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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 explore the quality control method of Runchang Mixture. Methods: Cistanche tuberculosis, Atractylodes macrocephala, Aloe vera and Ganoderma lucidum were identified by TLC. The content of atractylenolide Ⅰ and atractylenolide Ⅲ in Runchang mixture was determined by HPLC. The column was Agilent ZORBAXDB-C18 column (4.6 mm × 250 mm, 5 μm) with the mobile phase of methanol-water (70:30 , V / V), flow rate 1.0 m L / min, column temperature 25 ℃, detection wavelength 220 nm. Results: Cistanche, Atractylodes, Aloe, Ganoderma lucidum TLC identification has better specificity, negative control without interference. The injection volume of atractyloside I and atractyloside III in the range of 0.1649 ~ 0.9894,0.3075 ~ 1.8432μg showed a good linear relationship with their respective peak area integrals (r = 0.9999). The precision and stability of both , RSDs of reproducibility were all less than 3%. The average recoveries were 100.7% and 99.9%, respectively, with RSDs of 1.65% and 2.03%, respectively (n = 6). Conclusion: The standard can be used for quality control of Runchang mixture.