生物检定方法控制中药质量的思考  

Bioassay Based TCM Quality Control

作　　者：王伽伯[1] 李会芳[1] 肖小河[1] 金城[1] 

机构地区：[1]解放军第三○二医院全军中药研究所,北京100039

出　　处：《世界科学技术-中医药现代化》2007年第6期36-39,共4页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：科技部"十一五"科技支撑计划(2006BAI08B03):中药复方质量控制与评价技术研究;国家杰出青年科学基金(30625042):中药鉴定学

摘　　要：质量稳定可控是保证中药有效性和安全性的重要前提。现行的中药质控模式和方法仅能控制部分指标性成分的一致性和稳定性,难以全面、有效地控制中药的质量。而生物检定方法直接关切有效性和安全性,特别适用于结构复杂或者理化测定不能反映其临床疗效的药物,在中药质量控制和评价中具有独到的优势。在现行化学控制基础上建立中药生物检定质控方法,比目前主要基于指标性成分定性定量分析的质控体系具有更大的实际意义和优势,亦将成为中药质量控制发展的新趋势。Quality control is crucial to both the efficiency and safety of Traditional Chinese Medicine （TCM）. However, the efficiency and safety of TCM can hardly be guaranteed, under the current quality control system featured with chemical determination, though the system allows consistency for some marker substances. Bioassay has been considered a desirable quality control technique for the drugs, in particular, TCM, that are of complex substances, and are difficult to be determined using regular physical and chemical means. In this context, bioassay makes a better quality control technique, compared with the current system, and is a promising novel upgrade for quality control.

关 键 词：中药 质量控制 生物检定 方法学 

分 类 号：R282.71[医药卫生—中药学] R288[医药卫生—中医学]