XX(CN,1%)FormulationDevelopmentReportXX 凝胶(中国,1%)处方开发报告版本号:01报告批准批准意味着本文件已经被审核并且是完整和可接受的,可以据此指导后续研发工作。REPORTREVIEW/APPROVALSIGNATURES报告审核/批准签字Date 日期Submittedby 提出人Reviewedby 审核人Approvedby 批准人TableofContent目录1.概述........................................................................................3之产品设计.....................................................................................42.1处方 I:艺设计.........................................................................42.2产品属性..............................................................................53.原辅料研究.................................................................................73.1原料..................................................................................73.2辅料................................................................................1.03.3原辅料相容性..........................................................................II4.处方及工艺筛选.............................................................................II4/RLD 处方可行性考察......................................................................II4.1RLD 性质测定__________________________________________________________________________I?4.2粘度、pH 调节........................................................................124.3原型处方建立.........................................................................135.处方研究..................................................................................135.1处方变量的初始风险评估..............................................................1.35.2丙二醇用量研究.......................................................................155.3聚乙二肝 40 口用量研究...............................................................1.65.4k 波姆用量研究.......................................................................1.95.5「乙醇胺用量研究_______________________________...