自制阿昔洛韦乳膏与上市制剂体外释放度一致性评价  

Evaluation of Acyclovir Cream for Release Consistency in Vitro

作　　者：李嫦珍[1,2] 冯丽华 麦曦[1] LI Chang-zhen;FENG Li-hua;MAI Xi(The pharmacy college of Nanchang university,Nanchang Jiangxi 330006,China;Jiangxi province dermatological hospital,Nanchang Jiangxi 330001,China)

机构地区：[1]南昌大学药学院,江西南昌330006 [2]江西省皮肤病专科医院药剂科,江西南昌330001

出　　处：《药品评价》2018年第18期62-64,共3页Drug Evaluation

摘　　要：目的:建立自制阿昔洛韦乳膏释放度检查方法,并与上市制剂进行体外释放度的一致性评价。方法:利用固体制剂溶出仪,溶出杯为接受室,转蓝中的透析袋为供给室,生理盐水为介质,采用2015版《中国药典》二部中溶出度与释放度测定法中第一法(篮法)进行阿昔洛韦乳膏的体外释放度测定,并用f2相似因子法评价其与上市产品阿昔洛韦乳膏体外释放度的一致性。结果:乳膏基质及释放介质于254nm波长对测定无干扰,阿昔洛韦浓度的线性范围为1.06~10.6μg·m L-1(r=0.9993),平均回收率为99.65%,RSD为0.67%。自制样品和上市产品累积释放率相似因子f2为74.29。结论:本法简便、快速、准确度好,为建立阿昔洛韦乳膏的体外释放度检查法提供了依据;自制乳膏与上市产品释放行为相似。Objective： To developed the method of release test of acyclovir cream, and evaluated the release consistency in vitro. Methods： The in vitro release of acyclovir cream was determined by the first method （basket method） in the determination of dissolution and release test in part II of the Chinese Pharmacopiea （2015） by using solid preparation dissolution tester, dissolution cup as receiving room, the dialysis bag in the basket as supplying room, physiological saline as the release medium. The in vitro release of acyclovir cream was evaluated by f2 similarity factor method. Results： The cream base and test medium had no interference with the experiment.The linear range of acyclovir concentration were 1.06-10.6 μg·mL-1 （r=0.9993）. The average recovery and RSD were 99.65% and 0.67% （n=9）, respectively. The similarity factor f2 of cumulative release rate was 74.29 for the self-made samples and the marketed products.Conclusion： The method is convenient, rapid, and accurate and provides a basis for developing the method of release test of acyclovir cream. The release behavior of self-made creams is similar to that of marketed products.

关 键 词：阿昔洛韦乳膏 篮法 释放度 相似因子 

分 类 号：R751[医药卫生—皮肤病学与性病学]