摘要
目的:通过强降解实验考察施普睿达在一系列剧烈条件下的稳定性,了解其内在的稳定特性及其降解途径。为包装材料的选择和药品储存提供了科学依据,确保其使用期内的化学稳定性。方法:通过碱降解、酸降解、加热降解、光照降解等强制降解实验,用HPLC法测定其含量的变化,考察施普睿达的化学稳定性。结果:施普睿达在光照条件放置20 d基本稳定,170℃加热5 h,粉末颜色略有变黄,在酸性条件在氧化条件以及碱性条件下不稳定。结论:施普睿达原料药应该密闭保存。
Objective： To find out Sprida＇ s inherent stability characteristics and degradation pathways, provid a basis for the scien- title choice of packing and storaging drugs, and insure the chemical stability of Sprida in its period of validity. Strong degradation experiment study was implemented in a series of severe conditions. Method： The chemical stability of Sprida was investigated through determining its content by HPLC after forced degradation, such as alkaline degradation, oxidative degradation, acid degradation, heated degra- dation and illuminative degradation. Result： Sprida was still stable after illumination of 20 days, basically stable after 5 hour heating at 170 ℃ with slightly yellow color,unstable in oxidative condition and most unstable in alkaline or acid condition. Conclusion： Sprida shoud be stored in an air-tight container and protected from light.
出处
《中国药师》
CAS
2010年第7期979-981,共3页
China Pharmacist
基金
天津市科技计划项目(编号:072CKFSH00200)
关键词
施普睿达
强降解
稳定性
Sprida
Forced degradation
Stability
