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目的建立通脑溶栓胶囊的质量控制方法。方法采用薄层色谱法对制剂中的粉葛、黄芪、鸡血藤和赤芍进行定性鉴别;采用高效液相色谱法对制剂中的粉葛所含成分葛根素进行含量测定。色谱柱:C18色谱柱(4.6 mm×150 mm,5μm);流动相:甲醇-水(25∶75);检测波长:250 nm。结果在薄层色谱中均能检出粉葛、黄芪、鸡血藤和赤芍;葛根素进样量在0.06784~0.40704μg范围内与峰面积呈良好的线性关系,r=0.9998,平均回收率为98.9%(n=6),RSD为1.1%。结论本研究所建立的方法简便,准确,重复性好,可用于通脑溶栓胶囊的质量控制。
Objective To establish a quality control method for Tongrui thrombosis capsule. Methods TLC, HPLC, Radix Astragali, Radix Astragali and Radix Paeoniae Rubra were identified qualitatively. The contents of puerarin in Radix Puerariae were determined by high performance liquid chromatography. Column: C18 column (4.6 mm × 150 mm, 5 μm); mobile phase: methanol-water (25:75); detection wavelength: 250 nm. Results The contents of Pueraria lobata, Radix Astragali, Millettia radix and Radix Paeoniae Rubra were all detected in the thin layer chromatogram. The injection volume of Puerarin showed a good linear relationship with the peak area in the range of 0.06784 ~ 0.40704μg, r = 0.9998, the average recovery was 98.9% (n = 6), RSD 1.1%. Conclusion The method established in this study is simple, accurate and reproducible. It can be used for the quality control of thrombolytic capsules.