益母生化颗粒的质量标准研究

Study on Quality Standard of Yimu Shenghua Granules(益母生化颗粒)

目的:建立益母生化颗粒的质量标准。方法:采用薄层色谱法对处方中的木香、炮姜、当归、川芎进行定性鉴别;采用高效液相色谱法测定益母生化颗粒中阿魏酸的含量并进行方法学考察。结果:薄层色谱中均能检出当归、川芎、木香、炮姜,且特征斑点清晰,专属性强,阴性对照品无干扰;阿魏酸含量在0.012,7~0.050,8 mg范围内进样量与峰面积呈良好线性关系(r=0.999,9,n=5),平均回收率为98.49%(RSD%=1.6%,n=6),本品每袋含当归以阿魏酸(C_(10)H_(10)O_4)计,不得少于360μg。结论:该方法简便可靠、专属性强、重复性好,可用于益母生化颗粒的质量控制。

Objective： To establish the method to control the quality of Yimu Shenghua granules. Methods：Thin-layer chromatography was used to qualitatively identify the Muxiang（Radix Aucklandiae）, Paojiang（baked ginger）, Danggui（angelica sinensis） and Chuanqiong（Ligusticum chuanxiong Hort） of the prescription. The content of ferulic acid in Yimu Shenghua granules was determined by high performance liquid chromatography and the methodological investigation was conducted. Results： Muxiang（Radix Aucklandiae）, Paojiang（baked ginger）,Danggui（angelica sinensis） and Chuanqiong（Ligusticum chuanxiong Hort） were all detected in thin-layer chromatography. The spots were clear and the specificity was strong with no interference to the negative control.When the injection amount of ferulic acid was in the range of 0.012,7-0.050,8 mg, it showed a good linear relationship to the peak area（r=0.999,9, n=5） with an average recovery rate of 98.49%（RSD%=1.6%, n=6）. Only if the detected ferulic acid（C（10）H（10）O4） was no less than 360 μg, this product is considered the one with enough Danggui（angelica sinensis）. Conclusion： This method is simple, reliable, specific and reproducible, and can be used for the quality control of Yimu Shenghua granules.