注射用对氨基水杨酸钠的细菌内毒素检查

Bacterial Endotoxin Test on Amino Sodium salicylate for injection

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 develop the method of bacterial endotoxin test on amino sodium salicylate for injection. Method： The interference tests were performed to the quantitative test and gel limited method of bacterial endotoxin test included in CP 2005. Result： No interference was found when tested sample with concentration of 2.5 mg·ml^-1 and amehocyte lysate sensitivity of 0.06 EU.ml^- 1 in the gel limited method. The recovery was better than that of gel limited method when tested sample was same in the quantitative method and there were no interference also. Conclusion： Bacterial endotoxin test is applicable to amino sodium salieylate for injection.