注射用七叶皂苷钠细菌内毒素检查方法研究

Study on Bacterial Endotoxin Test to Sodium Aescinate for Injection

目的:建立注射用七叶皂苷钠细菌内毒素检查法。方法:采用《中华人民共和国药典》2005年版附录细菌内毒素检查法。结果:注射用七叶皂苷钠浓度为0.05mg·mL-1,用灵敏度为0.25EU·mL-1的鲎试剂检测细菌内毒素无干扰因素的影响。结论:注射用七叶皂苷钠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 sodium aescinate for injection. Methods ： According to the bacterial endotoxin test in Chinese pharmacopoeia 2005 edition. Results ： It was proved that the maximum noninterference concentration was 0. 05mg · mL^-1 and the sensitivity of TAL was 0. 25EU · mL^-1. Conclusion ：The results suggested that bacterial endotoxin test is suitable for the detection of endotoxin in sodium aeseihate for injection.