五加皮药材及饮片的质量分析及监管建议  

Quality Analysis and Regulatory Suggestions for Acanthopanacis Cortex and its Decoction Pieces

作　　者：杨建波[1] 张文娟[1] 程显隆[1] 王雪婷 魏锋[1] 马双成[1] YANG Jian-bo;ZHANG Wen-juan;CHENG Xian-long;WANG Xue-ting;WEI Feng;MA Shuang-cheng(National Institutes for Food and Drug Control)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国食品药品监管》2022年第3期66-73,共8页China Food & Drug Administration Magazine

摘　　要：目的:介绍五加皮药材及饮片存在的质量问题。方法:根据《中国药典》和地方药材标准,再结合2018年全国中药材及饮片专项抽验及市场调研结果,阐述五加皮的真伪优劣等问题。结果:通过性状特征、薄层色谱及聚合酶链式反应法,能够准确鉴定五加皮中的伪品。64批专项抽验样品中55批为五加皮正品、7批为香加皮、2批为穗序鹅掌柴的干燥根皮;15批专项抽验五加皮样品中浸出物合格率仅为33.3%,总灰分合格率为80%;13批采集于湖北省的五加皮,浸出物合格率为92.3%,总灰分合格率为100%。结论:建议修改部分省中药饮片炮制规范标准,规范种植细柱五加,加强对五加皮品种监管,从而保障人民群众用药安全与有效。Objective:To introduce quality problems of Acanthopanacis Cortex and its decoction pieces.Methods:Based on the Chinese Pharmacopoeia and local standards for medicinal materials,in combination with results of the national special sampling and testing program of Chinese crude drugs and decoction pieces in 2018 and results of market research,this paper analyzed the identification of Acanthopanacis Cortex and its adulterants.Results:The adulterations in Acanthopanacis Cortex could be accurately detected and identified using morphological characteristics,thin layer chromatography and polymerase chain reaction methods.Of the 64 batches sampled and tested,55 batches were authentic Acanthopanacis Cortex;7 batches were Periplocae Cortex and 2 batches were dried root bark of Schefflera delavayi.Of the 15 batches sampled and tested,the qualified rate of extract and total ash was 33.3% and 80% respectively;of the 13 batches collected from Hubei province,the qualified rate of extract and total ash was 92.3% and 100% respectively.Conclusions:The authors suggest to revise some of the provincial processing specifications and standards for decoction pieces,standardize the planting of Acanthopanax gracilistylus and strengthen supervision on Acanthopanacis Cortex in order to ensure drug safety and efficacy.

关 键 词：五加皮 聚合酶链式反应法 穗序鹅掌柴 浸出物 总灰分 

分 类 号：R288[医药卫生—中药学]