Abstract： Objective Based on the reverse engineering technology,the aim of this paper was to develop the racecadotril powders with the same quality of the reference listed drug(RLD).Methods Firstly,the literature information such as patents and leaflet was used to preliminarily understand the product formulation and preparation process.Secondly,according to the characteristics of the powders,the quality indexes such as size distribution,content distribution,and the in vitro dissolution characteristic were measured to recognize the quality attributes of the RLD.Finally,the process parameters including the granulation,sieving and mixing were investigated to confirm the influence trend of those process parameters on the key quality attributes of the product.Results The reverse analytical tests showed that the partial materials of the RLD formulation were compactly granulated and sieving to obtain the mixture with fine powder and tight granule,which could exhibit the characteristics of the biphasic dissolution.Further,the racecadotril powders with the same quality of RLD was developed based on the investigation and amplification of the product granulation,sieving and mixing process,which exhibiting the process was stable and feasible.Conclusion Based on the reverse engineering technology of solid granules or powders,this study successfully and efficiently developed products that are consistent with the characteristics of the RLD,and provides a reference for the research and development of such dosage forms.