注射用水溶性维生素细菌内毒素检查法质量标准研究

Study on Bacterial Endotoxin Test for Water-Soluble Vitamin for Injection

目的:在现行的国家标准的基础上对注射用水溶性维生素细菌内毒素检查法进行再研究。方法:按《中国药典》2005年版二部,确定本品合理的内毒素限值,并研究不使用缓冲液配制供试液对内毒素与鲎试剂反应的干扰情况。结果:本品使用现有的国家标准所确定的内毒素限值25EU·瓶-1;同时研究证明配制供试液不使用缓冲液完全可行。结论:注射用水溶性维生素细菌内毒素检查直接使用BET水配制供试液即可,而不需要使用缓冲液。

Objective： On the basis of the national standard, we have studied on bacterial endotoxin test for Water-soluble Vitamin for Injection. Methods： The limit of bacterial endotoxin in this product was defined according to ChP2005. we have studied the interference to bacterial endotoxins test by Water-soluble Vitamin for Injection in order to confirm the maximum noninterference concentration. Results：The most suitable limit of bacterial endotoxin in Water-soluble Vitamin for Injection was 25 EU/bottle. It was proved that the test solution can use BET water to confect and not use the special solution. Conclusion： Water-soluble Vitamin for Injection can sot up the standard for the bacterial endotoxins test ; at the same time the test solution can use the BET water to confect.