日本汉方药在国际市场上具有举足轻重的地位,是我国中药的强有力对手,而小柴胡汤（Sho-Saiko-to,以下简称SST）作为日本研究和使用最为广泛的方剂之一,在汉方药中有特殊之地位。该品种作为世界上为数不多的获得美国FDA临床批准、但仍处于研究活跃期的植物药品种之一,自1997年启动了进入美国医药市场的研究以来,尤其在临床研究方面,已经进行了许多前瞻性的探索工作。本文结合日本汉方药的发展历程,讨论了SST的研究进展情况,希望能对我国中药未来申报美国提供一些借鉴和参考。

As a main branch of Traditional Chinese Medicine （TCM）, Kampo Medicine plays a more important role in the primary healthcare service in Japan, compared with conventional medicines. Sho-Saiko-to （SST） is a major Kampo herbal preparation, and is also a representative IND approved by US FDA based on its wide use and popularity in Japan, though the drug is remaining active in research. Despite a tortuous process and daunting challenges, numerous exploratory researches have been conducted since 2000. This article introduces the progress of Sho-Saiko-To and its research and development efforts in the US, which can be an example for China's pharmaceutical industry that will head for the US market in the future.