注射用头孢哌酮钠的细菌内毒素检查方法探讨
注射用头孢哌酮钠,,注射用头孢哌酮钠,；细菌内毒素检查,；干扰试验,1实验材料,2方法与结果,3讨论,参考文献
摘 要 目的：建立注射用头孢哌酮钠的细菌内毒素检查法。方法：确定注射用头孢哌酮钠的细菌内毒素限值及进行干扰试验测定最大非干扰浓度。结果：注射用头孢哌酮钠对细菌内毒素检查有抑制作用，通过稀释的方法可排除干扰，其最大非干扰浓度为250 mg/mL。结论：选择适宜灵敏度的鲎试剂，注射用头孢哌酮钠的热原检查可用细菌内毒素检查法代替家兔法。关键词 注射用头孢哌酮钠 ；细菌内毒素检查 ；干扰试验
Study on the inspection method for bacterial endotoxin in sodium cefoperazone injection
Abstract Objective:To establish a inspection method for bacterial endotoxin in cefoperazone sodium injection. Methods: The limitation of endotoxin in sodium cefoperazone injection was determined and a disturbance test was applied to determine the maximum nondisturbing concentration. Results: Sodium cefoperazone injection could interfere the detection of bacterial endotoxin, which could be avoided through the dilution of the preparation to 2.50 mg mL. Conclusion: The determination of bacterial endotoxin can be used to replace the detection of pyrogen in sodium cefoperazone injection.
Key words sodium cefoperazone injection; bacterial endotoxin; testing for disturbance
注射用头孢哌酮钠为中国药典(2000年版二部)[1]收载的品种 ......
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