双黄清散剂质量标准研究

目的建立双黄清散剂的质量标准。方法采用薄层色谱法鉴别人工牛黄、黄柏、青黛、甘草、龙胆草;采用高效液相色谱法测定黄柏中有效成分盐酸小檗碱的含量。结果薄层鉴别方法专属性强,重复性好,空白无干扰;盐酸小檗碱在0.0802～0.802μg范围内呈良好的线性关系,r=0.9997,平均加样回收率为98.52%,RSD=1.05%(n=9)。结论本研究中建立的定性定量方法操作简便,专属性强,准确可靠,可以有效控制双黄清散剂的质量。

Study on Quality Standard for Shuanghuangqing Powder

Objective To establish the quality standard of Shuanghuangqing Powder. Methods Artificial Calculus Boris, Cortex Phellodendri Chinensis, Indigo Namralis, Radix Glycyrrhizae, Radix Gentianae in Shuanghuangqing Powder were identified by TLC, and content of berberine hydrochloride was determined by HPLC. Results The method for identification had good specificity and repeatability. There was no interference in blank control. The berberine hydrochloride determination method had good linearity from 0.080 2 to 0.802μg （r =0.999 7）. The average recovery was 98.52% and the relative standard deviation （RSD） was 1.05% （n =9）. Conclusion The qualitative and quantitative method is simple, specific, accurate and reliable. It can be used to effectively control the quality of Shuanghuangqing Powder.