Xu Qianqian, Gao Huilan, Zhu Fuqiang, Xu Wenliang, Wang Yubo, Xie Jinwen, Guo Guangjun, Yang Limei, Ma Li, Shen Zhiqiang, Li Jichang
Shandong Binzhou Animal Science and Veterinary Medicine Academy, Binzhou, China.
College of Veterinary Medicine, Northeast Agricultural University, Harbin, China.
Int J Anal Chem. 2024 May 10;2024:5535752. doi: 10.1155/2024/5535752. eCollection 2024.
Traditional Chinese medicine (TCM) serves as a significant adjunct to chemical treatment for chronic diseases. For instance, the administration of Baitouweng decoction (BTWD) has proven effective in the treatment of ulcerative colitis. However, the limited understanding of its pharmacokinetics (PK) has impeded its widespread use. Chinese Bama miniature pigs possess anatomical and physiological similarities to the human body, making them a valuable model for investigating PK properties. Consequently, the identification of PK properties in Bama miniature pigs can provide valuable insights for guiding the clinical application of BTWD in humans. To facilitate this research, a rapid and sensitive UPLC-MS/MS method has been developed for the simultaneous quantification of eleven active ingredients of BTWD in plasma. Chromatographic separation was conducted using an Acquity UPLC HSS T3 C column and a gradient mobile phase comprising acetonitrile and water (containing 0.1% acetic acid). The methodology was validated in accordance with the FDA Bioanalytical Method Validation Guidance for Industry. The lower limit of quantitation fell within the range of 0.60-2.01 ng/mL. Pharmacokinetic studies indicated that coptisine chloride, berberine, columbamine, phellodendrine, and obacunone exhibited low , while fraxetin, esculin, fraxin, and pulchinenoside B were rapidly absorbed and eliminated from the plasma. These findings have implications for the development of effective components in BTWD and the adjustment of clinical dosage regimens.
传统中药（TCM）是慢性病化学治疗的重要辅助手段。例如，白头翁汤（BTWD）已被证明在治疗溃疡性结肠炎方面有效。然而，对其药代动力学（PK）的了解有限阻碍了其广泛应用。中国巴马小型猪在解剖学和生理学上与人体相似，使其成为研究PK特性的宝贵模型。因此，确定巴马小型猪的PK特性可为指导BTWD在人类中的临床应用提供有价值的见解。为促进这项研究，已开发出一种快速灵敏的超高效液相色谱-串联质谱（UPLC-MS/MS）方法，用于同时定量血浆中BTWD的11种活性成分。使用Acquity UPLC HSS T3 C柱和由乙腈和水（含0.1%乙酸）组成的梯度流动相进行色谱分离。该方法按照美国食品药品监督管理局（FDA）工业生物分析方法验证指南进行了验证。定量下限在0.60-2.01 ng/mL范围内。药代动力学研究表明，盐酸小檗碱、黄连素、黄连碱、黄柏碱和奥巴库酮的血药浓度较低，而秦皮素、七叶苷、秦皮苷和紫堇苷B在血浆中吸收和消除迅速。这些发现对BTWD有效成分的开发和临床给药方案的调整具有重要意义。
