Preparation And Evaluation Of Levodopa-pramoxo Enteric Sustained Release Tablets

Objective:To develop a new drug levodopa-pramipa intestinal sustained release tablet for the treatment of Parkinson’s disease.The preparation process,quality standard and preliminary stability were investigated in order to provide experimental basis for new drug development and improvement of clinical efficacy.Methods:1.On the basis of single factor experimental investigation,the type and quantity of m atrix material,the type of filler,lubricant and wetting agent were used as indicators.On this basis,the effects of tablet pressure on the c μ mulative release of slow-release tablets were studied.Determine the coating prescription and study the influence of various factors on the coating effect.2.Study on the preparation process of sustained-release tablets with in vitro release as the index,select auxiliary materials,optimize the prescription,and determine the best molding process.3.The coating pot method was used to determine the coating materials for the plain enteric coating,and the in vitro release of the tablets after the enteric coating was compared with that of the plain tablets to investigate the coating quality.4.Quality evaluation of levodopa-pramoxo enteric-sustained release tablets was studied,including TLC identification,content determination,drug c μ mulative release determination,and other routine examination of tablets.5.Establish quality standards for levodopa-pramoxin enteric sustained release tablets.Results:1.The optimal prescriptions of levodopa-pramipa tablets were determined to be levodopa,pramipa,calci μ m phosphate,hydroxypropyl cellulose,pregelatinized starch,silica and magnesi μ m stearate.2.The types and quantities of matrix materials,the types of fillers,lubricants and wetting agents,and the effects of tablet pressure on the c μ mulative release of slow-release tablets were examined.On this basis,the coating prescription was determined by single factor research,and the influence of various factors on the coating effect was studied.To determine the process parameters of sustained-release tablet and coating preparation.3.Choose obadiol as coating material,coating prescription and determine the concentration of 12%obadiol,weight gain of 3%-4%.4.Levodopa-pramoxo enteric slow-release tablets were stable in nature,and the weight difference and c μmulative release of tablets met the requirements.Levodopa-pramoxo enteric sustained-release tablets have good stability in sealed plastic packaging.5.To establish the quality standard of levodopa-praxine enteric sustained release tablets.Conclusion:The levodopa-pramipexo enteral sustained release tablets developed in this paper,can exert the combined effect of the two drugs and their respective advantages to better treat Parkinson’s disease and improve the adverse reactions and conversions of levodopa.In this study,levodopa-pramipexole was prepared into enteric sustained-release tablets,which have good drug reproducibility and high bioavailability,and can slowly release drugs,eliminate the peak and valley phenomenon,prolong the drug action time and reduce the drug action time.Duration of administration,reduction of side effects,improvement of drug safety and patient compliance.