Study On The Preparation Technology Of Ezetimibe Tablet And The Development Of Impurity Analysis Method

Ezetimibe Tablets is a new type 2-azobutin compounds and it is a new type of oral lipidemic-modulating drugs.Ezetimibe tablet is a selective cholesterol absorption inhibitor,can inhibit the absorption of cholesterol from the small intestine.Because it can be used to enhance statin drugs effect and reduce the side effects,it has gained more attention in recent years,and industrial production has significant social and economic benefits.In this paper,the formulation selection and production process of ezetimibe tablet are studied.The formulation screening is on the basis of the formulation of original drug,dissolution and content,weight difference,hardness,appearance are treated as studies index,compare seven formulations in this study,and the formulation was finally determined.In this paper,the dissolution methodology of ezetimibe was studied and confirmed,and the test methods of impurity defluorinated ezetimibe A and defluorinated ezetimibe B were developed.By studying different granulation methods,wet-process granulation technology was finally selected,through the pilot production(large-scale production scale)to determine the granulation time and total blending time.The parameters of pretreatment,granulation,drying,blending and tablet compression are qualified through the three batches of large-scale production.