新目安眼用凝胶剂与目安眼用凝胶剂体外释药特性比较研究

目的：探索更昔洛韦替代阿昔洛韦组成的新目安眼用凝胶剂体外释药性能是否优于原目安眼用凝胶剂。方法：以更昔洛韦含量，阿昔洛韦含量为指标，采用桨法2（《中国药典》方法），进行体外释药试验。结果：新目安眼用凝胶剂释药特性等同于目安眼用凝胶剂，释药速度相似，释药量相同，皆达到或满足临床用药目的，凝胶基质对药物释放无影响，该基质能快速将药物释放出来溶解于泪液中发挥治疗作用。结论：新目安眼用凝胶剂释药特性符合眼用制剂需求。更昔洛韦替代阿昔洛韦组成的新目安眼用凝胶剂体外释药性能等同于原目安眼用凝胶剂，给药次数及间隔时间基本科学，合理，可行，并为下一步药效，毒理，临床研究提供依据。

Comparative Study of the Character of Release in vitro between New MU-AN Ophthalmic Gel and the Old

Objective： To search the release in vitro of new MU-AN ophthahnic gel consist of ganciclovir instead of aciclovir is whether better than the Old. Methods： Using the content of ganciclovir and acyclovir as the index, taking the second oar method （ in Ch. P 2010） , drug release in vitro test was investigated. Results： The character of drug release of new MU-AN ophthalmic gel was e- qual to the old, the rate of drug release was similar, The amount of drug release was the same. Both drugs met the requirements of clin- ical medication. The character corneal permeability of new MU-AN ophthalmic gel was better than the old. Gel matrix had no influ- ences on drug release, drug would be bring treatment effect after the way that it was released quickly then was dissolved in tear. Con- clusion： The drug release characteristics consistent with ophthalmic preparation requirements. The character of drug release of new MU-AN ophthalmic gel consist of ganciclovir instead of aciclovir is equal to the old, the time administer drug and interval time is gener- ally scientific, reasonable and feasible, providing the basis for the pharmacodynamics , toxicology and clinical study in the next step.