痛风宁胶囊质量标准研究
首发时间:2007-11-13
摘要:目的:研究痛风宁胶囊质量控制方法,以提高痛风宁胶囊的质量标准。方法:采用薄层色谱法对方中主要药味进行定性鉴别研究,采用HPLC法测定方中主要有效成分盐酸小檗碱的含量。结果:方中防己、黄柏、姜黄、薏苡仁、连翘5味药的薄层色谱具有鉴别特征,色谱斑点清晰,专属性强,Rf值适中,阴性对照无干扰;HPLC法测定盐酸小檗碱的含量在0.0826μg~0.826μg范围内线性关系良好,平均回收率为98.9%(n=6)。结论:方法简便可靠,专属性强,重现性好,能较全面反映该制剂内在质量,可用于该制剂的质量控制。
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Quality Standard for Tongfengning Capsule
Abstract:Objective:To establish the quality standard for Tongfengning Capsule.Method:Medicines in this Description were identified by TLC.The content of Berberine which is the effective element in the preparation was determined as the index by HPLC.Results: Radix Stephaniae Tetrandrae,Cortex Phellodendri,Rhizoma Curcumae Longae, Semen Coicis and Fructus Forsythiae could be detected by TLC from three batches of samples.The linear correlation of the Berberine is good in extent of 0.0826μg~0.826μg and the recovery is 98.9%(n=6).Conclusion: The quality control is feasible and can be applied to control the products from mass production.It can be ensured the stability of the pharmaceutical quality.
Keywords: Tongfengning capsule Quality standard TLC HPLC
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No.1631616676911949****
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