盐酸利多卡因凝胶-口服液的研制及质量控制.pdfVIP

制剂技术 盐酸利多卡因凝胶一口服液的研制及质量控制 苏华，王银娟，贾佳，刘莹，王曙东 (中国人民解放军南京军区南京总医院制剂科，江苏南京 210002) 摘要：目的筛选盐酸利多卡因凝胶一口服液处方，制备适合电子胃镜检查的辅助制荆。方法以卡波姆一940为基质、二甲基硅油为消泡 剂制备盐酸利多卡因凝胶一口服液，详细考察其性状均匀性、消泡能力、含量、pH，确定最优处方，并通过高温、低温及离心试验考察样品的 初步稳定性。结果2％盐酸利多卡因凝胶一口服液主要成分的最优处方为卡波姆一940 2％。除高温下会使样品主药含量略有下降外，其他性质均稳定。结论2％盐酸利多卡因凝胶一口服液的制备工艺简便，质地细腻均匀，室 温下稳定性好，消泡能力强，符合临床应用要求。 关键词：盐酸利多卡因；凝胶；口服液；消泡能力；卡波姆一940 中图分类号：R944．1+5；R971+．2文献标识码：A and ControlofLidocaineHvdrochlorideGel一0ral PreparationQuality Liquid SuHua,WangYinjuan,肋Jia，LiuYing,WangShudong r General 210002) DepartmentofPreparation，NanjingHospitalofNanjingMilitaryRegion，Na埘ng,Jiangsu，China ToscreentheformulationsofLidocaine Gel—Oral andtO the Al蚓traet：Objective HydrochlorideLiquid prepareauxiliary suitabletoelectronic Lidocaine Gel—Oral wasmade and carbopol一940 gastroscopy．MethodsHydrochlorideLiquid byusing materialand and valuewereselectedasindexesto ∞base antifoamingagentrespectively．Thehomogeneity，defoamingpower，contentpH theformula．The andchemical oftheformulationsWaS and optimize physical stability investigatedbyhightemperature，freezing ization．ResultsThe wasestablishedag0．3％carbopol940，1 optimumpreparation thicone．TheofLidocaine Gel—Oral Wasstable thatthecontentofthemain a quality HydrochlorideLiquid except component littleunder Lidocaine Gel—Oral the formulahas by simple hi