摘要
溶出度试验是评价药物固体制剂释放特性的一项重要技术手段,影响溶出度试验结果的因素主要来自4个方面:1溶出度试验装置。2实验环境。3分析者。4待测样品。溶出度试验仪的机械校准和性能确认是减小变异因素影响,实现溶出度结果重现的最好手段。通过查阅国内外文献,本文对国内外药物溶出试验仪的机械性能校验方法进行回顾,提出我国溶出仪性能校验的问题及建议。建议利用仿制药质量一致性评价的契机,建立我国溶出度试验仪机械校正和性能校验的操作规程。
Dissolution testing is widely used as an analytical technique for evaluating the drug release characteristics of a pharmaceutical product. Dissolution testing involves many variables,which can be grouped into four main categories： ① dissolution apparatus. ②testing environment. ③ analyst.④ sample. It is necessary to obtain reliable dissolution results via mechanically calibrating the dissolution apparatus. Here,the history of investigation,establishment of methods,mechanical calibration for dissolution tester qualification,and establishment of domestic mechanical calibration were discussed. It is an opportunity to set up the ＂Procedure for Mechanical Calibration and Performance Verification Test＂in our country in order to standardize consistency evaluation of the quality of generic drugs.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2014年第24期2892-2896,共5页
Chinese Journal of New Drugs
基金
天津市天大天发科技有限公司
关键词
溶出度仪
机械校正
药典
dissolution tester
mechanical calibration
Pharmacopoeia
