Preparation of Valsartan Tablets and evaluation of quality consistency / 药物评价研究

ABSTRACT

Objective To develop a formulation of generic Valsartan Tablets and evaluate the quality consistency in vitro.Methods Diovan(R)~ HCT (80 mg) was used as the reference drug.In order to determine the best formulation and the best preparation processing,the single factor experiments were applied to determining the best formulation and the best preparation processing.And dissolution test was used as the evaluation index in the single factor experiments.Meanwhile the dissolubility of generic Valsartan Tablets and original preparation was investigated in four different media to evaluate the similarity of dissolution by calculating similar factor (f2).Results The dissolution was above 85％ of three batches of generic Valsartan Tablets in the phosphate buffer (pH 6.8).The similar factors were all more than 50 in the water,hydrochloric acid solution (pH 1.2),and acetate buffer solution (pH 4.5).Conclusion The f2 similarity factor results indicate a similarity in the reference drug and generic Valsartan Tablets which were developed by single factor experiments,which means the quality of genetic Valsartan Tablets is qualified.