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牛黄清宫丸质量标准的研究
引用本文:李方,张清波,曹阳.牛黄清宫丸质量标准的研究[J].中国药品标准,2011,12(2):131-135.
作者姓名:李方  张清波  曹阳
作者单位:1. 黑龙江省药品检验所,哈尔滨,150001
2. 大庆市药品检验所,大庆,163316
摘    要:目的:建立牛黄清宫丸质量标准。方法:采用TLC法对处方中大黄、栀子、金银花进行了定性鉴别,并用HPLC法对处方中黄芩进行了含量测定,采用Diamonsil C18色谱柱,以甲醇-水-磷酸(46∶54∶0.2)为流动相,流速为1.0 mL.min-1,检测波长为280 nm。结果:薄层色谱斑点清晰,易于识别,专属性强;黄芩苷线性范围为0.117 5~1.175μg(r=1.000 0),平均加样回收率为99.5%,RSD为1.6%。结论:本方法操作简便,快速、准确、灵敏度高,重复性好,提高后的质量标准更有效的控制该制剂的质量。

关 键 词:牛黄清宫丸  薄层色谱  黄芩苷  高效液相色谱

Studies on Quality Standard of Niuhuang Qinggong Pills
Authors:Li Fang  Zhang Qing-bo and Cao Yang
Institution:Li Fang1,Zhang Qing-bo1,Cao Yang2(1.Heilongjiang Provincial Institute for Drug Control Harbin 150001,2.Daqing Institute for Drug Control,Daqing 163316)
Abstract:Objective: To determine the quality standard of Niuhuang Qinggong Pills. Methods: Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae Japonicae in Niuhuang Qinggong Pills were identified by TLC. The content of Baicalin was determined by HPLC. Using ODS column, Methanol-Water- Phosphoric acid (46: 54: 0. 2) as the mobile phase at flow rate of 1.0 mL ·min^-1, wavelength of the detection was 280 nm. Results:The qualitative identification with TLC were specific. The liner range of Baicalin was 0. 117 5 - 1. 175μg(r = 1. 000 0); the recovery was 99. 5% (RSD = 1.6% ). Conclusion: This method is simple,rapid,accurate,highly sensitive and well reproducible. This method can be used for the quality control of Niuhuang Qinggong Pills.
Keywords:Niuhuang Qinggong Pills  Quality control  TLC  Baicalin  HPLC  
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