杞菊地黄口服液质量控制研究  

Study on Quality Control of Qiju Dihuang Oral Liquid

作　　者：南荣华 张娜 康小凤 贾萌 黄艳 NAN Ronghua;ZHANG Na;KANG Xiaofeng;JIA Meng;HUANG Yan(Shaanxi Provincial Institute of Food and Drug Control,Xi'an,Shaanxi 710065,China;Shaanxi Medical Devices Quality Tasting Institute,Xixian New Area,Shaanxi712046,China;Key Laboratory of Drug Microbiological Detection Technology of State Drug Administration,Xi'an,Shaanxi 710065,China)

机构地区：[1]陕西省食品药品检验研究院,陕西西安710065 [2]陕西省医疗器械质量检验院,陕西西咸新区712046 [3]国家药品监督管理局药品微生物检测技术重点实验室,陕西西安710065

出　　处：《药品评价》2022年第11期648-651,共4页Drug Evaluation

摘　　要：目的:建立杞菊地黄口服液中没食子酸、绿原酸、莫诺苷、马钱苷、木犀草苷、丹皮酚的高效液相色谱测定方法,对制剂质量进行分析和评价。方法:色谱柱为安捷伦C18柱(4.6 mm×250 mm,5μm),以乙腈和0.1%甲酸溶液为流动相,梯度洗脱,流速为1.0 mL/min,柱温40℃,检测波长为240 nm和328 nm。结果:没食子酸、绿原酸、莫诺苷、马钱苷、木犀草苷、丹皮酚进样量在0.0566~1.1314μg、0.0233~0.4668μg、0.1510~3.0194μg、0.1425~2.8490μg、0.0208~0.4156μg、0.1500~3.0010μg范围内线性关系良好,平均加样回收率为:95.5%,93.2%,101.6%,100.3%,96.7%,98.2%。结论:此方法可同步测定六种成分的含量,同时一定程度评价市售样品的质量,为科学规范生产及质量评价提供新方法。Objective:To establish an HPLC method for the determination of gallic acid,chlorogenic acid,morroniside,loganin,luteoloside,paeonol content of qiju dihuang oral liquid,analyze and evaluate the quality of the preparation.Method:The determination was performed on a Agilent C18 column(4.6 mm×250 mm,5μm)with acetonitrile-0.1%formic acid solution as mobile phase gradient elution with a flow rate of 1.0 mL/min.The column temperature was set to 40℃,and the detection wavelength was 240 nm and 330 nm.Results:The gallic acid,chlorogenic acid,morroniside,loganin,luteoloside,paeonol Injection quality had good linear relationship in the ranges of 0.0566-1.1314μg,0.0233-0.4668μg,0.1510-3.0194μg,0.1425-2.8490μg,0.0208~0.4156μg,0.1500~3.0010μg,the average recoveries were 95.5%,93.2%,101.6%,100.3%,96.7%,98.2%.Conclusion:This method can simultaneously measure the content of six components.At the same time,the quality of the commercially available samples was evaluated to a certain extent,provide a new method for scientifically standardizing production and quality evaluation.

关 键 词：色谱法 高效液相 没食子酸 绿原酸 莫诺苷 马钱苷 木犀草 丹皮酚 杞菊地黄口服液 质量控制 

分 类 号：R286.0[医药卫生—中药学]