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果糖注射液(FRUCTOSE,テルモ果糖注5%)

2011-11-19 11:52:06  作者:新特药房  来源:中国新特药网天津分站  浏览次数:156  文字大小:【】【】【
简介: 药物名称:果糖注射液 英文名:Fructose 别名: 左旋糖 ,果糖 外文名:Fructose 适应症: 用于糖尿病、肝病病人供给能量和补充体液。可用于急性乙醇中毒的辅助治疗. 用量用法: 本品用以静注或静 ...
药物名称:果糖注射液

英文名:Fructose

别名: 左旋糖 ,果糖

外文名:Fructose

适应症: 用于糖尿病、肝病病人供给能量和补充体液。可用于急性乙醇中毒的辅助治疗.

用量用法: 本品用以静注或静滴,用量视病情而定。常用量为每次500~1000ml。
 
规格: 针剂:由右旋糖酐发酵母液经精制后配成的无色或带微黄色的液体,味甜。除含果糖外,尚含少量的葡萄糖及小分子右旋糖酐.12.5g(250ml), 25g(250ml,500ml), 50g(500ml).

注:以下产品不同规格和不同价格,购买时请以电话咨询为准!
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原产地英文商品名:
FRUCTOSE 5% INJ(テルモ果糖注5%) 500ML/BAG 20BAGS/BOX
原产地英文药品名:
FRUCTOSE
中文参考商品译名:
果糖5%注射液(テルモ果糖注5%) 500毫升/袋 20袋/盒
中文参考药品译名:
果糖
生产厂家中文参考译名:
泰尔茂株式会社
生产厂家英文名:
TERUMO(テルモ)
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原产地英文商品名:
FRUCTOSE 5% INJ(テルモ果糖注5%) 200ml/bag 30bags/box
原产地英文药品名:
FRUCTOSE
中文参考商品译名:
果糖5%注射液(テルモ果糖注5%) 200毫升/袋 30袋/盒
中文参考药品译名:
果糖
生产厂家中文参考译名:
泰尔茂株式会社
生产厂家英文名:
TERUMO(テルモ
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Fructose Injection
» Fructose Injection is a sterile solution of Fructose in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of fructose (C6H12O6). Fructose Injection contains no antimicrobial agents.

Packaging and storage— Preserve in single-dose containers, preferably of Type I or Type II glass.

Labeling— The label states the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, or where the label states that the Injection is not for direct injection but is to be diluted before use, the label alternatively may state the total osmolar concentration in mOsmol per mL.

Identification—
Silver nitrate solution— Dissolve 0.6 g of silver nitrate in 2.0 mL of water in a 100-mL volumetric flask, dilute with acetone to volume, and mix.
Sodium hydroxide solution— Dissolve 2.0 g of sodium hydroxide in 5.0 mL of water in a 100-mL volumetric flask, dilute with alcohol to volume, and mix.
Alcoholic monobasic sodium phosphate— Dissolve 4.0 g of monobasic sodium phosphate in 150 mL of water, and add, with mixing, 500 mL of alcohol. Use the entire mixture, even if there are two phases. Prepare the solution fresh daily.
Standard preparation— Prepare an aqueous solution containing 2.5 mg of USP Fructose RS per mL.
Test preparation— Dilute an accurately measured volume of Injection with water to obtain a solution having a known concentration of about 2.5 mg of fructose per mL.
Procedure— Immerse a suitable thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel, coated side down, in Alcoholic monobasic sodium biphosphate for 2.0 minutes. Remove the plate from the solution, place it, coated side up, on a clean, absorbent towel, dry it in a current of warm air, and activate it at 105 for 30 minutes. Cool to room temperature, and apply 5 µL each of the Standard preparation and the Test preparation. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of acetone, n-butyl alcohol, and water (50:40:10). Remove the plate, allow the solvent to evaporate, and spray the plate with Silver nitrate solution. Allow the plate to dry for 30 seconds, then spray with Sodium hydroxide solution: the RF value of the spot appearing within 3 minutes from the Test preparation corresponds to that obtained from the Standard preparation.
Bacterial endotoxins 85— It contains not more than 0.5 USP Endotoxin Unit per mL.
pH 791: between 3.0 and 6.0, determined on a portion to which 0.30 mL of a saturated potassium chloride solution has been added for each 100 mL and which previously has been diluted with water, if necessary, to a concentration of not more than 5% of fructose.
Heavy metals, Method I 231— Place a volume of Injection, equivalent to 4 g of fructose, in a porcelain dish, and evaporate to a volume of about 10 mL. Cool, and dilute with water to 25 mL: the limit is 5 ppm.

Limit of hydroxymethylfurfural— It meets the requirements of the test for Hydroxymethylfurfural under Fructose.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)

Other requirements— It meets the requirements under Injections 1.

Assay— Transfer an accurately measured volume of Injection, equivalent to 5 g of fructose, to a 100-mL volumetric flask. Add 0.2 mL of 6 N ammonium hydroxide, dilute with water to volume, and mix. After 30 minutes determine the angular rotation (see Optical Rotation 781), and record the observed rotation, a, as an absolute number. Calculate the quantity, in mg, of fructose (C6H12O6) in each mL of the Injection taken by the formula

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