基于国家药品评价性抽验的全国山药饮片质量情况分析与研究

Quality Analysis and Study on Dioscoreae Rhizoma Decoction Pieces Based on National Drug Evaluation Sampling Inspection

目的:了解全国山药饮片的质量状况及存在的问题,完善山药检验标准,为药品监管部门提供技术支撑。方法:从全国31个省级行政区抽取山药饮片样品,依据《中华人民共和国药典》2015年版山药质量标准进行检验,分析检验数据以评价山药饮片的质量状况;针对检验中发现的问题,开展探索性研究。结果:本次抽验的山药样品共168批,部分样品存在显微鉴别不合格、二氧化硫残留量超标、浸出物不合格问题;现行质量标准存在性状表述不准确、薄层鉴别效果欠佳和总灰分限度不合理的问题。探索性研究发现,不同规格山药饮片质量差异较大、麸炒山药炮制不规范等问题。结论:山药饮片总体质量状况一般,需要进一步加强监管;现行质量标准需要改进;鼓励采用趁鲜切制等新技术加工山药,提高山药的质量。

Objective:To analyze the overall quality status and related quality problems of Dioscoreae Rhizoma decoction pieces in order to improve inspection standards,provide technical supports for relevant regulatory departments.Methods:According to the current statutory standard of Dioscoreae Rhizoma,the quality inspection and data analysis was carried out to evaluate the quality of dioscoreae Rhizoma Decoction pieces which were sampled from 31 provinces in China.Moreover,exploratory study on the problems found in the inspection.Results:A total of 168 batches of Dioscoreae Rhizoma Decoction Pieces were tested.Some batches failed to qualify the microscopic identification,sulphur dioxide residues exceeding the standard,extractives is not qualified.The current statutory standard have problems of inaccurate description of properties,poor TLC identification effect and unreasonable total ash limit.Exploratory study found that the quality of different specifications of Dioscoreae Rhizoma Decoction pieces differed greatly,and the processing of prepared slice of Rhizoma Dioscoreae was not standardized.Conclusion:The overall quality of Dioscoreae Rhizoma Decoction pieces is general and needs further supervision.The current quality standards need to be improved,new technologies such as fresh cutting are encouraged to process Dioscoreae Rhizoma to improve its quality.