摘要
目的对注射用环磷腺苷葡胺进行凝胶法干扰试验,建立注射用环磷腺苷葡胺的细菌内毒素检查试验方法。方法按照《中国药典)2010年版(二部)附录ⅪE进行实验和结果判断。结果注射用环磷腺苷葡胺稀释至浓度0.15mg.mL-1时对细菌内毒素检查法无干扰作用。结论使用细菌内毒素检查法检查注射用环磷腺苷葡胺中的细菌内毒素是可行的,可用细菌内毒素检查法代替家兔热原检查法。
Objective To establish a method for bacterial endotoxin test of Meglumine Adenosine Cyclophosphate for Injection by gelation assay and interference test.Methods According to the method of bacterial endotoxin test approved by Appendix ⅪE of Chinese Pharmacopoeia 2010 VolⅡ.Results The interference on bacterial endotoxin test can be excluded when Meglumine Adenosine Cyclophosphate for Injection was diluted to 0.15 mg·mL^-1.Conclusion It was feasible to detect the bacterial endotoxin of Meglumine Adenosine Cyclophosphate for Injection by bacterial endotoxin test and the method may replace rabbit pyrogen test.
出处
《齐鲁药事》
2011年第3期146-147,共2页
qilu pharmaceutical affairs
关键词
注射用环磷腺苷葡胺
细菌内毒素
凝胶法
干扰试验
Meglumine Adenosine Cyclophosphate for Injection
Bacterial endotoxin
Gelation assay
Interference test
