替硝唑注射液的细菌内毒素检查研究

目的 想建立替硝唑注射液的细菌内毒素检查法最佳方法,研究以细菌内毒素检查法代替家兔法对替硝唑注射液进行热原检查的可行性.方法 本实验根据鲎试剂在不产生干扰条件下能对样品进行细菌内毒素检查的原理,按照〈中国药典〉2005年版附录XIE细菌内毒素检查法要求进行实验,采用凝胶法鲎试验法,用两个厂家生产的鲎试剂,对连续生产的3批替硝唑注射液按有效浓度范围稀释后,进行干扰实验观察,然后进行细菌内毒素检查,所得结果与家兔法检查热原的结果进行对比.结果 使用灵敏度为0.25 EU/ml的鲎试剂,替硝唑注射液的2倍稀释液对两个厂家的鲎试剂均不产生干扰,3批替硝唑注射液的细菌内毒素检查结果与家兔法所得结果一致.结论 细菌内毒素检查法代替家兔法对替硝唑注射液进行热原检查是可行的.

Bacterial endotoxin test for tinidazole injections

Objective To establish the best bacterial endotoxin test for tinidazole injections and to search the feasibility of bacterial endotoxin test for monitoring pyrogens of tinidazole injections. Methods Tachypleus amebocyte lysate could test the samples if they did not have interference, so the interference test was very important. It could judge whether the bacterial endotoxin test can be used in the samples. The interference test was conducted on three lots of tinidazole injections with two products of tachypleus amebocyte lysate (TAL) reagent according to the appendix XI E of Chinese. Pharmacopeia (2005) vol Ⅱ. The dilution times of the sample should be in the maximum valid dilution. And then proceed to bacterial endotoxin test. The finding of the bacterial endotoxin test was compared with the result of pyrogen test. Results Three lots of Tinidazole injection diluted up to two times did not interfere with bacterial endotoxin as the sensitivity of tachypleus amebocyte lysate was 0.25 EU/mL. The result of bacterial endotoxin test was the same as the pyrogen test.Conclusions Bacterial endotoxin test can be used to replace pyrogen test.