丙泊酚纳米注射液中溶血磷脂的含量测定及溶血性评价  

Determination of Lysolecithin and in Vitro Hemolysis of Propofol Nano-Injection

作　　者：蔡伟惠[1] 姚成丽[1] 居敏俐[1] 杨珲珲[1] 邓万定[1] 金方[1] 

机构地区：[1]上海医药工业研究院上海呼吸系统药物工程技术研究中心,上海200040

出　　处：《中国药学杂志》2013年第3期212-215,共4页Chinese Pharmaceutical Journal

基　　金：中国食品药品检定研究院化学新药质量标准研究与评价技术平台资助项目(2011ZX09303-001)

摘　　要：目的测定丙泊酚纳米注射液的溶血磷脂含量及体外溶血性。方法建立HPLC测定溶血磷脂的方法,色谱柱为Plati-sil C18(4.6 mm×250 mm,5μm);流动相A为乙腈-水(9∶1),流动相B体积分数为0.2%磷酸水溶液(三乙胺调节pH至2.5),线性梯度洗脱:0 min,60%A;15 min,60%A;16 min,90%A;22 min,90%A;23 min,60%A;35 min,60%A;流速为1.2 mL.min-1;柱温为30℃;检测波长为210 nm;使用分光光度法测定体外溶血百分率。结果溶血磷脂在19.8～198.0μg.mL-1内与其峰面积成良好的线性关系(r=0.999 8),平均回收率为102.0%,RSD为0.63%(n=9),3批样品溶血磷脂含量分别为0.313,0.273,0.318 mg.mL-1;3批样品溶血百分率分别为2.70%,3.37%,3.04%。结论本方法可用于丙泊酚纳米注射液中溶血磷脂的含量测定;3批样品溶血百分率均小于5%。OBJECTIVE To determine lysolecithin and in vitro hemolysis of propofol nano-injection. METHODS An HPLC method was established for determination of lysolecithin. The sample was analyzed with a Platisil ClS column （4. 6 mm × 250 mm, 5 μm） at 30 ~C. Mobil phase A was acetonitrile-water （9：1 ）. Mobil phase B was 0. 2% phosphoric acid aqueous solution （pH adjusted to 2. 5 with triethylamine）. Gradient elution program was used as follows： 0 min, 60% A; 15 min, 60% A; 16 min, 90% A; 22 min, 90% A; 23 min, 60% A; 35 min, 60% A. The flow rate was 1.2 mL · min^-1. The detection wave length was set at 210 nm. Spectrophotometric method was used to determine hemolysis. RESULTS The linear range of the calibration curve for lysolecithin was 19. 8 - 198. 0 μg·mL^-1 （r = 0. 999 8）. The average recovery was 102. 0% and RSD was 0. 63% （n =9）. The lysolecithin contents of three batches of samples were 0. 313, 0. 273 and 0. 318 mg·mL^-1, respectively. The hemolysis rates were 2. 70%, 3.37% and 3.04%, respectively. CONCLUSION The HPLC method can be used for the determination of lysolecithin in propofol nano-injection. The hemolysis rates of three batches of samples were less than 5%.

关 键 词：丙泊酚 溶血磷脂 含量测定 高效液相色谱法 溶血性 

分 类 号：R917[医药卫生—药物分析学]