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Preparation method of gentamicin injection

A kind of technology of gentamicin and gentamicin sulfate, applied in the field of preparation of gentamicin injection

Inactive Publication Date: 2010-12-01
华北制药集团制剂有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This proves that there are certain technical defects in the existing production process

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Take by weighing the following raw materials and auxiliary materials according to the following process prescription:

[0025] Gentamicin Sulfate Powder 40mg

[0026] Methylparaben 1.5mg

[0027] Propylparaben 0.2mg

[0028] Sodium bisulfite 3.2mg

[0029] EDTA---2Na 0.1mg

[0030] Add water for injection to 1ml

[0031] Set up a nitrogen sparger in the preparation tank. Prepare water for injection pre-connected with 60% of the total volume to the preparation tank under the condition of 10,000 grades, and pass nitrogen gas into the preparation tank through a nitrogen distributor; put the original powder into the preparation tank and stir to dissolve, and methyl p-hydroxybenzoate, p- Propyl hydroxybenzoate is fully dissolved with water for injection above 80°C and added to the preparation tank for stirring, followed by adding sodium bisulfite and EDTA --- 2Na solution and stirring for 15 minutes, using sodium bicarbonate to adjust the pH to the range of 5.5-6.0 Add...

Embodiment 2

[0033] (a) Take the following raw materials and auxiliary materials according to the following process prescription:

[0034] Gentamicin Sulfate Powder 40mg

[0035] Methylparaben 2.0mg

[0036] Propylparaben 0.1mg

[0037] Sodium bisulfite 3.0mg

[0038] EDTA---2Na 0.05mg

[0039] Add water for injection to 1ml

[0040] (b) Connect with 50% of the total volume of water for injection, use a nitrogen sparger to ventilate nitrogen, and control the water temperature at about 50°C.

[0041] (c) Put the original powder into the preparation tank and stir to dissolve, fully dissolve methyl p-hydroxybenzoate and propyl p-hydroxybenzoate with water for injection at 85°C and add them to the preparation tank, and then add sodium bisulfite and EDTA-- -2Na solution was stirred well for 15 minutes.

[0042] (d) Use 10% anhydrous sodium carbonate to adjust the pH to 5.5-6.0, add a specified amount of activated carbon and stir for 30 minutes. It is required to fill with nitrogen through...

Embodiment 3

[0045] Take by weighing the following raw materials and auxiliary materials according to the following process prescription:

[0046] Gentamicin Sulfate Powder 40mg

[0047] Methylparaben 1.6mg

[0048] Propylparaben 0.3mg

[0049] Sodium bisulfite 3.2mg

[0050] EDTA---2Na 0.1mg

[0051] Add water for injection to 1ml

[0052] Process with reference to embodiment 2.

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PUM

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Abstract

The invention discloses a preparation method of nitrogen a gentamycin sulfate injection. The method comprises the following steps: installing a nitrogen distributor in a dispensing tank; taking water for injection accounting for 50-60% of the total volume, placing gentamycin sulfate raw powder in the dispensing tank to stir and dissolve, adding accessories and a defined amount of water for injection; adjusting the pH value of the dispensed solution; and after the test proving that the medicine content is qualified, decarbonizing, performing aseptic filter-pressing, and filling. The accelerating test and sample observation show that the gentamycin sulfate injection prepared by the preparation method of the invention can not change color and the color of the same lot is uniform. The color grade qualification rate of the product can reach 100% under the specified storage conditions in the expiration date of the product.

Description

Technical field: [0001] The invention relates to a preparation method of medicine, in particular to a preparation method of gentamicin injection. Background technique: [0002] Gentamicin Sulfate Injection is an aminoglycoside antibiotic. The main ingredient is gentamicin sulfate, which is a multi-component antibiotic containing C1, C1a, C2a, C2 and other components. It has good antibacterial effect on various Gram-negative bacteria and Gram-positive bacteria, and has good antibacterial effect on various Enterobacteriaceae bacteria such as Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Enterobacter, Serratia and Pseudomonas aeruginosa have good antibacterial effect. It is suitable for the treatment of sensitive Gram-negative bacilli, such as Escherichia coli, Klebsiella, Enterobacter, Proteus, Serratia, Pseudomonas aeruginosa, and methicillin-sensitive strains of Staphylococcus Severe infection, such as sepsis, lower respiratory tract infection, intestinal i...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7036A61K47/18A61P31/04A61J3/00
Inventor 程丽霞李晓斌张西果赵辉王志良刘书睿赵霞路玉锋
Owner 华北制药集团制剂有限公司
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