Researches On Shenyan Kangfu Tablet Techniques Of Production And Quality Specification

Shenyan Kangfu tablet is a type of traditional Chinese medicine which was researched and developed independently by Tianjin Tongrentang Limited Liability Company,who has the independent intellectual property rights of it. After going on the market more than 20 years, certain techniques of the production become quite old, and the quality standards need to improve. Meanwhile, the treatment scope is not suitable for the market and need to widen.In this paper, the granulation process of Shenyan Kangfu tablet's was improved without major variations of the technology, in order to meet the demands of the increase of Shenyan Kangfu tablet in the treatment of diabetic nephropathy indications and pre-clinical research. Fluidized bed granulation technology was used to replace the traditional wet granulation process.At the same time, the granule's size distribution, the hardness, friability, disintegration and inherent quality of the tablets prepared with old and new methods were investigated comparatively.The alternative materials of film coating of Shenyan Kangfu tablet were studied. Through orthogonal test, the optimized amount of water-soluble coating material was found to replace the alcohol-coated material.The stability and quality standards of Shenyan Kangfu tablet were investigated. It is shown that the technology changes do not have the influence to the product quality. The qualitative methods for American ginseng and Platycodon Root were suggested. The Salvia's qualitative methods were simplified. The content determination of Salvia was improved and the quality specification was enhanced.