中药制药过程控制及集成化生产若干关键问题研究
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摘要
中药制药工业化生产一般分为中药前处理、中药浸膏生产、中药制剂与包装三个阶段,其中中药浸膏生产阶段包含提取、浓缩、干燥等工段,是中药工业化生产的核心过程。随着新工艺新方法的不断出现,以及GMP规范在中药制药过程生产管理中的实施,传统的控制方法和中药制药企业落后的基础自动化网络已不能满足中药制药工业发展的需求。
本文以中药浸膏生产过程为主要研究对象,在深入分析生产工艺及控制需求的基础上,针对当前生产管理中存在的一系列问题,系统研究了中药浓缩浓度软测量、中药温浸动态提取温度控制、中药制药过程控制系统的设计与构建、中药制药信息化集成技术和中药制药CIPS等一系列理论与应用问题。论文的主要工作归纳如下：
(1)针对中药浓缩过程中药液浓度难以在线测量的问题,提出了基于支持向量回归的浓度软测量方法。该方法利用支持向量机适用于小样本学习,具有学习速度快、全局最优和泛化性好的优点,采用基于数据驱动建模的思想,充分利用中药浓缩工段历史数据,选取六个辅助变量,用支持向量回归的方法建立软测量模型,并利用过程数据进行参数寻优和校验。利用优化后的模型对中药浓缩过程浓度进行了预测,验证了模型的学习性能和泛化性能。结果表明本文建立的软测量模型实现了对中药浓度较为精确的预测,有效解决了中药浓缩过程中难以实现的中药浓度在线测量问题,具有较高的实用价值。
(2)针对中药温浸动态提取工段温度的精确控制问题,本文以某制药厂中药提取系统为研究对象,分析了中药提取工段的工艺设备和传热过程,建立了简化模型。针对提取工段温度控制非线性、时变性、纯滞后的特点,设计了自适应模糊PID控制器,并进行了仿真研究。仿真结果表明采用参数自整定模糊PID控制,系统调节时间短,响应速度快、温度控制精度高、具有较好的鲁棒性。
(3)对中药提取、浓缩、干燥等工段的自动化需求和测控要点进行了分析,研究了中药制药设备集成方案。设计了基于Profibus-DP的现场总线控制网络,介绍了控制系统的硬件配置、系统组态、软件体系。利用Profibus和工业以太网的结合,实现对中药制药各工段的集中监控、分散控制,为实现更进一步的MES和ERP应用构建了平台。
(4)对中药制药信息集成化技术进行了研究,在分析了中药制药企业业务流程和信息特征的基础上,提出了中药制药信息集成方案。运用OPC技术和XML设备描述方法,采用OPC DA和OPC XML-DA两种标准进行系统集成。在此基础上,建立完善可靠的生产过程实时数据库系统和管理生产过程的关系数据库,通过基于WebServices的制药企业集成化平台实现企业的分布式和远程管理控制。本文对实现信息集成的关键化技术进行了详细论述。
(5)为实现中药制药全过程的优化控制,提出了中药制药过程集成过程控制系统(CIPS)的总体设计思想与设计原则,分析了各部分模块的功能,论述了关键技术。对MES和ERP系统的实施和功能模块进行了详细论述。
目前中药制药先进过程控制和集成化生产技术的研究刚刚起步,由于中药制药装备的标准化和中药质量控制体系还不完善,为在中药企业实施集成化过程控制系统带来了巨大困难。本文对在现阶段装备水平和技术水平下的中药制药企业过程控制和集成化生产技术的若干问题进行了研究,取得了一定成果,具有广阔的应用前景。自动化和信息化是实现我国中药制药现代化的必游之路,随着中药制药装备标准化和中药质量控制体系的逐步完善,本文的一些思想和方法对在更高基础和标准上实施中药制药集成化生产技术也具有一定的参考价值。
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.
本文以中药浸膏生产过程为主要研究对象,在深入分析生产工艺及控制需求的基础上,针对当前生产管理中存在的一系列问题,系统研究了中药浓缩浓度软测量、中药温浸动态提取温度控制、中药制药过程控制系统的设计与构建、中药制药信息化集成技术和中药制药CIPS等一系列理论与应用问题。论文的主要工作归纳如下：
(1)针对中药浓缩过程中药液浓度难以在线测量的问题,提出了基于支持向量回归的浓度软测量方法。该方法利用支持向量机适用于小样本学习,具有学习速度快、全局最优和泛化性好的优点,采用基于数据驱动建模的思想,充分利用中药浓缩工段历史数据,选取六个辅助变量,用支持向量回归的方法建立软测量模型,并利用过程数据进行参数寻优和校验。利用优化后的模型对中药浓缩过程浓度进行了预测,验证了模型的学习性能和泛化性能。结果表明本文建立的软测量模型实现了对中药浓度较为精确的预测,有效解决了中药浓缩过程中难以实现的中药浓度在线测量问题,具有较高的实用价值。
(2)针对中药温浸动态提取工段温度的精确控制问题,本文以某制药厂中药提取系统为研究对象,分析了中药提取工段的工艺设备和传热过程,建立了简化模型。针对提取工段温度控制非线性、时变性、纯滞后的特点,设计了自适应模糊PID控制器,并进行了仿真研究。仿真结果表明采用参数自整定模糊PID控制,系统调节时间短,响应速度快、温度控制精度高、具有较好的鲁棒性。
(3)对中药提取、浓缩、干燥等工段的自动化需求和测控要点进行了分析,研究了中药制药设备集成方案。设计了基于Profibus-DP的现场总线控制网络,介绍了控制系统的硬件配置、系统组态、软件体系。利用Profibus和工业以太网的结合,实现对中药制药各工段的集中监控、分散控制,为实现更进一步的MES和ERP应用构建了平台。
(4)对中药制药信息集成化技术进行了研究,在分析了中药制药企业业务流程和信息特征的基础上,提出了中药制药信息集成方案。运用OPC技术和XML设备描述方法,采用OPC DA和OPC XML-DA两种标准进行系统集成。在此基础上,建立完善可靠的生产过程实时数据库系统和管理生产过程的关系数据库,通过基于WebServices的制药企业集成化平台实现企业的分布式和远程管理控制。本文对实现信息集成的关键化技术进行了详细论述。
(5)为实现中药制药全过程的优化控制,提出了中药制药过程集成过程控制系统(CIPS)的总体设计思想与设计原则,分析了各部分模块的功能,论述了关键技术。对MES和ERP系统的实施和功能模块进行了详细论述。
目前中药制药先进过程控制和集成化生产技术的研究刚刚起步,由于中药制药装备的标准化和中药质量控制体系还不完善,为在中药企业实施集成化过程控制系统带来了巨大困难。本文对在现阶段装备水平和技术水平下的中药制药企业过程控制和集成化生产技术的若干问题进行了研究,取得了一定成果,具有广阔的应用前景。自动化和信息化是实现我国中药制药现代化的必游之路,随着中药制药装备标准化和中药质量控制体系的逐步完善,本文的一些思想和方法对在更高基础和标准上实施中药制药集成化生产技术也具有一定的参考价值。
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.
引文
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