消肿片质量标准研究

Study on the Quality Standard for Xiaozhong Tablets

目的建立消肿片(当归、地龙等)的质量标准。方法采用TLC法对处方中当归、地龙、五灵脂进行了定性鉴别;采用TLC法对乌头碱进行了限量检查;应用HPLC法对方中士的宁进行了含量测定。结果本品定性鉴别薄层色谱特征明显,专属性强;本品中士的宁的含量测定线性范围为0.52～1.56μg(r=0.9998),平均回收率为99.9%(RSD=1.77%,n=5)。结论薄层色谱鉴别和含量测定方法准确可行,重复性好,可有效地控制消肿片的质量。

Objective To establish the quality standard for Xiaozhong Tablets （Radix Angelicae Sinensis, Pheretima, etc.）. Methods TLC was performed to Radix Angelicae Sinensis, Pheretima, Ursolic acid. The content of Aconitine was identified by TLC. HPLC was used to determine Strychnine content. Results The characteristic for identification by TLC was distinct and hightly specific. The quantification method of Strychnine had the linear range of 0.52 - 1.56 μg （r=0.9998）. The average recovery was 99.9% （RSD=1.77%, n=5）. Conclusion The methods of identification and quantification were accurate, realizable and reproducible. It can be used effectively for the quality control of Xiaozhong Tablets.