Composition for building body and improving sexual function as well as preparation method and application of composition

Abstract

The invention provides a composition for building bodies and improving sexual functions as well as a preparation method and application of the composition, and relates to the technical field of medicinal and edible traditional Chinese medicines and food resources. The composition is prepared from the following components in parts by mass: 20 to 50 parts of oyster peptide, 5 to 20 parts of maca extract, 4 to 18 parts of fructus lycii extract, 4 to 18 parts of herba cistanche extract, 1.5 to 9 parts of radix ginseng extract, 0.3 to 2 parts of cordyceps militaris extract, 0.3 to 2.5 parts of rhizoma polygonati extract and 0.6 to 1.5 parts of vitamin C. Under the synergistic effect of all the components in the composition formula, the antioxidant activity can be remarkably improved, the effects of resisting fatigue and strengthening the physique are achieved, then the composition is beneficial to the male sexual function in multiple ways, cavernosum smooth muscle relaxation and penile erection are promoted, the effects of building the body and improving the sexual function are achieved, and the composition especially plays an important role in improving the sexual function of middle-aged and elderly people.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine as both food and medicine and food resources, specifically relating to a composition for strengthening the body and improving sexual function, its preparation method and application. Background Technology

[0002] With the accelerating aging of the population, age-related diseases are increasingly becoming a research focus, such as Alzheimer's disease, osteoporosis, and sexual dysfunction. Due to the gradual decline of various organs in middle-aged and elderly people, the secretion of neurotransmitters in brain tissue, and changes in the level of sex hormones in the body, men may experience sexual dysfunction (commonly known as erectile dysfunction or ED).

[0003] Traditional Chinese medicine (TCM) offers various explanations for the causes of erectile dysfunction (ED), and common treatment approaches include: treating ED based on principles such as clearing damp-heat in the lower burner, cooling the liver and purging fire, guiding the blood to nourish yin, promoting blood circulation and removing blood stasis, and nourishing blood; commonly using Longdan Xiegan Tang (Gentian Liver-Clearing Decoction) and Taohong Siwu Tang (Peach Blossom and Four Substances Decoction); treating ED based on the differentiation of damp-heat syndromes, and for those with severe blood stasis, often adding leeches to the five heat-clearing herbs to remove blood stasis and unblock the meridians; using methods that invigorate qi, promote blood circulation, and remove blood stasis to treat ED, commonly using Shaofu Zhuyu Tang (Lower Abdomen Blood Stasis-Removing Decoction) and Xuefu Zhuyu Tang (Blood Mansion Blood Stasis-Removing Decoction); and treating ED based on kidney deficiency and liver stagnation causing blood stasis, often using a combination of TCM formulas that tonify the kidneys, soothe the liver, and promote blood circulation.

[0004] Modern medical theory suggests several approaches to treating erectile dysfunction (ED): Alpha receptor blockers: Alpha receptors are divided into α1 and α2 types, both playing a crucial role in regulating penile arterial smooth muscle tone. α2 receptor blockers (such as yohimbine) can be used to promote penile erection and treat erectile dysfunction. Among the norepinephrine (NA) receptors in the corpus cavernosum smooth muscle, α1 receptors are particularly effective. Alpha-adrenergic blockers, which inhibit NA effects, can promote relaxation of the corpus cavernosum smooth muscle and penile erection. Alpha-adrenergic blockers are commonly used to treat ED, such as prazosin and phentolamine. Alpha-adrenergic agonists are used to treat priapism or abnormal erections, such as Aramine. Diabetic patients often have ED; experiments show that their intracavernosal pressure (ICP) is only 55% of that of the normal control group. Treatment with insulin or insulin plus oxygen free radical scavengers can restore it to normal levels.

[0005] Currently, commonly used drugs for treating erectile dysfunction (ED) in modern medicine include sildenafil (brand name: Viagra), tadalafil, and vardenafil. However, these typical aphrodisiacs can only be taken once, and frequent use can cause many side effects, such as headaches, visual disturbances, rashes, fatigue, nausea, mouth ulcers, insomnia, scanty and dark yellow urine, excessive libido, nocturnal emission, and premature ejaculation. Some of these side effects are irreversible and cannot be taken long-term. Therefore, there is an urgent need to develop a non-toxic, side-effect-free, long-term-use combination to strengthen the body and improve sexual function, so as to achieve the effect of strengthening the body and improving sexual function through long-term adjustment and improvement of physical condition and organ function. Summary of the Invention

[0006] To address the aforementioned technical problems, the primary objective of this invention is to provide a composition for strengthening the body and improving sexual function. The synergistic effect of the components in the composition significantly enhances antioxidant activity, achieving anti-fatigue and improved physical condition. This, in turn, benefits male sexual function through multiple pathways, promoting relaxation of the smooth muscle of the corpus cavernosum and penile erection, thus strengthening the body and improving sexual function, particularly playing a significant role in improving sexual function in middle-aged and elderly individuals.

[0007] A second object of the present invention is to provide a method for preparing the above-described composition.

[0008] A third objective of the present invention is to provide the use of the above-described composition in the preparation of a medicament for improving physical health and sexual function.

[0009] A fourth object of the present invention is to provide the use of the above-described composition in the preparation of a medicament that inhibits phosphodiesterase and increases the expression of nitric oxide synthase.

[0010] A fifth objective of the present invention is to provide the use of the above-described composition in the preparation of a medicament for improving oxidative stress and endocrine disorders.

[0011] The sixth objective of this invention is to provide the application of the above-described composition in the preparation of foods that enhance immunity and combat fatigue.

[0012] The seventh objective of this invention is to provide a preparation for strengthening the body and improving sexual function.

[0013] To achieve the above-mentioned objectives, the technical solution of the present invention is as follows: This invention provides a composition for strengthening the body and improving sexual function. The composition, by weight, comprises 20-50 parts oyster peptide, 5-20 parts maca extract, 4-18 parts wolfberry extract, 4-18 parts cistanche extract, 1.5-9 parts ginseng extract, 0.3-2 parts cordyceps extract, 0.3-2.5 parts polygonatum extract, and 0.6-1.5 parts vitamin C.

[0014] In one embodiment, the composition comprises, by weight parts, 25-40 parts oyster peptide, 8-17 parts maca extract, 6-15 parts wolfberry extract, 8-15 parts cistanche extract, 3.5-8.5 parts ginseng extract, 0.8-1.7 parts cordyceps extract, 0.8-2 parts polygonatum extract and 0.9-1.2 parts vitamin C.

[0015] In one embodiment, the oyster peptide contains ≥45% oligopeptides, ≥1% taurine, ≥45 mg / kg zinc, and ≥0.3 mg / kg selenium; the maca extract contains ≥10% protein and ≥10% polysaccharides; the wolfberry extract contains ≥20% polysaccharides; the cistanche extract contains ≥20% total phenylethyl glycosides and ≥10% polysaccharides; the ginseng extract contains 10-20% total ginsenosides; the cordyceps militaris extract contains ≥0.5% cordycepin, ≥0.2% adenosine, and ≥30% total polysaccharides; and the polygonatum extract contains 20-30% polysaccharides.

[0016] The present invention also provides a method for preparing the above-mentioned composition, comprising the following steps: weighing the raw materials according to the raw material ratio and mixing them.

[0017] The present invention also provides the use of the above-described composition in the preparation of a medicament for improving physical health and sexual function.

[0018] The present invention also provides the use of the above-described composition in the preparation of a medicament that inhibits phosphodiesterase and / or increases the expression of nitric oxide synthase.

[0019] The present invention also provides the use of the above-described composition in the preparation of a medicament for improving oxidative stress and / or endocrine disorders.

[0020] The present invention also provides the application of the above-described composition in the preparation of foods that enhance immunity and combat fatigue.

[0021] The present invention also provides a preparation for improving physical health and sexual function, comprising the above-mentioned composition and excipients.

[0022] In one embodiment, the dosage form of the preparation is tablets, capsules, or granules.

[0023] The advantages of this invention compared to existing technologies are as follows: This invention relates to a composition with oyster peptides as the main ingredient, which has the effects of tonifying kidney yang, nourishing essence and blood, moistening the intestines, promoting metabolism, tonifying qi and strengthening muscles, promoting appetite, and significantly anti-fatigue, tonifying qi and nourishing yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys. The raw materials of this invention's composition belong to the dual-use medicinal and edible raw materials stipulated by the Ministry of Health. Other raw materials besides dual-use medicinal and edible herbs are all food-grade raw materials and new resource functional foods. The content and dosage of their relevant active ingredients are within the allowable range stipulated by the national regulations for new resource foods. Therefore, this invention's composition has no toxic side effects and can be taken long-term.

[0024] In the composition of this invention, oyster peptides, Cordyceps militaris extract, and Polygonatum sibiricum extract have the effects of lowering blood lipids and cholesterol levels; oyster peptides, Lycium barbarum extract, and Polygonatum sibiricum extract can regulate blood sugar; oyster peptides, Polygonatum sibiricum extract, and Cordyceps militaris extract can stabilize blood pressure; Lycium barbarum extract can improve immunity; and maca extract, Lycium barbarum extract, and Cistanche deserticola extract have anti-fatigue effects. The combined composition can invigorate the body, combat fatigue, and provide antioxidant effects, significantly increasing the activity of glutathione peroxidase and creatine kinase, and decreasing the activity of lactate dehydrogenase and malondialdehyde (MDA) levels. It enhances immunity and regulates microcirculation. At the same time, the composition can also inhibit phosphodiesterase (PDE5) and increase the expression of nitric oxide synthase (NOS), increase nitric oxide content and arginine synthesis, increase the content of cyclic guanosine monophosphate (cGMP) in the body (corpus cavernosum), balance the secretion of human hormones, increase the sex hormone levels of corresponding organs and serum testosterone levels, inhibit the effects of norepinephrine (NA) as an α-adrenergic blocker, and promote the relaxation of smooth muscle in the corpus cavernosum and penile erection, thereby playing a role in strengthening the body and improving sexual function.

[0025] Because antioxidant activity is one of the important mechanisms of action in this invention, in addition to the various indicators required for the raw materials, the plant products of this invention were also subjected to free radical absorption capacity (ORAC) analysis and testing. The results showed that the synergistic effect of the components in the composition of this invention can significantly improve antioxidant activity, achieve the effects of anti-fatigue and physical enhancement, and thus benefit male sexual function through multiple pathways, especially playing an important role in improving sexual function in middle-aged and elderly people. Detailed Implementation

[0026] This invention provides a composition for strengthening the body and improving sexual function. The composition, by weight, comprises 20-50 parts oyster peptide, 5-20 parts maca extract, 4-18 parts wolfberry extract, 4-18 parts cistanche extract, 1.5-9 parts ginseng extract, 0.3-2 parts cordyceps extract, 0.3-2.5 parts polygonatum extract, and 0.6-1.5 parts vitamin C.

[0027] Preferably, the composition comprises, by weight parts, 25-40 parts oyster peptide, 8-17 parts maca extract, 6-15 parts wolfberry extract, 8-15 parts cistanche extract, 3.5-8.5 parts ginseng extract, 0.8-1.7 parts cordyceps extract, 0.8-2 parts polygonatum extract and 0.9-1.2 parts vitamin C.

[0028] More preferably, the composition comprises, by weight parts, 30 parts oyster peptide, 12 parts maca extract, 8 parts wolfberry extract, 10 parts cistanche extract, 5 parts ginseng extract, 1 part cordyceps extract, 1.2 parts polygonatum extract and 1 part vitamin C.

[0029] All raw materials used in this invention are dual-use medicinal and edible ingredients, as well as novel food resources, suitable for long-term consumption. Long-term use can enhance physical fitness, improve immunity, improve the function of corresponding organs, and benefit overall health and sexual function. The main drugs in the composition provided by this invention are described below: In this invention, the oyster peptides contain ≥80% of a relative molecular weight less than 1000, ≥45% oligopeptides, ≥1% taurine, ≥45 mg / kg zinc, and ≥0.3 mg / kg selenium. In addition to the main active ingredient, functional oligopeptides, it also contains a large amount of various amino acids (including arginine, which mediates the effects of strengthening the body and improving sexual function), is rich in polysaccharides, and contains abundant phosphoinositol, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and other physiologically active unsaturated fatty acids, B vitamins, and trace elements and minerals such as Fe, Zn, and Se. The zinc and selenium contents are particularly prominent, reaching up to 163 mg / kg and 0.646 mg / g, respectively. Oyster peptides contain small-molecule bioactive peptides of 200-1200 Da, which have significant antioxidant effects. They can significantly increase the activity of superoxide dismutase (SOD) and significantly reduce the content of lipid peroxidation product MDA, thereby increasing the levels of sex hormones and serum testosterone in corresponding organs. The polysaccharides and various trace elements in oyster peptides can supplement some nutrients needed by the body, enhance the body's immunity and disease resistance, protect the liver, repair damaged stem cells, and reduce transaminase levels. The unsaturated fatty acids in oyster peptides have the effects of lowering blood lipids, reducing blood sugar and cholesterol levels in diabetic patients (promoting insulin secretion, increasing insulin receptor sensitivity, and reducing insulin resistance), preventing atherosclerosis, and regulating immunity, thus improving the overall physical condition of middle-aged and elderly people.

[0030] In this invention, the maca extract contains ≥10% protein and ≥10% polysaccharides. Maca possesses strong antioxidant and reducing abilities, hydroxyl radical scavenging capabilities, and anti-lipid peroxidation abilities. It can restore the activity of superoxide dismutase (SOD) and reduced glutathione (GSH-Px). Its main material basis consists of polysaccharides, polyphenols, and alkaloids. Maca extract is a highly nutritious substance, rich in protein, and also includes natural active ingredients such as polysaccharides, alkaloids, sterols, and polyphenols. The abundant zinc and manganese in the formula play a crucial role in improving sexual function in middle-aged and elderly individuals by regulating neurohumoral hormones and promoting parasympathetic nerve excitation. In synergy with other components, they contribute significantly to improving sexual function. Macamide and macaenes have a significant effect on balancing human hormone secretion, enhancing sexual function, regulating endocrine function, and tonifying the kidneys and strengthening virility. Maca polysaccharides significantly increase the activity of glutathione peroxidase and creatine kinase, decrease lactate dehydrogenase activity, and significantly reduce blood urea nitrogen, lactate, and malondialdehyde levels. They also promote the secretion of NO, TNF-α, and IL-6 by cells. Maca polysaccharides are the main active ingredients responsible for anti-fatigue and enhanced immunity. In this invention, the combination of maca and ginseng significantly increases nitric oxide levels in the corpora cavernosa, significantly decreases phosphodiesterase type 5 content, upregulates the expression of acute regulatory protein (StAR) and 17β-hydroxysteroid dehydrogenase in testicular tissue, significantly reduces the content of malondialdehyde (MDA), a lipid peroxidation product, and significantly enhances anti-fatigue effects.

[0031] In this invention, the polysaccharide content of the wolfberry extract is ≥20%. The wolfberry extract contains various bioactive polysaccharides, trace elements, and vitamins. Wolfberry can warm and nourish the liver and kidneys, and strengthen kidney yang. Wolfberry polysaccharides enhance immunity, regulate blood lipids, and lower blood sugar. They can also increase serum testosterone (T) levels, effectively promoting metabolism, strengthening muscles and tendons, stimulating appetite, and exhibiting significant anti-fatigue effects. Various trace elements and vitamins work synergistically with other components in the formula to improve sexual function in middle-aged and elderly individuals.

[0032] In this invention, the total phenylethanoid glycoside content of Cistanche deserticola extract is ≥20%, and the polysaccharide content is ≥10%. The main active substances in Cistanche deserticola extract are phenylethanoid glycosides, lignans, iridoids, polysaccharides, and alkaloids, which have various effects such as aphrodisiac properties, antioxidant properties, and enhanced memory. Cistanche deserticola has a strong antioxidant effect, significantly inhibiting lipid peroxidation, significantly enhancing the activity of superoxide dismutase (SOD), and increasing the levels of six serum hormones (follicle-stimulating hormone FSH, luteinizing hormone LH, estradiol F2, progesterone P, testosterone P, and prolactin PRL). It can enhance immune function and promote metabolism to improve physical constitution.

[0033] In this invention, the total ginsenoside content in the ginseng extract is 10-20%. Ginseng can increase myocardial contractility, slow heart rate, increase cardiac output and coronary blood flow, and resist myocardial ischemia and arrhythmia. It has a certain effect on cardiac function, cardiovascular system, and blood flow, and can significantly enhance physical fitness. The saponins in the ginseng extract can improve the excitation and inhibition processes of the brain. Among them, ginsenosides Rb1 and Rg1 have a promoting effect on memory processes, can improve mental and physical labor capacity, and have a significant anti-fatigue effect. In this invention, the ginseng extract and oyster peptides work synergistically to significantly increase testosterone levels and decrease phosphodiesterase type 5 (PDD5) levels. It produces synergistic effects in anti-fatigue (reducing lactate, urea nitrogen, etc.), anti-oxidation (reducing MDA), and significantly improving sexual function (regulating hormone levels and improving the expression of NO and PDE-5 in the eNOS / NO / cGMP signaling pathway). It can improve cognitive function and enhance sexual function by increasing the NO and cGMP content in the corpora cavernosa of the penis.

[0034] In this invention, the Cordyceps militaris extract contains ≥0.5% cordycepin, ≥0.2% adenosine, and ≥30% total polysaccharides. The main components of the Cordyceps militaris extract are cordycepin, adenosine, adenine, uracil, uridine, guanine, hypoxanthine nucleoside, thymine, cordycepic acid, cordycepin sterols, polyphenols, flavonoids, cordyceps polysaccharides, peptides, superoxide dismutase, carotenoids, etc., and it also contains abundant protein, vitamins, amino acids, and various trace elements, among which selenium is the most important trace element in Cordyceps militaris. Cordyceps militaris has significant effects in lowering blood sugar, lowering blood lipids, reducing arteriosclerosis, anti-inflammation, anti-oxidation, and anti-lipid peroxidation, increasing SOD activity, and providing immune protection, effectively enhancing human immunity. The polysaccharides and peptides of Cordyceps militaris can inhibit acetylcholinesterase (AChE) and have neuroprotective effects; combined with its significant antioxidant capacity, it can significantly improve cognitive ability and memory. The Cordyceps militaris extract of this invention can have a good synergistic effect with ginseng extract and maca extract to improve sexual function. It can also synergistically increase the levels of TC, TG and LDL in the blood, while increasing the level of high-density lipoprotein and reducing liver index, thus improving the overall physical condition of middle-aged and elderly people.

[0035] In this invention, the polysaccharide content in the Polygonatum extract is 20-30%. The Polygonatum extract mainly contains polysaccharides, steroidal saponins, flavonoids, alkaloids, and other chemical components, and is rich in protein, various amino acids (including arginine), and abundant trace elements, especially K, Mg, Ca, Fe, and Mn. The manganese content can reach up to 210 mg / kg. The Polygonatum extract has the effects of tonifying Qi and nourishing Yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys. It also has anti-aging, antioxidant, hypoglycemic, immune-enhancing, antidepressant, lipid-lowering, cognitive-improving, and memory-enhancing effects. Polygonatum polysaccharides can alleviate liver pathological damage in mice with non-alcoholic fatty liver disease, improve abnormal lipid metabolism and oxidative stress, and balance the composition of the intestinal microbiota. It can reduce cAMP, relatively increase cGMP, decrease the cAMP / cGMP ratio, and reduce sympathetic nerve excitation. Polygonatum flavonoids have antioxidant, hypoglycemic, and blood circulation-improving functions.

[0036] The composition of this invention contains oyster powder, maca extract, cordyceps extract, and polygonatum, among other components rich in arginine and trace elements zinc, manganese, and selenium, which play a crucial synergistic role in the formulation. Zinc can stimulate sexual function, promote the development of male gonads, and increase plasma testosterone levels. Manganese can invigorate qi, warm yang, and even enhance virility. Zinc and manganese play an indispensable role in regulating neurohumoral hormones and promoting parasympathetic nerve excitation. Selenium, as the active center of glutathione peroxidase (GPX), exerts its antioxidant effect. Selenium also acts as the active center of deiodinase, regulating thyroid hormone secretion and thus affecting the body's physique. Selenium removes oxygen free radicals through the lipid oxidase pathway, maintaining cell membrane integrity. Selenium can reduce the incidence of age-related atherosclerosis, hypertension, decreased immune function, and central nervous system diseases.

[0037] The composition of this invention has the effects of tonifying kidney yang, nourishing essence and blood, moistening the intestines, promoting metabolism, tonifying qi and strengthening muscles, promoting appetite, and significantly anti-fatigue, tonifying qi and nourishing yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys. The formula of this invention contains a variety of active ingredients, such as polysaccharides, saponins, alkaloids, sterols, cordycepin, phenylethyl glycosides, lignans, iridoids, polypeptides, polyphenols and flavonoids, cordycepin, adenosine, adenine, uracil, uridine, guanine, hypoxanthine nucleoside, thymine, and also contains antioxidants such as superoxide dismutase and carotenoids. It also contains various unsaturated fatty acids, abundant protein, vitamins, amino acids, and various trace elements, and is rich in selenium, manganese, zinc, and other trace elements with important functions.

[0038] The present invention also provides a method for preparing the above-mentioned composition, comprising the following steps: weighing the raw materials according to the raw material ratio and mixing them.

[0039] Based on the fact that the composition of the present invention has the effect of strengthening the body and improving sexual function, the present invention also provides the application of the above composition in the preparation of a medicine for strengthening the body and improving sexual function.

[0040] Based on the ability of the composition of the present invention to inhibit phosphodiesterase (PDE5) and increase the expression of nitric oxide synthase (NOS), the present invention also provides the use of the above composition in the preparation of a medicament that inhibits phosphodiesterase and / or increases the expression of nitric oxide synthase.

[0041] Based on the antioxidant properties of the composition of the present invention and its ability to increase the levels of sex hormones and serum testosterone in the corresponding organs, the present invention also provides the use of the above composition in the preparation of a drug for improving oxidative stress and / or endocrine disorders.

[0042] Based on the ability of the composition of the present invention to invigorate the mind, replenish vital energy, and combat fatigue, the present invention also provides the application of the above composition in the preparation of food products that enhance immunity and combat fatigue.

[0043] The present invention also provides a formulation for improving physical health and sexual function, comprising the above-described composition and excipients. In the present invention, the excipients include fillers, binders, disintegrants, preservatives, solubilizers, and / or flavoring agents.

[0044] The dosage form of the preparation described in this invention is tablet, capsule or granule.

[0045] In this invention, the tablet preparation method includes ingredient formulation, granulation, drying, sizing, and tableting. The raw materials and excipients are weighed according to the above proportions, and the raw materials (except vitamin C) and excipients (except flavoring agents) are mixed evenly to form a mixed powder. The mixed powder is granulated, and the granulation method includes fluidized bed granulation or ethanol wet granulation; the ethanol wet granulation uses 70-85% ethanol. Then, drying is performed, and the drying method includes hot air drying at 45-65℃ to a moisture content of 3-5%, and passing through a 10-20 mesh sieve. After drying, it is mixed with vitamin C and flavoring agents, and then compressed into tablets. In this invention, the tablet hardness is greater than or equal to 4 kg, and the disintegration time of the tablet is ≤60 min. As an optional embodiment, after the tablets are formed, they are coated with a coating powder, and the amount of coating powder used is 1-3% of the weight of the unformed tablet.

[0046] In this invention, the preparation method of the granules includes ingredient mixing, granulation, drying, and granulation into granules. In this invention, raw and auxiliary materials are weighed according to the above proportions, and the raw materials (except vitamin C) and auxiliary materials (except flavoring agents) are mixed evenly to form a mixed powder. The mixed powder is granulated, and the granulation method includes fluidized bed granulation or ethanol wet granulation. Then, the granules are dried, and then mixed with vitamin C or other flavorings and flavoring agents to form a total granule. Appropriate packaging materials are selected and the filling amount is determined, and the granules are packaged into bags using packaging machinery. In this invention, 70-85% ethanol is used in the ethanol wet granulation. The drying method includes hot air drying at 45-65°C to a moisture content of 3-5%, and passing through a 10-20 mesh sieve.

[0047] In this invention, the method for preparing the capsules includes weighing the raw and auxiliary materials according to the above proportions, mixing, granulating, drying, and sizing according to the above granule preparation method, determining the appropriate capsules and filling amount, and filling them into capsule products using a capsule filling machine.

[0048] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be described in detail below with reference to the embodiments, but these should not be construed as limiting the scope of protection of this invention.

[0049] Unless otherwise specified, the materials, reagents, etc. used in the following examples are commercially available. Unless otherwise specified, they are generally used under conventional conditions or under conditions recommended by the company.

[0050] The raw materials used in this invention are commercially available products that meet the content indicators of each extract in this invention.

[0051] ORAC (Oxygen Radical Absorbance Capacity) assay is currently the simplest, most accurate, most sensitive, most widely used, and most influential method for evaluating the antioxidant activity of antioxidants internationally.

[0052] The methods for determining the oxygen free radical absorption capacity (ORAC) in various embodiments of the present invention are as follows: 1) Sample preparation: Take the sample, weigh it accurately, and extract it with 20 times (V / W) of 95% ethanol at room temperature by ultrasonic extraction for more than 20 min, centrifuge at 5000 rpm for 15 min, extract twice, and combine the supernatants. For water-soluble samples, use distilled water, and for lipid-soluble samples, use 95% ethanol. Dilute to 10.4 mg / ml to 24 mg / ml aqueous solution or ethanol solution, and then dilute 1600 times with pH=7.4 phosphate buffer to prepare a sample buffer solution with a concentration of 6.5 µg / ml to 15 µg / ml, which is the sample to be tested. 2) Determination of oxygen free radical absorption capacity (1) Measurement conditions: instrument set temperature: 35-37℃; excitation wavelength: 485 nm; emission wavelength: 538 nm; measurement time: 60 min; measurement frequency: 1 min / once; (2) Reagent preparation: FL (fluorescein) concentration: 0.63-0.67 nmol / ml; AAPH (azo compounds) concentration: 20~30 mg / ml; Trolox (water-soluble vitamin E) concentration: 0.01~0.07 µmol / ml; and select the concentration range in step 1) according to the antioxidant properties of the sample.

[0053] (3) Determination of oxygen free radical absorption capacity: Add 1.25 ml of phosphate buffer, 0.2 ml of FL solution, and 0.2 ml of sample (or Trolox) solution to a test tube, mix well, then add 0.35 ml of AAPH solution, shake well, and immediately take 1.3 ml into each test tube, place it in a fluorescence analyzer, and measure the change of fluorescence intensity over time according to the measurement conditions. ORAC value calculation formula: ; ORAC is measured in µmol TE / g; AUC 样品 Area under the fluorescence decay curve of sample + AAPH + FL; AUC Trolox Area under the fluorescence decay curve of Trolox + AAPH + FL; AUC 空白 Area under the fluorescence decay curve of AAPH+FL; The area under the blank, Trolox, and sample curves, AUC, is calculated using the trapezoidal rule, and the formula is as follows: .

[0054] (4) Calculate the results of the oxygen free radical absorption capacity test: examine the linear range between its net integral area AUC and concentration; take 5 samples with different concentrations within the linear range for inter-batch stability analysis, and then take 3 samples with the same concentration within the linear range for intra-batch stability analysis, and take the average value as its ORAC value.

[0055] Example 1 A composition for strengthening the body and improving sexual function (by weight parts): The composition contains 30 parts oyster peptide, 12 parts maca extract, 8 parts wolfberry extract, 10 parts cistanche extract, 5 parts ginseng extract, 1 part cordyceps extract, 1.2 parts polygonatum extract, and 1 part vitamin C. The oxygen free radical scavenging capacity (ORAC) value of the composition of this invention is 3100 (µmol TE / g).

[0056] Example 2 A composition for strengthening the body and improving sexual function (by weight parts): The composition contains 39 parts oyster peptide, 17 parts maca extract, 15 parts wolfberry extract, 15 parts cistanche extract, 8.5 parts ginseng extract, 1.7 parts cordyceps extract, 2 parts polygonatum extract, and 1.2 parts vitamin C. The oxygen free radical scavenging capacity (ORAC) value of the composition of this invention is 4100 (µmol TE / g).

[0057] Example 3 A composition for strengthening the body and improving sexual function (by weight parts): The composition contains 30 parts oyster peptide, 12 parts maca extract, 8 parts wolfberry extract, 10 parts cistanche extract, 5 parts ginseng extract, 1 part cordyceps extract, 1.2 parts polygonatum extract, and 1 part vitamin C. The oxygen free radical scavenging capacity (ORAC) value of the composition of this invention is 3500 (µmol TE / g).

[0058] Experiment Example 1: Test on anti-fatigue, anti-oxidation (enhancing physical fitness), and improved sexual function After acclimatization, healthy mice were randomly divided into three groups: a control group, experimental group 1, and experimental group 2, with eight mice in each group. Experimental group 1 was administered the composition of Example 1 at a dose of 0.6 g / kg, and experimental group 2 was administered the composition of Example 1 at a dose of 0.9 g / kg. The samples used in experimental groups 1 and 2 were entirely composed of the raw materials from the composition, without any added excipients. The composition of Example 1 was prepared into a 0.12 g / ml solution with water and administered orally at doses of 5 ml / kg (experimental group 1) and 7.5 ml / kg (experimental group 2), respectively, once daily for 6 weeks. The control group received physiological saline for 6 consecutive weeks.

[0059] 1. Anti-fatigue and antioxidant experiments Thirty minutes after the last administration, the three groups of mice were swam in a pool without load for 30 minutes. Immediately after swimming, blood samples were collected from the posterior ocular vein, centrifuged at 3000 r / min for 10 minutes to obtain serum, and the levels of lactate (LA) and blood urea nitrogen (BUN) in the serum of each mouse were measured. Skeletal muscle and liver tissue samples were also collected from the mice to determine the levels of malondialdehyde (MDA), a lipid peroxidation product, and liver glycogen (LG). The experimental results are shown in Table 1.

[0060] Table 1. Effects of Example 1 on antioxidant and anti-fatigue indices in mice.

[0061] Note: Compared with the blank group, Indicates a significant difference (P <0.05); This indicates that the difference is highly significant ( P <0.01).

[0062] As shown in Table 1, compared with the control group, experimental group 2 showed a decrease in lactic acid and urea nitrogen levels and an increase in liver glycogen levels. P The differences in <0.01 and the reduction in the content of malondialdehyde, a lipid peroxidation product, were both highly significant. P <0.01); compared with the blank group, experimental group 1 showed a highly significant decrease in lactic acid content ( P <0.01), significantly reducing the content of urea nitrogen ( P <0.05, significantly increased liver glycogen content ( P <0.05%, significantly reducing the content of malondialdehyde, a lipid peroxidation product (MDA). P <0.01).

[0063] 2. Sexual function experiment Mating experiments were conducted after the last administration of medication. Female mice in each group received a subcutaneous injection of 5 µg estradiol benzoate 48 h before the experiment, and a subcutaneous injection of 5 µg progesterone 5 h before the experiment to induce estrus. After 42 days of medication, male mice in each group were placed alone in cages in a dimly lit, quiet room with red lighting to allow them to acclimatize for 15 min. Mice from the same group were placed in the same cage, and their mating behavior was recorded over 25 min. Sexual behavior parameters for each group were recorded, including latency (the time interval between the first mounting behavior of the male), capture count (the number of times the male captured a female), insertion latency (the time between the first insertion behavior of the male), and ejaculation count (the total number of ejaculations by the male). After the mating experiment, blood samples were collected from the retroocular vein of the male mice, centrifuged at 3000 r / min for 10 min to obtain serum, and the concentrations of testosterone (T) and NO were measured. Separately, 0.01 ± 0.005 g of preserved mouse penile corpus cavernosum tissue was weighed and added to physiological saline at a material-to-liquid ratio of 1:9 (g:mL). The mixture was homogenized, centrifuged, and the supernatant was collected. The contents of nitric oxide (NO) and phosphodiesterase type 5 (PDE-5) were determined according to the ELISA reagent method. The experimental results are shown in Tables 2 and 3.

[0064] Table 2. Effects of experimental samples on mating behavior in mice.

[0065] Note: Compared with the blank group, Indicates a significant difference ( P <0.05); This indicates that the difference is highly significant ( P <0.01).

[0066] Table 3 Effects of experimental samples on sexual function indicators in mice

[0067] Note: Compared with the blank group, Indicates a significant difference ( P <0.05); This indicates that the difference is highly significant ( P <0.01).

[0068] As can be seen from Tables 2 and 3, compared with the control group, experimental group 2 showed highly significant differences in all sexual behavior indicators, including latency, number of captures, ejaculation latency, and number of ejaculations. P <0.01); serum testosterone, corpus cavernosum phosphodiesterase, and corpus cavernosum nitric oxide all showed highly significant differences in both experimental groups ( P <0.01). Experimental group 1 showed highly significant differences in the latency period and number of captures of sexual behavior indicators ( ). P <0.01, which was significant in both insertion latency and ejaculation frequency ( P <0.05%, showing a highly significant effect on phosphodiesterase in the corpus cavernosum ( P <0.01), significantly increasing serum testosterone and corpus cavernosum nitric oxide levels ( P <0.05).

[0069] Compared with the control group, the two dosage groups examined in this invention, 0.6 g / kg and 0.9 g / kg, showed highly significant or significant improvements in sexual function, sexual behavior, biochemical indicators, and various biochemical indicators related to antioxidant and anti-fatigue (enhancing physical fitness). In particular, the 0.9 g / kg dosage group showed highly significant differences in all indicators. P <0.01), which is superior to the 0.6 g / kg dosage group. This indicates that the composition of the present invention can promote the relaxation of the smooth muscle of the corpus cavernosum and penile erection.

[0070] Experiments on anti-fatigue, antioxidant (enhancing physical fitness), and improved sexual function showed that the product of this invention exhibited highly significant differences in its effects compared to the control group in both anti-fatigue, antioxidant (enhancing physical fitness) and multiple indicators of sexual function. In particular, the 0.9 g / kg dose significantly improved antioxidant activity, achieving anti-fatigue and physical fitness enhancement effects. This, in turn, benefits male sexual function through multiple pathways, promoting relaxation of the corpus cavernosum smooth muscle and penile erection, thus strengthening the body and improving sexual function. Based on a human dose (based on a human weight of 60 kg), which is 20 to 30 times the effective dose for mice (0.9 g / kg), the effective dosage of the raw materials in this invention is 1.8 to 2.7 g / day. Humans can achieve the effective dosage of the composition of this invention.

[0071] The above description is merely an embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural or procedural transformations made based on the content of the present invention specification, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. A composition for physical fitness and sexual function improvement, characterized by comprising, The composition comprises 20-50 parts of oyster peptide, 5-20 parts of maca extract, 4-18 parts of medlar extract, 4-18 parts of cistanche extract, 1.5-9 parts of ginseng extract, 0.3-2 parts of cordyceps militaris extract, 0.3-2.5 parts of rhizoma polygonati extract and 0.6-1.5 parts of vitamin C by mass fraction.

2. The composition of claim 1, wherein, The composition comprises 25-40 parts of oyster peptide, 8-17 parts of maca extract, 6-15 parts of medlar extract, 8-15 parts of cistanche extract, 3.5-8.5 parts of ginseng extract, 0.8-1.7 parts of cordyceps militaris extract, 0.8-2 parts of rhizoma polygonati extract and 0.9-1.2 parts of vitamin C by mass fraction.

3. The composition according to claim 1 or 2, characterized in that, The oligopeptide content of the oyster peptide is greater than or equal to 45%, the taurine content is greater than or equal to 1%, the zinc content is greater than or equal to 45 mg / kg and the selenium content is greater than or equal to 0.3 mg / kg; the protein content of the maca extract is greater than or equal to 10% and the polysaccharide content is greater than or equal to 10%; the polysaccharide content of the medlar extract is greater than or equal to 20%; the total phenylethanol glycoside content of the cistanche extract is greater than or equal to 20% and the polysaccharide content is greater than or equal to 10%; the total ginsenoside content of the ginseng extract is 10-20%; the cordycepin content of the cordyceps militaris extract is greater than or equal to 0.5%, the adenosine content is greater than or equal to 0.2% and the total polysaccharide content is greater than or equal to 30%; and the polysaccharide content of the rhizoma polygonati extract is 20-30%.

4. Process for the preparation of a composition according to any one of claims 1 to 3, characterized in that, The method comprises the following steps: The raw materials are weighed according to the raw material ratio and mixed.

5. Use of the composition of any one of claims 1-3 in the preparation of a drug for strengthening the body and improving sexual function.

6. Use of the composition of any one of claims 1-3 in the preparation of a drug for inhibiting phosphodiesterase and increasing the expression of nitric oxide synthase.

7. Use of the composition of any one of claims 1-3 in the preparation of a drug for improving oxidative stress and endocrine disorders.

8. Use of the composition of any one of claims 1-3 in the preparation of a food for improving immunity and resisting fatigue.

9. A physical fitness and sexual function improving preparation, characterized by The composition of any one of claims 1-3 and excipients.

10. The formulation of claim 9, wherein, The dosage form of the preparation is tablets, capsules or granules.

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