Quality Consistency Evaluation For Aspirin Enteric-coated Tablets In Vitro

Objectives:The comparison research of the quality consistency for self-made aspirin enteric-coated tablets(0.1 g)and the brand drug(Bayer S.p.A,0.1 g)in vitro,and the efficacy consistency evaluation in vivo will provide the basis for the generic drug research(IV chemical drug)of aspirin enteric-coated tablets(0.1 g).This paper studied that the similarity of dissolution curves about self-made drug and reference drug in four dissolution media.Methods:1.The crystal shape of aspirin API and reference drug was determined by X-ray diffraction to determine whether aspirin API was consistent with the reference drug.It investigated the solubility in different solvents and different dissolution media,and the dry weightlessness assay investigated the hygroscopic property.2.According to the fourth part of the Pharmacopoeia of the People's Republic of China(2015 Edition)0931,it established a method for dissolution determination of aspirin enteric-coated tablets.It performed the specificity,linear precision,stability,recovery,repeatability and film adsorption tests;according to the dissolution determination method,it studied that the dissolution curves of aspirin reference drug and self-made drug in four dissolution media;the method of the f2 similarity factor was used to calculate the similarity factor of the dissolution curves and evaluate the dissolution behavior.3.It determined the content of aspirin,and determined the free salicylic acid of reference drug and self-made drug,and compared their quality.Results:1.The aspirin crystal of API is consistent with the aspirin crystal used in the reference drug.Aspirin API has different solubility in different solvents,and it is easily soluble,slightly soluble in the water and easily soluble in the ethanol.The solubility of aspirin is pH dependent,and the solubility increases with the increasing of the pH.The API is not hygroscopic.2.The dissolution method of aspirin enteric-coated tablets performs good results,and the results show that the method is reliable and stable.The method of the f2 similarity factor is used to calculate the similarity factors of reference drug and self-made drug in four different dissolution media,and the results are all greater than 50%,and it shows the dissolution in vitro is similar to each other.3.The content of reference drug is 102.57%and the self-made drug is 101.43.All of them are within 93.0%-107.0%,which is the requirement of the provisions of Pharmacopoeia of the People's Republic of China(2015 Edition).The free salicylic acid of reference drug and self-made drug are 0.236%and 0.221%respectively,and both of them are less than 1.5%.Conclusions:The self-made aspirin enteric-coated tablets have the similar dissolution behavior as the reference drug in the four dissolution media.Therefore,it comes to a conclusion that the quality of the self-made aspirin enteric-coated tablets and the reference drug is basically consistent in vitro.