Microencapsulation transdermal absorption process for traditional Chinese medicine essential oil

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine essential oil microencapsulation transdermal absorption process. The core of the process is that a transdermal enhancer, traditional Chinese medicine essential oil and a wall material are synchronously added in an emulsification stage, a uniform emulsion system is formed through emulsification treatment, then curing treatment is performed to enable the wall material to be crosslinked to form microcapsules, and the microcapsules are separated, dried and dispersed in a matrix to prepare the transdermal preparation. According to the method, full integration of a transdermal enhancer and a microcapsule structure is realized, transdermal permeation of essential oil components is effectively promoted, meanwhile, the stability and biological activity of the essential oil are kept, and the clinical application value of the traditional Chinese medicine essential oil is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine preparation, more particularly, the present application relates to a microencapsulation transdermal absorption process of traditional Chinese medicine essential oil. BACKGROUND

[0002] As an important component of traditional Chinese medicine, traditional Chinese medicine essential oil has various biological activities, but its strong volatility and poor stability limit its application in the field of transdermal drug delivery. Microencapsulation technology can effectively protect essential oil active ingredients and prolong their action time, while transdermal absorption technology can promote drug delivery through the skin. The combination of the two has important significance for the modern application of traditional Chinese medicine essential oil.

[0003] The prior art has obvious deficiencies in the combination of microencapsulation and transdermal absorption of traditional Chinese medicine essential oil. First, traditional processes usually separate the preparation of microcapsules and the promotion of transdermal absorption into two independent stages, i.e., preparing complete microcapsules and then adding transdermal absorption promoters. This step-by-step processing results in the transdermal absorption promoters being present only on the outside of the preparation, which cannot effectively act on the encapsulated essential oil components. Second, the combination of transdermal absorption promoters and microcapsules in existing methods is not sufficient, and in most cases, they are simply mixed, making it difficult to achieve synergistic effects. Third, the selection of microcapsule wall materials in traditional processes is relatively single, lacking personalized design for different characteristics of traditional Chinese medicine essential oil, resulting in unstable encapsulation efficiency and inability to achieve precise controlled release during transdermal absorption. In addition, existing technologies often ignore the mutual influence between process parameters, such as the influence of emulsification conditions on subsequent solidification and transdermal absorption effects, resulting in low overall process efficiency and uneven product quality.

[0004] Therefore, a microencapsulation transdermal absorption process of traditional Chinese medicine essential oil is proposed to solve the problem of insufficient combination of transdermal absorption promoters and microencapsulation technology in existing technologies, improve the transdermal absorption efficiency of traditional Chinese medicine essential oil, maintain its stability and biological activity, and optimize the synergistic effect of the overall process. SUMMARY

[0005] To overcome the above-mentioned defects of the prior art, the embodiments of the present application provide a microencapsulation transdermal absorption process of traditional Chinese medicine essential oil to solve the problems raised in the background art.

[0006] To achieve the above-mentioned purpose, the present application provides the following technical solution: a microencapsulation transdermal absorption process of traditional Chinese medicine essential oil, comprising the following steps: S1, core material preparation: providing traditional Chinese medicine essential oil as the core material of microcapsules; S2, wall material preparation: selecting a natural polymer as the wall material and dissolving it in a solvent to form a wall material solution; S3. Emulsification treatment: The herbal essential oil, wall material solution and transdermal penetration promoter are emulsified in the presence of an emulsifier to form a stable emulsion system, wherein the transdermal penetration promoter is added simultaneously with the core material and wall material during the emulsification stage. S4. Curing treatment: The emulsion system is cured by adding a crosslinking agent or adjusting environmental conditions to crosslink or solidify the wall material to form microcapsules. S5. Separation and Drying: Microcapsules are collected from the reaction system through separation and drying operations; S6. Formulation preparation: The microcapsules are dispersed in a matrix to prepare a transdermal absorption formulation.

[0007] Preferably, in step S2, the wall material includes at least one of gelatin, gum arabic, chitosan or sodium alginate, the mass ratio of the wall material to the herbal essential oil is 1:1 to 1:5, the concentration of the wall material solution is 5% to 20%, and the solvent is water or a buffer solution with a pH of 6.0 to 7.5.

[0008] Preferably, in step S3, the emulsifier is selected from one or more of Tween-20, Tween-80, Span-80 or lecithin, and its amount is 0.5% to 5% of the total mass of the emulsion. The emulsification is achieved by mechanical stirring at a speed of 500 r / min to 3000 r / min and an emulsification time of 10 min to 60 min.

[0009] Preferably, in step S3, the transdermal penetration enhancer includes at least one of azone, oleic acid, or menthol, and is used in an amount of 0.1% to 5% of the total mass of the emulsion. The transdermal penetration enhancer is added at the beginning of the emulsification process along with other components and is kept uniformly dispersed throughout the emulsification process.

[0010] Preferably, in step S4, the curing process includes adding a crosslinking agent, which is one of glutaraldehyde, formaldehyde or genipin, and the amount added is 1% to 10% of the wall material mass. The curing reaction temperature is 20°C to 60°C and the reaction time is 1h to 24h.

[0011] Preferably, in step S4, the curing process further includes adjusting the pH value of the emulsion by adding an acid or alkali to adjust the pH to a range of 3.0 to 9.0. The pH adjustment is performed immediately after the emulsification process and is maintained within this pH range throughout the curing process.

[0012] Preferably, in step S5, the separation operation is achieved by centrifugation or filtration, with a centrifugation speed of 2000 r / min to 8000 r / min and a centrifugation time of 5 min to 20 min; the drying operation is carried out by ventilation drying or vacuum drying, with a drying temperature of 30°C to 50°C, until the moisture content of the microcapsules is less than 10%.

[0013] Preferably, in step S6, the matrix is ​​in the form of a water-based gel, ointment, or cream, and the matrix components include one or more of carboxymethyl cellulose, petrolatum, or lanolin. The mixing ratio of the matrix to the microcapsules is 10:1 to 1:1, and the mixing is achieved by mechanical stirring at a speed of 100 r / min to 500 r / min for a time of 20 min to 60 min.

[0014] Preferably, after step S1, a pretreatment step of the Chinese herbal essential oil is included. The pretreatment includes filtering to remove solid impurities or diluting with an appropriate amount of solvent to adjust the viscosity. The pretreated Chinese herbal essential oil is kept at a temperature between 20°C and 40°C during the subsequent emulsification process.

[0015] Preferably, after step S6, there are also packaging and storage steps. The packaging uses a light-proof and airtight container, and the storage conditions are a temperature of 15°C to 25°C, a relative humidity of 40% to 60%, and a storage time of no more than 24 months.

[0016] The technical effects and advantages of this invention are as follows: Compared to existing technologies, this invention achieves uniform molecular-level dispersion of the transdermal penetration enhancer with the essential oil core and wall materials during the emulsification stage through simultaneous addition of a transdermal penetration enhancer during the emulsification process. This treatment allows the transdermal penetration enhancer to fully penetrate the forming microcapsule structure and be fixed within the wall material network during subsequent curing. When the formulation is applied to the skin, the transdermal penetration enhancer and essential oil components are released simultaneously, effectively reducing the barrier function of the stratum corneum and creating favorable conditions for the transdermal absorption of the active ingredients in the essential oil. This design not only improves the bioavailability of the essential oil but also avoids component loss that may occur with stepwise addition, ensuring the stability of the formulation quality.

[0017] Compared to existing technologies, this invention optimizes the process transition between emulsification and curing, performing curing immediately after the formation of a stable emulsion and precisely controlling the timing of crosslinking agent addition and reaction conditions. This method ensures the orderly crosslinking of the microcapsule wall material in the presence of transdermal accelerators, forming dense and uniformly distributed microcapsule particles. The continuous process design reduces material transfer and waiting time between production stages, lowers the risk of essential oil volatilization and degradation during production, and improves production efficiency and product consistency, providing reliable technical support for industrial production.

[0018] Compared to existing technologies, this invention achieves long-term regulation of essential oil release rates by constructing a microcapsule system containing a transdermal penetration enhancer. Under the influence of the transdermal penetration enhancer, the microcapsule wall material can interact more fully with the skin environment, gradually releasing the active ingredients. This controlled release characteristic prolongs the drug's duration of action, reduces the frequency of administration, and avoids the burst release phenomenon commonly found in traditional formulations. The stable release characteristics combined with excellent transdermal performance enable the formulation to maintain stable blood drug concentrations, improving therapeutic efficacy and medication safety. Attached Figure Description

[0019] Fig. 1 This is a flowchart illustrating the overall process flow of the present invention.

[0020] Fig. 2 This is a detailed diagram of the emulsification process of the present invention.

[0021] Fig. 3 This is a detailed diagram of the curing process of the present invention.

[0022] Fig. 4 This diagram illustrates the formulation preparation and application of the present invention. Detailed Implementation

[0023] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] Example 1 As attached Figs. 1 to 4 The process described is a transdermal absorption technology using microencapsulation of traditional Chinese medicine essential oils. Through the systematic coordination of six core steps, it achieves an organic combination of transdermal absorption enhancers and the microencapsulation process. The first step involves core material preparation, selecting traditional Chinese medicine essential oils with clear pharmacological activity as the core raw materials. Next, a suitable wall material solution is prepared to provide a structural basis for microcapsule construction. Then, a stable emulsion system is formed through precisely controlled emulsification. This system is then solidified to construct the complete microcapsule structure. The dried microcapsule product is obtained through separation and drying. Finally, a transdermal absorption formulation ready for direct application is obtained through formulation preparation. The entire process design emphasizes the connection and coordination between each step to ensure the final product has stable quality and the expected transdermal absorption effect.

[0025] Furthermore, in the wall material preparation stage, a gelatin-gum arabic composite wall material system was used. The two materials were mixed at a 1:1 mass ratio and dissolved in a phosphate buffer solution with a pH of 6.8 to prepare a 12% wall material solution. This solution was continuously stirred in a 45°C water bath until completely dissolved, ensuring the formation of a uniform and transparent colloidal solution. Gelatin, as a protein-based wall material, contains a large number of amino and carboxyl groups in its molecular chain, enabling it to form a gel network under specific conditions; gum arabic, as a polysaccharide-based wall material, possesses excellent emulsifying and film-forming properties.

[0026] The combined use of the two wall materials can achieve a synergistic effect: gelatin provides structural strength, while gum arabic improves emulsion stability. During the dissolution process, controlling the temperature at 45℃ ensures that the gelatin is fully hydrated without denaturation, while simultaneously guaranteeing the complete dissolution of the gum arabic. Adjusting the pH of the wall material solution to 6.8 keeps the gelatin molecules near their isoelectric point, facilitating the subsequent formation of a composite aggregate layer through electrostatic interactions with the gum arabic. This composite wall material system can form a stable interfacial film during subsequent emulsification, with its hydrophilic and hydrophobic groups oriented at the oil-water interface, providing a structural basis for microcapsule formation.

[0027] Furthermore, in the emulsification process, a composite emulsifier consisting of Tween-80 and lecithin in a 2:1 mass ratio was selected, with an addition amount of 2.5% of the total emulsion mass. The emulsification process was carried out at a constant temperature of 50℃ using a high-speed shear emulsifier at a rotation speed of 2000 rpm for 30 minutes. Tween-80, as a nonionic surfactant, effectively reduces the oil-water interfacial tension, with a hydrophilic-lipophilic balance value of approximately 15, making it suitable for the preparation of oil-in-water emulsions. Lecithin, as a natural emulsifier, not only has surface-active properties but also interacts with lipids in the stratum corneum of the skin, enhancing transdermal absorption. Maintaining the temperature at 50℃ during emulsification ensures appropriate fluidity of the wall material while preventing excessive temperature from causing the essential oil components to volatilize. The shear condition of 2000 rpm provides sufficient energy input to disperse the essential oil droplets to a suitable particle size range. The 30-minute emulsification time ensures sufficient homogenization of the system, forming a stable emulsion system. Such emulsification conditions effectively reduce the interfacial tension between oil and water, allowing the essential oil droplets to be uniformly dispersed in the wall material solution, forming a stable emulsion system with a particle size distribution in the range of 1-10 μm. The synergistic effect of the composite emulsifier further enhances the stability of the emulsion, preventing droplet aggregation and stratification.

[0028] Furthermore, the transdermal penetration enhancer is added simultaneously with other components at the start of emulsification, using a composite system of azone and menthol in a 3:1 mass ratio, with a total addition amount of 2% of the total emulsion mass. Azone, as a highly effective transdermal penetration enhancer, works by altering the ordered arrangement of the stratum corneum lipid bilayer, increasing the fluidity of intercellular lipids. Menthol, in addition to its transdermal penetration enhancing effect, also produces a cooling sensation, improving the user experience. The combined use of these two transdermal penetration enhancers produces a synergistic effect.

[0029] During emulsification, transdermal penetration enhancer molecules co-distribute with wall material molecules at the oil-water interface. Azone, with its stronger lipophilicity, tends to gravitate towards the oil phase, while menthol, with some hydrophilicity, distributes more evenly within the interfacial layer. This timing of addition ensures that the transdermal penetration enhancer molecules fully participate in the emulsification process, aligning with the wall material molecules at the oil-water interface and thus effectively encapsulated within the microcapsule wall structure. When the formulation is applied to the skin, the transdermal penetration enhancer can be released simultaneously with the active ingredients of the essential oil, promoting transdermal drug penetration by altering the ordered arrangement of the stratum corneum lipid bilayer.

[0030] Furthermore, in the curing process, glutaraldehyde is used as a crosslinking agent. After emulsification, a 2.5% glutaraldehyde solution is slowly added dropwise, with the addition amount being 5% of the wall material mass. As a bifunctional crosslinking agent, the aldehyde groups at both ends of glutaraldehyde can undergo a Schiff base reaction with the amino groups in the gelatin molecules to form stable covalent crosslinks.

[0031] During the dropwise addition process, the dropping rate needs to be controlled to ensure a slow and uniform process, avoiding excessive local concentrations that could lead to over-crosslinking. The curing reaction is carried out with continuous stirring at 40℃ for 12 hours. This temperature ensures the rate of the crosslinking reaction without causing excessive volatilization of the essential oil components. The stirring speed is maintained at 500 r / min to ensure uniform mixing of the system while avoiding damage to the formed microcapsule structure. During the crosslinking process, the aldehyde groups of glutaraldehyde react with the amino groups of the wall material molecules, initially forming an unstable Schiff base intermediate, which then gradually transforms into a stable covalent crosslinked network. This crosslinking reaction significantly enhances the mechanical strength of the microcapsules, enabling them to withstand mechanical stress during subsequent processing, while effectively preventing premature release of the essential oil components.

[0032] Furthermore, pH adjustment was performed simultaneously during the curing process. A 1 mol / L hydrochloric acid solution was used to precisely adjust the pH of the emulsion to 4.5, and this pH range was maintained throughout the curing process. pH adjustment needed to be performed immediately after the addition of glutaraldehyde, with a precision pH meter used to monitor pH changes in real time. At pH 4.5, the degree of protonation of the amino groups in the gelatin molecules was moderate, ensuring the necessary number of basic groups for reaction with glutaraldehyde while avoiding excessively high pH levels that could lead to glutaraldehyde self-polymerization. Simultaneously, this pH condition also ensured that the carboxyl groups in the gum arabic molecules were in an appropriately ionized state, which is beneficial for maintaining the stability of the system.

[0033] Throughout the curing reaction, continuous monitoring and adjustment via an automatic pH control system are required. Acid or alkali solutions are added as needed using a micro-pump to ensure pH fluctuations do not exceed ±0.2. This specific pH condition promotes the cross-linking reaction rate between glutaraldehyde and the wall material molecules while preventing excessive acidity from damaging the active ingredients of the essential oils. Precise pH control ensures the orderly progress of the cross-linking reaction, resulting in dense and uniformly distributed microcapsule walls.

[0034] Furthermore, the separation and drying process employs a combination of centrifugal separation and vacuum drying. During centrifugation, the solidified reaction solution is centrifuged at 5000 rpm for 15 minutes. This centrifugal force effectively settles the microcapsule particles while avoiding excessive shear force that could damage the microcapsule structure. The supernatant after centrifugation contains unreacted glutaraldehyde, excess emulsifier, and other water-soluble components, which must be completely removed. The solution is then washed three times with deionized water. Each time, the microcapsules are redispersed in deionized water and then centrifuged at 3000 rpm for 10 minutes to ensure complete removal of residual crosslinking agents and byproducts.

[0035] During the vacuum drying stage, the cleaned microcapsules are evenly spread on a drying tray, with a thickness not exceeding 1 cm, and placed in a vacuum drying oven at 45℃. The vacuum level is maintained within the range of -0.085MPa to -0.095MPa. This vacuum condition can effectively lower the boiling point of water, allowing water to evaporate at a lower temperature and avoiding the damage of heat-sensitive essential oil components to high temperatures.

[0036] During the drying process, the microcapsules need to be turned regularly to ensure uniform drying. The drying endpoint is determined by monitoring the change in sample weight; the drying requirement is considered met when the difference between two consecutive weighings does not exceed 0.5%. This series of processes ensures the purity of the microcapsule product, while the vacuum drying conditions prevent the damage of heat-sensitive essential oil components to high temperatures, thus preserving the bioactivity of the essential oils.

[0037] Furthermore, in the formulation preparation stage, sodium carboxymethyl cellulose was selected as the matrix material to prepare a 3% hydrogel matrix. First, sodium carboxymethyl cellulose was slowly sprinkled into deionized water while stirring at 800 rpm to prevent clumping. After complete dissolution, the mixture was allowed to stand to remove bubbles, resulting in a transparent and uniform hydrogel matrix. The dried microcapsules were then added at a matrix-to-microcapsule mass ratio of 5:1, and stirred at 200 rpm for 40 minutes. Precise control of the stirring speed is crucial; excessively high speeds can generate shear forces that damage the microcapsule structure, while excessively low speeds make uniform dispersion difficult.

[0038] During the mixing process, the microcapsules gradually disperse into the three-dimensional network structure of the hydrogel. The carboxyl groups on the sodium carboxymethyl cellulose molecular chains may form hydrogen bonds with the functional groups on the microcapsule surface; this interaction contributes to the stable dispersion of the microcapsules within the matrix. The hydrogel matrix not only serves as a carrier for the microcapsules but also possesses moisturizing properties, maintaining the hydration of the stratum corneum and thus promoting transdermal drug absorption. The three-dimensional network structure of the hydrogel matrix effectively immobilizes the microcapsules, preventing sedimentation and aggregation, while providing suitable viscosity and spreadability for the formulation. This design allows the formulation to maintain stability while uniformly releasing the active ingredient upon application.

[0039] Furthermore, a pretreatment step is included after core material preparation. The herbal essential oils are filtered through a 0.45μm microporous membrane to remove solid impurities, and then diluted with olive oil at 1.5 times their volume. The filtration process uses a positive pressure filtration device, with the pressure controlled within the range of 0.1-0.2MPa to prevent oxidation of the essential oil components due to excessive pressure. The microporous membrane needs to be pre-saturated with a small amount of essential oil before use to reduce adsorption losses during filtration. The olive oil used for dilution needs to be pre-dehydrated, with a moisture content controlled below 0.1% to prevent moisture from affecting the subsequent emulsification process. The pretreatment process is carried out at a constant temperature of 35℃ using a water bath for precise temperature control, with temperature fluctuations not exceeding ±0.5℃. This temperature ensures the fluidity of the essential oils, facilitating filtration, while avoiding the loss of volatile components due to high temperatures.

[0040] Olive oil, used as a diluent, has a fatty acid composition similar to that of skin lipids, thus enhancing penetration and regulating the volatility of essential oils. Filtration removes impurities that might affect emulsification, while dilution adjusts the viscosity of the essential oils, making them easier to form uniform emulsion droplets.

[0041] Furthermore, a packaging and storage stage is included at the end of the process. The final formulation is dispensed into nitrogen-filled, sealed brown glass bottles and stored in the dark at a temperature of 20℃±2℃ and a relative humidity of 50%±5%. The packaging process must be carried out in a clean environment to avoid microbial contamination. First, the formulation is filled into brown glass bottles, with the filling volume controlled at 85%-90% of the container volume, leaving an appropriate headspace.

[0042] The air inside the bottle is then replaced with high-purity nitrogen using a nitrogen purging device, achieving a nitrogen purity of over 99.99% and an oxygen residue of less than 0.5%. Finally, the bottle is immediately sealed with a cap lined with a PTFE gasket. The storage environment requires an automatic temperature and humidity monitoring system to ensure the temperature is maintained at 20℃±2℃ and the relative humidity at 50%±5%. Light intensity should be controlled below 50 lux to prevent degradation of photosensitive components.

[0043] Brown glass bottles effectively block light from damaging photosensitive components, nitrogen purging eliminates the oxidation of essential oil components by oxygen, and constant temperature and humidity conditions ensure the physical and chemical stability of the formulation during storage.

[0044] Example 2 In a specific application scenario, let's take the preparation of a transdermal absorption gel of traditional Chinese medicine essential oils that relieves muscle fatigue as an example. This scenario addresses common problems such as muscle soreness and stiffness after exercise, selecting peppermint and eucalyptus essential oils, which have cooling, analgesic, anti-inflammatory, and soothing effects, as the main active ingredients. First, accurately weigh 50 grams of peppermint essential oil and 50 grams of eucalyptus essential oil, and mix them thoroughly in a 35°C constant temperature water bath. Using a positive pressure filtration device, the mixed essential oils are passed through a 0.45μm microporous membrane under a pressure of 0.15MPa to remove solid impurities such as plant fibers and waxes. Then, 150 grams of refined olive oil are added for dilution, and the dilution process is carried out by slow stirring at 35°C for 30 minutes to obtain a homogeneous pretreated essential oil mixture.

[0045] Next, prepare the wall material solution. Accurately weigh 25 grams of gelatin and 25 grams of gum arabic, mix the two wall material powders evenly, and slowly add them to 416 ml of phosphate buffer solution with a pH of 6.8. Dissolve the solution in a 45°C water bath at 500 rpm for 60 minutes, until a completely homogeneous and transparent colloidal solution is formed. During this period, carefully observe the solution to ensure there are no undissolved particles or lumps.

[0046] In the emulsification stage, the aforementioned pretreated essential oil mixture, wall material solution, and transdermal penetration enhancer were simultaneously added to the reaction vessel. The transdermal penetration enhancer consisted of 1.5 g of azone and 0.5 g of menthol, while the emulsifier used was 3.75 g of Tween-80 and 1.875 g of lecithin. The system temperature was raised to 50°C and maintained constant. A high-speed shear emulsifier was turned on and emulsified continuously at 2000 r / min for 30 minutes. During the emulsification process, the system was observed to gradually change from turbid to a milky white homogeneous emulsion. Under a microscope, the emulsion droplets appeared as regular spheres with a particle size distribution concentrated in the range of 1-10 μm.

[0047] The curing process was performed immediately after emulsification. First, the pH of the emulsion was precisely adjusted to 4.5 using a 1 mol / L hydrochloric acid solution, followed by the slow dropwise addition of 5 mL of a 2.5% glutaraldehyde solution. The dropwise addition was completed within 10 minutes, while the system was slowly stirred at 500 rpm. After the addition was complete, the reaction was continued at a constant temperature of 40°C for 12 hours. During this period, the pH of the reaction system was maintained within the range of 4.5 ± 0.2 using an automatic pH control system.

[0048] After solidification, the reaction solution was transferred to centrifuge tubes and centrifuged at 5000 rpm for 15 minutes. The supernatant was carefully removed. The collected microcapsule precipitate was redispersed with 200 mL of deionized water and centrifuged at 3000 rpm for 10 minutes. This washing process was repeated three times until the washing solution was clear and transparent. The washed microcapsules were evenly spread on a drying tray to a thickness of 0.8 cm and placed in a vacuum drying oven at 45°C. The vacuum degree was maintained at -0.09 MPa, and the microcapsules were turned over every 60 minutes during the drying process until the moisture content dropped to 7.5%.

[0049] In the formulation preparation stage, a 3% sodium carboxymethyl cellulose hydrogel matrix was first prepared. 6 g of sodium carboxymethyl cellulose powder was slowly added to 194 mL of deionized water while continuously stirring at 800 rpm. After complete dissolution, the mixture was allowed to stand for 2 hours to remove bubbles. 50 g of dried microcapsules were then mixed with 250 g of the hydrogel matrix and stirred at 200 rpm for 40 minutes until the microcapsules were uniformly dispersed in the matrix, yielding the final transdermal absorption gel formulation.

[0050] For packaging and storage, dispense the gel formulation into 100 ml amber glass bottles, each containing 90 grams of the formulation. Replace the air in the bottle with high-purity nitrogen, ensuring the residual oxygen level is below 0.3%, and immediately seal the bottle with a cap lined with a PTFE gasket. Store in a light-protected environment at 20℃±1℃ and 50%±3% relative humidity.

[0051] During use, apply an appropriate amount of gel to fatigued muscles and gently massage to promote absorption. The microcapsules gradually release active ingredients under skin temperature and pressure, while transdermal absorption enhancers and essential oils work synergistically to effectively relieve muscle discomfort. This formulation, with its precisely controlled release characteristics, maintains its effect for 4-6 hours, and ideal relief can be achieved with 2-3 applications daily. The entire process ensures the stability and bioavailability of the active ingredients, providing a safe and effective solution for muscle recovery after exercise.

[0052] Finally, the following points should be noted: First, in the description of this application, it should be noted that, unless otherwise specified and limited, the terms "installation", "connection", and "linkage" should be interpreted broadly, and can be mechanical or electrical connections, or internal connections between two components, or direct connections. "Up", "down", "left", "right", etc. are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may change. Secondly: The accompanying drawings of the embodiments disclosed in this invention only involve the structures involved in the embodiments disclosed in this invention. Other structures can refer to the general design. In the absence of conflict, the same embodiment and different embodiments of this invention can be combined with each other. In conclusion, the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A transdermal absorption process for microencapsulated traditional Chinese medicine essential oils, characterized in that, Includes the following steps: S1. Core Material Preparation: Provide Chinese herbal essential oils as the core material for microcapsules; S2. Wall Material Preparation: Select natural polymers as wall materials and dissolve them in a solvent to form a wall material solution; S3. Emulsification treatment: The herbal essential oil, wall material solution and transdermal penetration promoter are emulsified in the presence of an emulsifier to form a stable emulsion system, wherein the transdermal penetration promoter is added simultaneously with the core material and wall material during the emulsification stage. S4. Curing treatment: The emulsion system is cured by adding a crosslinking agent or adjusting environmental conditions to crosslink or solidify the wall material to form microcapsules. S5. Separation and Drying: Microcapsules are collected from the reaction system through separation and drying operations; S6. Formulation preparation: The microcapsules are dispersed in a matrix to prepare a transdermal absorption formulation.

2. The transdermal absorption process for microencapsulated traditional Chinese medicine essential oils according to claim 1, characterized in that, In step S2, the wall material includes at least one of gelatin, gum arabic, chitosan or sodium alginate, the mass ratio of the wall material to the Chinese herbal essential oil is 1:1 to 1:5, the concentration of the wall material solution is 5% to 20%, and the solvent is water or a buffer solution with a pH value of 6.0 to 7.

5.

3. The transdermal absorption process for microencapsulated traditional Chinese medicine essential oils according to claim 1, characterized in that, In step S3, the emulsifier is selected from one or more of Tween-20, Tween-80, Span-80 or lecithin, and its amount is 0.5% to 5% of the total mass of the emulsion. The emulsification is achieved by mechanical stirring at a speed of 500 r / min to 3000 r / min and an emulsification time of 10 min to 60 min.

4. The transdermal absorption process for microencapsulated traditional Chinese medicine essential oils according to claim 1, characterized in that, In step S3, the transdermal penetration enhancer includes at least one of azone, oleic acid, or menthol, and is used in an amount of 0.1% to 5% of the total mass of the emulsion. The transdermal penetration enhancer is added at the beginning of the emulsification process along with other components and is kept uniformly dispersed throughout the emulsification process.

5. The transdermal absorption process for microencapsulated traditional Chinese medicine essential oils according to claim 1, characterized in that, In step S4, the curing process includes adding a crosslinking agent, which is one of glutaraldehyde, formaldehyde or genipin, and the amount added is 1% to 10% of the wall material mass. The curing reaction temperature is 20°C to 60°C and the reaction time is 1h to 24h.

6. The transdermal absorption process for microencapsulated traditional Chinese medicine essential oils according to claim 1, characterized in that, In step S4, the curing process further includes adjusting the pH value of the emulsion by adding an acid or alkali to adjust the pH to a range of 3.0 to 9.

0. The pH adjustment is performed immediately after the emulsification process and is maintained within this pH range throughout the curing process.

7. The transdermal absorption process for microencapsulated traditional Chinese medicine essential oils according to claim 1, characterized in that, In step S5, the separation operation is achieved by centrifugation or filtration, with a centrifugation speed of 2000 r / min to 8000 r / min and a centrifugation time of 5 min to 20 min; the drying operation is carried out by ventilation drying or vacuum drying, with a drying temperature of 30°C to 50°C, until the moisture content of the microcapsules is less than 10%.

8. The transdermal absorption process for microencapsulated traditional Chinese medicine essential oils according to claim 1, characterized in that, In step S6, the matrix is ​​in the form of a water-based gel, ointment, or cream. The matrix components include one or more of carboxymethyl cellulose, petrolatum, or lanolin. The mixing ratio of the matrix to the microcapsules is 10:1 to 1:

1. The mixing is achieved by mechanical stirring at a speed of 100 r / min to 500 r / min for a time of 20 min to 60 min.

9. The transdermal absorption process for microencapsulated traditional Chinese medicine essential oils according to claim 1, characterized in that, The process after step S1 includes a pretreatment step for the Chinese herbal essential oil. The pretreatment includes filtering to remove solid impurities or diluting with an appropriate amount of solvent to adjust the viscosity. The pretreated Chinese herbal essential oil is kept at a temperature between 20°C and 40°C during the subsequent emulsification process.

10. The transdermal absorption process for microencapsulation of traditional Chinese medicine essential oils according to claim 1, characterized in that, The process after step S6 includes packaging and storage steps. The packaging uses a light-proof, airtight container, and the storage conditions are a temperature of 15°C to 25°C and a relative humidity of 40% to 60%, with a storage time not exceeding 24 months.

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