| 刺五加注射液指纹图谱的建立及其在质量控制中的应用 |
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| 引用本文： | 刘建娣,梁琼麟,罗国安,王义明. 刺五加注射液指纹图谱的建立及其在质量控制中的应用[J]. 中成药, 2006, 28(1): 3-5 |
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| 作者姓名： | 刘建娣 梁琼麟 罗国安 王义明 |
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| 作者单位： | 清华大学化学系分析中心,北京,100084 |
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| 基金项目： | 科技部十五攻关项目(2004BA721A13,2002BA2906A29-3)。 |
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| 摘 要： | 目的:建立刺五加注射液HPLC指纹图谱,为中成药产品及生产工艺过程质量控制提供有效的方法。方法:HPLC法,Kromasil-C18反相色谱柱,A相为0.2甲酸水溶液,B相为35乙腈水溶液,梯度洗脱,检测波长为270nm。对生产工艺中原料提取液、半成品、成品分别进行指纹图谱测定,进行比较。结果:10批刺五加注射液指纹图谱相似度≥0.977。刺五加药材提取物、中间体、成品进行指纹图谱有明显差异。结论:该方法稳定可靠,可以有效地用于刺五加注射液生产过程的质量控制和产品的质量评价。
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| 关 键 词： | 刺五加 高效液相色谱 指纹图谱 质量控制 |
| 文章编号： | 1001-1528（2006）01-0003-03 |
| 收稿时间： | 2005-01-30 |
| 修稿时间： | 2005-01-30 |
Fingerprint of Ciwujia Injection and its application in quality control |
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| LIU Jian-di,LIANG Qiong-lin,LUO Guo-an,WANG Yi-ming. Fingerprint of Ciwujia Injection and its application in quality control[J]. Chinese Traditional Patent Medicine, 2006, 28(1): 3-5 |
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| Authors: | LIU Jian-di LIANG Qiong-lin LUO Guo-an WANG Yi-ming |
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| Affiliation: | Analysis Center, Department of Chemistry, Tsinghua University, Beijing 100084, China |
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| Abstract: | AIM: An effective and convenient method was established for HPLC fingerprints of Ciwujia Injection (Radix et Rhizoma seucaulis acanthopanacis senticost) which provided an approach for quality control in production. METHODS: Komasil-C_(18) column, phase A: 0.2% formic acid, phase B: 35% Acetonitrile, eluted with a gradient program and detected at 270 nm. The fingerprints of extraction from crude herbs, intermediate and finished product were compared. RESULTS: The fingerprint method for Ciwujia Injection was established. The similarity of 10 batches of Ciwujia Injection was not lower than 0.977. Obvious difference was carried on among the extraction from crude herbs, intermediate and finished product. CONCLUSION: This validated method is available for quality evaluation and quality control in Ciwujia Injection's production. |
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| Keywords: | Ciwujia HPLC fingerprints quality control |
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