Study On The Preparation Of Capsules Containing Enteric Coated Microspheres Of Tiopronin

The purpose of research is to study and determine the composition, preparation procedure, quality control of tiopronin enteric coated microsphere;to investigate the stability of the microsphere and to lay a foundation for further clinical research.On the base of the formula and adjuvant's property of correlative products on the market, the formula of tiopronin enteric coated microsphere was determined. Using yield, pellets sphericity(angle of repose), tap density, friability and in vitro release as index, the composition and preparation procedure of tiopronin enteric coated microsphere were optimized. Using Chinese Pharmacopeia as reference, the method to examine related substance and content of tiopronin enteric coated microsphere was determined, the determination condition and test method of release degree was finalized and quality Criteria was established. According to Chinese Pharmacopeia, influential factor test, accelerating test and long-term test were studied.The formula of the tiopronin enteric coated microsphere was determined. The composition and preparation procedure of microsphere were optimized, and the release degree comply with the quality standards of Chinese Pharmacopeia. The quality criteria of tiopronin enteric coated microsphere was established.The optimized composition was reasonable and the preparation procedure was convenient and reliable. It can be industrialized. The quality criteria was simple, accurate and feasible. The preparation is safe, effective and controllable. The clinical trial should be further researched.