小儿清肺丸质量标准的研究

Study on quality criteria of Xiaoer Qingfei pill

关键词:  小儿清肺丸  黄芩苷  高效液相色谱  质量标准

Key words:  Xiaoer Qingfei pill  baikal shullcap  HPLC  quality criteria

摘要:

[目的]建立小儿清肺丸的质量标准。[方法]采用显微鉴别法和薄层色谱法(TLC)法鉴别方中的麻黄、石膏、桑白皮、苦杏仁、浙贝母、葶苈子,以高效液相色谱(HPLC)法测定黄芩苷的含量,色谱柱为scienhomeC18250mm×4.6mm,5μm;流动相:甲醇-水-冰乙酸(50:50:1);检测波长为280nm;流速:1mL/min;室温。[结果]显微鉴别法和TLC法鉴别可明显鉴别麻黄、石膏、桑白皮、苦杏仁、浙贝母、葶苈子,黄芩苷在0.394~3.94μg范围内,呈良好的线性关系,r=0.9999,平均回收率为100.2%,峰面积的相对均数加减标准差(RSD)=2.6%。[结论]本方法操作简便,结果准确,重现性好,可用于该制剂的质量控制。

Abstract:

[Objective] To establish the quality criteria of Xiaoer Qingfei (clearing away lung-heat in children) pill.[Methods] Using microscopic examination and TLC method the Chinese ephedra,gypsum,bark of white mulberry,seed of bitter apricot,bulb of thunberg fritillary and pepperweed seed were identified.The content of baikal shullcap was determined with HPLC.The chromatography column was scienhome C18,250mm×4.6mm,5μm;flow phase:methanol-water-ice ethanoic acid (50:50:1);wave length 280nm;flow speed:1mL/min;room temperature[Results] The microscopic examination and TLC method could obviously identified Chinese ephedra,gypsum,bark of white mulberry,seed of bitter apricot,bulb of thunberg fritillary,pepperweed seed.Baikal shullcap had a linear relationship at a range of 0.394~3.99μg.r=0.999 9.The average recovery rate was 100.2%,RSD=2.6%.[Conclusion] The method was simple in processing,results was accurate with good reproducibility.It could be used in quality control of this prescription.