西罗莫司滴眼液的质量控制及稳定性考察  

Quality control and stability of sirolimus eye drops

作　　者：黄楚龙[1] 王延东[1] 陈茂玲[1] 唐细兰[1] 

机构地区：[1]中山大学中山眼科中心,广州510060

出　　处：《中国实用医药》2012年第12期17-19,共3页China Practical Medicine

摘　　要：目的建立西罗莫司滴眼液的质量控制方法并观察其稳定性。方法根据中国药典2010年版眼用制剂项下有关规定拟定西罗莫司滴眼液的质量控制方法,用高效液相色谱法测定西罗莫司的含量,观察家兔眼部刺激性,并对制剂的稳定性进行考察。结果在20～80μg/ml浓度范围内,西罗莫司峰面积和质量浓度呈良好的线性关系(r=0.9997),平均回收率为100.09%,RSD为0.22%,精密度高,耐用性好,样品溶液可以在室温环境下24h内稳定。滴兔眼后无刺激性,而且稳定性相对较好。结论本方法专属性强,操作简便,结果准确,可用于西罗莫司滴眼液的质量控制。Objective To establish quality control methods of sirolimus eye drops and observe its stability at room temperature.Methods Quality standard of sirolimus eye drops was established according to ChP,and its content was determined by HPLC.Stimulus of sirolimus on rabbits＇ eyes and stability of sirolimus eye drops were observed.Results The calibration curve of sirolimus was linear within the concentration range of 20～80 μg/ml,r=0.9997.The average recovery rate of sirolimus was 100.09%（RSD=0.22%）.Sirolimus had no stimulus on rabbits＇ eyes and its stability was relatively good.Conclusion The method is simple,quick and specific.It can be used to contorl the quality of sirolimus eye drops.

关 键 词：西罗莫司 滴眼液 质量控制 稳定性 

分 类 号：R927.2[医药卫生—药学]