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目的:探讨细菌内毒素检查法在一次性使用无菌注射器和玻璃注射器检查中应用的可行性。方法:根据中国药典2000年版二部收载的细菌内毒素检查法的要求进行实验。结果:通过干扰实验证明,供试品提取液对鲎试剂的凝集反应无干扰作用,用标示灵敏度为(λ)0.25 EU·ml~(-1)的鲎试剂检查细菌内毒素的方法可行、有效。结论:该法可用于一次性使用无菌注射器和玻璃注射器的细菌内毒素检查。
Objective: To investigate the feasibility of bacterial endotoxin test in single-use sterile syringes and glass syringes. Methods: According to the Chinese Pharmacopoeia 2000 edition of the two contained bacterial endotoxin test requirements of the experiment. Results: The results of interference experiments showed that there was no interference effect on the agglutination reaction of the test reagent with the test sample extract. The method of checking the bacterial endotoxin with the test reagent labeled with (λ) 0.25 EU · ml -1 was feasible and effective . Conclusion: This method can be used for single-use sterile syringe and glass syringe bacterial endotoxin test.