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

Abstract

The invention discloses a traditional Chinese medicine composition and ointment for improving male sexual function and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 90-100 parts of rhizoma polygonati, 30-40 parts of Chinese wolfberry, 20-30 parts of angelica sinensis, 20-30 parts of pawpaw, 10-12 parts of cistanche, 9-11 parts of ginseng, 8-10 parts of calcined oyster shell, 5-6 parts of dogwood, 5-6 parts of fructus alpiniae oxyphyllae, 3-4 parts of walnut kernel, 3-4 parts of fructus perillae, 3-4 parts of raw rice sprout, 3-4 parts of raw rice sprout, 3-4 parts of poria cocos and 5-6 parts of liquorice. The prepared traditional Chinese medicine ointment is suitable for physique nursing and comprehensive improvement of male sexual function, is suitable for long-term administration, and is safe and reliable.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and provides a traditional Chinese medicine composition, ointment and preparation method for improving male sexual function. Background Technology

[0002] With the continuous improvement of living standards, men are paying more and more attention to their health, and the harmony of marital relationships is receiving increasing attention. In recent years, with increasing work and life pressures, the number of patients with sexual dysfunction or decreased sexual function has been increasing, becoming a key factor affecting the harmony of marital relationships. Coupled with the fast pace of life and irregular eating habits, sexual dysfunction is showing a trend of affecting younger people. Clinically, sexual dysfunction manifests as sexual desire disorders, erectile dysfunction, premature ejaculation, nocturnal emission, anejaculation, and retrograde ejaculation, making it impossible for patients to have successful sexual intercourse, greatly interfering with their daily lives and even their mental health. In severe cases, it can even lead to infertility.

[0003] Male sexual dysfunction is mostly treated through surgery, Western medicine, and traditional Chinese medicine. Surgical treatment is expensive and involves post-operative pain, making it a less desirable option for most patients. Western medicine treatments for sexual dysfunction are not ideal, and long-term use can easily lead to drug resistance and significant side effects such as headaches, nasal congestion, muscle pain, blurred vision, and facial flushing, severely damaging liver and kidney function and making long-term use unsuitable. Traditional Chinese medicine treatment has advantages such as fewer adverse reactions, suitability for long-term use, safety, reliability, and low cost. However, commonly available kidney-tonifying and aphrodisiac powders and capsules offer only a single treatment effect and cannot address both the symptoms and the root cause.

[0004] Therefore, it is essential to conduct research on traditional Chinese medicine for male sexual dysfunction. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition, ointment and preparation method for improving male sexual function, which comprehensively improves male sexual function, is suitable for long-term use and is safe and reliable.

[0006] To achieve the above objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine composition for improving male sexual function, which is made from the following components in parts by weight: 90-100 parts of Polygonatum sibiricum, 30-40 parts of Lycium barbarum, 20-30 parts of Angelica sinensis, 20-30 parts of Chaenomeles speciosa, 10-12 parts of Cistanche deserticola, 9-11 parts of Panax ginseng, 8-10 parts of calcined oyster shell, 5-6 parts of Cornus officinalis, 5-6 parts of Alpinia oxyphylla, 3-4 parts of walnut kernel, 3-4 parts of Perilla frutescens, 3-4 parts of raw rice sprout, 3-4 parts of raw barley sprout, 3-4 parts of Poria cocos, and 5-6 parts of Glycyrrhiza uralensis.

[0007] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of an ointment for improving male sexual function.

[0008] The present invention also provides an ointment for improving male sexual function, comprising the aforementioned traditional Chinese medicine composition.

[0009] This invention also provides a method for preparing the aforementioned ointment for improving male sexual function, the specific steps of which are as follows: (1) Take the prescribed amount of Angelica sinensis and papaya, wash, dry, crush and mix them to obtain Angelica sinensis and papaya powder; stir and disperse the Angelica sinensis and papaya powder in deionized water, adjust the pH, sterilize, inoculate with Lactobacillus plantarum solution, ferment, filter and take the filtrate to obtain fermentation liquid; (2) Take the prescribed amount of wolfberry, cornus officinalis, alpinia oxyphylla, walnut kernel, perilla seed, raw rice sprout, and raw barley sprout, add water and soak completely. Under the action of magnetic nanospheres, extract by pulsed magnetic field and ultrasonic coupling, filter and take the filtrate to obtain the pre-extracted medicine solution, and use a magnet to recover the magnetic nanospheres. (3) Take the prescribed amount of Cistanche deserticola and calcined oyster shell, add water to completely submerge them, soak for 60-70 minutes, bring to a boil over high heat, simmer over low heat for 30-40 minutes, add the prescribed amount of Polygonatum sibiricum, ginseng, Poria cocos and licorice, bring to a boil over high heat, simmer over low heat for 40-50 minutes, filter to obtain the filtrate, cool the filtrate and mix it evenly with the fermentation liquid and the pre-extracted medicinal liquid, concentrate under reduced pressure to obtain the ointment.

[0010] Preferably, in step (1), the amount of deionized water used is 10 to 12 times the mass of the Angelica sinensis and papaya powder, and the volumetric inoculation amount of Lactobacillus plantarum solution is 1.5 to 2%; the pH is adjusted to 6.0 using 1 mol / L citric acid solution; and the viable cell concentration of the Lactobacillus plantarum solution is 3 × 10⁻⁶. 8 cfu / mL.

[0011] Preferably, in step (1), the preparation method of Lactobacillus plantarum culture is as follows: after activating Lactobacillus plantarum, it is inoculated into sterile MRS medium at a volume inoculation amount of 3%, and anaerobic culture at 37°C for 36 hours to obtain the culture solution; then, the culture solution is inoculated into sterile MRS medium at a volume inoculation amount of 3%, and anaerobic culture at 37°C for 24 hours to obtain the culture solution.

[0012] Preferably, in step (1), the sterilization conditions are: temperature 121℃, pressure 0.1MPa, sterilization time 25 minutes.

[0013] Preferably, in step (1), the fermentation conditions are: fermentation at 30-35℃ for 55-65 hours; and stirring is performed every 12 hours during fermentation, with the stirring conditions being: stirring at 200r / min for 10 minutes.

[0014] Preferably, in step (2), the amount of water and magnetic nanospheres used is 10 to 12 times and 0.1 to 0.2 times the total mass of all Chinese medicine components in this step, respectively.

[0015] Preferably, in step (2), the magnetic nanospheres are prepared as follows: First, ferric chloride hexahydrate is dissolved in ethylene glycol and mixed evenly. Then, ammonium acetate and trisodium citrate are added and stirred at room temperature for 50-60 minutes. The mixture is then transferred to an oil bath at 170-180°C and stirred for 1-2 hours. The mixture is then heated to 190-200°C and stirred for 12-15 hours. The mixture is then naturally cooled to room temperature, filtered to obtain particles, washed successively with anhydrous ethanol and water, and dried at 50-60°C for 12 hours to obtain the final product. The ratio of ferric chloride hexahydrate, ethylene glycol, ammonium acetate, and trisodium citrate is 2-3g: 80-100mL: 7-8g: 0.8-1g.

[0016] Preferably, in step (2), the process conditions for pulsed magnetic field and ultrasonic coupling extraction are: magnetic field strength 4-6T, number of pulses 10-12, pulse duration 50-60ms; ultrasonic power 200-300W, frequency 40-50kHz; extraction time 10-12 minutes.

[0017] Preferably, in step (3), the amount of water used is 10 to 12 times the total mass of all Chinese herbal medicine components in this step.

[0018] Preferably, in step (3), the concentration is reduced by pressure to a relative density of 1.25 to 1.35 (20°C).

[0019] The beneficial effects of this invention are: This invention provides a traditional Chinese medicine composition, ointment, and preparation method for improving male sexual function. It is made from the following components in parts by weight: 90-100 parts of Polygonatum sibiricum, 30-40 parts of Lycium barbarum, 20-30 parts of Angelica sinensis, 20-30 parts of Chaenomeles speciosa, 10-12 parts of Cistanche deserticola, 9-11 parts of Panax ginseng, 8-10 parts of calcined oyster shell, 5-6 parts of Cornus officinalis, 5-6 parts of Alpinia oxyphylla, 3-4 parts of walnut kernel, 3-4 parts of Perilla frutescens, 3-4 parts of raw rice sprout, 3-4 parts of raw barley sprout, 3-4 parts of Poria cocos, and 5-6 parts of Glycyrrhiza uralensis. The ointment prepared by this invention is suitable for conditioning the body, comprehensively improving male sexual function, suitable for long-term use, and safe and reliable.

[0020] This invention screens traditional Chinese medicine components, follows the principles of monarch-minister-assistant-guide compatibility, and leverages the synergistic effects between the components to achieve comprehensive improvement in male sexual function. Specifically: The principal herbs are Polygonatum and ginseng, which replenish qi and yin, benefit the kidneys and replenish essence, enhance immunity, and comprehensively regulate and strengthen the body. Assistant herbs: wolfberry, angelica, cistanche, and calcined oyster shell, which enhance the efficacy of the principal herbs and improve physical condition while tonifying the kidneys and strengthening yang. The adjuvant herbs are: Cornus officinalis, Alpinia oxyphylla, walnut kernel, Perilla frutescens seed, raw rice sprout, raw barley sprout, and Poria cocos. They assist the principal and assistant herbs, further tonify the kidneys and strengthen yang, and reduce the side effects of the principal and assistant herbs. The guiding herbs are papaya and licorice, which direct the action of the other herbs and harmonize their effects.

[0021] In preparing the ointment, the components are grouped and processed according to their characteristics to ensure the full release of active ingredients, reduce the loss of active ingredients, reduce the formation of harmful ingredients, ensure efficacy, and reduce side effects. Angelica sinensis and papaya are fermented with Lactobacillus plantarum to promote the release of beneficial ingredients and make the active ingredients easier to absorb. Lycium barbarum, Cornus officinalis, Alpinia oxyphylla, walnut kernels, Perilla frutescens seeds, raw rice sprouts, and raw barley sprouts contain volatile oils or heat-sensitive components. This application utilizes pulsed magnetic field and ultrasonic coupling extraction under the action of magnetic nanospheres. Cistanche deserticola and calcined oyster shell are decocted first to promote the full release of active ingredients. The preparation method of this invention is reasonable, ensures efficacy, and reduces side effects.

[0022] Other advantages, objectives, and features of the invention will be set forth in part in the description which follows, and in part will be apparent to those skilled in the art from the following examination, or may be learned from practice of the invention. The objectives and other advantages of the invention can be realized and obtained through the following description. Detailed Implementation

[0023] The present invention will be further described below with reference to specific embodiments.

[0024] The Lactobacillus plantarum involved in this invention, CGMCC11160, was purchased from Beijing BioBio Biotechnology Co., Ltd. Example 1

[0025] A traditional Chinese medicine composition for improving male sexual function is made from the following components in parts by weight: 90 parts Polygonatum sibiricum, 30 parts Lycium barbarum, 20 parts Angelica sinensis, 20 parts Chaenomeles speciosa, 10 parts Cistanche deserticola, 9 parts Panax ginseng, 8 parts calcined oyster shell, 5 parts Cornus officinalis, 5 parts Alpinia oxyphylla, 3 parts walnut kernel, 3 parts Perilla frutescens, 3 parts raw rice sprout, 3 parts raw barley sprout, 3 parts Poria cocos, and 5 parts Glycyrrhiza uralensis.

[0026] A method for preparing a cream to improve male sexual function, comprising the following specific steps: (1) Take the prescribed amount of Angelica sinensis and papaya, wash, dry, crush and mix them to obtain Angelica sinensis and papaya powder; stir and disperse the Angelica sinensis and papaya powder in deionized water, adjust the pH, sterilize, inoculate with Lactobacillus plantarum solution, ferment, filter and take the filtrate to obtain fermentation liquid; (2) Take the prescribed amount of wolfberry, cornus officinalis, alpinia oxyphylla, walnut kernel, perilla seed, raw rice sprout, and raw barley sprout, add water and soak completely. Under the action of magnetic nanospheres, extract by pulsed magnetic field and ultrasonic coupling, filter and take the filtrate to obtain the pre-extracted medicine solution, and use a magnet to recover the magnetic nanospheres. (3) Take the prescribed amount of Cistanche deserticola and calcined oyster shell, add water to completely submerge them, soak for 60 minutes, bring to a boil over high heat, simmer over low heat for 30 minutes, add the prescribed amount of Polygonatum sibiricum, ginseng, Poria cocos and licorice, bring to a boil over high heat, simmer over low heat for 40 minutes, filter to obtain the filtrate, cool the filtrate and mix it evenly with the fermentation liquid and pre-extracted medicinal liquid, concentrate under reduced pressure to obtain the ointment.

[0027] In step (1), the amount of deionized water used is 10 times the mass of the Angelica sinensis and papaya powder, and the volume inoculation amount of Lactobacillus plantarum solution is 1.5%; the pH is adjusted to 6.0 using 1 mol / L citric acid solution; the viable cell concentration of the Lactobacillus plantarum solution is 3 × 10⁻⁶. 8 cfu / mL.

[0028] In step (1), the preparation method of Lactobacillus plantarum culture is as follows: after activating Lactobacillus plantarum, it is inoculated into sterile MRS medium at a volume inoculation amount of 3% and anaerobic culture at 37°C for 36 hours to obtain the culture solution; then the culture solution is inoculated into sterile MRS medium at a volume inoculation amount of 3% and anaerobic culture at 37°C for 24 hours to obtain the culture solution.

[0029] In step (1), the sterilization conditions are: temperature 121℃, pressure 0.1MPa, sterilization time 25 minutes.

[0030] In step (1), the fermentation conditions are: fermentation at 30℃ for 55 hours; stirring is performed every 12 hours during fermentation, and the stirring conditions are: stirring at 200r / min for 10 minutes.

[0031] In step (2), the amount of water and magnetic nanospheres used is 10 times and 0.1 times the total mass of all Chinese medicine components in this step, respectively.

[0032] In step (2), the magnetic nanospheres are prepared as follows: First, ferric chloride hexahydrate is dissolved in ethylene glycol and mixed evenly. Then, ammonium acetate and trisodium citrate are added and stirred at room temperature for 50 minutes. The mixture is then transferred to an oil bath at 170°C and stirred for 1 hour. The mixture is then heated to 190°C and stirred for 12 hours. After cooling naturally to room temperature, the particles are filtered and washed with anhydrous ethanol and water in sequence. The particles are then dried at 50°C for 12 hours to obtain the final product. The ratio of ferric chloride hexahydrate, ethylene glycol, ammonium acetate, and trisodium citrate is 2g:80mL:7g:0.8g.

[0033] In step (2), the process conditions for pulsed magnetic field and ultrasonic coupling extraction are as follows: magnetic field strength 4T, number of pulses 10, pulse duration 50ms; ultrasonic power 200W, frequency 40kHz; extraction time 10 minutes.

[0034] In step (3), the amount of water used is 10 times the total mass of all Chinese herbal medicine components in this step.

[0035] In step (3), the concentration is reduced to a relative density of 1.25 (20°C) under reduced pressure. Example 2

[0036] A traditional Chinese medicine composition for improving male sexual function is made from the following components in parts by weight: 100 parts Polygonatum sibiricum, 40 parts Lycium barbarum, 30 parts Angelica sinensis, 30 parts Chaenomeles speciosa, 12 parts Cistanche deserticola, 11 parts Panax ginseng, 10 parts calcined oyster shell, 6 parts Cornus officinalis, 6 parts Alpinia oxyphylla, 4 parts walnut kernel, 4 parts Perilla frutescens, 4 parts raw rice sprout, 4 parts raw barley sprout, 4 parts Poria cocos, and 6 parts Glycyrrhiza uralensis.

[0037] A method for preparing a cream to improve male sexual function, comprising the following specific steps: (1) Take the prescribed amount of Angelica sinensis and papaya, wash, dry, crush and mix them to obtain Angelica sinensis and papaya powder; stir and disperse the Angelica sinensis and papaya powder in deionized water, adjust the pH, sterilize, inoculate with Lactobacillus plantarum solution, ferment, filter and take the filtrate to obtain fermentation liquid; (2) Take the prescribed amount of wolfberry, cornus officinalis, alpinia oxyphylla, walnut kernel, perilla seed, raw rice sprout, and raw barley sprout, add water and soak completely. Under the action of magnetic nanospheres, extract by pulsed magnetic field and ultrasonic coupling, filter and take the filtrate to obtain the pre-extracted medicine solution, and use a magnet to recover the magnetic nanospheres. (3) Take the prescribed amount of Cistanche deserticola and calcined oyster shell, add water to completely submerge them, soak for 70 minutes, bring to a boil over high heat, simmer over low heat for 40 minutes, add the prescribed amount of Polygonatum sibiricum, ginseng, Poria cocos and licorice, bring to a boil over high heat, simmer over low heat for 50 minutes, filter to obtain the filtrate, cool the filtrate and mix it evenly with the fermentation liquid and pre-extracted medicinal liquid, concentrate under reduced pressure to obtain the ointment.

[0038] In step (1), the amount of deionized water used is 12 times the mass of the Angelica sinensis and papaya powder, and the volume inoculation amount of Lactobacillus plantarum solution is 2%; the pH is adjusted to 6.0 using 1 mol / L citric acid solution; the viable cell concentration of the Lactobacillus plantarum solution is 3 × 10⁻⁶. 8 cfu / mL.

[0039] In step (1), the preparation method of Lactobacillus plantarum culture is as follows: after activating Lactobacillus plantarum, it is inoculated into sterile MRS medium at a volume inoculation amount of 3% and anaerobic culture at 37°C for 36 hours to obtain the culture solution; then the culture solution is inoculated into sterile MRS medium at a volume inoculation amount of 3% and anaerobic culture at 37°C for 24 hours to obtain the culture solution.

[0040] In step (1), the sterilization conditions are: temperature 121℃, pressure 0.1MPa, sterilization time 25 minutes.

[0041] In step (1), the fermentation conditions are: fermentation at 35℃ for 65 hours; stirring is performed every 12 hours during fermentation, and the stirring conditions are: stirring at 200r / min for 10 minutes.

[0042] In step (2), the amount of water and magnetic nanospheres used is 12 times and 0.2 times the total mass of all Chinese medicine components in this step, respectively.

[0043] In step (2), the magnetic nanospheres are prepared as follows: First, ferric chloride hexahydrate is dissolved in ethylene glycol and mixed evenly. Then, ammonium acetate and trisodium citrate are added and stirred at room temperature for 60 minutes. The mixture is then transferred to an oil bath at 180°C and stirred for 2 hours. The mixture is then heated to 200°C and stirred for 15 hours. After cooling naturally to room temperature, the particles are filtered and washed successively with anhydrous ethanol and water. The particles are then dried at 60°C for 12 hours to obtain the final product. The ratio of ferric chloride hexahydrate, ethylene glycol, ammonium acetate, and trisodium citrate is 3g:100mL:8g:1g.

[0044] In step (2), the process conditions for pulsed magnetic field and ultrasonic coupling extraction are as follows: magnetic field strength 6T, number of pulses 12, pulse duration 60ms; ultrasonic power 300W, frequency 50kHz; extraction time 12 minutes.

[0045] In step (3), the amount of water used is 12 times the total mass of all Chinese herbal medicine components in this step.

[0046] In step (3), the concentration is reduced by pressure to a relative density of 1.35 (20°C). Example 3

[0047] A traditional Chinese medicine composition for improving male sexual function is made from the following components in parts by weight: 95 parts Polygonatum sibiricum, 35 parts Lycium barbarum, 25 parts Angelica sinensis, 25 parts Chaenomeles speciosa, 11 parts Cistanche deserticola, 10 parts Panax ginseng, 9 parts calcined oyster shell, 6 parts Cornus officinalis, 5 parts Alpinia oxyphylla, 4 parts walnut kernel, 3 parts Perilla frutescens, 3 parts raw rice sprout, 3 parts raw barley sprout, 4 parts Poria cocos, and 6 parts Glycyrrhiza uralensis.

[0048] A method for preparing a cream to improve male sexual function, comprising the following specific steps: (1) Take the prescribed amount of Angelica sinensis and papaya, wash, dry, crush and mix them to obtain Angelica sinensis and papaya powder; stir and disperse the Angelica sinensis and papaya powder in deionized water, adjust the pH, sterilize, inoculate with Lactobacillus plantarum solution, ferment, filter and take the filtrate to obtain fermentation liquid; (2) Take the prescribed amount of wolfberry, cornus officinalis, alpinia oxyphylla, walnut kernel, perilla seed, raw rice sprout, and raw barley sprout, add water and soak completely. Under the action of magnetic nanospheres, extract by pulsed magnetic field and ultrasonic coupling, filter and take the filtrate to obtain the pre-extracted medicine solution, and use a magnet to recover the magnetic nanospheres. (3) Take the prescribed amount of Cistanche deserticola and calcined oyster shell, add water to completely submerge them, soak for 65 minutes, bring to a boil over high heat, simmer over low heat for 35 minutes, add the prescribed amount of Polygonatum sibiricum, ginseng, Poria cocos and licorice, bring to a boil over high heat, simmer over low heat for 45 minutes, filter to obtain the filtrate, cool the filtrate and mix it evenly with the fermentation liquid and pre-extracted medicinal liquid, concentrate under reduced pressure to obtain the ointment.

[0049] In step (1), the amount of deionized water used is 11 times the mass of the Angelica sinensis and papaya powder, and the volume inoculation amount of Lactobacillus plantarum solution is 1.8%; the pH is adjusted to 6.0 using 1 mol / L citric acid solution; the viable cell concentration of the Lactobacillus plantarum solution is 3 × 10⁻⁶. 8 cfu / mL.

[0050] In step (1), the preparation method of Lactobacillus plantarum culture is as follows: after activating Lactobacillus plantarum, it is inoculated into sterile MRS medium at a volume inoculation amount of 3% and anaerobic culture at 37°C for 36 hours to obtain the culture solution; then the culture solution is inoculated into sterile MRS medium at a volume inoculation amount of 3% and anaerobic culture at 37°C for 24 hours to obtain the culture solution.

[0051] In step (1), the sterilization conditions are: temperature 121℃, pressure 0.1MPa, sterilization time 25 minutes.

[0052] In step (1), the fermentation conditions are: fermentation at 32℃ for 60 hours; stirring is performed every 12 hours during fermentation, and the stirring conditions are: stirring at 200r / min for 10 minutes.

[0053] In step (2), the amount of water and magnetic nanospheres used is 11 times and 0.15 times the total mass of all Chinese medicine components in this step, respectively.

[0054] In step (2), the magnetic nanospheres are prepared as follows: First, ferric chloride hexahydrate is dissolved in ethylene glycol and mixed evenly. Then, ammonium acetate and trisodium citrate are added and stirred at room temperature for 55 minutes. The mixture is then transferred to an oil bath at 175°C and stirred for 1.5 hours. The mixture is then heated to 195°C and stirred for 14 hours. After naturally cooling to room temperature, the particles are filtered and washed with anhydrous ethanol and water in sequence. The particles are then dried at 55°C for 12 hours to obtain the final product. The ratio of ferric chloride hexahydrate, ethylene glycol, ammonium acetate, and trisodium citrate is 2.5g:90mL:7.5g:0.9g.

[0055] In step (2), the process conditions for pulsed magnetic field and ultrasonic coupling extraction are as follows: magnetic field strength 5T, number of pulses 11, pulse duration 55ms; ultrasonic power 300W, frequency 45kHz; extraction time 11 minutes.

[0056] In step (3), the amount of water used is 11 times the total mass of all Chinese herbal medicine components in this step.

[0057] In step (3), the sample is concentrated under reduced pressure to a relative density of 1.3 (20°C).

[0058] Comparative Example 1 Cornus officinalis is omitted from the formula. The rest is the same as in Example 1.

[0059] Comparative Example 2 The formula composition excludes raw rice sprouts; The rest is the same as in Example 1.

[0060] Comparative Example 3 A method for preparing a cream to improve male sexual function, comprising the following specific steps: (1) Take the prescribed amount of wolfberry, cornus officinalis, alpinia oxyphylla, walnut kernel, perilla seed, raw rice sprout, and raw barley sprout, add water and soak completely. Under the action of magnetic nanospheres, extract by pulsed magnetic field and ultrasonic coupling, filter and take the filtrate to obtain the pre-extracted medicine solution, and use a magnet to recover the magnetic nanospheres. (2) Take the prescribed amount of Cistanche deserticola and calcined oyster shell, add water to completely submerge them, soak for 60 minutes, bring to a boil over high heat, simmer over low heat for 30 minutes, add the prescribed amount of Angelica sinensis, papaya, Polygonatum sibiricum, ginseng, Poria cocos and licorice, bring to a boil over high heat, simmer over low heat for 40 minutes, filter to obtain the filtrate, cool the filtrate and mix it evenly with the fermentation liquid and pre-extracted medicinal liquid, concentrate under reduced pressure to obtain the ointment.

[0061] The rest is the same as in Example 1.

[0062] Comparative Example 4 A method for preparing a cream to improve male sexual function, comprising the following specific steps: (1) Take the prescribed amount of Angelica sinensis and papaya, wash, dry, crush and mix them to obtain Angelica sinensis and papaya powder; stir and disperse the Angelica sinensis and papaya powder in deionized water, adjust the pH, sterilize, inoculate with Lactobacillus plantarum solution, ferment, filter and take the filtrate to obtain fermentation liquid; (2) Take the prescribed amount of wolfberry, cornus officinalis, alpinia oxyphylla, walnut kernel, perilla seed, raw rice sprout, and raw rice sprout, add water and soak completely, extract with ultrasonic waves, filter and take the filtrate to obtain the pre-extracted medicine solution. (3) Take the prescribed amount of Cistanche deserticola and calcined oyster shell, add water to completely submerge them, soak for 60 minutes, bring to a boil over high heat, simmer over low heat for 30 minutes, add the prescribed amount of Polygonatum sibiricum, ginseng, Poria cocos and licorice, bring to a boil over high heat, simmer over low heat for 40 minutes, filter to obtain the filtrate, cool the filtrate and mix it evenly with the fermentation liquid and pre-extracted medicinal liquid, concentrate under reduced pressure to obtain the ointment.

[0063] The rest is the same as in Example 1.

[0064] Comparative Example 5 A method for preparing a cream to improve male sexual function, comprising the following specific steps: (1) Take the prescribed amount of Angelica sinensis and papaya, wash, dry, crush and mix them to obtain Angelica sinensis and papaya powder; stir and disperse the Angelica sinensis and papaya powder in deionized water, adjust the pH, sterilize, inoculate with Lactobacillus plantarum solution, ferment, filter and take the filtrate to obtain fermentation liquid; (2) Take the prescribed amount of Cistanche deserticola and calcined oyster shell, add water to completely submerge them, soak for 60 minutes, bring to a boil over high heat, simmer over low heat for 30 minutes, add the prescribed amount of Polygonatum sibiricum, ginseng, Poria cocos, licorice, wolfberry, Cornus officinalis, Alpinia oxyphylla, walnut kernel, Perilla frutescens, raw rice sprouts, and raw rice sprouts, bring to a boil over high heat, simmer over low heat for 40 minutes, filter to obtain the filtrate, cool the filtrate and mix it evenly with the fermentation liquid and pre-extracted medicinal liquid, concentrate under reduced pressure to obtain the ointment.

[0065] The rest is the same as in Example 1.

[0066] Test case Adult male Kunming mice, weighing 24–27 g, were randomly divided into 9 groups, one of which was a blank control and the rest were experimental groups, with 10 mice in each group.

[0067] The blank control group was administered 0.5 mL of physiological saline once daily; the experimental groups were administered 5 g / kg / day of the ointment prepared in Examples 1-3 or Comparative Examples 1-5 (the ointment was diluted with 5 times its weight of 60°C warm water before use) once daily for 24 days. Starting from the 4th day of administration, the animals in each group were immersed in 30°C deep water for 3 hours daily as a stress response for four weeks. Sexual function tests were performed on the 7th day and the 35th day of administration (i.e., one week after the end of administration).

[0068] Adult female Kunming mice, weighing 24–27 g, were administered the estrogen diethylstilbestrol 0.4 mg / kg / day via intramuscular injection (to increase estrus rate). Two days later, vaginal smears examined under a microscope showed no nucleated keratinized cells on the surface, indicating they were in estrus. These estrus female mice were then placed in the same cage as male mice, and mating was observed over a 5-minute period. The results are shown in Table 1.

[0069] Table 1. Results of animal experiments Table 1 shows that the ointments obtained in Examples 1-3 can significantly improve male sexual function.

[0070] In Comparative Example 1, Cornus officinalis was omitted from the formulation; in Comparative Example 2, rice sprouts were omitted from the formulation; in Comparative Example 3, Angelica sinensis and papaya were not fermented during the preparation of the ointment; in Comparative Example 4, magnetic nanospheres and the corresponding pulsed magnetic field conditions were omitted in step (2) during the preparation of the ointment; and in Comparative Example 5, the pre-extraction in step (2) was omitted during the preparation of the ointment. The number of male mice that mated was significantly reduced, indicating that the specific formulation and special preparation method of the present invention work synergistically to improve the efficacy.

[0071] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. 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 be made to the technical solutions of the present invention without departing from the spirit and scope of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for improving male sexual function, characterized in that, It is made from the following components in parts by weight: 90-100 parts Polygonatum sibiricum, 30-40 parts Lycium barbarum, 20-30 parts Angelica sinensis, 20-30 parts Chaenomeles speciosa, 10-12 parts Cistanche deserticola, 9-11 parts Panax ginseng, 8-10 parts calcined oyster shell, 5-6 parts Cornus officinalis, 5-6 parts Alpinia oxyphylla, 3-4 parts walnut kernel, 3-4 parts Perilla frutescens, 3-4 parts raw rice sprout, 3-4 parts raw barley sprout, 3-4 parts Poria cocos, and 5-6 parts Glycyrrhiza uralensis.

2. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of an ointment for improving male sexual function.

3. A cream for improving male sexual function, characterized in that, It comprises the traditional Chinese medicine composition according to claim 1.

4. The method for preparing the ointment for improving male sexual function as described in claim 3, characterized in that, The specific steps are as follows: (1) Take the prescribed amount of Angelica sinensis and papaya, wash, dry, crush and mix them to obtain Angelica sinensis and papaya powder; stir and disperse the Angelica sinensis and papaya powder in deionized water, adjust the pH, sterilize, inoculate with Lactobacillus plantarum solution, ferment, filter and take the filtrate to obtain fermentation liquid; (2) Take the prescribed amount of wolfberry, cornus officinalis, alpinia oxyphylla, walnut kernel, perilla seed, raw rice sprout, and raw barley sprout, add water and soak completely. Under the action of magnetic nanospheres, extract by pulsed magnetic field and ultrasonic coupling, filter and take the filtrate to obtain the pre-extracted medicine solution, and use a magnet to recover the magnetic nanospheres. (3) Take the prescribed amount of Cistanche deserticola and calcined oyster shell, add water to completely submerge them, soak for 60-70 minutes, bring to a boil over high heat, simmer over low heat for 30-40 minutes, add the prescribed amount of Polygonatum sibiricum, ginseng, Poria cocos and licorice, bring to a boil over high heat, simmer over low heat for 40-50 minutes, filter to obtain the filtrate, cool the filtrate and mix it evenly with the fermentation liquid and the pre-extracted medicinal liquid, concentrate under reduced pressure to obtain the ointment.

5. The preparation method according to claim 4, characterized in that, In step (1), the amount of deionized water used is 10 to 12 times the mass of the Angelica sinensis and papaya powder, and the volumetric inoculation amount of Lactobacillus plantarum solution is 1.5 to 2%; the pH is adjusted to 6.0 using 1 mol / L citric acid solution; the viable cell concentration of the Lactobacillus plantarum solution is 3 × 10⁻⁶. 8 cfu / mL.

6. The preparation method according to claim 4, characterized in that, In step (1), the preparation method of Lactobacillus plantarum culture is as follows: after activating Lactobacillus plantarum, it is inoculated into sterile MRS medium at a volume inoculation rate of 3% and anaerobic culture at 37°C for 36 hours to obtain the culture solution; then the culture solution is inoculated into sterile MRS medium at a volume inoculation rate of 3% and anaerobic culture at 37°C for 24 hours to obtain the culture solution. The sterilization conditions were: temperature 121℃, pressure 0.1MPa, sterilization time 25 minutes; Fermentation conditions: 30-35℃ for 55-65 hours; stirring every 12 hours during fermentation, with stirring conditions of 200r / min for 10 minutes.

7. The preparation method according to claim 4, characterized in that, In step (2), the amount of water and magnetic nanospheres used is 10 to 12 times and 0.1 to 0.2 times the total mass of all Chinese medicine components in this step, respectively.

8. The preparation method according to claim 4, characterized in that, In step (2), the magnetic nanospheres are prepared as follows: First, ferric chloride hexahydrate is dissolved in ethylene glycol and mixed evenly. Then, ammonium acetate and trisodium citrate are added and stirred at room temperature for 50-60 minutes. The mixture is then transferred to an oil bath at 170-180°C and stirred for 1-2 hours. The mixture is then heated to 190-200°C and stirred for 12-15 hours. The mixture is then naturally cooled to room temperature, filtered to obtain particles, washed successively with anhydrous ethanol and water, and dried at 50-60°C for 12 hours to obtain the final product. The ratio of ferric chloride hexahydrate, ethylene glycol, ammonium acetate, and trisodium citrate is 2-3g: 80-100mL: 7-8g: 0.8-1g.

9. The preparation method according to claim 4, characterized in that, In step (2), the process conditions for pulsed magnetic field and ultrasonic coupling extraction are as follows: magnetic field strength 4-6T, number of pulses 10-12, pulse duration 50-60ms; ultrasonic power 200-300W, frequency 40-50kHz; extraction time 10-12 minutes.

10. The preparation method according to claim 4, characterized in that, In step (3), the amount of water used is 10 to 12 times the total mass of all Chinese herbal medicine components in this step; In step (3), the concentration is reduced by pressure to a relative density of 1.25 to 1.35.

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