人参归脾丸质量标准研究  

Quality Standard for Renshen Guipi Pills

作　　者：李正刚 李本淳 王路宏[1] 王丹彧 赵艳 马彧[1] LI Zhenggang;LI Benchun;WANG Luhong;WANG Danyu;ZHAO Yan;MA Yu(Siping Institute for Food and Drug Control,Siping Jilin,136000,China;Jilin Institutes for Drug Control)

机构地区：[1]四平市食品药品检验所,吉林四平136000 [2]吉林省药品检验研究院

出　　处：《质量安全与检验检测》2022年第3期128-131,共4页QUALITY SAFETY INSPECTION AND TESTING

基　　金：吉林省科技发展项目-医药健康领域-重点研发(20210204151YY)。

摘　　要：为建立人参归脾丸的质量控制方法,本文采用TLC法定性鉴别处方中木香、当归、人参3味药材,采用高效液相色谱法(HPLC-ELSD)测定黄芪甲苷含量。采用Zafex Supfex JX-C18色谱柱(4.6 mm×250 mm,5μm);以乙腈—水为流动相,梯度洗脱;流速为1.0 mL/min;柱温为30℃;漂移管温度90℃,载气流量1.5 L/min。结果显示,TLC斑点清晰,阴性无干扰;黄芪甲苷进样量在0.985μg~9.845μg范围内,线性关系良好(r=0.9998);平均加标回收率为99.0%,RSD为3.4%(n=6)。由此可见,该方法专属性强、重复性好,可作为人参归脾丸的质量控制方法。In order to establish a quality control method for Renshen Guipi pills,three medicinal materials in the prescription were identified by TLC,and the content of astragaloside IV was determined by HPLC-ELSD.Zafex Supfex JX-C18 column(4.6 mm×250 mm,5μm);acetonitrile water as mobile phase,gradient elution;the flow rate is 1.0 mL/min;the column temperature is 30℃;the drift tube temperature is 90℃,and the carrier gas flow is 1.5 L/min.The results showed that TLC spots were clear and negative without interference;Astragaloside IV injection amount is 0.985μg-9.845μg,the linear relationship is good(r=0.9998);The average recovery was 99.0%and RSD was 3.4%(n=6).It can be seen that this method has strong specificity and good repeatability,and can be used as a quality control method for Renshen Guipi pills.

关 键 词：人参归脾丸 高效液相色谱 蒸发光散射 薄层鉴别 黄芪甲苷 

分 类 号：R917[医药卫生—药物分析学]