Traditional Chinese medicine composition for improving male sexual function and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for improving male sexual function and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The invention aims to solve the problems that the existing medicine for treating male sexual dysfunction is obvious in side effect, cannot be used for a long time and is unstable in curative effect by combining the traditional Chinese medicine theory and the modern medicine extraction technology through the compatibility of specific medicinal materials and optimizing process steps. The traditional Chinese medicine composition integrates the synergistic effects of various medicinal materials, can improve male sexual dysfunction and reduce the occurrence risk of side effects, and is suitable for long-term administration; meanwhile, the preparation method optimizes the extraction efficiency of active ingredients through a modern extraction technology, and has the characteristics of stable curative effect and high safety; the traditional Chinese medicine composition and the preparation method have innovativeness, effectiveness and practicability, are expected to become a powerful tool for improving the male sexual function, make important contributions to the health and welfare of vast males and promote the innovative development of related industries.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition for improving male sexual function and a preparation method thereof. BACKGROUND

[0003] At present, the drugs for treating male sexual dysfunction on the market are mainly divided into western medicine and traditional Chinese medicine. Western medicine such as sildenafil and tadalafil has a significant effect on improving erectile function, and can quickly help patients solve the problem of erection, but its side effects are also obvious. These drugs may cause headache, dizziness, flushing, nasal congestion, indigestion, abnormal vision and other adverse reactions, and in severe cases, they may even lead to hypotension, shock and other life-threatening conditions. Long-term use may also cause potential harm to the cardiovascular system, such as increasing the risk of heart attack and stroke. In addition, these drugs only temporarily solve the problem of erection and cannot fundamentally regulate the body function. Once the drug is stopped, the symptoms may reappear.

[0004] In contrast, traditional Chinese medicine has unique advantages in treating male sexual dysfunction. Traditional Chinese medicine focuses on the whole body, and regulates the balance of yin and yang, the running of blood and qi, and the function of viscera to achieve the purpose of treating diseases. Traditional Chinese medicine treatment not only improves the symptoms of sexual dysfunction, but also improves the body's immunity and resistance, and enhances the constitution to fundamentally solve the problem. Moreover, the side effects of traditional Chinese medicine are relatively small, and it is safe and suitable for long-term use. Traditional Chinese medicine treatment can also be individually formulated according to the specific condition of the patient to better meet the needs of different patients. Therefore, it is of great practical significance and market demand to develop a safe, effective and less side-effect traditional Chinese medicine composition for improving male sexual function.

[0005] Patent CN110301633A discloses a health food for improving male sexual health and a preparation method thereof. The functional food components of the health food include functional food components of the same origin as medicine for tonifying kidney yin and kidney yang, increasing the ability of testosterone secretion, which are the main components. Functional food components of the same origin as medicine for soothing liver, softening liver and calming liver are the secondary components, and functional food components of the same origin as medicine for dredging meridians are the third components, and functional food components of the same origin as medicine for activating blood and removing stasis are the least components. The raw materials in the composition of the present application are combined with the processes of enzymolysis and chromatography to effectively release and fully enrich the functional active ingredients. The present application is a consumable food, which is safe and has no toxic and side effects, and can improve male erectile dysfunction, enhance sexual hormone level and improve sexual desire and function. However, the patent has the following shortcomings: it mainly focuses on the overall conditioning by functional food materials of the same origin as medicine, and does not make detailed description on the optimization of specific medicinal materials and specific dosage, which may be lacking in specificity and effect.

[0006] Patent CN108185077A discloses a production method of a kind of help male health's Huang-ji Sang-shi tea, its features are with Huang-ji, Sang-shi as raw material and are made Huang-ji Sang-shi coarse powder, then with medlar, shanyao, cordyceps militaris, gordon euryale seed, raspberry, fuling, ginseng and are made traditional Chinese medicine fermentation extract, then through mixing, granulating, packing step and are made.This application uses the composition science, Huang-ji, Sang-shi, medlar, shanyao, cordyceps militaris, gordon euryale seed, raspberry, fuling, ginseng in the prescription cover the nutrition and health care effect that help male health, the various drugs in the prescription are used together and jointly play the effect of male health, at the same time, by using modern food and medicine processing technology, bagged tea is made with the characteristics of natural, nutritious, convenient, safe, good taste, suitable for long-term drinking etc.However, the deficiency of this patent is that although the preparation method considers the synergistic effect of multiple medicinal materials, it lacks flexibility in specific proportioning and preparation process, and it is difficult to accurately adjust according to different individual needs, which may affect the applicability and efficacy of the final product. SUMMARY

[0007] The purpose of the present application is to provide a traditional Chinese medicine composition for improving male sexual function and a preparation method thereof, aiming to solve the problems of obvious side effects, inability to use for a long time and unstable efficacy of existing drugs for treating male sexual dysfunction by the combination of specific medicinal materials and optimized process steps, combining traditional Chinese medicine theory with modern drug extraction technology. The traditional Chinese medicine composition of the present application combines the synergistic effect of multiple medicinal materials, which can improve male sexual dysfunction while reducing the risk of side effects and is suitable for long-term use. The preparation method optimizes the extraction efficiency of active ingredients by modern extraction technology, which has the characteristics of stable efficacy and high safety. The traditional Chinese medicine composition and preparation method of the present application have innovation, effectiveness and practicality, and are expected to become a powerful tool for improving male sexual function, making important contributions to the health and well-being of the general male population, and promoting the innovative development of related industries.

[0008] In order to achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows: a traditional Chinese medicine composition for improving male sexual function and a preparation method thereof, the traditional Chinese medicine composition comprising the following components in weight parts: Herba Epimedii 10%~20%, Ligustrum Lucidum 8%~15%, Medlar 10%~15%, Semen Leonuri 8%~12%, Fructus Corni 5%~10%, Ophiopogon 5%~8%, Tadalafil 0.015%~0.01%, and Vitamin B12 0.01%~0.03%.

[0009] Preferably, the Herba Epimedii is selected from Herba Epimedii extract treated by alcohol purification, and the main active ingredient is icariin, with a content controlled between 60% and 80%. As the core active ingredient, icariin can promote testosterone secretion, regulate endocrine balance, and improve local blood supply by protecting vascular endothelial cells.

[0010] Preferably, the schisandra chinensis is selected from the extract of schisandra chinensis treated by water purification, and the main active ingredient is oleanolic acid, and the content is controlled between 40% and 60%. Oleanolic acid has the effects of anti-inflammatory and anti-oxidation, can reduce the tissue damage caused by inflammatory factors, and has the protective effect on liver metabolic function, thereby indirectly improving sexual dysfunction.

[0011] Preferably, the medlar is selected from the polysaccharide of medlar extracted by ultrasonic wave, and the polysaccharide content is controlled between 30% and 50%. The polysaccharide of medlar can enhance the body immunity, promote blood circulation, and has the regulating effect on the nervous system, and is helpful for relieving sexual dysfunction caused by stress.

[0012] Preferably, the cuscuta is selected from the flavone of cuscuta extracted by microwave, and the flavone content is controlled between 20% and 40%. The flavone of cuscuta can regulate kidney function, enhance the clearance capacity of kidney to toxins in the body, and has the anti-aging effect, and is helpful for improving the overall health status of men.

[0013] Preferably, the fructus corni is selected from the extract of fructus corni treated by low-temperature drying, and the main active ingredient is ursolic acid, and the content is controlled between 15% and 30%. Ursolic acid has the effects of significant anti-oxidation and anti-fatigue, can improve the tolerance of the body, and delay the fatigue occurrence time, thereby improving the sexual function performance.

[0014] Preferably, the ophiopogon is selected from the saponin extract of ophiopogon treated by high-pressure cooking, and the saponin content is controlled between 25% and 45%. The saponin of ophiopogon can nourish yin and moisten dryness, regulate the water balance in the body, and has the protective effect on the cardiovascular system, reduces the erectile dysfunction caused by circulation disorder.

[0015] Preferably, the tadalafil is treated by nanoscale dispersion technology, and the particle size is controlled between 50 nanometers and 100 nanometers. Through the nanoscale treatment, the solubility and absorption rate of tadalafil are significantly improved, can play a high efficient effect at a lower dose, and reduce the stimulation to the gastrointestinal tract.

[0016] Preferably, the vitamin B12 is selected from the methylcobalamin form, and the purity is controlled to be more than 98%. Methylcobalamin can promote the erythropoiesis, improve the oxygen supply capacity of the whole body, and participate in the synthesis of neurotransmitters, and has the positive effect on the function recovery of the central nervous system.

[0017] The application also provides a preparation method of the traditional Chinese medicine composition for improving male sexual function. (1) The epimedium, schisandra chinensis, medlar, cuscuta, fructus corni and ophiopogon are pretreated respectively to obtain corresponding extracts; (2) mixing Epimedium extract, Ligustrum lucidum extract, Fructus Lycii extract, Semen Leonuri extract, Fructus Corni extract and Radix Ophiopogonis extract according to mass percentage, stirring uniformly to obtain a base medicine powder; (3) adding tadalafil into the base medicine powder, treating by nano dispersion technology to make tadalafil uniformly distributed in the base medicine powder; (4) dissolving vitamin B12 in sterile water for injection to prepare a solution with a concentration of 1 mg / ml, and then uniformly spraying the solution into the mixture obtained in step S30; (5) drying the mixture obtained in step S40 under vacuum condition, controlling the drying temperature between 40-60℃, and the drying time is 4-6 hours; (6) sieving the dried mixture with a mesh size of 80-120 meshes to obtain a granular finished product; (7) packaging the granular finished product, and the packaging material is selected as an aluminum foil bag to prevent the influence of light and moisture on the finished product.

[0018] The beneficial effects achieved by the present application with the above structure are as follows: (1) the traditional Chinese medicine composition in the present application comprehensively utilizes the synergistic effect of multiple medicinal materials, can improve male sexual dysfunction while reducing the risk of side effects, and is suitable for long-term use; (2) the preparation method in the present application optimizes the extraction efficiency of active ingredients through modern extraction technology, and has the characteristics of stable curative effect and high safety; (3) the traditional Chinese medicine composition and preparation method in the present application have innovation, effectiveness and practicality, and are expected to become a powerful tool for improving male sexual function, make important contributions to the health and well-being of the general male population, and promote the innovative development of related industries. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 Dissolution rate of active ingredients of traditional Chinese medicine composition.

[0020] The accompanying drawings are included to provide a further understanding of the present application, and constitute a part of the specification, together with the embodiments of the present application, to explain the present application, and do not constitute a limitation on the present application. DETAILED DESCRIPTION

[0021] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0022] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. Methods and materials similar or equivalent to those described herein can be used in the practice of the present application. The described preferred embodiments are intended to be illustrative only and are not intended to limit the scope of the application.

[0023] The experimental methods in the following examples are all conventional methods unless otherwise specified; the experimental materials and test strains used in the following examples are all purchased from commercial channels unless otherwise specified. Example

[0024] A traditional Chinese medicine composition for improving male sexual function and a preparation method thereof The traditional Chinese medicine composition comprises the following components in parts by weight: 10% of Epimedium, 15% of Ligustrum lucidum, 10% of Medicago, 12% of Semen Leonuri, 5% of Fructus Corni, 8% of Ophiopogon, 0.005% of tadalafil, and 0.03% of vitamin.

[0025] The Epimedium is an Epimedium extract after alcohol purification treatment, and the main active ingredient is icariin, with a content controlled in a range of 60% to 80%.

[0026] The Ligustrum lucidum is a Ligustrum lucidum extract after water purification treatment, and the main active ingredient is oleanolic acid, with a content controlled in a range of 40% to 60%.

[0027] The Medicago is a Medicago polysaccharide extracted by ultrasonic wave assistance, and the polysaccharide content is controlled in a range of 30% to 50%.

[0028] The Semen Leonuri is a Semen Leonuri flavone extracted by microwave assistance, and the flavone content is controlled in a range of 20% to 40%.

[0029] The Fructus Corni is a Fructus Corni extract after low-temperature drying treatment, and the main active ingredient is ursolic acid, with a content controlled in a range of 15% to 30%.

[0030] The Ophiopogon is an Ophiopogon saponin extract after high-pressure cooking treatment, and the saponin content is controlled in a range of 25% to 45%.

[0031] The tadalafil is treated by a nanoscale dispersion technology, so that the particle size is controlled in a range of 50 nanometers to 100 nanometers.

[0032] The vitamin B12 is selected in the form of methylcobalamin, and the purity is controlled to be above 98%.

[0033] The application further provides a preparation method of the traditional Chinese medicine composition for improving male sexual function, and the preparation method comprises the following steps: (1) Pre-treat Epimedium, Ligustrum lucidum, Medlar, Semen Litchi, and Ophiopogon japonicus respectively to obtain corresponding extracts; (2) Mix Epimedium extract, Ligustrum lucidum extract, Medlar extract, Semen Litchi extract, and Ophiopogon japonicus extract according to mass percentage, stir uniformly to obtain a base medicine powder; (3) Add tadalafil to the base medicine powder, and process by nano dispersion technology to make tadalafil uniformly distributed in the base medicine powder; (4) Dissolve vitamin B12 in sterile water for injection to prepare a solution with a concentration of 1 mg / mL, and then uniformly spray the solution into the mixture obtained in step S30; (5) Dry the mixture obtained in step S40 under vacuum conditions, with the drying temperature controlled between 40°C and 60°C, and the drying time controlled between 4 hours and 6 hours; (6) Screen the dried mixture with a screen mesh of 80-120 meshes to obtain a granular finished product; (7) Package the granular finished product in aluminum foil bags to prevent light and moisture from affecting the product. Embodiment

[0034] A traditional Chinese medicine composition for improving male sexual function and a preparation method thereof The traditional Chinese medicine composition comprises the following components by weight: Epimedium 20%, Ligustrum lucidum 8%, Medlar 15%, Semen Litchi 8%, Ophiopogon japonicus 5%, tadalafil 0.01%, and vitamin B12 0.02%.

[0035] The Epimedium is an Epimedium extract treated by alcohol extraction, and the main active ingredient is icariin, with a content controlled between 60% and 80%.

[0036] The Ligustrum lucidum is a Ligustrum lucidum extract treated by water extraction, and the main active ingredient is oleanolic acid, with a content controlled between 40% and 60%.

[0037] The Medlar is a Medlar polysaccharide extracted by ultrasonic wave assistance, and the polysaccharide content is controlled between 30% and 50%.

[0038] The Semen Litchi is a Semen Litchi flavone extracted by microwave assistance, and the flavone content is controlled between 20% and 40%.

[0039] The Ophiopogon japonicus is an Ophiopogon japonicus extract treated by low-temperature drying, and the main active ingredient is ursolic acid, with a content controlled between 15% and 30%.

[0040] The Ophiopogon japonicus selects the Ophiopogon japonicus saponin extract after high pressure cooking treatment, and the saponin content is controlled to be between 25% and 45%.

[0041] The tadalafil is treated by adopting a nanoscale dispersion technology, so that the particle size is controlled to be between 50 nanometers and 100 nanometers.

[0042] The vitamin B12 selects a methylcobalamin form, and the purity is controlled to be above 98%.

[0043] The application also provides a preparation method of the traditional Chinese medicine composition for improving male sexual function. Embodiment

[0044] A traditional Chinese medicine composition for improving male sexual function and a preparation method thereof The traditional Chinese medicine composition comprises the following components in parts by weight: Herba Epimedii 15%, Ligustri Lucidi Fructus 12%, Fructus Lycii 12%, Semen Leonuri 10%, Fructus Corni 8%, Ophiopogon japonicus 7%, tadalafil 0.007%, and vitamin B12 0.02%.

[0045] The Herba Epimedii selects Herba Epimedii extract after alcohol purification treatment, and the main active ingredient is icariin, and the content is controlled to be between 60% and 80%.

[0046] The Ligustri Lucidi Fructus selects Ligustri Lucidi Fructus extract after water purification treatment, and the main active ingredient is oleanolic acid, and the content is controlled to be between 40% and 60%.

[0047] The Fructus Lycii selects lycium barbarum polysaccharide extracted by ultrasonic wave auxiliary extraction, and the polysaccharide content is controlled to be between 30% and 50%.

[0048] The Semen Leonuri selects Semen Leonuri flavone extracted by microwave auxiliary extraction, and the flavone content is controlled to be between 20% and 40%.

[0049] The Fructus Corni selects Fructus Corni extract after low-temperature drying treatment, and the main active ingredient is ursolic acid, and the content is controlled to be between 15% and 30%.

[0050] The Ophiopogon japonicus selects the Ophiopogon japonicus saponin extract after high pressure cooking treatment, and the saponin content is controlled to be between 25% and 45%.

[0051] The tadalafil is treated by adopting a nanoscale dispersion technology, so that the particle size is controlled to be between 50 nanometers and 100 nanometers.

[0052] The vitamin B12 selects a methylcobalamin form, and the purity is controlled to be above 98%.

[0053] The present application also provides a preparation method of the traditional Chinese medicine composition for improving male sexual function, which is performed according to the method of Example 1.

[0054] Test Example 1 The traditional Chinese medicine compositions prepared by the methods in Examples 1-3 were used as samples and divided into the Example 1 group, the Example 2 group and the Example 3 group. The control group used a common traditional Chinese medicine composition on the market. Each group was repeated three times, and the active ingredient dissolution rate of each group was tested.

[0055] Results analysis: As shown in Table 1, the traditional Chinese medicine compositions prepared in Examples 1-3 had higher active ingredient dissolution rates than the control group. Figure 1

[0056] Although the embodiments of the present application have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and alterations can be made thereto without departing from the principles and spirit of the present application, and the scope of the present application is defined by the appended claims and their equivalents.

[0057] The above describes the present application and its embodiments, which are not limited, and the embodiments shown in the drawings are only one of the embodiments of the present application, and the actual structure is not limited thereto. In summary, if a person of ordinary skill in the art is inspired thereby, without departing from the principles and spirit of the present application, without creative design, similar structural modes and embodiments to the technical solution should belong to the protection scope of the present application.​

Claims

1. A traditional Chinese medicine composition for improving male sexual function, characterized in that: The traditional Chinese medicine composition comprises the following components in parts by weight: 10%-20% of Epimedium, 8%-15% of Ligustrum lucidum, 10%-15% of Lycium chinense, 8%-12% of Semen Leonuri, 5%-10% of Fructus Corni, 5%-8% of Ophiopogon japonicus, 0.005%-0.01% of tadalafil and 0.01%-0.03% of vitamin B12. ​ 2. The traditional Chinese medicine composition for improving male sexual function according to claim 1, characterized in that: The Epimedium is selected from Epimedium extract treated by alcohol extraction, and the main active ingredient is icariin, the content of which is controlled to be between 60% and 80%; as the core active ingredient, icariin can promote the secretion of testosterone, regulate endocrine balance, and has a protective effect on vascular endothelial cells and improve local blood supply.

3. The traditional Chinese medicine composition for improving male sexual function according to claim 2, characterized in that: The Ligustrum lucidum is selected from Ligustrum lucidum extract treated by water extraction, and the main active ingredient is oleanolic acid, the content of which is controlled to be between 40% and 60%; oleanolic acid has the effects of anti-inflammation and anti-oxidation, can reduce tissue damage caused by inflammatory factors, and has a protective effect on liver metabolic function, thereby indirectly improving sexual dysfunction.

4. The traditional Chinese medicine composition for improving male sexual function according to claim 3, characterized in that: The Lycium chinense is selected from Lycium chinense polysaccharide extracted by ultrasonic wave assistance, and the polysaccharide content is controlled to be between 30% and 50%; Lycium chinense polysaccharide can enhance the body's immunity, promote blood circulation, and has a regulating effect on the nervous system, which helps to relieve sexual dysfunction caused by stress.

5. The traditional Chinese medicine composition for improving male sexual function according to claim 4, characterized in that: The Semen Leonuri is selected from Semen Leonuri flavones extracted by microwave assistance, and the flavone content is controlled to be between 20% and 40%; Semen Leonuri flavones can regulate kidney function, enhance the kidney's ability to remove toxins from the body, and have a certain anti-aging effect, which helps to improve the overall health status of men.

6. The traditional Chinese medicine composition for improving male sexual function according to claim 5, characterized in that: The Fructus Corni is selected from Fructus Corni extract treated by low-temperature drying, and the main active ingredient is ursolic acid, the content of which is controlled to be between 15% and 30%; ursolic acid has significant antioxidant and anti-fatigue effects, can improve the body's tolerance, and delay the occurrence of fatigue, thereby improving sexual function.

7. The traditional Chinese medicine composition for improving male sexual function according to claim 6, characterized in that: The Ophiopogon japonicus is selected from Ophiopogon japonicus saponin extract treated by high-pressure cooking, and the saponin content is controlled to be between 25% and 45%; Ophiopogon japonicus saponin can nourish yin and moisten dryness, regulate water balance in the body, and has a protective effect on the cardiovascular system, reducing erectile dysfunction caused by circulation disorders.

8. The traditional Chinese medicine composition for improving male sexual function according to claim 7, characterized in that: The tadalafil is treated by nanoscale dispersion technology, and the particle size is controlled to be between 50 nanometers and 100 nanometers; through nanoscale treatment, the solubility and absorption rate of tadalafil are significantly improved, which can play a high-efficiency role at a lower dose, and reduce the stimulation to the gastrointestinal tract.

9. The traditional Chinese medicine composition for improving male sexual function according to claim 8, characterized in that: The vitamin B12 is selected in the form of methylcobalamin, and the purity is controlled to be above 98%; methylcobalamin can promote the production of red blood cells, improve the oxygen supply capacity of the whole body, and participate in the synthesis of neurotransmitters, which has a positive effect on the functional recovery of the central nervous system.

10. A method for preparing the traditional Chinese medicine composition for improving male sexual function according to claim 9, characterized in that: The preparation method comprises the following steps: (1) pretreating Epimedium, Ligustrum lucidum, Lycium chinense, Semen Leonuri, Fructus Corni and Ophiopogon japonicus respectively to obtain corresponding extracts; (2) mixing Epimedium extract, Ligustrum extract, Fructus Lycii extract, Semen Euryale extract, Fructus Corni extract and Radix Ophiopogonis extract according to mass percentage, stirring uniformly to obtain a base medicine powder; (3) adding tadalafil into the base medicine powder, treating by nano dispersion technology to make tadalafil uniformly distributed in the base medicine powder; (4) dissolving vitamin B12 in sterile water for injection to prepare a solution with a concentration of 1 mg / ml, and then uniformly spraying the solution into the mixture obtained in step S30; (5) drying the mixture obtained in step S40 under vacuum conditions, the drying temperature is controlled between 40-60 DEG C, and the drying time is 4-6 hours; (6) sieving the dried mixture, the mesh size is 80-120 meshes, to obtain a granular finished product; (7) packaging the granular finished product, the packaging material is selected as an aluminum foil bag to prevent the influence of light and moisture on the finished product.

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