清热解毒类清开灵注射液中热原检测方法的比较  

The comparison of pyrogen test method for Qingkailing injection with heat-clearing and detoxifying effect

作　　者：杨国秀[1] 张同星[2] 彭国平[2] 

机构地区：[1]江苏省中医院,江苏南京210029 [2]南京中医药大学,江苏南京210029

出　　处：《中药与临床》2011年第2期27-29,共3页Pharmacy and Clinics of Chinese Materia Medica

基　　金：江苏省六大人才高峰计划

摘　　要：目的:清热解毒类中药注射剂热原检测中,家兔法和鲎试剂动态浊度法的方法比较。方法:清热解毒类中药以清开灵注射液为研究对象,以外加内毒素制成的清开灵内毒素为清开灵组,生理盐水外加内毒素作为内毒素组,生理盐水组为阴性对照,分别采用家兔热原检查法和动态浊度法进行热原检查。结果:动态浊度法测定生理盐水组、清开灵组、内毒素组的细菌内毒素含量分别为:0.090EU.mL-1、15.465EU.mL-1和15.000EU.mL-1。家兔法测定生理盐水组和清开灵组均无发热反应,清开灵注射液中内毒素热原检查呈假阴性,而内毒素组家兔体温升高均超过0.6℃,发生热原反应。结论:家兔热原检查法对清热解毒类中药注射剂热原检测容易出现假阴性;动态浊度法能定量检测中药注射剂中内毒素的含量。Objective:To compare the effect of rabbit pyrogen test and the tachypleus amebocyte lysate kinetic-turbidimetry assay in pyrogen test of heat-clearing and detoxifying traditional Chinese medicine injections.Method:Qingkailing injection was chosen to investigate.Qingkailing injection with endotoxin was set as the Qingkailing group,and normal saline with endotoxin as the Endotoxin group,and normal saline as set as Saline control group.Rabbit pyrogen test and kinetic-turbidimetry assay were used for pyrogen test respectively for each group.Result:Endotoxin content of Saline control group,Qingkailing group and Endotoxin group were 0.09 EU·mL-1,15.465 EU·mL-1 and 15.0 EU·mL-1 by tubidimetric-kinetic assay.No pyrogen reaction was detected by rabbit pyrogen test in Saline control and Qingkailing group.Negative result was found with the temperature of Endotoxin group rose more than 0.6 ℃.Conclusion:Rabbit pyrogen test for heat-clearing and detoxifying traditional Chinese medicine injections prone to false negative.The kinetic-turbidimetry assay could quantitatively detect the content of endotoxin in injections,and the method is accuracy and reliable.

关 键 词：清开灵注射液 热原 家兔热原检查法 动态浊度法 

分 类 号：R[医药卫生]