动态浊度法定量检测清开灵注射液中的内毒素

Quantitative Determination of Endotoxin in Qingkailing Injection by Kinetic Turbidimetric Technique

目的：对清开灵注射液进行内毒素动态浊度法检查实验，建立定量检测清开灵注射液中内毒素实验方法以代替热原检查法，提高内毒素的检出率，避免临床热原反应的发生。方法：采用《中国药典》2000年版附录检测内毒素的动态比浊法。结果：清开灵注射液经10倍及以上倍数释释后，对鲎试刺反应无干扰作用，内毒素回收率在50％-200％范围内。结论：本方法干扰因素小，检测结果准确，可作为日常检测使用。

Objective：To establish the kinetic turbidimetric technique for quality control on endotoxin content in Qingkailing Injection. To set up a reasonable limit of endotoxin for Qingkailing Injection and establish a rapid method for examining endotoxin instead of pyrogen test. Methods ：The kinetic turbidimetric technique in Chinese pharmacopoeia 2000 edition was used. Results：Qingkailing Injection did not interfere with limulus test in 1 ： 10 dilution,The endotoxin recovery was more than 50 percent and less than 200 percent. Conclusion：This mehod is slight in interference and accurate in detection result,and can be used in routine assay.