盐酸恩丹西酮缓释胶囊质量标准研究

Study on the quality standard of ondansetron hydrochloride sustained release capsules

目的:制定盐酸恩丹西酮缓释胶囊的质量标准。方法:采用 HPLC 法测定盐酸恩丹西酮的含量和溶出度。结果:盐酸恩丹西酮缓释胶囊含量在90.0%～110.0%范围内;体外释放曲线符合一级动力学方程和 Higuchi 方程;有关物质检查未见。结论:本法简便、准确,专属性强,可用于盐酸恩丹西酮缓释胶囊的质量标准研究。

Objective： To develop the quality standard of ondansetron hydrochloride sustained release capsules. Methods： The determinated on the content and the dissolution of ondansetron hydrochloride by HPLC. Results： The content of ondansetron hydrochloride sustained release capsules was the range of 90. 0% - 110. 0%. The release profile of ondansetron hydrochoride from the capsules followed the first -order dynamics equation and Higuchi kinetics equation ; related substance of which was not found. Conclusion： This method is simple, accurate, specific and may be used for the quality standard of ondansetron hydrochloride sustained release capsules.