香砂理中丸质量标准改进研究

Improvement of Quality Standard of Xiangsha Lizhong Pills

目的:改进香砂理中丸的质量标准。方法:显微鉴别方中党参、干姜、白术、砂仁和甘草;采用薄层色谱(TLC)法对白术、甘草进行定性鉴别;用高效液相色谱(HPLC)法测定木香中木香烃内酯和去氢木香内酯的含量。结果:显微鉴别法、TLC法图片清晰、专属性强;木香烃内酯、去氢木香内酯进样量分别在0.02～0.99、0.04～1.80μg范围内与各自峰面积积分值呈良好的线性关系(r均为0.9999),平均加样回收率分别为96.85%、99.34%,RSD分别为1.47%、3.24%(n均为6)。结论:本试验完善了香砂理中丸的质量标准。

OBJECTIVE： To improve the quality standard of Xiangsha lizhong pills. METHODS： Radix Codonopsis,Zingiber officinale, Atractylodes macrocephala, Fructus Amomi and Radix et Rhizoma Glycyrrhizae in the prescription were identified under microscope; A. macrocephala and Radix et Rhizoma Glycyrrhizae in Xiangsha lizhong pills was identified qualitatively by TLC; the content of costunolide and dehydrocostuslactone were determined by HPLC. RESULTS： The chromatograms of microscope and TLC were distinct and highly specific. The linear range of costunolide was from 0.02 to 0.99 μg（r=0.999 9）with an average recovery of 96.85%（RSD=1.47%,n=6）. The linear range of dehydrocostuslactone was from 0.04 to 1.80 μg （r=0.999 9） with an average recovery of 99.34%（RSD=3.24%,n=6）. CONCLUSION： The results are conducive to the improvement of quality standard of Xiangsha lizhong pills.