醒脑颗粒质量标准研究

目的完善醒脑颗粒质量标准。方法采用薄层色谱(TLC)法对制剂中的黄芩、冰片、大黄、玄参进行定性鉴别,采用高效液相色谱(HPLC)法测定制剂中黄芩苷、大黄素及大黄酚含量。结果黄芩、冰片、大黄、玄参的TLC特征性斑点清晰,分离度好,专属性强,阴性对照无干扰;黄芩苷、大黄素及大黄酚质量浓度分别在10. 36~82. 88μg/m L(r=0. 999 9)、3. 350~26. 80μg/m L(r=0. 999 9)、3. 354~26. 830μg/m L(r=0. 999 9)范围内与峰面积线性关系良好,平均加样回收率分别为98. 87%,97. 42%,98. 91%,RSD分别为1. 23%,1. 08%,1. 27%(n=6)。结论该方法操作简便、精确度高、结果可靠,可用于醒脑颗粒的质量控制。

Study on the Quality Standard for Xingnao Granules

Objective To improve the quality standard for Xingnao Granules. Methods Radix scutellariae,Borneolum syntheticum,Rheum officinale and Radix scrophulariae in the preparation were qualitatively identified by thin layer chromatography( TLC). The contents of baicalin,emodin and chrysophanol in the preparation were determined by high performance liquid chromatography( HPLC). Results TLC spots of Radix scutellariae,Borneolum syntheticum,Rheum officinale and Radix scrophulariae in the preparation were clear,the separation degree was good,the specificity was strong,and were negative without interference. Baicalin,emodin,and chrysophanol had good linear relationships in the range of 10. 36-82. 88 μg/m L( r = 0. 999 9),3. 350-26. 80 μg/m L( r = 0. 999 9),and 3. 354-26. 830 μg/m L( r = 0. 999 9),respectively;the average recoveries were 98. 87%,97. 42%,and 98. 91%,and the RSDs were 1. 23%,1. 08%,1. 27%( n = 6). Conclusion This method is simple,accurate,and reliable,and can be used for the quality control of Xingnao Granules.