| 引用本文: | 刘娅灵，邹霈，罗世能，谢敏浩，何拥军，吴军，王洪勇.辅料对碘昔兰注射液高温灭菌稳定性的影响[J].中国现代应用药学,2009,(3):221-223. |
| LIU Yaling,ZOU Pei,LUO Shineng,XIE Minhao,HE Yongjun,WU Jun,WANG Hongyong.The Effects of Excipient on the Sterile Stability of Ioxilan Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2009,(3):221-223. |
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| 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。 |
| 关键词: 辅料 碘昔兰注射液 稳定性 |
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| The Effects of Excipient on the Sterile Stability of Ioxilan Injection |
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LIU Yaling,ZOU Pei,LUO Shineng,XIE Minhao,HE Yongjun,WU Jun,WANG Hongyong
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| Abstract: |
| OBJECTIVE To observe the effects of excipient on the sterile stability of Ioxilan Injection. METHODSThe pH values,free iodide,chromatographic purity and the contents of Ioxilan Injection were measured. The change were calculated before and after sterilization at 120 ℃.RESULTSThe results showed that the injection containing tris(hydroxymethyl) aminomethane 1.0 mg·mL-1 and EDTA disodium calcium 0.1 mg·mL-1 is the stablest. CONCLUSIONIoxilan Injection should contain tris(hydroxymethyl) aminomethane1.0 mg·mL-1 and EDTA disodium calcium 0.1 mg·mL-1. |
| Key words: excipient Ioxilan Injection stability |
