Goodmanufacturingpractice(GMP)药品生产质量管理规范Standardoperatingprocedure(SOP)标准操作规范Goodlaboratorypractice(GLP)药物非临床研究质量管理规范Goodclinicalpractice(GCP)药物临床试验管理规范Glycerin甘油Dimethylsulfoxide(DMSO)二甲亚砜Polyethyleneglycol(PEG)聚乙二醇Liquidparaffin液状石蜡Flavouringagents矫味剂Coloringagents着色剂Phasevolumeratio相容积比:油水两相的容积之比。Highpressurehomogenizer乳匀机Colloidmill胶体磨Ultrasonichomogenizer超声波乳化器Sterilityassurancelevel(SAL)无菌保证水平(≤10-6)Heatsterilization热力灭菌法Mediumfiltration介质过滤Cakefiltration滤饼过滤Raysterilization射线灭菌法Intracutaneousinjection皮内注射Subcutaneousinjection皮下注射Intramuscularinjection肌内注射Intravenousinjection静脉注射Additivesforinjection注射剂的附加剂Rabbittest家兔法(热原检测)Limuluslysatetest鲎试剂法(热原检测)Electrolyteinfusions电解质输液Nutritioninfusions营养输液Colloidinfusions胶体Drug-containinginfusions含药输液Sterilepowderforinjection注射用无菌粉末Ophthalmicpreparation眼用制剂Drygranulation干法制粒Solidbridge固体桥Mechanicalinterlockingbonds机械镶嵌Pregelatinizedstarch预胶化淀粉Microcrystallinecellulose(MCC)微晶纤维素Carboxymethylcellulosesodium(CMC-Na)羧甲基纤维素钠Sodiumcarboxymethylstarch(CMS-Na)羧甲基淀粉钠Low-subsitutedhydroxypropylcellulose(L-HPC)低取代羟丙基纤维素Croscarmellosesodium(CCMC-Na)交联羧甲基纤维素钠Polyvinylpolypyrrolidone(PVPP)交联聚维酮Effervescentdisintegrants泡腾崩解剂:碳酸氢钠与枸橼酸混合物Magnesiumstearate硬脂酸镁Silicagel微粉硅胶Talc滑石粉Hydrogenatedvegetableoil氢化植物油Sodiumlaurylsulfate十二烷基硫酸钠Laminatingtablets裂片Entericcapsules肠溶胶囊Dimethylether(DME)二甲醚Foamingagents起泡剂Foamstabilizer稳泡剂Antifoamingagents消泡剂Stresstesting强化试验:即影响因素试验Acceleratedtesting加速试验Long-termtesting长期试验Leadoptimization先导化合物的优化Candidateselection确定候选化合物CurrentGoodManufacturePractice(cGMP)Lifecyclemanagement药品的生命周期管理Therapeuticindex治疗指数Targetproductprofile(TPP)目标产品特征Targetproductqualityprofile(TPQP)目标产品质量特征Fractionofabsorption(Fa)口服吸收分数Physiologicallybasedgastrointestinalmodel胃肠道生理模型Bioavailabilityclassificationsystem(BCS)生物药剂学分类系统Decoction煎煮法Maceration浸渍法Percolation渗漉法Vapordistillation水蒸气蒸馏法Ultrasound-assistedextraction(UAE)超声波提取法Medicinalliquor酒剂Separationbysedimentation沉降分离法Separationbycentrifuge离心分离法Separationbyfiltering过滤分离法Cyclodextrin(CD)环糊精Nanoemulsion纳米乳Submicroemulsion亚微乳Spraydrying喷雾干燥法Spraycongealing喷雾凝结法Fluidizedbedcoating流化床包衣法Multiorfice-centrifugalprocess多孔离心法Spinningdiskatomization转碟法1Unilamellarvesicles单层脂质体Multilamellarvesicles(MLVs)多层脂质体Endocytosis/phagocytosis内吞Encapsulationefficiency(EE)包封率Loadingefficiency(LE)载药率Erodiblematrixtablets溶蚀性骨架片Osmoticpressureactiveingredients渗透压活性物质Gastricfloatingretention胃内漂浮滞留Gastricadhesivesretention胃壁黏附滞留21绪论1.Pharmaceutics(Pharmacy)药剂学:是研究药物制剂的基本理论,处方设计,制备工艺,质量控制,合理使用等内容的综合性应用技术科学。2.Dosageforms剂型:适合于疾病的诊断、治疗或预防的需要而制备的与一定给药途径相适应的给药形式,就叫做药物剂型,简称剂型。3.Pharmaceuticalpreparations药物制剂:各种剂型中的具体药物或者为适应治疗或预防的需要而制备的不同给药形式的并规定有适应症、用法和用量的具...