Study On The Consistency Evaluation Of Gliclazide Tablets

Purpose: At present,the consistency evaluation of generic drugs is being carried out in China.The specific task at the current stage is to assess the quality consistency of oral pharmaceutical solid pharmaceuticals in the “National Essential Drug List”approved before October 1,2007.Gleazelite is among them.Therefore,in this article,the reference preparation was used as the control,and the similarity factor method was used to conduct in vitro consistency evaluation of gliclazide tablets by in vitro dissolution test.Thus,drugs with the same quality and efficacy as the original drug and reliable quality for clinical use were developed.Methods: Firstly,the determination of the solubility of drug substance was carried out.Secondly,the method of in vitro analysis was established and verified.Then,the formulation process was screened,and 3 batches of gliclazide tablets were prepared.The dissolution consistency of self-made tablets and reference preparations in four different dissolution media was investigated.Finally,quality control and influencing factors were investigated.Results: The drug substance was pH-dependent,slightly soluble in pH 7.4 and almost insoluble in water.HPLC was established for the determination of content-related substances.UV spectrophotometric determination of gliclazide in vitro was established.Dissolution,the method is accurate and sensitive,convenient and quick,and it satisfies the requirements of various analysis indexes in this experiment;it determines the optimal prescription and technology,and it has been verified that the reference formulation has in vitro dissolution consistency,appearance and content.The relevant substances are all in compliance with the Pharmacopoeia;under the conditions of the influencing factors,there are no obvious changes in the indicators and the quality is stable.Conclusion: By preparing the laboratory-made gliclazide tablet with reasonable prescription,feasible technique,controllable quality and good stability,it lays the foundation for the next step of bioequivalence test and generic drug declaration.