复方运脾口服液的制备及质量控制

Preparation and Quality Control of Fanghua Yunpi Oral Solution

目的:探索复方运脾口服液的制备及定量方法。方法:采用反相高效液相色谱法测定复方运脾口服液中的厚朴酚、和厚朴酚的含量,色谱柱Hypersil ODS_2(250 mm×4.6 mm,5μm);流动相为乙腈-水-冰醋酸-三乙胺(60:37:2:1);柱温为室温;紫外检测波长294 nm。流速1 ml·min^(-1)。结果:厚朴酚在1.0～20.0μg·ml^(-1)的浓度范围内线性关系良好,r=0.9999(n=6),平均回收率为98.6%,RSD为0.59%;和厚朴酚在0.50～10.0μg.ml^(-1)的浓度范围内线性关系良好,r=0.999 6(n=6),平均回收率为98.6%,RSD为0.35%。结论:该方法简便、结果准确、分离度高,可作为该制剂质量标准的内容。

Objective ： To explore preparation and quality control of fanghua yunpi oral solution. Method： Magnolol and honokiol were determined in fanghua yunpi oral solution with RP-HPLC. The chromatographic column was Hypersil ODS2 （250mm×4.6mm,5μm）. The mobile phase consisted of aeetonitrile-water-aeetic acid -triethylamine （60： 37： 2：1 ）. Detective wavelength was 294 nm. The flow rate was 1 ml.min^-1. Result： A good linearity was obtained over the range of 1.0 -20. 0 μg.ml^-1 for Magnolol and 0. 5-10. 0μg.ml^-1 for Honokiol. The average recovery of these two components was 98. 6% with an RSD of 0. 59% and 98. 6% with an RSD of 0. 35 % respectively. Conclusion： The method is simple, rapid, accurate as the quantity standard.