复方西羚解毒胶囊质量标准研究

摘要

Objective To study the quality standard of Compound XilingJiedu Capsules.MethodsBorneol, menthol, Forsythiae fructus and licorice were identified qualitatively by thin layer chromatography (TLC), and the content of chlorogenic acid in Compound Xiling Jiedu Capsules was determined by high performance liquid chromatography (HPLC).Results TLC results showed that the sample was well separated with no interference and the spot was clear. The linearity was good for chlorogenic acid in the range of 0.01-0.12 mg/mL. The average recovery was 97.69 %, withRSD of 0.94 % (n=6).Conclusion The standard is simple in operation and good in specificity, stability and repeatability, and is suitable for quality control of Compound Xiling Jiedu Capsules.%目的：研究复方西羚解毒胶囊的质量标准。方法采用薄层色谱法（TLC）对其制剂处方中的冰片、薄荷脑、连翘、甘草等进行定性鉴别；采用高效相色谱法（HPLC）测定复方西羚解毒胶囊中绿原酸含量。结果薄层色谱鉴别表明，样品分离度好，斑点清晰，且阴性对照无干扰，绿原酸浓度在0.01～0.12 mg/mL （r=0.9999）范围内呈良好线性关系，平均回收率为97.69%，RSD为0.94%（n=6）。结论该标准操作简便，专属性、稳定性、重复性良好，适用于复方西羚解毒胶囊的质量控制。