生化药物质量控制中生物测定的作用与局限  

Review the strengths and limitations of biological assays in quality control of biochemical drugs

作　　者：李湛军[1] 徐康森[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2007年第2期297-301,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：综述生物测定在药品质量控制中的应用与局限。尽管应用逐渐减少,但生物测定在生化药物质量控制中对鉴别、纯度、安全、活性、效价和稳定性等方面仍发挥重要作用,直到被其他更好的能保证临床用药安全、有效的方法所取代。An overview of the strengths and limitations of biological assays in quality control. Although the need is diminishing, biological assays still have an important place in the quality control of biochemical drugs in the assessment of identity, purity, safety, biological activity, potency and stability, bioassays will be required until adequate and appropriate alternatives can be shown to be sufficient to assure the product＇s efficacy and safety in clinical use.

关 键 词：生物测定 质量控制 应用与局限 

分 类 号：R917[医药卫生—药物分析学]