盐酸洛美沙星注射液光稳定性试验及影响因素研究—探索-中国药品标准.docVIP

探讨光稳定性试验在上市药品质量标准研究中的应用 孔爱英1，刘成红1，高锦1田增光1，桑志红*（药品仪器检验所，北京 100166；国家生物医学分析中心，北京 100850）摘要 目的。方法。结果 经HPLC检测可知，原料、片剂和胶囊剂直接光照15 d，固体样品主成分基本稳定；原料、片剂和胶囊剂的溶液光照24 h不稳定，有杂质产生；溶出度测定溶液光照24 h，降解动力学拟合符合0.5 级动力学方程；含量测定供试品溶液光照24 h，降解动力学拟合符合1级动力学方程。结论：光稳定性试验不仅可用于上市前的药品评价，亦可为上市药品质量标准研究提供数据支持。 关键词:; 盐酸洛美沙星; 光降解动力学 中图分类号: R917 文献标志码: A 文章编号: Application on photostability Experiment for the Revaluation of Postmarketing Drug Standards Kong Aiying1,Liu Chenghong1，1，Tian Zengguang1，Sang Zhihong* （Institute for Drug and Instrument Control , Department of Health, the Central Military Commission of the Central Military Commission ,Beijing 100166；National Central of Biomedical Analysis， Beijing 100850） Abstract Objective： To investigate the application of photostability experiment to the revaluation of postmarketing drug standards. Methods： According to the ICH principles of photostability and the quality standard of Lomefloxacin Hydrochloride, the stability of raw materials, tablets and capsules, as well as the photodegradation of Lomefloxacin Hydrochloride solution were inspected. Results： HPLC tests showed: the main constituents of solid?samples, such as raw materials, tablets and capsules which were directly illuminated for 15 days, were basically?stable; the samples of aqueous solution, which were illuminated for 24 hours, were not stable and there was impurity produced in it. The photodegradation of the dissolution solution which was illuminated for 24 hours followed the 0.5-order kinetics; the test solution of assaying under the determination followed the first-order kinetics. Conclusion： Photostability experiment can not only be used for the evaluation of drugs before listing, but also can provide data support for the revaluation of listed drug standards. Key words: photostability experiment; Lomefloxacin Hydrochloride； photodegradation kinetics 药物的稳定性试验是药品质量标准研究中重要的内容，其中光照稳定性作为稳定性试验的重要部分逐渐被重视。人用药品注册技术规范国际协调会（ICH）药物光稳定试验指导原则于1996年11月达成[1]。与ICH 药物光照稳定性指导原则相比较，我国光稳定性试验存在