摘要
开展药品评价性抽验是近年来药品检验所的一项重要工作。如何客观地评价国内药品的质量现状;分析产品的主要质量问题进而明确产品质量提高的方向,是评价性抽验中亟待解决的问题。本文在对历年抗生素评价性抽验结果总结的基础上,对评价性抽验的基本思路和方法进行探讨。
Quality evaluation of post-marketing drugs in China is a key work for quality control institutes recent years. However, how to evaluate objectively the quality of domestic drugs emphasized on finding the main problem of products for improving the quality becomes an important part in this evaluation. After summarizing the evaluation results of antibiotics recent years, author expounds how to approach the common problems of post-marketing drugs by using statistical methods from routine examination data, and how to evaluate quality, manufacture process and specification of drugs by using comprehensive analysis techniques such as LC-MS methods, database technology, toxic evaluation methods for trace quantity compound and dissolution profile comparing technology etc. in exploratory study of the evaluation. The hot issues in those fields focus on impurity profiling control, dissolution/disintegration evaluation of oral preparation, compatibility of API （active pharmaceutical ingredient） with packing materials and rationality of pharmaceutical formula. The quality of post-marketing drugs in China will be improved greatly by revising drug specifications according to the evaluation results.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2013年第1期1-11,共11页
Chinese Journal of Antibiotics
基金
重大新药创制专项化学新药质量标准研究与评价技术平台课题(课题编号:2011ZX09303-001)
关键词
药品质量
评价
抽验
质量控制
质量标准
Drug quality
Drug evaluation
Examination based on sampling
Quality control
Specification
