乌药干浸膏质量标准研究

Quality standard of Linder aggregata dry extract

目的研究乌药干浸膏的质量标准。方法采用TLC法对制剂中乌药进行定性鉴别；采用HPLC法对制剂中乌药醚内酯进行含量测定。HPLC法条件：HypersilODS2柱（250mm×4．6mm，5μm），流动相为乙腈-水（56：44），检测波长为235nm，流速为0．5mL·min^-1，柱温为20℃。结果采用TLC法可鉴别出与乌药对照药材相对应的位置上，显相同颜色的斑点；乌药醚内酯在0．08～0．40μg（r=0．9996）呈良好的线性关系；平均加样回收率为99．50％，RSD=2．69％。结论所建立的质量标准鉴别测定专属性强，定量方法简便、准确，可以用来评价乌药干浸膏的质量。

Objective To determine quality standards of Linder aggregata dry extract. Methods TLC method was used in the preparation to identify Linder aggregata. HPLC method was used to determine Linderane in the preparation. The HPI.C conditions were： Hypersil ODS2 （250 mm× 4. 6 mm, 5 μm）, mobile phase of acetonitrile -water （96 ： 4） mixture, with detection at 235 nm, flow rate 0.5 mL · min 1, and temperature 20 ℃. Results TLC method could be used to identify and control Lindera aggregata corresponding to the location of the medicine, with the same color spots . The linear range of Linderane was 0. 08-0.40 μg （r=0. 999 6）, the recovery was 99.50%, and RSD was 2.69%. Conclusion The quality standard established by the specific and quantitative method is simple and accurate. It can be used to evaluate the quality of Lindera aggregata dry extract.