摘要
目的：制备环抱素A的眼用胶体混悬剂，建立质量控制方法。方法：用聚山梨酯-80做增溶剂，以卡波姆为基质，制备环孢素A眼用胶体混悬剂；用高效液相色谱（HPLC）法测定环孢素A的含量，并对方法进行考察；对该制剂的稳定性、刺激性等理化指标进行了考察。结果：pH为5～6，环孢素A在60～600mg·L^-1范围内与峰面积呈良好的线性关系，r=0．9991，平均回收率为97．7％，RSD为0．39％（n=3）。结论：该制剂质量稳定，符合中国药典有关眼用制剂的标准；含量测定方法，稳定、灵敏。
OBJECTIVE To prepare eyclosporine A colloid suspensions for eye use and to establish a method for its quality control. METHODS Grind the drug with tween-80 the suspensions was prepared by taking carbomer-940 as a base in the suspensions; content of cyclosporine A was determined with HPLC. Stability of the preparation was observed. RESULTS The pH value of preparation was 5 - 6, concentration of cyclosporine A presented a good linear relation within the range of 60 600 mg·L^-1, r = 0. 999 1, the average recovery was 97. 7%, RSD = 0. 39% （n = 3）. CONCLUSION The preparation is stabile, the methodfor quality control is sensitive.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2006年第4期400-402,共3页
Chinese Journal of Hospital Pharmacy
