天麻素注射液细菌内毒素检查方法的标准化研究

目的建立天麻素注射液细菌内毒素的快速检查法,并进行标准化研究,以利于产品质控。方法按《中国药典》2010年版（二部）附录收载的细菌内毒素检查方法进行。结果不同生产厂家不同灵敏度的鲎试剂进行干扰试验,提示供试品1∶20稀释液无干扰作用。建立试验方法,选取10批供试品进行检查,并与家兔法对比,二者结果一致。结论该制剂以鲎试剂细菌内毒素检查法作为标准方法进行热原检查是可行的。细菌内毒素限值可定为0.1EU/mg。

Standardization for bacterial endotoxins test of Gastrodin Injection

Objective To establish a rapid standardized bacterial endotoxin test method for the quality control of Gastrodin Injection （GI）. Methods The tests were carried out according to the bacterial endotoxin test method in Chinese Pharmacopoeia 2010. Results The interferential test with tachypleus amebocyte lysate of different sensitivity and manufacturers was carried out for GI. The solution of GI （1：20） had no interference on the test. Furthermore, 10 batches of specimens were measured, and the results were coincident with those by rabbit pyrogen test. Conclusion The bacterial endotoxin test method for GI has been established and is feasible to use as a standard. The bacterial endotoxin limit could be 0.1 EU/mg.