HPLC法快速测定生脉注射液指纹图谱  

Rapid Detection of Fingerprint of Shengmai Injection by HPLC

作　　者：赵炳祥 董礼 

机构地区：[1]华润三九(雅安)药业有限公司,四川雅安625000

出　　处：《中国中医急症》2016年第6期965-966,1004,共3页Journal of Emergency in Traditional Chinese Medicine

基　　金：国家重大新药创制科技重大专项(2009ZX09502-030)

摘　　要：目的采用小粒径色谱柱和HPLC法,建立生脉注射液指纹图谱快速测定方法。方法色谱柱采用Waters X-Bridge^(TM) BEH Shield RP18(4.6 mm×100 mm,2.5μm);流动相为乙腈-水,梯度洗脱;流速为2 mL/min;检测波长为203 nm;柱温为30℃;进样量为4μL。检测10批生脉注射液,并建立对照指纹图谱。以指纹图谱轮廓计算快速法对照指纹图谱与法定对照指纹图谱相似度。结果快速法对照指纹图谱与法定对照指纹图谱相似度为0.944。结论快速测定法色谱轮廓与法定标准法一致。该方法检测快速、准确、可靠,可取代法定标准中指纹图谱检测法。Objective： To establish a rapid detection of the fingerprint of Shengmai injection with small diameter column and HPLC method. Method： The analysis was performed on a Waters X-Bridge^（TM） BEH Shield RP18（4.6mm× 100 mm,2.5 μm）. Mobile phase was acetonitrile-water with gradient elution;flow rate was 2.0mL/min;detection wavelength at 203 nm;column was 30 ℃,and injection volume was 4 μL. Then it conducted a new standard fingerprint by ten batches of Shengmai injection detection with the new method,and rapid method for calculating contour of fingerprints were compared between new standard fingerprint and legal standard fingerprint with profile data to find out the similarity. Result： The similarity between rapid standard fingerprint and legal standard fingerprint was 0.944. Conclusion： The chromatographic profile of the new method IS consistent with the legal standard chromatographic profile. And it is rapid,accurate and stable,which can replace the detection method of fingerprint in legal standard.

关 键 词：指纹图谱 生脉注射液 快速测定 相似度 

分 类 号：R91[医药卫生—药学]