顶空-气相色谱法测定舒肝宁注射液4种提取物中乙醇的残留量  

Determination of Residual Ethanol in Four Extraction of Shuganning Injection by Headspace Gas Chromatography

作　　者：何峰[1] 张昀 

机构地区：[1]贵州医科大学,贵州贵阳550004 [2]贵州瑞和制药有限公司,贵州贵阳550004

出　　处：《贵阳医学院学报》2016年第8期911-914,共4页Journal of Guiyang Medical College

基　　金：贵州省科技重大专项项目[黔科合重大专项字(2011)6019号]

摘　　要：目的：建立顶空一气相色谱法测定舒肝宁注射液中茵陈、栀子、板蓝根及灵芝提取物中乙醇残留量的方法。方法：采用ZB-624石英毛细管柱（30．0m×0．53mm×3μm），柱温采取程序升温的方法，载气为氮气，进样口温度为200℃，检测器温度为250℃，测定舒肝宁注射液上述4种提取物中乙醇残留量，探讨乙醇残留量检测的线性范围，回收率及最低检测限。结果：乙醇在15．46～773mg/L（r=0．9993）范围内线性关系良好，4种提取物的回收率均良好，最低检测限为11ng。结论：所建立的方法简单、灵敏、准确，可用于舒肝宁4种提取物中乙醇残留量的测定。Objective ： To determine the residual quantity of ethanol in four extracts （ wormwood, fruc- tus cardeniae , radix isatidis , and ganoderma lucidum ） in Shuganning injection by headspaee gas chro- matographic method. Methods： ZB-624 （30.0 m ×0.53 mm × 3 μm） column was used. The temper- ature programming was adopted for column temperature with carrying gas as nitrogen. Inlet temperature and FID detector were 200 ℃ and 250℃, respectively. The residual quantity of ethanol above-men- tioned 4 extracts in Shuganning injection was detected, and he linear range, recovery rate and the low- est detection limit of ethanol residue were discussed. Results： The result showed good linearity in the ethanol content range of 15.46 - 773 μg · mL- 1 （ r = 0. 999 3 ）, recovery of four kinds of extracts were good and the detection limit was 11 ng. Conclusion： This method is rapid, sensitive and accurate for detecting the residual ethanol in four extracts of Shuganning injection.

关 键 词：色谱法 气相 舒肝宁注射液 乙醇 残留量 

分 类 号：R917.7[医药卫生—药物分析学]