辅料对碘昔兰注射液高温灭菌稳定性的影响  

The Effects of Excipient on the Sterile Stability of Ioxilan Injection

作　　者：刘娅灵[1] 邹霈[1] 罗世能[1] 谢敏浩[1] 何拥军[1] 吴军[1] 王洪勇[1] 

机构地区：[1]江苏省原子医学研究所,江苏无锡214063

出　　处：《中国现代应用药学》2009年第3期221-223,共3页Chinese Journal of Modern Applied Pharmacy

基　　金：江苏省卫生厅科研项目(K200412)

摘　　要：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 observe the effects of excipient on the sterile stability of Ioxilan Injection. METHODS The pH values, free iodide, chromatographic purity and the contents of Ioxilan Injection were measured. The change were calculated before and after sterilization at 120 ℃. RESULTS The results showed that the injection containing iris （hydroxymethyl） aminomethane 1.0mg·mL^-1 and EDTA disodium calcium 0. 1mg·mL^-1 is the stablest. CONCLUSION Ioxilan Injection should contain tris （hydroxymethyl） aminomethane1. 0 mg·mL^-1 and EDTA disodium calcium 0. 1 mg·mL^-1

关 键 词：辅料 碘昔兰注射液 稳定性 

分 类 号：R927.13[医药卫生—药学]