全国地黄饮片评价性抽验结果分析  

Quality Analysis on Rehmanniae Radix Pieces Based on National Drug Evaluation Sampling Inspection Results

作　　者：黄霞 王晓燕[1] 李向阳[1] 李振国[1] 代雪平[1] 王艳伟[1] 张文静 李桂本[1] 赵一擎 Huang Xia;Wang Xiaoyan;Li Xiangyang;Li Zhenguo;Dai Xueping;Wang Yanwei;Zhang Wenjing;Li Guiben;Zhao Yiqing(Henan Institute for Food and Drug Control,Key Laboratory for Quality Control of Chinese Materia Medica and prepared slices,National Medical Products Administration,Zhengzhou 450018,China)

机构地区：[1]河南省食品药品检验所,国家药品监督管理局中药材及饮片质量控制重点实验室,郑州450018

出　　处：《中国药事》2020年第4期437-444,共8页Chinese Pharmaceutical Affairs

基　　金：2018年国家药品抽检计划中药饮片专项(食药监药化监[2017]131号);2018年度国家药品标准提高任务(编号2018Z008);国家中药标准化建设项目(编号ZYBZH-Y-HEN-18)。

摘　　要：目的:开展地黄饮片的全国评价性抽验,不断完善和修订标准方法,保障公众的用药安全和有效。方法:依据法定标准进行检验,并开展探索性研究。结果:共收到187批地黄饮片,不合格率22.5%。建立了地黄饮片中7种糖类成分的含量测定方法,探索不同炮制时间对地黄糖类成分的影响。增加熟地黄中甘露三糖的含量测定,完善熟地黄的质量标准。结论:通过本次抽验,发现地黄饮片仍存在质量问题,建议加强监管;地黄、熟地黄的标准仍需完善,建议修订标准。Objective:To carry out the national drug evaluation sampling inspection of Rehmannia Radix pieces,improve and revise the standard methods continuously,and ensure the safety and effectiveness of drug use by the public.Methods:According to the legal standards,the test was carried out and the exploratory research was carried out.Results:187 batches of Rehmannia Radix were received,and the unqualified rate was 22.5%.A method for the determination of 7 sugars in Rehmanniae Radix pieces was established,and the influence of different processing time on the sugars in Rehmanniae Radix was explored.The content determination of mannotriose was added in quality standard of Rehmanniae Radix praeparata so as to improve it.Conclusion:Quality problems in Rehmannia Radix pieces were spotted through this nationwide drug evaluation sampling inspection,and it is suggested to strengthen supervision.The standards of Rehmannia Radix and Rehmanniae Radix praeparata still need to be improved,and it is suggested to revise the standards.

关 键 词：生地黄 熟地黄 质量分析 高效液相色谱 问题与建议 

分 类 号：R95[医药卫生—药学]