注射用更昔洛韦细菌内毒素检查法的实验研究
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【摘要】 目的 研究注射用更昔洛韦对细菌内毒素检查实验的干扰情况，并建立其细菌内毒素检查的质量标准。方法 参照《中国药典》2000年版二部附录Ⅺ E细菌内毒素检查法进行试验，用二个不同厂家的鲎试剂对注射用更昔洛韦进行干扰试验研究。结果 注射用更昔洛韦稀释成0.5 mg/ml时对细菌内毒素检查无干扰作用。结论 可以用细菌内毒素检查法(凝胶法)代替家兔热原检查法控制其产品质量。
【关键词】注射用更昔洛韦；细菌内毒素检查；干扰试验
Research of Bacterial Endotoxin Test in Ganciclovir for Injection
【Abstract】 Objective To study the interference of Ganciclovir for Injection in bacterial endotoxin test and to establish bacterial endotoxin test method for the sample. Method According to China Pharmacopoeia 2000, inhibition or enhancement test for bacterial endotoxin test was performed with Amebocyte Lysate manufactured by two different companies. Results The interfere on the determination of bacterial endotoxins can be excluded when Ganciclovir for Injection was diluted 0.5 mg/ml.Conclusion The results suggest that Bacterial Endotoxins test (gel-clot method) can be used as an alternative method for the rabbit pyrogen test for Ganciclovir for Injection. ......
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