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。
黄霞, 王晓燕, 李向阳, 李振国, 代雪平, 王艳伟, 张文静, 李桂本, 赵一擎
. 全国地黄饮片评价性抽验结果分析[J]. 中国药事, 2020
, 34(4)
: 437
-444
.
DOI: 10.16153/j.1002-7777.2020.04.011
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.
[1] 吴普著. 神农本草经[M]. 北京:人民卫生出版社, 1963:12.
[2] 国家药典委员会. 中华人民共和国药典:一部[S]. 北京:中国医药科技出版社,2015:124-126.
[3] 徐军,付喆蹾. 地黄炮制品历史沿革及功效考辨探讨[J]. 中成药,2017,39(9):1913-1916.
[4] 孙娟娟. 10种中药材道地产地的本草文献研究[D]. 北京:中国中医科学院,2010.
[5] 卢多逊,尚志钧. 开宝本草[M]. 合肥:安徽科学技术出版社,1998:73.
[6] 张介宾. 景岳全书[M]. 上海:第二军医大学出版社, 2006:41.
[7] 李红伟,孟祥乐. 地黄化学成分及其药理作用研究进展[J]. 中草药,2015,38(2):218-228.
[8] 刘彦飞,梁东,罗恒,等. 地黄的化学成分研究[J]. 中草药,2014,45(1):16-22.
[9] 郭丽娜,白胶,裴月湖. 生地黄化学成分的分离与鉴定[J]. 沈阳药科大学学报,2013,30(7):506-508, 542.
[10] 谭灵莉,崔丹丹,祝慧风,等. 梓醇对异丙肾上腺素诱导的大鼠心肌损伤的保护作用及机制研究[J]. 中国医科大学学报,2013,42(3):244-247.
[11] 裴志勇,赵玉生,高伟,等. 地黄低聚糖对体外培养的小型猪脂肪组织来源干细胞增值的影响[J]. 中国临床保健杂志,2012,15(6):615-619.
[12] 曹燕,贾正平,张汝学. 地黄的化学成分及药理研究进展[J]. 中成药,2006,28(4):609-611.
[13] Zeng Y, Jia Z P, Zhang RX. The Progress in Studies on Chemical Constituents and the Change in the Course of Processing[J]. World Notes Plant Med,2007,22(3):102-108.
[14] Liu WX, Lu YW, Du HT, et al. Phamacological Actions of Radix Rehmanniae and Its Active Components Research Advances[J]. J Inter Pharm Res,2009,36(4):277-280.
[15] Shen Hongmei,Jiang Zhenglin. 熟地有效成分甘露三糖对高浓度皮质酮损伤的海马神经细胞SGK\BDNF\GCR表达的影响[J]. 中药药理与临床,2011;27(5):16-20.
[16] 张汝学,贾正平. 地黄寡糖对2型糖尿病大鼠外周血像、激素水平和胰岛病理学的影响[J]. 西北国防医学杂志,2009,30(3):161-164.
