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
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摘要: 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。Abstract: 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 exammatron.
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Key words:
- procaine hydrochloride injection /
- bacterial endotoxin /
- limulus test /
- extraction
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