四方胃片质量标准研究

Quality Standard Study for Sifangwei Tablets

目的:建立四方胃片的质量控制方法。方法:采用薄层色谱法对制剂中的延胡索和浙贝母进行定性鉴别,采用高效液相色谱法测定四方胃片中盐酸小檗碱的含量。结果:定性鉴别专属性强;盐酸小檗碱进样量在0.06～1.8μg范围内与峰面积积分值呈良好线性关系(r=0.9999),平均回收率为97.1%,RSD=1.6%(n=6)。结论:所建标准能有效控制该制剂的质量。

OBJECTIVE： To establish the quality control of Sifangwei tablets. METHODS： Corydalis yanhusuo and Fritillaria thunbergii were identified by TLC and the contents of berberine hydrochloride were determined by HPLC. RESULTS：The quanitative identification was specific. The linear range of berberine hydrochloride was 0.06～1.8 μg（r=0.999 9） with an average recovery of 97.1%,RSD=1.6%（n=6）. CONCLUSION： The standard is reliable for quality control of Sifangwei tablets.