复方丹参；_制剂；_原儿茶醛；_水溶性酚酸总量；

复方丹参制剂质量控制研究

http://www.100md.com 《时珍国医国药》 2006年第9期

复方丹参；,制剂；,原儿茶醛；,水溶性酚酸总量；,比色法,,复方丹参；,制剂；,原儿茶醛；,水溶性酚酸总量；,比色法,1仪器与试药,2方法与结果,3讨论,参考文献：

     摘要：目的建立复方丹参制剂中水溶性酚酸总量的测定方法，以其中酚酸总量做为质量控制指标全面控制药品质量。方法利用丹参中水溶性酚酸类成分与NaNO2-Al(NO3)3在碱性条件下的显色反应，比色法测定复方丹参制剂中水溶性酚酸(以原儿茶醛计)的总量。结果原儿茶醛在3.336~14.46 μg/ml范围内呈良好的线性关系，回归方程为：A=0.027 77C+0.012 79(r=0.099 96)，加样平均回收率为99.95%，RSD为0.16%。结论该法简便快速，结果准确，重现性好，可用于复方丹参制剂的质量控制。

    关键词：复方丹参；制剂；原儿茶醛；水溶性酚酸总量；比色法

    Studies on Quality Control Method of Compound Radix Salviae Miltiorrhizae Preparations

    HUANG Xiru， FAN Guimin, FENG Yuanyuan， YANG Yajun

    (Department of Analytical Chemistry,School of Pharmaceutical Sciences,Hebei Medical University, Shijiazhuang 050017,China)

    Abstract:ObjectiveTo establish an assay for the determination of the total components of water-soluble phenolic acidity in compound Danshen preparation.MethodsIn the solvent of 1 mol/L NaOH,using the reaction of the total components of water-soluble phenolic acidity in Danshen and the NaNO2-Al(NO3)3,the total components of water-soluble phenolic acidity in compound Danshen preparation(calculated with protocatechualdehyde )were determined by colorimetric spectrophotometry.ResultsThe linear range of protocatechualdehyde was over 3.336~14.46 μg/ml,the correlative equation was:A=0.027 77C+0.012 79(r=0.999 6).The average recovery and relative standard deviation were 99.95% and 0.16%,respectively.ConclusionThe method was simple,quick and accurate,and it is usable on controling the quality of compound Danshen preparation. ......

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