加味当归补血汤浓缩丸质量标准研究

Study on Quality Standard of Jiawei Danggui Buxuetang Concentrated Pill

目的建立加味当归补血汤浓缩丸的质量标准。方法采用薄层色谱法对加味当归补血汤浓缩丸中的当归、黄芪、麦冬、熟地黄进行定性鉴别;采用高效液相色谱法测定制剂中阿魏酸的含量,色谱柱:AgilentZorbax Extend-C18(4.6mm×250mm,5μm);流动相乙腈-0.085%磷酸(17:83);检测波长:316nm;流速:1.0ml/min;柱温:35℃。结果当归、黄芪、麦冬、熟地黄特征斑点清晰,分离度好,阴性对照无干扰。阿魏酸在24.144～120.72ng范围内呈良好的线性关系,r=1.00,平均回收率为101.94%,相对标准偏差值(RSD)=0.56%(n=6)。结论所建立的方法简便准确,专属性、重复性好,可作为加味当归补血汤浓缩丸的质量控制标准。

Objective To establish the quality standard of Jiawei Danggui Buxuetang concentrated pill. Methods Radis Angelicae Sinensis, Radix Astragali, Radix Ophiopogonis and Radix Rehmanniae Praeparata were identified by TLC. The content of ferulic acid was determined by HPLC. Agilent Zorbax Extend - C18 column was used （4.6 mm ×250 mm, 5 μm）. The mobile phase was consisted of Acetonitrile - 0.085 % phosphoric acid （ 17 ： 83 ） solution. The flow rate was 1.0 ml/min,and column temperature was at 35~C. The detection wave length was at 316 nm. Results The spots on TLC plates were clear without interference in the blank reference. The linearity range of ferulic acid was 24. 144 - 120. 72 ng, r = 1.00. The average recovery of ferulic acid was 101.94%, and RSD was 0. 56% （ n = 6）. Conclusion The estab- lished method is easy, accurate and reproducible. It can be used for the quality control of Jiawei Danggui Buxuetang con- centrated pill.