摘要
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 。
OBJECTIVE:To study the effect of sterilization temperature,pH and isotonic regulator to degradation produce of tinidazole injection.METHODS:Prepare the injection at different sterilization temperature,pH and isotonic regulator concentrations determine NO - 2 with diazotization method,determine the peak area percentage of the oragnic degradation product with HPLC.RESULTS:The concentration of NO - 2 and the peak area percentage increased with the raise of sterilization temperature and pH.CONCLUSIONS:The pH should be controled within 3.5 ～ 5.0 ,the best condition is 30 min at 110 ℃,the sodium chloride as isotonic regulator is reliable.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2000年第4期218-220,共3页
Chinese Journal of Hospital Pharmacy
关键词
替硝唑
灭菌温度
PH值
等渗调节剂
tinidazole
degradation product
diazotization method
HPLC
