萃取除扰鲎试验检查盐酸普鲁卡因注射液细菌内毒素

Detecting bacterial endotoxin in procaine hydrochloride injection by limulus test after excluding interferentail factor by extraction

目的:建立盐酸普鲁卡因注射液的细菌内毒素检查法,探讨萃取法排除鲎试剂与细菌内毒素凝集反应干扰因素的可行性。方法:利用普鲁卡因的脂溶性将普鲁卡因排除后行细菌内毒素检查法。结果:15批盐酸普鲁卡因注射液中细菌内毒素均低于0.5EU·mL^(-1),真实地反映普鲁卡因注射液中细菌内毒素的污染程 度。结论:萃取法去除鲎试验干扰因素可扩大细菌内毒素检查法的应用范围。

OBJECTIVE:To establish a method of detecting bacterial endotoxin( BET) in procaine hydrochlo-ride injection, and to explore the feasibility of excluding interferentail factor of limulus test by extraction. METHODS: After sodium hydroxide changed procaine hydrochloride into procaine, and chloroform extracted procaine, limulus test was performed. RESULTS: 15 batchs of procaine hydrochloride injection were detected. The quantity of BET in each batch was less than 0. 25EU· mL-1 , and their BET pollution degree were described truly. CONCLUSION: Extraction excluding the interferentail factors of limulus test could widen range of application of BET examination.