柏子养心丸中辅料炼蜜的质量研究  

Study on the Quality of Refined Honey in Baizi Yangxin Pills

作　　者：赵雯 袁铭铭 许妍 吴燕红 任琦 万林春 ZHAO Wen;YUAN Mingming;XU Yan;WU Yanhong;REN Qi;WAN Linchun(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌330029

出　　处：《药品评价》2020年第13期33-35,38,共4页Drug Evaluation

基　　金：江西省食品药品监督管理局科研项目(2017YP01)。

摘　　要：目的:采用HPLC-ELSD法对柏子养心丸中果糖、葡萄糖、麦芽糖进行测定,建立柏子养心丸中辅料炼蜜的质量评价方法。方法:采用Prevail Carbohydrate ES(250 mm×4.6 mm,5μm)色谱柱,流动相为乙腈-水(75∶25),流速1.0 mL/min,柱温30℃,漂移管温度60℃,载气(N2)流速1.8 L/min;以果糖和葡萄糖的总量、果糖、葡糖糖的总量与麦芽糖含量比值来判定柏子养心丸中辅料炼蜜的质量。结果:果糖、葡萄糖和麦芽糖的方法学考察结果均符合规定。根据《中国药典》(2015年版)蜂蜜项下的规定,拟定柏子养心丸辅料炼蜜中糖类成分的限度,26批样品中有5批样品超出拟定限度。结论:该法可用于柏子养心丸辅料炼蜜的质量考察。Objective:To adopt a HPLC-ELSD method to determine fructose,glucose,and maltose in Baizi Yangxin Pills as to establish a reliable quality evaluation method for refined honey in Baizi Yangxin Pills.Methods:A chromatographic column of Prevail Carbohydrate ES(250 mm×4.6 mm,5μm)was adopted.The mobile phase was the mixture of acetonitrile-water(75∶25)at a flow rate of 1.0 L/min with the column temperature set at 30℃.The drift tube temperature was taken at 60℃,the carrier gas flow rate at 1.8 L/min.The total content of fructose and glucose,and the total content of fructose and glucose-maltose ratio were considered as quality indexes.Results:The methodological results of fructose,glucose and maltose were in accordance with the regulations.Based on the honey standard in Chinese Pharmacopoeia(2015),the quality limits of carbohydrate components in refined honey were drawn up.5 of the 26 batches exceeded the limits.Conclusion:The method could be applied to the quality control of refined honey in Baizi Yangxin pills.

关 键 词：柏子养心丸 炼蜜 果糖 葡萄糖 麦芽糖 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]