马来酸氯苯那敏注射液BP2015翻译

Chlorphenamine Injection

马来酸氯苯那敏注射液

General Notices

总体概述

Action and use

使用及用途

Histamine H1 receptor antagonist; antihistamine.

组胺H1受体拮抗剂；抗组胺药。

DEFINITION

定义

Chlorphenamine Injection is a sterile solution of Chlorphenamine Maleate in Water for Injections free from dissolved air.

马来酸氯苯那敏注射液为马来酸氯苯那敏的灭菌水溶液。

The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.

此注射液符合注射用制剂通则的规定，并符合以下要求。

Content of chlorphenamine maleate, C16H19ClN2,C4H4O4

马来酸氯苯那敏的含量

90.0 to 110.0% of the stated amount.

标示量的90.0-110.0%

CHARACTERISTICS

性状

A colourless solution.

无色溶液

IDENTIFICATION

鉴别

Carry out the method for thin-layer chromatography, Appendix III A, using silica gel GF254 as the coating substance and a mixture of 20 volumes of 1M acetic acid , 30 volumes of methanol and 50 volumes of ethyl acetate as the mobile phase. Heat the plate at 105° for 30 minutes before use. Ap ply separately to the plate 2 μL of each of the following solutions. For solution (1) evaporate an appropriate volume to dryness in a current of nitrogen using the minimum amount of heat, dissolve the residue as completely as possible in sufficient chloroform to produce a solution containing 0.5% w/v of Chlorphenamine Maleate and centrifuge. Solution (2) contains 0.5% w/v of chlorphenamine maleate BPCRS in chloroform. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). The two principal spots in the chromatogram obtained with solution (1) correspond to those in the chromatogram obtained with solution (2). Spray the plate with dilute potassium iodobismuthate solution. The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).

使用薄层色谱方法，参看附件III A，采用硅胶GF254为涂层物质和1M乙酸-甲醇-乙酸乙酯(20：30：50)的混合物为流动相。使用前将硅胶板在105℃下活化30分钟。分别取以下溶液2μl，点于薄层板上。溶液（1）在氮气下加热蒸发至干，用足够的氯仿尽可能完全的溶解残渣，制成含0.5% w/v马来酸氯苯那敏，离心。溶液（2）含0.5% w/v的马来酸氯苯那敏标准品的氯仿溶液。移去平板后，在空气中风干，并在紫外线下254nm下检查。溶液（1）所显主斑点的位置和颜色应与溶液2 的主斑点一致。

TESTS

试验

Acidity

酸度

pH, 4.0 to 5.2, Appendix V L.

pH4.0至5.2（参见附录VL）

Related substances

有关物质

Carry out the method for thin-layer chromatography, Appendix III A, using silica gel GF254 as the coating substance and a mixture of 10 volumes of diethylamine, 40 volumes of chloroform and 50 volumes of cyclohexane as the mobile phase but allowing the solvent front to ascend 12 cm above the line of application. Apply separately to the plate 10 μL of each of the following solutions. For solution (1) evaporate a suitable volume of the injection to dryness in a current of nitrogen using the minimum amount of heat, dissolve the residue as completely as possible in sufficient chloroform to produce a solution containing 5% w/v of Chlorphenamine Maleate and centrifuge. For solution (2) dilute 1 volume of solution (1) to 500 volumes with chloroform. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.2%). Disregard any spot remaining on the chromatogram obtained with solution (2) (0.2%). Disregard any spot remaining on the line of application.

使用薄层色谱方法，参看附件III A，采用硅胶GF254为涂层物质以和1M二乙胺-氯仿-环己烷(10：40：50)的混合物为流动相，使溶剂前沿上行展开至基线12cm。吸取下述溶液10μl,分别点于薄层板上。

溶液1 :取适量注射液，在氮气下加热蒸发至干，用足够的氯仿尽可能完全的溶解残渣，制成含0.5% w/v马来酸氯苯那敏的溶液，离心。溶液（2）吸取1ml的溶液1至500ml容量瓶，用氯仿稀释并定量至刻度。移去平板后，在空气中风干，并在紫外线下254nm下检查。溶液（1）所显主斑点的颜色不得强于溶液2 得到的主斑点（0.2%）。从溶液2 得到了其他斑点可忽略不计。忽略任何保留的其他斑点。

ASSAY

含量

Dilute a volume containing 10 mg of Chlorphenamine Maleate to 500 mL with 0.25M sulfuric acid and measure the absorbance of the resulting solution at the maximum at 265 nm, Appendix II B. Calculate the content of C16H19ClN2,C4H4O4 taking 212 as the value of A(1%, 1 cm) at the maximum at 265 nm.

用0.25M的硫酸溶解并稀释制成每500ml中含马来酸氯苯那敏10mg，在265nm下测

E）为212定最大吸光度（参见附录II B）。计算含量，在265nm最大下吸收系数（1%

1cm STORAGE

储存

Chlorphenamine Injection should be protected from light.

成品应避光保存。