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目的:探讨药品首批抽验的特点及检验中存在的主要问题,为新药的监管及检验提供参考。方法:统计并分析了山东省食品药品检验所2008～2010年首批抽验情况,阐述检验中存在的主要问题及解决方法。结果:首批抽验的合格率为98.6%、全检率为98.3%;首批抽验中化学药所占比率最多为57.1%;片剂是首批抽验的主要剂型,但注射剂与胶囊剂呈逐年上升趋势;大型制药企业申报的批次最多。结论:首批抽验的全检率高、合格率高,首批抽验制度在一定程度上提高了上市新药的质量。
OBJECTIVE: To investigate the characteristics of the first sampling of drugs and the main problems in the testing, and to provide reference for the supervision and testing of new drugs. Methods: The first lottery tests of Shandong Food and Drug Administration from 2008 to 2010 were analyzed and analyzed, and the main problems and solutions in the test were expounded. Results: The first pass of the pass rate of 98.6%, the detection rate was 98.3%; the first batch of chemical drugs accounted for the largest proportion of 57.1%; tablets are the first batch of the main test formulations, but injection and capsule showed year after year Rising trend; large pharmaceutical companies to declare the largest batch. Conclusion: The first sampling of the high detection rate, high pass rate, the first batch of testing system to a certain extent, improve the quality of new drugs listed.