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张苍林, 张再兴, 杨亚明, 郭晓芳, 杨丽香, 李斌, 刘江云, 陈诗梅. 云南省抗疟疾药物质量监测分析[J]. 中国公共卫生, 2007, 23(3): 314-315. DOI: 10.11847/zgggws2007-23-03-32
引用本文: 张苍林, 张再兴, 杨亚明, 郭晓芳, 杨丽香, 李斌, 刘江云, 陈诗梅. 云南省抗疟疾药物质量监测分析[J]. 中国公共卫生, 2007, 23(3): 314-315. DOI: 10.11847/zgggws2007-23-03-32
ZHANG Cang-lin, ZHANG Zai-xing, YANG Ya-ming, . Antimalarial quality monitor in Yunnan province[J]. Chinese Journal of Public Health, 2007, 23(3): 314-315. DOI: 10.11847/zgggws2007-23-03-32
Citation: ZHANG Cang-lin, ZHANG Zai-xing, YANG Ya-ming, . Antimalarial quality monitor in Yunnan province[J]. Chinese Journal of Public Health, 2007, 23(3): 314-315. DOI: 10.11847/zgggws2007-23-03-32

云南省抗疟疾药物质量监测分析

Antimalarial quality monitor in Yunnan province

  • 摘要: 目的 了解云南省抗疟疾药物的质量情况,为抗疟疾药的使用和管理决策提供依据.方法 在勐腊县和瑞丽市2个监测点,用德国微型实验室检测技术(GPHF)对样品初筛,进行物理检测、样品裂解及薄层层析(TLC);将初筛过的样品(按送检比例)送国家药物质量控制实验室进行确认实验,内容包括视觉检查、活性成分检测等.结果 2个监测点收集到6种抗疟疾药共128个样品,其中勐腊59个,瑞丽69个.在初筛过程中检测出4个可疑样品和3个不合格样品,合格率为94.5%、可疑率为3.1%,不合格率为2.3%.30个样品送往食品药品监督局进行确认实验,其中的7个样品没有通过确认实验,确认实验合格率为76.7%.结论 云南部分抗疟疾药物存在质量不合格现象,需要对云南省抗疟疾药物质量持续监测.

     

    Abstract: Objective To understand the quality situation of antimalarial drugs in Yunnan prov ince.Methods The German Pharma Health Fund Mini-lab testing procedures and the techniques were used to screen for quality of samples at the sentinel sites.This tests include physical/visual examinations simple disinteg ration,and Thin-layer chromatography;The latest analytical methods and procedures of China Pharmacopoeia were used in this monitoring project for the verification and confirmatory testing at National Laboratories and Reference Laboratories.The tests included visual inspection obser vations,identification and content of each activeingredient(e.g.color imetic,Thin-layer chromatogr aphy,or HPLC).Results In the sentinel sites,total 6 varieties of 128 antimalar ial drug samples were collected from Ruli and Mengla counties,69 samples from Ruli and 59 sampls from Mengla.Four doubtful samples and 3 failing samples were found in the sentinel sites testing,while the pass sample rate was 94.5%,the doubtful samples made up 3.1% and 2.3% of failed samples;30 samples were sent out to SDA for verification test,and results showed that there were 7 samples which did not pass the verification test,and 76.7% samples passed.Conclusion Most antimalarial drug samples are good in quality,although some sub-standard samples are found in the sentinel sites.Continuous monitor on antimalarial drugs is necessary in Yunnan province.

     

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