摘要
目的建立丹参饮片质量评价的量化方法,明确丹酚酸B的含量限度范围。方法参照《中国药典(2025年版)》一部丹参原药材的检测方法,测定344家企业生产的丹参饮片中丹酚酸B含量,采用稳健Z比分数法对样本数据进行统计分析,通过中位值与标准化四分位距计算Z比分数,识别数据分布特征。结果按干燥品计算,建议丹参饮片中丹酚酸B的含量限度为2.5%~5.5%(g/g),该区间覆盖95%以上样本的稳健分布范围。结论本研究结合药典方法与稳健统计技术,提出的含量限度科学合理,可有效指导丹参饮片的质量控制与优劣评价,为中药饮片标准化提供实践参考。
Objective To establish a quantitative method for evaluating the quality of Salvia miltiorrhiza decoction pieces and determine the content limit range of salvianolic acid B.Methods Referring to the detection method of raw Salvia miltiorrhiza in the Chinese Pharmacopoeia(2025 Edition),Volume I,the content of salvianolic acid B in 344 batches of Salvia miltiorrhiza decoction pieces produced by different enterprises was determined.Robust Z-score method was used for statistical analysis of the sample data,and the Z-score was calculated based on the median and standardized interquartile range to identify the distribution characteristics of the data.Results Calculated on a dry basis,it is suggested that the content limit of salvianolic acid B in Salvia miltiorrhiza decoction pieces be 2.5% to 5.5%(g/g),which covers the robust distribution range of more than 95% of the samples.Conclusion This study,combining the pharmacopoeia method with robust statistical techniques,proposes a scientifically reasonable content limit,which can effectively guide the quality control and evaluation of the superiority and inferiority of Salvia miltiorrhiza decoction pieces,providing practical references for the standardization of traditional Chinese medicine decoction pieces.
作者
郑正
金凤华
刘业飞
ZHENG Zheng;JIN Fenghua;LIU Yefei(Hefei Food and Drug Safety Inspection and Testing Center,Hefei 230088,China)
出处
《药学前沿》
2026年第1期71-77,共7页
China Pharmacist
关键词
丹参饮片
丹酚酸B
稳健统计
Z比分数法
含量限度
质量控制
Salvia miltiorrhiza
Salvianolic acid B
Robust statistics
Z-score method
Content limit
Quality control
