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康乐鼻炎片的质量标准研究
引用本文:管志美.康乐鼻炎片的质量标准研究[J].成都医学院学报,2014,9(3):286-289.
作者姓名:管志美
作者单位:管志美 (湖南省药品审评认证与不良反应监测中心,长沙,410000);
基金项目:中国高校医学期刊临床专项资金(项目编号:11321315)
摘    要:目的 建立康乐鼻炎片的质量标准.方法 采用薄层色谱法对康乐鼻炎片中白芷、薄荷、黄芩和马来酸氯苯那敏做定性鉴别,采用高效液相色谱法对黄芩中黄芩苷的含量进行测定.结果 薄层色谱鉴别方法专属性强、重复性好,高效液相色谱法定量测定黄芩苷的线性范围是0.136-1.36 μg(r=0.9998),均加样回收率是99.44%,RSD=1.32%(n=9).结论 薄层色谱法和高效液相色谱法可以更好地控制康乐鼻炎片的药品质量.

关 键 词:康乐鼻炎片  薄层色谱法  高效液相色谱法  黄芩苷

Study on the Quality Standard for Kangle Biyan Tablet
Authors:GUAN Zhi-mei
Institution:GUAN Zhi-mei (Hunan Drug Review and Adverse Reaction Monitoring Center ,Changsha 410000,China)
Abstract:Objective To set up the quality standard for Kangle Biyan Tablet. Methods TLC was used for the identification of Radix Angelicae Dahuricae, Herba Menthae, Radix Scutellariae and Chlorpheniramine Maleate in Kangle Biyan Tablet forqualitative identification. HPLC was used for the determination of baicalin in Kangle Biyan Tablet. Results Conditions for TLC identification were specific and reproducible. In the HPLC determination of baicalin,the linear relationship was good when the amount of baicalin added was within the range of 0. 136-1.36 μg (r= 0.9998). The average rate of recovery was 99.44 %, and RSD: 1.32 % (n = 9). Conclusion TLC and HPLC are suitable to set up the quality standard for Kangle Biyan Tablet.
Keywords:Kangle Biyan Tablet  TLC  HPLC  Baicalin
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