甘油磷酸胆碱的稳定性研究

A Study on Stability of Glycerophosphatidylcholine

为了对甘油磷酸胆碱的稳定性进行研究。采用蒸发光散射检测器-高效液相色谱法,通过强光照射试验(4500 LX的强光照射10 d)、高温试验(60℃下烘烤10 d)、高湿试验(相对湿度75%条件下放置10 d)和加速试验(60℃、相对湿度75%的条件下放置6个月),研究抗老年痴呆症新药甘油磷酸胆碱的稳定性,并运用外标两点对数法计算样品含量。研究结果表明,该方法灵敏、准确、重现性好。同时,也证实了酶法制备的甘油磷酸胆碱的性状没有发生改变,稳定性良好。

To study the stability of glycerophosphatidylcholine, evaporative light scattering detector and HPLC were used to determine the stability of glycerophosphatidyleholine under the conditions of Glare test （4500 LX,10 d）, high-temperature test （60℃,10 d）, humidity testing （75% relative humidity, 10 d） and accelerated test （60℃, 75% relative humidity, 6 months）. Content of the component is calculated using two points with external standard logarithmic method. This method is sensitive, accurate and reproducible. The experiment proved the enzymatic preparation of glycerophosphatidyleholine is not changed and the tested material is stable.