【作者】 王水；

【导师】 杜纲；

【作者基本信息】 天津大学 ， 药事管理， 2010， 博士

【摘要】 提升我国医药企业的产品开发设计和创新能力是一个重要课题,研究如何基于一定的技术平台快速开发和扩展新的系列医药产品具有重要意义。本文借鉴产品族设计方法,研究医药产品开发设计和优化过程,建立了二维层次模型和方法体系。尽管工业工程领域关于产品族的研究已经较多,但将产品族设计思想应用于医药产品开发设计过程的相关研究还很少,因此本研究具有重要的学术价值与现实意义。本文的主要工作和创新点如下:第一,本文借鉴产品族设计的思想和方法,应用于医药产品开发设计过程,提出医药产品族的概念。通过研究,根据医药产品族物理构成的结构关系,把医药产品族主要分为4类,给出了医药产品族的设计的一般方法,建立了医药产品族设计二维层次模型。第二,基于医药产品物理构成的特点,通过与一般产品族的构成维比较,研究了医药产品族构成维层次模型;还研究了医药产品族的构成维的表达方式、层次、分析的方法和思路,并给出医药产品族构成维的架构。第三、建立了医药产品族的过程维层次模型,提出了患者需求空间、治疗原理空间、治疗功能空间和药品物理构成空间的概念,研究了其之间的映射关系,并给出基于构成维和过程维的医药产品族二维层次模型的整体框架。第四,基于医药产品族二维层次模型,研究了医药产品族二维层次模型设计优化过程,包括医药产品族战略的确定、二维层次模型与药品平台的形成、基于平台的药品变量设计。分析了医药产品族的动态演化过程,并通过二维层次模型对演化过程进行研究。第五,分析医药产品族优化模型的求解方式和特点,指出过程模拟是医药产品族模型优化的重要环节,研究了医药过程模拟特点,并提出医药生产过程的二元混合溶剂的固液相平衡模型。第六,结合实例,将所研究的医药产品族二维层次模型和方法应用于实际,取得了满意的结果,对我国医药企业生产过程具有一定理论指导意义。更多还原

【Abstract】 Pharmaceutical manufacturer should resonably determine product categories, quantity and combination mode for effective utilization of enterprise resources, seizing the opportunity, avoiding risks and threats. Pharmaceutical manufacturer systemly think effective structure of width, depth, length, and correlation of product line based on operation target. So this paper studies the development and design of the medical products on the basis of the design methods of product family. It is significant for our country to promote the independent innovation, increase the ability of research and development,improvement and innovation,variety of dosage forms,and reinforce the international competition. This undoubtedly,not been reported,has important academic value and practical significance.The main work and innovation points of this paper are following:Firstly, this paper proposes pharmaceutical product families based on the mass customization. On the basic categorization and characteristics of pharmaceutical product families,which pharmaceutical product families are mainly classified as four categorization, general design methods were given for pharmaceutical product families. Two-dimensionality hierarchical model was proposed for design of pharmaceutical product families based on the concept model frame of a two-dimension analytical model.Secondly, this paper research requirement and target of the composing dimension model about pharmaceutical product families by analyzing physical composition of drug and comparing with machine product families. It was discussed about expression, hierarchical model, method and thinking of the composing dimension, including Schematic diagram.Thirdly, the developed process hierarchical model is proposed for pharmaceutical product families. And it was discussed mapping relation between patient requirement spaces, treating principle spaces, treating function spaces and physical composition spaces of drug. The whole frame of two-dimension hierarchical model of pharmaceutical product families is built based on the developed process and the composing dimension hierarchical model.Fourthly, based on two-dimensionality hierarchical model of pharmaceutical product families, the process of two-dimensionality hierarchical design is proposed. It includes making product families strategies for pharmaceutical industry, constructing two-dimensionality hierarchical model, generating platform-based drug variants and customization drug being configured. The paper discussed how two-dimensionality hierarchical of pharmaceutical product families evolves.Fifthly, by comparing pharmaceutical product family and machinery manufacturing product family’s mathematical optimization model, the most important work is process simulation for optimization design of pharmaceutical product family. This article gives general model to correlate the solubility of pharmaceutical compounds with the variation of both temperature and initial composition of binary solvent mixtures for optimization design of pharmaceutical product family.Sixthly, two-dimensionality hierarchical model and method for pharmaceutical product family, studied in this paper, are applied in two examples.更多还原