盐酸左布比卡因及其注射剂细菌内毒素检查方法的建立

Establishment of Endotoxins Test Method of Levobupivacaine Hydrochloride and Its Injection

目的:建立盐酸左布比卡因及其注射剂细菌内毒素的检查方法。方法:按2010年版《中国药典》(二部)附录细菌内毒素检查法的要求,通过干扰试验确定样品最大不干扰质量浓度,并进行方法学验证。结果:样品的质量浓度为1.56 mg/ml(λ=0.25EU/ml)时对鲎试剂与细菌内毒素之间的凝集反应无干扰;样品的细菌内毒素限值确定为0.08 EU/mg。结论:所建立的方法可用于盐酸左布比卡因及其注射剂的细菌内毒素检查。

OBJECTIVE：To establish a method for the detection of endotoxins in Levobupivacaine hydrochloride（LH）and its injection. METHODS：According to the requirements of 2010 edition of Chinese Pharmacopoeia（second part）bacterial endotoxin inspection,the largest noninterfere quality concentration of samples was determined by interfering test with and method validation.RESULTS：There was no interference in the endotoxins test when the concentration of LH was 1.56 mg/ml（λ of TAL was 0.25 EU/ml）. The limitation of endotoxins was 0.08 EU/mg. CONCLUSIONS：The established method is feasible for the endotoxins test of LH and its injection.