Container-holding mesylate pazufloxacin aqueous solution and preparation method thereof

A technology of pazufloxacin mesylate and armored methanesulfonic acid, which is applied in the field of aqueous solutions of parenteral drugs, can solve the problems of unqualified foreign objects, achieve good compatibility, and improve stability and safety.

Inactive Publication Date: 2013-04-10
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved by the present invention is to provide a container-packed pazufloxacin mesylate aqueous solution and its preparation method, to solve the problem of unqualified visible foreign objects in the placement process of the pazufloxacin mesylate injection product
[0005] The present invention adopts the compound film (coating film) rubber stopper as the seal of packing, replaces common chlorinated butyl rubb

Method used

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  • Container-holding mesylate pazufloxacin aqueous solution and preparation method thereof
  • Container-holding mesylate pazufloxacin aqueous solution and preparation method thereof
  • Container-holding mesylate pazufloxacin aqueous solution and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0015] prescription:

[0016]

[0017] Preparation Process:

[0018] Measure the prescribed amount of water for injection, add the prescribed amount of pazufloxacin mesylate, stir to dissolve, then add the prescribed amount of sodium chloride, after all dissolve, adjust the pH value to 3-4 with methanesulfonic acid, add 0.2 % (g / ml) activated carbon, decarbonized after stirring for 30 minutes, after aseptic filtration, potted in a 100mL glass infusion bottle, sealed with a laminated rubber stopper, and rolled the cap. Autoclave at 117°C for 30 minutes.

[0019] In order to illustrate the superiority of the present invention, the above-mentioned same medicinal solution was prepared and sealed in the following containers respectively for compatibility experiments, and the visible foreign matter and the appearance change of the rubber stopper were used as the main detection items for preliminary investigation. The test results are shown in Table 1 :

[0020] Table 1. Prelim...

Embodiment 2

[0051] prescription:

[0052]

[0053] Preparation Process:

[0054] Measure the prescribed amount of water for injection, add the prescribed amount of pazufloxacin mesylate, stir to dissolve, then add the prescribed amount of sodium chloride, after all dissolve, adjust the pH value to 3-4 with methanesulfonic acid, add 0.2 % (g / ml) activated carbon, decarbonized after stirring for 30 minutes, after aseptic filtration, potted in a 100mL glass infusion bottle, sealed with a laminated rubber stopper, and rolled the cap. Autoclave at 117°C for 30 minutes.

[0055] In order to illustrate the superiority of the original packaging, the above-mentioned same medicinal solution was prepared and sealed in the following containers respectively, and the compatibility test was carried out, and the visible foreign matter and the appearance change of the rubber stopper were used as the main detection items for preliminary investigation. The test results Table 8 below.

[0056] Table 8....

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PUM

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Abstract

The present invention relates to a container-holding mesylate pazufloxacin aqueous solution. The mesylate pazufloxacin aqueous solution is stored in a container with a seal, and is characterized in that the pH of the aqueous solution is in the range of 1-4, the concentration of mesylate pazufloxacin in the aqueous solution is 0.001-0.01 g/ml, the container is sealed by complex membrane or a coating film rubber stopper, and the film used by the complex membrane or the coating film rubber stopper is fluoro-polymer film, poly-p-xylene-containing film or composite polyethylene glycol terephthalate film. The present invention solves the problem that visible foreign matter appears in the mesylate pazufloxacin injection products during placement.

Description

technical field [0001] The present invention relates to the aqueous solution of parenteral medicine, especially the aqueous solution of pazufloxacin mesylate. Background technique [0002] Pazufloxacin mesylate is a fourth-generation quinolone antibiotic developed by Japan Toyama Chemical Industry Co., Ltd. Pazufloxacin Mesylate Injection Sodium Chloride was listed in Japan in April 2002, and it is clinically applicable to bacteria caused by staphylococcus, streptococcus (except pneumococcus), enterococcus, Moraxella catarrhalis (Branham coli), Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Serratia, Proteus, Proteus moldii, Providencia, influenzae, Pseudomonas aeruginosa, not The following infections caused by the sensitive strains of the genus Animobacterium, Bacteroides, and Prevotella: (1) Trauma and postoperative infection. (2) Secondary infection of chronic respiratory diseases (chronic bronchitis, diffuse panbronchiolitis, bronchiectasis, emphysema, pulmon...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/5383A61P31/04A61J1/14A61J1/05
Inventor 陈延祥潘西海曹文冰张春华
Owner SHANDONG XINHUA PHARMA CO LTD
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