大败毒胶囊中黄柏与关黄柏混用鉴别方法研究  

A Quality Standard for Identification of Phellodendri Chinensis Cortex and Phellodendri Amurensis Cortex in Dabaidu Capsules

作　　者：张贵英 胡丹 张苗 马紫辉 曹红 ZHANG Gui-ying;HU Dan;ZHANG Miao;MA Zi-hui;CAO Hong(Administration for Drug and Instrument Supervision and Inspection of PLAJLSF,Beijing 100166,China)

机构地区：[1]联勤保障部队药品仪器监督检验总站,北京100166

出　　处：《解放军药学学报》2022年第5期394-399,共6页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：国家药品标准提高(中药)项目,No.(WX-17-07)395。

摘　　要：目的建立大败毒胶囊中黄柏与关黄柏混用鉴别的系统性质量标准,以期规范大败毒胶囊的处方工艺,提高药品质量,确保临床疗效的发挥。方法利用薄层色谱法对关黄柏中特征性成分盐酸巴马汀进行定性筛查;以高效液相色谱-质谱联用法进行盐酸巴马汀成分确证;采用高效液相色谱法进行盐酸巴马汀含量测定。结果上述3种方法检出限分别为0.5μg·ml^(-1)、0.1 ng·ml^(-1)和0.05μg·ml^(-1),方法学验证均良好。结论本文建立的3种方法可系统用于大败毒胶囊中黄柏与关黄柏混用的鉴别。Objective To establish a systematic quality standard for the identification of phellodendri chinensis cortex and phellodendri amurensis cortex in Dabaidu capsules.Methods Thin layer chromatography was used for qualitative screening of the characteristic chemical constituent(palmatine hydrochloride)in phellodendri amurensis cortex while a high performance liquid chromatography-mass spectrometer was used to corroborate this component,the content of which was determined using high performance liquid chromatography.Results The detection limits of the three methods were 0.5μg·ml-1,0.1 ng·ml^(-1)and 0.05μg·ml^(-1),respectively.Furthermore,the effect of the three methods proved to be excellent methodologically.Conclusion The three methods established in this study are able to systematically identify phellodendri chinensis cortex and phellodendri amurensis cortex when they are mixed in Dabaidu capsules.

关 键 词：大败毒胶囊 黄柏 关黄柏 盐酸巴马汀 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]