愈肝灵胶囊的制备与质量控制

Preparation and Quality Control of Yuganling Capsule

关键词:  愈肝灵胶囊  制备  质量控制

Key words:  Yuganling capsule  preparation  quality control

摘要:

目的 研究愈肝灵胶囊制备与质量控制的方法。方法 采用薄层色谱法对愈肝灵胶囊中的博落回进行定性鉴别；以HPLC对制剂中的白屈菜红碱进行含量测定。结果 薄层色谱清晰，无干扰，重复性良好；白屈菜红碱在0.104 8～0.628 9 μg.mL^-1内呈良好的线性关系，回收率达到99.50%，RSD=1.45%。结论 该方法准确度高，重复性好，简便快捷，可作为愈肝灵胶囊的质量控制指标。

Abstract:

OBJECTIVE To study the formulation and preparation procedure of Yuganling capsule and develop an HPLC method for the content determination. METHODS Plumepoppy was identified by TLC, and chelerythrine was determined by HPLC. RESLUTS TLC spots developed were fairly clear, and the blank test showed no interference. Chelerythrine showed a good linear relationship in the range of 0.104 8-0.628 9 μg.mL^-1 and the average recovery was up to 99.50%, RSD was 1.45%. CONCLUSION The method is accurate, reproducible, simple, and can be used as the quality control of this preparation.