Traditional Chinese medicine external application patch and preparation method thereof
The middle drug external plaster with a specific formulation addresses the issues of strong adhesion and residue by using frankincense for antimicrobial and adhesive properties, ensuring easy peeling and reduced skin damage.
Patent Information
- Application Number
- CN202510531878.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-04-25
- Publication Date
- 2025-07-15
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
The existing Chinese medicine patches have too strong adhesion to the skin, which can easily stick to hair when removed after use and may damage the skin, and the Chinese medicine layer is not easy to clean.
A drug-carrying layer consisting of styrene-isoprene-styrene triblock copolymer, frankincense, plasticizer, transdermal accelerator, etc. is used to combine the anti-adhesion layer and the backing layer to enhance the viscosity and antibacterial properties through the polysaccharides and volatile oils of frankincense, and reduce skin residues.
It achieves a firmer attachment of traditional Chinese medicine patches during use, and is easy to tear off after use, reducing skin damage and residue, and improving the comfort and safety of use.
Smart Images
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Abstract
Description
Technical Field
[0001] The present invention relates to the field of pharmaceutical technology, and particularly to a traditional Chinese medicine external application patch and a preparation method thereof. Background Art
[0002] In recent years, thanks to the strong support of our country for the cause of traditional Chinese medicine, the reform of traditional Chinese medicine compound external preparations has made rapid progress. As an innovative form of external preparation, the traditional Chinese medicine compound transdermal patch has attracted the attention of many traditional Chinese medicine researchers. With the continuous emergence of new matrix materials and transdermal technologies, the research field of traditional Chinese medicine compound transdermal patches has also witnessed rapid development. In particular, hot-melt elastomer resins have been applied to traditional Chinese medicine compound transdermal patches due to their characteristics such as high drug loading capacity, strong transdermal release ability, and high skin adhesion. However, this kind of traditional Chinese medicine patch has too strong adhesive force with the skin. When removed after use, it is easy to stick to hair, causing pain when torn off. If forcibly removed, it may damage the skin, and the traditional Chinese medicine paste layer may remain on the skin and is not easy to clean, bringing discomfort to patients and being unfavorable for patient use. Therefore, improving and innovating traditional Chinese medicine patches has become a major technical problem that urgently needs to be solved.
[0003] Therefore, the present invention is specifically proposed to solve the above technical problems. Summary of the Invention
[0004] To solve the technical problems existing in the background art, the present invention provides a traditional Chinese medicine external application patch and a preparation method thereof.
[0005] To achieve the above object, the present invention adopts the following technical solutions: A traditional Chinese medicine external application patch, which is characterized by comprising a backing layer, a drug-loading layer, and an anti-adhesive layer. The drug-loading layer is arranged between the backing layer and the anti-adhesive layer. The drug-loading layer comprises a traditional Chinese medicine prescription and a matrix. The matrix comprises the following raw materials in parts by weight: styrene-isoprene-styrene triblock copolymer 65 - 85 parts, frankincense 25 - 40 parts, plasticizer 10 - 25 parts, antioxidant 0 - 15 parts, and transdermal enhancer 0 - 10 parts.
[0006] Preferably, the plasticizer is composed of one or more of paraffin oil, silicone oil, vegetable oil, and mineral oil.
[0007] Preferably, the transdermal enhancer is composed of one or more of lauryl alcohol, propylene glycol, or azone.
[0008] Preferably, the mass ratio of the traditional Chinese medicine prescription to the matrix in the drug-loading layer is mixed in a ratio of 1:1 - 5.
[0009] Preferably, the traditional Chinese medicine prescription is a traditional Chinese medicine extract.
[0010] Preferably, the antioxidant consists of one or more of butyl anisole, tocopherol, and BHT (2,6 - di - tert - butyl - 4 - methylphenol).
[0011] Preferably, the anti - sticking layer is a polyester film coated with dimethyl silicone oil, a polyester film coated with siloxane, aluminized foil, or siliconized paper.
[0012] Preferably, the backing layer is any one of polyethylene, polyurethane, nylon, or non - woven fabric.
[0013] On the other hand, the present invention also provides a preparation method of the traditional Chinese medicine external application patch, and the specific steps are as follows: Weigh each component of the matrix glue according to the weight ratio. First, heat the styrene - isoprene - styrene triblock copolymer until it melts, then cool it down. When the temperature is 60 - 80 °C, add frankincense, plasticizer, antioxidant, and transdermal enhancer, and stir evenly. When the temperature is 50 - 60 °C, add the traditional Chinese medicine prescription and stir evenly to form a paste. Under the condition of heat preservation, coat the paste on the backing layer and the anti - sticking layer, place it at room temperature, slice, and package.
[0014] The beneficial effects of the present invention are as follows: The present invention provides a traditional Chinese medicine external application patch. Frankincense in it is a traditional plant medicine, which is the oleoresin exuded from the bark of Boswellia carterii Birdw. of the Burseraceae family. It has functions such as analgesia, anti - inflammation, and antioxidant, and has good adhesiveness. Its main components include volatile oil, resin, and gum. In the present invention, as a component of the matrix, the gum of frankincense is mainly composed of polysaccharide substances. Polysaccharide substances usually have high stability and good water - holding capacity, and can maintain their structure and performance unchanged under various environmental conditions. This property is crucial for the patch to maintain its shape and the stability of drug release during use. Polysaccharides also have excellent bio - adhesiveness and can form non - covalent bonds with the skin, so that the patch can adhere more firmly to the skin surface and reduce the phenomenon of falling off. The resin in frankincense contains polar groups, such as the carboxyl group of boswellic acid. They interact with other components in the external application patch matrix through hydrogen bonds and van der Waals forces, enhancing the intermolecular attraction, and thus improving the adhesion of the external application patch. In addition, low - polarity substances in the volatile oil, such as octyl acetate with a long alkyl chain, contribute to the spreading and entanglement at the interface, further enhancing the adhesiveness of the external application patch. During use, as the volatile oil in frankincense volatilizes, the adhesion performance of the external application patch becomes moderate, and it is easy to tear off after use without leaving residual paste on the skin, thus reducing the pulling damage to the skin.
[0015] Boswellic acid in frankincense in the present invention has strong antibacterial activity, can directly act on bacterial cells, and can effectively inhibit the growth and reproduction of a variety of pathogenic bacteria, endowing the external application patch with antibacterial properties.
[0016] In the present invention, frankincense not only functions as an antibacterial and viscosity-increasing component of the matrix, but also, due to its antioxidant properties, can be used as an antioxidant, thus saving the need for additional addition of an antioxidant during the preparation of the external application patch. Detailed implementation manners
[0017] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Apparently, the described embodiments are only a part of the embodiments of the present invention, rather than all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative efforts belong to the scope of protection of the present invention.
[0018] Embodiment 1 Weigh 65 g of styrene-isoprene-styrene triblock copolymer (model 1125), 25 g of frankincense, and 10 g of silicone oil.
[0019] First, heat the styrene-isoprene-styrene triblock copolymer until it melts, then cool it down. When the temperature reaches 60°C, add frankincense and silicone oil, and stir evenly. When the temperature reaches 50°C, add 100 g of traditional Chinese medicine extract, and stir evenly to form a paste. Under heat preservation conditions, coat the paste on a non-woven fabric backing layer and a release layer coated with dimethyl silicone oil polyester film, place it at room temperature, then cut it into appropriate sizes, and package it to obtain the traditional Chinese medicine external application patch.
[0020] The traditional Chinese medicine extract is an extract of traditional Chinese medicines including ephedra, cassia twig, kudzu root, mint, and borneol.
[0021] Embodiment 2 Weigh 70 g of styrene-isoprene-styrene triblock copolymer (model 5229), 32 g of frankincense, 18 g of soybean oil, 7 g of butyl anisole, and 5 g of lauryl alcohol.
[0022] First, heat the styrene-isoprene-styrene triblock copolymer until it melts, then cool it down. When the temperature reaches 70°C, add frankincense, soybean oil, butyl anisole, and lauryl alcohol, and stir evenly. When the temperature reaches 55°C, add 40 g of traditional Chinese medicine extract, and stir evenly to form a paste. Under heat preservation conditions, coat the paste on a polyurethane backing layer and a release layer of a polyester film coated with siloxane, place it at room temperature, then cut it into appropriate sizes, and package it to obtain the traditional Chinese medicine external application patch.
[0023] The traditional Chinese medicine extract is an extract of traditional Chinese medicines including dragon's blood, safflower, ligusticum wallichii, myrrh, achyranthes bidentata, motherwort, salvia miltiorrhiza, angelica dahurica, angelica sinensis, rhubarb, rehmannia glutinosa, and chuanxiong.
[0024] Embodiment 3 Weigh 85 g of styrene-isoprene-styrene triblock copolymer (Model 1124), 40 g of frankincense, 25 g of a combination of silicone oil and peanut oil in a mass ratio of 1:1, 15 g of a combination of tocopherol and butylhydroxyanisole in a mass ratio of 1:1, and 10 g of a combination of lauryl alcohol and propylene glycol in a mass ratio of 1:2.
[0025] First, heat the styrene-isoprene-styrene triblock copolymer until it melts, then cool it down. At 80 °C, add frankincense, peanut oil, tocopherol, butylhydroxyanisole, lauryl alcohol, and propylene glycol, and stir evenly. Then, add 35 g of the traditional Chinese medicine extract and stir evenly to form a paste. Under heat preservation conditions, coat the paste on a polyethylene backing layer and a siliconized aluminum foil anti-sticking layer, place it at room temperature, then cut it into appropriate sizes and package it to obtain the traditional Chinese medicine external application patch.
[0026] The traditional Chinese medicine extract is an extract of white mustard seed, kudzu root, sappanwood, clematis root, asarum, notopterygium root, and chuanxiong rhizome.
[0027] Example 4 Weigh 72 g of styrene-isoprene-styrene triblock copolymer (Model D1161), 30 g of frankincense, 20 g of peanut oil and silicone oil, 9 g of a combination of tocopherol, butylhydroxyanisole, and BHT (2,6-di-tert-butyl-4-methylphenol) in a mass ratio of 1:1:1, and 8 g of a combination of lauryl alcohol, propylene glycol, and azone in a mass ratio of 1:2:1.
[0028] First, heat the styrene-isoprene-styrene triblock copolymer until it melts, then cool it down. At 70 °C, add frankincense, peanut oil and silicone oil, tocopherol, butylhydroxyanisole, and BHT (2,6-di-tert-butyl-4-methylphenol), lauryl alcohol, propylene glycol, and azone, and stir evenly. Then, add 35 g of the traditional Chinese medicine extract and stir evenly to form a paste. Under heat preservation conditions, coat the paste on a nylon backing layer and a silicon paper anti-sticking layer, place it at room temperature, then cut it into appropriate sizes and package it to obtain the traditional Chinese medicine external application patch.
[0029] The traditional Chinese medicine extract is an extract of dragon's blood, safflower, Chinese thorowax herb, myrrh, achyranthes root, motherwort herb, red sage root, dahurian angelica root, rhubarb root, rehmannia root, and chuanxiong rhizome.
[0030] Comparative Example 1 Weigh 65 g of styrene-isoprene-styrene triblock copolymer (Model 1125) and 10 g of silicone oil.
[0031] First, heat the styrene-isoprene-styrene triblock copolymer until it melts, then cool it down. Add silicone oil at 60°C and stir evenly. At 50°C, add 100 g of the traditional Chinese medicine extract and stir evenly to form a paste. Under heat preservation conditions, coat the paste on a non-woven backing layer and a silicone oil-coated polyester film anti-sticking layer, let it stand at room temperature, then cut it into appropriate sizes and package it to obtain the traditional Chinese medicine external application patch.
[0032] The traditional Chinese medicine extract is an extract of ephedra, cassia twig, kudzu root, mint, and borneol.
[0033] Comparative Example 2 Weigh 70 g of styrene-isoprene-styrene triblock copolymer (model 5229), 18 g of frankincense, 7 g of butyl anisole, and 5 g of lauryl alcohol.
[0034] First, heat the styrene-isoprene-styrene triblock copolymer until it melts, then cool it down. Add frankincense, soybean oil, butyl anisole, and lauryl alcohol at 70°C and stir evenly. At 55°C, add 40 g of the traditional Chinese medicine extract and stir evenly to form a paste. Under heat preservation conditions, coat the paste on a polyurethane backing layer and a silicone-coated polyester film anti-sticking layer, let it stand at room temperature, then cut it into appropriate sizes and package it to obtain the traditional Chinese medicine external application patch.
[0035] The traditional Chinese medicine extract is an extract of dragon's blood, safflower, ligusticum wallichii, myrrh, achyranthes bidentata, motherwort, salvia miltiorrhiza, angelica dahurica, angelica sinensis, rhubarb, rehmannia glutinosa, and chuanxiong.
[0036] Comparative Example 3 Weigh 85 g of styrene-isoprene-styrene triblock copolymer (model 1124), 10 g of frankincense, a total of 5 g of a combination of silicone oil and peanut oil in a mass ratio of 1:1, a total of 15 g of a combination of tocopherol and butyl anisole in a mass ratio of 1:1, and a total of 10 g of a combination of lauryl alcohol and propylene glycol in a mass ratio of 1:2.
[0037] First, heat the styrene-isoprene-styrene triblock copolymer until it melts, then cool it down. Add frankincense, peanut oil, tocopherol and butyl anisole, lauryl alcohol and propylene glycol at 80°C and stir evenly. Then, add 35 g of the traditional Chinese medicine extract and stir evenly to form a paste. Under heat preservation conditions, coat the paste on a polyethylene backing layer and a siliconized aluminum foil anti-sticking layer, let it stand at room temperature, then cut it into appropriate sizes and package it to obtain the traditional Chinese medicine external application patch.
[0038] The traditional Chinese medicine extract is an extract of white mustard seed, kudzu root, sappanwood, clematis chinensis, asarum, notopterygium incisum, and chuanxiong.
[0039] Investigate the adhesion of Examples 1 - 3 and Comparative Examples 1 - 3 Initial adhesiveness: It is detected according to the first method (determination of initial adhesiveness) in General Principles 0952, Part IV of Chinese Pharmacopoeia (2020 Edition). The test sample (together with the packaging material) is placed at 18 - 25 °C and relative humidity of 40% - 70% for more than 2 hours. Then, take 3 pieces of the test sample, remove the cover liner at room temperature, place it on an inclined plane at an angle of 30° to the horizontal plane with the paste side up, and cover the upper 1 cm and the part below 6 cm of the test sample with polyester film, leaving a 5 - cm paste surface in the center. Take steel balls of different numbers and let them roll freely from the top of the test sample, record the largest steel ball number that can stay, and the largest ball number that can prevent falling should be 19 or above.
[0040] Adhesive holding power: It is detected according to the second method (determination of adhesive holding power) in General Principles 0952, Part IV of Chinese Pharmacopoeia (2020 Edition). Before the test, the test sample (together with the packaging material) is placed at 18 - 25 °C and relative humidity of 40% - 70% for more than 2 hours. Wipe the test plate and the loading plate with a wiping material dipped in anhydrous ethanol, and carefully dry it with a clean dust - free cloth. Repeat this cleaning process more than 3 times until the surfaces of the test plate and the loading plate are visually inspected to be clean. Take 1 piece of the test sample, cut it into a size of 7 cm × 7 cm, and paste the test sample parallel to the longitudinal direction of the plate in the middle of the adjacent test plate and loading plate respectively. Roll a roller back and forth on the test sample three times. After the product is pasted on the plate, let it stand at room temperature for 20 minutes, then fix it on the test rack, and record the time when the test sample falls off. The results are shown in Table 1.
[0041] Table 1 Detection results of initial adhesiveness and adhesive holding power of each example and comparative example As can be seen from the table, the adhesion performance of the traditional Chinese medicine external application patches prepared in Examples 1 - 3 of the present invention is good, and Example 2 is more prominent.
[0042] Subjective evaluation of the external application patches in Examples 1 - 3 Taking 120 consumers as subjects, randomly divided into 3 groups with 30 subjects in each group. The first group applies the external application patches prepared in Example 1, the external application patches prepared in Example 2, and the external application patches prepared in Example 3. The fourth group is a commercially available hot - melt pressure - sensitive adhesive plaster containing natural rubber. The application sites are selected on the back or limbs for easy operation and observation. During the application process, observe and record the use comfort and skin follow - up of the patch. The application time is set at 24 hours. After 24 hours, peel it off, and record the subjects' peeling feelings, skin reactions, removal difficulty, and skin residue conditions. The statistical results are shown in Tables 2 - 4 below Table 2 Application effects during the use of the first - third groups Table 3 Application effects during the use of the fourth group Functional evaluation results after use for the 1st to 4th groups in Table 4 It can be seen from this that the external application patch of the present invention has high skin adhesion, low skin irritation, no pain during removal and no residue of the plaster. This is because during the use process, as the volatile oil in frankincense volatilizes, the adhesion performance of the external application patch becomes moderate, and it is easy to tear off after use, without leaving a residual paste on the skin, thus reducing the pulling damage to the skin.
[0043] The above is only the preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present invention, according to the technical solution and inventive concept of the present invention, making equivalent substitutions or changes should be covered within the protection scope of the present invention.
Claims
1. A traditional Chinese medicine external application patch, characterized in that: It includes a backing layer, a drug-loading layer, and an anti-adhesive layer. The drug-loading layer is disposed between the backing layer and the anti-adhesive layer. The drug-loading layer includes a traditional Chinese medicine prescription and a matrix. The matrix comprises raw materials in the following parts by weight: 65 to 85 parts of styrene-isoprene-styrene triblock copolymer, 25 to 40 parts of frankincense, 10 to 25 parts of plasticizer, 0 to 15 parts of antioxidant, and 0 to 10 parts of transdermal enhancer.
2. The traditional Chinese medicine external application patch according to claim 1, characterized in that: The plasticizer is composed of one or more of paraffin oil, silicone oil, and vegetable oil.
3. The Chinese medicine external application patch according to claim 1, characterized in that: The transdermal enhancer is composed of one or more of lauryl alcohol, propylene glycol, or azone.
4. The traditional Chinese medicine external application patch according to claim 1, wherein: In the drug-loading layer, the traditional Chinese medicine prescription and the matrix are mixed in a mass ratio of 1:(1 to 5).
5. The Chinese medicine external application patch according to claim 1, characterized in that: The traditional Chinese medicine prescription is a traditional Chinese medicine extract.
6. The Chinese medicine external application patch according to claim 1, wherein: The antioxidant is composed of one or more of butyl anisole, tocopherol, and BHT.
7. The traditional Chinese medicine external application patch according to claim 1, wherein: The anti-adhesive layer is any one of a dimethyl silicone oil-coated polyester film, a silicone oxide-coated polyester film, a siliconized aluminum foil, or a siliconized paper.
8. The Chinese medicine external application patch according to claim 1, wherein: The backing layer is any one of polyethylene, polyurethane, nylon, or non-woven fabric.
9. A preparation method of a traditional Chinese medicine external application patch according to any one of claims 1 to 8, characterized in that, It includes the following steps: Weigh each component of the matrix according to the weight ratio. First, heat the styrene-isoprene-styrene triblock copolymer to melt, then cool it down. When the temperature is 60 to 80 °C, add frankincense, plasticizer, antioxidant, and transdermal enhancer, and stir evenly. When the temperature is 50 to 60 °C, add the traditional Chinese medicine prescription and stir evenly to form a paste. Under the condition of heat preservation, coat the paste on the backing layer and the anti-adhesive layer, place it at room temperature, slice it, and package it.