Research On Clean Production Technology Of Adhesive Plaster For External Use Only

Chinese medicinal rubber plasters refer to plasters of effects coated with the mixture of herbal extract, chemical drugs and rubber. Chinese medicinal rubber plasters, as a kind of drug transdermal preparations, have great significance in the treatment of diseases, especially for rheumatoid joint pain, muscle pain, sprains, back pain and other diseases, and also account for a large proportion in current clinical use of external preparation of Chinese herbs. However, such problems as poor security (high rate of allergies), ineffectiveness (low proportion of active ingredients, low skin permeation rate), poor comfort property (easy to apply and easy to be torn, no residue) and deficient quality control system and technical standards lie in the existing traditional Chinese Medicinal Plasters production. The hotmelt method widely used in China at present, consumed a large amount of gasoline which produces great pollution to the environment, and is unfavorable to the labor protection of the workers. What’s more, the solvent residues of the final products are easy to make people allergic. So, after a comprehensive analysis from prescription, technical route, advantages and disadvantages, production technology, product cost and equipment status and other aspects, the hot press method is recommended in the production of Shexiang Zhuanggu Gao in this thesis.Chapter Ⅰ made a summary on the history of Chinese medicine rubber plaster, characteristics, advantages and security issues, affirmed the role of traditional Chinese medicinal rubber plaster. The concept of cleaner production, development and significance were reviewed to clarify the Chinese rubber paste the need for cleaner production.Chapter Ⅱ made a comparison between hot-press method and solvent method, two different domestic production methods of traditional Chinese medicine rubber plaster. With a comprehensive analysis from different aspects of prescription dosage, technical route, advantages and disadvantages, it is found that hot-press method, without petrol in production, can not only reduce pollution and production costs, greatly raises the content of active ingredients, but also relive anaphylactic reaction of the patients, improve security in production. It’s worth further studying, for it’s in conformity with the national policies of energy-saving and emission-reduction, as well as environmental protection.In Chapter Ⅲ, a reasonable and practical Cleaner production processes-hot pressing is established by the small and intermediate scale laboratory tests.In Chapter Ⅳ, a new quality standard for Shexiang Zhuanggu Plaster is made by reference to relevant literature and quality standards in Chinese Pharmacopoeia (2010Edition), and menthol content determination is newly added. The new quality standard was proved reliable by content determination. The appearance, amount of medicinal cream heat resistance of the two kinds of plasters processed under two different methods were proved basically the same, but the content of the active ingredient of menthol under hot-press method is much higher than that under the solvent method. And a longterm stability studies of the products under the new process were also made and the products quality were proved stable and reliable.In short, improvement of the production processes reduces gasoline use, pollution and production costs and improves production security. Thereby it’s more suitable for industrial production, and also economically and socially beneficial.