乳癌术后方HPLC特征图谱的研究.docVIP

乳癌术后方HPLC特征图谱的研究 　　[摘要] 目的 建立临床有效验方乳癌术后方的HPLC特征图谱。 方法 使用Agilent Extend-C18色谱柱（4.6 mm×250 mm，5 μm）；以乙腈-0.05%磷酸溶液为流动相梯度洗脱，流速：1.0 mL/min；柱温为25℃；检测波长270 nm；以上述方法制备乳癌术后方提取液，获得特征峰，检测上述制备方法的重复性、精密度、稳定性和相似度。 结果 该方法重复性相对保留时间的RSD分别为0.06%、0.03%、0.02%、0.02%和0.04%，精密度相对保留时间的RSD分别为0.09%、0.02%、0.02%、0.008%、0.05%，稳定性相对保留时间的RSD分别为0.08%、0.03%、0.02%、0.02%和0.04%，均良好。采用该方法测定3批次乳癌术后方，均标示出6个共有峰，且相似度均高于95%。 结论 该研究为乳癌术后方的进一步物质基础研究及质量评价奠定了基础。 　　[关键词] 乳癌术后方；HPLC；特征图谱 　　[中图分类号] R284.1 [文献标识码] A [文章编号] 1673-7210（2017）05（a）-0004-05 　　HPLC specific chromatogram of Ruai Shuhou Recipe 　　SHAO Shijun1 WU Xueqing1 WAN Hua1 DU Ruofei2 FENG Yi2 　　1.Department of Galactophore， Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine， Shanghai 200021， China； 2.Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine， Shanghai University of Traditional Chinese Medicine， Shanghai 201203， China 　　[Abstract] Objective To establish the specific chromatogram of clinically proved effective Ruai Shuhou Recipe. Methods Agilent Extend-C18 cloumn （4.6 mm×250 mm， 5 μm） was adopted， with acetonitrile and water containing 0.05% phosphoric acid as the mobile phase， and the flow rate was 1.0 mL/min. The column temperature was set at 25℃， and the detection wavelength was 270 nm. This method was used to prepare the extract of Ruai Shuhou Recipe， and obtain specific chromatographic peaks. Meanwhile the repeatability， precision， stability and similarity were detect by this method. Results Good repeatability （RSD relative retention time were 0.06%， 0.03%， 0.02%， 0.02%， 0.04%）， precision （RSD relative retention time were 0.09%， 0.02%， 0.02%， 0.008%， 0.05%） and stability （RSD relative retention time were 0.08%， 0.03%， 0.02%， 0.02%， 0.04%） were proved. Three batches of Ruai Shuhou Recipe all showed 6 common specific chromatographic peaks with similarities above 0.95. Conclusion The study lays a foundation for the further study of material basis and quality ev