DiBiase M D, Rhodes C T
Department of Pharmaceutics, University of Rhode Island, Kingston 02881.
Pharm Acta Helv. 1991;66(5-6):165-9.
Three simple formulations, with various physicochemical characteristics, were designed as potential pharmaceutical bases for delivery of epidermal growth factor (EGF) to open wounds. The compatibility of EGF with formulation excipients and the release of EGF from each formulation were evaluated in vitro using a release cell apparatus. Samples were analyzed by competitive heterogeneous radioimmunoassay. The apparatus and procedures used in the study were validated to ensure EGF stability during the study, and to verify the absence of excipient interference with analytical procedure. Batches of Pluronic F-127 25% gel formulation and Carbopol gel formulation showed similar average EGF release rates of 17.12 and 16.55 micrograms/cm2/hr, respectively. A vanishing cream formulation similar to the commercial product Silvadene showed much slower release of 0.5 microgram/cm2/hr.
设计了三种具有不同理化特性的简单制剂,作为向开放性伤口递送表皮生长因子(EGF)的潜在药物基质。使用释放细胞装置在体外评估了EGF与制剂辅料的相容性以及每种制剂中EGF的释放情况。通过竞争性非均相放射免疫分析法对样品进行分析。对研究中使用的仪器和程序进行了验证,以确保研究期间EGF的稳定性,并验证辅料对分析程序无干扰。聚氧乙烯蓖麻油F-127 25%凝胶制剂批次和卡波姆凝胶制剂批次的平均EGF释放率相似,分别为17.12和16.55微克/平方厘米/小时。一种与市售产品磺胺嘧啶银相似的消失乳膏制剂的释放速度要慢得多,为0.5微克/平方厘米/小时。