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肤康宁搽剂的质量标准研究

Study on the quality specification of Fukangning liniment
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摘要 目的制定肤康宁搽剂的质量标准。方法采用薄层色谱法鉴别花椒和薄荷脑,以花椒的主要有效成分,香柑内酯为质控指标,用高效液相色谱法测定在花椒中的含量。结果花椒和薄荷脑的薄层斑点清晰,分离效果好,重现性好,分别与相应对照品性质相同;肤康宁搽剂中香柑内酯在0.4~1.6μg线性关系良好,平均回收率为99.8%,RSD为0.8%。结论本法简便、准确,可有效控制肤康宁搽剂质量。 Objective To establish the quality control standard for Fukangning liniment.Methods Pericarpium Zanthoxyli and Mentholum were identified by thin layer chromatography (TLC), and the content of bergapten,one of the ingredients of Pericarpium Zanthoxyli, was determined by high performance liquid chromatography (HPLC)as an indicator for Pericarpium Zanthoxyli.Result The TLC spots of Perlcarpium Zanthoxyli and Mentholum were fairly clear, the repeatability was good and the characteristics were the same as their reference substance, respectively. Bergapten showed a good linear relationship at a range of 0.4-1.6μg (r=0.9999). The average recovery rate of bergapten was 99.8% and RSD was 0.8%. Conclusion The above-mentioned methods are simple, accurate and qualified for the quality control of Fukangning liniment effectively.
出处 《实用医药杂志》 2007年第4期441-442,共2页 Practical Journal of Medicine & Pharmacy
基金 青岛市科技发展计划项目(02-z-kj-ng-3)
关键词 肤康宁搽剂 香柑内酯 薄层色谱 高效液相色谱 质量标准 Fukangning liniment Bergapten TLC HPLC Quality standard
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