清开灵注射液细菌内毒素检查法研究

Study on Bacterial Endotoxin Test Method Of Qingkailing Injection

目的:建立清开灵注射液细菌内毒素检查法。方法:依据2015年版《中国药典》四部(通则1143)细菌内毒素检查法,通过预干扰试验和干扰试验,确定清开灵注射液最大无干扰的浓度,并进行方法学验证。结果:将清开灵注射液稀释15倍,对细菌内毒素检测法无干扰作用。结论:建立的方法可用于检查清开灵注射液。

Objective To establish a method for bacterial endotoxin test of Qingkailing injection. Methods Maximal non - interference concentrations of samples were determined by pre - interference test according to The four part of the Chinese Pharmacopoeia 2015 Edition （general rules 1143 ）. And then methodology validation was conducted. Results The interference on bacterial endotoxin test could be excluded when the sample was diluted 15 times. Conclusion The established method is feasible to detect the bacterial endotoxin of Qingkailing injection.