美国药典 阿司匹林 中英文对照.doc

Aspirin Acetylsalicyiic Add,ph Eur monograph 0309) C9H8O4 180.2 [5O-78-2] Action and use Salicylate; non-selective cyclo-oxygenase inhibitor; antipyretic; analgesic; anti-inflammatory. Preparations Aspirin Tablets Dispersible Aspirin Tablets Effervescent Soluble Aspirin Tablets Gastro-resistant Aspirin Tablets Aspirin and Caffeine Tablets Co-codaprin Tablets Dispersible Co-codaprin Tablets DEFINITION 2-(Acetyloxy)benzoic acid. CONTENT 99.5 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder or colourless crystals. Solubility Slightly soluble in water, freely soluble in ethanol (96 per cent), MP About 143 °C (instantaneous method). IDENTIFICATION First identification A, B. Second identification B, C, D. A. Infrared absorption spectrophotometry {2.2.24). Comparison acetylsalicyiic acid CRS. B. To 0.2 g add 4 ml of dilute sodium hydroxide solution R and boil for 3 min. Cool and add 5 ml of dilute sulphuric add R A crystalline precipitate is formed. Filter, wash the precipitate and dry at 100-105 °C. The melting point (2.2.14) is 156 °C to 161 °C. C. In a test tube mix 0.1 g with 0.5 g of阿司司匹林 Acetylsalicyiic添加、ph值0309欧元专著) C9H8O4 180.2 [5O-78-2] 作用和用途 水杨酸盐;选择性的环氧化酶抑制剂;解热、镇痛、抗炎。 准备 阿司匹林药片 阿司匹林分散片 阿司匹林泡腾片 阿司匹林抗胃片 阿司匹林和咖啡因药片 复方可待因阿司匹林片 复方可待因阿司匹林分散片 定义 2 -(乙酰氧基)苯甲酸。 内容 99.5%到101.0%(干物质)。 特性 外观 白色或几乎白色,结晶粉末或无色晶体。 溶解度 微溶于水,易溶于乙醇 (96%)。 熔点 大约143°C(瞬时方法)。 鉴别 首先识别A,B。 第二个识别B,C,D。 a .红外吸收法{ 2.2.24)。 乙酰水杨酸 CRS 比较 b到0.2 g添加4 ml的氢氧化钠溶液的稀释R并且煮沸3分钟。冷却后加5毫升的稀硫酸添加R 形成晶状沉淀。过滤,洗沉淀和干在100 - 105°C。熔点(2.2.14)是156°C--160°C。 c .在试管中混合0.1g 和0.5 g的 calcium hydroxide R. Heat the mixture and expose to the fumes produced a piece of filter paper impregnated with 0.05 ml of nitmbenzaldehyde solution R. A greenish-blue or greenish-yellow colour develops on the paper. Moisten the paper with dilute hydrochloric acid R. The colour becomes blue. D.Dissolve with heating about 20 mg of the precipitate obtained in identification test B