山东省山药饮片专项抽验情况分析

Quality analysis on Shandong special sampling inspection of Dioscoreae Rhizoma decoction pieces

目的2019年山东省开展了重点中药饮片专项抽检,通过分析本单位承检的49批山药饮片的检验结果,找出潜在的风险隐患,为提高山药的质量标准提供依据。方法从山东省16地市经营单位、医疗机构等抽取样品,按照《中国药典》2015年版第一增补本山药项下规定检验,分析检验数据,并进行探索性研究。结果本次抽验的山药样品共计49批次,按现行质量标准检验合格样品45批,合格率91.84%,不合格样品4批,不合格项目为总灰分、二氧化硫残留量两项;探索性研究发现1批次饮片汞含量较高。结论本次抽验山药饮片总体质量较好。但仍需加强流通环节监督管理、完善检验标准,以规范市场,保障用药安全。

Objective Analysis of the results of 49 batches of Dioscoreae Rhizoma specially sampled in Shandong Province in 2019,and provide basis for improving the quality standard of Dioscoreae Rhizoma.Methods According to the current statutory standard of Dioscoreae Rhizoma stipulated in Pharmaco poeia of the People′s Republic of China(First Supplement 2015),the inspection data analysis and the exploratory research were carried out,which were sampled and inspected from business units and medical institutions in 16 cities of Shandong Province.Results A total of 49 batches of Dioscoreae Rhizoma piece samples collected were tested,among which 45 batches were qualified whereas 4 batches were unqualified according to the current quality standards,the qualified rate was 91.84%,the unqualified items were total ash and sulfur dioxide residual quantity.In exploratory research,the content of mercury in 1 batch of decoction pieces was high.Conclusion The overall quality of Dioscoreae Rhizoma piece samples collected were good.However,it is still necessary to strengthen the supervision and management of circulation links and improve the inspection standards in order to standardize the market.