HPLC法用于止血养元口服液中蒙花苷和人参皂苷Rg1的含量测定

Content determination of buddleoside and ginsenoside Rg1 in Zhixue Yangyuan Oral Liquid by HPLC

目的建立止血养元口服液中蒙花苷和人参皂苷Rg1含量的高效液相色谱(HPLC)测定方法。方法采用HPLC对小蓟中蒙花苷和人参中人参皂苷Rg1进行含量测定。小蓟中蒙花苷的含量测定:流动相为甲醇-0.5%醋酸溶液(50∶50),检测波长为326 nm。人参中人参皂苷Rg1的含量测定:流动相为乙腈-水(20∶80),检测波长为203 nm。结果蒙花苷在5～160μg/mL范围内与峰面积呈良好的线性关系(r=0.9997),平均加样回收率为97.73%,RSD=2.01%(n=6)。人参皂苷Rg1在0.025～0.8 mg/mL范围内与峰面积呈良好的线性关系(r=0.9998),平均加样回收率为98.62%,RSD=2.48%(n=6);3批样品含量测定结果均符合要求。结论本研究所用含量测定方法简单准确、重现性好,能有效控制止血养元口服液的药品质量。

Objective To establish high-performance liquid chromatography(HPLC)method for the content determination of buddleoside and ginsenoside Rg1 in Zhixue Yangyuan Oral Liquid.Methods HPLC was used to determine the content of buddleoside in Herba Cirsii and ginsenoside Rg1 in Radix Ginseng.The content of buddleoside in Herba Cirsii was determinated with mobile phase consisted of methanol-0.5%acetic acid water(50∶50).The detection wavelength was set at 326 nm.The content of ginsenoside Rg1 in Radix Ginseng was determinated with mobile phase consisted of acetonitrile-water(20∶80).The detection wavelength was set at 203 nm.Results There was a good linear relationship between buddleoside and peak area in the range of 5-160μg/mL(r=0.9997)with an average recovery of 97.73%,RSD=2.01%(n=6).There was a good linear relationship between ginsenoside Rg1 and peak area in the range of 0.025-0.8 mg/mL(r=0.9998)with an average recovery of 98.62%,RSD=2.48%(n=6).The content determination results of the three batches of samples all met the requirements.Conclusion The method is simple,accurate and reproducible.It is effective in controlling the quality of Zhixue Yangyuan Oral Liquid.