bcop 法评价滴眼液的角膜渗透性 - 浙江省食品药品检验所.pdf

BCOP 法评价滴眼液的角膜渗透性  谢珍 1 ，侯梦妮 2 ，孙叶丹 1 ，朱社敏 1 ，匡荣 1 ，李杨 1*(1.浙江省食品药品检验研究院，杭州 310052 ；2.浙江工业大学，杭 州 310014) 摘要：目的 采用牛角膜混浊和渗透性试验(bovine corneal opacity and permeability ，BCOP)方法对滴眼液的角膜渗透性进 行评价。方法 利用 BCOP 法，以无酚红 MEM 培养液为介质，前室加滴眼液样品，于不同时间点后室取样，用紫外-可 见分光光度法测定其苄达赖氨酸的含量，比较不同滴眼液样品的角膜渗透性。结果 不同厂家样品表现出不同的角膜渗 透性，包括角膜累积渗透量、透过速率、表观渗透系数和稳态渗透速率均不同。结论 可用 BCOP 法进行眼用制剂的角 膜渗透性研究。 关键词：牛角膜混浊和渗透性试验；苄达赖氨酸滴眼液；角膜渗透性 中图分类号：R965.2 文献标志码：B 文章编号：1007-7693(2017)03-0390-03 DOI: 10.13748/ki.issn1007-7693.2017.03.018 Study on the Application of BCOP in Corneal Permeability of Eye Drops 1 2 1 1 1 1* XIE Zhen , HOU Mengni , SUN Yedan , ZHU Shemin , KUANG Rong , Li Yang (1.Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China; 2.Zhejiang University of Technology, Hangzhou 310014, China) ABSTRACT: OBJECTIVE To evaluate corneal permeability of eye drops by bovine corneal opacity and permeability (BCOP) assay. METHODS Used BCOP method, phenol red-free MEM medium was used as release medium, loaded eye drops into the anterior chamber, collected the samples form posterior chamber in different time point and detected the content of bendazac lysine by UV spectrophotography to compare corneal permeability of different eye drops. RESULTS Eye drops from different manufacturers showed different corneal permeability, including the outcomes of permeation amount, permeation rate, apparent permeability and steady-state rate of permeation had been verified. CONCLUSION The BCOP assay can be used in the study of corneal permeability of ophthalmic preparation. KEY WORDS: bovine corneal opacity and permeability; bendazac lysine eye drops; corneal permeability 滴眼液局部给药后，需逐渐透过角膜在前房 1 仪器与材料 中发挥疗效，但眼组织具有复杂的保护机制，导