黄芪三七合剂质量标准研究  被引量:4

Quality Standard of Huangqi Sanqi Mixture

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作  者:张仕瑾 兰杨 王娅俐 赵茂林 郭廷东[1] 张燕[1] 唐志立[1] 谢席胜[3] ZHANG Shijin;LAN Yang;WANG Yali;ZHAO Maolin;GUO Tingdong;ZHANG Yan;TANG Zhili;XIE Xisheng(The Second Clinical Medical College of North Sichuan Medical College·Department of Pharmacy,Nanchong Central Hospital·Nanchong Key Laboratory of Individualized Drug Therapy,Sichuan,China 637700;School of Medical Imaging,North Sichuan Medical College,Nanchang,Sichuan,China637000;The Second Clinical Medical College of North Sichuan Medical College·Department of Nephrology,Nanchong Central Hospital,Nanchang,Sichuan,China637000)

机构地区:[1]川北医学院第二临床医学院·四川省南充市中心医院药学部·个体化药物治疗南充市重点实验室,四川南充637000 [2]川北医学院医学影像学院,四川南充637100 [3]川北医学院第二临床医学院·四川省南充市中心医院肾内科,四川南充637000

出  处:《中国药业》2021年第6期58-61,共4页China Pharmaceuticals

基  金:四川省科技厅科技计划项目[21ZDYF2053];四川省教育厅科研计划项目[18ZB0223];四川省中医药管理局中医药科研专项[2018QN026,2018YY007];四川省南充市哲学社会科学重点研究基地项目[YAZX19-Z-04,YAZX19-Y-02];四川省南充市市校合作科研专项[NSMC20170109,18SXHZ0453];川北医学院科研发展计划项目[CBY18-A-YB32]。

摘  要:目的建立黄芪三七合剂的质量标准。方法采用薄层色谱法对制剂中黄芪、三七、当归进行定性鉴别;采用高效液相色谱法测定人参皂苷Rg1含量,色谱柱为Shimadzu C18柱(150 mm×4.6 mm,5μm),流动相为乙腈-水(19∶81,V/V),流速为1.0 m L/min,检测波长为203 nm,柱温为35℃,进样量为10μL。结果黄芪、三七、当归薄层色谱图中,斑点清晰,阴性对照无干扰。人参皂苷Rg1质量浓度在0.178~0.890μg/m L范围内与峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于2.0%;平均加样回收率为99.30%,RSD为1.10%(n=6)。结论所建立的定性、定量方法专属性强,操作简单,重复性好,可用于黄芪三七合剂的质量控制。Objective To establish the quality standard of Huangqi Sanqi Mixture.Methods Thin-layer chromatography(TLC)was adopted for the qualitative identification of Astragali Radix,Notoginseng Radix et Rhizoma and Angelicae Sinensis Radix.High-performance liquid chromatography(HPLC)was adopted for the content determination of ginsenoside Rg1,the chromatographic column was Shimadzu C18 column(150 mm×4.6 mm,5μm),the mobile phase was acetonitrile-water(19∶81,V/V),the flow rate was 1.0 m L/min,the detection wavelength was 203 nm,the column temperature was 35℃,and the injection volume was 10μL.Results The TLC chromatograms of Astragali Radix,Notoginseng Radix et Rhizoma and Angelicae Sinensis Radix had clear spots and no negative interference.The linear range of ginsenoside Rg1 was 0.178-0.890μg/m L.The RSDs of precision,stability and repeatability tests were less than 2.0%.The average recovery of ginsenoside Rg1 was 99.30%with RSD of 1.10%(n=6).Conclusion The established qualitative and quantitative methods are specific,simple and reproducible,which can be used for the quality control of Huangqi Sanqi Mixture.

关 键 词:黄芪三七合剂 薄层色谱法 高效液相色谱法 人参皂苷RG1 质量标准 

分 类 号:R932[医药卫生—生药学] R284.1[医药卫生—药学]

 

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