| 基于UPLC特征图谱和一测多评法的穿心莲标准汤剂质量标准研究 |
| 投稿时间：2023-10-13 修订日期：2024-03-15 点此下载全文 |
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| 中文摘要:目的：采用UPLC法建立穿心莲标准汤剂的质量评价方法。方法：依照中药饮片标准汤剂制备要求,制备21批穿心莲饮片标准汤剂,建立超高效液相特征图谱分析方法,以穿心莲内酯为参照,建立新穿心莲内酯、14-去氧穿心莲内酯和脱水穿心莲内酯的一测多评法,并与外标法测定结果比较。结果：采用《中药色谱指纹图谱相似度评价系统(2012版)》软件进行特征图谱分析,共标定7个共有峰,指认了木犀草素-7-O-β-D-葡萄糖醛酸苷、穿心莲内酯、新穿心莲内酯、14-去氧穿心莲内酯和脱水穿心莲内酯5个成分,一测多评法与外标法测定各成分含量结果RSD均在3%以内。结论：所建立的特征图谱和一测多评方法准确、可靠,可较全面地反映穿心莲标准汤剂的内在质量,为穿心莲配方颗粒及其它制剂的质量评价提供依据。 |
| 中文关键词:穿心莲 标准汤剂 UPLC 一测多评法 特征图谱 质量标准 |
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| Study on Quality Standard of Andrographis Paniculata Standard Decoction Based on UPLC Characteristic Chromatogram and Quantitative Analysis of Multi-components by Single Marker |
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| Abstract:To establish quality evaluation method of Andrographis paniculata standard decoction by UPLC. METHODS: 21 batches of Andrographis paniculata standard decoctions were prepared according to the standardization method of TCM decoction pieces. The UPLC characteristic chromatograms analysis method was established. With andrographolide as a reference, quantitative analysis of multi-components by single marker (QAMS) was established for new neoandrographolide, 14 deoxyandrographolide and dehydrated andrographolide and the results were compared with the external standard method (ESM) to determine the accuracy of the method. RESULT: Similarity Evaluation System for Chromatographic Fingerprint of TCM (2012 edition) was used to analyze and compare the characteristic chromatograms, and seven common peaks were determined and and five were identified including luteolin-7-O-β-D-glucuronide, andrographolide, neoandrographolide, 14-deoxyandrographolide and dehydroandrographolide. The RSDs of content results of each component by QAMS and ESM were all within 3%. CONCLUSION: The determination method is reliable and accurate, which can be used to reflect the intrinsic quality of Andrographis paniculata standard decoction more comprehensively and provide the basis for the quality evaluation of Andrographis paniculata formula granules and other preparations |
| keywords:Andrographis paniculata standard decoction UPLC QAMS characteristic chromatogram quality standard |
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