Study on quality standards of hospital preparation Ganmao granules
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摘要: 目的 建立医院制剂感冒颗粒的质量标准。 方法 采用薄层色谱法(TLC)对黄芩、黄柏、柴胡进行薄层鉴别;采用高效液相色谱法(HPLC)测定黄芩苷的含量,色谱柱为Agilent HC-C18(250 mm×4.6 mm,5 μm),流动相为甲醇-0.2%磷酸(43:57),流速为1.0 ml/min,柱温30℃,检测波长为280 nm。 结果 黄芩、黄柏、柴胡的薄层色谱图均斑点清晰,阴性无干扰;黄芩苷在1.81~72.40 μg/ml范围内浓度与峰面积线性关系良好(r=0.999 9),平均回收率为98.55%,RSD为1.91%(n=9)。 结论 本研究建立的鉴别方法重现性更好,确定了黄芩苷的含量测定方法,增强了该制剂质量的可控性。Abstract: Objective To establish a quality standard for Ganmao granules of hospital preparations. Methods Radix Scutellariae, cortex phellodendri and radix bupleuri were identified by thin layer chromatography (TLC) qualitatively. High performance liquid chromatography (HPLC) was used for the content of baicalin. The determination was performed on Agilent HC-C18 column (250 mm×4.6 mm,5 μm) at 30℃ with mobile phase composed of methanol -0.2% phosphoric acid (43:57) at the flow rate of 1.0 ml/min. The detection wavelength was set at 280 nm. Results In TLC chromatograms, the spectra of different test products had spots of the same color at corresponding sites, with no interference from negative control. A good linearity range of baicalin was 1.81~72.40 μg/ml (r=0.999 9). The average recovery rate was 98.55% (RSD=1.91%, n=9). Conclusion The quality standard was established and the method of identification has good reproducibility. The method of determination of baicalin content improved the controllability of formulated quality of Ganmao granules.
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Key words:
- Ganmao granules /
- baicalin /
- TLC /
- HPLC
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[1] 国家药典委员会.中华人民共和国药典2010年版一部[S].北京:中国医药科技出版社,2010附录Ⅵ B:34. [2] 江涛,雷健,邢茂,等.口炎清胶囊的质量控制和稳定性试验[J].中国药业,2014,23(11):17-20. [3] 黄晓巧,李养学,胥爱丽,等.复方红黄洗剂质量标准研究[J].江西中医药,2014,45(8):73-75. [4] 何小英,黄艳萍. 胃肠乐片的质量标准研究[J].今日药学,2014,24(10):726-728. [5] 刘香玉,田民强,冯丽莉,等.复方解郁颗粒的质量标准研究[J].中国药师,2014,17(5):763-766. [6] 林海霞,王书林,王砚,等.HPLC测定竹叶柴胡中黄酮类成分的含量[J].中国实验方剂学杂志,2012,18(15):76-79. [7] 刘红,刘辉,刘彬果. 高效液相色谱法测定急麻颗粒中黄芩苷的含量[J].天津药学,2014,26(6):11-12. [8] 乡世健,翁立冬,黄德浩,等. HPLC测定小儿连番止泻颗粒中黄芩苷的含量[J].今日药学,2014,24(11):781-783. [9] 尹亚梅. HPLC法同时测定芩翘口服液中黄芩苷、连翘苷的含量[J].中国药师,2014,17(11):1973-1975. -
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