Lee Chia-Jung, Kapelemera Alinafe Magret, Tsai Yi-Zhe, Lee Ching-Tzu, Xu Ming-Yi, Wang Ching-Chiung
Graduate Institute of Pharmacognosy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan.
PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, Taipei, Taiwan.
Front Pharmacol. 2020 Sep 4;11:1245. doi: 10.3389/fphar.2020.01245. eCollection 2020.
Si-Wu-Tang (SWT), a traditional Chinese formula, is commonly used to relieve menstrual discomfort and climacteric syndrome. Water decoction (WD) and concentrated herbal extract (CHE) are the two most common formulations of traditional Chinese medicine (TCM). However, few studies have reported the equivalency of these two formulations. In this study, 23 healthy volunteers were included to determine the pharmacokinetic (PK) equivalent dosage of WD and CHE, and 25 infertile women with follicular maldevelopment to evaluate the pharmacodynamic (PD) effects on menstrual disorders. The randomized, two-way crossover comparative PK study of SWT-WD and SWT-CHE analyzed the active component, ferulic acid. The results showed that clinical doses of 170 mL SWT-WD and 18 g SWT-CHE produced the same amount of ferulic acid in the blood. The PD study showed that patients who took both of these formulations had an initial luteinizing hormone/follicle-stimulating hormone ratio of <1; however, the value returned to normal and their symptoms all improved after taken SWT. Our results showed that WD and CHE, both prepared from 40 g of SWT, displayed bioequivalence upon PK/PD analysis.
四物汤（SWT）是一种传统中药配方，常用于缓解月经不适和更年期综合征。水煎剂（WD）和浓缩草药提取物（CHE）是两种最常见的中药剂型。然而，很少有研究报道这两种剂型的等效性。本研究纳入了23名健康志愿者以确定WD和CHE的药代动力学（PK）等效剂量，并纳入了25名卵泡发育不良的不孕女性以评估其对月经紊乱的药效学（PD）作用。对SWT-WD和SWT-CHE进行的随机、双向交叉比较PK研究分析了活性成分阿魏酸。结果表明，170 mL SWT-WD和18 g SWT-CHE的临床剂量在血液中产生的阿魏酸量相同。PD研究表明，服用这两种剂型的患者最初的促黄体生成素/促卵泡生成素比值均<1；然而，服用SWT后该值恢复正常，且她们的症状均有所改善。我们的结果表明，由40 g SWT制备的WD和CHE在PK/PD分析中显示出生物等效性。
