夜宁胶囊的质量标准研究

Study on Quality Standard of Yening Capsule

目的研究中药制剂夜宁胶囊的质量标准。方法采用薄层色谱检测法(TLC)对灵芝、甘草、首乌藤等成分进行色谱鉴别,采用高效液相色谱法(HPLC)测定大黄素含量,并进行方法学考察。结果 TLC鉴别方法专属性强。含量测定大黄素在1.6μg/mL～16μg/mL范围内有良好的线性关系(r=0.9999),平均加样回收率为97.4%,RSD为0.87%(n=5)。结论本标准可有效控制夜宁胶囊的质量。

Objective To study the quality standard of Chinese medicine preparation Yening capsule.Method The components such as ganoderma,glycyrrhiza,and vine of multiflower knotweed were identified with the thin layer chromatography（TLC） method and the content of emodin was detected with high performance liquid chromatography method（HPLC）,and method validation was examined.Results The TLC identification method had a strong specificity.Emodin had a good linear relation（r=0.9999） with detected contents between 1.6 μg/mL^16 μg/mL,the average recovery was 97.4%,RSD was 0.87%（n=5）.Conclusion This standard can efficiently control the quality of Yening capsule.