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目的:建立吴茱萸降压颗粒的质量控制方法。方法:采用TLC方法对制剂中吴茱萸、人参、泽泻、大枣进行定性鉴别;采用HPLC法对制剂的主药吴茱萸中吴茱萸次碱、吴茱萸碱进行含量测定。采用SHIMADZU C18柱(150mm×4.6mm,5μm),以甲醇-水(70:30)为流动相,流速1.0mL.min-1,柱温25℃,检测波长225nm。结果:吴茱萸、人参、泽泻、大枣的定性鉴别方法专属性强,阴性无干扰;吴茱萸次碱、吴茱萸碱加样回收率(n=5)分别为100.2%和101.2%,RSD为1.3%和1.0%;吴茱萸次碱、吴茱萸碱进样量在0.33～1.64μg和0.24～1.18μg范围内与峰面积呈良好的线性关系。结论:本法简便可行,重复性好,可用于该制剂的质量控制。
Objective: To establish a method for quality control of blood pressure-reducing granules from Wusong. Methods: TLC method was used to qualitatively identify Evodia rutaecarpa, ginseng, Alisma jujube and jujube in the preparation. The main drug of the preparation, Evodia rutaecarpae and Evodiamine, was determined by HPLC. A SHIMADZU C18 column (150 mm×4.6 mm, 5 μm) was used with a methanol-water (70:30) mobile phase, a flow rate of 1.0 mL.min-1, a column temperature of 25° C., and a detection wavelength of 225 nm. RESULTS: The qualitative identification methods of E. wuxi, Ginseng, Alisma and jujube were highly specific, and there was no interference in negative. The recoveries of evodiamine and evodiamine (n=5) were 100.2% and 101.2%, respectively, and the RSD was 1.3%. And 1.0%; Rutaecarpine, evodiamine injection volume in the range of 0.33 ~ 1.64μg and 0.24 ~ 1.18μg within a good linear relationship with the peak area. Conclusion: This method is simple, feasible and reproducible. It can be used for the quality control of the preparation.