Research On Several Key Issues For Chinese Pharmaceutical Manufacturing Process Control And Integrated Manufacture

Industrialized production of Chinese pharmaceutical manufacturing is generally divided into Chinese medicine pretreatment, extracting, preparation and packaging three stages, and the stage of Chinese medicine extracting is the core process of the medicine industrialized production, which includes extraction, concentration, drying, etc. With the new craft new method continue to emerge and the implementation of GMP standard in production management of Chinese pharmaceutical manufacturing, conventional control method and the backward basic automation net in the enterprises have not meet the demand of the Chinese medicine industry's development.On the basis of deep analysis in extracting craft and control need, the paper mainly did research on the production process of extracting. For a range of problems in current production, these were systematically investigated, that include Chinese medicine concentration soft-sensor, temperature control of Chinese medicine warm immersion dynamic extraction, design and construction of control system in Chinese pharmaceutical manufacturing process, information integrated technique of Chinese pharmaceutical manufacturing, CIPS of Chinese pharmaceutical manufacturing and a series of theoretical and applied problems. All the main work of the paper is sum-up as follows:(1) For the problem of on line measuring Chinese medicine consistency was difficult in the process of concentration, the method of consistency soft-sensor based on Support Vector Regression was presented. The method has the advantage of fast learning speed, global optimum and well generalization performance, because Support Vector Regression has the ability of small sample learning. Applying the idea of data-driven modeling and making full use of Chinese medicine concentration's historical data, six auxiliary variables were selected. A soft-sensor model was established by Support Vector Regression, and the parameters were optimized and checked making use of the process-data. It made prediction on consistency during Chinese medicine concentration by using the optimized model, and the model's ability of learning and generalization were verified. The results show that the soft-sensor model could not only achieve the accurate prediction of Chinese medicine consistency, but also effectively resolve the problem of on line measuring Chinese medicine consistency in the process of concentration. Therefore, it has practical value.(2) Aimed at temperature accurate control of Chinese medicine warm immersion dynamic extraction, the paper focused on Chinese medicine extraction system in a pharmaceutical enterprise. Processing facilities and heat-transfer process of Chinese medicine extraction were analyzed, and the simplified model was established. Adapting to the characteristics of nonlinearity, time-varying and pure time-delay in temperature control in Chinese medicine extraction, a fuzzy self-tuning PID control system was designed and simulations were performed. The simulation results indicate that the system put up synthetic performance, such as less modulation time, quicker responses, high temperature control accuracy and good robustness stability.(3) The paper analyzed the automation requirement and measurement &control points in extraction, concentration, and drying, and researched Chinese pharmaceutical manufacturing's equipment integration. A monitoring control network was designed based on PROFIBUS-DP, and its hardware, system configuration, software system were introduced. Making use of the union of PROFIBUS and industrial Ethernet, the centralized monitor and decentralize control, which in every section of Chinese pharmaceutical manufacturing process, were realized, and the platform was built, which for widely applications in MES and ERP.(4) Based on the analysis of business process and information characteristics of pharmaceutical enterprise, the paper studied information integration technology of Chinese pharmaceutical manufacturing, and information integration plan of Chinese pharmaceutical manufacturing was presented. Using OPC technology and XML device description method, two standards of OPC DA and OPC XML-DA were employed for system integration. On this basis, these were established that include complete and reliable real-time database in the production process and relation database in the management process. Distributed control and remote administration control of the enterprises were achieved, through the integration platform of pharmaceutical enterprise that based on Web Services. The key technologies of realizing information integration were discussed in detail.(5) The main design and principle of the process of Chinese pharmaceutical manufacturing's computer integrated process system (CIPS) were presented, so as to achieve the optimum control in the whole process of Chinese pharmaceutical manufacturing. It analyzed the function of each part of the module, and discussed the key technologies. The implementation of MES and ERP system and functional module were discussed in detail, and the solution was proposed which satisfied advanced control and real-time optimization.At present, advanced process control and integrated manufacturing technology of Chinese pharmaceutical manufacturing research has just started. Because the standard of Chinese pharmaceutical manufacturing equipment and Chinese medicine quality control system were not be still perfect, that had brought enormous difficulties to the implement of integrated process control in pharmaceutical enterprises. The paper researched several problems existing in process control and integrated technology in pharmaceutical enterprise, under equipment and technology level at this stage, and the research got some achievements, moreover, it has a broad application prospect. Automation and information is the only way that realizes Chinese medicine modernization. With equipment standard of Chinese pharmaceutical manufacturing and quality control system of Chinese medicine gradually improving, some ideas and methods in the paper have some referenced value of the implement of integrated technology of Chinese pharmaceutical manufacturing based on higher basis and standard.