Attached auricular point treatment patch and preparation method thereof

Abstract

The invention discloses an attached auricular point treatment patch and a preparation method thereof, and particularly relates to the technical field of medical devices, the attached auricular point treatment patch comprises a core medicine layer, a protective isolation layer and a fixing layer, the core medicine layer is covered with the protective isolation layer, and the fixing layer is attached to the other side of the protective isolation layer; the core medicine layer is prepared from the following raw materials in parts by weight: 5 to 20 parts of radix angelicae sinensis, 5 to 15 parts of radix achyranthis bidentatae, 3 to 10 parts of rhizoma gastrodiae, 3 to 8 parts of rhizoma atractylodis macrocephalae, 1 to 5 parts of radix ginseng, 2 to 6 parts of rhizoma chuanxiong, 0.5 to 3 parts of nano folium ginkgo extract, 0.5 to 2 parts of radix astragali seu hedysari extract, a viscous matrix accounting for 5 to 20 percent of the total weight and a penetration enhancer accounting for 1 to 5 percent of the total weight; and the protective isolation layer is made of a medical grade polyethylene or polypropylene film with the thickness of 0.01-0.06 mm. The auricular point treatment patch can stably and continuously release medicine and effectively permeate into auricular points to achieve a good treatment effect, meanwhile, the solubility and bioavailability of the medicine are remarkably improved, the treatment effect is enhanced, and the comfort level and the fitting degree are good.

Description

Technical Field

[0001] The present invention relates to the field of medical device technology, and more specifically, to a fitted ear acupuncture point treatment patch and a preparation method thereof. Background Art

[0002] In traditional Chinese medicine theory, the ear is regarded as a holographic miniature of the human body's internal organs. There are many acupoints distributed on the auricle that correspond to various parts of the body. By stimulating these acupoints, the functions of the internal organs can be regulated, the meridians can be unclogged, and the circulation of qi and blood can be promoted, thereby achieving the purpose of preventing and treating diseases. This theory has laid a solid theoretical foundation for the formation of auricular acupressure therapy.

[0003] Traditional auricular acupoint pressing therapy usually uses specific medicinal seeds or pills to press on the ear points to achieve the therapeutic purpose through pressure stimulation. However, traditional auricular acupoint pressing therapy has certain limitations in terms of drug release performance, fit, comfort and usage methods.

[0004] In view of the above situation, the present invention provides a fitting ear acupuncture point treatment patch and a preparation method thereof. Summary of the invention

[0005] In order to overcome the above-mentioned defects of the prior art, the present invention provides a fitting ear acupuncture point treatment patch and a preparation method thereof to solve the problems raised in the above-mentioned background technology.

[0006] To achieve the above-mentioned purpose, the present invention provides the following technical scheme: a fitted ear acupuncture point treatment patch, comprising a core drug layer, a protective isolation layer and a fixing layer, wherein the protective isolation layer covers the core drug layer, and the fixing layer is attached to the other side of the protective isolation layer, and the core drug layer is composed of the following raw materials in parts by weight: 5-20 parts of angelica sinensis, 5-15 parts of Achyranthes bidentata, 3-10 parts of Gastrodia elata, 3-8 parts of Atractylodes macrocephala, 1-5 parts of Ginseng, 2-6 parts of Chuanxiong, 0.5-3 parts of nano-gingko leaf extract, 0.5-2 parts of Astragalus membranaceus extract, 5%-20% of the total weight of a viscous matrix, and 1%-5% of the total weight of a penetration enhancer;

[0007] The protective isolation layer is made of medical grade polyethylene or polypropylene film with a thickness of 0.01-0.06 mm;

[0008] The fixing layer is made of a sticky medical tape or a sticky patch, and the fixing layer has a sticking surface that matches the shape of the ear acupuncture points, and the area of ​​the sticking surface is 1-5 cm 2 , shapes include but are not limited to circle and oval.

[0009] Preferably, the particle size of the nano-gingko leaf extract is 50-200 nm, and the purity of the astragalus extract is >80%.

[0010] Preferably, the viscous matrix specifically includes one or more of polyacrylate, polyvinyl alcohol, gelatin or hydroxypropyl methylcellulose, and the penetration enhancer specifically includes one or more of azone, oleic acid, borneol or menthol.

[0011] Preferably, the therapeutic patch further comprises an adjustment layer, which is located between the core drug layer and the protective isolation layer and specifically comprises the following components: a thermosensitive polymer, an acrylic polymer, an ion exchange resin, a hydrogel and auxiliary materials, and the preparation method is as follows:

[0012] S1. Stir the thermosensitive polymer, acrylic polymer, ion exchange resin, hydrogel and auxiliary materials through a stirring device at 1600-2000 r / min for 45 min-1.5 h at a temperature of 18-25° C., during which ethanol, acetone and water are added at a concentration of 20%-45% to obtain a mixture;

[0013] S2, spraying the mixture of S1 between the core drug layer and the protective isolation layer at 0.1 to 0.5 MPa with a spraying thickness of 50-80 μm to obtain an adjustment layer;

[0014] S3, curing the adjustment layer at 100-150° C. for 5-10 hours.

[0015] Preferably, the temperature-sensitive polymer is poly-N-isopropylacrylamide;

[0016] The acrylic polymer is any one of polyacrylic acid or polymethacrylic acid;

[0017] The ion exchange resin is a strongly acidic cation exchange resin or a strongly basic anion exchange resin;

[0018] The hydrogel is polyvinyl alcohol hydrogel or polyacrylamide hydrogel;

[0019] The auxiliary materials use sodium carboxymethyl cellulose and sodium alginate as thickeners;

[0020] Vitamin E and sodium benzoate are used as stabilizers;

[0021] Polyoxyethylene sorbitan fatty acid ester and sodium lauryl sulfate are used as surfactants.

[0022] The present invention also provides a preparation method for preparing the above-mentioned fitted ear acupuncture point treatment patch, which specifically comprises the following steps:

[0023] S1, raw material pretreatment, angelica, Achyranthes bidentata, Gastrodia elata, Atractylodes macrocephala, ginseng and Chuanxiong are mixed and crushed to 0.5 mm, and dried at a temperature of 40-60°C for 2-6 hours;

[0024] S2, ultrasonic extraction, the raw material treated in S1 is subjected to ultrasonic extraction, during which nano-gingko leaf extract and astragalus extract are added, the ultrasonic frequency is 20-40kHz, the extraction time is 30-90min, and the Chinese medicine extract is obtained;

[0025] S3, mixing the raw materials, mixing the important extracts in S2 with the viscous matrix and the penetration enhancer uniformly, stirring at a speed of 500-1500rpm for 10-30min to form a core drug layer;

[0026] S4, cutting the protective isolation layer, cutting the protective isolation layer according to the shape and size of the core drug layer to obtain the protective isolation layer;

[0027] S5, spraying the regulating layer, spraying the regulating layer between the core drug layer and the protective isolation layer and drying and curing, and covering the protective isolation layer on the core drug layer;

[0028] S6, cutting and pasting the fixing layer, cutting the fixing layer according to the overall shape and size of the treatment patch and the shape of the ear acupuncture points to obtain the fixing layer, and pasting the fixing layer on the other side of the protective isolation layer to form a complete fitting ear acupuncture treatment patch;

[0029] S7. Packaging: The prepared therapeutic patch is sterilized by low-temperature plasma or steam for 10-30 minutes, and is vacuum-sterile packaged using medical-grade aluminum foil bags or composite film bags with a vacuum degree of -0.08MPa to -0.1MPa.

[0030] Preferably, in step S3, the uniform mixing process further includes grinding the mixture to improve the uniformity and dispersibility of the drug components.

[0031] Technical effects and advantages of the present invention:

[0032] 1. The therapeutic patch of the present invention contains a variety of Chinese herbal medicine ingredients with therapeutic effects and highly active ingredients such as nano ginkgo leaf extract and astragalus extract. Under the action of the viscous matrix and penetration enhancer, these ingredients can stably and continuously release drugs and effectively penetrate into the auricular acupuncture points to play a therapeutic role. In particular, the use of nano ginkgo leaf extract can significantly improve the solubility and bioavailability of the drug due to its small particle size and large specific surface area, further enhancing the therapeutic effect;

[0033] 2. The protective isolation layer of the therapeutic patch of the present invention is made of medical-grade polyethylene or polypropylene film, which has a suitable thickness and flexibility, can fit closely to the acupuncture points of the ear, and is not easy to fall off. At the same time, the design of the fixing layer also fully considers ergonomics, and has an adhesive surface that matches the shape of the acupuncture points of the ear, ensuring the stability and comfort of the therapeutic patch. In addition, the addition of the adjustment layer can also sense environmental changes, such as changes in pH, temperature or humidity, or biological signals such as changes in metabolites in the body, and automatically adjust its physical or chemical properties according to these changes, thereby controlling the release rate of the drug;

[0034] 3. The preparation method of the present invention is simple and efficient, and can ensure the quality and stability of the treatment patch. At the same time, the treatment patch is also very convenient to use. The patient only needs to stick the treatment patch on the corresponding ear acupuncture points without complicated operations or additional auxiliary tools. In addition, the treatment patch also adopts vacuum sterile packaging to ensure the safety and hygiene of the product. During use, the patient will not feel obvious discomfort or irritation, thereby improving the acceptance and compliance of the treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 It is the overall flow chart of the present invention.

[0036] Figure 2 This is a flow chart of the adjustment layer of the present invention. DETAILED DESCRIPTION

[0037] Embodiment 1,

[0038] The present embodiment provides a fitted ear acupuncture treatment patch, comprising a core drug layer, a protective isolation layer and a fixing layer, wherein the protective isolation layer covers the core drug layer, and the fixing layer is adhered to the other side of the protective isolation layer. The core drug layer in this embodiment is composed of the following raw materials in parts by weight: 10 parts of Angelica sinensis, 10 parts of Achyranthes bidentata, 6 parts of Gastrodia elata, 5 parts of Atractylodes macrocephala, 3 parts of Ginseng, 4 parts of Chuanxiong, 2 parts of nano Ginkgo biloba extract, 1 part of Astragalus membranaceus extract, 15% of the total weight of a viscous matrix, and 3% of the total weight of a penetration enhancer.

[0039] This embodiment also provides a preparation method for preparing the above-mentioned fitted ear acupuncture point treatment patch, which specifically comprises the following steps:

[0040] S1, raw material pretreatment, 10 parts of Angelica sinensis, 10 parts of Achyranthes bidentata, 6 parts of Gastrodia elata, 5 parts of Atractylodes macrocephala, 3 parts of Ginseng and 4 parts of Chuanxiong were mixed, and then crushed into 0.5 mm particle size using a crusher, and the crushed raw materials were placed in a drying oven and dried at 50° C. for 4 h;

[0041] S2, ultrasonic extraction, putting the pretreated raw materials into an ultrasonic extractor, adding 2 parts of nano-gingko leaf extract with a particle size of 100 nm and 1 part of astragalus extract with a purity of >80%, setting the ultrasonic frequency to 30 kHz, and the extraction time to 60 min, to obtain a Chinese medicine extract;

[0042] S3, mixing the raw materials, mixing the Chinese herbal extract with 15% of the total weight of the polyacrylate viscous matrix and 3% of the total weight of the azone penetration enhancer, using a stirrer at a speed of 1000 rpm for 20 minutes, during which the mixture is ground to ensure that the drug components are evenly dispersed;

[0043] S4, cutting the protective isolation layer: according to the shape and size of the core drug layer, use a cutting tool to cut the 0.03 mm thick medical grade polyethylene film into the corresponding protective isolation layer;

[0044] S5, spraying the regulating layer, stirring poly (N-isopropylacrylamide), polyacrylic acid, strongly acidic cation exchange resin, polyvinyl alcohol hydrogel, sodium carboxymethyl cellulose, sodium alginate, vitamin E and sodium benzoate in a stirring device at a speed of 1800 r / min for 1 hour, during which ethanol, acetone and water are added to obtain a mixture;

[0045] The mixture was sprayed between the core drug layer and the protective isolation layer using a spraying device at a pressure of 0.3 MPa, with a spraying thickness of 60 μm, and the sprayed regulating layer was cured at 120° C. for 8 h;

[0046] S6. Cut and paste the fixing layer. According to the overall shape and size of the treatment patch and the shape of the ear acupuncture points, use a cutting tool to cut the sticky medical tape into the corresponding fixing layer. The pasting area is 3cm 2 , the shape is circular, and the fixing layer is pasted on the other side of the protective isolation layer to form a complete fitting ear acupuncture treatment patch;

[0047] S7. Packaging: The prepared therapeutic patch is sterilized by low-temperature plasma for 20 minutes and vacuum-sterile packaged in medical-grade aluminum foil bags with a vacuum degree of -0.09 MPa.

[0048] Embodiment 2,

[0049] This embodiment is basically the same as Embodiment 1, but differs in the following aspects:

[0050] In the raw material pretreatment, the drying temperature is 45℃ and the drying time is 3h

[0051] In ultrasonic extraction, the nano-gingko leaf extract was 1 part with a particle size of 150nm, and the astragalus extract was 0.8 part with a purity of >85%;

[0052] In the raw material mixture, the viscous matrix accounts for 10% of the total weight, and the penetration enhancer accounts for 2% of the total weight;

[0053] In the spraying of the regulating layer, the spraying thickness is 70 μm, the curing temperature is 130 ° C, and the curing time is 7 h;

[0054] The fixed layer is being cut, and the pasting area is 2cm 2 , the shape is oval;

[0055] During packaging, steam sterilization is used, the sterilization time is 15 minutes, and the packaging material is a composite film bag.

[0056] Embodiment 3,

[0057] This embodiment is basically the same as Embodiments 1 and 2, but differs in the following aspects:

[0058] In the raw material pretreatment, the drying temperature is 60℃ and the drying time is 2h

[0059] In ultrasonic extraction, the nano-gingko leaf extract was 3 parts with a particle size of 50nm, and the astragalus extract was 1.5 parts with a purity of >90%;

[0060] In the raw material mixture, the viscous matrix is ​​a mixture of gelatin and hydroxypropyl methylcellulose, each accounting for 5 parts, accounting for 15% of the total weight, and the penetration enhancer is borneol 1 part, accounting for 1% of the total weight;

[0061] The regulating layer is being sprayed, the spraying thickness is 50μm, the curing temperature is 100℃, and the curing time is 10h. The fixing layer is being cut, and the pasting area is 4cm. 2 , the shape is circular;

[0062] During packaging, the sterilization time is 30 minutes and the vacuum degree is -0.1MPa.

[0063] The performance of the fitted auricular acupuncture treatment patch prepared in the above-mentioned Examples 1-3 and the traditional treatment patch were tested respectively, and the testing method is as follows:

[0064] Test 1: Drug release performance test

[0065] 1. The drug release performance of the therapeutic patches in Example 1, Example 2 and Example 3 was tested by high performance liquid chromatography. The specific data are shown in the following table:

[0066] Drug release (mg / cm2) Release time (h) Example 1 2.5 24 Example 2 2.4 24 Example 3 2.6 24

[0067] Note: The above data are average values, and the test conditions are at room temperature, simulating the human skin environment.

[0068] The test results show that the drug release effects of Examples 1-3 of the present invention are better than those of the comparative examples. The therapeutic patches in each example can stably release the drug within a specified time, and the release amount meets the preset standard.

[0069] 4. Another common auricular acupuncture patch on the market was selected as a comparative example, and its drug release performance was tested by high performance liquid chromatography. The specific data are shown in the following table:

[0070] Drug release (mg / cm2) Release time (h) Comparative Example 1.8 24

[0071] Note: The above data are average values, and the test conditions are at room temperature, simulating the human skin environment.

[0072] The test results show that the drug release amount of the comparative product within a specified time is lower than that of the therapeutic patch in the embodiment of the present invention.

[0073] Test 2: Skin irritation test

[0074] 1. 30 volunteers were selected, and the therapeutic patches in Example 1, Example 2 and Example 3 were applied to the inner skin of the volunteers' forearms, respectively. The skin reactions within 24 hours after application were observed and recorded. The test results showed that no obvious skin irritation reactions occurred in all volunteers, proving the safety of the therapeutic patches.

[0075] 2. Another 30 volunteers were selected, and the comparative product was applied to the inner skin of the volunteers' forearms. The skin reactions within 24 hours after application were observed and recorded. The test results showed that some volunteers had mild skin irritation reactions, such as redness, swelling, and itching. In comparison, the therapeutic patch in the embodiment of the present invention performed better in the skin irritation test.

[0076] Test 3: Clinical efficacy test

[0077] 1. 100 patients with ear diseases, such as tinnitus, deafness, etc., were selected and randomly divided into three groups. The treatment patches in Example 1, Example 2 and Example 3 were used for treatment, respectively. The treatment period was one month, and the patches were applied once a day. After the treatment, the treatment effect was evaluated by combining questionnaire surveys and medical examinations. The evaluation results showed that the treatment patches in each embodiment could effectively relieve the ear symptoms of the patients, and the treatment effect was significantly better than that of traditional treatment methods. The specific data are shown in the following table:

[0078]

[0079]

[0080] Note: Effective rate = number of effective cases / total number of cases × 100%.

[0081] 2. Another 100 patients with ear diseases were selected and randomly divided into two groups. They were treated with the comparative product and the traditional treatment method, respectively. The treatment period was the same as that of Examples 1-3, which was one month, and the patch was applied once a day. After the treatment, the treatment effect was evaluated by combining questionnaire surveys and medical examinations. The evaluation results showed that although the treatment effect of the comparative product was better than that of the traditional treatment method, it was significantly lower than that of the treatment patch in the embodiment of the present invention. The specific data are shown in the following table:

[0082] Number of effective cases Total number of cases Effectiveness (%) Comparative Example 25 50 50 Traditional treatment methods 20 50 40

[0083] Note: Effective rate = number of effective cases / total number of cases × 100%

[0084] According to the data in the above table, the fitted ear acupuncture treatment patch of the present invention has good advantages in many aspects, which not only improves the effectiveness and safety of the present invention, but also provides patients with better treatment options and experience.

[0085] 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 principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A fitted ear acupuncture patch, comprising a core drug layer, a protective isolation layer and a fixing layer, wherein: The protective isolation layer covers the core drug layer, and the fixing layer is pasted on the other side of the protective isolation layer, characterized in that the core drug layer is composed of the following raw materials in parts by weight: 5-20 parts of angelica sinensis, 5-15 parts of Achyranthes bidentata, 3-10 parts of Gastrodia elata, 3-8 parts of Atractylodes macrocephala, 1-5 parts of Ginseng, 2-6 parts of Chuanxiong, 0.5-3 parts of nano-gingko leaf extract, 0.5-2 parts of Astragalus membranaceus extract, 5%-20% of the total weight of the viscous matrix, and 1%-5% of the total weight of the penetration enhancer; The protective isolation layer is made of medical grade polyethylene or polypropylene film with a thickness of 0.01-0.06 mm; The fixing layer is made of a sticky medical tape or a sticky patch, and the fixing layer has a sticking surface that matches the shape of the ear acupuncture points, and the area of ​​the sticking surface is 1-5 cm 2 , shapes include but are not limited to circle and oval.

2. The fitted ear acupuncture patch according to claim 1, characterized in that: The particle size of the nano-gingko leaf extract is 50-200nm, and the purity of the astragalus extract is greater than 80%.

3. The fitted ear acupuncture patch according to claim 2, characterized in that: The viscous matrix specifically includes one or more of polyacrylate, polyvinyl alcohol, gelatin or hydroxypropyl methylcellulose, and the penetration enhancer specifically includes one or more of azone, oleic acid, borneol or menthol.

4. The fitted ear acupuncture point treatment patch according to claim 3, characterized in that: The therapeutic patch further comprises an adjustment layer, which is located between the core drug layer and the protective isolation layer and specifically comprises the following components: a thermosensitive polymer, an acrylic polymer, an ion exchange resin, a hydrogel and auxiliary materials, and the preparation method is as follows: S1. Stir the thermosensitive polymer, acrylic polymer, ion exchange resin, hydrogel and auxiliary materials through a stirring device at 1600-2000 r / min for 45 min-1.5 h at a temperature of 18-25° C., during which ethanol, acetone and water are added at a concentration of 20%-45% to obtain a mixture; S2, spraying the mixture of S1 between the core drug layer and the protective isolation layer at 0.1 to 0.5 MPa with a spraying thickness of 50-80 μm to obtain an adjustment layer; S3, curing the adjustment layer at 100-150° C. for 5-10 hours.

5. The fitted ear acupuncture patch according to claim 4, characterized in that: The temperature-sensitive polymer is poly-N-isopropylacrylamide; The acrylic polymer is any one of polyacrylic acid or polymethacrylic acid; The ion exchange resin is a strongly acidic cation exchange resin or a strongly basic anion exchange resin; The hydrogel is polyvinyl alcohol hydrogel or polyacrylamide hydrogel; The auxiliary materials use sodium carboxymethyl cellulose and sodium alginate as thickeners; Vitamin E and sodium benzoate are used as stabilizers; Polyoxyethylene sorbitan fatty acid ester and sodium lauryl sulfate are used as surfactants.

6. A preparation method for preparing the fitted ear acupuncture point treatment patch according to claim 5, comprising the following steps: S1, raw material pretreatment, angelica, Achyranthes bidentata, Gastrodia elata, Atractylodes macrocephala, ginseng and Chuanxiong are mixed and crushed to 0.5 mm, and dried at a temperature of 40-60°C for 2-6 hours; S2, ultrasonic extraction, the raw material treated in S1 is subjected to ultrasonic extraction, during which nano-gingko leaf extract and astragalus extract are added, the ultrasonic frequency is 20-40kHz, the extraction time is 30-90min, and the Chinese medicine extract is obtained; S3, mixing the raw materials, mixing the important extracts in S2 with the viscous matrix and the penetration enhancer uniformly, stirring at a speed of 500-1500rpm for 10-30min to form a core drug layer; S4, cutting the protective isolation layer, cutting the protective isolation layer according to the shape and size of the core drug layer to obtain the protective isolation layer; S5, spraying the regulating layer, spraying the regulating layer between the core drug layer and the protective isolation layer and drying and curing, and covering the protective isolation layer on the core drug layer; S6, cutting and pasting the fixing layer, cutting the fixing layer according to the overall shape and size of the treatment patch and the shape of the ear acupuncture points to obtain the fixing layer, and pasting the fixing layer on the other side of the protective isolation layer to form a complete fitting ear acupuncture treatment patch; S7. Packaging: The prepared therapeutic patch is sterilized by low-temperature plasma or steam for 10-30 minutes, and is vacuum-sterile packaged using medical-grade aluminum foil bags or composite film bags with a vacuum degree of -0.08MPa to -0.1MPa.

7. The preparation method according to claim 6, characterized in that: In step S3, the uniform mixing process also includes grinding the mixture to improve the uniformity and dispersibility of the drug components.

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