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目的 :探讨用细菌内毒素检查法检测氨甲苯酸注射液中热原。方法 :按《中国药典》 1995年版 1998年增补本规定的方法操作 ,设计干扰初筛及干扰验证试验 ,并与家兔法对照比较。结果 :供试品在稀释 8倍时 ,对试验仍存在抑制性干扰 ,进行 16倍以上稀释时 ,对试验的干扰消除。选用标示灵敏度为 0 0 6EU/ml的鲎试剂对所有供试品进行的干扰验证试验都符合要求 ;对供试品的常规检查与家兔法对比检查的结果一致。结论 :选用灵敏度为 0 0 6EU/ml鲎试剂 ,将供试品作 1∶16稀释 ,用细菌内毒素检查法取代家兔法对氨甲苯注射液作热原检查是可行的
Objective: To investigate the use of bacterial endotoxin test for the determination of pyrogen in amidofenac injection. Methods: According to “Chinese Pharmacopoeia” 1995 edition 1998 supplemented by the provisions of the method of operation, design interference screening and interference verification test, and compared with the rabbit law. Results: When the test sample was diluted 8 times, there was still inhibitory interference on the test. When it was diluted by more than 16 times, the interference of the test was eliminated. Selection of labeling reagent sensitivity of 0 0 6EU / ml of all the interference test for the test to meet the requirements; routine test for the test and rabbit contrast test results. Conclusion: The sensitivity of 0 0 6EU / ml 鲎 reagent, the test sample diluted 1: 16, bacterial endotoxin test instead of rabbit method of ammonia injection of toluene for pyrogen test is feasible