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颈椎康复丸质量标准研究

         

摘要

Objective To set up the quality standard of Cervical Vertebra Rehabilitation Pill. Methods TLC were used to the qualitative identification of Red-rooted Salvia and Rhizoma Cyperi in the preparation. The content of peoniflorin, the effective component of Radix Paeoniae Alba in the preparation, was determined by HPLC, using Agilent Eclipse XDB-C18 (150 mm×4.6 mm, 5 μm) and acetonitrile-0.1% phosphoric acid solution (14∶86) as mobile phase with flow rate of 1.0 mL/min. The column temperature was room temperature, and the detection wavelength was 230 nm. Results The TLC method for Root of Red-rooted Salvia and Rhizoma Cyperi identification showed strong specificity and good repetitiveness. Peoniflorin presented a good linear relationship within the range of 0.202 884-1.014 42 μg, and the recovery rate was 98.79%, RSD was 0.865% (n=5). Conclusion These methods are useful for quality control and improvement of Cervical Vertebra Rehabilitation Pill.%目的 建立颈椎康复丸质量标准.方法 采用薄层色谱法对制剂中丹参、香附进行定性鉴别.采用高效液相色谱法对制剂中白芍的有效成分芍药苷进行含量测定.Agilent Eclipse XDB-C18 (150 mm×4.6 mm,5 μm)色谱柱,乙腈-0.1%磷酸溶液(14∶86)为流动相,流速1.0 mL/min,柱温为室温,检测波长230 nm.结果 丹参、香附的薄层鉴别专属性强,重复性良好.芍药苷在0.202 884~1.014 42 μg范围内呈良好的线性关系,平均加样回收率为98.79%,RSD=0.865%(n=5).结论 本方法能很好地控制产品的质量,有利于颈椎康复丸质量的提升.

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