药学英语4.pptVIP

成都大学 生物产业学院 刘涛 2011年9月 药 学 英 语 美国：FDA 中国：SFDA 澳大利亚：TGA 日本：日本厚生省药品与食品安全局 欧洲：欧洲药品局 一、药品相关监管部门 FDA： Food and Drug Administration SFDA：State Food and Drug Administration TGA：Therapeutic Goods Administration CDE：Center for Drug Evaluation CDR： Center for Drug ReEvaluation 一、药品相关监管部门 :By law ,the FDA has responsibility to oversee the purity ,qulity,safety,usefulness………. Be achieved by …… Marketplace surveys ……. 二、关键词句 Depyrogenation in the Key Manufacturing Processes of Reduning Injection? [Abstract] Objective: To investigate the effect of removing bacterial endotoxin in the key processes of the Reduning injection. Methods: The content of bacterial endotoxins was detected by kenitic-turbidimetry and the removal efficacy was studied before and after using 0.8 % （w/v） of activated carbon and ultrafiltration with molecular weight cut-off of 10 KDa. Results: The adsorption rate of bacterial endotoxins was 78.7% by using activated carbon, while the removal efficacy of bacterial endotoxins was 99.6% with ultrafiltration membrane at cut-off molecular weight 10 000 Da. Conclusion: The key crafts can effectively guarantee the safety of Reduning injection. [Key words] Reduning injection; Removing Carbon; Ultrafiltration; Bacterial endotoxins ? 三、论文摘要 热毒宁注射液生产过程中关键工序对细菌内毒素去除效果研究? ? [摘要] 目的： 研究热毒宁注射液生产过程中关键工序对细菌内毒素去除效果的影响。方法：采用动态浊度法测定0.8 %（w/v）活性炭脱炭前后、10 kDa截留分子量超滤前后细菌内毒素含量变化，考察其去除情况。结果：活性炭对细菌内毒素吸附率为78.7 %、10 kDa截留分子量超滤对细菌内毒素去除率为99.6 %。结论：关键工序能有效保证热毒宁注射液的安全性。 [关键词] 热毒宁注射液；脱炭；超滤；细菌内毒素 ? ? ? 三、论文摘要