【摘要】 [目的]检验粘克TM可吸收医用膜是否符合生物材料的热原要求,建立粘克TM可吸收医用膜的细菌内毒素检查方法。[方法]按《中华人民共和国药典》2005年版附录及GB/16175-1996规定,同时采用热原检查法和细菌内毒素检查法对粘克TM可吸收医用膜72h的浸提液样品进行检测。[结果]该浸提液对细菌内毒检测不产生干扰,细菌内毒素试验结果为阴性。同时受试家兔体温升高均低于0.6℃,并且3只家兔体温升高总和低于1.4℃。[结论]粘克TM可吸收医用膜不含引起机体发热的内毒素或致热原,符合医用生物材料的使用标准。用细菌内毒素检查法替代家兔热原法对该可吸收膜进行热原检查是可行的。更多还原

【Abstract】 [Objective]To establish a new method for bacterial endotoxin test of NiankeTM absorptive medical film.[Methods]The pyrogen test and the bacterial endotoxin test were performed to detect NiankeTM absorptive medical film according to the Chinese Pharmacopoeia edited in 2005 and GB/16175-1996.[Results]The test showed that the extract from the absorptive medical film did not disturb the reaction with tachypleus amebocyte lysate. The NiankeTM absorptive medical film passed the pyrogen test.[Conclusion]The bacterial endotoxin test may replace the rabbit pyrogen test in detection the NiankeTM absorptive medical film.更多还原