目的 建立天麻素注射液細(xì)菌內(nèi)毒素的快速檢查法，并進(jìn)行標(biāo)準(zhǔn)化研究，以利于產(chǎn)品質(zhì)控。方法 按《中國藥典》2010年版（二部）附錄收載的細(xì)菌內(nèi)毒素檢查方法進(jìn)行。結(jié)果 不同生產(chǎn)廠家不同靈敏度的鱟試劑進(jìn)行干擾試驗(yàn)，提示供試品1∶20稀釋液無干擾作用。建立試驗(yàn)方法，選取10批供試品進(jìn)行檢查，并與家兔法對(duì)比，二者結(jié)果一致。結(jié)論 該制劑以鱟試劑細(xì)菌內(nèi)毒素檢查法作為標(biāo)準(zhǔn)方法進(jìn)行熱原檢查是可行的。細(xì)菌內(nèi)毒素限值可定為0.1 EU/mg。

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.