萸连胃漂浮缓释片的质量标准

Quality Specification of Rhizoma Coptidis Gastric Floating Sustained-Release Tablets

建立萸连胃漂浮缓释片的质量标准。采用TLC对制剂中的黄连和吴茱萸进行定性鉴别;采用HPLC测定制剂中盐酸小檗碱和吴茱萸次碱的含量。黄连和吴茱萸薄层图谱斑点清晰,分离效果好,专属性强,阴性对照无干扰;盐酸小檗碱在0.138—1.380μg呈良好的线性关系,r=0.9999,平均加样回收率为99.84%,RSD为1.29%;吴茱萸次碱在0.150—1.500μg呈良好的线性关系,r=0.9999,平均加样回收率为100.19%,RSD为1.10%。建立的定性、定量方法简单、重复性好,结果准确可靠,可作为萸连胃漂浮缓释片的质量控制方法。

The quality specification of rhizoma coptidisgastric floating sustained-release tablets was eatablished.coptis chinensis and fructus evodiae in tablets were qualitatively identified by TLC method,and the content of berberine hydrochloride and rutaecarpine in tablets were determined by HPLC.The spots in lamellar atlas of coptis chinensis and fructus evodiae were clear with good separation effect,strong specificity and no influence for the negative control.The berberine hydrochloride and rutaecarpine had good linear relationships in the range of 0.138—1.380μg and 0.150—1.500μg,respectively,the correlation coefficients of which were both 0.9999,and the average recoveries were respectively 99.84% and 100.19% with RSDs of 1.29% and 1.10%.The established method is simple qualitative and quantitative with good respeatability and accurate results,that can be used as the quality control method of rhizoma coptidisgastric floating sustained-release tablets.