汉中市药品抽检质量分析与对策  

Analysis of drug quality status in Hanzhong and the strategies for improvement

作　　者：王春艳 刘学平 WANG Chunyan;LIU Xueping(Hanzhong Food and Drug Inspection Team,Hanzhong 723000,China)

机构地区：[1]汉中市食品药品稽查支队,汉中723000

出　　处：《西北药学杂志》2018年第1期125-128,共4页Northwest Pharmaceutical Journal

基　　金：2014年国家药品计划抽验项目(编号:111)

摘　　要：目的评价汉中市近年来药品抽检的质量状况,分析药品质量安全问题的来源,为本市药品监督管理提供对策和参考。方法以6年内该市4 558批次药品的抽检结果为研究对象,统计分析抽检药品的种类、来源及总体质量情况,对比辖区药品在以上几个方面的差异,探讨本市药品抽检质量的发展趋势。结果该市不同品种的药物质量水平不同,中药材及饮片的合格率呈逐年递增的趋势,但中药材及饮片的合格率明显低于基本药物和非基本药物。基本药物和非基本药物在不同年份的合格率差异无统计学意义。该市生产企业、经营企业和医疗机构的基本药物、非基本药物在不同年份的合格率差异无统计学意义。来源于经营企业和医疗机构的中药及饮片的不合格率明显比其他各类药物更高;来源于经营企业和医疗机构的中药不合格率明显高于生产企业。该市中药饮片的总体质量不好,尤其是基层药店和诊所的不合格率高。结论该市药品质量总体状况较好,且药品检测合格率呈逐年增高的趋势。中药饮片质量状况相对较差,源于经营企业和医疗机构的中药质量状况较差。应从生产、流通和使用3个方面入手,加强中药材与中药类饮片的质量监督管理力度。To evaluate the quality status of drug sampling in Hanzhong,analyze the source of drug safety problems,and provide reference and improving strategies for drug quality.The sampling results of 4 558 batches of drugs in Hanzhong city were studied in 6 years.The type,source and overall of drugs were analyzed,the different drug quality levels of each year were compared and the development trend of drug sampling quality in Hanzhong were discussed.Different types of drugs of Hanzhong showed different quality levels?the qualified rate of Chinese medicine and beverage tablets showed a trend of increasing year by year,but it was significantly lower than that of basic drugs and non-essential drugs.There was no significant difference in the qualified rate of essential drugs and non-essential drugs in different years.The quality rate of the essential drugs and non-essential drugs from production enterprises,enterprises and medical institutions in Hanzhong city were not significant.The failure rate of traditional Chinese medicine and pieces from operating enterprises and medical institutions was significantly higher than that of other drugs.The failure rate of Chinese medicine from business enterprises and medical institutions was significantly higher than that of production enterprises.The overall quality of traditional Chinese medicine pieces from Hanzhong city was not good,especially in the grassroots pharmacies and clinics.The quality of medicines in Hanzhong city was improved in recent years?while the quality of Chinese medicine was relatively poor.The quality of traditional Chinese medicine from operating enterprises and medical institutions was more than that of operating enterprises.Therefore?the supervision and administration of traditional Chinese medicine should be enhanced from the aspects of production,circulation and application.

关 键 词：药品抽检 药品质量 对策 

分 类 号：R96[医药卫生—药理学]