[1]甄世福,李喜香,刘效栓,等.复方白鲜皮湿疹膏质量标准研究[J].西部中医药,2024,37(07):10-13.[doi:10.12174/j.issn.2096-9600.2024.07.03]
　ZHEN Shifu,LI Xixiang,LIU Xiaoshuan,et al.Study on Quality Standard of Compound Baixianpi Eczema Cream[J].Western Journal of Traditional Chinese Medicine,2024,37(07):10-13.[doi:10.12174/j.issn.2096-9600.2024.07.03]
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复方白鲜皮湿疹膏质量标准研究
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《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

卷:
37
期数:
2024年07期
页码:
10-13
栏目:
质量分析
出版日期:
2024-07-15

文章信息/Info

Title:
Study on Quality Standard of Compound Baixianpi Eczema Cream
作者:
甄世福1, 李喜香1, 刘效栓1, 李彦龙1, 孙晓龙2, 杨娟3
1.甘肃省中医院，甘肃 兰州 730050
2.烟台大学药学院，山东 烟台 264005
3.兰州市中医医院，甘肃 兰州 730050
Author(s):
ZHEN Shifu1, LI Xixiang1, LIU Xiaoshuan1, LI Yanlong1, SUN Xiaolong2, YANG Juan3
1.Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou 730050, China
2.School of Pharmacy, Yantai University, Yantai 264005, China
3.Lanzhou Hospital of Traditional Chinese Medicine, Lanzhou 730050, China
关键词:
复方白鲜皮湿疹膏; 薄层色谱法; 高效液相色谱法; 质量标准
Keywords:
compound eczema cream; TLC; HPLC; quality standard
分类号:
R28
DOI:
10.12174/j.issn.2096-9600.2024.07.03
文献标志码:
A
摘要:
目的参照2020版《中华人民共和国药典》复方制剂质量规范，建立复方白鲜皮湿疹膏的质量标准。 方法采用薄层色谱法（thin-layer chromatography，TLC）定性鉴别膏剂中的白鲜皮、蛇床子、黄柏、马齿苋，采用高效液相色谱法（high performance liquid chromatography，HPLC）测定膏剂中指标性成分绿原酸、盐酸小檗碱、白鲜碱的含量。 结果白鲜皮、蛇床子、黄柏、马齿苋的定性鉴别方法专属性强，且阴性对照无干扰；绿原酸在0.011 04～0.176 64 mg/mL（R=0.9998）、盐酸小檗碱在0.003 204～0.051 264 mg/mL（R=0.9996）、白鲜碱在0.003 018～0.048 288 mg/mL（R=0.9992）范围内线性关系均良好；其平均回收率分别为99.09%、98.30%、97.35%，RSD分别为1.77%、1.48%、1.04%。 结论该质量标准操作简便、准确、稳定且无干扰，可用于该制剂的质量控制。
Abstract:
ObjectiveTo establish the quality standard of compound Baixianpi eczema cream according to the quality standard of compound preparation in Pharmacopoeia of the People′s Republic of China (2020 edition). MethodsTLC was used to identify Baixianpi (Dictamni cortex), Shechuangzi (Cnidii fructus), Huangbo (Phello-dendri chinensis cortex) and Machixian (Portulacae herba) in the cream qualitatively, HPLC was applied to detect the contents of the index components chlorogenic acid, berberine hydrochloride and brucine in the cream. ResultsThe methods for qualitative identification of Baixianpi, Shechuangzi, Huangbo and Machixian, are specific and the negative control has no interference; chlorogenic acid, berberine hydrochloride and brucine presented good linear relation in the rang between 0.011 04 and 0.176 64 mg/mL (R=0.9998), 0.003 204 and 0.051 264 mg/mL (R=0.9996), 0.003 018 and 0.048 288 mg/mL (R=0.9992); and their average recovery rates were 99.09%, 98.30% and 97.35%, RSD were 1.77%, 1.48% and 1.04% respectively. ConclusionThe quality standard, which is easy to operate, accurate, stable and without interference, could be used for quality control of the preparation.

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备注/Memo

备注/Memo:
甄世福（1985—），男，主管中药师。研究方向：中药制剂、炮制、鉴定。兰州市卫生健康科技发展项目（2019-25）。
更新日期/Last Update: 2024-07-15