泻下类中药质量的生物控制方法及基本问题探讨  

Essential issues of bioassay methods for quality control of laxative traditional Chinese medicines

作　　者：王伽伯[1] 金城[1] 李会芳[1] 李寒冰[1] 肖小河[1] 曲毅[1] 

机构地区：[1]解放军中药研究所,解放军第三〇二医院,北京100039

出　　处：《药学学报》2009年第5期500-505,共6页Acta Pharmaceutica Sinica

基　　金："十一.五"国家科技支撑计划资助项目(2006BAI08B03);国家杰出青年科学基金资助项目(30625042)

摘　　要：本文以建立泻下中药质量的生物控制方法为实例,针对中药质量易受多种因素影响,样本总体波动范围大的特点,比较了不同生物检定数学模型的适用性,建议中药质量生物控制方法首选准确度相对较高的量反应平行线法,若供试品不能通过可靠性检验,可按质反应平行线法检测。对准确性要求不太高时,也可首选质反应平行线法,操作相对更简单。根据生物检定对参照物质和待测样品同质性的要求,建议采用对照药材提取物作为中药质量生物控制的标准物质,并采用化学参照物进行效价赋值,为效价传递及法定标准物质的建立提供参考。实际检测不同品种大黄药材及其复方制剂的致泻效价,取得较好结果,表明本文建立的生物检定方法及参照物质可用于泻下类中药的质量控制。The essential issues of bioassay methods for quality control of traditional Chinese medicines （TCM） were investigated and discussed through the instantiation of developing the bioassay methods for laxative drugs. For the relatively broad variation of the quality of TCM, which might be influenced much by many factors, the parallel lines model of quantitative response is preferred to control the quality of TCM for its relatively high accuracy. The parallel model of quantal response is alternative while the sample can not meet the reliability standard for quantitative response model. According to the requirement of homogeneity between reference and sample for bioassay, the extract from referenced crude meterial is suitable to be used as reference substance after standardizing and defining by chemical substances, and to give reference to the establishment and reproducibility of authorized standard substance. The results of determination of the purgative biopotency of different species of rhubarb and the compound preparations showed that the bioassay methods and self-made reference substance established in this study could be used to control the quality of laxative medicines.

关 键 词：质量控制 生物效价 大黄 泻下作用 

分 类 号：R917[医药卫生—药物分析学]