抗饥消渴片质量标准研究

Study on Quality Standard for Kangjixiaoke Tablets

目的:建立抗饥消渴片的质量标准。方法:采用薄层色谱法(TLC法)对处方中的黄连、黄柏、红参进行定性鉴别;采用高效液相色谱法(HPLC法)对黄连、黄柏中的盐酸小檗碱进行含量测定。色谱条件为PhenomenexC18柱(250mm×5mm,5μm),流动相为用磷酸调节pH=7的乙腈-0.03mol/L磷酸二氢钾溶液-1%三乙胺溶液(31∶59∶10),流速为1.0mL/min,检测波长为265nm。结果:在TLC图谱中可检测出黄连、黄柏、红参的特征斑点。盐酸小檗碱线性范围为0.0624～0.2808μg,平均回收率为98.34%,RSD=0.74%(n=6)。结论:方法简便、准确,可用于抗饥消渴片的质量控制。

Objective： To establish a quality standard for Kangjixiaoke tablets. Methods：Rhizoma coptidis, cortex Phellodendri, Radix Ginseng Rubra were identified by TLC, and the content for berberine hydrochloride in Kangjixiaoke tablets was determined by HPLC. Condition of HPLC was： Phenomenex C18 column （250 mm ×5 mm, 5μm）; the mobile phase was a mixture of acetonitrile-0. 03 mol/L phosphoric acid- 1% triethylamine（31 ： 59 ： 10）; the flow rate was 1, 0 mL/min;the detection wavelength was 265 nm. Results：Rhizoma coptidis, cortex Phellodendri, Radix Ginseng Rubra could be identified by TLC. Berberine hydrochloride showed a good linear relationship at a range of . 0624 -0. 2808μg The average recovery was 98.34% with RSD 0. 74% （n=6）, Conclusion： The method is simple,accurate and can be used for quality control of Kangjixiaoke tablets.