蒲芩消炎片的质量标准研究

Study on quality standard of Puqinxiaoyan Tablets

目的 :建立蒲芩消炎片 (黄芩 ,蒲公英 ,苦地丁等 )的质量标准。方法 :采用TLC法对蒲公英、苦地丁进行鉴别 ;用高效液相色谱法测定制剂中黄芩苷的含量。结果 :TLC鉴别方法专属性强。黄芩苷对照品在 0 .0 6 0～ 0 .6 6 0 μg范围内呈线性关系 ,r =0 .99991,加样回收率为 97.2 9% ,RSD为 2 .13%。含量限度黄芩苷为不少于 9mg·片 -1。本方法操作简便 ,结果准确 ,灵敏度高 ,重复性好。结论 :本质量标准可有效地控制蒲芩消炎片的质量。

AIM: To establish the quality standard of Puqinxiaoyan Tablets (Radix Scutellariae, Herba Taraxaci, Herba Corydalis Bungeanae, etc.). METHODS: TLC was used for identification of Herba Taraxaci, Herba Corydalis Bungeanae; HPLC was used for the determination of baicalin. RESULTS: The TLC identification was highly specific and the spots clear and concentrated. The linear range of baicalin was from 0.060～ 0.660μg, r = 0.99991, The recovery of the loading was 97.29%, RSD was 2.13%, respectively. The content of baicalin wasn't less than than 9.0mg per tablet. This method was easy to operate with accurate result, high sensitivity and good reproducibility. CONCLUSION: These methods are able to effectively control the quality of Puqinxiaoyan Tablets.