湖北省中药材质量抽验情况回顾与建议  

Review and Suggestions of Quality Sampling Inspection on Chinese Herbal Medicines in Hubei Province

作　　者：蔡丹宁 彭文兵 Cai Danning Peng Wenhing(Hubei Institute for Drug Control, Wuhan 430075, Chin)

机构地区：[1]湖北省药品监督检验研究院,武汉430075

出　　处：《中国药师》2017年第9期1615-1617,共3页China Pharmacist

摘　　要：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 provide specific suggestions for the reasonable application of various quality sampling inspection methods for Chinese herbal medicines in order to improve the scientificity of sampling inspection plan. Methods： The sampling inspection program and the overall quality of Chinese herbal medicines in Hubei province from 2014 to 2016 were reviewed and the existing problems were analyzed, finally, suggestions for improvement were proposed for the future work. Results and Conclusion： The current sampling inspection methods have made certain achievements; however, each method still needs optimization. It is suggested that the supervision sampling inspection be standardized to solidify the basis of sampling inspection, special sampling inspection be arranged periodically to target the complicated and recurring quality issues, and evaluation sampling inspection be strengthened for certain varieties to evaluate the overall quality status and discover the risk signals.

关 键 词：中药材 质量抽验 改进建议 

分 类 号：R927.1[医药卫生—药学]