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防己茯苓汤煎膏剂质量标准的建立 被引量:3

Quality Standard Establishment of Fangjifuling Decoction Agent
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摘要 目的:建立防己茯苓汤煎膏剂的质量标准。方法:对制剂中的黄芪、防己和甘草采用TLC法进行定性鉴别,对其主要成分粉防己碱和防己诺林碱采用HPLC法进行含量测定。结果:防己茯苓汤煎膏剂中防己、黄芪和甘草的薄层色谱鉴别斑点清晰,重现性好,阴性对照无干扰;含量测定粉防己碱在20.72~103.50μg/mL范围内线性关系良好,相关系数r=0.999 1、加样回收率为99.12%,RSD=1.15%(n=6);防己诺林碱在12.24~61.20μg/mL范围内线性关系良好,相关系数r=0.999 2,加样回收率为100.88%,RSD=1.68(n=6)。结论:建立的定性、定量方法简便易行、准确可靠、稳定可控,为防己茯苓汤煎膏剂的质量控制标准提供实验依据。 Objective:To study and set up the quality standards of Fangjifuling decoction agent.Methods:Radix Stephaniae tetrandrae,Radix Astragali and Radix Glycyrrhizae in Fangjifuling decoction agent were identified with the method of TLC.The concentration of Tetrandrine and fangchinoline were determined with the method of HPLC.Results:For TLC,the chromatogram spots of Radix Stephaniae tetrandrae,Radix Astragali and Radix Glycyrrhizae were well separated and without interference in their negative controls.The linear relationship of Tetrandrine was the range of 20.72~103.50μg/mL(r=0.9991,n=6).The average recovery rate was 99.12% and RSD=1.15%(n=6).And Fangchinoline was the range of 12.24~61.20μg/mL(r=0.9992,n=6).The average recovery rate was 100.88% and RSD=1.68(n=6).Conclusion:The methods set up by this study are easy,accurate and stable,and can be used as the quality control standards of Fangjifuling decoction agent.
出处 《中医药信息》 2012年第6期96-98,共3页 Information on Traditional Chinese Medicine
关键词 防己茯苓汤煎膏剂 质量标准 薄层色谱法 高效液相色谱法 Fangjifuling decoction agent Quality standards TLC HPLC
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  • 1国家药典委员会 二部.中华人民共和国药典[S].北京:化学工业出版社,2005.附录.

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