注射用头孢尼西钠-氯化钠注射液复方制剂的细菌内毒素检查方法学研究

Study on bacterial endotoxin test in Compound Preparation of Cefonicid Sodium for Injection and Sodium Chloride Injection

目的:研究注射用头孢尼西钠-氯化钠注射液复方制剂对细菌内毒素检查试验的干扰情况,建立其细菌内毒素限量检查的方法。方法:采用细菌内毒素凝胶法,用两个厂家的鲎试剂对注射用头孢尼西钠-氯化钠注射液复方制剂连续3批样品进行干扰试验。结果:注射用头孢尼西钠-氯化钠注射液复方制剂最大有效稀释倍氯化钠注射数为2倍稀释液。结论:注射用头孢尼西钠-氯化钠注射液复方制剂用凝胶法进行细菌内毒素检测可行,其内毒素限值为每1 mL复方制剂所含内毒素量应小于0.5 EU。

Objective:To study Compound Preparation of Cefonicid Sodium for Injection and Sodium Chloride Injection whether or not interfering with bacterial endotoxin test,we performed the work and established endotoxin limit in this drug.Methods:The gel-clot method was used in china pharmacopoeia as an evaluation criterion for bacterial endotoxin.The inhibition or enhancement test was carried out on these three lots drugs with two manufacturers tachypleus amebocyte lysate(TAL).Results:The Maximum Valid Dilution 2× of Compound Preparation of Cefonicid Sodium for Injection and Sodium Chloride Injection had no interfering effect.Conclusion:Bacterial endotoxin test on Compound Preparation of Cefonicid Sodium for Injection and Sodium Chloride Injection may be regarede as valid.The bacterial endotoxin limit of Compound Preparation of Cefonicid Sodium for Injection and Sodium Chloride Injection should less than 0.5 Eu/mL.