| 张静,任菲菲,郑艳青,刘德丽,闫雪.对《中国药典》2015年版甲醇量检查法(第一法)的探讨[J].中国药品标准,2017,18(3):186-189 |
| 对《中国药典》2015年版甲醇量检查法(第一法)的探讨 |
| The discussion of Test Method for Amount of Methanoln in Chinese Pharmacopoeia 2015 Edition |
| 投稿时间：2017-04-13 修订日期：2017-06-07 |
| DOI： |
| 中文关键词: 甲醇量 乙醇量 气相色谱法 基体匹配 |
| 英文关键词: amount of methanol amount of ethanol gas chromatography matrix matching |
| 基金项目: |
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| 摘要点击次数: 591 |
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| 中文摘要: |
| 目的 对《中国药典》2015年版甲醇量检查法(第一法)进行探讨。方法 用乙醇溶液代替水配制甲醇对照品溶液,采用气相色谱法,顶空进样的方式,测定含乙醇制剂中的甲醇量。结果 改进后的方法经方法学验证,回收率为99.3%,重复性试验RSD为2.9%。结论 改进后的方法使对照品溶液和样品溶液基体相匹配,测得的值更接近样品中甲醇的真实含量,建议采用改进后的方法测定含乙醇制剂中的甲醇量。 |
| 英文摘要: |
| Objective：To discuss the test method for Amount of Methanoln S(the first method) in Chinese Pharmacopoeia 2015 Edition. Motheds：Using ethanol solution instead of water to prepare the reference solution. Using gas chromatography headspace sampling way to determinated the amount of methanol in the medicine that contains ethanol .Results: The improved method was verified by methodology, the recovery rate was 99.3%, the repeatability test RSD was 2.9%.SConclusion: The improved method makes reference solution and sample solution matrix matching, and the results were closer to the real content of methanol in the sample,S suggested that using the improved method to check the amount of methanol in Drugs that contain ethanol. |
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