| HPLC-QAMS同时测定屏风生脉胶囊中9个指标成分含量 |
| 投稿时间：2021-07-28 点此下载全文
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| 引用本文：黄孝权,何人大,魏谭军,周殿儒,肖成,陈飞,周晓维,陈勇.HPLC-QAMS同时测定屏风生脉胶囊中9个指标成分含量[J].中国现代中药,2022,24(5):882-890 |
| DOI：10.13313/j.issn.1673-4890.20210728001 |
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| 作者中文名 | 作者英文名 | 单位中文名 | 单位英文名 | E-Mail |
| 黄孝权 |
HUANG Xiao-quan |
达州市中西医结合医院，四川 达州 635000 |
Dazhou Integrated TCM & Western Medicine Hospital, Dazhou 635000, China |
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| 何人大 |
HE Ren-da |
达州市中西医结合医院，四川 达州 635000 |
Dazhou Integrated TCM & Western Medicine Hospital, Dazhou 635000, China |
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| 魏谭军 |
WEI Tan-jun |
达州市中西医结合医院，四川 达州 635000 |
Dazhou Integrated TCM & Western Medicine Hospital, Dazhou 635000, China |
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| 周殿儒 |
ZHOU Dian-ru |
达州市中西医结合医院，四川 达州 635000 |
Dazhou Integrated TCM & Western Medicine Hospital, Dazhou 635000, China |
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| 肖成 |
XIAO Cheng |
达州市中西医结合医院，四川 达州 635000 |
Dazhou Integrated TCM & Western Medicine Hospital, Dazhou 635000, China |
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| 陈飞 |
CHEN Fei |
达州市中西医结合医院，四川 达州 635000 |
Dazhou Integrated TCM & Western Medicine Hospital, Dazhou 635000, China |
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| 周晓维* |
ZHOU Xiao-wei |
达州市中西医结合医院，四川 达州 635000 |
Dazhou Integrated TCM & Western Medicine Hospital, Dazhou 635000, China |
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| 陈勇 |
CHEN Yong |
成都地奥集团天府药业有限公司，四川 达州 635027 |
Chengdu Di′ao Group Tianfu Pharmaceutical Co., Ltd., Dazhou 635027, China |
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| 基金项目:四川省重大科技专项项目（2020YFS0533） |
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| 中文摘要:目的 建立高效液相色谱一测多评法（HPLC-QAMS）同时测定屏风生脉胶囊中毛蕊异黄酮葡萄糖苷、芒柄花苷、9,10-二甲氧基紫檀烷-3-O-β-D-葡萄糖苷、芒柄花素、升麻素苷、升麻素、亥茅酚苷、麦冬甲基黄烷酮A及甲基麦冬二氢高异黄酮B含量的方法。方法 采用Agilent ZORAX StableBond C18色谱柱（250 mm×4.6 mm，5 μm），流动相乙腈-0.1%甲酸溶液，梯度洗脱。多波长切换检测（0~36 min，254 nm，毛蕊异黄酮葡萄糖苷、芒柄花苷、9,10-二甲氧基紫檀烷-3-O-β-D-葡萄糖苷、芒柄花素、升麻素苷、升麻素和亥茅酚苷；36~60 min，296 nm，麦冬甲基黄烷酮A和甲基麦冬二氢高异黄酮B），进样量10 μL。以升麻素为内参物，建立其他8个指标成分的相对校正因子（RCF），并计算各成分含量。采用外标法（ESM）测定屏风生脉胶囊中9个指标成分含量对QAMS计算结果的准确性进行验证。结果 测定了3个厂家12批屏风生脉胶囊中9个指标成分的含量，9个指标成分分别在2.68~67.00（r=0.999 4）、1.76~44.00（r=0.999 1）、2.15~53.75（r=0.999 2）、4.37~109.25（r=0.999 7）、6.58~164.50（r=0.999 5）、2.49~62.25（r=0.999 2）、1.88~47.00（r=0.999 8）、1.36~34.00（r=0.999 2）、1.09~27.25 μg·mL–1（r=0.999 3）有良好的线性关系。平均加样回收率及RSD分别为99.34%（1.40%）、97.25%（1.13%）、98.73%（1.33%）、100.09%（0.68%）、100.04%（0.77%）、98.46%（1.26%）、97.94%（1.06%）、96.89%（1.03%）和98.90%（0.72%）。QAMS与ESM所测结果差异无统计学意义。结论 该方法操作便捷、结果准确，可用于屏风生脉胶囊中9个指标成分含量的同时测定，实现多指标质量控制。 |
| 中文关键词:屏风生脉胶囊 高效液相色谱一测多评法 多指标成分 相对校正因子 |
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| Simultaneous Determination of Nine Active Components in Pingfeng Shengmai Capsules by HPLC-QAMS |
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| Abstract:Objective To establish a high performance liquid chromatography-quantitative analysis of multi-components by single-marker (HPLC-QAMS) method for simultaneous determination of calycosin 7-O-β-D-glucopyranoside, ononin, 9,10-dimethoxy-pterocarpane-3-O-β-D-glucoside, formononetin, prim-O-glucosylcimifugin, cimifugin, sec-O-glucosylhamaudol, methylophiopogonanone A, and methylophiopogonanone B in Pingfeng Shengmai Capsules.Methods HPLC conditions are as follows: Agilent ZORAX StableBond C18 column (250 mm × 4.6 mm, 5 μm), gradient elution with the mobile phase of acetonitrile-0.1% formic acid solution, injection volume of 10 μL, detection wavelength of 254 nm (0-36 min) for calycosin 7-O-β-D-glucopyranoside, ononin, 9,10-dimethoxy-pterocarpane-3-O-β-D-glucoside, formononetin, prim-O-glucosylcimifugin, cimifugin, and sec-O-glucosylhamaudol, and 296 nm (36-60 min) for methylophiopogonanone A and methylophiopogonanone B. With cimifugin as an internal standard, the relative correction factors (RCFs) of the other 8 components were established and the content of each component was calculated. In order to validate the accuracy of QAMS, we also calculated the content of the 9 components with the external standard method (ESM).Results The content of 9 effective components in 12 batches of Pingfeng Shengmai Capsules from three manufacturers was determined, and they showed good linear relationships within the ranges of 2.68-67.00 (r=0.999 4), 1.76-44.00 (r=0.999 1), 2.15-53.75 (r=0.999 2), 4.37-109.25 (r=0.999 7), 6.58-164.50 (r=0.999 5), 2.49-62.25 (r=0.999 2), 1.88-47.00 (r=0.999 8), 1.36-34.00 (r=0.999 2), and 1.09-27.25 μg·mL–1 (r=0.999 3), respectively. Their average recoveries (RSDs) were 99.34% (1.40%), 97.25% (1.13%), 98.73% (1.33%), 100.09% (0.68%), 100.04% (0.77%), 98.46% (1.26%), 97.94% (1.06%), 96.89% (1.03%), and 98.90% (0.72%), respectively. There was no significant difference between the results yielded by HPLC-QAMS and ESM.Conclusion The established HPLC-QAMS method is convenient and accurate, which allows the simultaneous determination of 9 active components in Pingfeng Shengmai Capsules and the multi-index quality control. |
| keywords:Pingfeng Shengmai Capsules HPLC-QAMS multi-index component RCF |
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