| 《中国药典》2015年版收载的三种熔点测定方法的对比 |
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| 引用本文： | 黄朝瑜,陈民辉,蔡美明,李忠红.《中国药典》2015年版收载的三种熔点测定方法的对比[J].中国药品标准,2015,16(6):412-416. |
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| 作者姓名： | 黄朝瑜 陈民辉 蔡美明 李忠红 |
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| 作者单位： | 江苏省食品药品监督检验研究院, 南京 210008,江苏省食品药品监督检验研究院, 南京 210008,江苏省食品药品监督检验研究院, 南京 210008,江苏省食品药品监督检验研究院, 南京 210008 |
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| 摘 要： | 目的:对《中国药典》2015年版收载测定熔点的三种方法(传温液法、熔点自动测定仪法、热分析法)适用性进行比较。方法:采用熔点自动测定仪法结合传统传温液法以及热分析法对熔点标准品及复杂代表性药品的熔点进行测定。结果:传温液法和熔点自动测定仪法重复性、中间精密度结果良好,适用于测定均匀、物化性质稳定样品的熔点;热分析法适用于难以直观判断终点的熔融同时分解样品以及多晶型样品的熔点测定。结论:三种熔点测定方法各有优势,在日常药品熔点测定中可结合样品物化性质选择合适的方法测定其熔点。
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| 关 键 词： | 传温液法 熔点自动测定仪 熔点 差示扫描量热分析 热重分析 |
| 收稿时间： | 2015/5/30 0:00:00 |
| 修稿时间： | 2015/10/26 0:00:00 |
Comparison of Three Methods for Determining Melting Point in Chinese Pharmacopoeia 2015 |
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| Authors: | Huang Chaoyu Chen Minhui Cai Meiming and Li Zhonghong |
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| Institution: | Jiangsu Institute for Food and Drug Control, Nanjing 210008,Jiangsu Institute for Food and Drug Control, Nanjing 210008,Jiangsu Institute for Food and Drug Control, Nanjing 210008 and Jiangsu Institute for Food and Drug Control, Nanjing 210008 |
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| Abstract: | Objective: To compare three methods for determining melting point in Chinese Pharmacopoeia 2015. Methods: The melting points of standard materials and complex representative drugs were detected by automatic melting point determinator, traditional transmission fluid and thermal-analysis methods. Results: The transmission fluid and automatic melting point determinator methods had good repeatability and intermediate precision, could be applied to detect uniform and stable samples. Thermal-analysis method could be used to the hardly intuitive judgment and polymorphism samples. Conclusion: Three methods for determining melting point have advantages separately. |
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| Keywords: | transmission fluid method automatic melting point determinator melting point DSC TGA |
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