基于酒黄精炮制前后糖类成分的变化探讨《中国药典》酒黄精含量测定指标的合理性  

A Study on the Rationality of the Determination Index of Alcoholis Rhizoma Polygonat Set by Chinese Pharmacopoeia Based on the Changes of Sugar Components before and after Its Processing

作　　者：刁卓 刘军玲 胡冲 王浩 杨青山[1] 张亚中[1,2,3] Diao Zhuo;Liu Junling;Hu Chong;Wang Hao;Yang Qingshan;Zhang Yazhong(Anhui University of Chinese Medicine,Hefei 230012,China;Anhui Institute for Food and Drug Control,Hefei 230051,China;NMPA Key Laboratory for Quality Research and Evaluation of Traditional Chinese Medicine,Hefei 230051,China)

机构地区：[1]安徽中医药大学,合肥230012 [2]安徽省食品药品检验研究院,合肥230051 [3]国家药品监督管理局中药质量研究与评价重点实验室,合肥230051

出　　处：《中国药事》2022年第1期56-65,共10页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划项目-中药材净切制关键技术与智能设备研究及应用(编号2019YFC1711500)。

摘　　要：目的:从完善酒黄精饮片的质量控制出发,为《中华人民共和国药典》(简称《中国药典》)一部的修订提出一些建议。方法:对现行《中国药典》一部含酒黄精饮片的质量控制情况进行分析,并针对酒黄精炮制前后糖类成分发生变化这一问题,建立了以Prevail Carbohyrate ES为色谱柱,乙腈-水作为流动相,采用高效液相色谱-蒸发光散射法(HPLC-ELSD)对酒黄精的主要成分进行含量测定的检验方法。结果:指认了酒黄精炮制前后糖的种类,建立了果糖为其指标性成分的含量测定方法。结论:对酒黄精含量测定方法及限度修订提出建议,为其质量控制标准的完善提供参考。Objective: To improve the quality control of Alcoholis Rhizoma Polygonat decoction pieces and put forward some suggestions for the revision of Volume I of Chinese Pharmacopoeia. Methods: The quality control of Alcoholis Rhizoma Polygonat decoction pieces in Volume I of Chinese Pharmacopoeia was analyzed. A testing method for the content determination of the main components of Alcoholis Rhizoma Polygonat was established by using Prevail Carbohyrate ES as chromatographic column, acetonitrile water as mobile phase and HPLC-ELSD to solve the problem of the changes of sugar components before and after the processing of Alcoholis Rhizoma Polygonat. Results: The kinds of sugars before and after the processing of Alcoholis Rhizoma Polygonat were identified, and the content determination method of taking fructose as its index component was established.Conclusion: Suggestions for the revision of the determination method and limit of Alcoholis Rhizoma Polygonat are put forward so as to provide references for the improvement of its quality control standards.

关 键 词：《中华人民共和国药典》 酒黄精 果糖 含量测定 质量控制 

分 类 号：R954[医药卫生—药学]