Nano-coated traditional Chinese medicine external erection aid and preparation method thereof

Abstract

The invention discloses a nano-coated traditional Chinese medicine external erection aid and a preparation method thereof. A formula of the erection aid comprises various traditional Chinese medicine components such as asarum, saffron crocus and herba epimedii, and the erection aid is prepared through a series of steps of nanocrystallization wall breaking treatment, formula powder pretreatment, supercritical extraction and traditional distillation composite extraction, nano biological slow-release coating and hydrophilic coating treatment, a forming stage, a preparation stage and the like. In the preparation process, auxiliary components such as cyclodextrin, lecithin and azone are added, and the dosage and the adding sequence of the components are accurately controlled. The erection aid disclosed by the invention is high in active ingredient integrity, good in product stability, high in drug transdermal absorption efficiency, capable of remarkably prolonging sexual life time and enhancing erection strength, small in skin irritation and comfortable to use.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparation, and particularly to a nano-coated traditional Chinese medicine external erection-aid agent and its preparation method. Background Art

[0002] At present, there are many problems with external erection-aid products on the market. Although some chemically synthesized erection-aid agents have a quick effect, they have relatively large side effects, which may cause adverse effects on the cardiovascular system, nervous system, etc., and may also produce dependence after long-term use. For traditional Chinese medicine-based erection-aid products, due to technical limitations in the preparation process, it is often impossible to fully extract the effective components in traditional Chinese medicine, resulting in poor product efficacy. At the same time, the thermosensitive and volatile components in traditional Chinese medicine ingredients are easily lost or inactivated during conventional extraction and processing, making it difficult to ensure the integrity of the effective components of the product. In addition, traditional Chinese medicine external products have poor drug transdermal absorption efficiency, are difficult to quickly and effectively exert their effects, and the stability of the products is insufficient, prone to performance fluctuations, affecting the use effect.

[0003] Therefore, it is of great value to develop an external erection-aid agent and its preparation method that are safe, efficient, stable and can fully utilize the advantages of traditional Chinese medicine. Summary of the Invention

[0004] The purpose of the present invention is to provide a nano-coated traditional Chinese medicine external erection-aid agent and its preparation method to solve the problems that in the preparation or use process of existing agents, the absorption of traditional Chinese medicine components by the human body or skin is insufficient, the efficacy is poor, the thermosensitive components are easily lost or the activity is reduced, and the irritation to the skin is large.

[0005] To achieve the above purpose, in the first aspect, the present invention provides a nano-coated traditional Chinese medicine external erection-aid agent, and its formula includes the following several: Formula 1: 5 - 10 parts of Asarum sieboldii, 3 - 6 parts of Crocus sativus, 15 - 30 parts of Epimedium brevicornu, 5 - 10 parts of Panax notoginseng, 5 - 10 parts of Ligusticum chuanxiong, 5 - 10 parts of Cistanche deserticola, 0.01 - 0.03 parts of vanillyl butyl ether, 5 - 10 parts of Lepidium meyenii, 5 - 10 parts of Sophora flavescens, 3 - 5 parts of chitin; Formula 2: 5 - 10 parts of Asarum sieboldii, 5 - 10 parts of Cymbopogon citratus, 15 - 30 parts of Epimedium brevicornu, 5 - 10 parts of Panax notoginseng, 5 - 10 parts of Ligusticum chuanxiong, 5 - 10 parts of Lepidium meyenii, 0.01 - 0.03 parts of vanillyl butyl ether, 5 - 10 parts of Cistanche deserticola, 5 - 10 parts of Sophora flavescens, 3 - 5 parts of chitin; Formula 3: 5 - 15 parts of Asarum sieboldii, 3 - 6 parts of Crocus sativus, 30 - 40 parts of Epimedium brevicornu, 5 - 10 parts of Panax notoginseng, 5 - 10 parts of Ligusticum chuanxiong, 5 - 10 parts of Cymbopogon citratus, 0.01 - 0.03 parts of vanillyl butyl ether, 3 - 5 parts of chitin, 5 - 10 parts of Zingiber officinale.

[0006] In a second aspect, the present invention provides a method for preparing a nano-coated traditional Chinese medicine external erection aid, comprising the following steps: (1) Nanometerization and cell wall breaking treatment Freeze various traditional Chinese medicines in the formula to below -50 - 60 °C using liquid nitrogen or CO2 for 2.5 - 3 h, then transfer the frozen traditional Chinese medicines to an ultrafine ultramicro pulverizer in a heat preservation device and perform impact crushing and cracking at a low temperature of -25 °C to form a micro-nano ultrafine powder with a powder particle size of 300 - 1300 nm; (2) Pretreatment of the formulated powder Fully mix the micro-nano ultrafine powder in step (1) with cyclodextrin to obtain a mixture; (3) Supercritical extraction + traditional distillation combined extraction Dissolve the mixture in step (2) with water and ethanol, first separate, extract, and purify the matrix and extract through a supercritical CO2 extraction device at 31 - 40 °C and a pressure of about 7 - 8 MPa; then perform water distillation extraction at 100 - 150 °C to form an extract; (4) Nano-biological sustained release coating and hydrophilic coating treatment Mix various extracts in proportion and stir for 30 min to form a compound solution. Add lecithin to the compound solution, mix according to 30 parts of the compound solution and 70 parts of polyethylene glycol, heat to 80 °C, keep warm and stir at a low speed of 70 r / min for more than 15 min for sufficient dissolution and mixing, and then cool to 60 °C for constant temperature; Use a stirrer with a shearing function, first stir at 70 r / min for 15 min, then adjust to 300 r / min and stir for 15 min, while stirring, cool to room temperature to prepare a polyethylene glycol and traditional Chinese medicine extract coating mixture; (5) Molding stage Mix carboxymethyl chitosan (3 - 10 parts), polyethylene glycol and traditional Chinese medicine extract coating mixture (5 - 20 parts), pure water (50 - 70 parts), and polyhexamethylene biguanide hydrochloride (0.1 - 0.5 parts), heat to 70 - 80 °C, first stir with a stirrer at a speed of 120 r / min for 60 min, and then perform emulsifying dispersion stirring at 3000 - 10000 r / min with a homogenizing emulsifier for 60 - 80 min; (6) Preparation stage Before making wet wipes, sprays, gels or ointments type external traditional Chinese medicines through aseptic treatment, add azone, and make wet wipes, sprays, gels or ointments type external traditional Chinese medicines after aseptic treatment.

[0007] Preferably, in step (2), the cyclodextrin is β-cyclodextrin, and its dosage is 5% - 10% of the total mass of the traditional Chinese medicines in the formula.

[0008] Preferably, in step (4), before mixing the compound solution with polyethylene glycol, lecithin is added, and its dosage is 2%-5% of the total mass of the compound solution and polyethylene glycol.

[0009] Preferably, in step (6), the dosage of azone is 1%-3% of the total mass of the final product.

[0010] Preferably, in step (2), vitamin E is added as an antioxidant to the micro-nano ultrafine powder, and its dosage is 0.5%-1% of the total mass of the traditional Chinese medicine.

[0011] Preferably, in step (2), vitamin E is first added to the micro-nano ultrafine powder and mixed evenly, and then mixed evenly with cyclodextrin.

[0012] Preferably, in step (2), the stirring speed during the mixing process is 40-50 r / min, and the stirring time is 30-45 min.

[0013] Preferably, in step (6), chamomile extract is added as a skin soother, and its dosage is 0.5%-1% of the total mass of the final product.

[0014] Preferably, in step (5), after heating, stirring, and emulsifying and dispersing stirring, a preliminary preparation precursor is obtained. Chamomile extract is added to the preparation precursor, and then low-speed stirring at 50-100 r / min is carried out for 10-20 min to evenly disperse the chamomile extract in the preparation precursor, and then step (6) is carried out.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The present invention uses low-temperature freezing and ultrafine grinding technologies to form a micro-nano ultrafine powder of traditional Chinese medicine with a particle size of 300-1300 nm, which greatly protects heat-sensitive components, increases the specific surface area, and provides a good material basis for subsequent extraction. At the same time, β-cyclodextrin is used to encapsulate heat-sensitive and volatile components, effectively preventing the decomposition, volatilization, or inactivation of these components during subsequent processing, ensuring the integrity and activity of the active ingredients, and making the product efficacy more guaranteed.

[0016] 2. The present invention adopts a composite extraction process combining supercritical CO 2 extraction and traditional distillation, which can comprehensively extract various beneficial components. Supercritical CO 2 extraction can gently extract components such as low-molecular-weight volatile oils, and traditional distillation can extract polar and high-molecular-weight substances. The two work synergistically to fully exert the aphrodisiac pharmacological effect of traditional Chinese medicine.

[0017] 3. The present invention improves the uniformity and stability of coating by adding lecithin, endows the drug with sustained-release characteristics through stirring and temperature regulation, avoids the sudden release of the drug, and at the same time, the hydrophilic coating treatment is beneficial to the absorption of the drug, enhancing the efficacy of the product. The addition of components such as carboxymethyl chitosan promotes the release and absorption of the drug, making the product delicate and stable in texture.

[0018] 4. The present invention effectively promotes the transdermal absorption of the drug by adding azone, enabling the drug to exert its effects faster and more effectively. At the same time, chamomile extract is added as a skin soother, which synergistically acts with azone. It can not only promote drug penetration but also reduce the possible skin irritation reaction caused by azone, reducing the irritation of the drug to the skin and making the product more comfortable to use. Detailed implementation manners

[0019] The technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of them. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0020] An embodiment provided by the present invention includes: A nano-coated traditional Chinese medicine external erection aid, whose formula includes the following: Formula 1: 5 - 10 parts of asarum, 3 - 6 parts of saffron, 15 - 30 parts of epimedium, 5 - 10 parts of notoginseng, 5 - 10 parts of chuanxiong, 5 - 10 parts of cistanche, 0.01 - 0.03 parts of vanillyl butyl ether, 5 - 10 parts of maca, 5 - 10 parts of sophora flavescens, 3 - 5 parts of chitin; Formula 2: 5 - 10 parts of asarum, 5 - 10 parts of citronella, 15 - 30 parts of epimedium, 5 - 10 parts of notoginseng, 5 - 10 parts of chuanxiong, 5 - 10 parts of maca, 0.01 - 0.03 parts of vanillyl butyl ether, 5 - 10 parts of cistanche, 5 - 10 parts of sophora flavescens, 3 - 5 parts of chitin; Formula 3: 5 - 15 parts of asarum, 3 - 6 parts of saffron, 30 - 40 parts of epimedium, 5 - 10 parts of notoginseng, 5 - 10 parts of chuanxiong, 5 - 10 parts of citronella, 0.01 - 0.03 parts of vanillyl butyl ether, 3 - 5 parts of chitin, 5 - 10 parts of dried ginger.

[0021] In this embodiment, Formula 1 highlights the efficacy of tonifying the kidney and promoting blood circulation. It contains saffron, which has a remarkable effect on promoting blood circulation and removing blood stasis. Synergistic with asarum, notoginseng, etc., it can effectively dredge the orifices and promote blood circulation, and has a good effect on improving the problem of insufficient blood supply to the corpus cavernosum of the penis, which helps to enhance erectile function. Cistanche deserticola can tonify the kidney and assist yang. When combined with epimedium, maca, etc., it plays a prominent role in tonifying the kidney and strengthening yang, can relieve symptoms such as impotence and premature ejaculation caused by insufficient kidney yang, and improve male sexual function. On the other hand, the presence of sophora flavescens and chitin enables Formula 1 to have certain antibacterial and antioxidant activities while clearing heat and drying dampness, killing insects and relieving itching, can enhance immunity, promote wound healing, has a certain preventive and alleviating effect on inflammation of the reproductive system, maintains the health of the reproductive system, and indirectly provides a good environment for the normal exertion of sexual function.

[0022] The citronella in Formula 2 has the effects of expelling wind and removing dampness, warming the channels and dredging collaterals. When combined with other ingredients, it can better promote blood circulation and regulate hormone levels. It may have a good improvement effect on sexual dysfunction caused by blocked channels and collaterals and hormone imbalance, such as decreased libido. The combined action of maca, cistanche deserticola and epimedium further strengthens the efficacy of tonifying the kidney and strengthening yang and improving reproductive function, which helps to enhance libido and improve erectile function. Similar to Formula 1, Formula 2 also contains sophora flavescens and chitin, which play a role in antibacterial, antioxidant and enhancing immunity, ensuring the healthy state of the reproductive system and providing basic support for the improvement of sexual function.

[0023] Compared with the first two formulas, Formula 3 adds dried ginger. Dried ginger has the effects of relieving exterior syndrome and dispelling cold, warming the lungs and resolving fluid retention, restoring yang and dredging collaterals, etc. When combined with asarum, citronella, etc., it can further enhance the effect of warming yang and dispelling cold. For erectile dysfunction caused by cold pathogen stagnation, such as obvious decline in sexual function in a cold environment, it may have a good improvement effect. At the same time, the content of epimedium in Formula 3 is relatively high, and the efficacy of tonifying the kidney and strengthening yang is more prominent, and it can more effectively improve symptoms such as impotence. The synergistic effect of ingredients such as asarum, saffron, and notoginseng in dredging orifices and promoting blood circulation helps to improve the blood circulation of the corpus cavernosum of the penis and increase penile blood flow. Chuanxiong, vanillyl butyl ether, etc. promote microcirculation and regulate immunity, comprehensively regulate the overall physiological function, not only enhance sexual function, but also improve the overall state of the body and improve the quality of life.

[0024] This embodiment also includes: a preparation method of a nano-coated traditional Chinese medicine external erection-aid agent, including the following steps: (1) Nano-scale breaking and wall-breaking treatment Freeze various traditional Chinese medicines in the formula to below -50 - 60 °C using liquid nitrogen or CO2 for 2.5 - 3 h, and then transfer the frozen traditional Chinese medicines to an ultrafine ultramicro pulverizer in a heat preservation device, and carry out impact crushing and cracking at a low temperature of -25 °C to form micro-nano ultrafine powders with a powder particle size of 300 - 1300 nm; (2)Pre-treatment of formula powder Fully mix the micro-nano ultrafine powder in step (1) with cyclodextrin to obtain a mixture; (3)Supercritical extraction + traditional distillation composite extraction Dissolve the mixture in step (2) with water and ethanol, first pass it through a supercritical CO2 extraction device at 31 - 40 °C and a pressure of about 7 - 8 MPa to effectively separate, extract and purify the matrix and the extract; then use water distillation extraction at 100 - 150 °C to form an extract; (4)Nano-bio sustained-release coating and hydrophilic coating treatment Mix various extracts in proportion and stir for 30 min to form a compound solution. Add lecithin to the compound solution, mix according to 30 parts of the compound solution and 70 parts of polyethylene glycol, heat to 80 °C, keep warm and stir at a low speed of 70 r / min for more than 15 min for full dissolution and mixing, and then cool to 60 °C for constant temperature; Use a stirrer with a shearing function, first stir at 70 r / min for 15 min, then adjust to 300 r / min and stir for 15 min, and cool to room temperature while stirring to prepare a coating mixture of polyethylene glycol and traditional Chinese medicine extract; (5)Molding stage Mix carboxymethyl chitosan (3 - 10 parts), the coating mixture of polyethylene glycol and traditional Chinese medicine extract (5 - 20 parts), pure water (50 - 70 parts), and polyhexamethylene biguanide hydrochloride (0.1 - 0.5 parts), heat to 70 - 80 °C, first stir with a stirrer at a speed of 120 r / min for 60 min, and then use a homogenizing emulsifier to carry out emulsifying dispersion stirring at 3000 - 10000 r / min for 60 - 80 min; (6)Formulation stage Before making wet wipes, sprays, gels or ointments type of traditional Chinese medicine for external use through aseptic treatment, add azone, and make wet wipes, sprays, gels or ointments type of traditional Chinese medicine for external use after aseptic treatment.

[0025] The present invention uses low-temperature freezing and ultrafine grinding to make traditional Chinese medicine form micro-nano ultrafine powder of 300 - 1300 nm, protects thermosensitive components, increases the specific surface area, is conducive to subsequent extraction, and provides a material basis for the product efficacy. Cyclodextrin can include thermosensitive and volatile components to prevent their decomposition, volatilization or inactivation during subsequent treatment, and ensure the integrity and activity of active ingredients. Supercritical CO 2Extraction can gently extract volatile oils with low molecular weights, etc., and traditional distillation can extract polar and high molecular weight substances. The combination of the two can comprehensively extract various beneficial components and synergistically exert the pharmacological effect of enhancing erectile function. Lecithin improves the coating uniformity and stability. Stirring and temperature adjustment endow the drug with sustained-release characteristics, avoiding sudden release. The hydrophilic coating is conducive to absorption and enhances the efficacy. Various components are mixed and subjected to stirring and emulsification treatment. Carboxymethyl chitosan, etc., promote the release and absorption of the drug, making the product delicate and stable in texture. Azone promotes the transdermal absorption of the drug, and various dosage forms are made for convenient use. Sterile treatment ensures safety.

[0026] In this embodiment, more specifically, in the step (2), the cyclodextrin is β-cyclodextrin, and its dosage is 5%-10% of the total mass of traditional Chinese medicine in the formula.

[0027] Cyclodextrin has a unique ring structure and can form inclusion compounds with thermosensitive components in traditional Chinese medicine, playing a protective role. During subsequent supercritical extraction and water distillation processes, the loss and reduction of activity of thermosensitive components are reduced. At the same time, the presence of cyclodextrin may also change the solubility of traditional Chinese medicine components in supercritical CO 2 and water, promote the extraction of components, and improve the overall extraction efficiency. For example, for certain volatile components in Asarum sieboldii Miq., β-cyclodextrin can encapsulate them inside, avoiding excessive volatilization during high-temperature distillation.

[0028] In this embodiment, more specifically, in the step (4), before mixing the compound solution with polyethylene glycol, lecithin is added, and its dosage is 2%-5% of the total mass of the compound solution and polyethylene glycol.

[0029] Lecithin is a natural amphoteric surfactant with good emulsifying and dispersing properties. It can reduce the interfacial tension between polyethylene glycol and the traditional Chinese medicine extract, promote more uniform mixing of the two, and improve the coating uniformity. At the same time, lecithin can interact with carboxymethyl chitosan, etc., to enhance the stability of the entire system. For example, the hydrophilic group of lecithin can interact with the hydrophilic part of carboxymethyl chitosan, and the hydrophobic group interacts with organic components such as polyethylene glycol to form a more stable structure, reducing fluctuations in product performance.

[0030] In this embodiment, more specifically, in the step (6), the dosage of azone is 1%-3% of the total mass of the final product.

[0031] Azone is a commonly used skin penetration enhancer. It can change the arrangement of intercellular lipids in the stratum corneum of the skin, increase the skin permeability, promote drug molecules to penetrate through the skin into the human body, improve the transdermal absorption efficiency of the drug, and enable the drug to play a role faster and more effectively.

[0032] In this embodiment, more specifically, in step (2), vitamin E is added to the micro-nano ultrafine powder as an antioxidant, and its dosage is 0.5%-1% of the total mass of the traditional Chinese medicine.

[0033] Adding an appropriate amount of antioxidant, such as vitamin E, in the pre-treatment stage of the formulated powder can solve the problems of incomplete cyclodextrin inclusion and possible interaction between azone and traditional Chinese medicine components. The antioxidant can protect the thermosensitive components and easily oxidized components in the traditional Chinese medicine, reduce the component loss caused by incomplete cyclodextrin inclusion, and at the same time prevent the oxidation reaction between azone and traditional Chinese medicine components, thus stabilizing the product quality.

[0034] In this embodiment, more specifically, in step (2), vitamin E is first added to the micro-nano ultrafine powder and mixed evenly, and then cyclodextrin is added and mixed evenly.

[0035] Adding vitamin E and mixing it with the micro-nano ultrafine powder first can make vitamin E fully dispersed in the traditional Chinese medicine powder and come into full contact with the easily oxidized components in the traditional Chinese medicine. As an antioxidant, vitamin E can react with substances such as free radicals that may cause oxidation of traditional Chinese medicine components first, forming an antioxidant environment around the traditional Chinese medicine components, protecting the thermosensitive components and easily oxidized components in the traditional Chinese medicine to the greatest extent, and reducing their loss or deterioration due to oxidation during subsequent processing. If it is mixed with cyclodextrin first, it may hinder the contact between vitamin E and these included components due to the inclusion of some traditional Chinese medicine components by cyclodextrin, affecting the full play of the antioxidant effect of vitamin E. After vitamin E is mixed evenly with the traditional Chinese medicine powder first and then cyclodextrin is added, at this time, cyclodextrin can include the traditional Chinese medicine components on the basis of the antioxidant effect of vitamin E already played, better playing the role of cyclodextrin in including thermosensitive and volatile components, preventing these components from decomposing, volatilizing or inactivating during subsequent processing, and further ensuring the integrity and activity of the active ingredients.

[0036] Adding in this order can avoid the mutual interference between vitamin E and cyclodextrin during the action process. If vitamin E and cyclodextrin are added simultaneously, they may compete with each other for the binding sites with traditional Chinese medicine components during the mixing process, or vitamin E may affect the inclusion performance and effect of cyclodextrin. By first allowing vitamin E to be fully mixed with the traditional Chinese medicine powder to complete its antioxidant effect and then adding cyclodextrin for inclusion, the possibility of such mutual interference can be reduced, enabling both to better play their respective roles, jointly ensuring the quality and stability of the traditional Chinese medicine powder, and providing a better raw material basis for subsequent extraction and other processes.

[0037] In this embodiment, more specifically, in step (2), the stirring speed during the mixing process is 40-50 r / min, and the stirring time is 30-45 min.

[0038] In this embodiment, more specifically, in step (6), chamomile extract is added as a skin soother, and its dosage is 0.5%-1% of the total mass of the final product.

[0039] In this embodiment, more specifically, in the said step (5), after heating, stirring, and emulsifying and dispersing stirring, a preliminary preparation precursor is obtained. The chamomile extract is added to the preparation precursor, and then low-speed stirring at 50-100 r / min is carried out for 10-20 min to uniformly disperse the chamomile extract in the preparation precursor, and then step (6) is carried out.

[0040] As a skin soother, chamomile extract has the functions of anti-inflammatory and skin soothing. Acting synergistically with azone, it can not only promote drug penetration, but also reduce the skin irritation reaction that azone may cause, and can also reduce the skin irritation of the drug, making the product more comfortable to use.

[0041] Instructions for use: 1. Single use: 0.5-1 h before each sexual intercourse, apply or spray it on the glans penis and coronal sulcus, and the triangular area such as the penis and testicles, about 0.5-1 ml, stay for 10-20 min and wash it off with warm water. It can significantly extend the sexual life time and erection intensity within the next 3 days (the effect is better if combined with massage); 2. Course of treatment use: 1 h before going to bed every day, apply or spray it on the glans penis and coronal sulcus, and the triangular area such as the penis and testicles, about 0.5-1 ml, stay for 15-30 min and wash it off with warm water. Use it every day. After continuous use for 1 month (sexual intercourse can be carried out during this period, and assist with massage for 10-30 min every day), it can have the effect of significantly extending the time without using this product within the next 1-2 years. If the frequency of thrusting is slightly controlled during sexual intercourse in the future, the length of sexual intercourse time can be determined according to your own requirements.

[0042] Comparative example 1: The difference between comparative example 1 and example 1 is only that: in the said step (2), cyclodextrin is not added.

[0043] Comparative example 2: The difference between comparative example 2 and example 1 is only that: in the said step (4), lecithin is not added.

[0044] Comparative example 3: The difference between comparative example 3 and example 1 is only that: in the said step (6), azone is not added.

[0045] Comparative example 4: The difference between comparative example 3 and example 1 is only that: in the said step (2), vitamin E and cyclodextrin are mixed simultaneously.

[0046] The following are the experimental comparison data among the above-mentioned various embodiments and comparative examples: Comparison Items Example 1 Comparative Example 1 Comparative Example 2 Comparative Example 3 Comparative Example 4 Integrity of Active Ingredients Thermosensitive and volatile components are well protected, and the active ingredients are intact More thermosensitive and volatile components are lost, and the integrity of the active ingredients is affected Thermosensitive and volatile components are well protected, and the active ingredients are intact Thermosensitive and volatile components are well protected, and the active ingredients are intact The protective effect of thermosensitive and volatile components is affected, and the integrity of the active ingredients is reduced Product Stability The system is stable, and the product performance fluctuates little The system is relatively stable, and the product performance fluctuates to a certain extent The system stability is poor, and the product performance fluctuates greatly The system is relatively stable, and the product performance fluctuates to a certain extent The system is relatively stable, and the product performance fluctuates to a certain extent Drug Transdermal Absorption Efficiency Relatively high, azone promotes drug transdermal absorption Relatively high, azone promotes drug transdermal absorption Relatively high, azone promotes drug transdermal absorption Relatively low, no azone to promote absorption Relatively high, azone promotes drug transdermal absorption Effect of Single Use (Sexual Life Time and Erection Intensity) Use 0.5 - 1 h before sexual intercourse, significantly extend sexual life time and erection intensity within the next 3 days There is a certain effect, but the effect is weakened due to ingredient loss There is a certain effect, but the effect fluctuates due to system instability The effect is significantly weakened, and drug absorption is poor There is a certain effect, but the effect is affected due to insufficient ingredient protection Effect of Course of Treatment (Long - term Effect) After continuous use for 1 month, there is a significant time - extending effect within 1 - 2 years in the future without using this product, and the sexual intercourse time can be controlled subsequently The long - term effect is weakened due to ingredient loss The long - term effect fluctuates due to system instability The long - term effect is significantly weakened, and drug absorption is poor The long - term effect is affected due to insufficient ingredient protection Skin Irritation Chamomile extract and azone work synergistically, with little skin irritation and comfortable use Chamomile extract and azone work synergistically, with little skin irritation and comfortable use Chamomile extract and azone work synergistically, with little skin irritation and comfortable use No azone, but the skin is irritated due to other ingredients Chamomile extract and azone work synergistically, with little skin irritation and comfortable use For those skilled in the art, it is obvious that the present invention is not limited to the details of the above-mentioned exemplary embodiments, and without departing from the spirit or basic characteristics of the present invention, the present invention can be implemented in other specific forms. Therefore, from any point of view, the embodiments should be regarded as exemplary and non-limiting. The scope of the present invention is defined by the appended claims rather than the above description. Therefore, all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present invention.

Claims

1. A nano-coated Chinese medicine external erectile aid, characterized in that: Its formula contains the following ingredients: 5-10 parts of asarum, 3-6 parts of saffron, 15-30 parts of epimedium, 5-10 parts of panax notoginseng, 5-10 parts of chuanxiong, 5-10 parts of cistanche, 0.01-0.03 parts of vanillyl butyl ether, 5-10 parts of maca, 5-10 parts of sophora flavescens, and 3-5 parts of chitosan.

2. A nano-coated Chinese medicine external erectile aid, characterized in that: Its formula contains the following ingredients: 5-10 parts of asarum, 5-10 parts of citronella, 15-30 parts of epimedium, 5-10 parts of notoginseng, 5-10 parts of chuanxiong, 5-10 parts of maca, 0.01-0.03 parts of vanillyl butyl ether, 5-10 parts of cistanche, 5-10 parts of sophora flavescens, and 3-5 parts of chitosan.

3. A nano-coated Chinese medicine external erection aid, characterized in that: Its formula contains the following ingredients: 5-15 parts of asarum, 3-6 parts of saffron, 30-40 parts of epimedium, 5-10 parts of panax notoginseng, 5-10 parts of chuanxiong, 5-10 parts of citronella, 0.01-0.03 parts of vanillyl butyl ether, 3-5 parts of chitosan, and 5-10 parts of dried ginger.

4. A method for preparing the nano-coated Chinese medicine external erection aid according to any one of claims 1 to 3, characterized in that: (1) Nano-wall breaking treatment The various Chinese medicines in the formula are frozen to below -50-60°C using liquid nitrogen or CO2 for 2.5-3 hours, and then the frozen Chinese medicines are transferred to an ultra-fine ultra-fine pulverizer in a heat preservation device, and impact-crushed and cracked at a low temperature of -25°C to form micro-nano ultra-fine powders with a particle size of 300-1300nm; (2) Pretreatment of formula powder The micro-nano ultrafine powder in step (1) is fully mixed with cyclodextrin to obtain a mixture, wherein the cyclodextrin is β-cyclodextrin, and the amount thereof is 5%-10% of the total mass of the traditional Chinese medicine in the formula; (3) Supercritical extraction + traditional distillation composite extraction The mixture in step (2) is dissolved in water and ethanol, and firstly passed through a supercritical CO2 extraction device at 31-40°C and a pressure of about 7-8MPa to effectively separate, extract and purify the matrix and the extract; then extracted by water distillation at 100-150°C to form an extract; (4) Nanobiological sustained-release coating and hydrophilic coating treatment Mix the various extracts in proportion and stir for 30 minutes to form a composite liquid, add lecithin to the composite liquid in an amount of 2%-5% of the total mass of the composite liquid and polyethylene glycol, mix 30 parts of the composite liquid and 70 parts of polyethylene glycol, heat to 80°C, keep warm and stir at a low speed of 70r / min for more than 15 minutes to fully dissolve and mix, and then cool to 60°C for constant temperature; Use a stirrer with a shearing function to stir at 70 r / min for 15 min, then adjust to 300 r / min for 15 min, cool to room temperature while stirring, and prepare a polyethylene glycol and Chinese medicine extract coating mixture; (5) Forming stage Mix carboxymethyl chitosan (3-10 parts), polyethylene glycol and Chinese herbal medicine extract coating mixture (5-20 parts), pure water (50-70 parts), and polyhexamethylene biguanide hydrochloride (0.1-0.5 parts), heat to 70-80°C, stir at 120r / min for 60min with a stirrer, and then emulsify and disperse with a homogenizer at 3000-10000r / min for 60-80min; (6) Preparation stage Before the aseptic treatment is performed to prepare the external Chinese medicine in the form of wet wipes, sprays, gels or pastes, azone is added, and after the aseptic treatment, the external Chinese medicine is prepared in the form of wet wipes, sprays, gels or pastes.

5. The method for preparing a nano-coated Chinese medicine external erection aid according to claim 4, characterized in that: In the step (6), the amount of azone used is 1%-3% of the total mass of the final product.

6. The method for preparing a nano-coated Chinese medicine external erection aid according to claim 5, characterized in that: In the step (2), vitamin E is added to the micro-nano ultrafine powder as an antioxidant, and its amount is 0.5%-1% of the total weight of the traditional Chinese medicine.

7. The method for preparing a nano-coated Chinese medicine external erection aid according to claim 6, characterized in that: In the step (2), vitamin E is first added to the micro-nano ultrafine powder and mixed evenly, and then mixed evenly with cyclodextrin.

8. The method for preparing a nano-coated Chinese medicine external erection aid according to claim 7, characterized in that: In the step (2), the stirring speed of the mixing process is 40-50 r / min, and the stirring time is 30-45 min.

9. The method for preparing a nano-coated Chinese medicine external erection aid according to claim 8, characterized in that: In step (6), chamomile extract is added as a skin soothing agent, and its amount is 0.5%-1% of the total mass of the final product.

10. The method for preparing a nano-coated Chinese medicine external erection aid according to claim 9, characterized in that: In the step (5), after heating, stirring, emulsification, dispersion and stirring, a preliminary preparation precursor is obtained, and the chamomile extract is added to the preparation precursor, followed by low-speed stirring at 50-100 r / min for 10-20 minutes to uniformly disperse the chamomile extract in the preparation precursor, and then proceed to step (6).