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目的:考察清开灵注射液细菌内毒素检查法可行性。方法:利用不同厂家生产的鲎试剂和不同厂家生产的清开灵注射液进行干扰试验,全面考察清开灵注射液对细菌内毒素检查的干扰作用,以确定其最大不干扰浓度。结果:18批清开灵注射液稀释至60倍,使用灵敏度为0.125?EU·mL-1?的鲎试剂进行细菌内毒素检查,12批(66.7%)供试品细菌内毒素检查符合规定;其余6批(33.3%)供试品对此法存在一定干扰因素。结论:清开灵注射液细菌内毒素检查仍需要严格的方法学验证。
Objective: To investigate the feasibility of bacterial endotoxin test of Qingkailing injection. Methods: The interference test was conducted by using different reagents produced by different manufacturers and Qingkailing injection produced by different manufacturers to comprehensively investigate the interference effect of Qingkailing injection on bacterial endotoxin test to determine its maximum non-interference concentration. Results: 18 batches of Qingkailing injection were diluted to 60 times. Bacterial endotoxin test was carried out using the 鲎 reagent with a sensitivity of 0.125 EU-mL-1,. 12 batches (66.7%) of the samples were tested for bacterial endotoxin. The remaining six batches (33.3%) of the test for this method there is a certain interference factor. Conclusion: The bacterial endotoxin test of Qingkailing injection still needs rigorous methodological verification.