Qi Fei-Yu, Li Wen-Jing, Zhao Xiao-Qing, Cao Jun-Jie, Qiao Yan-Jiang, Xu Bing
Department of Chinese Medicine Informatics, Beijing University of Chinese Medicine Beijing 102400, China.
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, Beijing Municipal Science & Technology Commission Beijing 102400, China Engineering Research Center of Chinese Medicine Production and New Drug Development, Ministry of Education Beijing 102400, China.
Zhongguo Zhong Yao Za Zhi. 2023 Jun;48(12):3169-3179. doi: 10.19540/j.cnki.cjcmm.20221014.301.
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 1 308 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 pretreatment 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 mate-rials 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 processes of traditional Chinese medicine OSDs, and the application of pharmaceutical excipients is diversified. The results of this study are expected to provide reference for the processing route design and upgrading of OSDs for new traditional Chinese medicines.
口服固体制剂（OSD）在中国专利药品和新型中药市场中占据关键地位。炮制路线是中药口服固体制剂研发的基础。基于《中国药典》中收录的1308种中药口服固体制剂的处方和制备方法，我们总结了现代剂型（片剂、颗粒剂和胶囊剂）和传统剂型（丸剂和散剂）的炮制路线模式，并基于炮制路线构建了生产分类系统（MCS）。基于该生产分类系统，分别对预处理过程中的药材、药用辅料、提取溶剂、粉碎药材、浓缩与纯化方法以及干燥与制粒方法进行了统计分析，旨在揭示工艺特征。结果表明，每种剂型都可以通过不同的路线制备，饮片和制剂原料的加工方法各不相同。中药口服固体制剂的制剂原料包括全提取物、半提取物和全粉，它们所占比例不同。传统剂型的原料主要是饮片粉末。半提取物是片剂和胶囊剂的主要原料，分别占64.8%和56.3%。全提取物是颗粒剂的主要原料，占比77.8%。与片剂和胶囊剂相比，有溶出度要求的中药颗粒剂水提取工艺的比例更大，精制工艺的比例更高（34.7%），半浸膏颗粒中粉碎药材的比例更低。中药现代剂型中挥发油的添加有四种方式。此外，中药口服固体制剂的浓缩、过滤和制粒过程中采用了一些新技术和工艺，药用辅料的应用也呈现多样化。本研究结果有望为新型中药口服固体制剂的炮制路线设计和升级提供参考。
