| 指纹图谱结合一测多评在中成药丹参片质量控制中的应用 |
| 投稿时间：2023-01-16 点此下载全文
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| 引用本文：周亚楠,胡晓茹,戴忠,马双成.指纹图谱结合一测多评在中成药丹参片质量控制中的应用[J].中国现代中药,2023,25(9):1973-1978 |
| DOI：10.13313/j.issn.1673-4890.20230116001 |
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| 中文摘要:目的 采用指纹图谱结合一测多评法（QAMS）评价中成药丹参片的质量。方法 以丹参酮ⅡA为参照物建立丹参片醌类成分的高效液相色谱法（HPLC）指纹图谱。同时，测定丹参酮ⅡA与隐丹参酮、丹参酮Ⅰ的相对校正因子，以QAMS测定丹参片中丹参酮ⅡA、隐丹参酮、丹参酮Ⅰ的含量。结果 建立了丹参片HPLC指纹图谱，并指认了全部5个共有峰，12批丹参片的相似度均大于0.99；QAMS测定了丹参片中3个醌类成分的含量，样品间存在一定波动性。结论 指纹图谱与QAMS结合的质量控制模式准确可靠，可为全面合理评价丹参片的质量提供参考。 |
| 中文关键词:丹参片 指纹图谱 一测多评法 质量控制 |
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| Application of Fingerprint Combined with QAMS in Quality Control of Danshen Tablets |
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| Abstract:Objective To evaluate the quality of the Chinese patent medicine Danshen Tablets by using fingerprint combined with quantitative analysis for multiple components with a single marker (QAMS).Methods A high-performance liquid chromatography (HPLC) fingerprint of quinone components in Danshen Tablets was established using tanshinone ⅡA as a reference substance. Simultaneously, the relative correction factors of tanshinone ⅡA, cryptotanshinone, and tanshinone I were determined, and the content of tanshinone ⅡA, cryptotanshinone, and tanshinone I in Danshen Tablets was measured using QAMS.Results The HPLC fingerprint of Danshen Tablets was established, and all five common peaks were identified. The similarity of 12 batches of Danshen Tablets was greater than 0.99, and the content of the three quinone components in Danshen Tablets was determined using QAMS, showing some variability among the samples.Conclusion The quality control model combining fingerprint and QAMS is accurate and reliable, providing a comprehensive and rational reference for evaluating the quality of Danshen Tablets. |
| keywords:Danshen Tablets fingerprint QAMS quality control |
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