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哪位大哥有英文版的《中国药典》？
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我想查个盐酸多巴胺注射液中多巴胺含量的测定方法,哪位大哥大嫂能帮我找找？ 我的QQ:40052639,EMAIL:gzhu2004@126.com [ Last edited by hgz198908 on 2007-8-9 at 13:18 ] |
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2楼2007-08-10 13:43:16
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拼音名：Yansuan Duoba an Zhusheye 英文名：Dopamine pydrochloride Injection 【性状】 本品为无色的澄明液体。 【鉴别】 取本品，照盐酸多巴胺项下的鉴别（1）、（2）、（3）和（5）项试验，显相同的结果。 【检查】 pH值 应为3.0-4.5（附录Ⅵ H）。 其他 应符合注射剂项下有关的各项规定（附录Ⅰ B）。 【含量测定】 精密量取本品10ml，置100ml量瓶中。用硫酸溶液（1→350）稀释至刻度，摇匀，作为供试品溶液；另取盐酸多巴胺对照品约0.1g，精密称定，置100ml量瓶中。用硫酸溶液（1→350）溶解并稀释至刻度，摇匀，作为对照品溶液。精密量取对照品溶液与供试品溶液各5ml，分别置100ml量瓶中，各加新制的硫酸亚铁-酒石酸盐溶液（取硫酸亚铁1g。加酒石酸钾钠2g与亚硫酸氢钠0.1g，用水稀释至1000ml） 5ml，再加缓冲液（取醋酸铵50g，溶于20%乙醇1000ml中。并以氨试液调节pH值至8.5）稀释至刻度，摇匀，照紫外-可见分光光度法（附录Ⅳ A），在520nm的波长处分别测定吸光度，计算，即得。 【贮藏】 遮光，密闭保存。 【规格】 2ml：20mg 【化学成分】 本品为盐酸多巴胺的灭菌水溶液。含盐酸多巴胺（C8H11NO2·HCl）应为标示量的93.0%-107.0%。 【药理作用】 多巴胺受体激动药 |
3楼2007-08-10 14:05:00
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4楼2007-08-10 14:06:22
maxuedong
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hailang_zj(金币+2,VIP+0):恭喜金笔突破１０００大关！
hailang_zj(金币+2,VIP+0):恭喜金笔突破１０００大关！
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Dopamine Hydrochloride Injection » Dopamine Hydrochloride Injection is a sterile solution of Dopamine Hydrochloride in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C8H11NO2·HCl. It may contain a suitable antioxidant. NOTE—Do not use the Injection if it is darker than slightly yellow or discolored in any other way. Packaging and storage— Preserve in single-dose containers of Type I glass. Labeling— Label it to indicate that the Injection is to be diluted with a suitable parenteral vehicle prior to intravenous infusion. USP Reference standards 11— USP Dopamine Hydrochloride RS. USP Endotoxin RS. Identification— Transfer a volume of Injection to a suitable container, and dilute if necessary, with dilute methanol (1 in 5) to obtain a test solution having a known concentration of 1.6 mg per mL. Prepare a Standard solution of USP Dopamine Hydrochloride RS in dilute methanol (1 in 5) having the same concentration as the test solution. The test solution so obtained responds to the Thin-layer Chromatographic Identification Test 201, a mixture of n-butyl alcohol, glacial acetic acid, and water (4:1:1) being used as the developing solvent and 5 µL each of the test solution and Standard solution being applied to the thin-layer chromatographic plate. Bacterial endotoxins 85— It contains not more than 16.67 USP Endotoxin Units per mg of dopamine hydrochloride. pH 791: between 2.5 and 5.0. Particulate matter 788: meets the requirements for small-volume injections. Residual solvents 467: meets the requirements. (Official January 1, 2007) Other requirements— It meets the requirements under Injections 1. Assay— Mobile phase— Prepare a filtered and degassed mixture of 0.005 M sodium 1-octanesulfonate in 1% glacial acetic acid and acetonitrile (87:13). Make adjustments if necessary (see System Suitability under Chromatography 621). Standard preparation— Dissolve a suitable quantity of USP Dopamine Hydrochloride RS, accurately weighed, in Mobile phase to obtain a solution having a concentration of about 1.6 mg per mL. Pipet 10 mL of this solution into a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix to obtain a Standard preparation having a known concentration of about 0.16 mg of dopamine hydrochloride per mL. System suitability solution— Prepare a solution of benzoic acid in methanol containing about 20 mg per mL. Dilute 1 volume of this solution with 3 volumes of the Mobile phase to obtain a solution having a final concentration of about 5 mg per mL. Transfer 10.0 mL of this solution and 10.0 mL of a Standard solution containing 1.6 mg of USP Dopamine Hydrochloride RS per mL to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 16 mg of dopamine hydrochloride, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 280-nm detector and a 4-mm × 30-cm column packed with packing L1. The flow rate is about 1.5 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed under Procedure: the resolution, R, between benzoic acid and dopamine hydrochloride is not less than 4.0. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure: the relative standard deviation for replicate injections is not more than 3.0%. Procedure— Separately inject equal volumes (about 40 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of C8H11NO2·HCl in each mL of the Injection taken by the formula: (100C / V)(rU / rS), in which C is the concentration, in mg per mL, of USP Dopamine Hydrochloride RS in the Standard preparation; V is the volume, in mL, of Injection taken; and rU and rS are the responses of dopamine hydrochloride obtained from the Assay preparation and the Standard preparation, respectively. Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate Expert Committee : (MDCV05) Monograph Development-Cardiovascular USP29–NF24 Page 754 |
5楼2007-08-10 14:08:35