胃复宁片的质量标准

Quality Standard of Weifuning Tablets

建立胃复宁片的质量标准。采用薄层色谱法对胃复宁片中的延胡索和白术进行鉴别;采用HPLC测定胃复宁片中延胡索乙素的含量。薄层色谱斑点清晰,阴性对照无干扰;延胡索乙素含量在0.22—1.10μg范围内与峰面积呈良好线性关系(r=0.9992);平均回收率为97.1%,RSD=2.09%(n=6)。方法简单、准确、重现性好,可有效地控制胃复宁片的质量。

Quality standard of Weifuning tablets was established.Corydalis tuber and bighead atractylodes rhizome were identified by thin layer chromatography（TLC）,while the content of tetrahydropalmatine was determined by high performance liquid chromatography（HPLC）.The results showed that the TLC sports developed were fairly clear,and the blank test showed no interference.The peak area has a good linear relationship with the content of tetrahydropalmatine in the range of 0.22—1.10μg（r=0.9992）.The average recovery was 97.1% with RSD of 2.09%（n=6）.The method proved to be simple,accurate and reproducible.The quality standard can effectively control the quality of Weifuning tablets.