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***纤维素钠Sodiumcarboxymethylstarch(CMS-Na)羧***淀粉钠Low-subsitutedhydroxypropylcellulose(L-HPC)MC-Na)交联羧***纤维素钠Polyvinylpolypyrrolidone(PVPP)交联聚维***Effervescentdisintegrants泡腾崩解剂:apsules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:eleratedtesting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Unil
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