各类药品标准使用及变化趋势分析与标准提高的建议

目的 分析山东省食品药品检验所2006～2010年5年来药品抽验中各类质量标准的使用情况及变化趋势,为国家标准的规范与提高工作提供参考.方法 统计山东省食品药品检验所2006～2010年抽验的9033批共2169个品种药品采用的质量标准,分析各类质量标准使用的变化趋势,阐述我国药品质量标准存在的主要问题,并提出建议.结果 《中国药典》及国家食品药品监督管理局颁布标准的使用率逐渐上升,其他标准的使用率逐渐下降,但中成药及中药材使用部颁标准及地方标准的比例还很高.结论 应加快推进部颁标准的提高及地方中药材标准和中药炮制规范在制定和执行中的规范化.

Analysis of Usage and Change Trend of National Drug Standards and Suggestions on Improvement

Objective To analyze the situation and change trend of the use of national drug standards adopted by Shandong Institute for Food and Drug Control during drug sampling inspections in last five years from 2006 to 2010, so as to provide a reference for improvement and standardization of national drug standards. Methods Statistical analysis of quality standards applied to the sampling inspections of 9033 batches drugs in total of 2169 varieties from 2006 to 2010 by Shandong Institute for Food and Drug Control was conducted to analysis the change trend of the use of quality standards; problems of drug quality standard in our country were expounded, and suggestions were put forward. Results The using rate of ＂China Pharmacopoeia＂ and standards issued by the China Food and Drug Administration gradually increased, while the using rate of other standards gradually declined, but the usage proportion of ministerial standards of proprietary Chinese medicine and Chinese herbal medicine as well as local standard remained very high. Conclusion The improvement of ministerial standards should be hastened, and standardization in the formulation and implementation of local Chinese medicine standards and traditional Chinese medicine processing specification should be strengthened.