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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 quality control method of Maoxin Pingchuan Oral Liquid. METHODS: Radix Paeoniae Alba and tangerine peel were identified by TLC. The content of ephedrine hydrochloride in ephedra was determined by high performance liquid chromatography (HPLC). The mobile phase consisted of acetonitrile-0.1 with Agilent ZORBAX SB-C 18 column (150 mm × 4.6 mm, % Phosphoric acid solution (containing 0.1% triethylamine) (3:97); flow rate 1.0ml · min -1; detection wavelength 205 nm. Results: Thin-layer chromatography spots are clear and easy to identify. The linear range of ephedrine hydrochloride was 0.031 ~ 3.086μg (r = 0.999 9), with an average recovery of 98.8% and a RSD of 0.1% (n = 6). Conclusion: The method established in this standard has high precision, good reproducibility and stability, and can well control the quality of this product.