中药制造现代化——固体制剂产业化关键技术研究及应用

Modernization of Traditional Chinese Medicine Manufacturing:Research and Application of Key Technologies in Industrialization of Solid Preparations

中药现代化就是将传统中医药的优势特色与现代科学技术相结合,以适应当代社会发展需求的过程。高质量、高效率、高效能发展,是中药制剂制造现代化发展的方向。中药复方制剂的药味成分复杂多样,服用剂量大、制剂规格大,药辅占比高,物料吸湿性大、黏性强,传统中药制剂制造过程生产存在“产品质量低、生产效率低、生产能耗高”等一系列问题,成为严重制约中药制剂制造现代化发展难题。中药制造过程物料、工艺、技术和装备相互交织、互相影响,单一改进工艺、技术、装备,或者依靠简单引进“洋”技术与设备都难以从根本上解决问题,必须采用系统解决方案,走自主创新之路。项目组以临床广泛使用的剂型——中药固体制剂为例,多学科联合攻关,围绕制约中药固体制剂制造产业化的关键问题,以中药制剂的“提质、增效、绿色、升级”为目标,从设计、工艺、装备和质控等方面创建中药制剂制造产业化系统解决方案,创新了中药大规格高速压片技术与装备、中药大容量包衣技术与装备等,为中药固体制剂制造产业化升级提供范本,并构建了以健胃消食咀嚼片、草珊瑚含片、金水宝胶囊等为代表的中药大品种集群,为中药制造行业提供良好的示范。

The modernization of traditional Chinese medicine is the process of combining the advantages and characteristics of traditional Chinese medicine with modern science and technology to meet the needs of the development of the society.High quality and efficiency,and low energy consumption is the development direction of modern traditional Chinese medicine preparation manufacturing.The traditional Chinese medicine compound preparation has a series of problems,such as complex and diverse components,large dosage,large preparation specifications,high proportion of auxiliary drugs,large moisture absorption and strong viscosity of materials.All these result in a series of problems of the production of traditional Chinese medicine preparation,such as″low product quality and production efficiency,and high production energy consumption″,which seriously restrict the development of″high quality and efficiency and low energy consumption″in the modernization of Chinese medicine preparation manufacturing.Materials,technology,technology and equipment in the manufacturing process of traditional Chinese medicine interweave and influence each other.It is difficult to fundamentally solve the problem by simply improving process,technology and equipment,or by simply introducing″foreign″technology and equipment.We must adopt systematic solutions and take the road of independent innovation.Taking the widely used clinical dosage form-solid preparation of traditional Chinese medicine as an example,we focused on the key problems restricting the industrialization of solid preparation of traditional Chinese medicine manufacturing and established a systematic solution for the industrialization of traditional Chinese medicine preparation manufacturing from the aspects of design,technology,equipment and quality control,in order to achieve the goal of″improving quality,increasing efficiency,energy-saving green and technology upgrading″of traditional Chinese medicine preparation.Meanwhile,we innovated grid high-speed tablet pressing technology,large capacity coating technology and equipment suitable for large size herbal tablet to meet the high efficiency of traditional Chinese medicine manufacturing industry.The researches provided a model for the industrial upgrading of traditional Chinese medicine solid preparation manufacturing,and built up a large variety of Chinese medicine cluster represented by Jianwei Xiaoshi chewable tablets,Caoshanhu buccal tablets,Jinshuibao capsule,etc.