新技术及装备在中药丸剂现代制造中的应用与展望  

Application and outlook of new technologies and equipment in modern manufacturing of traditional Chinese medicine pills

作　　者：王翔 王学成 朱雯婷 唐培渝 李远辉 杨东印 易兵 伍振峰 WANG Xiang;WANG Xue-cheng;ZHU Wen-ting;TANG Pei-yu;LI Yuan-hui;YANG Dong-yin;YI Bing;WU Zhen-feng(Key Laboratory of Modern Chinese Medicine Formulations,Ministry of Education,Jiangxi University of Chinese Medicine,Nanchang 330004,China;Jiangxi Hebaikanghua Pharmaceutical Equipment Co.,Ltd.,Nanchang 330200,China)

机构地区：[1]江西中医药大学现代中药制剂教育部重点实验室,江西南昌330004 [2]江西赫柏康华制药设备有限公司,江西南昌330200

出　　处：《中国中药杂志》2024年第19期5125-5134,共10页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(82460774);国家自然科学基金项目(82003952);国家重点研发计划项目(2023YFC3504500);江西中医药大学重点学科建设经费资助课题(2023jzzdxk017);江西中医药大学科研基金项目(2022WBZR006)。

摘　　要：自古以来,中药丸剂在中药剂型当中占据非常重要的地位。为全面提升丸剂的整体质量,应对其关键工艺技术不断革新,因此该文从粉碎、灭菌、合坨、成型、干燥等关键工艺出发,对其中原理和新技术应用进行了总结和阐述。此外,现代生物传感技术、图像分析技术、质构特性评价技术和水分分析评价技术等可对中药丸剂制造关键物料进行全面、准确的质量表征,从而实现对其原料药、中间体、终产品质量严格控制,进一步监测、优化丸剂制备生产全过程。为进一步提高丸剂的生产质量和效率,该文对实施联动制造模式的关键技术和装备方案进行了简单阐述,并对中药丸剂多单元联动制造模式的应用进行展望,以期为中药丸剂全面实现多单元联动制造的研究提供参考。Since ancient times,traditional Chinese medicine pills have occupied a key position among different dosage forms of traditional Chinese medicine.With the aims of comprehensively improving the overall quality and innovating key technologies in the manufacturing of the pills,this article elaborates on the principles and new technology applications in pulverizing,sterilization,agglomeration,forming,and drying.In addition,modern technologies such as biosensing,image analysis,texture property evaluation,and moisture analysis can comprehensively and accurately characterize the quality of key materials in the manufacturing of traditional Chinese medicine pills,thereby achieving strict control over the quality of raw materials,intermediates,and final products and further monitoring and optimizing the entire production process of pill preparations.To further improve the production quality and efficiency of traditional Chinese medicine pills,this article briefs the key technologies and equipment schemes for the linkage manufacturing mode and looks forward to the application of the multi-unit linkage manufacturing mode for traditional Chinese medicine pills.This review is expected to provide reference for the research on the multi-unit linkage manufacturing of traditional Chinese medicine pills.

关 键 词：中药丸剂 关键工艺单元 质量快速评价新技术 多单元联动制造 质量提升 

分 类 号：R283.6[医药卫生—中药学]