丙泊酚注射液中溶血磷脂的测定  

Determination of Lysophosphatidylcholine In Propofol Injection

作　　者：汤毅 江桂生 岳峰 刘丽芳[3] 高越 

机构地区：[1]广州中大创新药物研究与开发中心有限公司,广州510060 [2]清远嘉博制药有限公司,广东清远511517 [3]广州市药品检验所,广州510080

出　　处：《中国药品标准》2011年第2期126-129,共4页Drug Standards of China

摘　　要：目的：建立一种用检测含卵磷脂注射剂中卵磷脂分解产物-溶血磷脂的HPLC测定方法。方法：采用C18色谱柱，流动相为磷酸溶液．乙腈，梯度洗脱；检测波长为210nm。结果：溶血磷脂的峰面积（Y）与浓度（X）在0．05～0．4mg·mL-1范围内具有良好线性关系，Y=345810X-1572．64，r=0．9995（／Z=5），溶血磷脂的检测限为1．1μg，精密度RSD为3．6％（n=6）。供试品溶液在制备后11h内稳定；样品测定的重复性的RSD为3．1％（n=5）。结论：本方法专属性强、准确、可靠，可用于丙泊酚注射剂中溶血磷脂的检查方法。Objective： To establish an HPLC method for testing lysophosphatidylcholine in the injection containing decompound prod- uct of lecithin. Method： A C j8 column was used with the mobile phase of phosphoric acid-acetonitrile, gradient elution, detection wavelength was 210 nm. Results： The peak area of lysophosphatidylcholine （Y） and concentration （X） in the 0.05 -0. 4 mg·mL-1 range has a good linear relationship within the framework Y = 345 810X-1 572. 64, r = 0. 999 7 （n = 5 ）, the detection limit of lysophosphatidylcholine was 1.1μg. Sampling precision of RSD was 3.6% （n =6）. The solution for testing was stability within 11 hours after preparation. Sample repeatability RSD for the determination was 3. 1% （ n = 5 ）. Conclusion ： The method is specific, accurate, and reliable. It can be used for the quality control of lysophosphatidylcholine in propofol injection.

关 键 词：HPLC法 卵磷脂 溶血磷脂 丙泊酚注射液 

分 类 号：R927[医药卫生—药学]