李 祥，梁 颖，杨新建(天津市中医药研究院附属医院，天津 300120)

    齐墩果酸滴丸的质量标准研究

    李 祥*，梁 颖#，杨新建(天津市中医药研究院附属医院，天津 300120)

    目的：建立齐墩果酸滴丸的质量标准。方法：鉴别制剂性状，检测制剂重量差异、溶散时限；采用超高效液相色谱法测定制剂中齐墩果酸的含量：色谱柱为ACQUITY UPLC BEH C18，流动相为乙腈-水(70∶30，V/V)，流速为0.30 mL/min，检测波长为206 nm，柱温为30℃，进样量为5 μL。结果：制剂鉴别特征明显，丸重差异为37.62%～46.56%，溶散时间均为24 min。齐墩果酸检测质量浓度线性范围为0.006～0.06 mg/mL(r＝0.999 8)；精密度、稳定性、重复性试验的RSD<2.0%；加样回收率为99.34%～100.40%(RSD＝0.4%，n＝6)。结论：该研究所建标准可用于齐墩果酸滴丸的质量控制。

    齐墩果酸滴丸；超高效液相色谱法；齐墩果酸；质量标准

    ABSTRACTOBJECTIVE：To establish the quality standard of Oleanolic acid dripping pills.METHODS：The property of the preparation was identified，and weight difference and dissolution time limit were detected.UPLC method was adopted to determine the content of oleanolic acid in the preparation.The determination was performed on ACQUITY UPLC BEH C18column with mobile phase consisted of acetonitrile-water(70∶30，V/V)at the flow rate of 0.30 mL/min.The detection wavelength was set at 206 nm ......