Preliminary Analysis And Evaluation On Quality Of Cefaclor Dispersible Tablets,Cefaclor Sustained Release Tablets Cefaclor Particles

Objective: The analysis and evaluation of drug quality is one of the important contents to control the quality of drugs,and it is the basis for ensuring the safety and effectiveness of drug use.This paper based on preliminary research and experiments,analyzes and evaluates the quality of domestic cefaclor bulk drugs,dispersible tablets,sustained-release tablets and granules,and provides reference for the cefaclor quality control.Methods: According to the current standards,cefaclor,cefaclor dispersible tablets,cefaclor sustained-release tablets,cefaclor granules were tested for traits,identification,inspection,content determination;The samples of cefaclor,cefaclor dispersible tablet,cefaclor sustained release tablet and cefaclor granule were tested by HPLC method to determine relative substance,and use SPSS software to analyze the relationship between the substance and the source of raw materials.The dissolution behavior of cefaclor dispersible tablets and cefaclor sustained-release tablets was investigated,and use the f2 factor method to evaluate whether the dissolution behavior of the sample and the reference preparation are consistent.The cefaclor dispersible tablet polymer was determined by HPLC.Results: According to the current quality standard,cefaclor,cefaclor dispersible tablets and cefaclor sustained release tablets all in requirements.The related substances are related to the source of raw materials,and are increased under accelerated damage conditions such as acid,alkali,high temperature and oxidative damage in cefaclor,cefaclor dispersible tablet,cefaclor sustained release tablet and cefaclor granule.The polymer in cefaclor dispersible tablet increases with the time of solution standed,needs to be used now when it is tested.Dissolution behavior is difference when the samples ofthe same dosage form from different manufacturers,so may have differences in bioavailability.Conclusion: The current quality standard can meet the quality control of cefaclor,cefaclor dispersible tablets,cefaclor sustained-release tablets,cefaclor granules in basically.Through determination the impurity of cefaclor bulk drugs,cefaclor dispersible tablets,and cefaclor sustained release tablets,and determination polymer in cefaclor dispersible tablet,and study the dissolution behavior of cefaclor dispersible tablets and cefaclor sustained-release tablets.Objectively evaluate the quality level of domestic cefaclor dispersible tablets,sustained release tablets.To provide a reference for ensuring the safe and effective use of drugs for clinical use.