血液的体积及组成精品.pptVIP

Classification for biological products Class IV Products derived from animal cell cultures: proteins obtained by rDNA, monoclonal antibodies, cytokines.. Risk encountered: Presence of viruses in the cells used in production and/or contamination of the product by viruses present in the reagent used in the process or a breakthrough in SMP. Viral safety: Characterization and control of the cell banks and of the reagents used in production; process capable of generating highly purified products.. Classification for biological products Class V Bacterial vaccines, toxoides and rDNA proteins expressed in bacteria or yeast. Risk encountered: Residual live bacteria in vaccines and the potential presence of viruses in the reagents of animal origin used for some bacteriological media (theoretical risk). * * * 血液的體積及組成 70公斤重的成年男子含有5公升的血量。 含紅血球、白血球及血小板。 成年人血漿(plasma)佔全身血液總量的50~60%。 血漿的大部分是水，水主要作為溶劑。血漿呈淡黃色，其中含有數百種血漿蛋白，包括白蛋白(albumin)、球蛋白(globulins)及纖維蛋白原(fibrinogen)。 人類血漿之特異性 是一種非常豐富及複雜之生物來源物質。 含超過100~200種以上不同的（醣）蛋白（包括凝血因子，蛋白分解酵素抑制劑，蛋白分解酵素，免疫球蛋白），白蛋白，peptide，生長因子….。 約17~20種血漿成分已建立治療價值。 是一人類治療所必需的兵工廠。 血漿來源 Source Plasma (from plasmapheresis) Recovered Plasma (from whole blood donations) 血液的功能 運送細胞的產物及廢物，並將養分及氧氣送到細胞。 血液內吞噬細胞的功用除了如清道夫外，並且能抵抗外來的感染。 為運輸激素的途徑。 平衡穩定體內的pH值。 將體熱帶到皮膚發散以維持體溫恆定。 Take a break! Viruses transmissible via blood and plasma products Human Viruses of ConcernWith Respect to Plasma Derivatives Enveloped Viruses Human Immune Deficiency Virus (HIV) Hepatitis B (HBV) Hepatitis C (HCV) Non-Enveloped Viruses Human Parvovirus B19 (B19) Hepatitis A (HAV) Not Significient Risks Human T-lymphotrophic virus (HTLV I II) Cytomegalovirus (CMV) Epstein Barr Virus (EBV) Unmeasurable Risks Transmissible Spongioform Encephalopathies (TSE, esp. CJD) Unidentified and /or emerging agents Significance of Viral Envelope Protein necessary for attachment and penetration of host cells are on the surfaces of viruses. Non-enveloped viruses tend to be more resistant to physico-chemic