Bushen Pills (BSPs), as a traditional Chinese medicine (TCM), is widely used in clinic to enrich Yang, nourish Yin, stem essence, and strengthen kidneys. Two chromatographic methods, liquid chromatography-mass spectrometry (LC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS), were applied to analyze the multiple active components of BSPs in dosage form for quality evaluation and in rat plasma for pharmacokinetics study, respectively. Three active constituents of BSPs, including paeoniflorin (PF), berberine hydrochloride (BBR), and schizandrin (SCH), were simultaneously determined by the established LC-MS method with electrospray ionization (ESI) in positive selected ion monitoring (SIM) mode at m/z 503.1, 336.0, and 455.2. The contents of PF, BBR, and SCH were (6.112 ± 0.166) mg/g, (335.1 ± 14.95) μg/g, and (5.867 ± 0.136) μg/g in BSPs. On this basis, PF and BBR were selected as targeted analytes for the pharmacokinetic study of BSPs in rats. Memantine hydrochloride was used as an internal standard (IS), and the plasma samples were processed by liquid-liquid extraction with ethyl acetate. All the analytes were separated on a C₁₈ reversed phase column, eluted with a mobile phase consisting of acetonitrile-formic acid (0.01%) (25 : 75, /), and detected by ESI in the selected ion mode with multiple reaction monitoring (MRM). The target fragment ions were m/z 525.3 ⟶ 449.5 for PF, 336.2 ⟶ 320.2 for BBR, and 180.1 ⟶ 163.1 for IS. The linear ranges of PF and BBR were 5–500 ng/mL and 0.1–20 ng/mL with good linearity (r² > 0.99). No obvious matrix effect was observed, and acceptable accuracy, precision, recovery, and stability were obtained. The proposed method has been successfully applied to the pharmacokinetic study of BSPs in rats after a single dose.

中文翻译：

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同时测定补肾丸中多种活性成分的含量，并在大鼠药代动力学研究中应用。

补肾丸（Bushen Pills，BSPs）作为一种传统中药（TCM），在临床上被广泛使用，以丰富阳气，滋阴养阴，茎精华和增强肾脏功能。液相色谱-质谱（LC-MS）和液相色谱-串联质谱（LC-MS / MS）这两种色谱方法分别用于分析剂型中BSP的多种活性成分以进行质量评估和大鼠血浆中分别进行药代动力学研究。通过建立的LC-MS方法采用电喷雾电离（ESI）以正选择离子监测（SIM）模式同时测定BSPs的三个活性成分，包括pa药苷（PF），盐酸小ber碱（BBR）和五味子素（SCH）。m / z503.1、336.0和455.2。BSP中PF，BBR和SCH的含量分别为（6.112±0.166）mg / g，（335.1±14.95）μg / g和（5.867±0.136）μg / g。在此基础上，选择PF和BBR作为目标分析物用于大鼠BSPs的药代动力学研究。盐酸美金刚用作内标（IS），血浆样品通过乙酸乙酯液-液萃取处理。所有分析物在C ₁₈反相色谱柱上分离，用乙腈-甲酸（0.01％）（25：75，/ ）组成的流动相洗脱，并通过ESI在选定的离子模式下进行多反应监测（ MRM）。目标碎片离子为m / zPF为525.3⟶449.5，BBR为336.2⟶320.2，IS为180.1⟶163.1。PF和BBR的线性范围为5–500 ng / mL和0.1–20 ng / mL，线性良好（r ²  > 0.99）。没有观察到明显的基质效应，并且获得了可接受的准确性，精密度，回收率和稳定性。所提出的方法已成功地应用于大鼠单剂量BSPs的药代动力学研究。