Study On Preparation Technology Of Pantoprazole Sodium Enteric Solid Dispersion Tablets

Objective:Formulation and process design of pH-sensitive drug pantoprazole sodium based on solid dispersion technology.The optimal preparation process of pantoprazole sodium enteric solid dispersion sheet is preferred,and the solid dispersion verification,molding process and preliminary stability study are carried out,and the quality standard is established.Methods:Establishing an in vitro assay method for pantoprazole sodium enteric solid dispersion.Screening method for preparing pantoprazole sodium enteric solid dispersion.Taking the dissolution rate in the buffer for 45 minutes as an indicator,the single factor method and the BBD response surface optimization test method were used to optimize the optimal prescription and preparation process.The tolazole sodium enteric-coated enteric solid dispersion was verified by dissolution rate method,infrared spectroscopy,Raman spectroscopy and differential scanning calorimetry.The dissolution process was taken as an indicator to optimize the molding process of pantoprazole sodium enteric solid dispersion sheet.The preliminary stability study was carried out on the pantoprazole sodium enteric solid dispersion tablets;the quality standard of pantoprazole sodium enteric solid dispersion tablets was established according to the requirements of General Regulation 9013.Results: The in vitro analysis method of pantoprazole sodium enteric solid dispersion was established by high performance liquid chromatography.The method was stable and feasible.The pantoprazole sodium enteric solid dispersion was prepared by solvent freeze drying,and pantoprazole sodium was dissolved.The optimal preparation process of the solid dispersion is a drug loading ratio of 1:4,a mixing speed of 370r/min,and a mixing time of 20 minutes.The pantoleazole sodium enteric solid dispersion tablet was prepared by direct compression of powder,the tableting pressure was 12~14kgf,and the tablet specification was 0.32g/table.The verification test showed that the process was stable and feasible.Solid dispersion verification test results show that pantoprazole sodium exists in an indeterminate form in the enteric solid dispersion,and its properties are stable;preliminary stability test results show that pantoprazole sodium enteric solid dispersion stability Good,no significant changes in various indicators,no aging phenomenon;the establishment of quality standards for enteric solid dispersion tablets.Conclusion: In vitro analytical method for pantoprazole sodium enteric solid dispersion tablets is stable and feasible.The preparation process of pantoprazole sodium enteric solid dispersion sheet is simple,the dissolution amount in the acid is less than 10% in 2h,and the dissolution amount in the buffer solution is more than 70% in 45 minutes.Pantoprazole sodium is present in an amorphous form in the enteric solid dispersion.The preliminary stability test results show that the pantoprazole sodium enteric solid dispersion sheet has good stability,no aging and recrystallization phenomenon;the quality is stable and controllable,and is suitable for industrial production.