鼻渊合剂的质量标准

Study on Quality Standard of Biyuan Mixture

目的:建立鼻渊合剂的质量控制方法。方法:采用薄层色谱法对鼻渊合剂中白芷、辛夷、桔梗、芦根进行定性鉴别;采用高效液相色谱法对制剂中欧前胡素含量进行测定。选用Kromasil C_(18)色谱柱(250 mm×4.6 mm,5μm);流动相为甲醇-水(65:35);检测波长为300 nm。结果:薄层色谱检出了白芷、辛夷、桔梗、芦根特征斑点;欧前胡素在0.112～7.128μg·ml^(-1)浓度范围内呈良好的线性(r=0.999 9),平均加样回收率为100.60%,RSD=2.41%。结论:本试验建立的方法简便、准确、重复性好,可用于鼻渊合剂的质量控制。

Objective： To establish a quality standard of biyuan mixture. Method： The Radix Angelicae Dahuricae, Flos Magnoliae,Radix Platycodonis and Rhizorna Phragmitis were identified by TLC;Imperatorin was determined by HPLC. A Kromasil C is column （250 mm × 4. 6 mm,5 μm） was used, the mobile phase was methanol-water （65：35 ） , and the detection wavelength was 300 nm. Resuit： The characteristic maculae of Radix Angelicae Dahuricae, Flos Magnoliae, Radix Platycodonis and Rhizoma Phragmitis were detected by TLC. Imperatorin showed a good linear relationship wtithin the range of 0. 112-7. 128 μg· ml^ - 1 （ r = 0. 999 9 ）, and the average recovery was 100. 60% , RSD = 2.41%. Conclusion： The established method is simple, accurate and repeatable, and it can be used for the quality control of biyuan mixture.