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目的考察不同辅料对国产碘昔兰注射液高温灭菌稳定性的影响。方法测定120℃高温灭菌前后8组含不同辅料的碘昔兰注射液的pH值、游离碘离子浓度、色谱纯和含量变化。结果同时含三羟甲基氨基甲烷1.0mg·mL-1和乙二胺四乙酸二钠钙0.1mg·mL-12种辅料时,碘昔兰注射液最稳定。结论碘昔兰注射液应含辅料三羟甲基氨基甲烷1.0mg·mL-1和乙二胺四乙酸二钠钙0.1mg·mL-1。
Objective To investigate the effects of different excipients on the stability of domestic sterilized Isesilan injection at high temperature. Methods The changes of pH value, free iodine ion concentration, chromatographic purity and content of 8 groups of iodine blue injection with different excipients before and after high temperature sterilization at 120 ℃ were determined. The result showed that the iosilan injection was the most stable when containing 1.0 mg · mL-1 trihydroxymethyl aminomethane and 0.1 mg · mL-12 calcium disodium edetate. Conclusion Ioxilan injection should contain trometamol 1.0mg · mL-1 and edetate 0.1mg · mL-1.