基于正交试验的新药中试工艺参数设计

Orthogonal Experimentation-Based Process Parameter Determination in Pilot Production for Drug Development

从某制药公司新药中试阶段工艺参数存在问题入手,应用系统工程理论中的解释结构模型法对工艺参数流程进行分析,发现该公司在新药中试阶段问题的症结是工艺参数的确定缺乏系统性和科学性。随后应用正交试验工具为新产品工艺参数的改进提出设计思路,进行数理分析,得到了一组满意的工艺参数组合。绩效显示优化方案有效降低了制药企业中试成本。

The problem of process parameter determination during pilot production of a new drug development in a pharmaceutical company is presented.By analyzing statistical data,it is shown that drug hardness does not meet required standard.With interpretive structural modeling（ISM） method,factors causing the problem are analyzed.Result shows that it is unreasonable process parameters that cause the problem.Thus,orthogonal experiment is designed to determine optimal combination of process parameters.The resulting parameter combination solves this problem,and meanwhile total cost is reduced.