Quality Consistency Evaluation And Dry Suspension Preparation Of Simvastatin Tablets

Simvastatin is the first-line drug that treat hyperlipidemia and its main form is tablet at present and it was selected into the directory of consistency evaluation firstly.This paper mainly studied the consistency evaluation of the generics and original drugs of simvastatin tablets and researched the stability and preparation of dry suspension.The main content are followed:1.Quality consistency evaluation of simvastatin:To carry out the comparative consistency evaluation and we choose two kinds of the generic and original drugs of simvastatin.And evaluate the differences of generic drugs of simvastatin in quality through the norms which were conclude the content,relative substance,dissolution and crystallinity.The results show that the generic and original drugs of simvastatin have no significant differences in the aspect of content and related substances and they are in line with the relevant provisions of the Chinese Pharmacopoeia of 2015,but the dissolution profile of two kinds generic drug and original preparations were dissimilar.2.Study the dry suspension of simvastatin:Amount of additive method was used to blend the active pharmaceutical ingredients and supplementary materials.The optimum formulation was investigated with the orthogonal design and sedimentation and redispersibility as the content index.High performance liquid chromatography method was used to detect the content and relative substance and establish the method of dissolution.The stability of the suspension was studied by observing the particle size,zeta potential acidity,affecting factors and accelerated test.The result show that the preparation of dry suspension of simvastatin have many unreasonable that we should improve,but the result of affecting factors and accelerated test show its stability under the high temperature,humidity and light basically.