杏丁注射液细菌内毒素检测

THE DETERMINATION OF THE ENDOTOXIN IN XINGDING INJECTION

目的:建立杏丁注射液细菌内毒素的检查方法。方法:按中国药典2000版二部附录ⅪE、ⅪⅩ F进行实验和结果判断。结果:用标示灵敏度为0.5EU·ml^(-1)的鲎试剂,杏丁注射液在≤最大有效稀释倍数(6—MVD)时,对细菌内毒素检查无干扰作用。13批杏丁注射液中细菌内毒素量均小于3EU·ml^(-1)。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热原。

Objective: To set up the endotoxin determination method for monitoring pyrogen ofXingding Injection. Methods: The experiment was made and the result was judged according to the ap-pendix XI E,XIX F of Chinese Pharmacopeia (2000) vol Ⅱ. Results:The reaction with amebocyte lysatewas not disturbed in six times to maximum valid dilution by Xingding Injection, when sensitivity was0.5EU·ml^(-1). The endotoxin content was even less than 3EU·ml^(-1) in each of thirteen lots Xingding Injec-tion. Conclusions:Amebocyte Lysate method can be used in place of rabbit method for pyrogen monitoringof Xingding Injection.