盐酸克林霉素注射液细菌内毒素检查无干扰的最佳浓度探讨

Establishment of bacterial endotoxin test of Clindamycin hydrochloride injection

目的确定盐酸克林霉素注射液细菌内毒素检查无干扰的最佳浓度。方法根据选择不同灵敏度的市售鲎试剂,进行干扰预实验和干扰实验,确定盐酸克林霉素注射液与鲎试剂无干扰的浓度。结果 2.5 mg/mL以下浓度的盐酸克林霉素注射液对鲎试剂无干扰。结论盐酸克林霉素注射液细菌内毒素检查应稀释48倍(2.5 mg/mL),选择灵敏度为0.25～0.03 EU/mL的鲎试剂。

Objective To determine the optimal concentration that the clindamycin hydrochloride injection did not interfere with bacterial endotoxin test.Methods The concentration of sample were determined by pre-interference test according different sensitivity of commercially available limulus reagenLResults Below 2.5mg/mL concentration of clindamycin hydrochloride injection did not interfere with the limulus reagentConclusion The bacterial endotoxin of clindamycin hydrochloride injection should choose the sensitivity of 0.25-0.03 EU/mLlimulus reagent when the sample was diluted 48 times.