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目的 :考察灭菌温度、pH值、等渗调节剂对替硝唑注射液降解产物的影响 ,指导制剂的开发和生产。 方法 :制备不同灭菌温度、pH值、等渗调节剂的注射液样品 ,采用重氮化偶合比色法测定NO-2 的浓度 ,HPLC面积归一法测定有机降解物峰面积百分比。结果 :随灭菌温度、pH值的升高 ,NO-2 的浓度和有机降解物峰面积百分比均有不同程度的增加 ,其中pH值影响较大 ,有机降解物增加较为明显。结论 :注射剂 pH值应控制在3.5～ 5 .0之间 ,灭菌条件以 110℃ 30min为佳 ,以氯化钠调节等渗是可行的
OBJECTIVE: To investigate the effects of sterilization temperature, pH and isotonicity regulator on the degradation products of tinidazole injection and to guide the development and production of the preparation. Methods: The injection samples with different sterilization temperature, pH value and isotonicity regulator were prepared. The concentration of NO-2 was determined by diazotization coupling colorimetric method. The area percentage of organic degradation products was determined by HPLC area normalization. Results: With the increase of sterilization temperature and pH value, the concentration of NO-2 and the percentage of peak area of organic degradates all increased to some extent. Among them, pH value had a great effect and the organic degradates increased more obviously. CONCLUSION: The pH value of injection should be controlled between 3.5 and 5.0, and the sterilization conditions should be 110 ℃ and 30 min, and it is feasible to adjust the isotonicity with sodium chloride