2011～2013年武汉药品医疗器械检验所抽验药品质量分析

Quality Analysis of Drug Sampling and Testing in Wuhan Institute for Drug and Medical Device Control in 2011-2013

目的：对武汉药品医疗器械检验所抽验药品的质量状况进行评价。方法：采用回顾性方法，对武汉药品医疗器械检验所2011～2013年抽验药品的检验结果进行统计分析。结果：2011-2013年抽验药品批次分别为3280批、3614批、2804批，不合格率分别为18．2％、12．6％、6．5％。原料药、化学药品、抗生素制剂、中成药、中药材（饮片）、辅料（胶囊壳）的不合格平分别为0．7％、10．5％、1．4％、9．6％、36．6％、14．0％，其中中药材（饮片）每年的不合格率居高不下，主要不合格项目为性状和鉴别。结论：各类药品均存在一定的质量问题，其中中药材（饮片）存在较大问题，监督管理部门要加大监督和惩处力度。

Objective： To evaluate the quality of drug sampling and testing in Wuhan institute for drug and medical device control in 2011-2013. Methods： Using a retrospective method, the inspection results of drug sampling and testing in Wuhan institute for drug and medical device control in 2011-2013 was analyzed statistically. Results： From 2011 to 2013, the sampling batch respectively was 3 280, 3 614 and 2 804, and the fraction defective was 18.2% , 12.6% and 6.5% , respectively. The unqualified rate of raw material medicines, chemicals, antibiotic preparations, Chinese patent medicines, Chinese herbal medicines （pieces） and excipients （capsule shells） was 0.7% , 10.5% , 1.4% , 9.6% , 36.6% and 14.0% , respectively, and that of Chinese herbal medicines （pieces） in each year remained high. Conclusion： All kinds of drugs have some quality problems, and the problems in Chinese herbal medicines （pieces） are more severe,so supervision and punishment should be strengthened.