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四季三黄片质量控制方法的研究
引用本文:卞艳晶,高延甲,王建.四季三黄片质量控制方法的研究[J].齐鲁药事,2010,29(1):20-22.
作者姓名:卞艳晶  高延甲  王建
作者单位:1. 济宁市药品检验所,山东济宁,272000
2. 东营市药品检验所,山东,东营257091
摘    要:目的建立四季三黄片的质量控制方法。方法薄层色谱法定性鉴别四季三黄片中大黄,栀子,黄芩,黄柏。HPLC法测定黄芩苷的含量,色谱柱:ODS-2 HYPERSIL(250mm×4.6mm,5μm);流动相:乙腈-水-磷酸(25∶75∶0.2);流速:1.0mL.min-1;检测波长280nm;柱温25℃;紫外检测波长280nm。结果薄层鉴别专属性强,色谱斑点清晰。黄芩苷在0.02968~0.5935μg范围内呈良好的线性关系,加样平均回收率为98.05%,RSD=0.9946%(n=6)。结论本法简便,可靠,准确,可用于该制剂的质量控制。

关 键 词:四季三黄片  质量控制  薄层色谱法  高效液相色谱法

Study on the quality control of Sijisanhuang Tablets
BIAN Yan-jing,GAO Yan-jia,WANG Jian.Study on the quality control of Sijisanhuang Tablets[J].qilu pharmaceutical affairs,2010,29(1):20-22.
Authors:BIAN Yan-jing  GAO Yan-jia  WANG Jian
Institution:BIAN Yan-jing,GAO Yan-jia1,WANG Jian(Jining Institute for Drug Control,Jining 272000,1.Dongying Institute for Drug Control,Dongyjng 257091)
Abstract:OBJECTIVE To establish a method to control the quality of Sijisanhuang Tablets. METHODS The effective ingredients in Radix et Rhizoma Rhei, Fructus Gardeniae, Radix Scutellariae and Cortex Phellodendri Chinenesisi were distinguished by TLC. Baicalin was determined by HPLC. Column : ODS- 2 HYPERSIL (250mm × 4.6mm, 5μm), mobile phase: acetonitrile--water-- phosphoric acid (25 : 75: 0.2), flow rate: 1.0mL.min^-1 , wavelength: 280nm, column temperature: 25℃ RESULTS TLC method had a good specificity,TLC spectrum was clear. The linear range was 0. 02968 - 0. 5935μg ( r 1. 0000) and recovery rate was 98. 05%, RSD = 0. 9946% ( n = 6). CONCLUSION This method was simple, reliable, accurate,and can be used to contol the quality of Sijisanhuang Tablets.
Keywords:Sijisanhuang Tablets  quality control  TLC  HPLC  
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