溃疡散胶囊质量标准提高研究

Study on the Improvement of Quality Standard of Kuiyangsan Capsule

目的提高溃疡散胶囊的质量标准。方法采用薄层色谱（TLC）法鉴别溃疡散胶囊中的黄芩、甘草,并用高效液相色谱法测定甘草中甘草酸的含量。结果 TLC法定性鉴别重复性好,阴性无干扰;甘草酸铵进样量在0.149 6～1.795 2μg（r=0.999 9）范围内与峰面积积分值呈良好的线性关系,平均回收率为102.52%,RSD=1.09%（n=6）。结论该法操作简便、重复性好,结果准确可靠,可用于溃疡散胶囊的质量控制。

Objective To study the quality standard of Kuiyangsan Capsule. Methods The thin layer chromatography（ TLC） was adopted to identify Radix scutellariae and Radix et rhizoma glycyrrhiza. The glycyrrhizinate content from Radix et rhizoma glycyrrhiza was determined by HPLC. Results The TLC qualitative identification had good reproducibility without the negative interference. The linear range of glycyrrhizinate was 0. 149 6- 1. 795 2 μg（ r = 0. 999 9）. The average recovery rate was 102. 52%, RSD = 1. 09%（ n = 6）. Conclusion The established method is simple to operate,better repeatable,accurate and reliable in detection results,and can be used in the quality control of Kuiyangsan Capsule.