摘要
目的以微乳为载体,制备适合眼部用药的地塞米松滴眼液。方法选择适宜的油、表面活性剂和助表面活性剂,以离心稳定性和乳滴粒径为评价标准,优化处方和工艺。通过影响因素试验初步评价地塞米松眼用微乳的稳定性,并通过家兔眼刺激性实验评价了地塞米松眼用微乳的安全性。结果地塞米松眼用微乳的乳滴平均粒径为36.8 nm,经离心(13 000 r.min-1,30 min)稳定,高温、强光条件下考察10 d,乳滴粒径、pH值和含量均未见显著变化,对家兔的眼部组织无刺激性。结论微乳作为热力学稳定系统,制备工艺简单,生物相容性好,适合作为眼部用药的载体。
OBJECTIVE To prepare dexamethasone microemulsion for topical ocular chug delivery. METHODS Centrifuge test and the average diameter of droplet were used as the criterion to optimize the formulation and process. The optimized preparation was obtained and put into the condition of high temperature（60 ℃） or strong light（4 500 ± 500）lx for 10 d to observe its stability. Ocular irritation test was performed in rabbits to evaluate the safety of the dexamethasone mlicroemulsion.RESULTS Dexamethasone microemulsion for ocular appilication was stable. The average diameter of droplet was 36.8 nm. The ocular irritation test suggested that the microemulsion was sale to c.ornea, conjunctiva and iris. CONCLUSION Microcmulsions are suitable vehicles for ocular drug delivery systems, owing to their stability, simple process and low-toxicity.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2006年第5期358-362,共5页
Chinese Pharmaceutical Journal
关键词
地塞米松
微乳
稳定性
眼刺激性
dexamethasone
microemulsion
stability
ocular irritation
