桃红通脉颗粒质量标准提高研究
投稿时间:2017-07-20  修订日期:2017-12-22  点此下载全文
引用本文:金伟华,陈华,张明,于波涛,蒲志强,宋宗辉.桃红通脉颗粒质量标准提高研究[J].药学实践杂志,2018,36(2):162~165,169
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作者单位E-mail
金伟华 原成都军区总医院药剂科, 四川 成都 610083  
陈华 原成都军区总医院药剂科, 四川 成都 610083  
张明 原成都军区总医院药剂科, 四川 成都 610083  
于波涛 原成都军区总医院药剂科, 四川 成都 610083 yu-bo-tao@sohu.com 
蒲志强 原成都军区总医院药剂科, 四川 成都 610083  
宋宗辉 原成都军区总医院药剂科, 四川 成都 610083  
基金项目:2014年度军队医疗机构制剂标准提高科研专项课题(14ZJZ18-2)
中文摘要: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 HC-C18柱(250 mm×4.6 mm,5 μm),流动相为乙腈-水(13:87),流速为1.0 ml/min,柱温为30℃,检测波长为230 nm。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1.79~57.28 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。
中文关键词:桃红通脉颗粒  薄层色谱  高效液相色谱  芍药苷
 
Study on improving the quality standard of Taohong Tongmai granule
Abstract: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(250mm×4.6mm,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. Results These TLC spots were fairly clear, and the blank test showed no interference;The paeoniflorin at the range of 1.79-57.28 μg/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.
keywords:Taohong Tongmai granule  TLC  HPLC  Paeoniflorin
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