摘要
目前仿制药在我国医药市场占据很大规模,口服固体制剂一致性评价得到的关注最多。其中药品的体内外相关性一直是研究者关注的重点及难点,如何通过控制再评价品种与参比制剂体外某些特性(如溶出、制剂学因素等)的相似,达到两者体内生物等效,对于缩短药品的一致性评价进度,降低研究成本具有重大的意义。就目前口服固体制剂一致性评价体内外相关性的相关研究进展进行综述,以期为开展口服固体制剂一致性评价研究工作提供参考。
At present,generic drugs occupy a large scale in Chinese pharmaceutical market,and the consistency evaluation of oral solid preparations gained the most attention.The in vitro-in vivo correlation(IVIVC)study is the hot point and difficulty on researches about evaluation of oral preparations,it is benefit for decreasing the research progress and cost of drug consistency evaluation that how to control the similarity of some vitro characteristics(such as dissolution and formulation factors,etc.)of the reevaluate preparation and the reference preparation to achieve the vivo bioequivalence of them.This article will review the current research progress on the IVIVC of oral solid drug consistency evaluation,in order to provide reference for the study on the consistency evaluation of oral solid preparations.
作者
刘湾
涂亮星
杨世林
金一
LIU Wan;TU Liangxing;YANG Shilin;JIN Yi(National Engineering Research Center for Manufacturing Technology of Traditional Chinese Medicine Solid Preparations,Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China)
出处
《药物评价研究》
CAS
2020年第12期2565-2570,共6页
Drug Evaluation Research
基金
江西中医药大学“1050青年人才工程”项目(5142001012)。
关键词
口服固体制剂
一致性评价
溶出
制剂学因素
oral solid preparations
consistency evaluation
dissolution
formulation factors
