四逆散出自《伤寒论》，用于治疗阳郁厥逆证，后世医家取其疏肝理脾之功，治疗肝郁脾虚型失眠有一定疗效。研究表明，四逆散具有类似地西泮的镇静催眠作用和改善创伤后应激障碍（PTSD）所致睡眠障碍的作用。《中国药典》2015年版中没有收录四逆散相关成方制剂，故将四逆散开发为适用于临床的新药制剂有一定意义。通过对四逆散镇静催眠和改善PTSD所致睡眠障碍作用的文献报道进行整理归纳，对镇静催眠药理作用、作用机制、药效物质基础、药动学等研究及其改善PTSD所致睡眠障碍的作用机制进行系统梳理。基于四逆散镇静催眠作用的现代研究提出符合中医理论“安神”的新功效，从而完善四逆散适用范围，为其临床合理使用提供参考。根据我国中医药各类法律法规，分析四逆散遴选入古代经典名方的可能性，并以此分析四逆散古代经典名方复方制剂研发的关键性问题；然后从四逆散院内制剂的开发及其中药新药研发2个途径剖析，对进一步的研究提出展望，为开发四逆散“透邪解郁、疏肝理脾、安神”的中药新药制剂提供参考。

Sini Powder is the traditional Chinese medicine compound, which comes from Treatise on Febrile Diseases. It is used to treat the syndrome of yang depression and reversal cold of limbs. Sini Powder has a certain effect on treating insomnia caused by liver depression and spleen deficiency. Lots of researches have shown that Sini Powder has a sedative and hypnotic effect similar to diazepam and plays an important role in improving sleep disorders caused by post-traumatic stress disorder (PTSD). Sini Powder is not included in Chinese Pharmacopoeia (2015 edition). It is probably to develop Sini Powder into a new drug for the clinic. We collated and summarized the literature about the sedative and hypnotic effect and the improvement of sleep disorders caused by PTSD of Sini Powder. Based on the modern research on the sedative and hypnotic effect of Sini Powder, we think the effect of "relieve uneasiness of mind and body tranquilization" adapts the theory of traditional Chinese medicine, so that it can improve the applied range of Sini Powder. Meanwhile, we analyzed the possibility of Sini Powder being selected into the ancient classical prescription and key problem in research and development on drug preparation of Sini Powder according to regulations of traditional Chinese medicine. Then we put forward some suggestions for further research from two aspects which are the development of Sini Powder and new drugs of traditional Chinese medicine, to provide a reference for the development of new Chinese medicine preparation of Sini Powder focus on "expelling pathogen and relieving depression, soothing liver and regulating spleen, tranquilizing mind".

国家自然科学基金-地区科学基金资助项目（81960731）；国家自然科学基金资助项目（81460611）；甘肃省自然科学基金创新基地和人才计划项目（18JR3RA197）；甘肃省中药质量与标准研究重点实验室开放基金（ZYZL18-008）