Preliminary Study on Dissolution Curves in Vitro of Home-made and Original Patented Cloperastine Hydrochloride Tablets / 中国药学杂志

ABSTRACT

OBJECTIVE: To compare the similarity of the dissolution curves of cloperastine hydrochloride tablets in four kinds of dissolution media to provide reference for evaluating the consistency of the quality of domestic generics and revising the drug standards. METHODS: The dissolution curves of home-made and original patented cloperastine hydrochloride tablets in hydrochloric acid solution (pH 1.2), disodium hydrogen phosphate and citric acid buffer solution (pH 4.0), phosphate buffer solution (pH 6.8) and water were determined and the similarity was evaluated according to the AV values. RESULTS: In the four kinds of media, the AV values were more than 15.0. CONCLUSION: The dissolution behaviors of home-made and original patented cloperastine hydrochloride tablets in the four kinds of media are dissimilar, which indicates that the domestic generics urgently need to be improved in the prescription or the manufacturing process.