Drug Quality Study Based On The Drug Quality Annoucement By CFDA

Drug quality,the cradle of drug security,directly holds the key to people’s physical health and life safety,which additionally serves as the backbone of national economy and people’s livelihood as well as the top priority of national drug supervision and control.The Drug Quality Announcement,regularly publicized by the China Food and Drug Administration in accordance to quality inspection standard,is aiming at supervising the drug quality in a dynamic manner.Based on the Drug Quality Announcement presented on the official website of China Food and Drug Administration,this thesis gives a detailed analysis on the status in quo of drug quality at home;exposes the features of unqualified drugs dissemination;finds the main factors and relevance of drug quality so as to provide references for national drug supervision and control.This thesis makes a study centering on the issue of unqualified drugs.First of all,on the basis of literature pertaining to the drug quality security,this thesis sorts out the data of unqualified drugs given by the Drug Quality Announcement from 2014 to 2017 by CFDA;and then,this thesis selects real and effective data to the EXCEL and establishes the original database of unqualified drugs;next,this thesis,with aid of SPSS 21.0,uses Frequency Analysis,Cluster Analysis and One Way ANOVA as well as Aproiori Algorithm concerning Association Rules in the SPSS MODELER 14.1.In the end,this thesis makes a penetrated analysis on the concluded data through pharmacy theory and provides constructive suggestions.Statistics shows that,among the unqualified drugs,traditional Chinese medicines prepared in ready-to-use forms accounts for 53.63%,Chinese patent drugs 30.27% and chemical drugs 15.03% and the quality of traditional Chinese medicines prepared in ready-to-use forms urgently needs improving.Among the chemical drugs,injection makes up 42.29% and tablet 34.14%;concerning to the unqualified Chinese patent drugs,tablets comprises 49.07% and capsule 27.01%.Statistics from major unqualified items present that,with regard to chemical drugs,unqualified items of visible foreign matters constitute 25.91%,relevant matter items 14.15% and content determination items 14.03%;with regard to the Chinese patent drugs,unqualified items of characters accounts for 32.09%,filling difference items 17.00% and moisture items 13.78%;with regard to the traditional Chinese medicines prepared in ready-to-use forms,unqualified items of characters accounts for 39.48%,content determination items 12.98% and moisture items 11.89%.Particularly,the dissemination of unqualified Chinese patent drugs presents regional relevance.The conclusions are as follows according to the study findings.One,the issue of drug quality should be addressed in a targeted manner,such as the injections of chemical drugs,the tablets of Chinese patent drugs,items of visible foreign matters of unqualified chemical drugs and character items of Chinese patent drugs and traditional Chinese medicines prepared in ready-to-use forms.Two,the quality of traditional Chinese medicines prepared in ready-to-use forms plays an all-important role in the supervision and control on the quality of traditional Chinese medicine;and a set of complete and appropriate quality standards pertaining to the quality of traditional Chinese medicines prepared in ready-to-use forms should be settled as soon as possible.Three,the unqualified Chinese patent drugs have difference correlation with the place of origin and picked areas and it can be divided into southern and northern areas.Then the security risks of drug quality can be controlled in accordance to the drugs of same-typed provinces;and experience exchanges and cooperation concerning to the drug security risk control should be vigorously promoted.Four,normalized management should be made on the unqualified drugs announcement so as to let the data from Announcement harness a better role in the drug security supervision and control.