| 建立评价结合雌激素质量的GC指纹图谱分析方法 |
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| 引用本文： | 孔金金,高晓黎. 建立评价结合雌激素质量的GC指纹图谱分析方法[J]. 西北药学杂志, 2008, 23(3): 131-134 |
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| 作者姓名： | 孔金金 高晓黎 |
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| 作者单位： | 1. 新疆特丰药业股份有限公司,新疆,乌鲁木齐,830054
2. 新疆医科大学药学院,新疆,乌鲁木齐,830054 |
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| 基金项目： | 国家科技专项基金 , 新疆维吾尔自治区高新技术研究发展计划项目 |
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| 摘 要： | 目的建立结合雌激素GC指纹图谱研究方法。方法毛细管色谱柱DB-225柱(20mm×0.18mm×0.20μm);进样口温度230℃;采用程序升温法,柱温200℃保持5min,然后每5min程序升温,达到220℃后,保持60min,载气为氦气,流速0.79mL·min-1,分流比为1∶40;FID检测器,检测器温度240℃。结果该方法具有良好的稳定性和重复性,通过分析和对照8批倍美力的GC指纹图谱,标示出20个共有峰,相似度分析大于0.99。结论建立的GC指纹图谱分析法可较全面地反映结合雌激素的内在质量,可作为结合雌激素产品的质量控制方法。
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| 关 键 词： | 结合雌激素 倍美力 GC指纹图谱 |
| 文章编号： | 1004-2407(2008)03-0131-04 |
| 修稿时间： | 2008-01-04 |
Establishment of GC fingerprints for the quality control of conjugated estrogens |
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| KONG Jinjin,GAO Xiaoli. Establishment of GC fingerprints for the quality control of conjugated estrogens[J]. Northwest Pharmaceutical Journal, 2008, 23(3): 131-134 |
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| Authors: | KONG Jinjin GAO Xiaoli |
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| Abstract: | Objective To establish the GC fingerprints of conjugated estrogens(CE).Methods GC conditions were as follows:capillary chromatographic column DB-225(20 mm×0.18 mm×0.20 μm);injector temperature 230 ℃;oven temperature programming:initial temperature200 ℃,isothermal 200 ℃ for 5 min,increasing to 220 ℃ at 5 ℃/min and maitaining for 60 min.Results The method showed good stability and reproducibility.According to the results of 8 batches of Premarine Tablets,there were 20 common peaks and their similarities were more than 0.99.Conclusion The GC fingerprints could fully reflect the inner quality of CE and could be used as the quality control method for CE products. |
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| Keywords: | conjugated estrogens Premarine GC fingerprint |
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