喷昔洛韦乳膏体外释放一致性研究  

In vitro release consistency of penciclovir cream

作　　者：信长颖 赵龙山 多凯 于新颖 寻延滨 刘利群 XIN Chang-ying;ZHAO Long-shan;DUO Kai;YU Xin-ying;XUN Yan-bin;LIU Li-qun(Heilongjiang Institute for Drug Control,Harbin 150088;Shenyang Pharmaceutical University,Shenyang 110016)

机构地区：[1]黑龙江省药品检验研究院,哈尔滨150088 [2]沈阳药科大学,沈阳110016

出　　处：《中南药学》2023年第5期1212-1217,共6页Central South Pharmacy

基　　金：2021年国家药品抽检中央补助地方经费项目(No.42)。

摘　　要：目的建立并验证喷昔洛韦乳膏体外释放的测定方法,比较国内仿制制剂与参比制剂体外释放行为的差异。方法采用Franz扩散池,以生理盐水作为接收液,以混合纤维素微孔滤膜作为隔离膜,采用HPLC法测定喷昔洛韦乳膏的体外释放速率。并采用Mann-Whitney U检验评价仿制制剂与参比制剂体外释放速率的一致性。结果经验证,所建立的体外释放测定方法线性、日内及日间精密度良好,具有一定的灵敏性、特异性、选择性和耐用性,可用于喷昔洛韦乳膏体外释放速率的测定。国内7家企业仿制制剂仅有1家喷昔洛韦乳膏的体外释放速率与参比制剂一致,其他6家企业的样品与参比制剂均不一致。结论本研究表明体外释放试验结果具有高度灵敏性,可区分不同喷昔洛韦乳膏之间释放行为的差异,为进一步开展乳膏等半固体制剂的质量一致性评价奠定基础。Objective To establish and verify the in vitro release method of penciclovir cream,and to compare the in vitro release behaviors of domestic generic preparations and reference preparations.Methods A Franz diffusion cell with normal saline as the receiving fluid was used,and a mixed cellulose membrane was used as the isolation membrane.The in vitro release rate of penciclovir cream was determined by high performance liquid chromatography.The consistency of the in vitro release rates of the generic and reference preparations was evaluated by Mann-Whitney Test.Results The established in vitro release method has good linearity,good intra-day and inter-day precision,sensitivity,specificity,selectivity and durability,which can be used to determine the in vitro release of penciclovir cream.Among the 7 domestic imitation preparations,only 1 penciclovir cream showed the same in vitro release as the reference preparation,and the samples of the other 6 enterprises are inconsistent with the reference preparation.Conclusion The in vitro release is highly sensitive and can distinguish the difference in release behaviors of different products,laying a foundation for further quality consistency evaluation of semi-solid preparations such as cream.

关 键 词：喷昔洛韦乳膏 体外释放 方法学验证 一致性研究 

分 类 号：R94[医药卫生—药剂学]