壬二酸纳米凝胶处方的研究、制备方法及安全评价

Study on Prescription,Preparation Method and Safety Evaluation of Azelaic Acid Nano Gel

介绍了一种壬二酸纳米凝胶制剂处方的凝胶相、油相的选择,工艺处方的组成,以及纳米凝胶的制备方法和粒径测试方法。经过6个月的长期稳定性考查,制备的样品无分层和破乳现象。通过DelsaNano C纳米粒度仪的测定,其平均粒径小于1 000 nm,且稳定性良好。经过多次皮肤刺激性试验,证明该样品对家兔的多次皮肤刺激性为无,安全性良好。

This paper mainly introduces the selection of gel phase and oil phase of azelaic acid nano gel prescription,the composition of technological prescription,the preparation method and particle size test of nano gel.After 6 months of long-term stability inspection,the prepared samples have no stratification and demulsification.Through the determina⁃tion of DelsaNano C nanometer particle size analyzer,the average particle size is less than 1000 nm,and the stability is also pretty good.After several skin irritation tests,it was proved that the sample was non irritating and safe to rabbits.