Quality Research and Risk Analysis of Domestic Pancreatin Enteric-coated Tablets
To study the quality of domestic pancreatin enteric-coated tablets,and analyze the existing quality risks of products and the testing items that need to be improved in the quality standard,forty-nine batches of products were included nationwide and investigated.Examination and exploratory studies,including dissolution,bubble tightness,water content,residual solvent,enzyme activity and species identification were carried out according to the Chinese pharmacopoeial method (Volume Ⅱ,2015 Edition).Further investigation was employed for cause and quality risk of description disqualification.Consistency evaluations of enzyme activities and dissolution curves were carried out between domestic and imported similar preparations.Revision was proposed that absolute enzyme activity needed to be replaced by relative enzyme activity.Its necessity was also demonstrated.Results showed that potential risks existed in effectiveness of the products.The Chinese pharmacopoeial standard is relatively simple and key indexes which influence the quality of products need to be improved,including new admission of dissolution and water content,and revision of enzyme activity.The current study provided research ideas and data for perfecting the quality standard and improving product quality.
NETL
NSTL
万方数据
维普
