Three-in-one plaster with traditional Chinese medicine formula, kinesio plaster and soluble microneedle technology

Abstract

The invention discloses a three-in-one innovative plaster with a traditional Chinese medicine formula, a kinesio plaster and a soluble microneedle technology. The traditional Chinese medicine paste formula mainly relates to trauma extravasated blood type and wind-dispelling and blood-activating type. The trauma extravasated blood type prototype is based on an external traumatic injury treatment plaster special for treating traumatic injury in the Qingzhou province, and the wind-dispelling and blood-activating type prescription is based on a body pain and stasis removing decoction of the Qingzhou province province in the Qingzhou province. Through reasonable compatibility of a plurality of traditional Chinese medicines and with the assistance of the kinesio and microneedle technology, the purposes of promoting blood circulation to remove blood stasis and dispelling wind and eliminating dampness can be achieved. Relates to the technical field of kinesio stickers. According to the technical scheme, the kinesio stickers are characterized by comprising a protective gel bottom layer, a gel layer and a woven fabric layer; the gel layer is located between the protective gel bottom layer and the woven fabric layer, the woven fabric layer is located at the top of the gel layer, and the protective gel layer is located at the bottom of the gel layer; the gel layer comprises a medical spandex pressure-sensitive adhesive with medicine property and soluble microneedles which are alternately arranged. And through the soluble microneedle, higher-efficiency transdermal drug delivery and controllable absorption of effective components of the drug are realized, so that the sensitization of the product is further reduced, the absorption rate of the effective components of the drug is greatly improved, and a better effect of preventing and treating the sport injury is obtained. And meanwhile, the pair of multifunctional glasses has the characteristics of plastic deformation, elasticity, water resistance, sweat resistance, comfort in wearing, low possibility of falling off and the like.

Description

1. Technical Field

[0001] The present invention relates to the field of kinesio patch technology, and more specifically, to a soluble microneedle kinesio patch for improving muscle and joint cartilage damage. On the basis of the existing kinesio patch market, traditional Chinese medicine paste prescriptions and soluble microneedle technology are innovatively added. 2. Background technology

[0002] The present invention mainly uses soluble microneedle technology to carry drugs through microneedles and directly act on the skin, significantly improving the transdermal permeability of drugs, allowing the drugs in the preparation to quickly diffuse and penetrate the skin, which can better improve muscle and joint cartilage injuries, etc.

[0003] Microneedle technology is an emerging technology to promote drug absorption. It is a drug delivery method between subcutaneous injection and transdermal patch. It is a 1-2 cm microneedle prepared by microfabrication technology. 2 The patch with fine needle cluster array arrangement, microscopic diagram is shown in Figure 1 Microneedles are attached to the skin to increase the permeability of drugs, but do not touch the nerves in deeper tissues, are painless, and can increase drug permeability for local administration, systemic administration, and vaccine delivery.

[0004] Microneedles are divided into two types: hollow and solid. Hollow microneedles use the "poke and flow" method for transdermal drug delivery, and the drug solution is delivered transdermally through the microneedle holes. There are three ways to deliver solid microneedles transdermally. "Poke and patch" first uses microneedles to make holes on the skin surface, and then attaches a suitable preparation to allow the drug in the preparation to diffuse through the skin. "Poke and release" uses soluble microneedles and relies on the dissolution of the microneedles to release the drug. "Coat and poke" first uses microneedles to pierce the skin's stratum corneum, and the coating layer on the surface of the microneedle is hydrated to release the drug.

[0005] Because the microneedles are thin and sharp, the general puncture depth is only in the stratum corneum, without touching the nerve endings. The sharpness also greatly reduces the chance of the needle tip touching the nerve endings, reducing the degree of damage to the corresponding appendages of the body, and does not cause pain, so it is a painless drug delivery method. At the same time, the microneedles can adjust or terminate drug delivery at any time, which is particularly effective in adjusting the size of the drug dosage. The mechanism of microneedle penetration is to use the needle tip to open the skin channel, so that the needle tip and the backing layer of drugs directly enter the skin. The penetration-promoting effect is seen Figure 4 The microneedle transdermal drug delivery system combines the advantages of traditional syringes and transdermal patches, can significantly improve the transdermal permeability of drugs, and has good commercial application prospects. 3. Summary of the invention

[0006] The purpose of the present invention is to provide a three-in-one plaster of traditional Chinese medicine prescription + intramuscular patch + soluble microneedle technology for improving muscle and joint cartilage injuries. By adding soluble microneedle technology, the paste liquid containing active ingredients is integrated into the soluble microneedles. With the help of soluble microneedles, more efficient transdermal drug delivery and controllable absorption of active ingredients of drugs are achieved, thereby further reducing the sensitization of the product and greatly improving the absorption rate of active ingredients of drugs, thereby achieving better effect of preventing and treating sports injuries.

[0007] The above technical purpose of the present invention is achieved through the following technical scheme: a three-in-one innovative plaster of traditional Chinese medicine paste + intramuscular patch + soluble microneedle technology for improving muscle and joint cartilage injuries, including a protective gel base layer, a gel layer and a woven fabric layer; the gel layer is located between the protective gel base layer and the woven fabric layer, the woven fabric layer is located on the top of the gel layer, absorbing the paste liquid, and the protective gel layer is located at the bottom of the gel layer; the gel layer includes alternatingly arranged medicinal spandex pressure-sensitive adhesive and soluble microneedles containing medicine.

[0008] The present invention is further configured as follows: the soluble microneedles are solidified bodies of 15% hyaluronic acid mixed liquid, the soluble microneedles are in the form of quadrangular pyramids, the size of which is 100um×100um×200um, and the arrangement spacing of the soluble microneedles is 400um.

[0009] The present invention is further configured as follows: the width of the medical spandex pressure-sensitive adhesive is 0.3 cm, the medical spandex pressure-sensitive adhesive is wavy as a whole, and the interval between two adjacent waves is 0.18 cm.

[0010] The present invention is further configured as follows: the woven fabric layer is made of a blend of 97% cotton and 3% spandex.

[0011] The present invention is further configured as follows: the preparation method of the traditional Chinese medicine component and the microneedle is:

[0012] (1) Extraction of active ingredients from traditional Chinese medicine:

[0013] The selected drugs (frankincense, myrrh, Chuanxiong, Achyranthes bidentata, processed Chuanwu, processed Caowu, etc.) were made into Chinese medicine granules, and 80% ethanol (solid-liquid ratio 1:10) was added to the beaker, and the water bath was heated and degreased three times at 80°C, each time for 3 hours. The alcohol extract was filtered out with four layers of medical gauze, leaving the drug residue, and the defatted drug residue was placed in a constant temperature drying oven for drying. The dried drug residue was continued to be added to the round-bottomed beaker, and distilled water (solid-liquid ratio of 1:10) was added, and the water bath was extracted three times at 80°C, each time for 3 hours. The three extracts were combined and centrifuged at 4000r / min for 10 minutes. After removing the bottom precipitate, the supernatants were combined again and concentrated to a certain volume using a rotary evaporator. The concentrate was placed at room temperature and protein was removed using the Sevage method. After the protein was completely removed, the concentrate was placed in a dialysis bag for 3 days, with deionized water replaced every 24 hours. After the dialysis was completed, the pre-frozen solution was placed in a freeze drying oven for freeze drying for 48 hours to finally obtain the preliminary purified effective ingredients of traditional Chinese medicine.

[0014] (2) Preparation of needle solution

[0015] 5% of the effective component solution of traditional Chinese medicine and 25% of the PVP solution were prepared respectively, and the volume ratio of the two solutions was 1:1 to prepare a mixed solution, which was the needle solution.

[0016] (3) Preparation of microneedles

[0017] Microneedle mold specifications (the needle is a cone with a diameter of 200μm and a height of 800μm, 10×10 needles are distributed on a 9mm×9mm patch, and the distance between the tips of two adjacent needles is 400μm). The microneedles are prepared by a two-step method, that is, the needle and the base part use different material formulations and drying processes, and are cast in two steps. For dissolving microneedles, this is a way to minimize drug waste. The specific preparation steps are: first, add the needle solution to the mold, cover it with a smooth film, add it to a centrifuge tube with a wooden stopper, ensure that the mold will not be affected by other factors during the centrifugation process, centrifuge at 4000r·min-1 for 6min to fill the needle cavity with the solution, absorb and scrape off the excess solution with a shovel, and try to ensure that there is no drug residue in the base part, and dry it at 37℃ for 1h to obtain the microneedle needle. In the second step, add the base solution to the mold, centrifuge it at 4000r·min-1 for 4min, add a little base solution, and dry it at room temperature for 1.5d to obtain the microneedle.

[0018] In summary, the present invention has the following beneficial effects: by adding soluble microneedles to the kinesio patch, the liquid medicine containing the active ingredient is melted into the soluble microneedles, and with the help of the soluble microneedles, more efficient transdermal drug delivery and controlled absorption of the active ingredient of the medicine are achieved, thereby further reducing the sensitization of the product, greatly improving the absorption rate of the active ingredient of the medicine, and thus obtaining a better effect of preventing and treating sports injuries. At the same time, it also has the characteristics of plastic deformation, elasticity, water resistance, sweat resistance, comfortable wearing, and not easy to fall off. 4. Description of the drawings

[0019] Figure 1 It is a microscopic picture of microneedles;

[0020] Figure 2 This is a high-variation microscopic perspective image of the soluble microneedle needle;

[0021] Figure 3 It is a diagram showing the penetration-enhancing effect of the soluble microneedles in the present invention.

[0022] Figure 4 1 is a schematic diagram of the structure of a soluble microneedle intramuscular patch according to an embodiment of the present invention, wherein: 1. soluble microneedles; 2. protective gel bottom layer; 3. gel layer; 4. fabric layer; 5. Specific implementation methods

[0023] The following is combined with Figure 3 The present invention is described in further detail.

[0024] Example: A three-in-one innovative plaster that combines traditional Chinese medicine paste prescription + Kinesio patch + soluble microneedle technology to improve muscle and joint cartilage damage, such as Figure 3 , Figure 4 As shown, it includes a protective gel bottom layer, a gel layer and a woven fabric layer; the gel layer is located between the protective gel bottom layer and the woven fabric layer, the woven fabric layer is located on the top of the gel layer, and the protective gel layer is located at the bottom of the gel layer; the gel layer includes alternatingly arranged medical spandex pressure-sensitive adhesive containing medicine and soluble microneedles.

[0025] Further, the soluble microneedle is a solidified body of 15% hyaluronic acid mixed liquid, and the soluble microneedle is a quadrangular pyramid (such as Figure 3 The size of the microneedle is 100um×100um×200um, and the arrangement spacing of the soluble microneedles is 400um.

[0026] It is further configured as follows: the width of the medical spandex pressure-sensitive adhesive is 0.3 cm, the medical spandex pressure-sensitive adhesive is wavy as a whole, and the interval between two adjacent waves is 0.18 cm.

[0027] The invention is further configured as follows: the fabric layer is made of a blend of 97% cotton and 3% spandex.

[0028] The present invention is further configured as follows: the preparation method of the traditional Chinese medicine component and the soluble microneedle is:

[0029] (1) Extraction of active ingredients from traditional Chinese medicine:

[0030] The selected drugs (frankincense, myrrh, Chuanxiong, Achyranthes bidentata, processed Chuanwu, processed Caowu, etc.) were made into Chinese medicine granules, and 80% ethanol (solid-liquid ratio 1:10) was added to the beaker, and the water bath was heated and degreased three times at 80°C, each time for 3 hours. The alcohol extract was filtered out with four layers of medical gauze, leaving the drug residue, and the defatted drug residue was placed in a constant temperature drying oven for drying. The dried drug residue was continued to be added to the round-bottomed beaker, and distilled water (solid-liquid ratio of 1:10) was added, and the water bath was extracted three times at 80°C, each time for 3 hours. The three extracts were combined and centrifuged at 4000r / min for 10 minutes. After removing the bottom precipitate, the supernatants were combined again and concentrated to a certain volume using a rotary evaporator. The concentrate was placed at room temperature and protein was removed using the Sevage method. After the protein was completely removed, the concentrate was placed in a dialysis bag for 3 days, with deionized water replaced every 24 hours. After the dialysis was completed, the pre-frozen solution was placed in a freeze drying oven for freeze drying for 48 hours to finally obtain the preliminary purified effective ingredients of traditional Chinese medicine.

[0031] (2) Preparation of needle solution

[0032] 5% of the effective component solution of traditional Chinese medicine and 25% of the PVP solution were prepared respectively, and the volume ratio of the two solutions was 1:1 to prepare a mixed solution, which was the needle solution.

[0033] (3) Preparation of microneedles

[0034] Microneedle mold specifications (the needle is a cone with a diameter of 200μm and a height of 800μm, 10×10 needles are distributed on a 9mm×9mm patch, and the distance between the tips of two adjacent needles is 400μm). The microneedles are prepared by a two-step method, that is, the needle and the base part use different material formulations and drying processes, and are cast in two steps. For dissolving microneedles, this is a way to minimize drug waste. The specific preparation steps are: first, add the needle solution to the mold, cover it with a smooth film, add it to a centrifuge tube with a wooden stopper, ensure that the mold will not be affected by other factors during the centrifugation process, centrifuge at 4000r·min-1 for 6min to fill the needle cavity with the solution, absorb and scrape off the excess solution with a shovel, and try to ensure that there is no drug residue in the base part, and dry it at 37℃ for 1h to obtain the microneedle needle. In the second step, add the base solution to the mold, centrifuge it at 4000r·min-1 for 4min, add a little base solution, and dry it at room temperature for 1.5d to obtain the microneedle.

[0035] The three-in-one innovative patch, which combines traditional Chinese medicine ointment + kinesiology patch + soluble microneedle technology to improve muscle and joint cartilage injuries, is divided into three layers: a fabric layer that contacts the outside world and provides elasticity (97% cotton, 3% spandex blended), a gel layer that provides viscosity (medical glue provides viscosity to minimize allergic reactions; the "wave-type" design greatly improves the comfort of the patch), and a protective gel bottom layer; the gel layer is the drug-carrying part and is equipped with soluble microneedles, and the protective gel bottom layer is back-friendly paper.

[0036] The fabric layer is made of 97% cotton and 3% spandex, a blended cotton fabric that is close to the thickness and quality of the skin. Its unique weaving method allows the patch to be stretched longitudinally to 140% of its initial length. The bottom layer of the protective gel is a backing paper, which makes the patch easy for users to tear and stick, and also isolates the gel from the outside world to protect it.

[0037] The three-in-one innovative plaster of traditional Chinese medicine prescription + kinesio patch + soluble microneedle technology for improving muscle joint cartilage damage through the preparation method of the woven fabric layer can be used to prevent and treat joint muscle swelling and pain caused by improper exercise and to treat and relieve acute soft sports injuries. By adding soluble microneedles to the kinesio patch, the liquid containing active ingredients is melted into the soluble microneedles. With the help of soluble microneedles, more efficient transdermal drug delivery and controlled absorption of active ingredients of drugs can be achieved, thereby further reducing the sensitization of the product and greatly improving the absorption rate of active ingredients of drugs, so as to obtain better effect of preventing and treating sports injuries. At the same time, it also has the characteristics of plastic deformation, elasticity, water resistance, sweat resistance, comfortable wearing, and not easy to fall off.

[0038] This specific embodiment is merely an explanation of the present invention and is not a limitation of the present invention. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed. However, as long as they are within the scope of the claims of the present invention, they are protected by the patent law.

Claims

1. A three-in-one innovative plaster that combines traditional Chinese medicine prescriptions, intramuscular patch, and soluble microneedle technology. Its features are: The kinesio patch comprises a protective gel bottom layer, a gel layer and a fabric layer; the gel layer is located between the protective gel bottom layer and the fabric layer, the fabric layer is located on the top of the gel layer, and the protective gel layer is located on the bottom of the gel layer; the gel layer comprises alternately arranged medical spandex pressure-sensitive adhesive containing medicine and soluble microneedles.

2. The three-in-one innovative plaster of traditional Chinese medicine prescription + intramuscular patch + soluble microneedle technology according to claim 1 is characterized by: The soluble microneedles are solidified bodies of 15% hyaluronic acid mixed liquid. The soluble microneedles are in the shape of quadrangular pyramids with a size of 100um×100um×200um. The arrangement spacing of the soluble microneedles is 400um, which is used for perfusing liquid.

3. The three-in-one innovative plaster of traditional Chinese medicine prescription + intramuscular patch + soluble microneedle technology according to claim 1 is characterized by: The width of the medical spandex pressure-sensitive adhesive is 0.3 cm, and the medical spandex pressure-sensitive adhesive is wavy as a whole, with an interval of 0.18 cm between two adjacent waves.

4. The three-in-one innovative plaster of traditional Chinese medicine prescription + intramuscular patch + soluble microneedle technology according to claim 1 is characterized by: The fabric layer is made of a blend of 97% cotton and 3% spandex.

5. The three-in-one innovative plaster of traditional Chinese medicine prescription + intramuscular patch + soluble microneedle technology according to claims 1-4 is characterized by: The preparation method of the effective ingredient of traditional Chinese medicine is as follows: A. The selected drugs (frankincense, myrrh, Chuanxiong, Achyranthes bidentata, processed Chuanwu, processed Caowu, etc.) were made into Chinese medicine granules. 80% ethanol (solid-liquid ratio 1:10) was added into a beaker. The granules were heated in a water bath at 80°C for three times for 3 hours each time to defat. B. Use four layers of medical gauze to filter out the alcohol extract, leaving the residue, and put the defatted residue into a constant temperature drying oven to dry. Add the dried residue into a round-bottom beaker, add distilled water (solid-liquid ratio is 1:10), and extract three times in a water bath at 80°C, each time for 3 hours. C. The three extracts were combined and centrifuged at 4000 r / min for 10 min. After removing the bottom precipitate, the supernatants were combined and concentrated to a certain volume using a rotary evaporator. D. Place the concentrated solution at room temperature and use the Sevage method to remove protein. After the protein is completely removed, place the concentrated solution in a dialysis bag for 3 days, and replace the deionized water every 24 hours. After the dialysis is completed, place the pre-frozen solution in a freeze drying box for freeze drying for 48 hours to finally obtain the preliminary purified effective ingredients of traditional Chinese medicine.

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