粉末直压工艺是制备高载药量中药片剂极具潜力的发展方向。但中药粉体流动性与压缩性通常较差，无法实现粉末直压。长期以来中药片剂成型主要照搬化学药固体制剂成型“外延桥”模式，加入大量辅料以实现中药片剂成型，导致中药片剂载药量低，从而对患者的顺应性和临床治疗效果产生不利影响，严重制约了中药产业高质量发展。在包衣液、外加机械力或氢键等诱导或激发下，中药粒子与少量辅料粒子发生塑性形变，通过有序包合或吸附、液化连接、互相嵌合等变化，产生“内生桥”，促进制剂成型。从“内生桥”角度出发，分别对“液-固内生桥”“液体内生桥”和“固体内生桥”进行概述，以期对高载药量中药粉末直压技术与工艺的发展提供一定的思路与理论基础。

The powder direct compaction is a promising development trend for producing traditional Chinese medicine (TCM) tablets with high drug loading. However, the suboptimal flowability and compactibility of TCM powder pose significant challenges for achieving direct compaction. The formulation of TCM tablets was accomplished through incorporation of a high proportion of excipients, primarily following the design principles of chemical solid dosage forms, utilizing an “extended bridge” approach. The model has resulted in a low drug loading capacity of TCM tablets, negatively impacting patient compliance and clinical efficacy. It has long hindered the high-quality development of the TCM industry. Under the stimulation and induction of coating solution, external mechanical forces, or hydrogen bond, TCM particles and a little excipient undergo plastic deformation, “endogenous bridge” is generated to promote the formation of preparations through orderly encapsulation or adsorption, liquefaction connection, and mutual embedding. The present review employs the concept of the “endogenous bridge” to summary the “liquid-solid endogenous bridge”, “liquid endogenous bridge” and “solid endogenous bridge”. This review could provide ideas and theory basis for the development of TCM powder direct compaction with high drug loading.

R283.6

国家自然科学基金资助项目（82574594）；国家自然科学基金资助项目（82360777）；江西中医药大学博士科研启动基金项目资助（2022BSZR003）