莪术油及其注射液指纹(特征)图谱的建立  

Establishment of HPLC Fingerprint (Specific Chromatograms) for Zedoary Turmeric Oil and Its Related Injections

作　　者：何欢[1] 袁文娟 马双成[1] 田颂九[1] 张启明[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]云南省食品药品检验所,昆明650011

出　　处：《中国药学杂志》2010年第10期784-790,共7页Chinese Pharmaceutical Journal

基　　金：国家十一五科技支撑计划项目(2006BAI14B01)

摘　　要：目的建立评价莪术油及其注射液HPLC指纹(特征)图谱的分析方法。方法色谱条件,色谱柱:Waters Symmetry C18(4.6mm×250mm,5μm);流动相为甲醇-水,梯度洗脱;流速:1.0mL.min-1;柱温:30℃;检测波长:215nm。在该色谱条件下,分别测定10批莪术油、15批莪术油注射液和13批莪术油葡萄糖注射液HPLC指纹(特征)图谱。结果莪术油与莪术油注射液HPLC指纹(特征)图谱相关性良好。与水蒸气蒸馏的莪术油对照图谱比较,超临界萃取莪术油的HPLC色谱图差异很大。结论莪术油及其注射液HPLC指纹(特征)图谱特征性及专属性强,可结合药材特征图谱用于全面控制药品质量。OBJECTIVE To establish a method for determining the fingerprints of zedoary turmeric oil and its related injections by HPLC.METHODS The analysis was performed on a Waters Symmetry C18 （4.6 mm×250 mm,5 μm） column.The mobile phase consisted of methanol-water with linear gradient elution.The flow rate was 1.0 mL·min^-1 and the temperature of column was 30 ℃.The UV detection wavelength was set at 215 nm.HPLC analysis was performed for 10 batches of zedoary turmeric oil,15 batches of zedoary turmeric oil injection and 13 batches of zedoary turmeric oil and glucose injection.RESULTS There was a good correlation in the HPLC fingerprint （specific chromatograms） of zedoary turmeric oil and its related injections.There was great difference between the zedoary turmeric oil which obtained by steam distillation and CO2-supercritical fluid extraction.CONCLUSION The HPLC fingerprints of zedoary turmeric oil and its related injections are characteristic and specific,and it can control the quality of zedoary turmeric oil injection combined with curcuma zedoary’s fingerprints.

关 键 词：莪术油 莪术油注射液 指纹(特征)图谱 质量控制 

分 类 号：R284[医药卫生—中药学]