灯盏细辛注射液生物活性限度测定方法适用性研究  

The Study of Bioactivity Limit Method on Fleabane Injection

作　　者：芮菁[1] 张月玲[1] 李元静[1] 唐元泰[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《中国药品标准》2010年第2期95-99,共5页Drug Standards of China

摘　　要：目的:探讨灯盏细辛注射液生物活性测定方法的适用性。方法:经预试验,采用小鼠体内血栓形成试验和急性脑缺血试验、大鼠体内和体外血小板聚集试验,观察不同批号灯盏细辛注射液的药理作用,作为生物活性测定方法和限值确定依据。结果:3批样品中有2批样品小鼠30mL.kg-1可明显增加血栓形成试验偏瘫恢复数,明显延长急性脑缺血试验小鼠存活时间;大鼠10mL.kg-1可降低体内血小板最大聚集率,另一批反应较弱。3批样品对ADP诱导大鼠体外血小板聚集率有明显抑制作用,体内体外结果作用趋势相近。结论:灯盏细辛注射液三批样品对不同药理模型呈现不同的活性作用差别,考虑均可作为生物活性测定方法。建议选用其中之1～2种方法和10～30mL.kg-1限值剂量对产品进行质量内部控制,积累数据,为制定正式标准提供依据。Objective： To investigate the applicability of bioactivity assay method on the Fleabane Injection. Methods： After pre-test, to observe the pharmacological effects of different batches of Fleabane Injection by thrombosis test in vivo and acute cerebral ischemia test on mice, platelet aggregation test in vivo and in vitro on rats, as the definition evidences of bioactivity assay method and limit value. Results ： Among the three batches of samples, there are two batches can signifieantly increase the number of hemiplegia recovery in thrombosis test,prolong the survival time in acute cerebral ischemia test on mice 30 mL · kg^-1 , and reduce the maximum platelct aggregation rate in vivo on rats 10 mL · kg^-1 , but the response of another batch is so weak. Three batehes of samples can significantly inhibit the ADP-induced platelet aggregation rate in vitro on rats, and action trend is similar between in vitro and in vivo. Conclusions： The three batches of Fleabane Injection samples show different bioactivity effects on the various pharmaeological models, and all of them can be used as the assay method of bioactivity. One or two kinds of the methods and 30 mL · kg^-1 limit dose can be choosed to use in the internal quality control of produets and the accumulation of data, in order to provide the evidences for making formal standards.

关 键 词：灯盏细辛注射液 中药质量标准 生物活性 限度测定方法 

分 类 号：R277.733.3[医药卫生—中医学]