摘要
以药物制剂中活性成分的载药量和辅料的干扰情况为依据,对原研药中原料药的晶型反向研究进行分类,并以实例分别探讨了各类型原研药的晶型反向研究策略,旨在为国内仿制药研发及质量与疗效一致性评价提供参考。
In the paper,reverse study of the drug substance crystal form for reference listed drug(RLD)was classified based on the drug loading of the drug substance in the pharmaceutical preparations and the interference of the excipients.In addition,the reverse research strategy of crystal form of each type was discussed with examples,which can provide a reference for the consistency evaluation of its generic drugs.
作者
徐云
孙碧芸
姚晓敏
冯明声
Xu Yun;Sun Biyun;Yao Xiaomin;Feng Mingsheng(Nanjing Hicin Pharmaceutical Co.,Ltd.,Nanjing210046,China)
出处
《山东化工》
CAS
2022年第3期25-32,35,共9页
Shandong Chemical Industry
关键词
晶型
反向研究
仿制药
粉末X射线衍射法
crystal
reverse research
generic drugs
powder X-ray diffractometry
