ReinhardWedhase--国际血浆代用品市场的发展趋势.pptVIP

* Parenteral Drug Congress 2013 Medicinal Products for Plasma Substitution – Experiences, Peculiarities, Market Trends Nanjing, June 21st 2013 Prof. Dr. Reinhard Weidhase Serumwerk Bernburg AG, Germany Parenteral Drug Congress 2013 Main Topics General Remarks The Active Pharmaceutical Ingredients Gelatine and Hydroxyethyl Starch The Characteristics of Hydroxyethylstarch Clinical Particulars and Market Trends Parenteral Drug Congress 2013 History of Plasmasubstitution Year Source Investigators 1878 Saline SANDER 1881 Saline LANDERER 1915 Gelatine HOGAN 1937 PV-Alcohol BRAUN/JORNS PV-Pyrrolidone REPPE/WEESE/ HECHT 1944 Dextrane GR?NWALL/INGELMANN Parenteral Drug Congress 2013 History of Plasmasubstitution Year Source Investigators 1951/52 modified GEL CAMPBELL/ TOURTELOTTE 1957 Oxyethylstarch WIEDERSHEIM 1962 Urea-linked GEL SCHMIDT-THOME 1962 HES THOMPSON/WALTON Since 1970 several variations of HES by different companies 2011 Monograph for HES of Pharm. Eur. Parenteral Drug Congress 2013 Developments in Serumwerk Bernburg AG Year Source 1959 Dextranes for clinical use Modified Gelatine in saline 1991 Modified Gelatine in balanced solution HES 200/0.5 based on potato starch HES 130/0,42 based on potato starch in saline and in balanced solution as well 2008 New plant for Manufacturing of HES Parenteral Drug Congress 2013 Substances for colloidal volume replacement Sources Biological Origin Non-Biological Origin Synthetic Polymers PVP Human Origin Other Biological Origin Dextran (Microbes) Gelatine (Animal) Starch (Plants) Human Plasma HSA Parenteral Drug Congress 2013 Requirements for Volu