在体生物测定法已应用一百多年，过去用于不能单独用理化技术测定的生化药品，如今这一概念已发生深刻的变化，越来越多的生化药品由ＤＮＡ重组技术生产，产品达到成分清楚、结构明确、高纯稳定、单一组分，对其活性检测趋向于理化测定代替生物测定。论述了两种方法的相关性及理化测定法代替生物测定法在ＤＮＡ重组生化药品质量控制中的应用。 In vivo bioassays have been in use for over a hundred years, and in the past, biochemicals, which can not be determined by physico-chemical techniques alone, have undergone profound changes in the concept nowadays. More and more biochemicals are produced by DNA recombination technology and the products reach Clear composition, clear structure, high purity and stability, a single component, its activity test tend to physical and chemical determination of biological tests instead. The relevance of the two methods and the application of physicochemical assay instead of bioassay in the quality control of DNA recombinant biochemical drugs are discussed.