复方颠茄氢氧化铝散质量标准提高

摘要

目的：对复方颠茄氢氧化铝散质量标准进行提高。方法：采用薄层色谱法对颠茄浸膏进行定性鉴别；采用高效液相色谱法对碳酸氢钠进行含量测定，色谱柱为Merck ZIC ®-HILIC（4.6 mm ×150 mm，5μm），以0.02 mol· L－1醋酸铵缓冲液（用冰醋酸调节pH至4.8）-乙腈（80∶20）为流动相，用蒸发光散射检测器检测（参考条件：飘移管温度70℃），流量0.5 mL · min－1。结果：薄层色谱鉴别方法斑点清晰，重现性好；Na＋进样量在0.39～3.96μg范围内线性关系良好（ r＝0.9998），平均回收率为99.3％（n＝9）。结论：所建立的方法简便、准确，可更好地控制该制剂的质量。%Objective:To improve the quality standard of Compound Belladonna and Aluminum Hydroxide Powder.Methods:Bella-donna extract was identified by TLC.Sodium Bicarbonate was determined by HPLC-ELSD.A Merck ZIC ®-HILIC column(4.6 mm × 150 mm,5 μm) was adopted with the mobile phase of 0.02 mol· L-1 ammonium acetate buffer solution ( adjusted to pH 4.8 with gla-cial acetic acid)-acetonitrile(80∶20), the drift pipe temperature of ELSD detector was advised at 70℃and the flow rate was 0.5 mL · min-1 .Results:The TLC spots developed were clear with good reproducibility.The linear range of sodium ion was 0.39-3.96μg (r=0.999 8) and the average recovery was 99.3%(n=9).Conclusion: The methods are simple and accurate, which can be ap-plied to the quality control of Compound Belladonna and Aluminum Hydroxide Powder.