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.
ABSTRACT
OBJECTIVE: To establish a new dissolution method of Ligustrazine Phosphate Pills, which provides reference for revising the quality standard. METHODS: The dissolution media were hydrochloric acid solution(pH 1.2), acetate buffer solution(pH 4.5), phosphate buffer solution(pH 6.8) and water. The dissolution curves of six batches of Ligustrazine Phosphate Pills in the four kinds of dissolution media were compared to establish the dissolution method. Apparatus 2 was used for the new method of dissolution test, using 500 mL water as the dissolution medium, at the rate of 75 r·min-1. The dissolution solution was taken at 20 min and analyzed by HPLC. The dissolution limit was set at 80%. RESULTS: The dissolution curves of the six batches of samples were similar in the four kinds of dissolution media. The pills were dissolved completely within 15 min. CONCLUSION: The determination method is highly reproducible, accurate and reliable, which can objectively reflect the dissolution of ligustrazine phosphate pills, and provides a basis for the reasonable unification and revision of the dissolution test of the current quality standard.