他克莫司软膏体外释放效率检测方法的研究  

Studies on the in vitro Release Efficiency of Tacrolimus Ointment

作　　者：王娟[1] 陈宇翔[1] 陈群 江宁宇[1] 陈韡彬 魏宗有[1] WANG Juan;CHEN Yu-xiang;CHEN Qun;JIANG Ning-yu;CHEN Wei-bin;WEI Zong-you(Fujian Institute of Microbiology,Fuzhou 35007,China)

机构地区：[1]福建省微生物研究所,福建福州350007

出　　处：《药物生物技术》2023年第1期38-41,共4页Pharmaceutical Biotechnology

基　　金：福建省属公益类研究所基本科研专项(No.2019R1005-11)。

摘　　要：探究建立一种他克莫司软膏体外释放效率的测定方法。采用改进Franz扩散池进行体外释放试验,以高效液相色谱法测定接收介质中他克莫司浓度,考察了他克莫司在不同比例的乙醇-生理盐水溶液中的溶解度,不同种类人工膜及其膜孔径大小对他克莫司体外释放率的影响,最终确定选择以乙醇-生理盐水(40∶60)为接收介质,孔径为1.2μm的混合纤维膜为释放隔离膜进行他克莫司软膏体外释放效率的测定。该方法适用于他克莫司软膏的体外释放试验,可为软膏处方的筛选优化及质量控制提供实验依据。A method was developed to determine the in vitro release efficiency of tacrolimus ointment.This test was carried out using a modified Franz-type diffusion cells.And the concentration of tacrolimus in receiving medium was determined by HPLC.The solubility of tacrolimus in different ethanol-saline at(25+2)℃ was studied.The effect of different kinds and different pore sizes of synthetic membranes on the release of tacrolimus was also studied.Finally,ethanol-saline(40:60)was selected as the receiving medium,and the mixed fiber membrane with a pore size of 1.2μm was used as the release isolation membrane for the determination of the in vitro release efficiency of tacrolimus ointment.This method was previously applied to evaluate the in vitro release of tacrolimus ointment.And it could also provide a reference for prescription optimization and quality control of tacrolimus ointment.

关 键 词：他克莫司 软膏 体外释放 人工膜 接收介质 高效液相色谱法 

分 类 号：R94[医药卫生—药剂学]