| 姚永青,刘英.对于2015年版《中国药典》注射用氨苄西林钠舒巴坦钠有关物质氨苄西林二聚体定位方法的建议[J].中国药品标准,2016,17(4):243-246 |
| 对于2015年版《中国药典》注射用氨苄西林钠舒巴坦钠有关物质氨苄西林二聚体定位方法的建议 |
| Suggestion about the positioning method of Ampicillin dimer for Related Substance of Ampicillin Sodium and Sulbactam Sodium for Injection in Chinese Pharmacopoeia 2015 Edition |
| 投稿时间：2016-04-18 修订日期：2016-07-14 |
| DOI： |
| 中文关键词: 氨苄西林钠舒巴坦钠 氨苄西林二聚体 |
| 英文关键词: Ampicillin Sodium and Sulbactam Sodium Ampicillin dimer |
| 基金项目: |
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| 中文摘要: |
| 目的：对《中国药典》注射用氨苄西林钠舒巴坦钠有关物质氨苄西林二聚体定位方法进行完善。方法：选择3根不同色谱柱，分别采用药典方法和氨苄西林系统适用性对照品标准图谱方法定位氨苄西林二聚体峰，考察两者结果是否一致。结果：采用药典方法与氨苄西林系统适用性对照品法定位结果不一致。结论：现行标准欠妥，建议对二聚体的定位方法修改为：取氨苄西林系统适用性对照品适量，加初始流动相溶解并稀释制成每1 ml中约含2 mg的溶液，取10 μl注入液相色谱仪，记录的色谱图应与标准图谱一致。 |
| 英文摘要: |
| Objective: To improve the locating method of Ampicillin dimer - related substance of Ampicillin Sodium and Sulbactam Sodium for Injection in Chinese Pharmacopoeia. Methods: Three different chromatographic columns were examined by pharmacopoeia method and Ampicillin system suitability standard diagram method，their results were inspected for consistency ot . Results: The results of two methods were not consistent. Conclusion: The current standard is inappropriate, the dimer locating method should be amended as: take the right amount of Ampicillin system suitability CRS, plus the initial mobile phase dissolved and diluted to make per 1 ml containing about 2 mg of solution, take 10 μl injected to liquid chromatograph, the recorded chromatograms should be consistent with the standard diagram. |
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