Study on quality control of Jianpibushen granules
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摘要: 目的 建立健脾补肾颗粒的质量标准。 方法 采用薄层色谱法（TLC）鉴别制剂中黄芪、丹参、党参、陈皮和白芍五味药材。用高效液相色谱法（HPLC）测定白芍中芍药苷的含量：色谱柱：Agilent Eclipse Plus C18柱（4.6 mm×250 mm，5 μm）；流动相：乙腈-0.1%磷酸水溶液梯度洗脱；流速：1.0 ml/min；柱温：25℃；检测波长：230 nm。 结果 5种药材的TLC图谱斑点清晰，无阴性对照干扰；芍药苷在8.676~277.632 μg/ml范围内线性关系良好，（r=0.999 9）。 结论 该法操作简单、重复性好，能够有效控制健脾补肾颗粒的质量。Abstract: Objective To establish a quality standard for Jianpibushen granules. Methods The five main ingredients of the formulation:Astragalus membranaceus, Salvia miltiorrhiza Bunge, Codonopsis pilosula, Citrus reticulata Blanco and Paeonia lactiflora Pall, were identified by thin layer chromatography (TLC) respectively. The content of peoniflorin in Paeonia lactiflora was determined by high performance liquid chromatography (HPLC). The separation was performed on Agilent Eclipse Plus C18 column(4.6 mm×250 mm, 5 μm). The mobile phase was acetonitrile and 0.1% potassium dihydrogen phosphate solution for gradient elution. The flow rate was 1 ml/min, the column temperature was 25℃, the UV detection was performed at 230 nm. Results The spots in TLC were clear without interference in negative control. A good linear relationship was shown within the range of 8.676-277.632 μg/ml for peoniflorin (r=0.999 9). Conclusion This method is simple, accurate and reproducible, and can be used as an effective quality control of Jianpibushen granules.
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Key words:
- Jianpibushen granules /
- quality standard /
- peoniflorin /
- TLC /
- HPLC
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