痰咳净片质量标准改进研究  

Study on improvement of quality standards for Tankejing Tablets

作　　者：康小凤 南荣华 刘嘉澍 王梦琪 李青 黄艳 KANG Xiaofeng;NAN Ronghua;LIU Jiashu;WANG Mengqi;LI Qing;HUANG Yan(Department of Traditional Chinese Medicine,Shaanxi Institute for Food and Drug Control,Shaanxi,Xi'an 710065,China)

机构地区：[1]陕西省食品药品监督检验研究院中药室,陕西西安710065

出　　处：《中国医药科学》2021年第19期75-79,共5页China Medicine And Pharmacy

基　　金：国家药典委员会药品标准制修订研究课题(2018Z053)。

摘　　要：目的完善痰咳净片的质量标准。方法采用薄层色谱(TLC)法对甘草、桔梗进行定性鉴别;采用高效液相色谱(HPLC)法测定甘草中甘草酸的含量及咖啡因的含量。结果定性鉴别方法斑点清晰,专属性强。甘草酸在0.091~2.278μg范围内与峰面积积分值线性关系良好(r=0.99999),平均回收率为96.98%,RSD为2.88%(n=6);咖啡因进样量在0.2262~0.9048μg范围内与峰面积积分值线性关系良好(r=0.99999),平均回收率为98.21%,RSD为1.77%(n=6)。结论改进后的质量标准可行,可用于痰咳净片的质量控制。Objective To improve the quality standards for Tankejing Tablets.Methods Thin layer chromatography(TLC)was used for qualitative identification of licorice and platycodon,and high performance liquid chromatography(HPLC)was used to determine the content of glycyrrhizic acid and caffeine in licorice.Results The qualitative identification method had strong specificity,showing clear spots.Glycyrrhizic acid in the range of 0.091~2.278μg showed a good linear relationship with the integration value of peak area(r=0.99999),with an average recovery rate of 96.98%and RSD of 2.88%(n=6).Caffeine injection volume in the range of 0.2262~0.9048μg showed a good linear relationship with the integration value of peak area(r=0.99999),with an average recovery rate of 98.21%and RSD of 1.77%(n=6).Conclusion The improved quality standards are feasible and can be used for the quality control of Tankejing Tablets.

关 键 词：痰咳净片 薄层色谱鉴别 甘草酸 咖啡因 HPLC法 质量标准 

分 类 号：R286[医药卫生—中药学]