肠安片质量控制研究  

Study on the quality control of Chang′an Tablets

作　　者：程立方[1] 闫雪生[1] 郭威[1] 

机构地区：[1]山东省中医药研究院,山东济南250014

出　　处：《药学研究》2013年第1期6-9,共4页Journal of Pharmaceutical Research

基　　金：山东省中医药科技发展计划(编号2009-136)

摘　　要：目的建立肠安片质量标准。方法采用薄层层析法对制剂中各味药物进行鉴别;采用高效液相色谱法,Diamosil C18(4.6 mm×250 mm,5μm)色谱柱,乙腈-0.05 mol.L-1磷酸二氢钾溶液(45∶55)为流动相,对制剂中的盐酸小檗碱含量进行测定。结果建立了本制剂中白头翁、黄连、木香、苦参的薄层层析鉴别方法,建立了本制剂中盐酸小檗碱的高效液相色谱含量测定方法。结论建立的薄层鉴别和含量测定方法,具有灵敏度高、专属性强等特点,可用于肠安片的质量控制。Objective To establish the quality standard of Chang＇an Tablets. Methods Each of the drug in Chang＇an Tablets were identified by TCL and the content of berberine hydrochloride was determined by HPLC, using Diamosil C18 （ 4. 6 mm × 250 mm ,5μm） column with a mobile phase of acetonitrile -0.05 mol·L-1 potassium dihydrogen phosphate solu- tion （ 45 ： 5 ）. Results The TLC method for identification of pulsatillae radix, eoptidis rhizoma, aueklandiae radix, radix so- phorae fiavescentis and the HPLC method for determination of berberine hydrochloride were established. Conclusion The established identification and determination method was sensitive and specific, and it can be used for quality control of Chang＇an Tablets.

关 键 词：肠安片 薄层鉴别 高效液相色谱 盐酸小檗碱 含量测定 

分 类 号：R927.1[医药卫生—药学]