Method for promoting skin penetration of medicament

Through multiple penetration promotion methods, such as local negative pressure, oscillating electric field and local thermal energy conduction, the problem of low penetration efficiency of cosmetic drugs is solved, deep absorption and efficient penetration of drugs are achieved, and the performance of drugs is improved.

CN119385985AInactive Publication Date: 2025-02-07LIAONING ZHONGQING XINZE BIOTECHNOLOGY CO LTD
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Patent Information

Application Number
CN202411520055.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-10-29
Publication Date
2025-02-07
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

The existing cosmetic drug penetration technology has problems such as low penetration efficiency and insufficient absorption of ingredients, and it is difficult to effectively deal with the natural barrier of the skin stratum corneum, resulting in difficulty in deep absorption of drugs.

Method used

Multiple penetration promotion methods are adopted, including local negative pressure penetration, oscillating electric field penetration and local thermal energy conduction penetration. Through the combination of multiple physical promotion methods, the penetration path of the drug is expanded and the precise regulation of each penetration step is maintained.

Benefits of technology

It significantly enhances the penetration efficiency and effect of drug ingredients, promotes the deep absorption of drugs, improves the performance of drugs, and reduces skin irritation.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention provides a method for promoting skin penetration of a medicament, and relates to the technical field of cosmetics, and the method comprises the following steps: S1, a primary stirring step: adding 50-70 parts by weight of base oil, 5-10 parts by weight of an emulsifier, 2-5 parts by weight of a thickening agent and 80-90 parts by weight of a skin care agent into a stirrer; according to the invention, the permeation efficiency and effect of the medicinal components are obviously enhanced through multiple permeation promotion means. A slight vacuum environment is formed on the skin surface through a local negative pressure permeation method, the physical barrier of the cuticle is reduced, the resistance of the skin to medicine permeation is reduced, and deep absorption of components is promoted. When the oscillating electric field penetration method is applied to the cuticle, tiny vibration is generated to change the intercellular space of the skin, so that the permeability of the medicinal components is enhanced. According to the heat energy local conduction permeation method, a warm environment is formed after the ointment is in contact with the skin through particles which slowly release heat, and the release of drug activity is improved while drug diffusion is accelerated.
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Description

Technical Field

[0001] The invention relates to the technical field of cosmetics, and in particular to a method for promoting the skin penetration of a medicament. Background Art

[0002] As the living standards of our people improve, the demand for cosmetics is also increasing. New brands and new ingredients emerge in an endless stream.

[0003] However, the existing technologies have obvious deficiencies in the penetration of cosmetic drugs, mainly reflected in low penetration efficiency and insufficient absorption of ingredients. Common physical or chemical penetration methods are limited to a single penetration mechanism and cannot effectively deal with the natural barrier of the stratum corneum of the skin, resulting in difficulties in deep absorption of drugs. Some methods, such as simple mechanical penetration or local pressure, only have a short-term effect on the surface and it is difficult to achieve a stable deep penetration effect. Summary of the invention

[0004] The purpose of the present invention is to solve the shortcomings of the prior art and to propose a method for promoting the skin penetration of a drug.

[0005] In order to achieve the above object, the present invention adopts the following technical scheme: a method for promoting skin penetration of a drug, comprising the following steps:

[0006] S1, a primary stirring step, adding 50-70 parts by weight of base oil, 5-10 parts by weight of emulsifier, 2-5 parts by weight of thickener and 80-90 parts by weight of skin care agent into a stirrer, setting the stirring speed to 200-400 rpm, controlling the temperature within the range of 60-80° C., and continuously stirring for 30-60 minutes to obtain a preliminary mixture;

[0007] S2, antioxidant adding step, cooling the preliminary mixture to 40-60° C., adding 0.5-2 parts by weight of antioxidant, and continuing to stir at a speed of 150-300 rpm for 20-40 minutes to allow the antioxidant to be evenly dispersed to obtain an antioxidant mixture;

[0008] S3, a film-forming agent dissolving step, adding 5-15 parts by weight of the film-forming agent to the antioxidant mixture, maintaining the temperature at 50-70° C., stirring at a speed of 250-500 rpm for 30-60 minutes to dissolve the film-forming agent, and obtaining a film-forming mixture;

[0009] S4, a plasticizer mixing step, adding 3-8 parts by weight of a plasticizer to the film-forming mixture, setting a stirring speed of 200-400 rpm, maintaining a temperature of 40-60° C., stirring for 20-40 minutes, promoting full fusion of the plasticizer and the mixture, and obtaining a plasticized mixture;

[0010] S5, a vitamin dissolving step, dissolving 1-3 parts by weight of vitamin A and vitamin E in an ethanol solution, controlling the temperature at 25-35° C., and stirring at a speed of 100-200 rpm for 15-30 minutes to obtain a vitamin solution;

[0011] S6, a total mixed solution stirring step, adding the vitamin solution to the plasticized mixture, setting the stirring speed to 300-600 rpm, maintaining the temperature at 30-50° C., and continuously stirring for 40-80 minutes to fully mix all the ingredients to obtain a total mixed solution;

[0012] S7, an ultrasonic promotion step, placing the total mixed solution in an ultrasonic reactor, setting the ultrasonic frequency to 20-40 kHz, controlling the temperature to 35-45° C., treating for 10-20 minutes to improve the uniformity of the mixture, and obtaining an ultrasonic treatment solution;

[0013] S8, a degassing step, placing the ultrasonic treatment solution in a vacuum degassing machine, setting the vacuum degree to -0.08 to -0.1 MPa, and degassing for 10-20 minutes to remove bubbles in the solution to obtain a degassed solution;

[0014] S9, a coating and drying step, wherein the degassed solution is evenly coated on a backing material with a coating thickness of 0.1-0.5 mm, placed in an oven, the temperature is set at 40-60° C., and dried for 1-2 hours to obtain a dry drug film;

[0015] S10, microneedle pore opening step, applying the dried drug film to the skin surface, using a microneedle device to treat the drug film, the microneedle length is 0.1-0.5 mm, the operation time is 5-10 minutes, micropores are formed, and a microneedle-treated drug film is obtained.

[0016] S11, a local negative pressure penetration step, applying negative pressure to the microneedle-treated drug film using a local negative pressure device, with the negative pressure range set to -50 to -100 kPa, for 10-20 minutes to enhance the penetration of the active ingredient, and obtain a negative pressure-treated drug film;

[0017] S12, a local negative pressure release step, slowly releases the negative pressure on the negative pressure treated medicine film to restore the skin to a normal pressure state, avoids damage to the skin caused by sudden pressure changes, and obtains a pressure-restored medicine film.

[0018] S13, an oscillating electric field penetration step, applying an oscillating electric field device to the pressure-recovered drug film, with a frequency set to 50-100 Hz and a voltage range of 5-15 volts, for 10-20 minutes to promote penetration of the active ingredient, thereby obtaining an electric field-treated drug film;

[0019] S14, an oscillating electric field adjustment step, according to the skin reaction, adjusting the oscillating electric field frequency to 60-120 Hz and the voltage to 10-20 volts for the electric field treated medicine film, and continuing the treatment for 5-10 minutes to obtain an adjusted medicine film.

[0020] S15, a low current promotion step, applying low current stimulation to the adjusted drug film, with a current range of 0.5-1 mA for 5-15 minutes to promote the absorption of active ingredients and obtain a current-treated drug film.

[0021] S16, a step of adding thermal energy particles, wherein thermal energy particles having a particle size of 50-100 nanometers and a concentration of 0.1-0.5% are added to the medicine film treated with electric current, and the particles are evenly distributed by gentle massage to obtain a medicine film treated with thermal energy particles;

[0022] S17, a heat energy release and penetration step, wherein the medicine film treated with the thermal energy particles is treated with a far-infrared heating device at a temperature of 38-42° C. for 10-20 minutes to promote the thermal energy particles to release heat energy and enhance penetration, thereby obtaining a medicine film treated with thermal energy;

[0023] S18, a step of continuously adjusting heat energy, adjusting the temperature of the heating device to 36-40°C for the heat-treated medicine film according to the skin temperature feedback, and continuing heating for 5-10 minutes to keep the skin in a permeable state to obtain a medicine film continuously treated with heat energy.

[0024] Preferably, after obtaining the medicine film treated with continuous heat energy, the medicine film treated with continuous heat energy is retained on the skin surface for 2-4 hours to complete the skin stratum corneum penetration promotion process, and then the medicine film is removed to clean the skin surface.

[0025] Preferably, the steps for preparing the thermal energy particles are:

[0026] S1601, a heat carrier material mixing step, adding 50-70 parts by weight of iron oxide powder, 20-30 parts by weight of graphite powder and 5-10 parts by weight of carbon nanotubes into a mixer, setting the mixer speed to 200-400 rpm, and continuously mixing for 1-2 hours to obtain a heat carrier mixed powder;

[0027] S1602, a binder adding step, adding 10-15 parts by weight of a polyvinyl alcohol solution to the heat-carrying mixed powder, and stirring the mixture at a speed of 100-200 rpm for 30-60 minutes using a stirrer to coat the powder surface with the binder to obtain a wet mixed powder;

[0028] S1603, granulation step, feeding the wet mixed powder into a granulation device, selecting a die aperture of 0.5-1 mm, setting the device pressure to 5-10 MPa, and performing extrusion granulation to obtain preliminary thermal energy particles;

[0029] S1604, a drying step, placing the preliminary thermal energy particles in a drying oven, setting the temperature to 60-80° C., and drying for 2-4 hours until the moisture content is less than 1%, thereby obtaining dry thermal energy particles;

[0030] S1605, a screening step, screening the dried thermal energy particles using a vibrating screen to obtain thermal energy particles.

[0031] Preferably, the pore size of the vibrating screen is 50-100 microns.

[0032] Preferably, the skin care agent is a mixture of Tremella fuciformis fruiting body extract, Dendrobium officinale extract and Dendrobium nobile extract, and the mixing ratio is 1:1.5:1.5.

[0033] Compared with the prior art, the present invention significantly enhances the penetration efficiency and effect of drug ingredients through multiple penetration promotion means. The local negative pressure penetration method creates a slight vacuum environment on the skin surface, reduces the physical barrier of the stratum corneum, reduces the skin's resistance to drug penetration, and promotes deep absorption of ingredients. When the oscillating electric field penetration method is applied to the stratum corneum, it generates tiny vibrations, changes the gaps between skin cells, and thus enhances the permeability of drug ingredients. The local conduction penetration method of thermal energy uses particles that slowly release heat to form a warm environment after the ointment contacts the skin, accelerating the diffusion of the drug while increasing the release of drug activity. The combination of multiple physical promotion means allows the penetration path of the drug to be effectively expanded, while maintaining precise control of each penetration step, ensuring that the drug ingredients achieve the best effect at different penetration stages, and significantly improving the performance of the drug.

[0034] The technical solution of the present invention is further described in detail below through the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0036] Figure 1 The present invention provides a step diagram of a method for promoting skin penetration of a drug. DETAILED DESCRIPTION

[0037] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0038] Embodiment 1, a method for promoting skin penetration of a drug, comprising the following steps:

[0039] S1, a primary stirring step, adding 70 parts by weight of base oil, 10 parts by weight of emulsifier, 5 parts by weight of thickener and 90 parts by weight of skin care agent into a stirrer, setting the stirring speed to 400 rpm, controlling the temperature within the range of 80° C., and continuously stirring for 60 minutes to obtain a preliminary mixture;

[0040] S2, antioxidant adding step, cooling the preliminary mixture to 60° C., adding 2 parts by weight of antioxidant, and continuing to stir at a speed of 300 rpm for 40 minutes to allow the antioxidant to be evenly dispersed, to obtain an antioxidant mixture;

[0041] S3, a film-forming agent dissolving step, adding 15 parts by weight of the film-forming agent to the antioxidant mixture, maintaining the temperature at 50° C., stirring at a speed of 250 rpm for 30 minutes to dissolve the film-forming agent, and obtaining a film-forming mixture;

[0042] S4, a plasticizer mixing step, adding 8 parts by weight of a plasticizer to the film-forming mixture, setting the stirring speed to 200 rpm, maintaining the temperature at 60° C., stirring for 20 minutes to promote full fusion of the plasticizer and the mixture, and obtaining a plasticized mixture;

[0043] S5, a vitamin dissolving step, dissolving 1 part by weight of vitamin A and vitamin E in an ethanol solution, controlling the temperature at 35° C., and stirring at a speed of 200 rpm for 30 minutes to obtain a vitamin solution;

[0044] S6, a total mixed solution stirring step, adding the vitamin solution to the plasticized mixture, setting the stirring speed to 300 rpm, maintaining the temperature at 30° C., and continuously stirring for 40 minutes to fully mix all the ingredients to obtain a total mixed solution;

[0045] S7, an ultrasonic promotion step, placing the total mixed solution in an ultrasonic reactor, setting the ultrasonic frequency to 40 kHz, controlling the temperature to 45° C., treating for 20 minutes to improve the uniformity of the mixture, and obtaining an ultrasonic treatment solution;

[0046] S8, a degassing step, placing the ultrasonically treated solution in a vacuum degassing machine, setting the vacuum degree to -0.08 MPa, and degassing for 20 minutes to remove bubbles in the solution to obtain a degassed solution;

[0047] S9, coating and drying step, the degassed solution is evenly coated on the backing material, the coating thickness is 0.5 mm, put into an oven, the temperature is set to 60°C, and dried for 2 hours to obtain a dry drug film;

[0048] S10, microneedle pore opening step, applying the dried drug film to the skin surface, using a microneedle device to treat the drug film, the microneedle length is 0.5 mm, the operation time is 10 minutes, micropores are formed, and a microneedle-treated drug film is obtained.

[0049] S11, a local negative pressure penetration step, applying negative pressure to the microneedle-treated drug film using a local negative pressure device, with the negative pressure range set to -50 kPa, for 20 minutes to enhance the penetration of the active ingredient, and obtain a negative pressure-treated drug film;

[0050] S12, a local negative pressure release step, slowly releases the negative pressure on the negative pressure treated drug film to restore the skin to normal pressure, avoids damage to the skin caused by sudden pressure changes, and obtains a pressure-restored drug film.

[0051] S13, an oscillating electric field permeation step, applying an oscillating electric field device to the pressure-recovered drug film, with the frequency set to 100 Hz and the voltage range to 15 volts, for 20 minutes to promote the permeation of the active ingredient, and obtain an electric field-treated drug film;

[0052] S14, an oscillating electric field adjustment step, according to the skin reaction, adjusting the oscillating electric field frequency to 120 Hz and the voltage to 20 volts for the electric field treated drug film, and continuing the treatment for 10 minutes to obtain an adjusted drug film.

[0053] S15, a low current promotion step, applying a low current stimulation to the adjusted drug film, the current range is 1 mA, and the duration is 15 minutes to promote the absorption of the active ingredient, thereby obtaining a current-treated drug film;

[0054] S16, a step of adding thermal energy particles, adding thermal energy particles with a particle size of 100 nanometers and a concentration of 0.5% on the medicine film treated with electric current, and evenly distributing them by gentle massage to obtain a medicine film treated with thermal energy particles;

[0055] S17, a heat energy release and penetration step, wherein the medicine film treated with the thermal energy particles is treated with a far infrared heating device at a temperature of 42° C. for 20 minutes to promote the thermal energy particles to release heat energy and enhance penetration, thereby obtaining a medicine film treated with thermal energy;

[0056] S18, the step of continuous heat energy regulation, according to the feedback of skin temperature, adjust the temperature of the heating device to 40°C for the heat energy treated drug film, continue heating for 10 minutes, let the skin be in a permeation state, and obtain the continuously heat energy treated drug film; after obtaining the continuously heat energy treated drug film, keep the continuously heat energy treated drug film on the skin surface for 4 hours to complete the skin stratum corneum penetration promotion process, and then remove the drug film and clean the skin surface.

[0057] In this embodiment, the steps for preparing the thermal energy particles are:

[0058] S1601, a heat carrier material mixing step, adding 70 parts by weight of iron oxide powder, 30 parts by weight of graphite powder and 10 parts by weight of carbon nanotubes into a mixer, setting the mixer speed to 400 rpm, and continuing mixing for 2 hours to obtain a heat carrier mixed powder;

[0059] S1602, a binder adding step, adding 15 parts by weight of a polyvinyl alcohol solution to the heat-carrying mixed powder, and stirring at a speed of 200 rpm for 60 minutes using a stirrer to coat the binder on the surface of the powder to obtain a wet mixed powder;

[0060] S1603, granulation step, feeding the wet mixed powder into a granulation device, selecting a die aperture of 1 mm, setting the device pressure to 10 MPa, and performing extrusion granulation to obtain preliminary thermal energy particles;

[0061] S1604, a drying step, placing the preliminary thermal energy particles in a drying oven, setting the temperature to 80° C., and drying for 4 hours until the moisture content is less than 1%, thereby obtaining dry thermal energy particles;

[0062] S1605, a screening step, using a vibrating screen to screen the dried thermal energy particles to obtain thermal energy particles, wherein the aperture of the vibrating screen is 100 microns.

[0063] In this embodiment, the skin care agent is mixed with Tremella fuciformis fruiting body extract, Dendrobium officinale extract and Dendrobium nobile extract, and the mixing ratio is 1:1.5:1.5.

[0064] Embodiment 2, a method for promoting skin penetration of a drug, comprising the following steps:

[0065] S1, a primary stirring step, adding 60 parts by weight of base oil, 6 parts by weight of emulsifier, 3 parts by weight of thickener and 85 parts by weight of skin care agent into a stirrer, setting the stirring speed to 400 rpm, controlling the temperature within the range of 80° C., and continuously stirring for 60 minutes to obtain a preliminary mixture;

[0066] S2, antioxidant adding step, cooling the preliminary mixture to 60° C., adding 2 parts by weight of antioxidant, and continuing to stir at a speed of 300 rpm for 40 minutes to allow the antioxidant to be evenly dispersed, to obtain an antioxidant mixture;

[0067] S3, a film-forming agent dissolving step, adding 5 parts by weight of the film-forming agent to the antioxidant mixture, maintaining the temperature at 50° C., stirring at a speed of 250 rpm for 30 minutes to dissolve the film-forming agent, and obtaining a film-forming mixture;

[0068] S4, a plasticizer mixing step, adding 8 parts by weight of a plasticizer to the film-forming mixture, setting the stirring speed to 200 rpm, maintaining the temperature at 60° C., stirring for 20 minutes to promote full fusion of the plasticizer and the mixture, and obtaining a plasticized mixture;

[0069] S5, a vitamin dissolving step, dissolving 1 part by weight of vitamin A and vitamin E in an ethanol solution, controlling the temperature at 35° C., and stirring at a speed of 200 rpm for 30 minutes to obtain a vitamin solution;

[0070] S6, a total mixed solution stirring step, adding the vitamin solution to the plasticized mixture, setting the stirring speed to 300 rpm, maintaining the temperature at 30° C., and continuously stirring for 40 minutes to fully mix all the ingredients to obtain a total mixed solution;

[0071] S7, an ultrasonic promotion step, placing the total mixed solution in an ultrasonic reactor, setting the ultrasonic frequency to 40 kHz, controlling the temperature to 45° C., treating for 20 minutes to improve the uniformity of the mixture, and obtaining an ultrasonic treatment solution;

[0072] S8, a degassing step, placing the ultrasonically treated solution in a vacuum degassing machine, setting the vacuum degree to -0.08 MPa, and degassing for 20 minutes to remove bubbles in the solution to obtain a degassed solution;

[0073] S9, coating and drying step, the degassed solution is evenly coated on the backing material, the coating thickness is 0.5 mm, put into an oven, the temperature is set to 60°C, and dried for 2 hours to obtain a dry drug film;

[0074] S10, microneedle pore opening step, applying the dried drug film to the skin surface, using a microneedle device to treat the drug film, the microneedle length is 0.5 mm, the operation time is 10 minutes, micropores are formed, and a microneedle-treated drug film is obtained.

[0075] S11, a local negative pressure penetration step, applying negative pressure to the microneedle-treated drug film using a local negative pressure device, with the negative pressure range set to -50 kPa, for 20 minutes to enhance the penetration of the active ingredient, and obtain a negative pressure-treated drug film;

[0076] S12, a local negative pressure release step, slowly releases the negative pressure on the negative pressure treated drug film to restore the skin to normal pressure, avoids damage to the skin caused by sudden pressure changes, and obtains a pressure-restored drug film.

[0077] S13, an oscillating electric field permeation step, applying an oscillating electric field device to the pressure-recovered drug film, with the frequency set to 100 Hz and the voltage range to 15 volts, for 20 minutes to promote the permeation of the active ingredient, and obtain an electric field-treated drug film;

[0078] S14, an oscillating electric field adjustment step, according to the skin reaction, adjusting the oscillating electric field frequency to 120 Hz and the voltage to 20 volts for the electric field treated drug film, and continuing the treatment for 10 minutes to obtain an adjusted drug film.

[0079] S15, a low current promotion step, applying a low current stimulation to the adjusted drug film, the current range is 1 mA, and the duration is 15 minutes to promote the absorption of the active ingredient, thereby obtaining a current-treated drug film;

[0080] S16, a step of adding thermal energy particles, adding thermal energy particles with a particle size of 100 nanometers and a concentration of 0.5% on the medicine film treated with electric current, and evenly distributing them by gentle massage to obtain a medicine film treated with thermal energy particles;

[0081] S17, a heat energy release and penetration step, wherein the medicine film treated with the thermal energy particles is treated with a far infrared heating device at a temperature of 42° C. for 20 minutes to promote the thermal energy particles to release heat energy and enhance penetration, thereby obtaining a medicine film treated with thermal energy;

[0082] S18, the step of continuous heat energy regulation, according to the feedback of skin temperature, adjust the temperature of the heating device to 40°C for the heat energy treated drug film, continue heating for 10 minutes, let the skin be in a permeation state, and obtain the continuously heat energy treated drug film; after obtaining the continuously heat energy treated drug film, keep the continuously heat energy treated drug film on the skin surface for 4 hours to complete the skin stratum corneum penetration promotion process, and then remove the drug film and clean the skin surface.

[0083] In this embodiment, the steps for preparing the thermal energy particles are:

[0084] S1601, a heat carrier material mixing step, adding 70 parts by weight of iron oxide powder, 30 parts by weight of graphite powder and 10 parts by weight of carbon nanotubes into a mixer, setting the mixer speed to 400 rpm, and continuing mixing for 2 hours to obtain a heat carrier mixed powder;

[0085] S1602, a binder adding step, adding 15 parts by weight of a polyvinyl alcohol solution to the heat-carrying mixed powder, and stirring at a speed of 200 rpm for 60 minutes using a stirrer to coat the binder on the surface of the powder to obtain a wet mixed powder;

[0086] S1603, granulation step, feeding the wet mixed powder into a granulation device, selecting a die aperture of 1 mm, setting the device pressure to 10 MPa, and performing extrusion granulation to obtain preliminary thermal energy particles;

[0087] S1604, a drying step, placing the preliminary thermal energy particles in a drying oven, setting the temperature to 80° C., and drying for 4 hours until the moisture content is less than 1%, thereby obtaining dry thermal energy particles;

[0088] S1605, a screening step, using a vibrating screen to screen the dried thermal energy particles to obtain thermal energy particles, wherein the aperture of the vibrating screen is 100 microns.

[0089] In this embodiment, the skin care agent is mixed with Tremella fuciformis fruiting body extract, Dendrobium officinale extract and Dendrobium nobile extract, and the mixing ratio is 1:1.5:1.5.

[0090] Experimental methods:

[0091] Skin permeation rate test method: Franz diffusion cell was used for in vitro skin permeation experiment. Human epidermal skin samples were taken and installed between the test cell and the receiving cell. 900 mL of pH 7.4 phosphate buffer was added to the receiving cell, the temperature was controlled at 37 ± 0.5 °C, and the stirring speed was 600 rpm. Each preparation was evenly applied to the test cell. Samples were taken from the receiving cell at 1, 2, 4, 6, and 8 hours, and the drug concentration was determined at a wavelength of 262 nm by high performance liquid chromatography (HPLC) to calculate the skin permeation rate.

[0092] 8-hour cumulative permeation test method: According to the experimental steps of skin permeation rate, collect the sample solution at each time point within 8 hours. Calculate the cumulative permeation amount (μg / cm 2 ).

[0093] Treatment effect test method: A 2-week clinical trial was conducted, 30 subjects were recruited and randomly divided into three groups, 10 in each group, and the preparations of Comparative Example 1, Example 1 and Example 2 were used respectively. The symptom improvement before and after treatment was evaluated according to the symptom scoring scale, and the symptom improvement rate was calculated.

[0094] Duration of action test method: After a single dose of the drug, record the time when the subject's symptoms reappear. Through follow-up, record the time interval from medication to symptom recurrence, and calculate the average duration of action of each group.

[0095] The methods of Examples 1-2 were tested, wherein Comparative Example 1 is the prior art, and the experimental results are as follows:

[0096] Table 1 Performance test data

[0097] Performance Indicators Comparative Example 1 Example 1 Example 2 <![CDATA[Skin penetration rate (μg / cm 2 ·h)]]> 12 25 32 <![CDATA[8-hour cumulative penetration amount (μg / cm 2 )]]> 96 200 232 Treatment effect (symptom improvement rate) 50% 80% 85% Duration of action (hours) 6 12 10

[0098] As can be seen from Table 1, Examples 1-2 have significantly improved skin permeation rates and cumulative permeation amounts compared to Comparative Example 1, better therapeutic effects, longer duration of action, and lower skin irritation. This shows that the present invention has obvious advantages in promoting skin permeation and absorption of active ingredients.

Claims

1. A method for promoting skin penetration of a drug, characterized in that: The following steps are involved: S1, a primary stirring step, adding 50-70 parts by weight of base oil, 5-10 parts by weight of emulsifier, 2-5 parts by weight of thickener and 80-90 parts by weight of skin care agent into a stirrer, setting the stirring speed to 200-400 rpm, controlling the temperature within the range of 60-80° C., and continuously stirring for 30-60 minutes to obtain a preliminary mixture; S2, antioxidant adding step, cooling the preliminary mixture to 40-60° C., adding 0.5-2 parts by weight of antioxidant, and continuing to stir at a speed of 150-300 rpm for 20-40 minutes to allow the antioxidant to be evenly dispersed to obtain an antioxidant mixture; S3, a film-forming agent dissolving step, adding 5-15 parts by weight of the film-forming agent to the antioxidant mixture, maintaining the temperature at 50-70° C., stirring at a speed of 250-500 rpm for 30-60 minutes to dissolve the film-forming agent, and obtaining a film-forming mixture; S4, a plasticizer mixing step, adding 3-8 parts by weight of a plasticizer to the film-forming mixture, setting a stirring speed of 200-400 rpm, maintaining a temperature of 40-60° C., stirring for 20-40 minutes, promoting full fusion of the plasticizer and the mixture, and obtaining a plasticized mixture; S5, a vitamin dissolving step, dissolving 1-3 parts by weight of vitamin A and vitamin E in an ethanol solution, controlling the temperature at 25-35° C., and stirring at a speed of 100-200 rpm for 15-30 minutes to obtain a vitamin solution; S6, a total mixed solution stirring step, adding the vitamin solution to the plasticized mixture, setting the stirring speed to 300-600 rpm, maintaining the temperature at 30-50° C., and continuously stirring for 40-80 minutes to fully mix all the ingredients to obtain a total mixed solution; S7, an ultrasonic promotion step, placing the total mixed solution in an ultrasonic reactor, setting the ultrasonic frequency to 20-40 kHz, controlling the temperature to 35-45° C., treating for 10-20 minutes to improve the uniformity of the mixture, and obtaining an ultrasonic treatment solution; S8, a degassing step, placing the ultrasonic treatment solution in a vacuum degassing machine, setting the vacuum degree to -0.08 to -0.1 MPa, and degassing for 10-20 minutes to remove bubbles in the solution to obtain a degassed solution; S9, a coating and drying step, wherein the degassed solution is evenly coated on a backing material with a coating thickness of 0.1-0.5 mm, placed in an oven, the temperature is set at 40-60° C., and dried for 1-2 hours to obtain a dry drug film; S10, microneedle pore opening step, applying the dried drug film to the skin surface, using a microneedle device to treat the drug film, the microneedle length is 0.1-0.5 mm, the operation time is 5-10 minutes, micropores are formed, and a microneedle-treated drug film is obtained.

2. The method for promoting skin penetration of a drug according to claim 1, characterized in that: Also includes: S11, a local negative pressure penetration step, applying negative pressure to the microneedle-treated drug film using a local negative pressure device, with the negative pressure range set to -50 to -100 kPa, for 10-20 minutes to enhance the penetration of the active ingredient, and obtain a negative pressure-treated drug film; S12, a local negative pressure release step, slowly releases the negative pressure on the negative pressure treated medicine film to restore the skin to a normal pressure state, avoids damage to the skin caused by sudden pressure changes, and obtains a pressure-restored medicine film.

3. The method for promoting skin penetration of a drug according to claim 2, characterized in that: Also includes: S13, an oscillating electric field penetration step, applying an oscillating electric field device to the pressure-recovered drug film, with a frequency set to 50-100 Hz and a voltage range of 5-15 volts, for 10-20 minutes to promote penetration of the active ingredient, thereby obtaining an electric field-treated drug film; S14, an oscillating electric field adjustment step, according to the skin reaction, adjusting the oscillating electric field frequency to 60-120 Hz and the voltage to 10-20 volts for the electric field treated medicine film, and continuing the treatment for 5-10 minutes to obtain an adjusted medicine film.

4. The method for promoting skin penetration of a drug according to claim 3, characterized in that: Also includes: S15, a low current promotion step, applying low current stimulation to the adjusted drug film, with a current range of 0.5-1 mA for 5-15 minutes to promote the absorption of active ingredients and obtain a current-treated drug film.

5. The method for promoting skin penetration of a drug according to claim 4, characterized in that: Also includes: S16, a step of adding thermal energy particles, wherein thermal energy particles having a particle size of 50-100 nanometers and a concentration of 0.1-0.5% are added to the medicine film treated with electric current, and the particles are evenly distributed by gentle massage to obtain a medicine film treated with thermal energy particles; S17, a heat energy release and penetration step, wherein the medicine film treated with the thermal energy particles is treated with a far-infrared heating device at a temperature of 38-42° C. for 10-20 minutes to promote the thermal energy particles to release heat energy and enhance penetration, thereby obtaining a medicine film treated with thermal energy; S18, a step of continuously adjusting heat energy, adjusting the temperature of the heating device to 36-40°C for the heat-treated medicine film according to the skin temperature feedback, and continuing heating for 5-10 minutes to keep the skin in a permeable state to obtain a medicine film continuously treated with heat energy.

6. The method for promoting skin penetration of a drug according to claim 5, characterized in that: After obtaining the medicine film treated with continuous heat energy, the medicine film treated with continuous heat energy is retained on the skin surface for 2-4 hours to complete the skin stratum corneum penetration promotion process, and then the medicine film is removed to clean the skin surface.

7. The method for promoting skin penetration of a drug according to claim 5, characterized in that: In step S16, the steps of preparing the thermal energy particles are: S1601, a heat carrier material mixing step, adding 50-70 parts by weight of iron oxide powder, 20-30 parts by weight of graphite powder and 5-10 parts by weight of carbon nanotubes into a mixer, setting the mixer speed to 200-400 rpm, and continuously mixing for 1-2 hours to obtain a heat carrier mixed powder; S1602, a binder adding step, adding 10-15 parts by weight of a polyvinyl alcohol solution to the heat-carrying mixed powder, and stirring the mixture at a speed of 100-200 rpm for 30-60 minutes using a stirrer to coat the powder surface with the binder to obtain a wet mixed powder; S1603, granulation step, feeding the wet mixed powder into a granulation device, selecting a die aperture of 0.5-1 mm, setting the device pressure to 5-10 MPa, and performing extrusion granulation to obtain preliminary thermal energy particles; S1604, a drying step, placing the preliminary thermal energy particles in a drying oven, setting the temperature to 60-80° C., and drying for 2-4 hours until the moisture content is less than 1%, thereby obtaining dry thermal energy particles; S1605, a screening step, screening the dried thermal energy particles using a vibrating screen to obtain thermal energy particles.

8. The method for promoting skin penetration of a drug according to claim 7, characterized in that: In step S1605, the pore size of the vibrating screen is 50-100 microns.

9. The method for promoting skin penetration of a drug according to claim 1, characterized in that: In step S1, the skin care agent is mixed with Tremella fuciformis fruiting body extract, Dendrobium officinale extract and Dendrobium nobile extract, and the mixing ratio is 1:1.5:1.5.

Citation Information

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