山芝麻清感胶囊质量标准研究  

Study on the Quality Sandards of Radix Helicteris Qinggan Jiaonang

作　　者：沈泓佑 张颖 文志云 韦韡 Shen Hongyou;Zhang Ying;Wen Zhiyun;Wei Wei(Guangxi Institute of Traditional Chinese Medicine,Nanning 530022,China;Guangxi Key Laboratory of Quality Standard Research of Traditional Chinese Medicine,Nanning 530022,China)

机构地区：[1]广西壮族自治区中医药研究院,广西南宁530022 [2]广西中药质量标准研究重点实验室,广西南宁530022

出　　处：《亚太传统医药》2024年第9期24-28,共5页Asia-Pacific Traditional Medicine

基　　金：广西壮族自治区卫生厅中医药科技专项(GZZJ13-13)。

摘　　要：目的:建立山芝麻清感胶囊的质量标准。方法:首先采用薄层色谱法对处方中金银花和甘草进行定性鉴别。然后采用高效液相色谱法测定绿原酸的含量,色谱柱为appolo-C18键合硅胶柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.4%磷酸溶液(9∶91,V/V),检测波长为327 nm,柱温为室内温度,流速为1.0 mL/min,进样量为10μL,绿原酸计算理论塔板数应≥1000。结果:金银花和甘草的TLC斑点清晰,阴性无干扰,可作为定性方法。绿原酸在5.2~166.4μg/mL范围内呈线性关系(R2=0.9991,n=6)。平均加样回收率为98.5%~101.4%,RSD为0.99%(n=6)。精密度、稳定性、重复性试验结果的RSD均<2.0%,山芝麻清感胶囊每粒含绿原酸0.667 mg。结论:所建立的方法简便、准确、可靠,可用于山芝麻清感胶囊的质量控制。Objective:To establish a quality standard for Radix Helicteris Qinggan Jiaonang.Methods:First,Thin-layer chromatography(TLC)method was used to identify Lonicera japonica and liquorice in the prescription qualitatively.Then,High-performance liquid chromatography(HPLC)method was used for the content determination of Chlorogenic acid,the chromatographic column was appollo-C 18 bonded silica gel column(4.6 mm×250 mm,5μm),the mobile phases were acetonitrile-0.4%phosphoric acid solution(9∶91,V/V),the detection wavelengths were 327 nm,the column temperatures were indoor temperature,the flow rate was 1.0 mL/min,and the injection volume was 10μL.The number of theoretical plates calculated by chlorogenic acid should not be less than 1,000.Results:The TLC spots of Lonicera japonica and liquorice were clear without any interference from the negative references,which can be used as a qualitative method.The linear ranges of Chlorogenic acid were 5.2-166.4μg/mL(R 2=0.9991,n=6).The average recoveries of Chlorogenic acid were 98.5%-101.4%,RSD was 0.99%(n=6).The RSD s of precision,stability,and repeatability test results were all lower than 2.0%.Each 1 granule of Radix Helicteris qinggan jiaonang contained 0.667 mg of Chlorogenic acid.Conclusion:Theestablished method is simple,accurate and reliable,which can be used for the quality control of Radix Helicteris Qinggan Jiaonang.

关 键 词：山芝麻清感胶囊 金银花 甘草 绿原酸 

分 类 号：R284.1[医药卫生—中药学]