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奇白消软膏的定性鉴别与定量检测
引用本文:梁林辉,章斌,姚永秀,彭东,刘德军,赵君. 奇白消软膏的定性鉴别与定量检测[J]. 中国民族民间医药杂志, 2024, 33(1): 28-32
作者姓名:梁林辉  章斌  姚永秀  彭东  刘德军  赵君
作者单位:1.雅安职业技术学院药学与检验学院,四川 雅安 625000;2.雅安市食品药品应用开发工程技术研究中心,四川 雅安 625000;雅安蒲源生物技术有限公司,四川 雅安 625000;成都医学院药学院,四川 成都 610000
基金项目:四川省中医药管理局项目:2020CP0031;雅安市2021年度省级转移支付项目:22ZYZFO003。
摘    要:目的:建立奇白消软膏的定性鉴别与含量测定方法,加强奇白消软膏的质量控制。方法:采用薄层色谱(TLC)法对制剂中的黄连和人工牛黄进行定性鉴别;采用高效液相色谱法(HPLC)测定制剂中黄连有效成分盐酸小檗碱的含量。结果:奇白消软膏的TLC斑点清晰、阴性无干扰、分离度好;盐酸小檗碱在1.28~38.4μg;回归方程为Y=49873.84X-554.74(r=1)。精密度、稳定性、重复性试验的RSD分别为0.41%、0.38%、1.8%;加样回收率为98.88%~101.23%,RSD为0.95%(n=6)。结论:本研究建立的TLC和HPLC简便易行,准确、重复性好,可用于奇白消软膏的质量控制。

关 键 词:奇白消软膏  盐酸小檗碱  薄层色谱法  高效液相色谱法  质量控制
收稿时间:2023-04-03

Research on TLC Indentification and Content Determination of Qibaixiao Ointment
LIANG Linhui,ZHANG Bin,YAO Yongxiu,PENG Dong,LIU Dejun,ZHAO Jun. Research on TLC Indentification and Content Determination of Qibaixiao Ointment[J]. Chinese Journal of Ethnomedicine and Ethnopharmacy, 2024, 33(1): 28-32
Authors:LIANG Linhui  ZHANG Bin  YAO Yongxiu  PENG Dong  LIU Dejun  ZHAO Jun
Affiliation:1. School of Pharmacy and Medical Laboratory Science, Ya''an Polytechnic College, Ya''an, 625000, China;2. Ya''an Food and Drug Application Development Research Center, Ya''an, 625000, China;1. School of Pharmacy and Medical Laboratory Science, Ya''an Polytechnic College, Ya''an, 625000, China;2. Ya''an Food and Drug Application Development Research Center, Ya''an, 625001, China;1. School of Pharmacy and Medical Laboratory Science, Ya''an Polytechnic College, Ya''an, 625000, China;2. Ya''an Food and Drug Application Development Research Center, Ya''an, 625002, China;Ya''an Puyuan Biotechnology Co. , Ltd, Ya''an, 625000, China; School of pharmacy, Chengdu Medical College, Chengdu, 610000, China
Abstract:Objective To establish the identification and content determination methods of Qibaixiao Ointment, to enhance thequality controllability of Qibaixiao Ointment. Methods Thin layer chromatography method (TLC) was used for qualitative identifica-tion of Coptis chinensis Franch, Bovis calculus Artifactus. Using high performance liquid chromatography (HPLC) was used for con-tent determination of Berberine hydrochloride. Results The TLC spots were clear spots with less negative interference, well separatedand good reproducibility. Berberine hydrochloride showed a good linear relationship in the range of 1. 28 –38. 4 ug. The regression e-quation was: Y =49873. 84X -554.74 (r = 1). The RSD values of precision, repeatability and stability experiments were 0. 41% ,0. 38% , 1. 8%. The average recovery rates was 98. 88% –101. 23% with RSD was 0. 95% (n =7). Conclusion The qualitative i-dentification method and content determination method established method in this study for Qibaixiao Ointment are easy to operate withgood reproducibility and accurate, reliable. It can be used to evaluate the quality of Qibaixiao Ointment.
Keywords:Qibaixiao Ointment   Berberine Hydrochloride   TLC   HPLC   Quality Control
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