复方北豆根氨酚那敏片质量标准研究

目的 完善复方北豆根氨酚那敏片的质量标准。方法 采用薄层色谱法对复方北豆根氨酚那敏片中北豆根、野菊花、金银花进行定性鉴别，同时采用高效液相色谱法对其中马来酸氯苯那敏含量进行测定。结果 复方北豆根氨酚那敏片中北豆根、野菊花、金银花供试品色谱中，在与对照品及对照药材色谱相应位置上显示相同颜色的斑点；马来酸氯苯那敏进样量在0.03382～0.67640μg与峰面积呈良好线性关系（R2=0.9999），平均加样回收率为98.76%（RSD=0.85％）；马来酸氯苯那敏含量均高于5.60 mg/g，标示含量均高于95.00%。结论 高效液相色谱法测量马来酸氯苯那敏含量回收率高、重现性好、简便、快速、准确，可用于复方北豆根氨酚那敏片的质量控制。

Study on quality standard of compound asiatic moonseed,paracetamol and chlorphenamine maleat tablets

Objective To improve the quality standard for compound asiatic moonseed ,paracetamol and chlorphenamine maleat tablets. Methods The asiatic moonseed root,wild chrysanthemum and honeysuckle in compound asiatic moonseed,paracetamol and chlorphenamine maleat tablets were identified by TLC and the content of chlorphenamine maleat in the oral liquid were determined by HPLC. Results Among sample Chromatography of asiatic moonseed root ,wild chrysanthemum and honeysuckle in compound asiatic moonseed ,paracetamol and chlorphenamine maleat tablets ,it showed the same color spot at the correspondent position of reference samples and reference medical materials. The sample volume of chlorphenamine maleat had a good linear relationship with peak area at the level of 0.0338 2-0.676 4 μg（R^2=0.999 9） with the average recovery being 98.76%（RSD=0.85%）. The chlorphenamine maleat content is grater than 5.60 mg/g （95.00%）. Conclusion The method is simple,fast,and reproducible and of high recovery rate,which can be used as quality control for compound asiatic moonseed, paracetamol and chlorphenamine maleat tablets. The HPLC measuring the proportion of chlorphenamine maleat is simple ,rapid and correct with high recovery rate and good reproducibility.