注射用甲磺酸加替沙星细菌内毒素检查法研究

The Bacterial Endotoxins Test of Gatifloxacin Mesylate for Injection Experimental Study

目的建立注射用甲磺酸加替沙星细菌内毒素检测方法。方法用不同厂家的鲎试剂对不同批号的注射用甲磺酸加替沙星分别进行干扰试验,考察确立注射用甲磺酸加替沙星细菌内毒素检测方法。结果注射用甲磺酸加替沙星稀释液500μg.mL-1、83.3μg.mL-1对细菌内毒素检测无干扰。结论注射用甲磺酸加替沙星可用细菌内毒素检查方法取代家兔热原检查法。

OBJECTIVE To study the bacterial endotoxin test for gatifloxacin mesylate for injection using tachypleus amebocyte lysate. METHODS By interfering test, the inhibition/enhancement action of gatifloxacin mesylate for injection with limulus lysate was studied. RESULTS The interference between the sample and the relative TAL was eliminable when the sample was diluted 500 μg · mL^-1 or 83.3 μg · mL^-1. CONCLUSION The result of bacterial endotoxin test of gatifloxacin mesylate for injection is the same as that of the pyrogen test with healthy mature rabbits.