肉蔻五味丸质量标准研究

Quality Standard of Roukou Wuwei Pills

目的:建立肉蔻五味丸的质量标准。方法:采用薄层色谱(TLC)法对肉蔻五味丸中的肉豆蔻、广枣与荜茇进行定性鉴别;采用高效液相色谱法对广枣中没食子酸的含量进行测定。结果:肉豆蔻、广枣与荜茇的TLC斑点清晰。没食子酸进样量在5.01～25.05μg·mL-1范围内与峰面积积分值呈良好线性关系(r=0.999 9);平均加样回收率为99.0%,RSD=1.10%(n=6)。结论:所建标准可用于肉蔻五味丸的质量控制。

OBJECTIVE： To establish the quality standard of Roukou wuwei pills. METHODS： Myristica fragrans, Choerospondias axillaris and Piper longum in Roukou wuwei pills were identified qualitatively by TLC and the content of Gallic acid was determined by HPLC.RESULTS： Myristica, fragrans, Choerospondias axillaris and Piper longum showed clear TLC spots.Good linear relationship was achieved between Gallic acid and peak area when the concentration of Gallic acid was 5.01-25.05 μg·mL ^-1（ r = 0.999 9） .The average recovery rate was 99.0% （RSD = 1.10%, n = 6） .CONCLUSION： The established quality standard is suitable for the quality control of Roukou wuwei pills.