通窍耳聋丸的质量标准研究

Study on quality standard of Tongqiao Erlong Pills

目的建立通窍耳聋丸的质量控制标准。方法对通窍耳聋丸中各味药材进行显微鉴别,并对柴胡、龙胆进行薄层色谱鉴别;采用HPLC法测定龙胆苦苷含量。采用Phenomenon Luna C18柱(4.6 mm×250 mm,5μm);流动相为甲醇-水(25∶75);流速为0.8 ml/min;检测波长270 nm;柱温35℃。结果显微鉴别特征专属,薄层色谱斑点清晰阴性对照无干扰;龙胆苦苷在0.091~0.912μg与峰面积呈良好的线性关系(r=0.9999,n=6);平均回收率为99.9%(n=6),RSD=1.2%。结论本方法易于操作,结果准确,重现性良好,可用于通窍耳聋丸制剂的质量控制。

Objective To establish quality control standards for Tongqiao Erlong Pills.Methods Microscopical identification was used to qualitative of material medcine prescription,thin layer chromatography（TLC） method were established to identify Bupleuri Radix and Gentianae Radix et Rhizoma,gentiopicroside was determined by HPLC with Phenomenon Luna C18column（4.6 mm×250 mm,5 μm） used with the mobile phase of mthanol-water（25∶75） at a flow rate of 0.8 ml/min.The detecting wavelength was 270 nm,the column temperature was 35℃.Results Microscopic identification features were exclusive.The spots of TLC were clear and the negative control without interference.The linear range of gentiopicroside was 0.091-0.912 μg（r=0.9999,n=6） with a great linear relationship.The mean recovery rates were99.9%（n=6）,RSD equal to 1.2%.Conclusion This method is simple,rapid,reproducible,precise,reliable and accurate.It can be used for the quantification of Tongqiao Erlong Pills.