喷雾干燥法制备前体脂质体的基础研究

A Study on the Preparation of Proliposome by the Spray Drying Method

研究了喷雾干燥法制备前体脂质体（ＰｒｏＬｉｐｏｓｏｍｅ，ＰＬ）的处方工艺，及将ＰＬ水合成重建脂质体（ＲＬ）的可行性，ＲＬ的粒径及影响因素．用丙二醛监测法、碘值法、酸度法考查了脂质体膜材在喷干过程中经受瞬间高温的稳定性．实验结果证明用简单振摇的方法即可将ＰＬ水合为ＲＬ，在通常范围内振摇时间及温度对ＲＬ的粒径无显著影响．制备脂质体所用豆磷脂可以经受喷干的瞬间高温，未有氧化水解等显著破坏，稳定性良好．实验证明，利用制备前体脂质体的方法可以解决脂质体以水溶液形式储存的氧化、水解、聚集、分层等问题，这是脂质体走向工业化生产的关键．与冻干法比，喷干法成本低，生产周期短．喷干法也可适用有机溶媒，这里将更降低喷干的时间和温度，更适于不稳定的药物．此法也可制备无菌制剂．

This study is on the prescription and technology for the preparation of proliposome by the spray drying method,on the reconstitution of liposome from proliposome and on the factors affecting the diameter of reconstituted liposome.The stability of soybean lecithin and proliposome was studied by the method of determining MDA.Iodium value and acid value. The result showed that reconstituted liposome might be prepared from proliposome by the shaking method and this method was easy to operate and repeatable.Both soybean lecithin in liposome in the process f spray drying and proliposome in store were stable.Therefore the preparation of proliposome by the spray drying method is advisable in pharmaceutical production.