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目的:针对中药材抽验中各种抽验方式的应用提出具体建议,进一步提高抽验计划制订的科学性。方法:对2014~2016年湖北省中药材药品质量抽验计划及其质量情况进行回顾,分析现有抽验方式存在的问题,并提出下一步工作建议。结果与结论:现有的监督抽验、专项抽验及评价抽验方式取得了一些成效,但各抽验方式的内容有待优化,建议规范监督抽验,夯实抽验工作基础;定期组织专项抽验应对情况复杂、反复出现的共性问题;加强特定品种的评价抽验,全面评价其质量状况并发掘风险信号。
OBJECTIVE: To put forward specific suggestions on the application of various sampling methods in the sampling of Chinese herbal medicines, and to further improve the scientificness of the sampling plan. Methods: The medical quality sampling plans and quality of Chinese herbal medicines in Hubei Province from 2014 to 2016 were reviewed, the existing problems of the existing sampling methods were analyzed, and the suggestions for further work were put forward. RESULTS AND CONCLUSION: The existing supervision and sampling tests, special sampling tests and evaluation sampling methods have achieved some results. However, the content of each sampling method needs to be optimized. It is suggested that supervision and sampling should be standardized and the foundation of sampling test should be compacted. Common problems; strengthen the evaluation of specific varieties of sampling, a comprehensive evaluation of the quality of the situation and explore the risk signal.