Adress of Welcome_Lipoid-Chinese.pdf

11stChinese Lipoid Conference第一届Lipoid中国研讨会Phospholipids for Advanced Drug Delivery磷脂对于给药系统的完善Shanghai,June 21st2007上海，2007.6.212Agenda议程安排09:00 Registration登记签到09:30 Address of welcome from Lipoid and introductionof the Lipoid GroupLipoid致欢迎词及Lipoid简介09:45 Address of welcome from the Phospholipid Research Center磷脂研究中心致欢迎词10:00 Phospholipids in parenteral systems I注射用磷脂13Agenda议程安排10:45 Coffee Break议间休息11:00 Phospholipids in parenteral systems II注射用磷脂212:00 Lunch午餐13:00 Phospholipids in topical and oral systems磷脂在外用及口服系统中的运用14:00 Coffee Break议间休息14:15 Regulatory and safety aspects规定及安全方面15:15 Closing结束4The CompanyThe Company公司简介?Founded1977成立于1977?Holding 控股Lipoid Verwaltungs GmbH?Affiliates 分支Lipoid GmbH,LudwigshafenLipoid AG,SwitzerlandLipoid LLC,USAALC,USAR&R Extrakte,KlnPhospholipid GmbH,Kln5The LIPOID GroupLIPOID集团Production工厂工厂PhospholipidGmbHGermanyPhospholipid工厂工厂（德国）（德国）Lipoid GmbHGermany利宝益工厂利宝益工厂（德国）（德国）R&R Extrakte GmbHGermanyR&R工厂（德国）工厂（德国）6The LIPOID GroupLIPOID集团Marketing销售销售AmericanLecithinCompanyConnecticutALC公司公司(康涅狄格康涅狄格)PhospholipidGmbHGermanyPhospholipid(德国德国)Lipoid LLCNew Jersey利宝益利宝益LLC（新泽西）（新泽西）Lipoid AGSwitzerland利宝益利宝益(瑞士瑞士)7The CompanyThe Company公司简介?Lipoid GmbH,Ludwigshafen利宝益工厂，位于路德维希港?Production of phospholipids 磷脂的生产环境8The CompanyThe Company公司简介?R&R Extrakte,Kln R&R公司?Production of plant extract 植物提取物的生产?Second production site of phospholipids 磷脂生产基地9The CompanyThe Company公司简介?Lipoid LLC,USA利宝益美国?ALC,USA ALC美国?Lipoid AG,Switzerland利宝益瑞士?Technical support and sales技术支持与销售业务10The Company公司简介?Phospholipid GmbH,Kln Phospholipid公司?Development and production of soyphospholipids进行大豆磷脂的深加工和生产?Sales and technicalsupport worldwide,except USA and Canada提供全球（不包括美国和加拿大）技术支持及销售业务11The Company公司简介-Natural PL from egg and soya 天然的蛋黄和大豆磷脂-Hydrogenated PL from egg and soya 氢化蛋黄和大豆磷脂-Synthetic PL合成磷脂-Tailored lipid blends 磷脂混合物Core Business 业务核心业务核心?Phospholipids for pharmaceutical applications磷脂在医药行业的应用?Highly purified oils 精制油类-Soybean oil 大豆油-Olive oil 橄榄油-MCT 中链甘油三酸酯-Fish oil 鱼油12The Company公司简介?Manufacturing in industrial scale工业化大生产Focus 主营主营?Development of new phospholipidsand related substances开发新的磷脂和相关产品13The Company公司简介?Manufacturing processes developed and validated by ourselves自行改进和检验生产工艺?Products for parenteral use filtered through 0.2 m into a clean roomclass ISO 5(=class 100)注射用产品需通过0.2 m过滤进入ISO 5的净室?Drying and packaging under aseptic conditions在无菌环境下干燥和包装Technology 技术技术14The Company公司简介Quality System 质量体系质量体系?cGMP?Certified according to ICH Q7A?ISO 9001?Drug Master Files15Products产品?Pharmaceutical(80%)药用客户（占80%）?Cosmetic 化妆品?Dietetic 保健品行业Customers目标客户目标客户Pharmaceutical Application 药用方面药用方面?Mainly for parenteral use(90%)主要供注射用-Fat emulsions 脂肪乳-Liposomes 脂质体-Mixed micelles 混合胶束16Definition of Lecithin 卵磷脂的定义USP:“Lecithin is a complex mixture of acetone-insolublephosphatides,which consist chiefly of phosphatidylcholine,phosphatidyl ethanolamine,phosphatidyl serine andphosphatidyl inositol,combined with various amounts ofother substances such as triglycerides,fatty acids andcarbohydrates,as seperated from the crude vegetable oilsource.It contains not less than 50%of“Acetone-Insoluble Matter“.美国药典：“卵磷脂系一种不溶于丙酮的混合物，主要成分包括磷脂酰胆碱磷脂酰乙醇胺、磷脂酰丝氨酸、磷脂酰肌醇，以及甘油三酸酯、脂肪酸、碳水化合物等从植物油中提取的其他物质。磷脂中丙酮不溶物的含量应不低丙酮不溶物的含量应不低于于50%。”EP:“.not less than 60%of“Acetone-Insoluble Matter“.欧洲药典：“.丙酮不溶物的含量应不低于丙酮不溶物的含量应不低于60%。”17Definition of Phospholipids磷脂的定义All lipids that contain phosphorus are called Phosphatides or Phospholipids所有的含磷脂类都称为磷脂?Phosphatidyl choline(PC)磷脂酰胆碱?Phosphatidyl ethanolamine(PE)磷脂酰乙醇胺?Phosphatidyl inositol(PI)磷脂酰肌醇?Phosphatidyl serine(PS)磷脂酰丝氨酸e.g.OOOPOOOMe3NOO+-hydrophiliclipophilic18Natural Lecithins Lipoid GmbH利宝益的天然卵磷脂系列Egg蛋黄卵磷脂蛋黄卵磷脂Soybean大豆卵磷脂大豆卵磷脂LIPOID E 25LIPOID S 05LIPOID S 31LIPOID ELIPOID S 05 BLIPOID S 35 FSLIPOID E 80 SLIPOID S 10LIPOID S 40LIPOID E 80 LIPOID S 20LIPOID S 45LIPOID S 21LIPOID S 75LIPOID S 30LIPOID S 10019Natural Phospholipids Lipoid GmbH利宝益的天然磷脂系列Egg蛋黄磷脂蛋黄磷脂Soybean大豆磷脂大豆磷脂LIPOID E PC SLIPOID S PCLIPOID E LPCLIPOID S LPCLIPOID E PGLIPOID S PGLIPOID E PELIPOID S PELIPOID E SM20HydrogenatedPhospholipids and Lecithins Lipoid GmbH利宝益的氢化磷脂和卵磷脂系列Egg蛋黄蛋黄Soybean大豆大豆LIPOID S 75-3(N)LIPOID S 100-3LIPOID E PC-3LIPOID S PC-3LIPOID S LPC-3LIPOID S PG-3LIPOID S PA-3LIPOID S PE-321Synthetic Phospholipids Lipoid GmbH利宝益的合成磷脂系列Phosphatidyl CholinesPhosphatidyl Glycerols磷脂酰胆碱磷脂酰甘油磷脂酰胆碱磷脂酰甘油LIPOID PC 14:0/14:0 (DMPC)LIPOID PG 14:0/14:0 (DMPG)LIPOID PC 16:0/16:0 (DPPC)LIPOID PG 16:0/16:0 (DPPG)LIPOID PC 18:0/18:0 (DSPC)LIPOID PG 18:0/18:0 (DSPG)LIPOID PC 16:0/18:1 (POPC)LIPOID PG 16:0/18:1 (POPG)LIPOID PC 18:1/18:1 (DOPC)LIPOID PG 18:1/18:1 (DOPG)Phosphatidyl EthanolaminesPhosphatidic Acids磷脂酰乙醇胺磷脂酸磷脂酰乙醇胺磷脂酸LIPOID PE 14:0/14:0 (DMPE)LIPOID PA 16:0/16:0 (DPPA)LIPOID PE 16:0/16:0 (DPPE)LIPOID PA 18:0/18:0 (DSPA)LIPOID PE 18:0/18:0 (DSPE)LIPOID PE 18:1/18:1 (DOPE)22Natural Lecithins Phospholipid GmbHPhospholipid天然卵磷脂系列Soybean 天然大豆卵磷脂天然大豆卵磷脂Phospholipon80/80 NPhospholipon85 GPhospholipon90 NGPhospholipon90 G23Hydrogenated Phospholipidsand Lecithins Phospholipid GmbHPhospholipid的氢化磷脂和卵磷脂系列Soybean 氢化大豆磷脂和卵磷脂氢化大豆磷脂和卵磷脂Phospholipon80 HPhospholipon90 H24Special Systems Phospholipid GmbHPhospholipid的特殊系列Phosal35 SBPhosal50 PGPhosal50 SA+Phosal53 MCTPhosal75 SA25Phospholipids in Pharmaceuticals药用磷脂系列Important Formulation Types with PL 主要配方主要配方?O/W emulsions for i.v.Nutrition 静脉注射营养型脂肪乳?O/W emulsions containing drugs 含药乳剂?Mixed micelles for parenteral application注射用混合胶束?Liposomes for parenteral application 注射用脂质体?Suspensions for parenteral application 注射用混悬液?Liposomes for topical application 外用脂质体?Oral formulations 口服配方