目的：通过国家评价性抽验工作对我国当前中药五味子（包括中国药典收载的五味子和南五味子）的市场质量情况分析，为监管和临床用药工作提供建议。方法：检验数据和文献整理相结合，分析五味子的质量、标准及临床使用问题，同时提出建议。结果：质量方面，部分五味子饮片存在染色现象；标准方面，五味子检测方法专属性欠佳，研究提出专属性强的检测方法；临床应用方面，《中国药典》按品种来源分五味子、南五味子，而临床上，两个来源均统称为五味子，且各地在名称、处方应付方面差别较大，使用较为混乱。结论：建议在提升标准、规范生产和流通环节外，加强标准和临床使用的衔接。对临床使用环节中不同来源五味子的名称、饮片规格、处方等进行明确和规范。
Objective:To analyze current quality of the traditional Chinese medicine (TCM) Schisandrae Fructus (including Schisandrae Chinensis Fructus and Schisandrae Sphenantherae Fructus according to Chinese Pharmacopoeia) based on national evaluation sampling inspection and to provide recommendations for regulation and clinical use. Methods:Data inspection were combined with literature reviews to analyze the problems related to quality, standards and clinical use of Schisandrae Fructus. Suggestions and solutions for the problems were Data inspection put forward. Results:The problems related to the quality were that illegal dyeing or pigments were detected from Schisandrae Fructus. The problem related to the standards was that the specificity of testing method was not good enough. A more specific testing method was proposed. The problem related to the clinical use was the mixture of Schisandrae Chinensis Fructus and Schisandrae Sphenantherae Fructus. Schisandrae Fructus were divided into Schisandrae Chinensis Fructus and Schisandrae Sphenantherae Fructus according to the Chinese Pharmacopoeia. both of them are used as Schisandrae Fructus clinically. However, there was a big difference in terms of name and prescription in different areas. Conclusion:It was recommended to strengthen the connection between standards and clinical use in addition to standard improvement, standardization of production and circulation. The names, specifications of prepared slices and prescription for Schisandrae Fructus from different sources in clinical use should be specified and standardized.
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