传统丸剂历史沿革、科学内涵及丸剂二次开发的发展构想

Historical evolution and scientific connotation of traditional pills and the development assumption of the secondary development of pills

丸剂是我国古代重要的中药剂型,当前正处于传统剂型转型升级的关键期,梳理丸剂历史沿革,总结丸剂发展规律对了解古代制剂学史、实现丸剂现代化具有重要意义。丸剂理论经历了“药性有宜丸者”“疾有宜服丸者”“丸者,缓也”三次总结及提升,确立了“丸者,缓也”的核心理论。丸剂缓释的特点与其剂型、辅料密切相关,辅料呈现由博返约的特点;传统丸剂剂型也演变为以蜜丸、水丸、水蜜丸、浓缩丸为主,糊丸、蜡丸为辅,且后二者面临淘汰的处境。丸剂现代化必须依据现代制剂手段,从释药体系、药物载体、药效成分等方面全面解析复方制剂,构建新型丸剂,使丸剂保留缓释特点的同时实现定时可控给药。在辅料方面,应当注重饴糖、糯米、蜂蜡等传统辅料的继承与开发,深挖特色、传承精华。

Pills were an important dosage form in ancient China in the critical period of transformation and upgrading of traditional dosage forms.It is important to understand the history of ancient pharmaceuticals and realize the modernization of bolus by combing history and summarizing the development law of bolus.The theory of pills has been summarized three times and gradually established the core theory of pills’slow release.The scientific connotation of pills’slow release is closely related to their dosage form and excipients.Excipients show the characteristics of being varied and reduced.Traditional pill formulation also evolved into the honey pill,water pill,water honey pill,concentrated pill,paste pill,and wax pill as the supplement.The two are facing the situation of elimination.The modernization of pills must be based on modern means of preparation;the comprehensive analysis of compound preparations from the aspects of the drug release system,drug carrier,and pharmacodynamic components;and the construction of new pills.The aim is to maintain the characteristics of the sustained release of pills and realize time-controlled drug delivery.In the aspect of traditional supplementary materials,we should focus on the scientific interpretation of traditional supplementary materials such as caramel,glutinous rice,and beeswax as well as dig deep into the characteristics and inherit the essence.