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目的 :考察不同辅料对国产碘海醇 (Iohexol)注射液稳定性的影响。方法 :测定高温灭菌前后 6组不同辅料的碘海醇注射液pH、碘离子浓度、含量变化。结果与结论 :同时含三羟甲基氨基甲烷 (Tris ,1 .2mg/ml)、乙二胺四乙酸二钠钙 (EDTA Na2 Ca ,0 .1mg/ml) 2种辅料时 ,碘海醇注射液最稳定。
Objective: To investigate the effects of different excipients on the stability of Iohexol injection in China. Methods: The changes of pH value, iodine ion concentration and content of iohexol injection of 6 different excipients before and after high temperature sterilization were determined. RESULTS AND CONCLUSION: When two kinds of excipients containing tris (hydroxymethyl aminomethane) (1. 2mg / ml) and EDTA Na2 Ca (0.1mg / ml) The most stable liquid.