Composition for treating male erectile dysfunction by using super nano coating technology and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, and provides a composition for treating male erectile dysfunction by using a super nano coating technology and a preparation method thereof. The preparation method comprises the following steps: mixing a tribulus terrestris extract, a South African drunken solanum extract, L-arginine, an eurycoma longifolia extract, a ganoderma lucidum extract, a caraway extract, a radix puerariae extract, a burdock root extract and fructus cannabis peptide with ultrapure water and ethanol to obtain a mixture; gelatin and chitosan are dissolved with ultrapure water, and a wall material solution is obtained; the mixture and the wall material solution are mixed, a surfactant is added, stirring and drying are conducted, and nanometer wrapped particles are obtained; and filling the nano-coated particles with a capsule filling machine to obtain the composition. According to the composition prepared by a nano coating technology, the stability and the bioavailability of the medicine can be improved; meanwhile, the traditional Chinese medicine components in the composition are compatible with one another, so that the sperm motility and the kidney motility are improved, the anti-fatigue ability of the body is enhanced, and the effect of treating the sexual dysfunction is further achieved.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a composition for treating male erectile dysfunction using super nano-encapsulation technology and its preparation method. Background Technology

[0002] In modern society, with the accelerated pace of life and increased work pressure, more and more people are paying attention to their health, especially men's health. Erectile dysfunction (ED) is one of the most common male sexual dysfunctions, seriously affecting patients' quality of life and mental health. In ancient times, people recognized that certain natural herbs, such as Tribulus terrestris and Tongkat Ali, had the effects of enhancing sexual ability and tonifying the kidneys. These herbs were used to make liquids and pills for easy consumption and preservation.

[0003] In recent years, with in-depth research into the pathological mechanisms of erectile dysfunction (ED) and increased emphasis on natural medicines, traditional Chinese medicine (TCM) has shown great potential in treating ED. However, traditional TCM preparations suffer from low bioavailability, poor stability, incomplete absorption, and a strong bitter taste, which limits their therapeutic effects. How to maximize the efficacy of TCM components, increase the concentration of active ingredients, and ensure the quality and stability of the drugs remains a challenge in drug manufacturing.

[0004] Patent CN 101524409 B discloses a traditional Chinese medicine composition for increasing serum testosterone levels and its preparation method, comprising the following raw materials: American ginseng extract, senna extract, rhodiola rosea extract, cistanche extract, tribulus terrestris extract, and excipients. This traditional Chinese medicine composition can increase serum testosterone levels in athletes during training. However, the traditional Chinese medicine extracts in this invention are simply mixed to prepare the medicine, which reduces bioavailability and prevents the active ingredients from exerting their effects.

[0005] Therefore, there is an urgent need to develop a composition using super nano-encapsulation technology to treat male erectile dysfunction, which can improve the bioavailability of the composition and ensure the quality of the drug. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this invention provides a composition for treating male erectile dysfunction using super nano-encapsulation technology and its preparation method. The composition prepared using nano-encapsulation technology improves drug stability and bioavailability; simultaneously, the various traditional Chinese medicine components in the composition synergistically enhance sperm motility and kidney function, strengthen the body's anti-fatigue ability, and thus achieve a therapeutic effect on erectile dysfunction.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0008] This invention provides a method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology, comprising the following steps:

[0009] S1. Mix Tribulus terrestris extract, Ashwagandha extract, L-arginine, Tongkat Ali extract, Shilajit extract, Caraway extract, Pueraria lobata extract, Arctium lappa root extract, hemp seed peptide, ultrapure water, and ethanol to obtain a mixture;

[0010] S2. Dissolve gelatin and chitosan in ultrapure water, heat to 60-70℃ and stir for 2-3 hours, centrifuge to obtain a wall material solution with a concentration of 0.8-2wt%;

[0011] S3. Mix the mixture obtained in step S1 and the wall material solution obtained in step S2, add a surfactant, stir, dry, and pulverize to obtain nano-encapsulated particles;

[0012] S4. Fill the nano-encapsulated particles obtained in step S3 using a capsule filling machine to obtain the composition.

[0013] The reaction mechanism and function of this invention are as follows:

[0014] 1. The components in this invention work synergistically to enhance the therapeutic effect on male erectile dysfunction. The applicant prepared the composition using super nano-encapsulation technology, which not only protects the active ingredients from external environmental influences and prevents drug degradation, thereby improving drug stability, but also significantly enhances drug solubility and bioavailability, promoting drug absorption. In addition, this nano-encapsulation technology can also reduce the toxic side effects of the drug, reduce irritation, improve the taste of traditional Chinese medicine components, and increase patient acceptance.

[0015] 2. Tongkat Ali extract is widely considered a natural aphrodisiac. On one hand, it can significantly increase testosterone levels, improve sperm count and motility, thus treating erectile dysfunction in men. On the other hand, it has kidney-tonifying effects, enhancing kidney function, relieving fatigue, and boosting physical strength. However, Tongkat Ali extract has a bitter taste, which affects user compliance.

[0016] This invention first treats Tongkat Ali root with an enzyme solution to improve its utilization rate, then adds a specific mass ratio of mixed bacteria for fermentation. This results in an increased polysaccharide content in the obtained Tongkat Ali extract, thereby improving the taste and flavor of the medicine. Simultaneously, the Tongkat Ali extract obtained in this application significantly enhances the stability of the composition in the gastrointestinal tract. This is because the antioxidant content in the Tongkat Ali extract increases after enzymatic fermentation, allowing the efficacy of each herb to be stably exerted, further enhancing the therapeutic effect on erectile dysfunction.

[0017] In some embodiments, the mixture in step S1 comprises, by weight: 120-150 parts of Tribulus terrestris extract, 40-60 parts of Ashwagandha extract, 40-60 parts of L-arginine, 26-40 parts of Tongkat Ali extract, 15-25 parts of Shilajit extract, 15-25 parts of Caraway extract, 10-20 parts of Pueraria lobata extract, 8-12 parts of Burdock root extract, 8-12 parts of Cannabis sativa peptide, 300-500 parts of ultrapure water, and 200-400 parts of ethanol.

[0018] In some embodiments, the mass ratio of gelatin to chitosan in step S2 is 1:(1-2).

[0019] Preferably, the mass ratio of gelatin to chitosan is 1:1.5.

[0020] More preferably, the concentration of the wall material solution in step S2 is 1.5 wt%.

[0021] In some embodiments, the mass ratio of the mixture to the wall material solution in step S3 is 1:(4-6).

[0022] In some embodiments, the surfactant in step S3 is any one or more of lecithin, Tween 80, and sodium dodecylbenzenesulfonate.

[0023] In some embodiments, the preparation method of the Tongkat Ali extract includes the following steps:

[0024] Q1. Pulverize the Tongkat Ali root, sterilize it, immerse it in an enzyme solution for enzymatic hydrolysis, and inactivate the enzyme to obtain Tongkat Ali enzymatic hydrolysate.

[0025] Q2. Inoculate the mixed seed culture into the Tongkat Ali enzymatic hydrolysate obtained in step Q1, ferment, filter, and dry to obtain Tongkat Ali extract.

[0026] In some embodiments, the enzyme in the enzyme solution in step Q1 is composed of cellulase, hemicellulase and pectinase in a mass ratio of 1:(0.1-0.3):(0.4-0.8).

[0027] In some embodiments, the concentration of the enzyme solution in step Q1 is 1.5-3 wt%.

[0028] Preferably, the particle size of the pulverized material in step Q1 is 10-60 mesh.

[0029] Preferably, the enzymatic hydrolysis temperature in step Q1 is 37-45℃, and the enzymatic hydrolysis time is 3-5h.

[0030] In some embodiments, the concentration of the mixed seed solution in step Q2 is (1-9)×10⁻⁶. 6-8CFU / mL, the amount of the mixed seed culture is 2-5 wt% of Tongkat Ali enzymatic hydrolysate.

[0031] In some embodiments, the mixed seed solution in step Q2 is composed of Bacillus seed solution, lactic acid bacteria seed solution and Aspergillus seed solution in a volume ratio of 1:(1-2):(0.3-0.7).

[0032] Preferably, the Bacillus seed solution is Bacillus coagulans seed solution, the lactic acid bacteria seed solution is Lactobacillus plantarum seed solution, and the Aspergillus seed solution is Aspergillus oryzae seed solution.

[0033] Preferably, the fermentation temperature in step Q2 is 30-35℃, and the fermentation time is 48-96h.

[0034] In another aspect, the present invention provides a composition for treating male erectile dysfunction obtained by the preparation method described above.

[0035] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0036] 1. The various traditional Chinese medicine components in the composition of the present invention work synergistically to enhance sperm motility and kidney function, strengthen the body's anti-fatigue ability, and thus play a role in treating sexual dysfunction.

[0037] 2. The composition prepared by the present invention through super nano-encapsulation technology can not only improve the stability, solubility and bioavailability of drugs and promote drug absorption, but also reduce the toxic side effects of drugs, improve the taste of traditional Chinese medicine components, and enhance patient acceptance.

[0038] 3. This invention first treats Tongkat Ali root with an enzyme solution, then adds a specific mass ratio of mixed bacteria for fermentation. The resulting extract has a high content of effective active ingredients, and the polysaccharide content of the Tongkat Ali extract is also increased, thereby improving the taste and flavor of the medicine. Furthermore, the Tongkat Ali extract after enzymatic fermentation exhibits increased antioxidant content, significantly improving the stability of the composition in the gastrointestinal tract, thus allowing the efficacy of each herbal medicine to be stably exerted, further enhancing the therapeutic effect on erectile dysfunction. Detailed Implementation

[0039] The present invention will be described below with reference to specific embodiments. It should be noted that the following embodiments are examples of the present invention and are used only to illustrate the invention, not to limit it. Other combinations and various modifications within the scope of the present invention can be made without departing from its spirit or scope.

[0040] Each composition was prepared according to the proportions and preparation methods of the raw materials specified in the following examples and comparative examples.

[0041] To facilitate implementation of this invention by those skilled in the art, the manufacturers of some raw materials for the embodiments and comparative examples are described below:

[0042] Bacillus coagulans (CICC 23843), Lactobacillus plantarum (CICC 10345), and Aspergillus oryzae (CICC 2339) are all deposited at the China Industrial Microbial Culture Collection Center.

[0043] Cellulase, hemicellulase and pectinase: purchased from Hebei Pengyu Biotechnology Co., Ltd., all with enzyme activity of 100,000 U / g;

[0044] Potato glucose liquid culture medium:

[0045] Peel the potatoes and cut them into pieces about 1cm in size. 3 Take 100g of potato pieces and boil them in 500mL of deionized water for 30 minutes. Filter the solution through double-layered gauze, add 10g of glucose to the filtrate, and then add deionized water to 500mL. Adjust the pH to 7 with 1mol / L sodium hydroxide solution, sterilize at 120℃ for 20 minutes, and let it cool naturally to room temperature to obtain potato glucose liquid culture medium.

[0046] Chitosan and gelatin: purchased from Shandong Guante Bioengineering Co., Ltd.

[0047] Tongkat Ali extract, Tribulus terrestris extract, Pueraria lobata extract, and Arctium lappa root extract: purchased from Shanyang Lianfeng Biotechnology Co., Ltd.

[0048] Ashwagandha extract and Shilajit extract from South Africa: purchased from Shaanxi Tianshengyuan Biotechnology Co., Ltd.

[0049] Caraway seed extract: purchased from Lanzhou Waterles Biotechnology Co., Ltd.;

[0050] Hemp seed peptides: purchased from Jiangsu Duoyang Bioengineering Technology Co., Ltd.;

[0051] Unless otherwise specified, all other raw materials can be purchased from the market.

[0052] Preparation Example 1

[0053] The preparation steps for Bacillus coagulans seed culture are as follows:

[0054] (1) Under sterile conditions, 100 μL of bacterial solution was taken from the glycerol tube containing the Bacillus coagulans strain and evenly spread on LB agar plates using the streak plate method. The plates were incubated upside down at 37°C until colonies grew, thus obtaining activated Bacillus coagulans.

[0055] (2) Under aseptic conditions, the activated Bacillus coagulans was inoculated into 500 mL of LB liquid medium and cultured at 37 °C and 100 rpm for 2 days with shaking. The cells were then separated by centrifugation at 5000 r / min and diluted with sterile water to a final concentration of 6 × 10⁻⁶. 8 CFU / mL was used to obtain a culture of Bacillus coagulans.

[0056] Preparation Example 2

[0057] The preparation steps for Lactobacillus plantarum seed culture are as follows:

[0058] (1) Under sterile conditions, 100 μL of bacterial solution was taken from the glycerol tube containing the Lactobacillus plantarum strain and spread evenly on LB agar plates using the streak plate method. The plates were incubated upside down at 37°C until colonies grew, thus obtaining activated Lactobacillus plantarum.

[0059] (2) Under aseptic conditions, the activated *Lactobacillus plantarum* was inoculated into 500 mL of MRS liquid medium and cultured at 37°C and 100 rpm for 1 day with shaking. The cells were then separated by centrifugation at 5000 r / min and diluted with sterile water to a final concentration of 6 × 10⁻⁶. 8 CFU / mL was used to obtain Lactobacillus plantarum seed culture.

[0060] Preparation Example 3

[0061] The preparation steps for Aspergillus oryzae seed culture are as follows:

[0062] (1) Under sterile conditions, a 0.5cm×0.5cm mycelial block was inoculated on PDA slant medium from the preserved Aspergillus oryzae mother culture and cultured at 37℃ until the mycelium was fully developed to obtain activated Aspergillus oryzae.

[0063] (2) Under aseptic conditions, the activated Aspergillus oryzae was inoculated into 500 mL of potato dextrose liquid medium and cultured at 37 °C and 100 rpm for 3 days with shaking. The bacterial cells were then separated by centrifugation at 5000 r / min and diluted with sterile water to a concentration of 6 × 10⁻⁶. 8 CFU / mL was used to obtain Aspergillus oryzae seed culture.

[0064] Preparation Example 4

[0065] The preparation method of Tongkat Ali extract A includes the following steps:

[0066] Q1. Mix cellulase, hemicellulase and pectinase at a mass ratio of 1:0.2:0.6 and dissolve in ultrapure water to obtain an enzyme solution with a concentration of 2.2wt%. Crush Tongkat Ali root and sieve it to a particle size of 30 mesh, sterilize it at 120℃ for 15 min, immerse it in the enzyme solution for enzymatic hydrolysis at a temperature of 40℃ for 4 h, and inactivate the enzyme at 75℃ for 40 min to obtain Tongkat Ali enzymatic hydrolysate.

[0067] Q2. The Bacillus coagulans seed solution, Lactobacillus plantarum seed solution and Aspergillus oryzae seed solution obtained in Preparation Examples 1-3 were mixed at a volume ratio of 1:1.5:0.5 to obtain a mixed seed solution. The mixed seed solution was inoculated into the Tongkat Ali enzymatic hydrolysate obtained in step Q1. The amount of mixed seed solution was 3.5 wt% of the Tongkat Ali enzymatic hydrolysate. Fermentation was carried out at pH 6 and temperature 32°C for 72 h. After filtration, the mixture was dried at 125°C for 3 h to obtain Tongkat Ali extract A.

[0068] Preparation Example 5

[0069] The preparation method of Tongkat Ali extract B is the same as that in preparation example 4, except that in step Q1: cellulase, hemicellulase and pectinase are mixed in a mass ratio of 1:0.2:0.3 and dissolved in ultrapure water to obtain an enzyme solution with a concentration of 2.2wt%.

[0070] Preparation Example 6

[0071] The preparation method of Tongkat Ali extract C is the same as that of preparation example 4, except that in step Q2: the Bacillus coagulans seed liquid, Lactobacillus plantarum seed liquid and Aspergillus oryzae seed liquid obtained in preparation examples 1-3 are mixed in a volume ratio of 1:0.8:0.5 to obtain mixed bacterial seed liquid.

[0072] Preparation Example 7

[0073] The preparation method of Tongkat Ali extract D is the same as that of preparation example 4, except that in step Q2: the Bacillus coagulans seed liquid and Lactobacillus plantarum seed liquid obtained in preparation examples 1-2 are mixed at a volume ratio of 1:1.5 to obtain mixed seed liquid.

[0074] Preparation Example 8

[0075] The preparation method of Tongkat Ali extract E is the same as that in preparation example 4, except that in step Q2, the amount of mixed seed liquid used is 1.8 wt% of Tongkat Ali enzymatic hydrolysate.

[0076] Example 1

[0077] A method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology, comprising the following steps:

[0078] S1. Mix the Tribulus terrestris extract, Ashwagandha extract, L-arginine, Tongkat Ali extract A, Shilajit extract, Caraway extract, Pueraria lobata extract, Burdock root extract, ultrapure water, and ethanol evenly to obtain a mixture; wherein, the mixture comprises, by weight, 135 parts of Tribulus terrestris extract, 50 parts of Ashwagandha extract, 50 parts of L-arginine, 33 parts of Tongkat Ali extract A, 20 parts of Shilajit extract, 20 parts of Caraway extract, 15 parts of Pueraria lobata extract, 10 parts of Burdock root extract, 10 parts of hemp seed peptide, 400 parts of ultrapure water, and 300 parts of ethanol;

[0079] S2. Dissolve 6g of gelatin and 9g of chitosan in 1000mL of ultrapure water, heat to 65℃ and stir for 2.5h, then cool to 5℃ and centrifuge at 10000r / min for 20min to obtain the wall material solution;

[0080] S3. Mix 100g of the mixture obtained in step S1 with 500g of the wall material solution obtained in step S2, add 2g of Tween 80, stir with a magnetic stirrer for 20min, sonicate for 10min, stir again for 90min, adjust the pH to 7.5, heat to 90℃ and react for 8h, spray dry for 10s at a feed rate of 5mL / min, inlet gas temperature of 140℃ and outlet gas temperature of 78℃, and pulverize to obtain nano-encapsulated particles;

[0081] S4. Fill the nano-encapsulated particles obtained in step S3 using a capsule filling machine to obtain the composition.

[0082] Example 2

[0083] A method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology, comprising the following steps:

[0084] S1. Mix the Tribulus terrestris extract, Ashwagandha extract, L-arginine, Tongkat Ali extract A, Shilajit extract, Caraway extract, Pueraria lobata extract, Burdock root extract, ultrapure water, and ethanol evenly to obtain a mixture; wherein, the mixture comprises, by weight, 120 parts of Tribulus terrestris extract, 40 parts of Ashwagandha extract, 40 parts of L-arginine, 26 parts of Tongkat Ali extract A, 15 parts of Shilajit extract, 15 parts of Caraway extract, 10 parts of Pueraria lobata extract, 8 parts of Burdock root extract, 8 parts of hemp seed peptide, 300 parts of ultrapure water, and 200 parts of ethanol;

[0085] S2. Dissolve 6g of gelatin and 9g of chitosan in 1875mL of ultrapure water, heat to 70℃ and stir for 2h, then cool to 5℃ and centrifuge at 10000r / min for 20min to obtain the wall material solution;

[0086] S3. Mix 100g of the mixture obtained in step S1 with 600g of the wall material solution obtained in step S2, add 2g of Tween 80, stir with a magnetic stirrer for 20min, sonicate for 10min, stir for another 90min, adjust the pH to 7.5, heat to 90℃ and react for 8h, spray dry for 10s at a feed rate of 5mL / min, inlet gas temperature of 140℃ and outlet gas temperature of 78℃, and pulverize to obtain nano-encapsulated particles;

[0087] S4. Fill the nano-encapsulated particles obtained in step S3 using a capsule filling machine to obtain the composition.

[0088] Example 3

[0089] A method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology, comprising the following steps:

[0090] S1. Mix the Tribulus terrestris extract, Ashwagandha extract, L-arginine, Tongkat Ali extract A, Shilajit extract, Caraway extract, Pueraria lobata extract, Burdock root extract, ultrapure water, and ethanol evenly to obtain a mixture; wherein, the mixture comprises, by weight, 150 parts of Tribulus terrestris extract, 60 parts of Ashwagandha extract, 60 parts of L-arginine, 40 parts of Tongkat Ali extract A, 25 parts of Shilajit extract, 25 parts of Caraway extract, 20 parts of Pueraria lobata extract, 12 parts of Burdock root extract, 12 parts of hemp seed peptide, 500 parts of ultrapure water, and 400 parts of ethanol;

[0091] S2. Dissolve 6g of gelatin and 9g of chitosan in 750mL of ultrapure water, heat to 60℃ and stir for 3h, then cool to 5℃ and centrifuge at 10000r / min for 20min to obtain the wall material solution;

[0092] S3. Mix 100g of the mixture obtained in step S1 with 400g of the wall material solution obtained in step S2, add 2g of Tween 80, stir with a magnetic stirrer for 20min, sonicate for 10min, stir for another 90min, adjust the pH to 7.5, heat to 90℃ and react for 8h, spray dry for 10s at a feed rate of 5mL / min, an inlet temperature of 140℃ and an outlet temperature of 78℃, and pulverize to obtain nano-encapsulated particles;

[0093] S4. Fill the nano-encapsulated particles obtained in step S3 using a capsule filling machine to obtain the composition.

[0094] Example 4

[0095] A composition for treating male erectile dysfunction using super nano-encapsulation technology and its preparation method are described. The specific implementation method is the same as in Example 1, except that an equal amount of Tongkat Ali extract B is used instead of Tongkat Ali extract A.

[0096] Example 5

[0097] A composition for treating male erectile dysfunction using super nano-encapsulation technology and its preparation method are described. The specific implementation method is the same as in Example 1, except that an equal amount of Tongkat Ali extract C is used instead of Tongkat Ali extract A.

[0098] Example 6

[0099] A composition for treating male erectile dysfunction using super nano-encapsulation technology and its preparation method are described. The specific implementation method is the same as in Example 1, except that an equal amount of Tongkat Ali extract D is used instead of Tongkat Ali extract A.

[0100] Example 7

[0101] A composition for treating male erectile dysfunction using super nano-encapsulation technology and its preparation method are described. The specific implementation method is the same as in Example 1, except that an equal amount of Tongkat Ali extract E is used instead of Tongkat Ali extract A.

[0102] Example 8

[0103] A composition for treating male erectile dysfunction using super nano-encapsulation technology and its preparation method are described. The specific implementation method is the same as in Example 1, except that in step S2: 8.8g of gelatin and 6.2g of chitosan are dissolved in 1000mL of ultrapure water, heated to 60℃ and stirred for 3h, then cooled to 5℃ and centrifuged at 10000r / min for 20min to obtain a wall material solution.

[0104] Example 9

[0105] A composition for treating male erectile dysfunction using super nano-encapsulation technology and its preparation method are described. The specific implementation method is the same as in Example 1, except that in step S4, the amount of wall material solution added is 370g.

[0106] Example 10

[0107] A composition for treating male erectile dysfunction using super nano-encapsulation technology and its preparation method are described. The specific implementation method is the same as in Example 1, except that an equal amount of commercially available Tongkat Ali extract is used instead of Tongkat Ali extract A.

[0108] Comparative Example 1

[0109] A method for preparing a composition for treating erectile dysfunction in men, comprising the following steps:

[0110] S1. Mix the Tribulus terrestris extract, Ashwagandha extract, L-arginine, Tongkat Ali extract A, Shilajit extract, Caraway extract, Pueraria lobata extract, Burdock root extract, ultrapure water, and ethanol evenly to obtain a mixture; wherein, the mixture comprises, by weight, 135 parts of Tribulus terrestris extract, 50 parts of Ashwagandha extract, 50 parts of L-arginine, 33 parts of Tongkat Ali extract A, 20 parts of Shilajit extract, 20 parts of Caraway extract, 15 parts of Pueraria lobata extract, 10 parts of Burdock root extract, 10 parts of hemp seed peptide, 400 parts of ultrapure water, and 300 parts of ethanol;

[0111] S2. The mixture was spray-dried for 10 seconds at a feed rate of 5 mL / min, an inlet air temperature of 140°C, and an outlet air temperature of 78°C, and then filled using a capsule filling machine to obtain the composition.

[0112] Effect evaluation:

[0113] The compositions prepared in Examples 1-10 and Comparative Example 1 were tested and analyzed, and the specific results are shown in Tables 1-2.

[0114] Performance testing:

[0115] (1) Sex hormone test: 120 healthy male mice, weighing 20-25g, were acclimatized for one week according to national standards. The mice were then randomly divided into a normal control group and an experimental group, with 10 mice in each group. The mice were administered the drug via gavage at a dose of 0.20g / 25g mixed with water between 9:30 and 10:00 AM daily for 10 consecutive days. The control group received no drug. Testosterone (T) levels were measured, and the specific results are shown in Table 1. Testosterone is the main male sex hormone, primarily produced by the testes, and plays a crucial role in male reproductive function. Testosterone levels directly affect libido, sexual ability, sperm production, and prostate problems.

[0116] Table 1

[0117] Serial Number T(pg / mL) control group 648.3±19.3 Example 1 779.3±19.2 Example 2 759.1±20.5 Example 3 780.8±18.6 Example 4 727.4±18.8 Example 5 708.3±17.4 Example 6 692.2±16.8 Example 7 701.7±19.0 Example 8 713.7±20.8 Example 9 695.8±22.7 Example 10 683.8±20.1 Comparative Example 1 667.4±28.3

[0118] As shown in Table 1, the compositions prepared in Examples 1-3 can increase the level of testosterone in the body, effectively improve sperm motility and kidney function, and thus play a role in treating sexual dysfunction.

[0119] Compared to Example 1, Examples 4-7 show that in the preparation of Tongkat Ali extract, Example 4 changed the mass ratio of cellulase, hemicellulase, and pectinase in the enzyme solution; Example 5 changed the volume ratio of Bacillus seed solution, Lactobacillus seed solution, and Aspergillus seed solution in the mixed seed solution; Example 6 changed the types of mixed bacteria in the mixed seed solution; and Example 7 changed the amount of mixed seed solution. The corresponding changes in enzymes and bacteria in Examples 4-7 will reduce the medicinal active ingredients of the main component, Tongkat Ali extract, decrease the stability of the composition in the gastrointestinal tract, and thus affect the overall medicinal effect and reduce the level of testosterone in the body.

[0120] Compared to Example 1, Examples 8 and 9 show that in the preparation of the composition, Example 8 changed the mass ratio of gelatin and chitosan, and Example 9 changed the mass ratio of the mixture and the wall material solution. Both of these changes resulted in fewer active ingredients encapsulated in the prepared nano-encapsulated particles, reduced bioavailability, and consequently affected the overall medicinal effect and lowered the level of testosterone in the body.

[0121] Compared to Example 1, Example 10 uses an equal amount of commercially available Tongkat Ali extract to replace Tongkat Ali extract A, resulting in fewer active ingredients. Compared to Example 1, Comparative Example 1 uses a simple mixture to prepare a composition, which has low bioavailability and may affect the overall medicinal effect, thus reducing the level of testosterone in the body.

[0122] (2) Clinical Trial: 25 volunteers were selected, with 5 volunteers participating in each of the 25 trial examples. These volunteers all suffered from premature ejaculation and agreed to be treated with the compositions prepared in Examples 1-3, 10 and Comparative Example 1 in the clinical trial. The average age of the patients was 40 years (35-45 years), and the duration of illness was 1-3 years. Each volunteer took one tablet of the composition of the present invention per dose, and was encouraged to have sexual intercourse within 1-6 hours after taking the medication, once a week for a total of 4 times. The study investigated the control of ejaculation time, the couple's satisfaction with their sexual life, and the taste of the medication. The satisfaction results are shown in Table 2.

[0123] Note: A = Very satisfied, B = Satisfied, C = Neutral, D = Unsatisfied.

[0124] Table 2

[0125]

[0126] As shown in Table 2, the compositions prepared in Examples 1-3 have good therapeutic effects on erectile dysfunction, good oral satisfaction, and high overall satisfaction, while the overall satisfaction of Examples 10 and Comparative Example 1 is lower.

[0127] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present application in any way. Although the present application discloses the preferred embodiment as described above, it is not intended to limit the present application. Any changes or modifications made by those skilled in the art without departing from the scope of the technical solution of the present application using the disclosed technical content are equivalent to equivalent implementation cases. Any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the scope of the technical solution of the present invention are still within the scope of the technical solution.

Claims

1. A method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology, characterized in that, It includes the following steps: S1. Mix Tribulus terrestris extract, Ashwagandha extract, L-arginine, Tongkat Ali extract, Shilajit extract, Caraway extract, Pueraria lobata extract, Arctium lappa root extract, hemp seed peptide, ultrapure water, and ethanol to obtain a mixture; S2. Dissolve gelatin and chitosan in ultrapure water, heat to 60-70℃ and stir for 2-3 hours, centrifuge to obtain a wall material solution with a concentration of 0.8-2wt%; S3. Mix the mixture obtained in step S1 and the wall material solution obtained in step S2, add a surfactant, stir, dry, and pulverize to obtain nano-encapsulated particles; S4. Fill the nano-encapsulated particles obtained in step S3 using a capsule filling machine to obtain the composition.

2. The method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology according to claim 1, characterized in that, The mixture described in step S1 comprises, by weight: 120-150 parts of Tribulus terrestris extract, 40-60 parts of Ashwagandha extract, 40-60 parts of L-arginine, 26-40 parts of Tongkat Ali extract, 15-25 parts of Shilajit extract, 15-25 parts of Caraway extract, 10-20 parts of Pueraria lobata extract, 8-12 parts of Burdock root extract, 8-12 parts of Cannabis sativa peptide, 300-500 parts of ultrapure water, and 200-400 parts of ethanol.

3. The method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology according to claim 1, characterized in that, The mass ratio of gelatin to chitosan in step S2 is 1:(1-2).

4. A method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology according to claim 2, characterized in that, The mass ratio of the mixture and the wall material solution in step S3 is 1:(4-6).

5. A method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology according to claim 1, characterized in that, The surfactant mentioned in step S3 is any one or more of lecithin, Tween 80, and sodium dodecylbenzenesulfonate.

6. A method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology according to claim 1, characterized in that, The preparation method of the Tongkat Ali extract includes the following steps: Q1. Pulverize the Tongkat Ali root, sterilize it, immerse it in an enzyme solution for enzymatic hydrolysis, and inactivate the enzyme to obtain Tongkat Ali enzymatic hydrolysate. Q2. Inoculate the mixed seed culture into the Tongkat Ali enzymatic hydrolysate obtained in step Q1, ferment, filter, and dry to obtain Tongkat Ali extract.

7. A method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology according to claim 6, characterized in that, The enzyme in the enzyme solution described in step Q1 is composed of cellulase, hemicellulase and pectinase in a mass ratio of 1:(0.1-0.3):(0.4-0.8).

8. A method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology according to claim 6, characterized in that, The concentration of the enzyme solution in step Q1 is 1.5-3 wt%.

9. A method for preparing a composition for treating male erectile dysfunction using super nano-encapsulation technology according to claim 6, characterized in that, The concentration of the mixed seed culture in step Q2 is (1-9)×10⁻⁶. 6-8 CFU / mL, the amount of the mixed seed culture is 2-5 wt% of Tongkat Ali enzymatic hydrolysate.

10. A composition for treating male erectile dysfunction obtained by the preparation method according to any one of claims 1-9.

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