Study On The Preparation And Quality Standard Of Propafenone Hydrochloride Tablets

Objectives:In order to ensure the safety and effectiveness of the drug,by optimizing the prescription process and improving the quality of medicines,we designed the formulations and techniques of Propafenone Hydrochloride Tablets in this work,and study the drug consistency evaluation with the reference products.Methods:(1)In prescription screening study,single factor experiment was carried out preliminarily.The influence of the formulation factors such as fillers,adhesive agents and disintegrating agents,and the technique factors such as machine pressure,tables'hardness on the preparation was examined.On the basis of single factor experiment,orthogonal designed experiments were used to optimize the prescription.The similarity factor of dissolution curves was evaluated and the optimized formulation was decided.(2)The dissolution method by UV-Vis spectrophotometric method was established for determination of Propafenone Hydrochloride dissolution from tablets.At the same time,The content of Propafenone Hydrochloride and its related substances were determined by HPLC method.(3)Inspect the stability of self-made tablets through influencing factors,accelerated experimental tests and long-term experiments.Results:(1)The results showed that formulation factors containing the amount of adhesive agents and disintegrating agents,as well as the techniques factors,machine pressure,had significant effect.Three small samples were produced according to the prescriptions and processes determined by orthogonal experiments.Compare to the commercial tablet of Rytmonorm?,all the similarity factors of dissolution curves in four media were more than 50.(2)UV spectrophotometry methodological results show that Propafenone Hydrochloride concentration in 0.5~60?g/mL(R~2?0.9999)had good linearity and the method had high accuracy and good precision,and meets the requirements of the Pharmacopoeia.At the same time,the content determination method for Propafenone Hydrochloride was established by HPLC method.Propafenone Hydrochloride concentration in 2~20?g/mL had good linearity and the method had high accuracy and good precision.The examination method of related substances of Propafenone Hydrochloride was also studied with high detection sensitivity,good specificity and good reproducibility.(3)In the study of stability,the results of influence factor tests showed that the related substances were slightly increased in the 92.5%humidity conditions.These were indicated that this product should be air tightened.The accelerated testing for 6 months and 6 months at room temperature showed that the appearance,content,dissolution curves and related substances had no significant changes.Conclusions:(1)The validation study of prescription showed that the preparation process was stable and controllable in quality which can meet the production demand.(2)By establishing an in vitro method for the analysis of Propafenone Hydrochloride tablets,the method validation results show that the methods are scientific,accurate,and rapid,and can be effectively used for the study of the quality of the tablet.(3)The stability of Propafenone Hydrochloridetablets was preliminary investigated.The results showed that the prepared Propafenone Hydrochloridetablets were stable and controllable in quality and could ensure the safety and efficacy of medication.