动态浊度法检测5种中药注射液的内毒素含量

目的:通过特异性及非特异性鲎试剂(TAL)动态浊度法对5种中药注射液的内毒素含量进行检测,探讨该方法对中药注射液检测的适用性。方法:采用特异性及非特异性动态浊度试剂盒,对不同批次的鱼腥草注射液、双黄连注射液、清开灵注射液、葛根素注射液、香丹注射液进行检测。结果:无色的中药注射剂如鱼腥草注射剂、葛根素注射剂对检测干扰较少,非特异性及特异性动态比浊法对其无显著影响;对非单一成分,颜色较深的中药注射液,如清开灵、香丹、双黄连注射液,采用动态比浊法进行检测,干扰大,检测结果不稳定;清开灵注射剂采用特异性试剂盒进行检测能有效的消除干扰,但香丹、双黄连注射液仍不能消除干扰。结论:用特异性或非特异性动态浊度法可以检测鱼腥草和葛根素注射液中的内毒素含量,采用特异性动态浊度法可以检测清开灵注射液中内毒素含量,双黄连和香丹注射液的检测结果不稳定。

Detection of Bacterial Endotoxin for Five Traditional Chinese Medicine Injections by Kinetic Turbidimetric Assay

Objective : To investigate the applicability of the detection of bacterial endotoxin in five kinds of traditional Chinese medicine injections by nonspecific and specific tachypleus amebocyte lysate(TAL) of kinetic turbidimetric assay. Method: Yuxingcao, Shuanghuanglian, Qingkailing, Gegensu, and Xiangdan injections were detected by nonspecific and specific TAL lysate of kinetic turbidimetric assay. Result: There were less interferences during detective process of achromaticity injections such as Yuxingcao and Gegensu, on the other hand, there were more interference of multi-component and dark color such as Shuanghuanglian, Qingkailing, and Xiangdan injections using TAL of kinetic turbidimetric assay, interference was big and the result was instable. The interference could be removed effectively by using specific TAL of kinetic turbidimetric assay, such as the case of Qingkailing. However, the interference for shuanghuanglian, Xiangdan injections could not be eliminated interference using this method. Conclusion : It is feasible to perform the bacterial endotoxin test on Yuxingcao and Gegensu injection using normal TAL and specific TAL through kinetic turbidimetric assay, using specific TAL of kinetic turbidimetric assay as a substitute for nonspecific is a effective method in removing the interference for Qingkailing injection, the detection result of Shuanghuanglian and Xiangdan injection are instable.