润肠合剂质量标准的建立

Establishment of Quality Standard for Runchang Mixture

目的：探讨润肠合剂的质量控制方法。方法：采用薄层色谱法对润肠剂中肉苁蓉、白术、芦荟、灵芝进行定性鉴别。采用高效液相色谱法测定润肠合剂中白术内酯Ⅰ和白术内酯Ⅲ含量：色谱柱为Agilent ZORBAXDB-C18柱（4.6 mm×250 mm,5μm）,流动相为甲醇-水（70∶30,V/V）,流速1.0 m L/min,柱温为25℃,检测波长为220 nm。结果：肉苁蓉、白术、芦荟、灵芝TLC鉴别具有较好的专属性,阴性对照无干扰。白术内酯Ⅰ和白术内酯Ⅲ的进样量分别在0.1649-0.9894、0.3075-1.8432μg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）;二者精密度、稳定性、重复性试验的均RSD〈3%;平均加样回收率分别为100.7%和99.9%,RSD分别为1.65%和2.03%（n=6）。结论：所建标准可用于润肠合剂的质量控制。

Objective：To establish the quality standard of Runchang mixture. Methods：Cistanche,Atractylodes,Ganoderma lucidum,aloe vera were identified by TLC. The content of AtractylenolideⅠ and Atractylenolide III in Atractylodes was determined by HPLC：the determination was performed on Agilent ZORBAXDB-C18（4.6 mm×250 mm,5 μm）column with mobile phase consisted of Methanol and water（70∶30,V/V）at the flow rate of 1.0 m L/min. The column temperature was 25℃,and the detection wavelength was set at 220 nm for AtractylenolideⅠ and Atractylenolide III. Results：TLC identification methods of 4 materials had good specificities without interference from negative control. For AtractylenolideⅠ,linear range was 0.1649-0.9894 μg and the average recovery was 100.7.22%,RSD was 1.65%（n=6）;and for Atractylenolide III,linear range was 0.3075-1.8432 μg and the average recovery was 99.9%,RSD was 2.03%（n=6）.Conclusions：The established standard can be used for the quality control of Runchangmixture.