十七味大活血胶囊的质量标准研究.docVIP

十七味大活血胶囊的质量标准研究 　　[摘要] 目的 建立十七味大活血胶囊的质量标准。 方法 显微法对延胡索进行鉴别；薄层色谱法对三七、大黄进行鉴别；HPLC法测定丹酚酸B、苦杏仁苷的含量。丹酚酸B色谱条件为：以C18为色谱柱，流动相为乙腈-0.1%甲酸溶液（22∶78）；检测波长为286 nm；苦杏仁苷色谱条件为：以C18为色谱柱，流动相为甲醇-水（20∶80）；检测波长为210 nm。 结果 显微鉴别粉末特征明显；薄层鉴别斑点清晰，阴性无干扰；丹酚酸B在17.23～172.3 μg/mL范围内线性关系良好（r=1），平均回收率为97.9%，RSD为1.1%；苦杏仁苷在11.04～110.38 μg/mL范围内线性关系良好（r=0.9998），平均回收率为100.1%，RSD为1.5%。三批样品中两种成分的平均含量分别为1.57、0.41 mg/粒。 结论 该法准确、简单，适用于十七味大活血胶囊的质量控制。 　　[关键词] 十七味大活血胶囊；显微鉴别；薄层色谱；丹酚酸B；苦杏仁苷 　　[中图分类号] R927.2 [文献标识码] A [文章编号] 1673-7210（2016）04（c）-0147-05 　　[Abstract] Objective To establish the quality control of Shiqiweidahuoxue Capsules. Methods The microscopical identification was adopted to analyze rizoma corydalis. TLC method was used to identity radix notoginseng and rhubarb. The contents of slvianolic acid B and amygdalin were determined by HPLC method. Svianolic acid B was separated on C18 column with acetonitrile-0.1% formic acid solution （22∶78） as mobile phase， detection wavelength was 286 nm. Amygdalin was separated on C18 column with methanol-water （20∶80） as mobile phase， detection wavelength was 210 nm. Results Microscopic identification had powder characteristics of Rhizoma Corydalis. The spots were clear without interference in the blank reference. The linear ranges of salvianolic acid B and amygdalin were 17.23-172.3 μg/mL （r=1）， and 11.04-110.38 μg/mL （r=0.9998）. The average recoveries of salvianolic acid B and amygdalin were 97.9% （RSD=1.1%）， and 100.1% （RSD=1.5%）. Two average contents of 3 batches of samples were 1.57 mg/grain， 0.41 mg/grain. Conclusion The method is accurate and simple， which can be used for the quality control of Shiqiweidahuoxue Capsules. 　　[Key words] Shiqiweidahuoxue Capsules； Microscopical identification； TLC； Salvianolic acid B； Amygdalin 　　社会进步、交通发达、老龄化进程等因素使骨折的发生率逐年增加。骨折患者在早期常会发生肢体肿胀现象，使患肢无法得到充足的血液和营养供给[1]。如不及时处理，则引起组织康复时间延长、骨痂生长缓慢等情况[2]。 　　中医学认为骨伤初期及术后肿胀是由于外力损伤脉络，血溢脉外，滞留皮肉筋骨，使气机失调，津液输布受阻，水溢脉外，留滞在肌肤腠理之间，表现为肿胀[3]。在整个治疗过程中，中医治疗有明显的疗效，发挥着越来越大的作用[4-7]。 　　本方由丹参、茯苓