【摘要】 目的 提升咳喘合剂的质量标准。方法 采用薄层色谱法对咳喘合剂中麻黄、甘草、苦杏仁进行定性鉴别；依据2020年版《中国药典（四部）》进行pH、相对密度与装量检查；采用高效液相色谱法测定制剂中盐酸麻黄碱和盐酸伪麻黄碱的含量，色谱柱为Waters XBridge C₁₈柱（250 mm×4.6 mm,5μm），流动相为0.01 mol/L磷酸二氢钾溶液（用磷酸调pH至2.3）-甲醇（11∶89,V/V），流速为1.0 mL/min，柱温为35℃，检测波长为210 nm，进样量为10μL。结果 麻黄、甘草、苦杏仁的薄层色谱斑点清晰，分离度良好，且阴性对照无干扰。10批样品（规格为每瓶250 mL）的pH为4.81～4.96，相对密度为1.030 4～1.047 7，平均装量为248～258 mL。盐酸麻黄碱及盐酸伪麻黄碱的质量浓度分别在0.523～41.800μg/mL和0.269～21.537μg/mL（r=1.000 0,n=8）范围内与峰面积线性关系良好；重复性、精密度、稳定性试验结果的RSD均小于3.0%；平均加样回收率分别为92.00%和102.07%,RSD分别为2.54%和2.62%（n=6）。结论 该方法操作简便、结果准确、重复性好，可用于咳喘合剂的质量控制。更多还原

【Abstract】 Objective To improve the quality standard of Kechuan Mixture.Methods Ephedrae Herba,Glycyrrhizae Radix et Rhizoma,Armeniacae Semen Amarum in Kechuan Mixture were qualitatively identified by the thin-layer chromatography （TLC）method.According to the the Chinese Pharmacopoeia （2020 Edition,VolumeⅣ），pH,relative density,and average loading capacity were determined.The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride in Kechuan Mixture were determined by the high-performance liquid chromatography（HPLC）method,the chromatographic column was C₁₈column（250 mm×4.6 mm,5μm）,the mobile phase was 0.01 mol/L monopotassium phosphate solution （pH was adjusted to 2.3 with phosphoric acid）-methanol（11∶89,V/V）,the flow was 1.0 mL/min,the column temperature was 35℃，the detection wavelength was 210 nm,and the injection volume was 10μL.Results The TLC spots of Ephedrae Herba,Glycyrrhizae Radix et Rhizoma and Armeniacae Semen Amarum were clear with good separation,without interference from the negative control.The pH was in the range of 4.81-4.96,the relative density was in the range of 1.030 4-1.047 7,and the average loading capacity was in the range of 248-258 mL in 10 batches of samples （with a specification of 250 mL per bottle）.The linear ranges of ephedrine hydrochloride and pseudoephedrine hydrochloride were 0.523-41.800μg/mL and 0.269-21.537μg/mL （r=1.000 0,n=8）.The RSDs of the repeatability,precision and stability test results were lower than 3.0%.The average recoveries of ephedrine hydrochloride and pseudoephedrine hydrochloride were 92.00%and 102.07%with RSDs of 2.54%and 2.62%（n=6）,respectively.Conclusion The method is simple,accurate,and reproducible,which can be used for the quality control of Kechuan Mixture.更多还原