十味平痤胶囊质量标准研究

Study on the Quality Criteria of ShiWei PingCuo Capusule

目的:建立十味平痤胶囊的质量标准。方法:以薄层鉴别法对方中的大黄、知母、蒲公英、紫花地丁和当归进行了鉴别;采用HPLC法测定了成品中的大黄素的含量。结果:样品中共检视出大黄、知母、蒲公英、紫花地丁和当归,斑点清晰,阴性无干扰;大黄素在0.01792～0.224μg具有良好线性,平均加样回收率100.14%,RSD=0.71%。结论:该法操作简便、结果准确,重现性好,可用于十味平痤胶囊质量的控制。

Objective：To establish quality criteria of ShiWei PingCuo capsule. Method：Indentified the radix rhizome,anemarrhena rhizome,dandelion,violae herba and angelica root with the thin layer chromatography（TLC）; testing the concentration of emodin in the capsule with high performance liquid chromatography（HPLC）. Result：The radix rhizome,anemarrhena rhizome,dandelion,violae herba and angelica root are examined from the ShiWei PingCuo capusule. The emodin is in linea with the absorption area when the amount between 0.01792 and 0.224 μg .the average recovery rate of emodin is 100.14% and RSD=0.71%. Conclusion：The quality criteria established is stable and reliable. It could control the quality effectively.