscorea opposita, 5 parts turtle shell edge, 3 parts Eucommia ulmoides leaf, and 10 parts Grifola frondosa.

[0010] Preferably, the components include the following parts by weight: 20 parts Cistanche deserticola, 10 parts Polygonatum sibiricum, 15 parts Cornus officinalis, 8 parts Lycium barbarum, 8 parts Cordyceps militaris fruiting body, 15 parts fish maw polypeptide, 20 parts deer skin glue, 8 parts Rehmannia glutinosa, 15 parts Dioscorea opposita, 10 parts turtle shell edge, 8 parts Eucommia ulmoides leaf, and 15 parts Grifola frondosa.

[0011] Preferably, the components include the following parts by weight: 17 parts Cistanche deserticola, 6 parts Polygonatum sibiricum, 12 parts Cornus officinalis, 7 parts Lycium barbarum, 8 parts Cordyceps militaris fruiting body, 13 parts fish maw polypeptide, 20 parts deer skin glue, 8 parts Rehmannia glutinosa, 15 parts Dioscorea opposita, 10 parts turtle shell edge, 8 parts Eucommia ulmoides leaf, and 13 parts Grifola frondosa.

[0012] The preparation method of the composition for improving male sexual function and relieving fatigue as described above includes the following steps: S1. Weigh each component according to the proportion and remove surface dust and impurities; dry the Cistanche deserticola, Polygonatum sibiricum, Dioscorea opposita, and Eucommia ulmoides leaves at 60-80℃ and then pulverize them separately through a 60-80 mesh sieve; S2. After mixing the powders obtained in S1, add ultrapure water to allow each component powder to fully absorb water. Then add twice the volume of ultrapure water and maintain the temperature at 30-45°C with stirring until the water content is 45-55%. S3. Chop the dried Cornus officinalis, Lycium barbarum, Rehmannia glutinosa, Trionyx sinensis, Grifola frondosa, and Cordyceps militaris fruiting bodies into pieces no larger than 5 mm in diameter. Then, add 1 volume of corn oil to each of the chopped Lycium barbarum, Rehmannia glutinosa, and Cordyceps militaris fruiting bodies and homogenize them by ultrasonication. Add 1 volume of ultrapure water to each of the Cornus officinalis, Trionyx sinensis, and Grifola frondosa and homogenize them by ultrasonication. S4. Dissolve the deerskin glue in 2 times the volume of ultrapure water at 80~100℃, and stir at 200rpm at 80~100℃ until completely dissolved, then continue stirring for 1 hour; S5. Dissolve the fish maw peptides in 1 volume of ultrapure water. S6. Mix the homogenate obtained in S3, the deer skin glue solution after stirring in S4, and the fish maw polypeptide solution obtained in S5 evenly, and add them in batches to the mixture with a water content of 45-55% obtained in S2, and stir until well mixed. S7. Evaporate the mixture obtained in S6 to a moisture content of 60% under stirring at 30~45℃, then dry it at 60~65℃ to a moisture content of 25~35%, and knead it into balls.

[0013] Preferably, the ultrasonic homogenization conditions in S3 are 4℃ and 25KHz.

[0014] Preferably, S7 is replaced by: stirring the mixture obtained in S6 at 30~45°C until the water content is 60%, then drying it at 60~65°C and pulverizing it into powder.

[0015] The use of the composition for improving male sexual function and relieving fatigue as described above in the preparation of a drug for improving male sexual function, wherein the drug uses the composition for improving male sexual function and relieving fatigue as an active ingredient.

[0016] Cistanche deserticola (Cistanche deserticola Ma.) is a tall herbaceous plant belonging to the genus Cistanche in the family Orobanchaceae. It is a succulent plant with mild and moderate medicinal properties, hence its name. It has high medicinal value and is known as "desert ginseng." According to the *Compendium of Materia Medica* and *Rihuazi Materia Medica*, Cistanche deserticola can be used to treat kidney yang deficiency, depletion of essence and blood, lower back and knee pain, tinnitus, blurred vision, leukorrhea, frequent urination, metrorrhagia, infertility, and constipation. On November 9, 2023, it was listed as a "substance that is traditionally both a food and a medicinal herb."

[0017] Cistanche deserticola contains a variety of active substances, including phenylethanoid glycosides, iridoids, lignans, polysaccharides, more than a dozen amino acids, and various alkaloids. It is also rich in trace elements essential for the human body, including zinc. The total phenylethanoid glycosides are the main active ingredient in Cistanche deserticola, stimulating testicular interstitial cells, promoting testosterone synthesis and secretion, and reducing the breakdown of testosterone metabolites. Continuous use can significantly increase serum testosterone concentration, regulate hormone balance, promote luteinizing hormone secretion, improve sperm quality, and alleviate hypogonadism. Furthermore, Cistanche deserticola can act on hypothalamic gonadotropin-releasing neurons, increasing the pulsed release of luteinizing hormone, improving the spermatogenesis microenvironment, optimizing the sperm maturation environment, reducing sperm DNA fragmentation rate, and increasing sperm density and forward motility. In addition, Cistanche deserticola improves blood perfusion in gonadal tissues through multiple targets, enhances mitochondrial function in gonadal cells, and delays testicular aging. It can also scavenge free radicals in the reproductive system and protect the seminiferous epithelium from oxidative damage.

[0018] Polygonatum ( Siberian Polygonum*Polygonatum sibiricum* (Delar. ex Redoute) is a perennial herb belonging to the order Asparagales, family Liliaceae, and genus *Polygonatum*. The ancient Chinese medical text *Baopuzi* records, "The ancients believed this herb received the qi of the earth and the essence of heaven and earth, hence its name." The rhizome of *Polygonatum sibiricum* can be used medicinally. It is sweet in taste, neutral in nature, and enters the spleen, lung, and kidney meridians. It has the effects of nourishing yin and moistening the lungs, tonifying the spleen and replenishing qi, and nourishing the kidneys and replenishing essence. In cosmetics, it also has antibacterial, anti-aging, whitening, moisturizing, and sun protection properties.

[0019] The active ingredients in Polygonatum include Polygonatum polysaccharides, flavonoids, saponins, alkaloids, amino acids, and trace elements. This traditional Chinese medicine has the effects of replenishing Qi and nourishing Yin, enhancing physical strength, relieving fatigue, and improving symptoms such as dry mouth and throat, and soreness in the lower back and knees. It can also help regulate blood sugar and blood lipid levels, alleviate problems such as decreased appetite and indigestion caused by spleen and stomach weakness; help replenish the body's nutrients, relieve fatigue, and improve dry mouth and throat; enhance gastrointestinal function, improve loss of appetite and abdominal distension, relieve dry cough and throat discomfort, and regulate symptoms such as weakness in the lower back and legs, easy fatigue, and frequent urination at night.

[0020] Cornus officinalis, a Chinese medicinal herb, refers to the plant Cornus officinalis, belonging to the Cornaceae family. Cornus officinalis The dried, ripe pulp of Sieb. et Zucc. is sour and astringent in taste, slightly warm in nature, and enters the liver and kidney meridians. It has the effects of tonifying the liver and kidneys, astringing and consolidating, and is often used for dizziness and tinnitus, soreness of the waist and knees, impotence and seminal emission, enuresis and frequent urination, metrorrhagia and leukorrhea, profuse sweating and collapse, and internal heat and thirst.

[0021] Goji berries, a traditional Chinese medicine, are the mature fruit of the Lycium barbarum plant, belonging to the Solanaceae family. They are sweet and neutral in nature, and enter the liver and kidney meridians. They nourish the kidneys, moisten the lungs, tonify the liver, and improve eyesight. They are effective in treating liver and kidney yin deficiency, soreness and weakness of the lower back and knees, dizziness, blurred vision with excessive tearing, consumptive cough, thirst, and seminal emission.

[0022] Cordyceps militaris ( Cordyceps militaris *Cordyceps militaris* (L. ex Fr.) Link. is a fungus belonging to the Clavicipitaceae family and the *Cordyceps* genus. Also known as North Cordyceps, it is a complex composed of the stroma (fruiting body, the grass-like part) and the sclerotium (the insect-like part). It is a fungus used for both food and medicine. Its protein content is as high as 40.7%, 15.25% higher than that of *Cordyceps sinensis* (25.4%). Its protein contains 19 amino acids, including all the essential amino acids in sufficient quantities and in appropriate proportions, essentially consistent with *Cordyceps sinensis*. Artificially cultivated *Cordyceps militaris* also contains abundant vitamins and minerals, making it highly valuable. The stroma of *Cordyceps militaris* can be used medicinally; it is neutral in nature and sweet in taste, benefiting the lungs and kidneys, stopping bleeding and resolving phlegm. It is generally used for tuberculosis, weakness in the elderly, and anemia. Fish maw peptides are small-molecule collagen peptides extracted from the swim bladders of deep-sea cold-water fish fry. With a molecular weight of approximately 2000-5000 Daltons, they are rich in amino acids, trace elements, and other nutrients, making them easily absorbed by the human body. Their absorption rate is approximately 90%, higher than ordinary collagen (about 30%), and they contain more active peptides, resulting in more significant effects. In addition, they contain glycine, proline, and hydroxyproline, essential components for maintaining healthy skin and ligaments, regulating immune cell activity, and helping to repair damaged tissues. They also contain minerals such as calcium, iron, and zinc, which participate in bone metabolism and immune regulation; and mucopolysaccharides such as hyaluronic acid, which help retain moisture and enhance the skin barrier function.

[0023] Deer hide glue is a traditional Chinese medicine made from the hide of sika deer or red deer. It has a salty taste, warm properties, and enters the liver and kidney meridians. According to the *Compendium of Materia Medica*, deer hide glue has the effects of tonifying qi, astringing essence, and healing sores, and is mainly used to treat weakness, soreness of the waist and knees, etc. In the *Shennong's Classic of Materia Medica*, it is listed as a superior medicine, capable of strengthening yang, tonifying qi and blood, with effects comparable to deer antler. Modern research shows that deer hide glue contains various amino acids and trace elements such as zinc and germanium, as well as acidic polysaccharides, and also has the effects of tonifying blood and stopping bleeding, tonifying the kidneys, and enhancing immunity.

[0024] Rehmannia glutinosa, a traditional Chinese medicine, is the fresh or dried tuberous root of the plant Rehmannia glutinosa Libosch., belonging to the Scrophulariaceae family. It can be used fresh or processed. Depending on the processing method, processed Rehmannia glutinosa is divided into raw Rehmannia glutinosa (sun-dried) and prepared Rehmannia glutinosa (steamed). Prepared Rehmannia glutinosa has the effects of nourishing blood and replenishing essence, benefiting the liver and kidneys, with a focus on nourishing liver blood. It also improves heart function and nourishes the kidneys. It is used to improve pale complexion, dizziness, palpitations, and scanty menstruation caused by blood deficiency, and to regulate lower back and knee weakness, tinnitus, and premature graying of hair caused by liver and kidney deficiency.

[0025] Yam ( Dioscorea polystachya Turcz. is a tonic food that is both food and medicine. It not only contains nutrients such as starch, protein, fat, free amino acids, vitamins, and minerals, but also active ingredients such as polysaccharides, saponins, allantoin, polyphenols, protein peptides, and flavonoids. Its main function is to enhance the function of the spleen, stomach, and lungs, improve problems such as loss of appetite and indigestion, and at the same time improve the body's resistance and relieve fatigue. It is suitable for people who are weak, easily fatigued, have poor appetite, or suffer from chronic diarrhea to use for daily conditioning.

[0026] The edge of a tortoise shell is the soft tissue along its edge. Traditional Chinese medicine believes it has the effects of nourishing yin and kidneys, strengthening muscles and bones, nourishing blood and calming the mind. It is often used to improve physical weakness, lower back and knee pain, and insomnia. It is also rich in collagen, natural chondroitin, amino acids, and minerals, which can promote bone development, increase bone density, improve bone toughness, and contribute to beauty, skin health, and enhanced immunity.

[0027] Eucommia ulmoides leaves are slightly pungent and warm in nature, and enter the liver and kidney meridians. They have the effects of tonifying the liver and kidneys, strengthening tendons and bones, and lowering blood pressure. They are mainly used to treat symptoms such as liver and kidney deficiency, soreness and weakness of the waist and knees, and weakness of tendons and bones. They are also rich in nutrients, including VB1, VE, β-carotene, 17 kinds of free amino acids, 15 kinds of trace elements such as germanium and selenium, linoleic acid (1.59%), linolenic acid (45.85%), as well as flavonoids, iridoids, phenylpropanoids, lignans, polysaccharides, and active ingredients such as Eucommia ulmoides rubber.

[0028] Grifola frondosa is a fungus used in both food and medicine. It is rich in nutrients such as dietary fiber, protein, potassium, selenium, iron, and vitamin D, which help regulate immunity, provide antioxidant benefits, and have a certain auxiliary effect on cardiovascular health.

[0029] Therefore, the present invention provides a composition for improving male sexual function and relieving fatigue, a method for preparing the composition, and its application. The specific technical effects are as follows: (1) Phenylehnic acid glycosides in Cistanche deserticola can promote the synthesis and secretion of testosterone and reduce its metabolism; the zinc element contained in Cistanche deserticola, Cordyceps militaris fruiting body, Polygonatum sibiricum, fish maw polypeptide, deer skin glue, and Eucommia ulmoides leaves can help maintain normal testosterone levels by participating in testosterone synthesis, regulating the secretion of related hormones and protecting testicular function; Cistanche deserticola can also improve the blood perfusion of gonadal tissues through multiple targets, enhance the mitochondrial function of gonadal cells, delay testicular aging, and thus achieve the effects of enhancing libido, erectile function, and improving premature ejaculation and spermatorrhea. (2) Phenylehnic acid glycosides, polysaccharides, flavonoids and iridoids in Cistanche deserticola; polysaccharides, saponins and flavonoids in Polygonatum sibiricum; strychnine, monosodium glutamate and other compounds in Cornus officinalis; Lycium barbarum polysaccharides, carotenoids, vitamin C and flavonoids and other compounds in Lycium barbarum; superoxide dismutase, cordycepic acid and other polyphenols in Cordyceps militaris fruiting bodies; vitamin C and carotene in Rehmannia glutinosa; abundant vitamin C, vitamin E and viscous protein in Dioscorea opposita; flavonoids, amino acids and vitamins in Trichosanthes kirilowii and Eucommia ulmoides leaves; Grifola frondosa polysaccharides in Grifola frondosa all have strong antioxidant effects. Collagen peptides in fish maw and deer skin glue also have certain antioxidant effects. They can remove free radicals in the body, reduce the damage of oxidative stress to (nerve) cells, repair damaged cells and restore the smoothness of neural networks. (3) While providing protection to tissue cells through antioxidant effects, the penile tissue damage is repaired and the skin barrier function is enhanced under the action of abundant short peptides, collagen peptides and hyaluronic acid and other mucopolysaccharides in fish maw polypeptides and deer skin glue. Nerve endings are covered by healthy tissue cells and skin and are no longer exposed, resulting in decreased penile sensitivity and effectively relieving / treating premature ejaculation. In addition, the addition of Cornus officinalis and Lycium barbarum also helps to enhance the body's control over semen. (4) Essence and blood are the basic substances for maintaining life and reproductive activities in traditional Chinese medicine theory. High psychological stress, poor sleep, sexual activity, etc. can all deplete kidney essence, leading to kidney yang deficiency and physical and mental fatigue. This situation will further aggravate the depletion of kidney essence. The patient's self-confidence will be even worse, and sexual dysfunction will be further aggravated, thus forming a vicious cycle. Polygonatum tonifies the spleen and replenishes qi, enhancing gastrointestinal function; Cornus officinalis removes wind-evil from the stomach and intestines; Dioscorea opposita enhances the spleen, stomach, and lung functions, increases appetite, and improves digestive ability. Together, they enhance the body's ability to digest and utilize ingested nutrients, and replenish the blood and nutrients required by the body. Polygonatum, Cordyceps militaris fruiting bodies, and Dioscorea opposita benefit the lungs, enhance lung function, provide sufficient oxygen supply for the normal operation of all parts of the body, increase blood oxygen content, and promptly expel waste gas from the body; Cistanche deserticola treats kidney yang deficiency, depletion of essence and blood, and relieves fatigue; Polygonatum sibiricum nourishes the kidneys and replenishes essence, relieving fatigue; Cornus officinalis, Lycium barbarum, and Eucommia ulmoides leaves tonify the liver and kidneys, and treat lower back and knee pain; Cordyceps militaris fruiting bodies benefit the lungs and kidneys; deer skin glue tonifies blood and kidneys; Rehmannia glutinosa tonifies blood and replenishes essence, and benefits the liver and kidneys; Dioscorea opposita relieves fatigue; and Trionyx sinensis var. sinensis tonifies yin and kidneys, nourishes blood and calms the mind. Together, they improve liver and kidney function, promote the body's use of absorbed nutrients to generate blood, promote blood circulation, and thus provide the body with sufficient essence and blood. Polygonatum helps the body regulate blood sugar and blood lipid levels; Rehmannia glutinosa improves heart function; Eucommia ulmoides leaves lower blood pressure; and Grifola frondosa has a certain auxiliary effect on cardiovascular health. Together, they help maintain the health of blood vessels and blood. The tortoise shell edge strengthens muscles and bones and improves bone toughness; fish maw peptides maintain skin and ligament health; Eucommia ulmoides leaves strengthen muscles and bones; under the blood-nourishing and calming effects of the tortoise shell edge, it promotes a peaceful state of mind and improves sleep quality, which has a positive effect on relieving psychological stress and increasing kidney yang. With the support of a healthy heart, muscles and bones and sufficient qi and blood, fatigue is effectively relieved. (5) All the components in this invention are food and medicine materials. With proper configuration, they have very little toxic side effects on the body, which can even be ignored. They also contain rich nutrients and can be used to replenish the body's essence and blood, thereby fundamentally improving or treating male sexual dysfunction.

[0030] The technical solution of the present invention will be further described in detail below through embodiments. Detailed Implementation

[0031] The technical solution of the present invention will be further described below through embodiments.

[0032] To make the objectives, technical solutions, and advantages of this application clearer, more thorough, and more complete, the technical solutions of the present invention are clearly and completely described below through embodiments. The following detailed descriptions are all illustrations of embodiments, intended to provide further detailed explanations of the present invention. Unless otherwise specified, all technical terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0033] The instruments, equipment, reagents, and materials used in the examples were all obtained commercially.

[0034] Example 1 The specific steps for preparing a composition to improve male sexual function and combat fatigue are as follows: S1. Remove impurities from each component, then rinse with running water to remove surface dust, and dry in an oven at 60℃. Cistanche deserticola, Polygonatum sibiricum, Dioscorea opposita, and Eucommia ulmoides leaves are pulverized and passed through an 80-mesh sieve.

[0035] S2. Accurately weigh the following powders from S1 that have been pulverized through an 80-mesh sieve: 17g of Cistanche deserticola, 6g of Polygonatum sibiricum, 15g of Dioscorea opposita, and 8g of Eucommia ulmoides leaf powder. Mix them evenly, then add ultrapure water to allow each component powder to fully absorb water until the powder no longer absorbs water. Then add more ultrapure water so that the volume ratio of powder to ultrapure water on top of the powder is 1:2 after standing. Maintain stirring conditions at 40℃ and 200rpm until the water content is 50%.

[0036] S3. Chop the dried Cornus officinalis, Lycium barbarum, Rehmannia glutinosa, Trionyx sinensis, Grifola frondosa, and Cordyceps militaris fruiting bodies into pieces with a diameter of no more than 5 mm. Then weigh 7 g of chopped Lycium barbarum, 8 g of chopped Rehmannia glutinosa, and 8 g of chopped Cordyceps militaris fruiting bodies and add them to 1 volume of corn oil. Soak the mixture in ultrasonic homogenate at 25 kHz for 30 min.

[0037] Add 12g of chopped Cornus officinalis, 10g of chopped Trionyx sinensis, and 13g of chopped Grifola frondosa to 1 volume of ultrapure water and homogenize by ultrasonication at 25 kHz for 30 minutes.

[0038] S4. Dissolve 20g of deerskin glue in twice the volume of ultrapure water at 80℃, and stir at 40℃ and 200rpm until completely dissolved, then continue stirring for 1 hour.

[0039] S5. Dissolve 13g of fish maw peptides in 1 volume of ultrapure water.

[0040] S6. Mix the homogenate obtained in S3, the deer hide glue solution after stirring in S4, and the fish maw polypeptide solution obtained in S5 evenly, and add them in batches to the mixture with a water content of 50% obtained in S2, stirring until well mixed.

[0041] S7. Evaporate the mixture obtained in S6 at 40°C and 200 rpm with stirring until the water content is 60%, and then dry it at 60°C for 0.5~1h until it can be rolled into balls, 6g / ball.

[0042] Example 2 A composition for improving male sexual function and relieving fatigue was prepared, and the specific steps were the same as in Example 1, except that the drying temperature in S1 was 80°C.

[0043] Example 3 A composition for improving male sexual function and relieving fatigue was prepared, and the specific steps were the same as in Example 1, except that the material in S1 was pulverized through a 60-mesh sieve.

[0044] Example 4 A composition for improving male sexual function and relieving fatigue was prepared. The specific steps were the same as in Example 1, except that the deerskin glue in S4 was dissolved in ultrapure water at 100°C.

[0045] Example 5 A composition for improving male sexual function and relieving fatigue was prepared. The specific steps were the same as in Example 1, except that in S7 the mixture was dried at 60°C and then pulverized into powder.

[0046] Example 6 A composition for improving male sexual function and relieving fatigue was prepared, with the specific steps being the same as in Example 1, except that the amounts of each component were as follows: 20g Cistanche deserticola, 10g Polygonatum sibiricum, 15g Cornus officinalis, 8g Lycium barbarum, 8g Cordyceps militaris fruiting body, 15g fish maw polypeptide, 20g deer skin glue, 8g Rehmannia glutinosa, 15g Dioscorea opposita, 10g turtle shell edge, 8g Eucommia ulmoides leaf, and 15g Grifola frondosa.

[0047] Example 7 A composition for improving male sexual function and relieving fatigue was prepared, with the specific steps being the same as in Example 1, except that the amounts of each component were as follows: 15 parts Cistanche deserticola, 5 parts Polygonatum sibiricum, 10 parts Cornus officinalis, 3 parts Lycium barbarum, 3 parts Cordyceps militaris fruiting body, 10 parts fish maw polypeptide, 15 parts deer skin glue, 3 parts Rehmannia glutinosa, 10 parts Dioscorea opposita, 5 parts turtle shell edge, 3 parts Eucommia ulmoides leaf, and 10 parts Grifola frondosa.

[0048] The component information for Examples 1 to 7 is shown in Table 1.

[0049] Table 1. Component information for Examples 1 through 7

[0050] Among them, examples Example Example of effect 1 The effects of the compositions prepared in Examples 1-7 for improving male sexual function and combating fatigue on the sexual function of mice were investigated, as follows: Forty-eight adult male ICR mice (22±2g) were randomly divided into eight groups of six each. Each group was administered the compositions prepared in Examples 1-7 via gavage. The compositions were dissolved in drinking water at a concentration of 10mg / mL, and each mouse was given 1mL via gavage at 7 PM every evening for four consecutive weeks. Mice given an equal volume of sterile drinking water via gavage served as the control group. During the gavage period, mice had free access to food and water, and all other conditions were the same as in conventional feeding.

[0051] Adult female mice (weighing 25±2g) were administered diethylstilbestrol (0.4mg / kg / day) via intramuscular injection daily. Two days later, vaginal smears were examined under a microscope. Mice with predominantly anucleate keratinocytes in the superficial layer were considered to be in estrus. Five mice were placed in each cage. Every morning at 7:00 AM, one male mouse was added to the female's cage after gavage. The number of matings, mountings, and mounting latency within 20 minutes were observed and recorded. The monitoring was conducted for one week, and the average values ​​were taken. The results are shown in Table 2.

[0052] Table 2 Results of the study on the effects on sexual function in mice

[0053] The statistical results show that the composition prepared in Example 5 has the best effect, followed by the composition prepared in Example 1. The only difference between Example 1 and Example 5 is that Example 1 was made into rolled pills, while Example 5 was made into dried powder, indicating that drying at 60℃ does not affect the activity of the active ingredients. The better effect of Example 5 compared to Example 1 may be because the total amount of composition administered via gavage in Example 5 was higher than that in Example 1, suggesting that appropriately increasing the dosage of the prepared composition can improve its efficacy. The composition in Example 1 has the best formulation.

[0054] The results of Examples 2 and 3 were relatively poor, indicating that drying at 80°C would damage the activity of the active ingredients in the components, while smaller particle size of the pulverized material is more conducive to the dissolution and utilization of the active ingredients. The mice treated with the compositions prepared in Examples 1 to 7 by gavage showed significantly better sexual function than the control group, and no other abnormalities were observed in any of the groups of mice in Examples 1 to 7 during the experiment.

[0055] Example 2 The effect of the compositions prepared in Examples 1 to 7 on the anti-fatigue effect was investigated, as follows: Forty-eight adult male ICR mice (22±2g) were randomly divided into eight groups of six each. Each group was administered the compositions prepared in Examples 1-7 via gavage. The compositions were dissolved in drinking water at a concentration of 10mg / mL, and each mouse was given 1mL via gavage at 7 PM every evening for four consecutive weeks. Mice given an equal volume of sterile drinking water via gavage served as the control group. During the gavage period, mice had free access to food and water, and all other conditions were the same as in conventional feeding.

[0056] After gavage administration, mice were subjected to a weight-bearing swimming exhaustion test. The weight was 5% of the mouse's body weight, and the weight was applied to the tail section from 1 / 3 to 2 / 3 of its length. Exhaustion was defined as the mouse sinking without resurfacing for 3 seconds. The results are shown in Table 3.

[0057] Table 3 Results of anti-fatigue effect test

[0058] The results of the anti-fatigue test were basically consistent with the results of the test on the effect on sexual function. The composition of Example 5 had the best anti-fatigue effect, followed by the composition of Example 1, but both were significantly better than the control group.

[0059] Therefore, the composition provided by this invention can, on the one hand, promote testosterone synthesis and secretion, and maintain normal testosterone levels in the body; on the other hand, it can improve blood perfusion in gonadal tissues, enhance mitochondrial function in gonadal cells, and delay testicular aging, thereby enhancing libido and erectile function, and improving premature ejaculation and nocturnal emission; it also has the function of protecting nerves and cell tissues from oxidative damage, repairing damaged tissues, thereby reducing penile sensitivity, and effectively improving or curing premature ejaculation; by providing the body with sufficient kidney essence and blood, it can improve sleep and psychological disorders / stress, and enhance anti-fatigue ability.

[0060] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit them. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the technical solutions of the present invention, and these modifications or equivalent substitutions cannot cause the modified technical solutions to deviate from the spirit and scope of the technical solutions of the present invention.

Claims

1. A composition for improving male sexual function and relieving fatigue, characterized in that: The product comprises the following components in parts by weight: 15-20 parts Cistanche deserticola, 5-10 parts Polygonatum sibiricum, 10-15 parts Cornus officinalis, 3-8 parts Lycium barbarum, 3-8 parts Cordyceps militaris fruiting body, 10-15 parts fish maw polypeptide, 15-20 parts deer skin glue, 3-8 parts Rehmannia glutinosa, 10-15 parts Dioscorea opposita, 5-10 parts turtle shell edge, 3-8 parts Eucommia ulmoides leaf, and 10-15 parts Grifola frondosa. The preparation method of the composition for improving male sexual function and relieving fatigue includes the following steps: S1. Weigh each component according to the proportion and remove surface dust and impurities; dry the Cistanche deserticola, Polygonatum sibiricum, Dioscorea opposita, and Eucommia ulmoides leaves at 60-80℃ and then pulverize them separately through a 60-80 mesh sieve; S2. After mixing the powders obtained in S1, add ultrapure water to allow each component powder to fully absorb water. Then add twice the volume of ultrapure water and maintain the temperature at 30-45°C with stirring until the water content is 45-55%. S3. Chop the dried Cornus officinalis, Lycium barbarum, Rehmannia glutinosa, Trionyx sinensis, Grifola frondosa, and Cordyceps militaris fruiting bodies into pieces no larger than 5 mm in diameter. Then, add 1 volume of corn oil to each of the chopped Lycium barbarum, Rehmannia glutinosa, and Cordyceps militaris fruiting bodies and homogenize them by ultrasonication. Add 1 volume of ultrapure water to each of the Cornus officinalis, Trionyx sinensis, and Grifola frondosa and homogenize them by ultrasonication. S4. Dissolve the deerskin glue in 2 times the volume of ultrapure water at 80~100℃, and stir at 200rpm at 80~100℃ until completely dissolved, then continue stirring for 1 hour; S5. Dissolve the fish maw peptides in 1 volume of ultrapure water. S6. Mix the homogenate obtained in S3, the deer skin glue solution after stirring in S4, and the fish maw polypeptide solution obtained in S5 evenly, and add them in batches to the mixture with a water content of 45-55% obtained in S2, and stir until well mixed. S7. Evaporate the mixture obtained in S6 to a moisture content of 60% under stirring at 30~45℃, then dry it at 60~65℃ to a moisture content of 25~35%, and knead it into balls.

2. The composition for improving male sexual function and relieving fatigue according to claim 1, characterized in that, The components include the following parts by weight: 15 parts Cistanche deserticola, 5 parts Polygonatum sibiricum, 10 parts Cornus officinalis, 3 parts Lycium barbarum, 3 parts Cordyceps militaris fruiting body, 10 parts fish maw polypeptide, 15 parts deer skin glue, 3 parts Rehmannia glutinosa, 10 parts Dioscorea opposita, 5 parts turtle shell edge, 3 parts Eucommia ulmoides leaf, and 10 parts Grifola frondosa.

3. The composition for improving male sexual function and relieving fatigue according to claim 1, characterized in that, The components include the following parts by weight: 20 parts Cistanche deserticola, 10 parts Polygonatum sibiricum, 15 parts Cornus officinalis, 8 parts Lycium barbarum, 8 parts Cordyceps militaris fruiting body, 15 parts fish maw polypeptide, 20 parts deer skin glue, 8 parts Rehmannia glutinosa, 15 parts Dioscorea opposita, 10 parts turtle shell edge, 8 parts Eucommia ulmoides leaf, and 15 parts Grifola frondosa.

4. The composition for improving male sexual function and relieving fatigue according to claim 1, characterized in that, The components include the following parts by weight: 17 parts Cistanche deserticola, 6 parts Polygonatum sibiricum, 12 parts Cornus officinalis, 7 parts Lycium barbarum, 8 parts Cordyceps militaris fruiting body, 13 parts fish maw polypeptide, 20 parts deer skin glue, 8 parts Rehmannia glutinosa, 15 parts Dioscorea opposita, 10 parts turtle shell edge, 8 parts Eucommia ulmoides leaf, and 13 parts Grifola frondosa.

5. The composition for improving male sexual function and relieving fatigue according to claim 1, characterized in that: The ultrasonic homogenization conditions in S3 are 4℃ and 25KHz.

6. The composition for improving male sexual function and relieving fatigue according to claim 1, characterized in that, Replace S7 with: Stir the mixture obtained in S6 at 30~45℃ until the water content is 60%, then dry it at 60~65℃ and pulverize it into powder.

7. The use of the composition for improving male sexual function and relieving fatigue as described in any one of claims 1 to 6 in the preparation of a drug for improving male sexual function, characterized in that: The drug uses the composition according to any one of claims 1 to 6 that improves male sexual function and relieves fatigue as its active ingredient.

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