前列舒片的质量标准研究

Study on quality standards of Qianlieshu tablets

目的:建立前列舒片的质量控制方法。方法:采用高效液相色谱法测定盐酸小檗碱的含量:以质量分数为0.1%磷酸溶液-乙腈(75∶25)为流动相,检测波长为270 nm。结果:供试品与对照品色谱相应位置上有相同颜色的斑点,盐酸小檗碱在10.15μg/m l^81.20μg/m l之间线性关系良好,相关系数r=0.9997,回收率为98.89%,RSD为1.76%。结论:本法灵敏、简便、准确,可用于本制剂的测定和质量控制指标。

Objective： To establish quality control method for QianlieShu tablets. Methods： The contents of Berberine hydrochloride were determined with HPLC method. The mobile phase consisted of 0. 1% phosphoric acid - acetonitrile （75： 25） and the UV detection wave length was at 270nm. Results： The linearity was obtained over the range of 10.15 μg/ml - 81.20μg/ml （ r = 0.9997）. The average recovery was 98.89%, with RSD = 1.76%. Conclusion： This method is sensitive, simple, sepecific and accurate for the determination of Berberine hydrochloride in Qianlieshu tablets.