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华阳,谢飞,周虹,李志明.基于HPLC-QAMS多指标成分定量与化学计量学的延丹胶囊质量评价研究[J].湖南中医药大学学报英文版,2023,43(5):857-863.[Click to copy
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| 基于HPLC-QAMS多指标成分定量与化学计量学的延丹胶囊质量评价研究 |
| 华阳,谢飞,周虹,李志明 |
| (海安市人民医院药剂科, 江苏 海安 226600;南京中医药大学药学院, 江苏 南京 210023) |
| 摘要: |
| 目的 采用高效液相色谱一测多评(high performance liquid chromatography-quantitative analysis of multi-components by single marker, HPLC-QAMS)法同时检测延丹胶囊中10种主要成分含量,建立延丹胶囊多组分定量与化学计量学的综合分析方法,构建延丹胶囊质量评控体系。方法 采用Hedera ODS-2(C18)色谱柱,乙腈-0.1%冰醋酸为流动相,梯度洗脱,检测波长230 nm(检测3,29-二苯甲酰基栝楼仁二醇和3,29-二苯甲酰基栝楼仁三醇)和280 nm(检测二氢丹参酮Ⅰ、隐丹参酮、丹参酮Ⅰ、丹参酮ⅡA、原阿片碱、延胡索乙素、紫堇碱和四氢小檗碱);选取丹参酮ⅡA为内参比物质,建立其与其他9种成分的相对校正因子,计算各成分含量,同时运用外标法验证所建立HPLC-QAMS法的重复性、合理性和可行性;运用化学计量学方法对10批样品的10种成分含量数据进行分析,挖掘对其质量控制具有显著贡献的主要成分。结果 定量分析的10种成分线性关系良好(r>0.999);平均加样回收率96.93%~100.14%(RSD<2.0%);HPLC-QAMS法所测结果与外标法无显著性差异;偏最小二乘-判别分析结果显示丹参酮ⅡA、3,29-二苯甲酰基栝楼仁三醇、丹参酮Ⅰ和延胡索乙素是影响延丹胶囊产品质量的差异性标志物(VIP值>1)。结论 所建立的HPLC-QAMS多指标成分定量控制方法操作便捷,重复性与稳定性良好,结果准确可靠,结合化学计量学分析,可用于延丹胶囊的整体质量控制和综合评价。 |
| 关键词: 延丹胶囊 多指标成分 高效液相色谱一测多评法 相对校正因子 化学计量学 质量评价 |
| DOI：10.3969/j.issn.1674-070X.2023.05.014 |
| Received:October 06, 2022 |
| 基金项目:南通市基础科学研究和社会民生科技计划项目（JCZ2022010）。 |
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| Quality evaluation of Yandan Capsule by multi-component content determination using HPLC-QAMS and chemometrics |
| HUA Yang,XIE Fei,ZHOU Hong,LI Zhiming |
| (Department of Pharmacy, The People's Hospital of Hai'an, Hai'an, Jiangsu 226600, China;College of Pharmacy, Nanjing University of Chinese Medicine, Nanjing, Jiangsu 210023, China) |
| Abstract: |
| Objective To determine the content of 10 main components in Yandan Capsule (YDC) by high performance liquid chromatography-quantitative analysis of multi-components by single-marker (HPLC-QAMS) method simultaneously and to establish a comprehensive analysis method for multi-component quantification and chemometrics of YDC so as to construct a quality evaluation and control system for YDC. Methods The gradient elution was performed on a Hedera ODS-2 (C18) column with acetonitrile-0.1% glacial acetic acid as the mobile phase. The detection wavelengths were set at 230 nm for 3, 29-dibenzoyloxykarounidiol and 3, 29-dibenzoyl rarounitriol, and 280 nm for dihydrotanshinone Ⅰ, cryptotanshinone, tanshinone Ⅰ, tanshinone ⅡA, protopine, tetrahydropalmatine, corydaline and tetrahydroberberine. Tanshinone ⅡA was selected as the internal reference substance to establish the relative correction factors with the other 9 components, the content of each component was calculated and the repeatability, rationality and feasibility of the established HPLC-QAMS method were verified by external standard method (ESM). The content data of 10 components in 10 batches of samples were analyzed by chemometrics, and the main components that contributed significantly to its quality control were explored. Results The 10 components by quantitative analysis had a good linear relationship (r>0.999); the average recoveries of the 10 components were 96.93%～100.14% (RSD<2.0%); there was no significant difference between the quantitative results of HPLC-QAMS and ESM; the results of partial least squares-discriminant analysis showed that tanshinone ⅡA, 3,29-dibenzoyl rarounitriol, tanshinone I and tetrahydropalmatine were the differential markers affecting the quality of YDC (VIP>1). Conclusion With good repeatability and stability, the established HPLC-QAMS multi-index component quantitative control method is convenient to operate, and the results are accurate and reliable. Combined with chemometric analysis, it can be used for overall quality control and comprehensive evaluation of YDC. |
| Key words: Yandan Capsule multi-index component high performance liquid chromatography-quantitative analysis of multi-components by single-marker relative correction factors chemometrics quality evaluation |
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