通便灵胶囊中松果菊苷的含量测定及质量情况分析  

Content Determination and Quality Analysis of Echinacoside in Tongbianling Capsules

作　　者：谢秉湘 朱环 张丽萍 李志梅 XIE Bingxiang;ZHU Huan;ZHANG Liping;LI Zhimei(Wenzhou Institute for Food and Drug Control,Wenzhou Zhejiang 325000,China.)

机构地区：[1]温州市食品药品检验科学研究院,浙江温州325000

出　　处：《药品评价》2022年第8期457-461,共5页Drug Evaluation

基　　金：温州市基础性医疗卫生科技项目(Y20211067);温州市基础性医疗卫生科技项目(Y20210237);浙江省市场监督管理局雏鹰计划核心项目(CY2022227);温州市基础性农业科技项目(N20210002)。

摘　　要：目的:建立通便灵胶囊中肉苁蓉有效成分松果菊苷的含量测定方法,了解通便灵胶囊的整体质量情况,保障公众用药安全有效。方法:采用高效液相色谱法(HPLC)测定松果菊苷的含量,流动相为甲醇-0.1%甲酸溶液,梯度洗脱,检测波长为340 nm。结果:松果菊苷在2.867~286.742μg/mL之间呈良好的线性关系(r=0.9999),回收率为102.1%,RSD为0.8%。通过对45批次通便灵胶囊的松果菊苷含量测定,发现各批次之间质量状况存在差异,提示部分生产厂家存在少投或用劣质药材(饮片)投料的现象。结论:该方法操作简便、结果准确,为通便灵胶囊的全面质量控制提供了科学依据。Objective:To establish the method for determining the content of Cistanche deserticola Y.C.Ma active ingredient echinacoside in tongbianling capsules,so as to know the overall quality condition of tongbianling capsules and ensure safe and effective drug use for the public.Methods:High performance liquid chromatography(HPLC)was performed to determining the content of echinacoside,where the mobile phase methanol-0.1%formic acid solution and detection wavelength 340 nm.Results:Echinacoside showed linear relationship with the peak area at 2.867-286.742μg/mL(r=0.9999),and the average recovery rate was 102.1%,RSD=0.8%.Through the determination of echinoside in 45 batches of tongbenling capsules,echinacoside were subject to considerable batch-to-batch variation,it was found that some producers input only a few or even poor medicinal materials(medicinal slices)during production.Conclusion:The results indicated that this method for tongbianling capsules control quality detection has high sensitivity,precision,and a simplified operation protocol.

关 键 词：通便灵胶囊 肉苁蓉 松果菊苷 高效液相色谱法 

分 类 号：R286.0[医药卫生—中药学]