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Pazufloxacin mesilate injection composition and preparation method thereof

A technology of pazufloxacin mesylate and pazufloxacin, which is applied in the field of pazufloxacin mesylate injection composition and its preparation, can solve the problem of high substance content, large growth rate, and problems of pazufloxacin mesylate Provide effective solutions to the stability of Shaxing Injection and other issues to achieve the effect of less dosage, low content of related substances and safe excipients

Active Publication Date: 2016-02-03
HEBEI ZHITONG BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the prior art, CN03108561.X, CN201110293459.1 etc. have carried out certain research to Pazufloxacin Mesylate Injection, but there are still problems such as relatively high content of related substances or relatively large growth rate during storage. Did not provide an effective solution to the stability problem of pazufloxacin mesylate injection

Method used

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  • Pazufloxacin mesilate injection composition and preparation method thereof
  • Pazufloxacin mesilate injection composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Example 1 Pausu acid Paushu Stepper Injection Line Composition of the invention

[0052] prescription:

[0053] Paushu Sulfan (with Pazuta Shaxing) 300g,

[0054] 2 g of methyl sulfonic acid,

[0055] Amber 5g,

[0056] Sodium chloride 90g,

[0057] Add injection water to 10L.

[0058] Preparation:

[0059] 1) Add the prescribed sulfonic acid, amber acid, sodium chloride to the appropriate amount of injection water and stir well;

[0060] 2) Add the prescribed amount of metharodic acid Paushu star, stir until fully dissolved;

[0061] 3) Injecting water to 10L, adjust the pH value of 2.0-4.0 with sodium hydroxide;

[0062] 4) Pre -filtering of 1.0 μm filtrate, ultrafiltration, 0.22 μm microporous filter membrane fine filter;

[0063] 5) The seal to 1,000 bars, sterilize 15min at 121 ° C, packaged.

Embodiment 2

[0064] Example 2 Paushu Socciences Injection Line Composition of the present invention

[0065] prescription:

[0066] Paushu Sulfan (with Pazuta Shaxing) 300g,

[0067] Tunulfonic acid 2.7g,

[0068] Amber 10g, 10g

[0069] Sodium chloride 90g,

[0070] Add injection water to 10L.

[0071] Preparation:

[0072] Same Example 1.

Embodiment 3

[0073] Example 3 Paushu Socciences Injection Line Composition of the invention

[0074] prescription:

[0075] Paushu Sulfan (with Pazuta Shaxing) 300g,

[0076] 4G sulfonic acid,

[0077] Amber 15g,

[0078] Sodium chloride 90g,

[0079] Add injection water to 10L.

[0080] Preparation:

[0081] Same Example 1.

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PUM

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Abstract

The invention provides a pazufloxacin mesilate injection composition and a preparation method thereof. The pazufloxacin mesilate injection composition comprises pazufloxacin mesila, methanesulfonic acid, succinic acid and common salt. The pazufloxacin mesilate injection composition has the characteristics of high stability, low content of relevant substances and suitability for industrialized production.

Description

Technical field [0001] The present invention involves the field of drug preparation technology, which specifically involves a new type of methadosilicine Paushu injector and its preparation methods. Background technique [0002] PazufloxacinmeSilate (PazufloxacinmeSilate) belongs to the fourth -generation penitoone spectrum antibiotics, which can be used to treat Gram -positive bacteria and negative bacteria infections, such as bronchial and lung infections, bacterial dysentery, urinary systems, skin and soft tissue infectionswait.The chemical name of Paushu Sulfanic acid Paushu is "(s)-(-)-10- (1-amino-1-cyclopenyl) -9-fluorine-3-methyl-2, 3-dihydrous-7-oxygen-7h-pyridine and [1, 2, 3-de] [1, 4] benzene mezide -6-carboxylic acid sulfonate ", the structure is as follows: [0003] [0004] Among the existing technologies, CN03108561.X, CN201110293459.1 and other problems have been studied on moxulfonic acid Paushu Stepper injection, but there are still problems such as high mate...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/5383A61K47/20A61K47/12A61P31/04
Inventor 夏彤郭超许峰张电追侯磊张云升
Owner HEBEI ZHITONG BIOLOGICAL PHARMA
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