RP-HPLC-DAD法在复方黄柏液涂剂质量控制方面的研究.docxVIP

RP- HPLC-DAD法在复方黄柏液涂剂质量控制方面的研究 王玉团，许丽丽，徐丽华 （山东省食品药品检验研究院，济南 250101） 摘要：目的：针对通过分析复方黄柏液涂剂现行标准存在的缺陷，提高和完善其进而采用RP-HPLC-DAD法进行质量控制方法研究，达到定性定量研究的目的。方法：采用RP-HPLC-DAD法建立了复方黄柏液涂剂中连翘、黄柏、金银花、蒲公英统一的液相色谱分析条件，通过与对照药材和对照品的谱图比较，选择了13个色谱峰，进行了色谱峰的来源归属及连翘苷和盐酸小檗碱的含量测定。结果：复方黄柏液涂剂中存在与连翘、黄柏、金银花、蒲公英的对照药材以及连翘苷和盐酸小檗碱对照品相对应的色谱峰，可以实现上述药材的定性鉴别及上述对照品的含量测定。结论：该方法简便、准确、可行、，是复方黄柏液涂剂的质量评价的一种合理、有效的技术手段。 关键词：反相高效液相色谱-二极管阵列检测RP-HPLC-DAD；复方黄柏液涂剂；定性；定量 Quality Control Research i on Quality Control of Fufang Huangbaiye Tuji by RP-HPLC-DAD WangANG Yutuan *，XuU Lili，XuU Lihua （Shandong Institute For Food?And?Drug?Control，Jinan 250101） Abstract Objective OBJECTIVE: To improve the quality control method of Fufang Huangbaiye Tuji Bby analyzing the defects in current standard. of Fufang Huangbaiye Tuji,using RP-HPLC-DAD to study the quality control for distinguish and determination. Methods METHODS: A RP-HPLC-DAD method was adopted and Establish an uniform liquid chromatography analysis conditions for Forsythiae fructus suspensa、, Phellodendrion chinensise cortex、,Lonicerae japonicae flos and Taraxaci herbaum mongolicum in Fufang Huangbaiye Tuji were established by using RP-HPLC-DAD. By comparing the spectra of Ccontrol medicinal herbs and reference materials, we choose 13 chromatographic peaks finally,then study the sources and attribution of chromatographic peaks were studied, determine the contents of phillyrin and berberine hydrochloride were determined. Results RESULTS: There wereare corresponding chromatographic peaks between aboved the standand materials and Fufang Huangbaiye Tuji ,it can be used tofor distinguish the above medical materials and assay determination of phillyrin and berberine. Conclusion CONCLUSIONS: Theis method is simple accurate and accurate reliable,it is an reasonable and effective technical means ofor quality evaluation ofor Fufang Huangbaiye Tuji. Key words: [KEY WORDS] RP-HPLC-DAD; Fufang Huangbaiye Tuji; distinguish ; Ddetermination; 复方黄柏液涂液剂（复方黄柏液）主要有由连翘、黄柏、金银花、蒲公英和蜈蚣五味药组成，具