亲脂性抗炎性子囊霉素巨内酰胺衍生物吡美莫司的高效液相色谱及家兔眼部刺激观察  

HPLC Determination of Pimecrolimus Eye Drops and its Stimulus Effect on Rabbit Eyes

作　　者：王延东[1] 王炜[2] 

机构地区：[1]中山大学中山眼科中心,广东广州510060 [2]华南理工大学轻工与食品学院,广东广州510641

出　　处：《现代食品科技》2011年第2期216-218,134,共4页Modern Food Science and Technology

基　　金：广东省科技计划项目(2006B13001003);广东省中医药局基金项目(2009165)

摘　　要：吡美莫司是亲脂性抗炎性的子囊霉素巨内酰胺的衍生物,可细胞选择性地抑制前炎症细胞因子的产生和释放,中山眼科中心首创将吡美莫司制成滴眼液,以进一步探讨其在眼科领域的应用。根据中国药典2005年版眼用制剂项下规定建立吡美莫司滴眼液的质量控制方法,用高效液相色谱法测定吡美莫司的含量,观察家兔眼部刺激性,并对该制剂的稳定性进行考察。结果表明:吡美莫司在20～80mg·L^(-1)浓度范围内线性关系良好(r=0.9998),平均回收率为(100.47±1.46)%,RSD为1.12%,方法重现性的RSD为1.38%(n=6)。滴眼后无刺激性,该制剂在6个月内质量稳定。本方法专属性强、操作简便、结果准确,可用于吡美莫司滴眼液的质量控制。A quality control method for determination of pimecrolimus eye drops was established according to ChP and its content was determined by HPLC. Its stimulus effect on pimecrolimus on rabbits＇ eyes and stability were also observed. Result showed that the calibration curve of pimecrolimus was linear within the concentration range of 20-80mg.L-1（r：0,9998）. The average recovery rate of pimecrolimus was （100.47±1.46）% （RSD=l.12%）, and the RSD of the repeatability test was 1.38% （n=6）. Pimecrolimus had no stimulus effect on rabbit eyes and its preparation was stable in 6 months. The method was simple, quick and specific. It can be used to control the quality of pimecrolimus eye drops.

关 键 词：吡美莫司 滴眼液 高效液相色谱法 稳定性 

分 类 号：R988.1[医药卫生—药品]