麻辛平喘口服液质量标准的考察

Establishment of Quality Standard for Maxin Pingchuan Oral Solution

目的:建立麻辛平喘口服液的质量控制方法。方法:薄层色谱鉴别白芍和陈皮;高效液相色谱法测定麻黄中盐酸麻黄碱含量,Agilent ZORBAX SB-C_(18)色谱柱(150 mm×4.6 mm,5μm);流动相为乙腈-0.1%磷酸溶液(含0.1%三乙胺)(3:97);流速1.0ml·min^(-1);检测波长205 nm。结果:薄层色谱斑点清晰,易于识别。盐酸麻黄碱线性范围为0.031～3.086μg(r=0.999 9),平均回收率为98.8%,RSD为0.1%(n=6)。结论:本标准中建立的方法精密度较高、重复性和稳定性良好,能较好地控制本品的质量。

Objective ： To establish a method for quality control of maxin pingehuan oral solution. Method ： The paeoniae alba and auraraii nobilis pericarpium were identified by TLC. The content of ephedrine hydrochloride was determining by HPLC with Agilent ZORBAX SB-C18 analytical column （150 mm × 4.6 mm, 5 μm）. The mobile phase was acetonitrile-0. 1% phosphoric acid solution （ contains 0.1% triethylamine） （3： 97） at 1.0 ml · min ^- 1 flow rate ; UV wavelength was set at 205 nm. Result： Spots were clear in TLC. The calibration curve was linear within the range of 0.031-3. 086 μg（ r = 0.999 9） , the average recovery rate was 98.8% with the RSD of 0.1% （ n = 6 ）. Conclusion： The method is precision, repeatable and stable, and can be used for the quality control of maxinpingchuan oral solution.