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目的制备胰岛素自复乳化给药系统并评价其质量。方法以自复乳的微观结构、体积平均粒径和自乳化速率为评价指标筛选较优处方,并考察其稳定性及体外释放特性。结果优选的处方组成为内水相-中链甘油三酸酯-亲脂乳化剂-亲水乳化剂(21∶24∶6∶9),平均粒径为6.74±0.55μm,包裹进入复乳的胰岛素为86.8%±8.2%;于25℃静置30 d后,其显微形态及平均粒径等指标均未见明显变化;8 h后胰岛素在体外的累计释放量达约80%,具一定缓释作用。结论成功制备了胰岛素自复乳化给药系统,可为蛋白多肽类药物的口服给药提供新的方法。
Objective To prepare insulin self-renewal drug delivery system and evaluate its quality. Methods Based on the microstructure, volume average particle size and self-emulsification rate of self-renewal milk, the optimal prescriptions were screened and their stability and release characteristics in vitro were investigated. Results The preferred formulation consisted of an internal aqueous phase - medium chain triglyceride - lipophilic emulsifier - hydrophilic emulsifier (21:24: 6: 9) with an average particle size of 6.74 ± 0.55 μm, Insulin was 86.8% ± 8.2%. After standing at 25 ℃ for 30 days, no significant changes were observed in the morphology and mean diameter of insulin. After 8 hours, the cumulative release of insulin in vitro was about 80% Slow release. Conclusion The insulin self-renewal drug delivery system was successfully prepared, which could provide a new method for the oral administration of protein peptides.