8号烧伤膏质量标准研究

Quality standard of No8 burn cream

目的建立8号烧伤膏的质量标准。方法采用TLC法鉴别方中大黄、五倍子、地榆、冰片。用HPLC法测定没食子酸的含量,采用Shimpack C18柱,以甲醇-0.1%磷酸溶液(15∶85)为流动相,检测波长为273 nm。结果 TLC色谱中分别检出大黄素和大黄酚、没食子酸、龙脑,阴性对照无干扰。没食子酸在9.692～48.460 mg.L-1范围内呈良好的线性关系(r=0.999 9),平均回收率为99.52%,RSD=0.76%(n=6)。结论该研究建立的TLC和HPLC方法专属性强、灵敏度高、重现性好,可用于8号烧伤膏的质量控制。

Aim To establish the quality standard of No8 burn cream.Methods Chrysophanol,Galla Chinensis,Sanguisorba and Borneol were identified by TLC.HPLC method for determining the Gallic Acid content was established.The measurement was performed on a Shim-Pack ODS column,with a mobile phase of methanol-0.1% H3PO4（15∶85）,and the detection wavelength was 273 nm.Results Chrysophanol,Galla Chinensis,Sanguisorba and borneol could be identified by TLC and there was no interference of the negative control.The linearity of the concentration of Gallic Acid is fine in the range between 9.692~48.460 mg·L-1（r=0.999 9）.The average recovery was 99.52%,and RSD was 0.76%（n=6）.Conclusion The method and is of good specialization,high sensitivity and fine reproducibility,so it can be used as quantity control for No8 burn cream.