Department of Cardiology, Institute of Cardiovascular Disease of Integrated Traditional Chinese Medicine and Western Medicine, Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Shanghai Key Laboratory of Traditional Chinese Clinical Medicine, Shanghai, China.
Biomed Chromatogr. 2022 Apr;36(4):e5329. doi: 10.1002/bmc.5329. Epub 2022 Jan 22.
Fuzheng Huayu recipe (FZHY) is a Chinese patent medicine for the treatment of liver fibrosis. This study aimed to investigate the toxicokinetics of FZHY in beagle dogs after oral administration. Blood samples were collected on days 1, 15 and 28 after oral gavage of FZHY dosages of 400 or 1,200 mg/kg body weight once a day. A UHPLC-Q-Orbitrap method was developed and validated to simultaneously determine and quantify eight components of FZHY in beagle dog plasma. The times to peak concentration for eight components were18-120 min. The peak concentrations (C ) of amygdalin, genistein, daidzein and 3,4-dihydroxybenzaldehyde were 1.43-43.50 ng/ml, the areas under the concentration-time curve (AUC ) were 2.45-6,098.25 ng min/ml, and the apparent volumes of distribution (V ) were 0.05-131.23 × 10 ml/kg. The values of C of prunasin, schisantherin A, schisandrin A and schisandrin were 7.35-1,450.73 ng/ml, the values of AUC were 3,642.30-330,388.65 ng min/ml, and the values of V were 11.15-1,087.18 × 10 ml/kg. No obvious accumulation of the eight compounds was observed in beagle dogs. The results showed that the method is rapid, accurate and sensitive, and is suitable for detecting the eight analytes of FZHY. This study provides an important basis for the assessment of FZHY safety.
扶正化瘀方（FZHY）是一种治疗肝纤维化的中药专利药。本研究旨在研究 FZHY 在口服给药后犬体内的毒代动力学。在口服 FZHY 剂量为 400 或 1200mg/kg 体重，每天一次的第 1、15 和 28 天采集血样。建立并验证了一种 UHPLC-Q-Orbitrap 方法，以同时定量测定比格犬血浆中 FZHY 的 8 种成分。8 种成分的达峰时间为 18-120min。杏仁苷、染料木素、大豆苷元和 3,4-二羟基苯甲醛的峰浓度（C ）为 1.43-43.50ng/ml，浓度-时间曲线下面积（AUC ）为 2.45-6098.25ng min/ml，表观分布容积（V ）为 0.05-131.23×10 ml/kg。Prunasin、五味子甲素、五味子丙素和五味子乙素的 C 值为 7.35-1450.73ng/ml，AUC 值为 3642.30-330388.65ng min/ml，V 值为 11.15-1087.18×10 ml/kg。在比格犬体内未观察到 8 种化合物的明显蓄积。结果表明，该方法快速、准确、灵敏，适用于检测 FZHY 的 8 种分析物。本研究为评估 FZHY 的安全性提供了重要依据。
