Soluble traditional Chinese medicine thumbtack needle based on sodium hyaluronate and preparation method and application of soluble traditional Chinese medicine thumbtack needle

Abstract

The invention discloses a soluble traditional Chinese medicine thumbtack needle based on sodium hyaluronate and a preparation method and application of the soluble traditional Chinese medicine thumbtack needle based on sodium hyaluronate. The soluble traditional Chinese medicine thumbtack needle mainly comprises sodium hyaluronate, and the molecular weight range of the sodium hyaluronate is 10 kDa to 500 kDa; the length of the needle body is 0.5-2 mm, and the diameter of the needle tip is smaller than 100 microns; the needle body is conical or pyramid-shaped, the needle body contains medicines or functional components, the needle body adopts an ultra-short length design of 0.5-2mm, the diameter of the needle tip is less than 100 microns, and the needle body is conical / pyramid-shaped to optimize a puncture angle, so that mechanical stimulation during skin puncture is remarkably reduced, painless or slight pain treatment experience is realized, and compared with a traditional metal acupuncture needle or thumbtack needle, the needle body has the advantages that the needle body is simple in structure and convenient to use. The device is simple in structure and convenient to use, the fear of a patient to acupuncture is greatly reduced, the device is particularly suitable for children, old people and people terrorist of acupuncture, comfort and compliance in the treatment process are fundamentally improved, operation of professional medical staff is not needed, and the patient can complete acupuncture point application according to an instruction book by himself / herself.

Description

Technical Field

[0001] The present invention belongs to the technical field of acupuncture needles, and in particular relates to a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate, and a preparation method and application thereof. Background Art

[0002] As an external treatment method that continuously stimulates acupuncture points through needles to achieve therapeutic purposes, traditional Chinese medicine acupuncture therapy is widely used in clinical practice for pain management, functional regulation, and chronic disease prevention and treatment. Traditional acupuncture needles are mostly made of metal. The needle body needs to be manually inserted into the skin and fixed to the surface of the acupuncture point to exert its effect through physical stimulation. However, metal acupuncture needles have problems such as requiring professional medical personnel to operate, patients' tolerance to acupuncture pain varies greatly, long-term retention may cause skin infection or metal allergic reaction, and foreign matter may be left behind when removed. In addition, although traditional acupuncture point patch therapy avoids the risk of metal needle insertion, the drug release efficiency that relies on transdermal absorption is low, the action time is short, and it is difficult to achieve long-term therapeutic effects.

[0003] From the existing technology, the traditional press needle has the following problems:

[0004] 1. May cause pain or discomfort during use;

[0005] 2. It requires professional operation and is difficult for patients to use on their own;

[0006] 3. Metal materials are non-degradable and pose an environmental pollution risk.

[0007] Therefore, a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate and a preparation method and application thereof are proposed. Summary of the Invention

[0008] In order to overcome the above-mentioned defects of the prior art, the embodiments of the present invention provide a soluble traditional Chinese medicine press needle based on sodium hyaluronate and its preparation method and application, which solve the problems that traditional press needles may cause pain or discomfort during use, require professional operation, are difficult for patients to use by themselves, and the metal material is non-degradable and poses an environmental pollution risk.

[0009] To achieve the above object, the present invention provides the following technical solutions:

[0010] A soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate, the main component of which is sodium hyaluronate, the molecular weight of which ranges from 10kDa to 500kDa; the needle body length is 0.5mm to 2mm, the needle tip diameter is less than 100μm; the needle body is conical or pyramidal, and the needle body contains a drug or an effective ingredient.

[0011] Preferably, the medicine or effective ingredient is one or more of a traditional Chinese medicine extract, vitamins, and minerals, wherein the traditional Chinese medicine extract accounts for 1%-10% of the mass of the mixed solution.

[0012] Preferably, the Chinese herbal extract is one or more of Danshen extract, Astragalus extract, and Angelica extract, and the needle body is biodegradable and gradually dissolves in the skin.

[0013] Preferably, a method for preparing a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate comprises the following steps:

[0014] S1: Prepare sodium hyaluronate solution: dissolve sodium hyaluronate powder with a molecular weight of 10 kDa to 500 kDa in deionized water, stir at 25°C-35°C until completely dissolved, and prepare a sodium hyaluronate solution with a concentration of 10%-30%;

[0015] S2: Adding drugs or active ingredients: Add Chinese herbal extracts, vitamins or minerals to the sodium hyaluronate solution at a mass ratio of 1%-10%, and stir at a speed of 200-500 rpm for 30-60 minutes until the mixture is uniformly mixed;

[0016] S3: Mold forming: injecting the mixed solution into a microneedle mold having a conical or pyramidal needle structure, wherein the mold is made of medical-grade polytetrafluoroethylene;

[0017] S4: Drying and curing: placing the mold in a vacuum drying oven with a vacuum degree of ≤10kPa and drying at 30°C-50°C for 12-24 hours to solidify the solution to form a needle body;

[0018] S5: Demolding: Use medical-grade silicone demolding tools to separate the cured microneedles from the mold to obtain soluble traditional Chinese medicine press needles.

[0019] Preferably, the concentration of the sodium hyaluronate solution is 15%-25%, and the drying temperature is 35°C-45°C.

[0020] Preferably, the Chinese herbal medicine extract is tanshinone extract, astragalus polysaccharide or ferulic acid, and is sterilized by a 0.22 μm microporous filter membrane before addition.

[0021] Preferably, a soluble traditional Chinese medicine push needle based on sodium hyaluronate is used, in which the push needle is pressed on the surface of the skin of the human acupuncture point, and the needle body gradually dissolves after piercing the skin, thereby achieving continuous release of drug ingredients and acupuncture point stimulation.

[0022] Preferably, the acupoints include meridian acupoints such as Zusanli, Hegu, and Neiguan, which are used to improve gastrointestinal function, regulate immunity or relieve pain.

[0023] Preferably, the pressing needle is used and replaced every 24-72 hours, and the single application time does not exceed 96 hours.

[0024] Preferably, the acupuncture needles are used in combination with traditional Chinese medicine application therapy to form a soluble microneedle-acupoint application composite treatment system.

[0025] The technical effects and advantages of the soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate and its preparation method and application are as follows:

[0026] 1. This invention features an ultra-short needle length of 0.5-2mm, a tip diameter of less than 100μm, and a conical / pyramidal shape to optimize the insertion angle, significantly reducing mechanical stimulation during skin puncture and achieving a painless or minimally painful treatment experience. Compared to traditional metal acupuncture needles or press needles, this invention significantly reduces patients' fear of acupuncture, making it particularly suitable for children, the elderly, and those with needle phobia, fundamentally improving treatment comfort and compliance.

[0027] 2. This invention eliminates the need for specialized medical personnel; patients can perform acupoint application themselves according to the instructions. Simply pressing the needles secures them to target acupoints such as Zusanli and Hegu, meeting the needs of self-care at home or in the community. The standardized frequency of application further reduces operational difficulty, avoids the reliance on specialized expertise required by traditional acupuncture, and promotes the convenience and accessibility of external TCM treatments.

[0028] 3. This invention, based on medical-grade sodium hyaluronate, allows the needle to gradually degrade into water and carbon dioxide within the skin through the body's own enzymatic process, eliminating the need for manual removal. This completely eliminates the problems of foreign matter residue, infection risks, and metal allergies associated with traditional metal push needles. Furthermore, the degradation process releases no toxic or harmful products, achieving zero pollution from the source. This aligns with the concept of green medicine, combining clinical safety with environmental protection.

[0029] 4. This invention, based on Traditional Chinese Medicine (TCM) meridian theory, activates meridian conduction through physical stimulation of acupuncture points, simultaneously releasing traditional Chinese medicine ingredients (1%-10%), including Danshen extract and Astragalus polysaccharide, as well as vitamins and minerals, creating a dual mechanism of action: "continuous acupuncture point stimulation + targeted drug penetration." The sustained-release properties of sodium hyaluronate enable sustained release of the active ingredient over 24-96 hours. Compared to traditional patch therapy, this significantly prolongs the duration of action and improves drug bioavailability, demonstrating more sustained and effective therapeutic effects for indications such as gastrointestinal function regulation, immune enhancement, and pain relief.

[0030] 5. This invention utilizes sodium hyaluronate as a natural moisturizing factor, which improves the local skin microenvironment during needle dissolution, minimizing minor acupuncture trauma, accelerating epidermal repair, and reducing the incidence of adverse reactions such as redness, swelling, and itching. The smooth needle surface, molded from a medical-grade polytetrafluoroethylene mold, further minimizes mechanical damage to the skin, achieving a balance between therapeutic efficacy and comfort.

[0031] 6. This invention can act on specific acupuncture points alone, or it can be combined with traditional Chinese medicine patch therapy to form a complex treatment system, which is suitable for individualized treatment plans for different diseases. The preparation process is standardized through vacuum drying (30℃-50℃), microporous filter membrane sterilization and other technologies to ensure the stability of the needle body hardness, drug loading and degradation rate of each batch of products, providing reliable guarantee for large-scale production and clinical promotion. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 This is a product structure diagram of a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate and its preparation method and application proposed by the present invention;

[0033] Figure 2 This is a flow chart of a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate and its preparation method and application. DETAILED DESCRIPTION

[0034] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts shall fall within the scope of protection of the present invention.

[0035] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or apparatus that includes a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or apparatus. In the absence of further restrictions, the elements defined by the sentence "include..." do not exclude the existence of other identical elements in the process, method, article or apparatus that includes the elements.

[0036] Example 1

[0037] refer to Figure 1 This embodiment provides a soluble TCM acupuncture needle based on sodium hyaluronate and its preparation method and application, which are used for the implementation of soluble TCM acupuncture needle. The specific implementation content includes:

[0038] Composition structure:

[0039] Sodium hyaluronate: molecular weight 100kDa, accounting for 80% of the total mass of the needle body;

[0040] Drug ingredients: Danshen extract (tanshinone content ≥ 98%), accounting for 5% of the mixed solution mass;

[0041] Needle parameters: length 1.2mm, needle tip diameter 80μm, conical shape.

[0042] Technical features:

[0043] Sodium hyaluronate forms a three-dimensional network structure through intermolecular hydrogen bonds, serving as a drug carrier matrix;

[0044] The Danshen extract was evenly dispersed in the needle matrix and sterilized by 0.22 μm filter membrane;

[0045] Needle body hardness test: Shore hardness A25-30 (meets skin puncture mechanical requirements).

[0046] Implementation effect:

[0047] Drug release characteristics: In vitro transdermal experiments showed that the cumulative release rate of tanshinone reached 45% within 24 hours and 85% within 72 hours, achieving continuous acupuncture drug delivery.

[0048] Biodegradation performance: After implantation into the pig skin model, the needle mass decreased by 60% in 48 hours and was completely degraded into hyaluronic acid monomers and salvia miltiorrhiza extract metabolites in 96 hours.

[0049] Preliminary clinical evaluation: After application of the patch on 50 subjects, the incidence of local skin erythema at the Zusanli acupoint was 1.2%, which was significantly lower than that of traditional metal acupuncture (15%).

[0050] Example 2

[0051] This embodiment provides a soluble TCM acupuncture needle based on sodium hyaluronate and its preparation method and application, which are used for the implementation of soluble TCM acupuncture needle. The specific implementation content includes:

[0052] Composition structure:

[0053] Sodium hyaluronate: molecular weight 300kDa, concentration 20% aqueous solution;

[0054] Composite drug: Astragalus polysaccharide (4%) + ferulic acid (2%), total weight accounting for 6%;

[0055] Needle body parameters: pyramidal needle body, length 1.5mm, needle tip angle 30°.

[0056] Technical features:

[0057] Gradient freeze-drying technology is used to form a porous sustained-release structure;

[0058] Astragalus polysaccharide forms glycosidic cross-links with sodium hyaluronate to delay drug release;

[0059] Biodegradation test: The degradation rate reaches 60% in 48 hours and completely disintegrates in 72 hours.

[0060] Implementation effect:

[0061] Sustained-release performance: Ferulic acid release presents a biphasic pattern (15% burst release in the initial 2 hours, followed by a sustained release of 80% over the next 72 hours), which meets the needs of long-term stimulation of acupoints.

[0062] Mechanical properties: Needle tip puncture force ≤ 0.8N (better than the industry standard 1.2N), the needle body maintains intact shape rate ≥ 95% after 24 hours of application.

[0063] Synergistic efficacy: Animal experiments showed that the paw swelling inhibition rate of this press in adjuvant-induced arthritis rats reached 42%, which was significantly higher than that of the single components (astragalus polysaccharide 28%, ferulic acid 30%).

[0064] Example 3

[0065] refer to Figure 2 This embodiment provides a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate and its preparation method and application, which is used for the implementation of the preparation process. The specific implementation content includes:

[0066] Preparation steps:

[0067] S1: Solution preparation: Dissolve 15 kDa sodium hyaluronate powder (lower molecular weight limit) in deionized water at 25°C to a 20% solution and stir at 300 rpm for 45 minutes.

[0068] S2: Drug mixing: add angelica extract (ferulic acid content ≥ 90%), accounting for 3% by weight, and stir at 200 rpm for 60 minutes;

[0069] S3: Mold molding: medical-grade polytetrafluoroethylene mold (taper 1:5), needle array density 50 pieces / cm 2 ;

[0070] S4: Drying and curing: vacuum degree 8kPa, drying at 40℃ for 18 hours, weight loss rate controlled at 12%-15%;

[0071] S5: Demolding treatment: Medical silicone demoulding tool (Shore hardness A40), demoulding success rate ≥98%.

[0072] Implementation effect:

[0073] Needle body quality: needle tip roundness error ≤5%, length consistency deviation ≤±0.05mm (in line with YY / T0876-2019 medical microneedle standard).

[0074] Drug stability: The ferulic acid retention rate of Angelica sinensis extract during the preparation process is ≥95% (HPLC detection), which is better than the conventional wet heat process (80%).

[0075] Production efficiency: The single batch mold production capacity is 5,000 pieces, and the yield rate is ≥96%, meeting the requirements of industrial production.

[0076] Example 4

[0077] This embodiment provides a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate and its preparation method and application, which are used to optimize the implementation of the process. The specific implementation content includes:

[0078] Key parameter adjustments:

[0079] Solution concentration: 25% (upper limit) sodium hyaluronate solution (molecular weight 500 kDa, upper limit);

[0080] Drying conditions: vacuum degree 5kPa, 45℃ (upper limit) drying for 12 hours;

[0081] Sterilization treatment: Tanshinone extract (purity ≥ 99%) was sterilized by 0.22 μm polyethersulfone filter membrane.

[0082] Implementation effect:

[0083] Mechanical strength: The breaking force of the needle body is increased to 1.6N (1.2N in traditional process), and the storage resistance is enhanced (strength retention rate ≥90% for 3 months under 40℃ and 75% humidity environment).

[0084] Drug encapsulation rate: up to 92% (85% for conventional processes), reducing drug loss during the production process.

[0085] Process optimization: drying time is shortened by 40% (from 24 hours to 12 hours), energy consumption is reduced by 30%, and production costs are reduced by 25%.

[0086] Example 5

[0087] This embodiment provides a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate and its preparation method and application, which are used in the implementation of a composite treatment system. The specific implementation content includes:

[0088] Implementation scenario: Acupoint selection: Zusanli (gastrointestinal function regulation) + Neiguan (analgesia) combined application.

[0089] Implementation method: Change once every 48 hours, apply for 72 hours at a time, and use it simultaneously with mugwort patch (3cm in diameter).

[0090] Implementation efficacy:

[0091] Gastrointestinal function: Serum gastrin levels increased by 35% after treatment (n=50).

[0092] Pain score: VAS score decreased from 6.2 to 3.1 (after 72 hours).

[0093] Biocompatibility: The allergy incidence rate is 0.8% (compared to 4.2% for traditional metal press pins).

[0094] Implementation effect:

[0095] Synergistic therapeutic effect: The warm stimulation of the mugwort compress increases local skin blood flow by 20% and promotes the transdermal rate of acupuncture drugs by 30% (Franz diffusion cell test).

[0096] Shortened treatment cycle: The average onset time for patients with chronic gastric pain is shortened from 48 hours with traditional treatment to 24 hours, and the symptom relief rate within 72 hours reaches 85% (62% in the control group).

[0097] Improved compliance: The soluble material avoids the foreign body sensation of metal needles, and the patient's 24-hour retention rate increases from 70% to 92%.

[0098] Comparative Example 1

[0099] This embodiment provides a traditional metal press pin, specifically including:

[0100] Material: Medical stainless steel (316L austenitic stainless steel, diameter 0.2mm, length 2mm).

[0101] Structure: Solid metal needle body, surface treated with medical-grade titanium coating, without drug loading structure.

[0102] Preparation process:

[0103] Stainless steel wire cutting and forming (tolerance ±0.02mm);

[0104] Electrochemical polishing of the needle tip (roughness Ra ≤ 0.2 μm);

[0105] Titanium coating deposition (thickness 5-8 μm, using physical vapor deposition PVD technology);

[0106] Sterilized with ethylene oxide (residual amount ≤ 10 μg / g).

[0107] Usage: Fix to the skin of the acupuncture point with medical tape. The application period is 72 hours and needs to be removed with tweezers.

[0108] Compared with Examples 1-2 and Comparative Example 1, the soluble TCM acupuncture needles of the present invention use sodium hyaluronate as the core material and achieve functional differentiation through the combination of different molecular weights and drug ingredients:

[0109] Example 1 uses 100 kDa sodium hyaluronate loaded with 5% Danshen extract to form a conical needle body (length 1.2 mm, needle tip 80 μm), which is completely degraded within 96 hours, achieving basic drug carrier and acupoint targeted drug delivery, solving the defect of traditional press needles with no drug efficacy;

[0110] Example 2 uses 300kDa sodium hyaluronate, composite-loaded with 6% astragalus polysaccharide and ferulic acid, and uses a pyramidal porous structure design to achieve controlled degradation and sustained drug release over 72 hours, utilizing the synergistic effect of traditional Chinese medicine components to enhance efficacy (e.g., anti-inflammatory effect increased by 42%).

[0111] Comparative Example 1 relies on medical stainless steel material. The solid needle body only provides physical stimulation, has no drug loading capacity, is non-degradable, and needs to be manually removed. There is a risk of mechanical damage to the skin and allergies (erythema incidence rate is 12%).

[0112] Comparing the embodiments and comparative examples, the product parameters of Examples 1-2 and Comparative Example 1 are compared in Table 1.

[0113] Table 1, Comparison of product parameters of Examples 1-2 and Comparative Example 1

[0114]

[0115]

[0116] Compared with Examples 3-4 and Comparative Example 1, the preparation method of the soluble TCM acupuncture needle of the present invention is to construct a preparation system by optimizing parameters:

[0117] Example 3 uses 15kDa sodium hyaluronate (concentration 20%) and vacuum-dries at 40°C for 18 hours to achieve a needle length consistency deviation of ≤±0.05mm and a yield rate of 96%, which is suitable for standardized production.

[0118] Example 4: The molecular weight of sodium hyaluronate was increased to 500 kDa and the concentration was 25%. The drying conditions were optimized to 45°C / 12 hours. The breaking force of the needle body was increased to 1.6 N, the drug encapsulation efficiency reached 92%, and the energy consumption was reduced by 30%, achieving a balance between strength, stability, and production efficiency.

[0119] Comparative Example 1 only involves cutting, polishing and sterilization of the metal needle body, without a drug loading step, and cannot solve the degradation and strength balance problems of the soluble needle body.

[0120] Comparing the examples with the comparative examples, the preparation method parameters of Examples 3-4 and Comparative Example 1 are compared in Table 2.

[0121] Table 2, Comparison of preparation method parameters of Examples 3-4 and Comparative Example 1

[0122]

[0123]

[0124] Example 5 Combined Zusanli and Neiguan acupoints were applied, changed every 48 hours, and a single application lasted 72 hours. Synchronous application of mugwort reduced the VAS pain score by 50%, the allergy rate by 0.8%, and the drug transdermal rate by 30% due to the thermal effect. The treatment cycle was shortened by 24 hours compared with the traditional regimen.

[0125] Traditional applications rely on physical stimulation of a single acupoint, and the patch needs to be removed with tweezers after 72 hours. It has a strong foreign body sensation and no drug synergy. The efficacy depends solely on mechanical stimulation, the allergy rate is as high as 4.2%, and it is easy to cause micro-damage to the epidermis (incidence rate 22%).

[0126] The above embodiments may be implemented in whole or in part through software, hardware, firmware or any other combination. When implemented using software, the above embodiments may be implemented in whole or in part in the form of a computer program product.

[0127] Those skilled in the art will appreciate that the modules and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented with electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. Professional and technical personnel can use different methods to implement the described functions for each specific application, but such implementation should not be considered to be beyond the scope of this application.

[0128] In addition, each functional module in each embodiment of the present application may be integrated into one processing module, or each module may exist physically separately, or two or more modules may be integrated into one module.

[0129] The above is only a specific implementation method of the present application, but the scope of protection of the present application is not limited to this. Any technician familiar with this technical field can easily think of changes or replacements within the technical scope disclosed in this application, which should be included in the scope of protection of the present application. Therefore, the scope of protection of the present application should be based on the scope of protection of the claims.

[0130] Finally: 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 in the scope of protection of the present invention.

Claims

1. A soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate, characterized in that: The main component is sodium hyaluronate, the molecular weight of which ranges from 10kDa to 500kDa; the needle body length is from 0.5mm to 2mm, and the needle tip diameter is less than 100μm; the needle body is conical or pyramidal, and the needle body contains drugs or effective ingredients.

2. The soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate according to claim 1, characterized in that: The medicine or effective component is one or more of traditional Chinese medicine extracts, vitamins, and minerals, wherein the traditional Chinese medicine extracts account for 1% to 10% of the mass of the mixed solution.

3. The soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate according to claim 2, characterized in that: The Chinese medicine extract is one or more of salvia miltiorrhiza extract, astragalus extract, and angelica extract, and the needle body is biodegradable and gradually dissolves in the skin.

4. A method for preparing a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate, characterized in that: The following steps are involved: S1: Prepare a sodium hyaluronate solution by dissolving sodium hyaluronate powder with a molecular weight of 10 kDa to 500 kDa in deionized water and stirring at 25°C-35°C until completely dissolved to prepare a sodium hyaluronate solution with a concentration of 10%-30%; S2: Add drugs or functional ingredients, add Chinese herbal medicine extracts, vitamins or minerals to the sodium hyaluronate solution at a mass ratio of 1%-10%, and stir at a speed of 200-500 rpm for 30-60 minutes until the mixture is uniformly mixed; S3: Mold forming, injecting the mixed solution into a microneedle mold with a conical or pyramidal needle structure, wherein the mold is made of medical-grade polytetrafluoroethylene; S4: Drying and curing: placing the mold in a vacuum drying oven with a vacuum degree of ≤10kPa and drying at 30°C-50°C for 12-24 hours to solidify the solution into a needle body; S5: Demolding: Use medical-grade silicone demoulding tools to separate the cured microneedles from the mold to obtain soluble traditional Chinese medicine press needles.

5. The method for preparing a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate according to claim 1, characterized in that: The concentration of the sodium hyaluronate solution is 15%-25%, and the drying temperature is 35°C-45°C.

6. The method for preparing a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate according to claim 5, characterized in that: The Chinese herbal medicine extract is tanshinone extract, astragalus polysaccharide or ferulic acid, and is sterilized by a 0.22 μm microporous filter membrane before being added.

7. An application of a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate, characterized in that: The needle is pressed on the surface of the skin of the human acupuncture point, and the needle body gradually dissolves after piercing the skin, thereby achieving continuous release of the drug components and acupuncture point stimulation.

8. The use of a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate as claimed in claim 7, characterized in that: The acupoints include Zusanli, Hegu, Neiguan and other meridian acupoints, which are used to improve gastrointestinal function, regulate immunity or relieve pain.

9. The use of a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate as claimed in claim 7, characterized in that: The frequency of use of the press needle is to replace it every 24-72 hours, and the single application time shall not exceed 96 hours.

10. The use of a soluble traditional Chinese medicine acupuncture needle based on sodium hyaluronate as claimed in claim 7, characterized in that: The acupuncture needle is used in combination with traditional Chinese medicine application therapy to form a soluble microneedle-acupoint application composite treatment system.

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