Department of Pharmaceutical Analysis, School of Pharmacy, Hebei Medical University, Shijiazhuang, Hebei Province, 050017, PR China.
Department of Pharmaceutical Analysis, School of Pharmacy, Hebei Medical University, Shijiazhuang, Hebei Province, 050017, PR China; Hebei General Hospital, Shijiazhuang, Hebei Province, 050051, PR China.
J Pharm Biomed Anal. 2020 Jan 5;177:112835. doi: 10.1016/j.jpba.2019.112835. Epub 2019 Aug 27.
Tuberculosis of cervical lymph nodes is called scrofula in Traditional Chinese Medicine (TCM). Clinical manifestation is that unilateral or bilateral neck can have multiple enlarged lymph nodes of different sizes. Current therapeutic drugs include Lysionotus pauciflorus Maxim. tablets and compound of Lysionotus pauciflorus Maxim., which have a significant effect on tuberculosis of cervical lymph nodes. This compound is composed of three herbs, Lysionotus pauciflorus Maxim., Prunella vulgaris L. and Artemisia argyi Levl.et Vant. A selective and sensitive LC-MS/MS method was established and validated in rat plasma for the first time. Chromatographic separation was achieved on a Wonda Cract ODS-2 C Column (150 mm × 4.6 mm, 5 μm). The mobile phase contained 0.1% formic acid aqueous solution and acetonitrile with a flow rate of 0.8 mL/min. The detection was performed in negative electrospray ionization mode and the precursor/product ion transitions of six components and internal standard (IS) sulfamethoxazole were quantified in multiple reaction monitoring (MRM) using QTRAP-3200 MS/MS. The method fulfilled US Food and Drug Administration guidelines for selectivity, sensitivity, accuracy, precision, matrix effect, extraction recovery, dilution integrity, and stability. This proposed method was then successfully applied to a pharmacokinetic study after oral administration of 10 mL/kg compound extracts in rats. The pharmacokinetic parameters and plasma concentration-time profiles would prove valuable in pre-clinical and clinical investigations on the disposition of compound medicine.
中医称颈部淋巴结结核为瘰疬。临床表现为单侧或双侧颈部可有多枚大小不一的肿大淋巴结。目前的治疗药物包括了灯台叶片和灯台叶复方，它们对颈部淋巴结结核有显著疗效。该复方由三种草药组成，包括了灯台叶、夏枯草和艾叶。本研究首次在大鼠血浆中建立并验证了一种选择性和灵敏的 LC-MS/MS 方法。色谱分离在 Wonda Cract ODS-2 C 柱（150mm×4.6mm，5μm）上实现。流动相由 0.1%甲酸水溶液和乙腈组成，流速为 0.8mL/min。采用负离子电喷雾电离模式进行检测，并采用 QTRAP-3200 MS/MS 在多重反应监测（MRM）模式下对 6 个成分和内标（磺胺甲恶唑）的前体/产物离子跃迁进行定量分析。该方法符合美国食品和药物管理局（FDA）对选择性、灵敏度、准确性、精密度、基质效应、提取回收率、稀释稳定性和稳定性的指南要求。该方法随后成功应用于大鼠口服 10mL/kg 复方提取物后的药代动力学研究。药代动力学参数和血浆浓度-时间曲线将有助于临床前和临床研究中对复方药物的处置情况进行研究。
