盐酸丁卡因注射液细菌内毒素检查可行性研究

Study on the Feasibility of Bacterial Endocoxin test forTetr-acaine Hydrochloride Injection

目的探讨盐酸丁卡因注射液细菌内毒素检查的可行性,拟建立规范检查方法。方法按《中国药典》(2005年版二部)规定,用两个厂家生产的鲎试剂(TAL)对盐酸丁卡因注射液进行细菌内毒素干扰试验。结果盐酸丁卡因注射液经10倍稀释后对细菌内毒素与鲎试剂的反应无干扰作用。结论用凝胶法进行细菌内毒素检查是可行的。

Objective To study the feasibility of bacterial endocoxin test for Tetracaine Hydrochloride injection as a substitution for pyrogen test.Methods According to Chinese Pharmacopoeia（second part,2005）,interference test was carried on endotoxin detection of Tetracaine Hydrochloride Injection with limulus lysate test agents produced by two different factories.Results There was no interference with the reaction between bacterial endotoxin and limulus lysate test agents in Tetracaine Hydrochloride Injection in 10-fold dilution.Conclusion It is feasible to use the gelatin method in bacterial endotoxin test.