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目的:建立注射用对氨基水杨酸钠的细菌内毒素检查法。方法:参照《中国药典》2005年版二部细菌内毒素检查的定量测定法与凝胶限量法,对两种方法进行干扰实验。结果:通过对样品进行适当的稀释,凝胶法:样品浓度为2.5mg·ml~(-1)使用灵敏度为0.06EU·ml~(-1)的鲎试剂进行细菌内毒素检查无干扰作用;定量测定法:与凝胶法相同的样品浓度回收率较好,无干扰作用。结论:注射用对氨基水杨酸钠可以建立细菌内毒素检查法。
Objective: To establish a bacterial endotoxin test for sodium p-aminosalicylate for injection. Methods: According to the quantitative determination of bacterial endotoxin in two Chinese Pharmacopoeia (2005 edition) and the gel restriction method, two methods were used to interfere the experiment. Results: By the appropriate dilution of the sample, the gel method: the sample concentration of 2.5mg · ml -1 with a sensitivity of 0.06EU · ml -1 鲎 reagent for bacterial endotoxin test without interference; Quantitative determination method: the same sample concentration gel recovery rate is good, no interference effect. Conclusion: Sodium p-aminosalicylate for injection can be used to establish bacterial endotoxin test.