药学研究2017，Vol.36Issue(6)：311-314,336,5.DOI:10.13506/j.cnki.jpr.2017.06.001
药品质量的影响因素--化学固体药物的晶型研究
Polymorphism of drugs:the main factor affecting the drug quality
摘要
Abstract
The quality of the small molecule drugs is an important and complex problems which related to clinical therapeutic effects.There are many different factors influencing the quality of drugs include API,excipients and preparation technology related factors.Except these factors,the crystal form of API is the core factors which closely related with bioavailability of drugs.Appliation and controlling the Optimal Drug Crystal form (ODC) of API in solid pharmaceutical preparations are the key procedures for drug quality.This article discussed the discovery,detection,evaluation and application requirements of drug crystal,to provide information for the study of crystalline drugs.关键词
化学固体药物/晶型/药品质量/影响因素Key words
Chemical solid medicine/Crystal form/Drug quality/Influencing factors分类
医药卫生引用本文复制引用
杜冠华,吕扬..药品质量的影响因素--化学固体药物的晶型研究[J].药学研究,2017,36(6):311-314,336,5.基金项目
国家科技重大专项"重大新药创制"项目(No.2013ZX09508104、No.2013ZX09402203) （No.2013ZX09508104、No.2013ZX09402203）
国家科技部重点研发计划(No.2016YFC1000905) （No.2016YFC1000905）
