经典名方苓桂术甘汤复方制剂的研制

Development of compound preparation for famous classic prescription Linggui Zhugan Decoction

苓桂术甘汤出自《金匮要略》,是温阳化饮法治疗“痰饮病”的代表方,由茯苓、桂枝、白术、甘草组成,具有温阳化饮、健脾利湿之功效,用于中阳不足之痰饮,证见胸胁支满、目眩心悸、短气而咳、舌苔白滑、脉弦滑,为国家中医药管理局发布的《古代经典名方目录(第一批)》之第19首,《古代经典名方关键信息表(7首方剂)》之第1首。为了满足临床需要,课题组前期依据《按古代经典名方目录管理的中药复方制剂药学研究技术指导原则(试行)》和《中药注册分类及申报资料要求》的要求,将苓桂术甘汤开发为现代制剂苓桂术甘颗粒,是首个按照中药注册分类3.1类按古代经典名方目录管理的中药复方制剂申请上市的品种,于2022年12月27日首个获批。本研究探讨苓桂术甘颗粒研发过程关键环节的技术要点,以期为其他经典名方复方制剂的相关研究提供思路与参考。

Linggui Zhugan Decoction(LZD),a formula from the Essential Prescriptions of the Golden Cabinet(EPGC)by Zhang Zhongjing of the Eastern Han Dynasty,is typically effective in the management of phlegm and fluid retention due to its efficacy in warming yang.The decoction is composed of Poria Cocos(Fulin),Cinnamoni Ramulus(Guizhi),Atractylodis Macrocephalae Rhizoma(Baizhu),and Glycyrrhizae Radix et Rhizoma(Gancao),contributing effects of warming yang for resolving fluid-retention,as well as fortifying the spleen and eliminating dampness.It is often used for propping fullness in the chest and the ribside,dizzy vision and palpitations,shortness of breath and coughing,white moist coated tongue,and thready and slippery pulse seen in phlegm-retention caused by the deficiency in middle warmer(yang).LZD was listed as the 19 th formula in the Catalogue of Ancient Classical Famous Prescriptions(First Batch)issued by the State Administration of Traditional Chinese Medicine,and the 1 st in the Key Information List of Ancient Classical Famous Prescriptions(7 prescriptions).To satisfy a clinical demand,LZD has been developed into the modern dosage form of granules to meet the standards of the Technical Guidelines for Pharmacological Research on Compound Preparations Derived from Ancient Classic Recipes(Trial Implementation),and the Requirements for the Registration Classification and Declaration of Chinese Medicine.Complying with standard for Category 3.1 of ancient classic recipe,Linggui Zhugan Granules were officially approved to be commercially available on Dec.27,2022..Our discussions on the key technical process in the development of Linggui Zhugan Granules may highlight the R&D strategies for other famous classical TCM prescriptions,and thus their developments into Category 3.1 new TCM drugs.