摘要
生物制品多由不耐热的多组分活性成分组成,且结构不易鉴别,工艺过程的变化很容易导致其性状参数发生改变而影响产品的质量,制品的安全性、有效性很大程度上依赖于生产工艺的耐受性和全过程的质量监控。与一般药品标准相比生物制品质量标准具有其相对的特点。本文介绍了我国生物制品质量标准体系的概况和特点。
Biological products are a complexity of multiple active ingredients the structure is not easy to i- dentify. Process variation is very easy to cause the product character parameter changes, which influences the qual- ity monitoring of the products, product safety and effectiveness. Compared with the standards of general drugs, the quality standards of biological products have unique characteristics. This review presented the profile and specialty of the national quality standard system of biological products.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2014年第9期994-997,1003,共5页
Chinese Journal of New Drugs
关键词
生物制品
质量标准
体系
biological products
quality standard
system
