冠心苏合丸辅料炼蜜的质量研究  

Study on Quality of Refined Honey in Guanxin Suhe Pills

作　　者：黄晓婧 刘莉 曾桢 肖春霞 赵小勤 李婷婷 HUANG Xiao-jing;LIU Li;ZENG Zhen;XIAO Chun-xia;ZHAO Xiao-qin;LI Ting-ting(Chengdu Institute for Drug Control/NMPA Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine,Chinese Materia Medica,Sichuan Chengdu 610045,China)

机构地区：[1]成都市药品检验研究院,中药材质量监测评价重点实验室,四川成都610045

出　　处：《中国药物评价》2021年第4期299-304,共6页Chinese Journal of Drug Evaluation

基　　金：2018年国家药品计划抽验项目(食药监药化监<2017>131号,中央补助地方经费项目)。

摘　　要：目的:建立冠心苏合丸中辅料炼蜜质量评价方法,对样品中炼蜜质量进行考察。方法:采用HPLC-ELSD法分别测定果糖、葡萄糖、蔗糖、麦芽糖的含量及寡糖的定性检测。以Prevail Carbohyrate ES(4.6 mm×250 mm,5μm)为色谱柱;流动相分别为乙腈-水(75∶25)和乙腈(A)-水(B)的梯度洗脱;柱温为30℃;流速均为1 mL·min^(-1)。结果:果糖、葡萄糖、蔗糖、麦芽糖及寡糖的测定方法学考察符合规定,参照《中国药典》2020年版蜂蜜项下的规定拟定限度,9家生产企业共24批次中有1批次果糖、葡萄糖总量低于拟定限度,麦芽糖含量超过拟定限度。结论:该方法操作简便,可用于冠心苏合丸中辅料炼蜜的质量考察。Objective:To Establish a method for evaluating the quality of refined honey in Guanxin Suhe Pills and inspect the quality of refined honey in samples.Methods:HPLC-ELSD method was used to determine the content of fructose,glucose,sucrose,and maltose and the qualitative detection of oligosaccharides.Prevail Carbohyrate ES(250×4.6mm,5μm)was used as the chromatographic column.The mobile phases were acetonitrile-water(75∶25)and with a gradient elution program usingacetonitrile(A)-water(B).The column temperature was 30℃.Both were 1 mL·min^(-1).Results:The methodological investigation of the determination of fructose,glucose,sucrose,maltose and oligosaccharides complied with the regulations,and the limits were drawn up with reference to the provisions of the Chinese Pharmacopoeia 2020 edition of honey.Among the 24 batches of 9 production enterprises,1 batch of total fructose and glucose was lower than the planned limit,and the content of maltose exceeded the planned limit.Conclusion:This method is easy to operate and can be used to investigate the quality of refined honey in Guanxin Suhe Pills.

关 键 词：冠心苏合丸 HPLC-ELSD法 炼蜜 

分 类 号：R284[医药卫生—中药学]