注射用双黄连指纹图谱的研究  

Fingerprinting of Shuanghuanglian powder injection

作　　者：贺璐[1] 冷光[2] 张淑秋[1] 

机构地区：[1]山西医科大学药学院临床药学教研室,太原030001 [2]山西医科大学第一医院药剂科

出　　处：《中国药物与临床》2011年第6期621-623,共3页Chinese Remedies & Clinics

基　　金：山西省自然科学基金(2007011088)

摘　　要：目的建立注射用双黄连冻干粉指纹图谱的高效液相色谱分析方法,并对10批注射用双黄连进行相似性评价。方法采用C18(150mm×4.6mm,5μm)色谱柱,流动相为甲醇-0.25%冰醋酸,流速为1.0ml/min,检测波长350nm,柱温30℃,梯度洗脱的方法进行色谱分离。结果得到注射用双黄连及其对照品的指纹图谱,并对10批样品进行相似性评价,结果>0.97。结论 10批产品质量稳定,指纹谱检测方法简便、可靠,可用于注射用双黄连的质量控制及进一步安全性研究。Objective To establish the fingerprints of freeze-dried Shuanghuanglian powder injection by high performance liquid chromatography （HPLC） and to evaluate the comparability of 10 batches of Shuanghuanglian powder injection.Methods A column of Diamosil C18 （150 mm×4.6 mm,5 μm） was used for separation.The mobile phase consisted of methanol and 0.25% acetic acid,delivered at a flow-rate of 1.0 ml/min using a gradient elution mode.The UV detection wavelength was set at 350 nm and column temperature was kept at 30 ℃.Results Fingerprints of Shuanghuanglian powder injection and of reference standards were established.The similarity factor for 10 batches of samples was over 0.97.Conclusion The quality of 10 batches of Shuanghuanglian powder injection in this study was stable.The fingerprinting detection method appears easy to use and reliable,and therefore can be used for quality control of Shuanghuanglian powder injection or in further studies of safety profiles.

关 键 词：双黄连注射剂 图谱 色谱法 高压液相 

分 类 号：R286[医药卫生—中药学]