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目的研究苄达赖氨酸温敏型眼用原位凝胶体外释放性及离体角膜渗透性。方法考察泊洛沙姆P407及P188用量对处方凝胶温度的影响,并对结果进行二项式拟合筛选出最优处方;以市售滴眼液或溶液剂为对照,采用无膜法、透析袋法、透析膜法考察了该处方的体外释放性;采用Franz扩散池对该处方进行了离体角膜渗透研究。结果该优选处方对角膜刺激性较小,胶凝温度为31.5℃,p H为6.95,渗透压为397 m Osmol·kg?1;相比于对照组,该处方缓释效果明显,未出现突释效应;离体角膜渗透研究结果表明,该优选处方6 h角膜累积渗透率及渗透速率均低于市售处方。结论温敏型原位凝胶缓释效果明显,有望成为治疗白内障药物苄达赖氨酸的新剂型。
OBJECTIVE To study the in vitro release and ex vivo corneal permeability of benidamic-lysine-sensitive in situ gels. Methods The effects of poloxamer P407 and P188 dosage on the gel temperature of the prescription were investigated. The results were binomial fit and the optimal prescription was screened. Taking the commercial eye drops or solution as control, Dialysis bag method, dialysis membrane method to investigate the in vitro release of the prescription; the Franz diffusion cell in vitro prescription of the corneal permeability study. Results The optimal prescription showed less corneal irritation, gelatinization temperature was 31.5 ℃, p H was 6.95 and osmotic pressure was 397 m Osmol · kg -1; Compared with the control group, Release effect; In vitro corneal permeability study showed that the preferred prescription 6 h corneal cumulative permeability and infiltration rate were lower than the commercial prescription. Conclusions Temperature-sensitive in-situ gel has a good sustained-release effect and is expected to be a new dosage form for treatment of cedilanid.