前列腺素E_1脂质体的制备及稳定性初步研究

Preparation of Prostaglandin E_1 Liposome and Rudimentary Study on Its Stability

目的:研制含量稳定、包封率较高的前列腺素E脂质体制剂,为临床新制剂的开发提供参考。方法:采用逆相蒸发法制备前列腺素1E脂质体,固相萃取-高效液相色谱法测定主药含量及包封率,并用加速试验对制剂的稳定性作出初步考察。结果:前列腺素E脂质体平11均粒径为127.5nm,包封率为92.35%,具有良好的稳定性。结论:前列腺素E脂质体制备工艺可行,质量控制方法简单、可靠,该脂质体是1一种比较理想的制剂。

Objective:To prepare and study the prostaglandin E1 liposome with stable concentration and high entrapment efficiency in order to develop a new therapeutic preparation.Methods:Prostaglandin E1 liposome was prepared by the reverse evaporating method and using the technique of HPLC combined with solid phase extraction to determine the concentration of prostaglandin E1 in liposome and the encapsulation.The liposome stability was proved by acceleration experiment.Results:The particle size of the prostaglandin E1 liposome was 127.5 nm.The entrapment efficiency reached 92.35%.The liposome was stable.Conclusion:The technics of preparing the prostaglandin E1 liposome is feasible and the method of quality control is simple and reliable.The liposome is expected to be an ideal preparation of liposomes.