七味苦参软膏的质量标准研究  

Study on Quality Standard of Qiwei Kushen Ointment

作　　者：姜俊玲 彭亚楠 俞涛 张雪梅 崔明筠 彭霜 单丽芳 张天武 JIANG Jun-ling;PENG Ya-nan;YU Tao;ZHANG Xue-mei;CUI Ming-jun;PENG Shuang;SHAN Li-fang;ZHANG Tian-wu(Puer Hospital of Traditional Chinese Medicine,Puer 665000,China;Puer National Traditional Medicine Research Institute,Puer 665000,China)

机构地区：[1]普洱市中医医院,云南普洱665000 [2]普洱市民族传统医药研究所,云南普洱665000

出　　处：《食品与药品》2025年第2期109-114,共6页Food and Drug

基　　金：云南省科技厅基础研究计划(编号:202101AZ070001-175);全国中药特色技术传承人才培训项目(编号:国中医药人教函[2023]96号)。

摘　　要：目的建立七味苦参软膏的质量标准。方法采用薄层色谱法(TLC)对七味苦参软膏中苦参、白鲜皮、黄柏进行定性鉴别;采用高效液相色谱(HPLC)法对软膏中盐酸小檗碱进行定量分析。结果苦参、白鲜皮、黄柏的TLC鉴别图谱主斑点清晰,阴性对照无干扰。盐酸小檗碱在0.168~0.840μg范围内线性良好,平均回收率为98.12%,RSD为1.02%。软膏稳定性考察期间质量稳定。结论所建立方法专属性强、准确度高、重现性好,可用于七味苦参软膏的质量控制。Objective To establish the quality standard of Qiwei Kushen Ointment.Methods Thin Layer Chromatography(TLC) was applied to identify Sophorae Flavescentis Radix,Dictamni Cortex and Phellodendri Chinensis Cortex.The contents of berberine hydrochloride were determined by high performance liquid chromatography(HPLC).Results TLC spots of Sophorae Flavescentis Radix,Dictamni Cortex and Phellodendri Chinensis Cortex were fairly clear and the negative control showed no interference.Berberine hydrochloride had good linearity in the range of 0.168-0.840 μg.The average recovery was 98.12 %,with RSD of 1.02 %.The quality of the ointment was stable during the stability inspection period.Conclusion The established method is specific,accurate and reproducible,and can be used for quality control of Qiwei Kushen Ointment.

关 键 词：七味苦参软膏 质量标准 薄层色谱法 高效液相色谱法 盐酸小檗碱 

分 类 号：R927.1[医药卫生—药学]