Painting is an external patch with water-soluble polymer as the matrix material. It was introduced to my country in the 1980s. Due to the shortage of equipment and matrix materials, as well as the common problems of insufficient viscoelasticity and poor stability of preparations, it has not been developed for many years. After more than ten years of unremitting efforts, the Institute of Traditional Chinese Medicine of the Chinese Academy of Chinese Medical Sciences has solved the above technical problems and achieved satisfactory results through in-depth and systematic research on the traditional Chinese medicine cataplasm matrix and its preparation process. This achievement won the 2005 Annual Second Prize of Beijing Science and Technology Award.
Professor Liu Shuzhi, director of the Traditional Chinese Medicine Preparation Research Center of the Institute of Traditional Chinese Medicine, is the person in charge of the project. When I went to interview her, she showed me a cataplasm plaster, which felt good in texture and viscoelasticity. Very good, it still maintains its original stickiness after being peeled off repeatedly and feels very comfortable. Talking about the characteristics of cataplasm and its advantages compared with other topical patches, Liu Shuzhi said that the driving force behind the research on cataplasm was that it has a series of advantages that are different from other external patches and has broad market demand. Although traditional black plaster and modern rubber plaster are effective, black plaster is inconvenient to use, contaminates clothing, and the production process affects the environment. The irritation, allergy, and aging properties of rubber paste limit its clinical use. Cataplasm shows obvious advantages in just these aspects. It is moisturizing, breathable and resistant to aging. It has a large drug loading capacity and is less irritating and allergic. It is a suitable dosage form for external use of traditional Chinese medicine. Liu Shuzhi was interested in researching this dosage form in the early 1990s, but due to lack of financial support, she only consulted a large number of related foreign literature and patents to accumulate information. It was not until 1994 that the "Young Seedling Project" of the Institute of Traditional Chinese Medicine helped her realize her wish to conduct research on traditional Chinese medicine cataplasm, funded the preliminary trial, and made progress. In 1995, it was funded by the State Administration of Traditional Chinese Medicine's key project bidding. This was the first nationally funded basic and applied research project on traditional Chinese medicine cataplasm in China. From then on, she and her research team began a ten-year series of research on traditional Chinese medicine cataplasm.
In the early 1980s, some domestic manufacturers purchased cataplasm production equipment and patented technology from Japan, but they did not form a large scale. There was a lack of exchange of relevant literature and materials, and the research on cataplasm was almost blank. To conduct research on traditional Chinese medicine cataplasm, you can imagine how difficult it is to start from scratch. During those days, Liu Shuzhi and her research team endured tremendous pressure and challenges, and the workload and difficulty were extremely high. There are only a few varieties of matrix excipients in China, and the range of choices is very small. There are no experimental and production equipment, and there is a lack of ready-made experimental methods to learn from. It is really difficult. However, they did not doubt their choices, overcame many difficulties, and worked hard towards the established goals. . They conducted systematic experimental research on the selection of matrix and auxiliary materials for cataplasm, matrix formula, preparation process and influencing factors. They used new matrix skeleton materials and unique preparation processes, and compared single factor comparison with orthogonal design and uniform design. A combination of experimental methods, using visual analysis, variance analysis, regression analysis and other analytical methods, using the adhesion, tensile force and peel strength of traditional Chinese medicine cataplasm as quantitative indicators, combined with appearance and sensory indicators, to analyze the formula and matrix material of traditional Chinese medicine cataplasm. The preparation process and influencing factors were systematically studied experimentally, and the matrix formula and preparation process were determined. At the same time, a quality control index and dosage form evaluation system has been established, including preparation stability evaluation, transdermal absorption effect evaluation, pharmacodynamic evaluation, and safety evaluation. The results prove that the matrix formula and preparation process have broad solubility to various single Chinese medicines and compound extracts, and can be used to make cataplasms with various Chinese medicines, forming an excellent technical platform. It has good viscoelasticity, easy to control preparation conditions, short production cycle, and is suitable for large-scale production. It has a large drug loading capacity, is moisturizing, breathable, and anti-aging. It can be applied repeatedly, is non-irritating and allergic, is comfortable to apply, and is easy to use. The research team conducted tests on intact skin and damaged skin of animals and found no irritating reactions. Human experiments also show that the irritation and allergy of traditional Chinese medicine cataplasm is very small, which is obviously better than rubber ointment and other dosage forms.
Liu Shuzhi said that due to a series of characteristics of cataplasm, it is very suitable for carrying traditional Chinese medicine. Because traditional Chinese medicine is used as a compound medicine, it is difficult to purify the active ingredients. Most of them need to be extracted and refined into an extract of a certain concentration. Corresponding preparations can be made with a large amount of medicine, and the cataplasm has a very large drug load, can be applied repeatedly, and can still maintain good stickiness when applied again.
The traditional Chinese medicine cataplasm matrix and its preparation process technology applied for a national invention patent in January 2000. Since then, the research team has continued to develop and improve this patent to make it suitable for industrial promotion. Obtained national invention patent in February 2004. Using this technology, the research team has cooperated with enterprises to research and develop a series of traditional Chinese medicine cataplasm products. He has published many research papers on cataplasm, provided a large amount of technical consultation to enterprises and scientific research institutes, and produced gratifying social and economic benefits. During the "Tenth Five-Year Plan" period, the "863" plan also supported Liu Shuzhi's research group's "Research and Development of Traditional Chinese Medicine Compound Transdermal Drug Delivery System - Traditional Chinese Medicine Cataplasma", relying on varieties, to conduct more in-depth research on Chinese medicine cataplasm. Experimental research has further improved the technical platform, making this research at the highest level in China. It not only promotes the research process of domestic cataplasms, but also provides relevant references for other researchers’ experiments. It has a wide social impact and has formed a certain Awareness.
Liu Shuzhi finally said that the research, development and industrial promotion of traditional Chinese medicine cataplasm has enriched the types of dosage forms of traditional Chinese medicine for external use. Although it has a series of advantages and characteristics, it does not mean that it can completely replace rubber. Ointments and other external patches have their own characteristics and play a role in people's prevention and treatment of diseases. Traditional Chinese medicine cataplasm only provides a new medication choice for the general public and facilitates treatment. At the same time, she also mentioned that in the previous period, as Chinese medicine cataplasm was a hot topic in research and development, some individuals without research capabilities also joined the team and labeled preparations that were not cataplasm at all as Chinese medicine cataplasm. Labeling has caused a lot of confusion, but with the improvement of awareness of traditional Chinese medicine cataplasm and the gradual standardization of the market, this phenomenon will become less and less.