Study On The Preparation Technology Of Candesartan Cilexetil Tablets

Objective:In vitro analysis of candesartan cilexetil nanoparticles;optimization of the best formulation and preparation process of candesartan cilexetil and its tablets,establishment of its quality standards;investigation of its initial stability;and candesartan The in vitro release of the ester nanoparticulate tablets and the commercially available candesartan cilexetil tablets were compared.Method:The HPLC method was applied to determine the in vitro analysis method of red candesartan citrate nanoparticles.The candesartan cilexetil nanoparticles were prepared by emulsification solvent diffusion method,and the candesartan cilexetil nanoparticles were prepared by freeze-drying,and the encapsulation efficiency was used as the encapsulation efficiency.Investigate the indicators,optimize the prescription and preparation process of candesartan citrate nanoparticles by single factor investigation and response surface optimization method,and evaluate the quality;use single factor method to freeze-dried powder traits and yield In order to investigate the index,the optimal freeze-drying process of candesartan cilexetil nanoparticles was optimized.The optimal formulation and preparation process of candesartan cilexetil nanosheets were optimized by taking the appearance,hardness and release of the tablets as indicators.To establish the quality standard of candesartan cilexetil nanoparticle tablets;to investigate the preliminary stability of candesartan citrate nanoparticles and their tablets;to use the release model to fit the release process of candesartan cilexetil nanoparticle tablets,The drug release mechanism was discussed.The in vitro release rate was used as an indicator to evaluate the efficacy of candesartan cilexetil and the commercially available preparations.Results:The in vitro analysis of candesartan cilexetil nanoparticles by HPLC is stable and feasible.The optimal preparation of candesartan cilexetil is based on soy lecithin as emulsifier and poloxamer 188 as emulsion protection.Agent,anhydrous ethanol as solvent,the ratio of drug to emulsifier is 1:20,the ratio of drug to milk drop protectant is1:40,the solvent dosage is 5ml,the stirring speed is 600r per minute;differential scanning proves the ridge Dexartan ester is present in the nanoparticle in an amorphous rather than crystalline state;the best process for candesartan ester nanoparticle powder is freeze-drying,the lyoprotectant is PVP_k30,the amount is 2%;candesartan cilate nano The optimal preparation process of the granules is lactose as a filler,and the powder is directly compressed;the quality standard of candesartan cilexetil nanoparticles is established;the accelerated test results show that candesartan cilexetil nanoparticles have good stability;The release results showed that the candesartan cilexetil nanoparticle tablets had a relatively slow release effect and a higher release rate than the commercially available candesartan ester tablets.Conclusion:The preparation process of candesartan cilexetil and its tablets is simple,stable and feasible,and the quality standard is perfect.Compared with the commercially available candesartan ester tablets,the candesartan cilexe nano tablets have a good blood pressure lowering effect.