【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%。更多还原

【Abstract】 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 C18 column(4.6 mm×250 mm,5 μm) at 30 ℃.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%.更多还原