中药固体制剂大品种智能制造过程现状、问题与发展趋势分析

Current status,challenges,and development trends in intelligent manufacturing of traditional Chinese medicine solid preparations

中药固体制剂大品种智能制造是当前中药产业发展的重要方向之一,中药企业智能制造、数字化转型正如火如荼,新装备、新技术为中药行业赋予新的能力。随着全球医药市场的快速发展,大品种药物制造水平在很大程度上代表了国家制药工业的先进性,固体制剂作为中药主要剂型,其制造过程具有工艺复杂多样,质量管控严格等特点。一批企业抓住机遇对原有药品制造过程进行重塑,对药品质量进行精益改进,在药性感知、质量辨识、量值传递、智能控制等方向重点突破,朝着绿色节能、装备协同、质效同增目标前进。推动中药固体制剂大品种的智能制造,不仅能提高生产效率和药品质量,还能有效解决管控难题,具有重要的现实意义和广阔的发展前景。该文参考近年来我国中药制造相关政策与研究情况,在此基础上分析现阶段存在问题,探讨中药大品种当前智能制造现状和未来发展趋势,为后续中药固体制剂智能制造相关方面的研究提供参考。

The intelligent manufacturing of traditional Chinese medicine(TCM)solid preparations is an important direction in the current development of the TCM industry.TCM enterprises are fervently pursuing intelligent manufacturing and digital transformation,and new equipment and technologies are empowering the development of this industry.With the rapid development of the global pharmaceutical market,the manufacturing level of large-scale drugs represents the advancement in the pharmaceutical industry of a country.Solid preparations,being a main dosage form of TCM,have complex and diverse manufacturing processes and stringent quality control requirements.A number of enterprises are seizing the opportunity to reshape their original drug manufacturing processes,making lean improvement in drug quality and achieving key breakthroughs in drug sensory perception,quality recognition,value quality and efficiency.Promoting the intelligent manufacturing of TCM solid preparations can not only improve the production efficiency and drug quality but also solve control challenges,being of significant practical importance and offering broad development prospects.By reviewing the recent policies and studies on TCM manufacturing in China,this paper analyzes the challenges,current status,and development trends in the intelligent manufacturing of TCM solid preparations,providing a reference for subsequent research in this field.