桃红通脉颗粒质量标准提高研究
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摘要
目的提高桃红通脉颗粒的质量标准。方法采用薄层色谱(TLC)法对赤芍、地黄、甘草进行薄层鉴别,以及采用高效液相色谱法对主药桃仁的有效成分苦杏仁苷进行鉴别;采用高效液相色谱法测定芍药苷的含量,色谱柱为Agilent HCC18柱(250mm×4.6mm,5μm),流动相为乙腈-水(13∶87),流速为1.0ml/min,柱温为30℃,检测波长为230nm。结果赤芍、地黄、甘草的TLC图均斑点清晰,阴性无干扰;芍药苷在1.79~57.28μg/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99.99%,RSD为2.05%(n=9)。结论提高桃红通脉颗粒质量标准后,鉴别方法重现性更好,优化了芍药苷的含量测定方法,增强了成品质量的可控性。
Objective To improve the quality standard of Taohong Tongmai granule.Methods TLC was used to make qualitative identification of Paeoniae Radix Rubra,Rehmanniae Radix,Glycyrrhizae Radix;The effective components of the main walnut kernel were identified by HPLC;and HPLC was used to do quantitative determination of Paeoniflorin,the determination was performed on Agilent HC-C18(250 mm×4.6 mm,5μm)column with mobile phase consisted of Acetonitrile-water(13∶87)at the flow rate of 1.0 ml/min,the column temperature was 30 ℃ and the detection wavelength was set at 230 nm.ResultsThese TLC spots were fairly clear,and the blank test showed no interference;The paeoniflorin at the range of 1.79-57.28μg/ml was linear with peak area(r= 0.999 9),its average recovery rate was 99.99% and RSD was 2.05%(n=9).Conclusion The quality standard of Taohong Tongmai granule had been improved,identification method was better reproducibility,the determination method of paeoniflorin content had enhanced the controllability of product quality.
Objective To improve the quality standard of Taohong Tongmai granule.Methods TLC was used to make qualitative identification of Paeoniae Radix Rubra,Rehmanniae Radix,Glycyrrhizae Radix;The effective components of the main walnut kernel were identified by HPLC;and HPLC was used to do quantitative determination of Paeoniflorin,the determination was performed on Agilent HC-C18(250 mm×4.6 mm,5μm)column with mobile phase consisted of Acetonitrile-water(13∶87)at the flow rate of 1.0 ml/min,the column temperature was 30 ℃ and the detection wavelength was set at 230 nm.ResultsThese TLC spots were fairly clear,and the blank test showed no interference;The paeoniflorin at the range of 1.79-57.28μg/ml was linear with peak area(r= 0.999 9),its average recovery rate was 99.99% and RSD was 2.05%(n=9).Conclusion The quality standard of Taohong Tongmai granule had been improved,identification method was better reproducibility,the determination method of paeoniflorin content had enhanced the controllability of product quality.
引文
[1]向清宇,于波涛,范开华,等.桃红通脉颗粒的提取工艺研究[J].药学服务与研究,2011,11(2):147-148.
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[4]吴金萍,刘志军.赤芍六味退黄颗粒的薄层色谱定性鉴别[J].内蒙古医学杂志,2015,47(1):72-73.
[5]刁保忠,冯家龙,赵文法.芪麦苓口服液质量标准研究[J].食品与药品,2016,18(3):174-179.
[6]栗建明,侯惠婵,顾利红.HPLC法测定白灵片中芍药苷的含量及不确定度评价[J].中国药房,2015,26(36):5152-5154.
[7]顾蕾蕾,武露凌,李祥,等.桃仁、红花及其药对挥发油的气相-质谱分析[J].中成药,2008,30(5):719-722.
[8]杜晓琳,姜云平,于波涛.高效液相色谱法测定桃红通脉颗粒中芍药苷的含量[J].解放军药学学报,2011,27(4):346-347.
[2]国家药典委员会.中华人民共和国药典(一部):2015年版[S].北京:中国医药科技出版社,2015:86-87;158-159;277-278.
[3]国家药典委员会.中华人民共和国药典(四部):2015年版[S].北京:中国医药科技出版社,2015:57-61.
[4]吴金萍,刘志军.赤芍六味退黄颗粒的薄层色谱定性鉴别[J].内蒙古医学杂志,2015,47(1):72-73.
[5]刁保忠,冯家龙,赵文法.芪麦苓口服液质量标准研究[J].食品与药品,2016,18(3):174-179.
[6]栗建明,侯惠婵,顾利红.HPLC法测定白灵片中芍药苷的含量及不确定度评价[J].中国药房,2015,26(36):5152-5154.
[7]顾蕾蕾,武露凌,李祥,等.桃仁、红花及其药对挥发油的气相-质谱分析[J].中成药,2008,30(5):719-722.
[8]杜晓琳,姜云平,于波涛.高效液相色谱法测定桃红通脉颗粒中芍药苷的含量[J].解放军药学学报,2011,27(4):346-347.