This project belongs to the field of biology and medicine technology and is the result of the national 11th Five-Year Plan science and technology supporting project "Technology and application research on extraction-azeotropic rectification coupled enrichment of volatile components in traditional Chinese medicine." A total of 4 patents were applied and 3 authorized patents were obtained; he published 2 SCI papers, 1 EI paper, and 10 domestic core journal papers, which he cited 62 times.
Volatile components of traditional Chinese medicine are an important type of active substances in proprietary Chinese medicines. They usually contain one or more groups such as-OH. They are easy to form an azeotrope with the lowest azeotropic point with water and are difficult to separate and prepare, resulting in many preparations containing volatile oils of traditional Chinese medicine. Such substances are not detected. The technology of the invention adds a (variable diameter) rectification tower between the extraction tank and the condenser of the traditional steam distillation device, which couples the extraction and rectification processes to extract volatile components in traditional Chinese medicines, greatly improving the enrichment efficiency of volatile oil in medicinal materials; the extraction-rectification-extraction coupling process can further improve the degree of oil-water separation in the volatile oil collector and reduce the loss of volatile oil. The theoretical number of trays of the rectification column of the device disclosed by the invention is 3 pieces/meter; the tower diameter is 100-300mm; and the treatment capacity of medicinal materials is 15-200kg/batch. Its main innovations are as follows:
(1) Adopt coupling technology and patented device to achieve efficient enrichment of volatile oil. For the first time, the extraction of traditional Chinese medicine, rectification of volatile oil and extraction processes are put in one operating unit to complete two or three processes simultaneously, shortening the process flow., reduce the loss of volatile components, make the extraction rate of volatile oil higher, and have a wider applicability to raw materials.
(2) The extraction tank is both a device for extracting medicinal materials and a heating device for volatile components, and the rectification column is both a device for enriching volatile components and a reflux device for the extraction tank. The content of volatile components in the reflux liquid is extremely low, avoiding the need to replenish water during the reflux process. Under the same operating time and energy consumption, multiple distillations of the volatile oil of traditional Chinese medicine can be realized, greatly improving the enrichment efficiency of the volatile oil.
(3) When the extraction-rectification-extraction coupling process extracts volatile components with density close to that of water, slightly soluble in water and very viscous, a suitable amount of excipients allowed by the Pharmacopeia are added to the oil-water separator as extractant, which improves the oil-water separation efficiency, avoids losses caused by volatile components being dissolved in water or sticking to the inner wall of the oil-water separator, and eliminates the need for separation and recovery of the extractant, is environmentally friendly, and meets GMP requirements.
The technology of the invention uses a series of small scale, pilot scale and production-scale devices as carriers to form a series of mature technologies and is used for the production of a series of volatile oil-containing products and the research and development of new products in traditional Chinese medicine enterprises. Laboratory research and industrial implementation results show that compared with the steam distillation process specified in the Pharmacopeia, the technology of the present invention can increase the yield of volatile oil by 2-5 times and the concentration of volatile oil by 2-3 times at small and pilot scale. The main substance is the same as the volatile oil of the steam distillation process. Enterprises on an industrial scale have never obtained Bupleurum volatile oil by adopting other processes. By adopting the technology of the present invention, about 40mL/100kg Bupleurum volatile oil and 100mL/100kg Szechuan rhizome volatile oil can be stably obtained. The technology of the invention has particularly significant advantages when enriching volatile components of traditional Chinese medicine with strong water solubility and a volatile oil content of less than 2%.
The technology of the invention improves the preparation process of volatile oil in Jingfukang Granules, the main product of Jingfukang Pharmaceutical Group Company, and forms a new quality standard for Jingfukang Granules on the basis of the new process. In addition, this technology has also been successfully applied in the extraction of volatile oil from Jingfukang Company's Chaiqin Soft Capsule and Xinjianwei Tablet products and the preparation of volatile oil from Rushuan Capsule clinical research preparation, which has improved the production and quality of these products. and guaranteed. The production of Jingfukang Granules, Chaiqin Soft Capsules and Xinjianwei Tablets has all passed the new version of GMP certification. During the three-year period from 2011 to 2013, the above three products added 159 million yuan in output value and increased profits and taxes of 30.496 million yuan. It reflects the role of science and technology in promoting productivity and social progress, and achieves the original intention of supporting project establishment.