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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。
Objective To evaluate the corneal permeability of eye drops by bovine corneal opacity and permeability (BCOP) method. Methods Using BCOP method, phenol red-free MEM culture medium was used as the medium, and the anterior chamber was filled with eyedrops. Samples were taken at different time points and the benzyl-lysine contents were determined by UV-Vis spectrophotometry Corneal permeability of eye drops samples. Results Samples from different manufacturers showed different corneal permeability, including corneal cumulative infiltration, permeation rate, apparent permeability coefficient and steady-state permeation rate. Conclusion The BCOP method can be used to study the corneal permeability of ophthalmic preparations.