柴胡饮片中非药用部位地上茎限量控制方法研究  

Study on Limit Control Method of Non-Medicinal Part of the Stem of Radix Bupleurum Medicinal

作　　者：郭晓霞 李欣 张平 王娟弟 李冬华 张明童 马潇 宋平顺 Guo Xiaoxia;Li Xin;Zhang Ping;Wang Juandi;Li Donghua;Zhang Mingtong;Ma Xiao;Song Pingshun(Gansu Institute for Drug Control,Lanzhou 730070,China;NMPA Key Laboratory for Quality Control of TCM,Lanzhou 730070,China)

机构地区：[1]甘肃省药品检验研究院,甘肃兰州730070 [2]国家药品监督管理局中药材及饮片质量控制重点实验室,甘肃兰州730070

出　　处：《亚太传统医药》2023年第7期48-51,共4页Asia-Pacific Traditional Medicine

基　　金：国家药品监督管理局中药材及饮片质量控制重点实验室项目(2021GSMPA-KL06);兰州市科技计划项目(2022-3-41);甘肃省药品监督管理局项目(2023GSMPA0020,2022GSMPA0017)。

摘　　要：目的:采用HPLC法建立柴胡饮片中地上茎杂质超标的检测方法。方法:选用SVEA 5μm C_(18)色谱柱(4.6 mm×250 mm,5μm);流动相为乙腈(A)-0.1%磷酸溶液(B),进行梯度洗脱,流速1.0 mL/min;进样量:10μL,检测波长330 nm,柱温:25℃。结果:3,5-O-二咖啡酰基奎宁酸对照品回归方程r和线性范围均符合要求,其线性关系良好;精密度、稳定性、重复性的RSD分别为0.06%、1.4%、1.0%,表明仪器精密度、稳定性、重复性良好。结论:该方法稳定可靠,分离度、重复性较好,可应用于柴胡饮片中地上茎杂质超标的检测方法。Objective:HPLC method was used to establish the detection method of overstandard of Radix Bupleurum.Methods:The chromatographic column was SVEA 5μm C_(18)(4.6mm×250mm,5μm);The mobile phase was acetonitrile(A)-0.1%phosphoric acid(B)gradient elution,and the flow rate was 1.0mL/min.Injection volume:10μL,the detection wavelength was 330nm;The column temperature was 25℃.Results:The correlation coefficients and linear range of the regression equations of 3,5-O-Dicaffeoylquinic Acid was good.The RSD of precision,stability,repeatability was 0.06%,1.4%,1.0%,it shows good precision,stability and repeatability.Conclusion:The method was stable and reliable,with good separation and repeatability,and could be applied to the detection of overground part of Radix Bupleurum.

关 键 词：柴胡饮片 HPLC 3 5-O-二咖啡酰基奎宁酸 

分 类 号：R284.1[医药卫生—中药学]