汉防己甲素注射液细菌内毒素检查方法研究

Study on Bacterial Endotoxin Test to Tetrandrine Injection

目的:建立汉防己甲素注射液细菌内毒素检查法。方法:采用《中国药典》2005年版附录细菌内毒素检查法。结果:汉防己甲素注射液浓度为0.25mg.mL-1,用灵敏度为0.25 Eu.mL-1的鲎试剂检测细菌内毒素无干扰因素的影响。结论:汉防己甲素注射液可应用鲎试剂进行细菌内毒素检查。

Objective ： To Establish detection method of bacterial endotoxin test to tetrandrine injection. Methods ： According to the bacterial endotoxin test in Chinese pharmacopoeia 2005 edition. Results： It was proved that the maximum noninterference concentration was 0, 25mg· mL^-1 and the sensitivity of TAL was 0.25 Eu · mL^-1. Conclusion： The results suggested that bacterial endotoxin test is suitable for the detection of endotoxin in tetrandrine injection,