Pharmacokinetic assessment of twenty compounds from Bufei Huoxue capsule in rats using HPLC-MS/MS

IF 3.1 3区医学 Q2 CHEMISTRY, ANALYTICAL

Journal of pharmaceutical and biomedical analysis Pub Date : 2025-08-18 DOI:10.1016/j.jpba.2025.117123

Wenwen Li , Jinyue Ma , Zijing Zhang , Kaili Zhang , Wenhan Lin , Lu Chen , Zhenguo Lv , Yameng Zhu , Huizi Ouyang , Jihong Feng , Jun He

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引用次数: 0

Abstract

Bufei Huoxue capsule (BHC), consisting of Astragali Radix, Paeoniae Radix Rubra, and Psoraleae Fructus, demonstrates remarkable efficacy in treating various pulmonary conditions. In this research, an original approach using high-performance liquid chromatography-triple quadrupole mass spectrometry (HPLC-MS/MS) was devised to quantitatively determine twenty components (calycosin-7-O-β-D-glucoside, methylnissolin, calycosin, genistein, formononetin, daidzein, angelicin, psoralen, astragaloside IV, 6′-O-galloyl paeoniflorin, benzoylpaeoniflorin, albiflorin, paeoniflorin, oxypaeoniflorin, psoralenoside, isopsoralenoside, catechin, kaempferol, p-coumaric acid, and protocatechuic acid) of BHC in rat plasma. For the twenty selected quantitative prototypes, all calibration curves exhibited excellent linearity (r ≥ 0.9926) within their respective linear ranges. All analytes showed intra-day and inter-day precision (RSD) below 13.41 %, with the accuracy varying between –13.56 % and 12.97 %. The extraction recoveries were measured in the interval of 62.17–96.05 %, and the matrix effects exhibited a range from 74.42 % to 115.96 %. The stability tests indicated that the twenty compounds maintained stability across four distinct storage conditions, and their relative standard deviations did not exceed 14.34 %. Following validation, this methodology was applied to determine the pharmacokinetic behavior of twenty compounds in BHC after oral administration to rats, with relevant pharmacokinetic parameters derived. The obtained data provided a valuable reference for future protocol enhancements and clinical applications.

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HPLC-MS/MS法评价补肺活血胶囊中20种化合物在大鼠体内的药动学

补肺活血胶囊（BHC）由黄芪、芍药、补骨脂组成，对多种肺部疾病有显著疗效。本研究采用高效液相色谱-三联四极杆质谱法（HPLC-MS/MS）定量测定了20种成分(花蕊花素-7- o -β- d -葡萄糖苷、甲基山羊绒苷、花蕊花素、染料木素、刺芒花素、大豆苷、当归苷、补骨脂素、黄芪甲苷、6′- o -没食子酚芍药苷、苯甲酰芍药苷、芍药苷、芍药苷、氧芍药苷、补骨脂苷、异补骨脂苷、儿茶素、山柰酚、对香豆酸、和原儿茶酸)。所选的20个定量样品的校准曲线在各自的线性范围内均具有良好的线性关系（r ≥ 0.9926）。日内、日间精密度（RSD）均低于13.41 %，准确度在-13.56 % ~ 12.97 %之间。提取回收率为62.17 ~ 96.05 %，基质效应为74.42 % ~ 115.96 %。稳定性试验表明，这20种化合物在4种不同的贮存条件下均保持稳定，相对标准偏差均不超过14.34 %。验证后，应用该方法测定了大鼠口服六六六中20种化合物的药代动力学行为，并推导了相关的药代动力学参数。所获得的数据为未来的方案改进和临床应用提供了有价值的参考。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of pharmaceutical and biomedical analysis 医学-分析化学

CiteScore

6.70

自引率

5.90%

发文量

588

审稿时长

37 days

期刊介绍： This journal is an international medium directed towards the needs of academic, clinical, government and industrial analysis by publishing original research reports and critical reviews on pharmaceutical and biomedical analysis. It covers the interdisciplinary aspects of analysis in the pharmaceutical, biomedical and clinical sciences, including developments in analytical methodology, instrumentation, computation and interpretation. Submissions on novel applications focusing on drug purity and stability studies, pharmacokinetics, therapeutic monitoring, metabolic profiling; drug-related aspects of analytical biochemistry and forensic toxicology; quality assurance in the pharmaceutical industry are also welcome. Studies from areas of well established and poorly selective methods, such as UV-VIS spectrophotometry (including derivative and multi-wavelength measurements), basic electroanalytical (potentiometric, polarographic and voltammetric) methods, fluorimetry, flow-injection analysis, etc. are accepted for publication in exceptional cases only, if a unique and substantial advantage over presently known systems is demonstrated. The same applies to the assay of simple drug formulations by any kind of methods and the determination of drugs in biological samples based merely on spiked samples. Drug purity/stability studies should contain information on the structure elucidation of the impurities/degradants.