Quality standard study on Dictamni Cortex  

白鲜皮质量标准研究（英文）

作　　者：王玲[1] 赵明波[1] 姜勇[1] 屠鹏飞[1] 郭晓宇[1] 

机构地区：[1]北京大学医学部药学院天然药物及仿生药物国家重点实验室,北京100191

出　　处：《Journal of Chinese Pharmaceutical Sciences》2017年第4期298-303,共6页中国药学（英文版）

基　　金：Program of Ligusticum Chuanxiong etc.100 kinds of Herbs Recommended International Quality Standards(Grant No.201307002);the Safety Testing Technology and Standard Platform of Traditional Chinese Medicine of Major New Drug Projects(Grant No.2014ZX09304307)

摘　　要：As a traditional Chinese medicine （TCM）, Dictamni Cortex is widely used for the treatment of rheumatism and skin diseases. To promote the internationalization of Dictarnni Cortex, we established a recommended quality standard of Dictamni Cortex according to the European Pharmacopoeia （EP） in the present study. Foreign matter, loss on drying, total ash and ash insoluble in hydrochloric acid were determined according to the procedures of EP 8.0. The thin layer chromatography （TLC） identification method was established by using obacunone and fraxinellone as the reference substances. The content of dictarnnine, obacunone and fraxinellone was assayed by reversed phase high performance liquid chromatography （RP-HPLC）. Furthermore, we tested 21 batches of the prepared slices of Dictamni Cortex from different regions. The results indicated that the established quality standard was specific, accurate and internationalized, which could be used for the quality control of Dictamni Cortex.白鲜皮为我国传统中药,广泛用于风湿病和皮肤病等多种疾病的治疗。为了推进中药白鲜皮的国际化,本研究依据《欧洲药典》规范建立了白鲜皮质量标准。参照《欧洲药典》的相关要求,对白鲜皮饮片开展了杂质、水分、灰分及酸不溶性灰分等检查项的检测,并以梣酮和黄柏酮为对照品建立了白鲜皮饮片的薄层鉴别方法,采用反相高效液相法建立了白鲜碱、黄柏酮和梣酮的含量测定方法。采用此质量标准,对21批白鲜皮饮片进行了评价。结果表明,该质量标准具有很好的专属性和准确性,更具有国际规范性,可应用于白鲜皮的质量控制。

关 键 词：Dictamni Cortex Quality standard European Pharmacopoeia HPLC 

分 类 号：R284.1[医药卫生—中药学]