速效止泻胶囊定性定量检测方法研究  

Study on qualitative and quantitativedetection method for Suxiao Zhixie capsules

作　　者：刘文炜[1] 刘建华[1] 李凤[1] 高玉琼[1] 霍昕[1] 杨廼嘉[1] 

机构地区：[1]贵州省生物技术研究开发基地,贵阳550002

出　　处：《药物分析杂志》2012年第5期887-891,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立速效止泻胶囊的定性定量检测方法。方法:采用TLC法鉴别速效止泻胶囊中盐酸小檗碱和拳参;采用HPLC法测定处方中盐酸小檗碱含量及拳参中绿原酸含量。盐酸小檗碱色谱条件:依利特Hypersil ODS2(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.05 mol·L-1磷酸二氢钾溶液-三乙胺(40∶60∶0.1)为流动相,流速1 mL·min-1,紫外检测波长346 nm,柱温为30℃;绿原酸色谱条件:依利特Hypersil ODS2(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.01 mol·L-1磷酸二氢钾溶液-三乙胺-磷酸(7∶93∶0.4∶0.3)为流动相,流速1 mL·min-1,紫外检测波长327 nm,柱温为30℃。结果:盐酸小檗碱和拳参薄层色谱定性鉴别特征明显;盐酸小檗碱与绿原酸含量测定,分别在2.0～6.0μg(r=0.9992)和0.1～1.8μg(r=0.9999)线性关系良好;平均回收率(n=6)分别为99.2%和102.3%,RSD分别为0.77%和1.3%。结论:本法可准确地定性、定量,有效地控制速效止泻胶囊的质量。Objective：To establish the qualitative and quantitative detection method for Suxiao Zhixie capsules.Methods：Berberine hydrochloride and Bistortae Rhizoma in this preparation were identified by TLC.The contents of berberine hydrochloride and chlorogenic acid from Bistortae Rhizoma were determined by HPLC.The separation of berberine hydrochloride was performed on Hypersil ODS2（4.6 mm×250 mm,5 μm）column,the mobile phase consisted of acetonitrile-0.05 mol·L-1 monopotassium phosphate-triethylamine（40∶60∶0.1）with the flow rate of 1.0 mL·min-1,and UV detection wavelength was 346 nm and column temperature was 30 ℃;The separation of chlorogenic acid was performed on Hypersil ODS2（4.6 mm×250 mm,5 μm）,the mobile phase consisted of acetonitrile-0.01 mol·L-1 monopotassium phosphate-triethylamine-phosphoric acid（7∶93∶0.4∶0.3）with the flow rate of 1.0 mL·min-1,and UV detection wavelength was 327 nm and column temperature was 30 ℃.Results：The TLC showed obvious features for the identification of berberine hydrocholoride and Bistoreae Rhizoma;Good linearities were obtained over the ranges of 2.0-6.0 μg（r=0.9992）for berberine hydrochloride,and 0.1-1.8 μg（r=0.9999）for chlorogenic acid;The average recoveries（n=6）of berberine hydrochloride and chlorogenic acid were 99.2%（RSD=0.77%）and 102.3%（RSD=1.3%）.Conclusion：The methods of qualitative and quantitative analysis are accurate,and suitable for effectively quality control of Suxiao Zhixie capsules.

关 键 词：中西药复方制剂 速效止泻胶囊 盐酸小檗碱 拳参 绿原酸 薄层色谱 高效液相色谱 抗菌药物 质量控制 标准完善 

分 类 号：R917[医药卫生—药物分析学]