[Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines(Ⅰ): classification of processing routes]. 2023

Fei-Yu Qi, and Wen-Jing Li, and Xiao-Qing Zhao, and Jun-Jie Cao, and Yan-Jiang Qiao, and Bing Xu
Department of Chinese Medicine Informatics, Beijing University of Chinese Medicine Beijing 102400, China.

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.

UI MeSH Term Description Entries
D008516 Medicine, Chinese Traditional A system of traditional medicine which is based on the beliefs and practices of the Chinese culture. Chinese Medicine, Traditional,Chung I Hsueh,Traditional Medicine, Chinese,Zhong Yi Xue,Chinese Traditional Medicine,Traditional Chinese Medicine,Traditional Tongue Assessment,Traditional Tongue Diagnosis,Hsueh, Chung I,Tongue Assessment, Traditional,Tongue Diagnoses, Traditional,Tongue Diagnosis, Traditional,Traditional Tongue Assessments,Traditional Tongue Diagnoses
D011208 Powders Substances made up of an aggregation of small particles, as that obtained by grinding or trituration of a solid drug. In pharmacy it is a form in which substances are administered. (From Dorland, 28th ed) Powder
D002214 Capsules Hard or soft soluble containers used for the oral administration of medicine. Capsule,Microcapsule,Microcapsules
D005079 Excipients Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc. Excipient,Stabilizing Agent,Stabilizing Agents,Suspending Agent,Suspending Agents,Agent, Stabilizing,Agent, Suspending,Agents, Stabilizing,Agents, Suspending

Related Publications

Fei-Yu Qi, and Wen-Jing Li, and Xiao-Qing Zhao, and Jun-Jie Cao, and Yan-Jiang Qiao, and Bing Xu
June 2023, Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica,
Fei-Yu Qi, and Wen-Jing Li, and Xiao-Qing Zhao, and Jun-Jie Cao, and Yan-Jiang Qiao, and Bing Xu
August 2023, Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica,
Fei-Yu Qi, and Wen-Jing Li, and Xiao-Qing Zhao, and Jun-Jie Cao, and Yan-Jiang Qiao, and Bing Xu
January 2015, Pharmaceutical development and technology,
Fei-Yu Qi, and Wen-Jing Li, and Xiao-Qing Zhao, and Jun-Jie Cao, and Yan-Jiang Qiao, and Bing Xu
May 2024, Pharmaceutical development and technology,
Fei-Yu Qi, and Wen-Jing Li, and Xiao-Qing Zhao, and Jun-Jie Cao, and Yan-Jiang Qiao, and Bing Xu
August 2021, Pharmaceutics,
Fei-Yu Qi, and Wen-Jing Li, and Xiao-Qing Zhao, and Jun-Jie Cao, and Yan-Jiang Qiao, and Bing Xu
April 2020, International journal of pharmaceutics,
Fei-Yu Qi, and Wen-Jing Li, and Xiao-Qing Zhao, and Jun-Jie Cao, and Yan-Jiang Qiao, and Bing Xu
October 2022, The Journal of pharmacy and pharmacology,
Fei-Yu Qi, and Wen-Jing Li, and Xiao-Qing Zhao, and Jun-Jie Cao, and Yan-Jiang Qiao, and Bing Xu
November 2018, Pharmaceutical research,
Fei-Yu Qi, and Wen-Jing Li, and Xiao-Qing Zhao, and Jun-Jie Cao, and Yan-Jiang Qiao, and Bing Xu
September 2013, Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica,
Fei-Yu Qi, and Wen-Jing Li, and Xiao-Qing Zhao, and Jun-Jie Cao, and Yan-Jiang Qiao, and Bing Xu
February 1993, Professional nurse (London, England),
Copied contents to your clipboard!