野木瓜注射液HPLC指纹图谱研究  

Study on HPLC fingerprint of Yemugua injection

作　　者：杨毅生 钟瑞建 洪挺 王栋 

机构地区：[1]江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心,江西南昌330029 [2]江西省食品检验检测研究院,江西南昌330046

出　　处：《中国医药科学》2015年第19期58-60,78,共4页China Medicine And Pharmacy

基　　金：江西省自然科学基金(20142BAB205086)

摘　　要：目的建立野木瓜注射液HPLC指纹图谱分析方法。方法应用反相高效液相色谱法,采用Zorbax SB-C18（4.6mm×250mm,5μm）色谱柱,以乙腈（A）-0.5%冰醋酸溶液（B）为流动相进行梯度洗脱（0~40min,95%→70%B;40~60min,70%→50%B）,流速1.0m L/min,检测波长为326nm,柱温为25℃。结果通过指纹图谱相似度评价软件,对35批野木瓜注射液的HPLC指纹图谱进行了相似度计算,结果均〉0.90。结论该方法简单可行,可用于野木瓜注射液的质量控制与评价。Objective To establish the HPLC fingerprint analysis for the quality of Yemugua injection. Methods RP-HPLC method was conducted on a Zorbax SB-C18 column（4.6mm×250mm,5μm）with the gradient elution solvent system composed of acetontrile（A） and 0.5% acetic acid（B）（0 ~ 40 min,95% → 70% B;40 ~ 60 min,70% → 50% B）. The flow rate was 1.0m L/min,the detection wavelength was set at 326 nm and the column temperature was maintained at 25℃. Results Using special software,we got the HPLC fingerprint similarity of 35 injection and found the similarity 〉0.90. Conclusion The method is simple and reliable,and it is capable of effectively controlling the quality of Yemugua injection.

关 键 词：野木瓜注射液 反相高效液相色谱法 指纹图谱 

分 类 号：R284[医药卫生—中药学] R286[医药卫生—中医学]