透骨散的质量标准研究

Study on the quality standard of Tougu Powder

目的:建立透骨散的质量标准。方法:采用TLC法对透骨散中黄柏、芫花、大黄、没药进行定性鉴别;采用显微鉴别方法对透骨散中黄柏、芫花、大黄、白芷、红大戟、紫花地丁进行了鉴别;采用HPLC测定透骨散中盐酸小檗碱的含量,色谱柱Diamonsil C_(18)(250 mm×4.6 mm,5μm)流动相甲醇-2.2%醋酸水(40:60),柱温25℃,检测波长265 nm。结果:定性鉴别中检出黄柏、芫花、大黄、白芷、没药,分离度好、专属性强且阴性无干扰。盐酸小檗碱线性范围为0.0875~1.4μg(R^2=0.9999),平均加样回收率99.57%(RSD 0.55%)。结论:建立的质量控制方法操作简单、重复性好,可较好的控制透骨散的质量,为该制剂的工业化生产提供参考。

Objective: To establish the quality standard of Tougu Powder.Method: Huangbo,Yuanhua,Dahuang and Moyao in Tougu Power were identified qualitatively by TLC.Microscopic identification of Huangbo,Yuanhua,Dahuang,Baizhi,Hongdaji,and Zihuadiding in Tougu Powder was carried out.Berberine hydrochloride content in Tougu Powder was determined by HPLC.The analysis was carried on a Diamonsil C18（250 mm ×4.6 mm,5μm） column.The mobile phase was composed of methanol and 2.2% acetic acid water（40:60）.The column temperature was 25℃ and detection wavelength was set at 265 nm.Result:Huangbo,Yuanhua,Dahuang,Baizhi and Moyao were detected by qualitative identification,which had good separation,strong specificity and had no negative interference.The linear range ofberberine hydrochloride was 0.08751.4 μg（R2=0.9999）with the average recoveries of 99.57%（RSD 0.55%）.Conclusion: The method is simple,rapid and accurate,which can be used as Tougu Powder’s quality control method.