| 李曙光,杨淡梅,张政,等.健心平律滴丸高效液相色谱法指纹图谱及多组分定量分析[J].安徽医药,2026,30(9):1762-1769. |
| 健心平律滴丸高效液相色谱法指纹图谱及多组分定量分析 |
| HPLC fingerprint and multi-component quantitative analysis of Jianxin Pinglü dripping pills |
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| DOI：10.3969/j.issn.1009-6469.2026.09.012 |
| 中文关键词: 中草药 主成分分析 健心平律滴丸 指纹图谱 含量测定 多组分定量分析 化学计量法 |
| 英文关键词: Drugs, Chinese herbal Principal component analysis Jianxin Pinglü dripping pills Fingerprint Content determi. nation Multi-component quantitative analysis Chemometrics |
| 基金项目:广东省中医药局科研项目( 20222202)；深圳市科技计划项目( ZDSYS201606081515458)；深圳市医疗卫生三名工程项目( SZZYSM202111002) |
| 作者 | 单位 | E-mail | | 李曙光 | 深圳市中医院中药制剂中心,广东深,圳518033
深圳市医院中药制剂研究重点实验室,广东深圳 518033 | | | 杨淡梅 | 深圳市慢性病防治中心、深圳市皮肤病防治研究所制剂科,广东深圳 518020 | | | 张政 | 深圳市保健委员会办公室药剂科,广东深圳 518020 | | | 陈香玲 | 深圳市中医院中药制剂中心,广东深,圳518033 | | | 刘志承 | 深圳市中医院中药制剂中心,广东深,圳518033 | | | 简晓莉 | 深圳市中医院中药制剂中心,广东深,圳518033
深圳市医院中药制剂研究重点实验室,广东深圳 518033 | 16634289@qq.com |
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| 中文摘要: |
| 目的建立健心平律滴丸高效液相色谱法( HPLC)指纹图谱和多成分含量测定方法。方法 2023年 1月至 2025年 1月，采用 Agilent Eclipse XDB C18色谱柱( 250.0 mm×4.6 mm，5 μm)以乙腈( A)-0.1%磷酸溶液( B)为流动相进行梯度洗脱，流速为 1.0 mL/min，柱温为 25 ℃，检测波长为 240 nm。结果建立了健，心平律滴丸 HPLC指纹图谱，标定 27个共有峰，指认了 8 |
| 英文摘要: |
| Objective To establish an HPLC fingerprint and a multi-component quantitative analysis method for Jianxin Pinglü drip. ping pills.Methods From January 2023 to January 2025, the analysis was performed on an Agilent Eclipse XDB C18 (250.0 mm×4.6mm, 5 μm) column, using a mobile phase consisting of acetonitrile (A) and 0.1% phosphoric acid solution (B) with gradient elution. Theflow rate was 1.0 mL/min, the column temperature was maintained at 25 ℃, and the detection wavelength was set at 240 nm.Results The HPLC fingerprint of Jianxin Pinglü dripping pills was established, and 27 common peaks were identified. Among them, 8 peakswere assigned and quantitatively analyzed, namely calycosin-7-O-β-D-glucoside, 2,3,5,4'-tetrahydroxy stilbene 2-Ο-β-D-glucoside, fe.rulic acid, naringin, salvianolic acid B, cryptotanshinone, tanshinone Ⅰ, tanshinone ⅡA. All methodological validation results met theanalytical requirements. The fingerprint similarities of the 10 batches of samples were all greater than 0.94. Cluster analysis and princi.pal component analysis grouped the 10 batches of samples into 3 categories according to production year, indicating certain quality dif.ferences among batches. Orthogonal partial least squares discriminant analysis (OPLS-DA) indicated that 17 peaks had a significant im. pact on the quality.Conclusion The established HPLC fingerprint and multi-component quantitative analysis method can provide a reference for the development and revision of the quality standard for Jianxin Pinglü dripping pills. |
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