美国药典阿司匹林中英文对照
Aspirin
Acetylsalicyiic Add,ph Eur monograph 0309) C9H8O4180.2 [5O-78-2]
Action and u
Salicylate; non-lective cyclo-oxygena 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 expo 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 in 10 ml of water R and cool. The solution gives reaction (a) of salicylates {2.3.1).
TESTS
Appearance of solution
The solution is clear (2.2.1) and colourless (2.2.2, Method II)
.
Dissolve 1.0 g in 9 ml of ethanol (96 per cent) R.
Related substances
Liquid chromatography (2.2.29). Prepare the solutions immediately before u.
Test solution Dissolve 0.10 g of the substance to be examined in acetonitrile for chromatography R and dilute to 10.0 ml with the same solvent.
Reference solution (a) Dissolve 50.0 mg of salicylic acid R in the mobile pha and dilute to 50.0 ml with the mobile pha. Dilute 1.0 ml of this solution to 100.0 ml with the mobile pha.
Reference solution (b) Dissolve 10.0 mg of salicylic acid R in the mobile pha and dilute to 10.0 ml with the mobile pha. To 1.0 ml of this solution add 0.2 ml of the test solution and dilute to 100.0 ml with the mobile pha.
Mobile pha phosphoric acid R, acetonitrile for chromatography R, water R (2:400:600 VIVIV).
氢氧化钙 R 加热混合物，将薄层板用0.05 毫升的硝基苯甲醛溶液溶解R.
蓝绿色或黄绿色的颜色在薄层板上生长。
把纸用稀盐酸弄湿，颜色就变成蓝色。
D.加热溶解大约20毫克在鉴定测试B的沉淀中的10毫升R水并冷却。这个方案给予反应(一个)的水杨酸酯{ 2.3.1)。
测试
溶液的外观
溶液澄清，无色
溶解1.0 g在9毫升的乙醇(96%)R。
有关物质
液相色谱法(2.2.29)。准备使用前的溶液。
试验溶液溶解0.10 g的物质乙腈色谱审查R并用相同的溶剂稀释到10.0毫升
参比溶液(a) 在流动相中溶解50.0 mg的水杨酸R 并稀释到50.0毫升。用流动相稀释1.0毫升
的这种溶液到100.0毫升。
参比溶液(b) 溶解10.0毫克的水杨酸R在流动相中并用流动相稀释到10.0毫升。将1.0毫升的这种溶液和0.2毫升的测试溶液用流动相稀释到
100.0ml 。
流动相磷酸R:乙腈R、水R(2:400:600 V/V/V)。
Flow rate 1 ml/min.
Detection Spectrophotometer at 237 nm, Injection 10 ul.
Reference solution (b):
-- resolution: minimum 6.0 between the 2 principal peaks
Limits:
-- any impurity: for each impurity, not more than the area of the principal peak in the chro
matogram obtained with reference solution (a) (0.1 per cent);
--total: not more than 2.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.25 per cent);
-disregard limit. 0.25 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.025 per cent). Heavy metals (2.4.8)
Maximum 20 ppm.
Dissolve 1.0 g in 12 ml of acetone R and dilute to 20 ml with water R. 12 ml of this solution complies with test B. Prepare the reference solution using lead standard solution (1 ppm Pb) obtained by diluting lead standard solution (100 ppm Pb) R with a mixture of 6 volumes of water R and 9 volumes of acetone R.
