论文部分内容阅读
目的:建立HPLC测定疏经防痛胶囊中芍药苷、丹参酮ⅡA含量的方法,为该制剂的临床推广提供参考。方法:芍药苷和丹参酮ⅡA的色谱柱分别选择Luna 5u C18(4.6 mm×250 mm,5μm)和Diamonsil C18(4.6 mm×250 mm,5μm),流动相分别为0.05%磷酸二氢钾-乙腈(85∶15)和甲醇-水(80∶20),检测波长分别为230 nm和270 nm,进样量分别为10μL和20μL,柱温均为25℃。结果:芍药苷、丹参酮ⅡA的线性范围分别为0.020 4~0.204,0.043 2~0.864μg;平均加样回收率分别为99.89%(RSD 1.5%),100.43%(RSD 1.1%),重复性、稳定性、精密度试验的RSD均<2%。结论:建立的方法简便、定量准确、重复性好,适用于疏经防痛胶囊的质量控制。
OBJECTIVE: To establish a HPLC method for the determination of paeoniflorin and tanshinone ⅡA in Shujing anti-pain capsule, and to provide a reference for the clinical application of this preparation. Methods: Paeoniflorin and tanshinone Ⅱ A were separated on the column of Luna 5u C18 (4.6 mm × 250 mm, 5 μm) and Diamonsil C18 (4.6 mm × 250 mm, 5 μm) respectively. The mobile phases were 0.05% potassium dihydrogen phosphate - acetonitrile 85:15) and methanol-water (80:20). The detection wavelength was 230 nm and 270 nm, respectively. The injection volumes were 10 μL and 20 μL, respectively. The column temperature was 25 ℃. Results: The linear ranges of paeoniflorin and tanshinone ⅡA were 0.020 4 ~ 0.204 and 0.043 2 ~ 0.864 μg, respectively. The average recoveries were 99.89% (RSD 1.5%) and 100.43% (RSD 1.1%) respectively, with reproducibility and stability RSD of both sex and precision tests were <2%. Conclusion: The established method is simple, accurate and reproducible, and it is suitable for quality control of Shujing anti-pain capsule.