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细菌内毒素检查法是利用鲎试剂与细菌内毒素产生凝集反应的机理,以判定供试品中的细菌内毒素的限值是否符合规定的一种方法。细菌内毒素检查法与热原检查法(家兔法)相比,具有操作简单、灵敏度高、重现性好的特点。随着对细菌内毒素检查法的深入研究,检查品种也逐步增加,为此,我们对克林霉素磷酸酯葡萄糖注射液细菌内毒素检查的可行性进行验证,认为鲎试验法检测本品中的细菌内毒素是可行的。
Bacterial endotoxin test is the use of limulus agents and bacterial endotoxin produce agglutination reaction mechanism to determine whether the limits of bacterial endotoxin in the test is in line with the provisions of a method. Bacterial endotoxin test and pyrogen test (rabbit law) compared with the simple operation, high sensitivity, good reproducibility. With the in-depth study of bacterial endotoxin test, the test species also gradually increased, therefore, we test the feasibility of bacterial endotoxin test clindamycin phosphate glucose injection to verify that 鲎 test method to detect this product Bacterial endotoxins are viable.