HPLC法测定扶正化瘀片中五味子醇甲、乙含量  

Determination of schisandrol A and B in Fuzheng Huayu tablets by HPLC

作　　者：张玉杰 谢富玲 付庆帅 李荣胜 潘一峰 ZHANG Yujie;XIE Fuling;FU Qingshuai;LI Rongsheng;PAN Yifeng(Shanghai Huanghai Pharmaceutical Co.Ltd.,Shanghai 200942,China;Shanghai Sundise Chinese Medicine Co.Ltd.,Shanghai 200050,China)

机构地区：[1]上海黄海制药有限责任公司,上海200942 [2]上海现代中医药股份有限公司,上海200050

出　　处：《上海医药》2022年第13期103-106,共4页Shanghai Medical & Pharmaceutical Journal

基　　金：上海市国际科技合作基金项目科研计划项目“扶正化瘀片临床前安全性研究(18400731400)”。

摘　　要：目的:建立HPLC法同时测定扶正化瘀片中五味子醇甲、乙含量的方法,为扶正化瘀片的质量标准提升提供参考依据。方法:采用Agilent Zorbax Extend C18柱对五味子醇甲和五味子醇乙进行HPLC分析,流动相为甲醇-水,梯度洗脱;流速1.0 mL/min;柱温30℃;检测波长250 nm。结果:五味子醇甲、乙质量浓度分别在0.0240~1.2034 mg/mL(r=0.9999)、0.0157~0.7845 mg/mL(r=0.9999)范围内线性关系良好,平均加样回收率分别为105.63%(RSD 0.90%、n=9)、103.24%(RSD 3.81%、n=9)。结论:该方法准确稳定,重复性好,适用于扶正化瘀片中五味子醇甲、乙的质量控制。Objective:An HPLC method was established for the content determination of schisandrol A and B in Fuzheng Huayu tablets,so as to provide reference for the improvement of the quality standard.Methods:An HPLC for the determination of schisandrol A and B was performed on an Agilent Zorbax Extend C18 column with the mobile phase comprising of methanol-water flowing at 1.0 mL/min in a gradient elution manner at the detection wavelengths of 250 nm and column temperature of 30℃.Results:The schisandrol A and B showed a good linearity in the range of 0.0240-1.2034 mg/mL(r=0.9999)and 0.0157-0.7845 mg/mL(r=0.9999),respectively.The average recoveries were 105.63%(RSD 0.90%,n=9)for schisandrol A and 103.24%(RSD 3.81%,n=9)for schisandrol B.Conclusion:This method is accurate,stable and repeatable and is suitable for the quality control of schisandrol A and B in Fuzheng Huayu tablets.

关 键 词：HPLC 扶正化瘀片 五味子醇甲 五味子醇乙 

分 类 号：R927.2[医药卫生—药学] R286