复方贞芪颗粒的质量标准研究

Quality Standard of Compound Zhenqi Granula

目的建立复方贞芪颗粒的质量标准。方法采用薄层色谱法(TLC)对处方中黄芪、刺五加、白芍3味中药进行定性鉴别,采用高效液相色谱法(HPLC)对制剂中的齐墩果酸含量进行定量测定。结果 TLC法能定性检出黄芪、刺五加、白芍,斑点清晰,且阴性对照无干扰;HPLC法测定齐墩果酸在0.493 0～0.030 8 mg/mL之间呈现良好的线性关系,r=0.999 9;平均加样回收率为101.87%,RSD=1.50%。结论所建立的定性、定量检测方法操作简便、结果准确可靠、重现性好,能有效地控制复方贞芪颗粒的质量。

Objective To establish the quality standard for Compound Zhenqi Granula. Methods The qualitative identification of Radix Astragali, Radix et Rhizome Aeanthopanaeis Sentieosi and Rhizoma Atractylodis Macrocephalaewas carried out by TLC, and the content of oleanonic acid was determined by HPLC. Results The relevant spots on TLC plates were clear without any interference by the blank reference. The content of oleanonic acid showed a good linearity in the range of 0.493 0-0.030 8 mg/mL. The average recovery rate was 101.87 % and RSD was 1.50 %. Conclusion Established qualitative and quantitative method are simple, accurate, reliable and reproducible, and can be effectively used for the quality standards of Compound Zhenqi Granula.