少腹逐瘀丸质控方法研究
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中央财政公共卫生专项(Z135080000022); 河北省自然科学基金(H2016208059)


Study on quality control methods of Shaofu Zhuyu pills
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    摘要:

    为了解决现行《中华人民共和国药典》中关于少腹逐瘀丸的鉴别存在项目单一、不同剂型之间质控标准不统一等问题,通过对处方中主要药效成分进行定性和定量研究,建立了一种更为全面的少腹逐瘀丸质控方法。采用薄层色谱法定性鉴别处方中的蒲黄、延胡索、肉桂3味药材,通过高效液相色谱法测定芍药苷的含量。结果表明:在薄层色谱图中观察到蒲黄、延胡索、肉桂药材的特征斑点,芍药苷进样量在0.128~1.28 μg范围内线性关系良好,精密度、稳定性、重复性试验的RSD值均小于2.0%,平均回收率为92.10%,RSD值为1.40%(n=9),芍药苷含量的建议值不低于1.20 mg/g。所建立的方法准确可靠,可行性高,重复性良好,可以作为完善少腹逐瘀丸质量标准的参考依据。

    Abstract:

    In order to solve the problems in the identification of Shaofu Zhuyu pills in the current pharmacopoeia of the People's Republic of China, such as single items and inconsistent quality control standards among different dasage forms, a more comprehensive quality control method for Shaofu Zhuyu pills was established by qualitative and quantitative research on the main pharmacodynamic components in the prescription. Three medicinal herbs including Pollen typhae, Corydalis Rhizoma and Cinnamon in the prescription are identified by TLC, and the content of Paeoniflorin in Shaofu Zhuyu pills is determined by HPLC. Characteristic spots of Pollen typhae, Corydalis Rhizoma and Cinnamon are observed in the thin-layer chromatogram. The linearity of Paeoniflorin is investigated and the results show a good linear relationship in the range of 0.128~1.28 μg. The RSDs of precision, the stability test and the reproducibility are all no more than 2.0%, the average recovery if of 92.10%, and the RSD is of 1.40%(n=9). It is suggested that the content limit of Paeoniflorin should not be less than 1.20 mg/g. The established method is accurate and reliable with high feasibility and good repeatability, and can provide the basis for the total quality control of Shaofu Zhuyu pills.

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史利瑶,李建晨,田 蜜.少腹逐瘀丸质控方法研究[J].河北科技大学学报,2019,40(3):208-214

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  • 收稿日期:2019-01-29
  • 最后修改日期:2019-03-29
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  • 在线发布日期: 2019-06-27
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