论文部分内容阅读
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3 280批、3 614批、2 804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)的不合格率分别为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 the medicines tested by Wuhan Medical Equipment Inspection. Methods: The retrospective method was used to analyze the test results of drug testing in Wuhan Medical Device Testing Institute from 2011 to 2013. Results: 3 280 batches, 3 614 batches and 2 804 batches of tested drugs were obtained from 2011 to 2013 with the failure rates of 18.2%, 12.6% and 6.5% respectively. The unqualified rate of raw material medicine, chemical medicine, antibiotic preparation, traditional Chinese medicine, Chinese herbal medicine (Pieces) and auxiliary materials (capsule shell) were 0.7%, 10.5%, 1.4%, 9.6%, 36.6% and 14.0% (Pieces) The annual failure rate is high, the main unqualified items traits and identification. Conclusion: There are certain quality problems in all kinds of medicines. Among them, there are major problems in traditional Chinese medicine (Pieces), and supervisory and administrative departments should step up supervision and punishments.