摘要
目的建立丁桂儿脐贴HPLC指纹图谱分析方法,为其质量控制提供新方法。方法对丁桂儿脐贴HPLC指纹图谱测定方法的专属性、精密度、重复性、稳定性和耐用性进行考察。选用指纹图谱测定方法对3批次丁桂儿脐贴样品进行测定,采用国家药典委员会《中药色谱指纹图谱相似度评价系统》(2012版本)进行相似度评价。结果建立了丁桂儿脐贴HPLC指纹图谱测定方法,色谱条件:AgilentZORBAXSB-C18色谱柱(250mm×4.6mm,5μm),甲醇为流动相A,0.2%甲酸溶液为流动相B,梯度洗脱(0-15min,8%-25%A;15-25min,25%-40%;25-50min,40%-70%;50-90min,70%-90%A),检测波长254nm,柱温30℃,流速1.0ml/min,进样量10μl。指纹图谱中共确定了12个共有峰,6号峰为对照峰(S)(桂皮醛),测定方法的专属性、精密度、重复性、稳定性和耐用性良好,供试品指纹图谱与对照指纹图谱的相似度均在0.9以上。结论建立的丁桂儿脐贴HPLC指纹图谱方法分离效果好、准确、高效,为丁桂儿脐贴质量评价提供了新方法。
Objective To establish the HPLC fingerprint of Ding Gui Er Qi Tie in order to provide a new method for its quality control.Methods The specificity,precision,repeatability,stability and durability of the HPLC fingerprint of Ding Gui Er Qi Tie were investigated.Three batches of Ding Gui Er Qi Tie samples were determined,and the similarity was evaluated by the Similarity Evaluation System for Chromatographic Fingerprint of TCM(2012 A edition).Results HPLC fingerprint of Ding Gui Er Qi Tie was established on Agilent ZORBAX SB-C18 chromatographic column(250 mm×4.6 mm,5μm).Methanol(A)and 0.2%formic acid(B)were used to elute the samples under gradient conditions(0-15 min,8%-25%A;15-25 min,25%-40%;25-50 min,40%-70%;50-90 min,70%-90%A).The detection wavelength was 254 nm,the column temperature was 30℃,the flow rate was 1.0 ml/min,and the injection volume was 10μl.A total of 12 common peaks were identified in the fingerprint,and the sixth peak was the control peak(S)(cinnamaldehyde).The specificity,precision,repeatability,stability and durability of the method were good.The similarity between the fingerprint and the control fingerprint was above 0.9.Conclusion The HPLC fingerprint can be used as an effective and accurate method for the quality control,which provides a new method for quality evaluation of Ding Gui Er Qi Tie.
作者
刘军
郑晓芬
周丽娟
周海燕
杨海燕
曹建军
LIU Jun;ZHENG Xiaofen;ZHOU Lijuan;ZHOU Haiyan;YANG Haiyan;CAO Jianjun(Yabao Pharmaceutical Group Co.Ltd.,Yuncheng 044600,China)
出处
《山西医科大学学报》
CAS
2019年第7期985-991,共7页
Journal of Shanxi Medical University
关键词
丁桂儿脐贴
高效液相色谱法
指纹图谱
相似度
Ding Gui Er Qi Tie
high performance liquid chromatography
fingerprint
similarity
