Objective To provide a reference for the development of generic Pregabalin Oral Solution.Methods The reference preparation of Pregabalin Oral Solution was taken as the research object,and reverse engineering was used for prescription analysis and small-scale process research of preparations.High-performance liquid chromatography(HPLC)method was used for the content determination of antibacterial agents hydroxybenzoate and hydroxypropyl ester,and the antibacterial efficacy test was conducted.Ultraviolet(UV)spectrophotometry combined with pH detection method was used for the content determination of buffering agents sodium dihydrogen phosphate monohydrate and sodium dihydrogen phosphate dodecahydrate.HPLC method was used for the content determination of sweetener sucralose.The amount of strawberry essence was adjusted according to taste and character.The dissolution temperature and preparation sequence of raw materials and excipients were screened by the single factor test,and the small-scale process of Pregabalin Oral Solution was determined.Results The Pregabalin Oral Solution with the specification of 20 mg/mL(200 mL)was dissolved at 85℃with 0.25 g of hydroxybenzoate and 0.033 g of hydroxypropyl ester.After cooling down to 30℃,0.748 g of sodium dihydrogen phosphate monohydrate,0.210 g of sodium hydrogen phosphate dodecahydrate,4 g of pregabalin,0.65 g of sucralose and 0.1 g of strawberry essence were added successively,and stirred until completely dissolved,80 mL of purified water were added and stirred for 20 min until uniform.Conclusion The quality of Pregabalin Oral Solution prepared by this method is stable,which can provide a reference for the development of generic drugs.
Pregabalin Oral Solutionreverse engineeringprescription researchsmall-scale process
万方数据
维普
