鲁中医药产业带PAT技术服务平台工程化建设研究

发布时间：2018-11-25 09:23

【摘要】：目前,国内医药行业普遍存在生产经营方式粗放式,药品生产工艺技术落后,药品质量水平较低的问题；同时,国家为提高医药行业整体创新能力和生产水平,先后启动了国家新药创制重大专项等一系列项目,其中就包括大品种技术改造、关键技术改造等技术领域。山东省是我国的制药大省,拥有全国约1/10的制药企业,其中以淄博、潍坊为核心的鲁中医药产业带是山东制药企业的主要聚集区,生产总值多年居全省第一,但多以原料药、低端制剂为主,技术装备水平落后,产品附加值低,在生产过程中面临质量不稳定、产品批次差异、效率不高等问题,亟需通过技术创新和产品质量提升来增强企业市场竞争力。针对这一问题,研究建立过程分析技术(Process Analytical Technology, PAT)服务平台成为解决此问题的有效方式。PAT技术是以过程分析仪器或方法为手段,通过对制药过程物质的物理或化学性质进行分析,实现对制药过程的全面理解,从而实现对制药工艺的在线优化、对制药过程的在线监测和控制。制药PAT技术具备的显著提高药品质量与稳定性、产品收率、降低生产成本、提高生产过程和环境安全性的特点完全契合淄博医药产业的现状,能够有效帮助当地医药产业改善上述薄弱环节,提高行业竞争力,实现产业快速转型。PAT技术服务平台建设的目标与任务是立足鲁中医药产业需求,通过产学研合作建立基于产业化的化学合成原料药、中药、制剂等品种的过程分析与监控技术,并通过示范性建设与推广,建立面向医药企业的生产过程控制解决方案,提升产品质量和生产效益。同时,基于物联网和云平台技术,以山东大学淄博生物医药研究院为基点,面向鲁中医药产业带,通过技术输出、设备供给、方案定制、人才培训等手段,建立个性化服务与定制方式相结合的服务模式,构建全方位、专业化的PAT技术网络服务体系。在该平台的建设过程中,重点围绕化学合成原料药、中药、制剂三个类别进行设计研究,其设施配套与资源匹配将按照鲁中医药产业需求和专业特点进行综合安排。项目建成后,将会在技术服务、中试生产、产业效率和质量提升方面起到积极的作用,极大推动鲁中医药产业带的发展。本课题于2013年12月被列为山东省科技厅科技发展计划项目(项目编号2013GGX32113,《制药过程在线分析检测共用技术研发》)。
[Abstract]:At present, there are many problems in the domestic pharmaceutical industry, such as extensive production mode, backward technology and low quality of drugs. At the same time, in order to improve the overall innovation ability and production level of the pharmaceutical industry, the state has initiated a series of major projects such as the national new drug creation and major special projects, including the technical transformation of large varieties, key technology transformation and other technical fields. Shandong Province is a big pharmaceutical province in China, with about a tenth of the pharmaceutical enterprises in the country. Among them, the Shandong traditional Chinese medicine industrial belt, with Zibo and Weifang as the core, is the main gathering area of Shandong pharmaceutical enterprises, and the gross domestic product ranks first in the province for many years. However, most of them are raw materials, low-end preparations, backward technical equipment, low value-added products, and face problems such as unstable quality, different batches of products, and low efficiency in the process of production. It is urgent to enhance the market competitiveness of enterprises through technological innovation and product quality improvement. To solve this problem, the establishment of process analysis technology (Process Analytical Technology, PAT) service platform has become an effective way to solve this problem. PAT technology is based on process analysis instruments or methods. Through the analysis of the physical or chemical properties of the pharmaceutical process, the overall understanding of the pharmaceutical process is realized, so as to realize the on-line optimization of the pharmaceutical process and the on-line monitoring and control of the pharmaceutical process. Pharmaceutical PAT technology has the characteristics of significantly improving drug quality and stability, product yield, reducing production costs, improving production process and environmental safety, which is fully in line with the current situation of the pharmaceutical industry in Zibo. Can effectively help the local pharmaceutical industry to improve the above weak links, improve the competitiveness of the industry, realize the rapid transformation of the industry. The goal and task of PAT technology service platform construction is based on the needs of the pharmaceutical industry in the middle of Shandong. Through the cooperation of industry, university and research to establish the process analysis and monitoring technology based on the industrialization of chemical synthetic raw material medicine, traditional Chinese medicine, preparation and so on, and to establish a production process control solution for pharmaceutical enterprises through demonstration construction and popularization. Improve product quality and production efficiency. At the same time, based on the technology of the Internet of things and the cloud platform, and based on the Zibo Institute of Biomedicine of Shandong University, facing the Lu traditional Chinese Medicine Industry Belt, through the means of technology output, equipment supply, program customization, personnel training, and so on, This paper establishes the service mode of the combination of individualized service and customizing mode, and constructs the all-around and specialized PAT technology network service system. During the construction of the platform, the design and research of chemical synthetic raw material medicine, traditional Chinese medicine and preparation are focused on. The matching of facilities and resources will be arranged in accordance with the needs and professional characteristics of the pharmaceutical industry in the middle of Shandong Province. After the completion of the project, it will play an active role in technical service, pilot production, industrial efficiency and quality improvement, and greatly promote the development of Shandong traditional Chinese medicine industrial belt. This subject was listed as the project of Science and Technology Development Plan of Shandong Science and Technology Department in December 2013 (Project No. 2013GGX32113, Research and Development of Common Technology for On-line Analysis and Detection of Pharmaceutical process).
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：TQ460.6

【相似文献】