奥美拉唑肠溶胶囊(中国药典2005版)中英文.docxVIP

Omeprazole Enteric-coated capsules自己翻译：奥美拉唑肠溶胶囊Omeprazole Enteric-coated capsules contain not less than 90.0% and not than 110.0% of the labeled amount of omeprazole (C17H19N3O3S).自己翻译：奥美拉唑肠溶胶囊包含奥美拉唑（C17H19N3O3S）标示量不能少于90.0%并且不能高于110.0%。药典翻译：本品含奥美拉唑（C17H19N3O3S）应为标示量的90.0%-110.0%。小结：简洁，“本品”替换“奥美拉唑肠溶胶囊”，“含”替换“包含”。Description Capsules containing white or almost white small enteric-coated pills or granules.自己翻译：【性状】胶囊为白色或者近似于白色的小的肠溶片或颗粒。药典翻译：【性状】本品内容物为白色或类白色肠溶小丸或颗粒。小结：almost white small enteric-coated pills or granules 类白色肠溶小丸或颗粒Identification自己翻译：【鉴别】To a quantity of powdered contents, equivalent to about 10 mg of omeprazole, add 20 ml of 0.1 mol/L sodium hydroxide solution, shake to dissolve omeprazole, filter. Add 1 ml of silicotungstic acid TS to 3 ml of the filtrate, mix well. Add a few drops of dilute hydrochloric acid; a white flocculent precipitate is produced immediately.自己翻译：把一定量的粉末（相当于10mg 奥美拉唑）加入到20ml的0.1mol/L Nacl 溶液中，震荡直至溶解，过滤。加入1毫升硅钨酸？到3毫升的滤液中，混匀。加几点稀盐酸将会产生马上生成白色絮状沉淀。药典翻译：取本品内容物的细粉适量（约相当于奥美拉唑10mg），加0.1mol/L氢氧化钠溶液20ml，振摇使奥美拉唑溶解，滤过，取滤液3ml，加硅钨酸1ml，摇匀，滴加稀盐酸数滴，即产生白色絮状沉淀。小结：单位放后面，CS：比色液，是colorimetric solution的缩写。TS：试液，是Test Solution的缩写。VS：滴定液，是volumetric solution的缩写。BS：缓冲液，是Buffer solution的缩写。sodium hydroxide 氢氧化钠silicotungstic acid 硅钨酸flocculent precipitate 絮状沉淀filter滤过The retention time of principal peak in the substance being examined in the chromatogram obtained in the Assay is identical with that of the principal peak in the chromatogram of the reference solution correspondingly.自己翻译:含量测定当中在色谱图包含的检测出的物质的首个峰的保留时间和相应的参照溶液的色谱图中的首个峰相同。药典翻译：在含量测定项下记录的色谱图中，供试品溶液主峰的保留时间应与对照品溶液主峰的保留时间一致。小结：principal peak 主峰 substance being examined 供试品溶液reference solution 对照品溶液To a quantity of the powdered contents, add 0.1 mol/L sodium hydroxide solution to produce a solution of 15 μg per ml and filter. The light absorption of the filtrate exhibits maxima at 276 nm and 305 nm, and minima at 256 nm and 281 nm(Appendix Ⅳ A).自己翻译：把一定量的粉末加入到0.1mol/L的Nacl溶液中制成15μg每毫升的溶液，然后过滤。滤液的