Nifuratel and nystatin vaginal soft capsule raw material pretreatment method and preparation preparation method

The invention provides a pretreatment method of nifuratel, and the pretreatment method comprises a pretreatment step of performing wet granulation on nifuratel to prepare high-dispersion fine powder particles. The preparation of the nifuratel high-dispersion fine powder particles includes the following steps: the nifuratel and an additive solution are subjected to wet granulation and drying to obtain high-dispersion fine powder particles, wherein the additive solution includes a surfactant or a wetting agent. The invention further provides a nifuratel pharmaceutical preparation prepared by the method. A preparation process of a soft capsule preparation includes the following steps of preparing a suspension from the nifuratel high-dispersion fine powder particles and nystatin, and performing pelleting to prepare the nifuratel-containing soft capsule preparation. The amount of related substances in the nifuratel pharmaceutical preparation prepared by the preparation method provided by the invention can be obvio