更年宁中辅料炼蜜的质量评价研究  

Quality Evaluation of Refined Honey in Gengnianning

作　　者：蒋芦荻 杨琰 刘亚楠 李海燕 王海波 王晓燕 JIANG Lu-di;YANG Yan;LIU Ya-nan;LI Hai-yan;WANG Hai-bo;WANG Xiao-yan(NMPA Key Laboratory of Quality Control of Chinese Herbal Medicines and Decoction Pieces,Henan Institute for Drug and Medical Device Inspection,Zhengzhou 450018,China)

机构地区：[1]河南省药品医疗器械检验院,国家药品监督管理局中药材及饮片质量控制重点实验室,河南郑州450018

出　　处：《食品与药品》2024年第6期542-547,共6页Food and Drug

基　　金：2022年国家药品抽检(中央补助地方经费项目)(No.41);河南省市场监督管理局科技计划项目(编号:2023sj61);中国药品监管科学行动计划第二批重点项目(编号:NMPAJGKX-2023-028)。

摘　　要：目的采用高效液相色谱法(HPLC)分别对更年宁中果糖、葡萄糖、蔗糖、麦芽糖及5-羟甲基糠醛进行测定,建立更年宁中辅料炼蜜的质量评价方法。方法糖类成分及5-羟甲基糠醛的测定分别选用示差折光检测器和紫外检测器(284 nm),流动相分别为乙腈-水(75:25)和乙腈-0.1%磷酸(5:95),色谱柱分别采用Prevail Carbohyrate ES和Agilent ZORBAX SB-C18,柱温分别为40℃和30℃,流速均为1 ml/min。结果果糖、葡萄糖、蔗糖、麦芽糖及5-羟甲基糠醛的方法学考察结果均符合规定。44批更年宁样品中果糖与葡萄糖的总量、蔗糖含量、麦芽糖含量及5-羟甲基糠醛含量分别为10.3%~36.2%,0.6%~4.6%,0~11.9%,0.01%~0.44%。更年宁样品中糖类成分和5-羟甲基糠醛含量存在明显差异。根据《中国药典》2020年版蜂蜜项下规定,拟定更年宁中糖类成分和5-羟甲基糠醛的限度,结果11批样品超出拟定限度。结论本方法简便、准确,可用于更年宁中辅料炼蜜的质量评价。Objective To determine fructose,glucose,sucrose,maltose and 5-hydroxymethylfurfural(5-HMF)in Gengnianning to establish a method for evaluation of the quality of refined honey in Gengnianning.Methods The separation was performed on a Prevail Carbohyrate ES column with the refractive index detector,using acetonitrile-water(75:25)as mobile phase for determination of the carbohydrate components.The Agilent ZORBAX SB-C18 column with UV detector(284 nm)was used for determination of 5-HMF,using acetonitrile-0.1%phosphoric acid(5:95)as mobile phase.The column temperature was set at 40℃and 30℃,respectively,and the flow rate were all 1 ml/min.Results The methodological investigation results of fructose,glucose,sucrose,maltose and 5-HMF all met the requirements.The total content of fructose and glucose and the contents of sucrose,maltose and 5-HMF in 44 batches of Gengnianning samples were 10.3%-36.2%,0.6%-4.6%,0-11.9%,0.01%-0.44%,respectively.There were obvious differences in the samples detection results of carbohydrate components and 5-HMF in Gengnianning.Based on the standard in Chinese Pharmacopoeia(2020 Edition),the quality limits of carbohydrate components and 5-HMF in Gengnianning were formulated.The results showed that 11 out of 44 samples exceeded the limits.Conclusion This method is simple and accurate,and can be used for the quality evaluation of refined honey in Gengnianning.

关 键 词：更年宁 炼蜜 果糖 葡萄糖 蔗糖 麦芽糖 5-羟甲基糠醛 高效液相色谱法 

分 类 号：R927.1[医药卫生—药学]