胞磷胆碱钠注射液中有关物质研究

目的：对胞磷胆碱钠注射液中的有关物质进行分析,考察最大杂质的影响因素.方法：采用XtimateTM C18（250 mm×215;4.6 mm,5 μm）柱,以磷酸盐缓冲液（0.1 mol·L^-1的磷酸二氢钾溶液和四丁基铵溶液（取0.01 mol·L^-1四丁基氢氧化铵溶液用磷酸调节pH至4.5）等量混合]）-甲醇（95：5）为流动相;流速：1.0 ml·min^-1;柱温：30℃;检测波长：276 nm; 进样量：10 μl.结果：通过47批样品有关物质检查、破坏性试验、异常毒性试验及灭菌温度比较,建立样品的杂质谱,并找出最大杂质的影响因素.结论：该杂质在碱性条件和高温条件下会明显增加,在生产工艺中应控制pH和灭菌温度.

Analysis of Related Substances in Citicoline Sodium Injections

Objective： To analyze the related substances in citicoline sodium injections and investigate the influencing factors on the maximum impurity. Methods： An Xtimate^TM-C18 （250 mm ×4.6 mm,5 μm）column was used with the mobile phase of phosphate buffer（0.1 mol·L^-1 potassium dihydrogen phosphate solution and tetrabutyl ammonium solution） -methanol（95：5 ）. The flow rate was 1.0 ml·min^-1. The column temperature was 30℃, the detection wavelength was 276nm, and the injection volume was 10 μl. Results： Impurity spectrum of the samples was established and the influencing factors on the maximum impurity was found after the tests on the related substances in 47 batches of the samples, including the destructive experiment, abnormal toxicity experiment and the comparison of sterilization temperature. Conclusion： The content of the maximum impurity increases under the condition of high tem- perature and alkaline environment. During the preparation process, pH and sterilization temperature should be controlled.