探讨光稳定性试验在上市药品质量标准研究中的应用

Application on photostability Experiment for the Revaluation of Postmarketing Drug Standards

目的:探讨光稳定性试验在上市药品质量标准研究的应用。方法:按照ICH药物光稳定性试验指导原则,依据盐酸洛美沙星的质量标准,考察光强制破坏条件下,盐酸洛美沙星原料、片剂和胶囊剂的稳定性及其盐酸洛美沙星溶液的光降解动力学。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24h,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。

Objective： To investigate the application of photostability experiment to the revaluation of postmarketing drug stand- ards. 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 in- spected. 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 illumi- nated for 24 hours followed the 0.5-order kinetics ; the test solution of assaying under the determination followed the first-order ki- netics. 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.