Analysis Evaluation Of Drug Dissolution Process Clinical Common Ribavirin Tablets、Levofloxacin Hydrochloride Tablets And Cefalexin Tablets

Objective:The research objects are three kinds of basic clinical medicine, ribavirin tablets, levofloxacin hydrochloride tablets and cefalexin tablets in accordance with the national evaluative testing task.The original medicine is the harbinger of clinical medicine, but the generic drugs are still the subject medicine in china. The preparation process, production industry and quality control vary among different country and districts.This test use technology of medicine dissolution process analysis to establish the clinical commonly used ribavirin tablets, levofloxacin hydrochloride tablets and cefalexin tablets drug dissolution method, evaluate the same drug specifications and different manufacturer drug reflected by the dissolution in vitro bioequivalence.According to the data from the in vitro dissolution to objective evaluate the clinical commonly used drug preparation quality and performance of the preparation technology.Methods:Using series concentration solution (dissolve out percentage)20%,40%,60%,80%,100%,120%inspection best optical path. According to100%dissolving rate of absorbance and the concentration and lambert beer’s law calculation, determine the probe specifications; Establish the dissolve out curve database of clinical commonly used drugs in four dissolve out medium; Contrast dissolution curve of clinical common original medicine and generics medicine and with f2factor method analysis results.Results:establishing ribavirin tablets dissolution evaluation method, and with USP methods on methodology validation,the qualified samples have different dissolved out behavior with two testing methods; With the method of building to test11batch of ribavirin tablets from different manufacturers in four menstruum dissolved out behavior, analyze and evaluate ribavirins vitro bioequivalence from different manufacturers,which reflected the uniformity of product samples were not good without comparison significance;with The "Chinese pharmacopoeia2010edition two department" methods,5batch of cefalexin tablets and9batch of levofloxacin hydrochloride tablets from different manufacturers in four menstruum dissolved out behavior were determined and similar factors were compared,which reflected the dissolved out behavior of product samples were different and the conditions of the f2factor method wasn’t conformed.The dissolution courses were different in different mediums.Conclusion:using Fiber drug dissolution tester and the drug dissolution process analysis technology to establish the different specifications of ribavirin tablet、 cefalexin tablets and levofloxacin hydrochloride tablets dissolution method, evaluate the dissolution in vitro bioequivalence of the same drug specifications and different manufacturers.the method showed the same preparation quality from different manufacturers had big different.the products corresponding the national standard were far from original drugs in the clinical effect. According to the data from the vitro dissolution, pharmaceutical preparation quality and process quality of ribavirin tablets、cefalexin tablets and levofloxacin hydrochloride tablets were objectively evaluated, more comprehensive scientific, objective and impartial, accurate and reliable evaluation indexes were provided for clinical using.