药物研发与与生产过程中质量控制新理念和新技术.ppt

* * * * BCS是什么? 渗透性与溶解度的分类 * 生物药剂类型 溶解度 渗透性 I High High II Low High III High Low IV Low Low 近端人类胃肠道模拟液汁 模拟胃液 模拟肠汁 Fasted Fed (FeSSGF) Fasted Fed (FaSSGF) Early Middle Late (FaSSIF) (FeSSIF) Na taurocholate NaCl NaCl NaCl Na taurocholate Na taurocholate Lecithin Milk/buffer HoAc H3PO4 Lecithin Lecithin Pepsin HCl/NaOH, pH 6.4 NaoAc NaH2PO4 Maleic acid Glyceryl monooleate NaCl 559 mOsm/kg Milk/buffer Milk/buffer NaCl Na oleate HCl, pH 1.6 HCl/NaOH, pH 5 HCl/NaOH, pH 3 NaOH, pH 6.5 Maleic acid 121 mOsm/kg 500 mOsm/kg 300 mOsm/kg 180 mOsm/kg NaOH, pH 5.8 390 mOsm/kg Pharm. Res. 2008, 25(7), pp.16