氨磷汀热原检查方法研究

目的：考察氨磷汀对家兔体温的影响，建立氨磷汀细菌内毒素检查方法。方法：采用热原检查法测定家兔注射氨磷汀后的体温，并用不同厂家的鲎试剂对不同厂家不同批号的氨磷汀和注射用氨磷汀分别进行细菌内毒素检查试验。结果：氨磷汀（80 mg·kg^-1）致家兔体温明显下降，在0.5~1 h 时家兔体温降低达1.0 ℃以上，降温幅度最大。在200 只家兔中，体温下降0.4~0.5 ℃的比率为26%，降低0.6~1.0 ℃的比率为39%，且细菌内毒素5 EU·kg^-1 不能有效翻转其降温作用；氨磷汀细菌内毒素检查法的最大不干扰浓度为2.5 mg·mL^-1。结论：家兔法不适合用于氨磷汀的热原检查，不能有效进行质量控制；细菌内毒素检查法是可行的，不易产生假阴性结果。其限度拟订为0.2 EU·mg^-1。

Objective:To investigate effect of amifostine on rabbits body temperature,so as to provide bacterial endotoxin test(BET)method for amifostine.Methods:The body temperature of rabbits following administration of amifostine were taken according to pyrogen test,and interference tests were conducted on different batches of amifostine and amifostine for injection with different TAL manufactures.Results:The body temperature of rabbits dropped significantly after injecting amifostine(80 mg·kg^-1),a maximal temperature drop in body temperature was recorded within 30 minutes to 60 minutes (more than 1.0 ℃).A temperature drop of 0.4 ℃ to 0.5 ℃ and 0.6 ℃ to 1.0 ℃ induced by amifostine were 26% and 39% among 200 rabbits,respectively.5 EU·kg^-1 of bacterial endotoxin could not antagonize the change in body temperature caused by amifostine.The maximum non-interfered concentration of amifostine for bacterial endotoxin test was 2.5 mg·mL^-1.Conclusion:Our data infer that the rabbit pyrogen test method is not suitable for amifostine quality control.Instead,the BET may be a reliable method to control quality of amifostine which can reduce false negative results.The endotoxin limit is specified in 0.2 EU·mg^-1.

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