胆清胶囊质量标准研究.docVIP

胆清胶囊质量标准研究 　　【摘要】目的：建立胆清胶囊中虎耳草的薄层色谱鉴别及虎耳草中岩白菜素的含量测定方法。方法：采用薄层色谱法对胆清胶囊中虎耳草进行定性鉴别，采用高效液相色谱法测定虎耳草中岩白菜素的含量；色谱柱为Thermo C18（46mm×250mm，5μm）；流动相以乙腈为流动相A，以01%磷酸溶液为流动相B，采用梯度洗脱；流速1mL/min；柱温30℃；检测波长为275nm。结果：薄层色谱鉴别斑点清晰，阴性对照无干扰；岩白菜素在005048μg～070666μg范围中线性关系良好，r=09993，平均回收率为9801%，RSD为139%（n=6）。结论：所建立的方法简便、准确、重复性好，可用于胆清胶囊中虎耳草鉴别和岩白菜素的含量测定。 　　【关键词】 胆清胶囊；虎耳草；岩白菜素 　　【中图分类号】R2841【文献标志码】 A【文章编号】1007-8517（2017）11-0046-03 　　Study on Quality Standard of Danqing Capsule 　　CHANG Ling1WU Menglan2SHU Ke1WANG Dingbing3LONG Jiandan3ZHU Dan3 　　1.Guizhou Provincial Institute for Drug Control， Guiyang 550004，China；2.Qiandongnan Prefecture Food Drug Inspection Testing Center， Kaili 556000，China；3.Guizhou Shengjitang Pharmaceutical Co. Ltd.Guiyang 550004，China 　　Objective To establish a method for the determination of Danqing capsule in the Saxifraga stolonifera by TLC and the content of Bergenin in Saxifraga stolonifera. Methods The TLC method of Danqing capsule in in the Saxifraga stolonifera were identified， the content of Bergenin in Saxifraga stolonifera was determined by HPLC； column chromatography Thermo C18 （46mm×250mm，5μ）， flow phase： with acetonitrile as the mobile phase A， with 01% phosphoric acid as mobile phase B， the gradient elution， flow rate of 1ml/min， column temperature 30℃， detection wavelength was 275nm.Results TLC spots were clear， without the interference of negative control； Bergeninum in 005048μg～070666μg range linear relationship is good， r=09993. The average recovery rate was 9801%， RSD=139% （n=6）. Conclusion The established method is simple， accurate and with good reproducibility and can be used for the determination of the content of Bergenin in Saxifraga stolonifera in Danqing capsule and the identification of Saxifraga stolonifera. 　　Danqing Capsule； Saxifraga stolonifera； Bergenin 　　?清胶囊是按苗医理论组方的复方制剂，具有清热利湿、舒肝利胆的作用，临床用于肝胆湿热所致的脘胁疼痛、呃逆呕恶、口干口苦、大便秘结，以及胆囊炎、胆石症见上述证候者。胆清胶囊由虎耳草、凤尾草、大黄和牛胆汁四味药材组成[1]，方中虎耳草、凤尾草、大黄粉碎成最细粉备用，牛胆汁滤过，与上述最细粉混匀，制成颗粒，干燥，装入胶囊即得。原标准中只有大黄、牛胆汁及凤尾草的薄