中药口服固体制剂制造分类系统(Ⅰ):工艺路线分类  

Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines(Ⅰ):classification of processing routes

作　　者：齐飞宇 李文静[1] 赵晓庆 曹君杰 乔延江[1,2,3] 徐冰 QI ei-yu;LI Wen-jing;ZHAO Xiao-qing;CAO Jun-je;QIAO Yan-jang;XU Binog(Department of Chinese Medicine Informatics,Beijing University of Chinese Medicine,Beijing 102400,China;Beijing Key Laboratory of Chinese Medicine Manufacturing Process Control and Quality Evaluation,Bejing Municipal Science&Technology Commission,Beijing 102400,China;Engineering Research Center of Chinese Medicine Production and New Drug Development,Ministry of Education,Beijing 102400,China)

机构地区：[1]北京中医药大学中药信息学系,北京102400 [2]北京市科委中药生产过程控制与质量评价北京市重点实验室,北京102400 [3]中药制药与新药开发教育部工程研究中心,北京102400

出　　处：《中国中药杂志》2023年第12期3169-3179,共11页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(82074033);连云港市重大技术攻关“揭榜挂帅”项目(CGJBGS2101);创新药物与高效节能降耗制药设备国家重点实验室开放基金项目(GZSYS202007)。

摘　　要：中药口服固体制剂(oral solid dosage, OSD)是已上市中成药和中药新药开发的主体,工艺路线设计是中药口服固体制剂研发的根基。该文依据现行版《中国药典》收载的1 308例中药OSD的处方和制法信息,归纳了中药现代剂型(片剂、颗粒剂和胶囊剂)和传统剂型(丸剂和散剂)的工艺路线模式,构建了以工艺路线分类为基础的制造分类系统(manufacturing classification system, MCS),从工艺角度反映了中药复方制剂物质基础传递模式。基于MCS对处方药味、药用辅料、前处理工艺中提取溶剂、粉碎药味、浓缩和精制的方式,制粒以及干燥的工艺特征进行了统计分析。研究结果表明,各剂型可依据不同的饮片处理方式和制剂成型原料实现工艺路线划分,中药复方OSD提取精制工艺具有“尊重传统用药经验”特点。中药OSD成型工艺原料均包括全浸膏、半浸膏和全粉3种形式,传统剂型的成型原料主要为饮片细粉,片剂与胶囊剂的成型原料主要为半浸膏(占比分别为64.8%和56.3%),颗粒剂成型原料主要为全浸膏(占比77.8%)。与片剂和胶囊相比,存在溶化性要求的中药颗粒剂具有水提工艺占比大、精制工艺占比高(34.7%)、且半浸膏颗粒中粉碎药味占比低的特点。在中药现代剂型中,挥发油存在4种加入方式。此外,一些新技术和新工艺已运用于中药OSD浓缩、滤过和制粒等工序,药用辅料的应用呈多元化趋势。该文研究结果预期为中药OSD工艺路线设计、工艺二次开发或变更提供参考。Oral solid dosage(OSD)occupies a key position in the market of Chinese patent medicines and new traditional Chinese medicines.Processing route is the foundation for the research and development of traditional Chinese medicine OSDs.On the basis of prescriptions and preparation methods of 1308 traditional Chinese medicine OSDs recorded in the Chinese Pharmacopoeia,we summarized the patterns of processing routes of both modern dosage forms(tablets,granules,and capsules)and traditional dosage forms(pills and powder)and constructed a manufacturing classification system(MCS)based on the processing routes.Based on the MCS,statistical analyses were conducted respectively on medicinal materials,pharmaceutical excipients,extraction solvents in the pretreat ment process,crushed medicinal materials,methods of concentration and purification,and methods of drying and granulation,aiming to uncover the process features.The results showed that each dosage form can be prepared via different routes with different processing methods of decoction pieces and raw materials for dosage preparation.The raw materials for dosage form preparation of traditional Chinese medicine OSDs included total extract,semi-extract,and total crushed powder,which accounted for different proportions.The raw materials for traditional dosage forms are mainly decoction pieces powder.Semi-extracts are the main raw materials for tablets and capsules,which account for 64.8%and 56.3%,respectively.Total extracts are the main raw materials for granules,with a proportion of 77.8%.Compared with tablets and capsules,traditional Chinese medicine granules with dissolubility requirements had a larger proportion of water extraction process,a higher proportion of refining process(34.7%),and a lower proportion of crushed medicinal materials in semi-extract granules.There are four ways to add volatile oil to the modern dosage forms of traditional Chinese medicine.In addition,some new technologies and processes have been used in concentration,filtration,and granulation process

关 键 词：中药 口服固体制剂 制造分类系统 工艺路线 工艺设计 

分 类 号：R283[医药卫生—中药学]