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健康相关产品评价暨动物实验公共服务技术平台的建立
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摘要
为建立服务于创新生命科技与生物医药产业的公共服务技术平台,本人根据武汉国家生物产业基地总体规划设计了“健康相关产品评价暨动物实验公共服务技术平台”,并在九峰创新园实施了该计划,其核心是建立符合国际良好动物实验室管理规范即GLP动物实验技术条件。为此,本人从控制影响动物实验结果的系统误差、偶然误差及过失误差三方面的因素考虑,充分利用建筑结构工艺、空气净化技术、动物饲养独立通风换气技术、信息与控制技术及各种实验动物的生物学特性,以建立恒温、恒湿、洁净、无臭、正压的屏障动物实验设施,并对工作人员舒适屏障环境与动物生活屏障环境实施物理隔离控制,以满足工作人员与动物福利条件的要求;利用可再生能源技术建立分布式能源站,以满足独立通风即IVC动物屏障系统的能源需要及工作人员卫生热水需要,并得到节能经济运行的目的;利用药物、农药、保健食品及化妆品毒理学实验技术要求,建立相应毒理实验室、动物病理实验室、动物临床检验实验室、细胞室、Ames实验室、功能实验室、中央控制室、档案室、样品室等;利用国际上先进的GLP管理技术,以建立体系完整的评价技术组织管理机构、专业技术队伍、各种管理制度及标准操作管理文件,使各项毒理学动物评价实验结果能够客观真实、质量可控、能够追溯。结果表明,本项目技术平由4235.8m2的综合楼及7894.2m2的动物实验楼组成,总投资12100万元。包括药物安全性GLP研究和药品常规安全性检测评价技术平台;新药药效学筛选与评价和药代动力学研究平台;农药登记毒理学试验与评价技术平台;食品(包括保健食品)毒理与功能学检测评价技术平台;化妆品检验测试评价技术平台;生物产品理化、微生物分析测试平台;公共检测评价与生命科学实验开放技术平台。其中平台资源有小鼠IVC3200笼位、大鼠IVC4595笼位、兔1567笼位、豚鼠740笼位、犬180笼位、猴/猪56笼位、猫6笼位、热原81笼位,每天可实现经济效益64863.5元。试运行结果表明,技术平台公共服务条件已经被国家发改委、国家农业部、食品药品监督局、国家实验室认可委、湖北省卫生厅、湖北省科技厅、武汉国家生物产业基地及湖北省预防医学科学院湖北省疾病预防控制中心认可,并获得了相应的认可证书或文件,技术平台正式投入公共服务,有利于生物医药及生命科技创新研究与产业化工作。
To establish the technology platform of public service that serves to innovative biotechnology and biomedicine industry, this thesis designs "the technology platform of public service concerning the evaluation of health-related products and animal experiments" according to the overall plan of National Base of Bioindustry in Wuhan. We have also put the programme into execution in Jiufeng Innovative Park, while the core of the programme is to set up the technical conditions that comply with the international "Good Laboratory Practice (GLP)". For this reason, how to control the influencing factors of the systematic residuals, accidental errors and gross errors of animal experiments is considered. We utilize the building structure and craft, air purification technology, independent ventilatory technology in animal feeding, information and control technology, and the biological characteristics of experimental animals, with a purpose to establish barrier animal-experiment facilities of constant temperature, constant humidity, clean and odourless, and positive pressure. The cozy barrier-environment of technical peronnel is physically segregated from the living barrier-environment of animals to meet the well-beings of personnel and animals. We also utilize the renewable-energy technology to set up distributing energy station, with the view to meet the needs of energy cost required by IVC animal barrier-system and sanitary hot water required by personnel, and can also achieve the purpose of energy-saving and economical operation. Based on the requirment of toxicology experiments concerning medicines, farm chemicals, health-care food, and cosmetics, we establish relevant toxicity laboratory, pathology laboratory, clinical examination laboratory, cell culture laboratory, Ames laboratory, functional laboratory, central control room, archives, and sample room etc.. Moreover, according to the international advanced GLP operation management, we aim to build an administrative organization with evaluating technique of integrate system, a professional technical team, a variety of managerial system, and standard operation procedure, making sure every toxicity experimental results can be objective, real, quality-controllable, and retrospective. The results show that, this technology platform consists of a
     Comprehensive Building with area of4235.8square meters and a Animal Experiment Building with area of7894.2square meters, with total investment of121million RMBs. All the platforms are as follows:①Dthe evaluating technology platform of drug safety GLP research and drug's safety routine test;②he platform of pharmacodynamic screening as well as evaluation and pharmacokinetics research;③the technology platform of agriculture chemical registration in toxicity experiments and evaluation;④the evaluating and examing platform concerning the toxicity and function of foods including health-care foods;⑤he evaluating and examing platform of cosmetics inspection;⑥he test platform of physio-chemical and microorganism analysis concerning biological products⑦he open technology platform of public test evaluation and life science experiments. The platform resources include3,200IVC mice cages,4,595IVC rat cages,1,567rabbit cages,740cobaya cages,180dog cages,56monkey/pig cages,6cat cages, and81pyrogen cages. The ecnomic performance can be achieved everyday with64,863.5RMBs. Its trial running results indicated that the technology platform of public service has been recognized by the following agencies:National Development and Reform Committee, National Ministry of Agriculture, Food and Drug Administration, National Laboratory Accreditation, Hubei Provincial Department of Public Health, Hubei Provincial Department of Technology, Wuhan National Base of Bioindustry, Hubei Academy of Preventive Medicine, and Hubei Center for Disease Control and Prevention. The relevant accreditation and certification have been achieved. The operation and implementation of the technogy platform for public service are beneficial to the innovation research and industrialization of biological medicine and biotechnology.
引文
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