HPLC测定清胃黄连丸的体外溶出度  

Dissolution study of Qingwei Huanglian pill in vitro by HPLC

作　　者：李宝红[1] 韩芸[2] 吴君[3] 邓妙丽[1] 吴劲东[1] 

机构地区：[1]广东医学院药学院,广东东莞523808 [2]广州中医药大学,广东广州510405 [3]山东中医药高等专科学校,山东烟台264199

出　　处：《华西药学杂志》2013年第1期77-79,共3页West China Journal of Pharmaceutical Sciences

基　　金：2009年广东省自然科学基金项目(编号:9152402301000025)

摘　　要：目的以栀子苷、盐酸小檗碱为指标,采用RP-HPLC法研究清胃黄连丸的体外溶出度。方法模拟体外胃肠道溶出实验方法,HPLC法采用Diamonsil C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.5%三乙胺水溶液(磷酸调pH2.8),梯度洗脱,检测波长230 nm,流速1.0 mL.min-1。结果 3批样品中栀子苷、盐酸小檗碱在4 h内均基本溶出且溶出百分数均超过80%,溶出曲线与Weibull分布曲线拟合度较好,r分别为0.9895、0.9945;栀子苷、盐酸小檗碱的T50分别为35、40 min。结论所用方法准确、可靠、简便,适用于清胃黄连丸体外溶出度研究,同时也可用于该制剂的质量研究。OBJECTIVE To study the dissolution of jasminoidin and berberine from the preparation of Qingwei Huanglian pill by HPLC.METHODS The dissolution of Qingwei Huanglian pill in gastrointestinal tract in vitro was simulated.The HPLC method was developed by using a Diamonsil column（250 mm×4.6 mm,5 μm）,with acetonitrile and 0.5% triethylamine（adjusting the pH to 2.8 with phosphoric acid） as mobile phases,gradient elution at the flow rate of 1.0 mL·min-1,and 230 nm as ultraviolent detector wavelength.RESULTS More than 80% jasminoidin and berberine were dissolved from the preparation of Qingwei Huanglian pill within 4 hours in triplicate.The dissolution curves pertained to Weibull distribution curve and the coefficient correlations for Jasminoidin and berberine were 0.9895 and 0.9945,respectively.Moreover,the T50 for jasminoidin and berberine were 35 and 40 min,respectively.CONCLUSION The method is accurate,simple and reliable,which can be applied to investigate the dissolution of Qingwei Huanglian pill as well as control to the quality of this preparation.

关 键 词：反相高效液相色谱法 清胃黄连丸 栀子苷 盐酸小檗碱 体外溶出度 

分 类 号：R917[医药卫生—药物分析学]