复方颠茄合剂质量标准研究

Study on quality standard of Compound Belladonna Mixture

目的提高复方颠茄合剂的质量控制标准。方法采用薄层色谱法(TLC)对复方颠茄合剂中的吗啡进行定性鉴别;采用高效液相色谱法(HPLC)测定复方颠茄合剂中吗啡的含量。以WondaSil C_(18)(4.6mm×150mm,5μm)为色谱柱;A相:0.01 mol/L磷酸二氢钾溶液-0.002 5 mol/L庚烷磺酸钠溶液(含0.1%三乙胺,磷酸调pH至2.5),B相:乙腈,A∶B=90∶10为流动相;流速:1.0ml/min;检测波长:220nm;柱温:30℃。结果在TLC图谱中可检出吗啡的特征斑点。吗啡在0.525~10.5μg/ml范围内与其峰面积线性关系良好(r=0.999 9),平均回收率为99.44%,RSD=0.23%(n=9)。结论本方法简便准确,专属性强,能够用于复方颠茄合剂的含量测定和质量控制。

Objective To improve the quality standard for Compound Belladonna Mixture.Methods TLC was used for the qualitative identification of morphine.HPLC was used for the content of morphine in the Compound Belladonna Mixture.Results Morphine could be identified by TLC.A good linear correlation of morphine was observed within the range of 0.525~10.5 μg/ml （r=0.999 9）.The average recovery was 99.44% with RSD of 0.23% （n=9）.Conclusion This method is simple,accurate and quick, which could be used for determination and quality control of Compound Belladonna Mixture with good selectivity and repeatability.