Investigation and Research on Mechanical Parameter Validation of Drug Dissolution Meters at Home and Abroad
According to the mechanical verification standard requirements of dissolution meter,In this paper,the automatic sampling dissolution instrument of Agilent 708-DS in the United States,SOT AX AT-Xtend in Switzer-land,Hanson Vision-Elite8 in the United States,Shimadsu SNTR-8600AST in Japan,and Fukos FADT-1202 in Shanghai are taken as the research object.Summarize and analyze the mechanical verification parameters.The re-sults showed that the mechanical verification parameters of each automatic sampling dissolution instrument met the requirements,and it could be used for the experimental method research of in vitro dissolution of oral solid prepara-tions,providing laboratory technical support for the research and development of new drug prescription and the qual-ity consistency evaluation of generic drugs.
dissolutionmechanical verification of dissolution meterconsistency evaluationbioequivalence test
万方数据
维普
