摘要
长效注射剂不仅要符合注射剂一般质控要求,还需结合其释放机制和制剂特点进行针对性的质量研究与控制。本文对已上市长效注射剂(化学药品)的药学信息进行总结分析,提出对此类制剂质量控制的一般考虑,为研发者提供相关产品的质控思路。
Long-acting injections not only should meet the general technical requirements of injections,but should also be studied and controlled according to the combination of their release mechanisms formulation charisteristics.This article summarizes and analyzes the pharmaceutical information of approved long-acting injections and puts forward the general considerations of long-acting injections,giving quality control ideas of related products to researchers.
作者
马骏威
任连杰
MA Jun-wei;REN Lian-jie(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第9期845-849,共5页
Chinese Journal of New Drugs
关键词
长效注射剂
质量控制
释放机制
long-acting injection
quality control
release mechanisms
