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ⅪE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/m l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。
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 Ganeiclovir 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.
出处
《中国实用医药》
2008年第27期69-71,共3页
China Practical Medicine
