OBJECTIVE:To explore drug quality dynamic evaluation mechanism based on analysis of drug quality announce-ment data. METHODS:The sorts and types of drugs,places of origin,quantity of production enterprises and frequency distribu-tion of being mentioned were analyzed on the basis of drug quality announcement issued by CFDA and provincial administration in 2013. RESULTS & CONCLUSIONS:Frequency of TCM being mentioned (0.75%) was higher than that of chemical drug (0.30%). Among drugs mentioned more than 10 times,the most chemical drugs were injection (70%) and the most TCM were tablet(66.7%). Among all types,drug types produced by more than 100 enterprises accounted for 62.5%,and those produced by more than 50 enterprises accounted for 93.75%,which indicated the frequency of problems was in relatively direct proportion to the quantity of drug manufacturing enterprises. Top 10 provinces in the list of the number of drug quality announcements showed different characteristics of problem type distribution. In compassion,the quality problems of TCM in Jilin,Guangxi,Mongolia,Si-chuan were prominent,and reference number proportion of involved TCM were 85%,80%,97% and 69%,respectively;the quality problems of chemical drugs in Henan,Shanxi,Jiangsu,Guangdong,Anhui,Shandong should be paid attention,and refer-ence number proportion of involved chemical drugs were 62%,61%,95%,57%,86% and 65%,respectively. It is suggested that the government should carry out the dynamic risk assessment system based on data of drug quality announcement,and strength-en standard management of data collection of local drug quality announcement.

The objective of the study was to determine the potential effects of Naomaili granules on rats subjected to ischemia and reperfusion. With the exception of animals in sham group, all animals in treatment groups were subjected to ischemia and reperfusion by middle cerebral artery occlusion(MCAO)with thread technique. The ability of anti-cerebral ischemia, relieving cerebral edema and antioxidation was evaluated by the measurement of neurological deficit score, ratios of infarction area, brain water content, histopathological score and biochemical indexes related to oxidative stress in brain tissue. Significantly reduction of infarction area, histopathological score, contents of H2O2 and MDA were observed at 6 g/kg and 3 g/kg Naomaili granules compared to animals in the model group; the capacity of inhibition of superoxide anion radical(O-·2)and hydroxyl radial( ·OH)were also found to have increased. Additionally, Naomaili granules(6 g/kg)improved neurological function, reduced brain water content, and increased the level of GSH, GSH-Px and SOD compared with model group. The result suggested that Naomaili granules exhibited obvious protection against cerebral ischemia and reperfusion-induced injury due to its antioxidating effect.