Fudosteine injection and preparation method thereof

A technology for fudosteine ​​and injection, applied in the field of pharmaceutical preparations

Inactive Publication Date: 2014-05-07
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is only an oral dosage form of fudosteine ​​on the domestic market,

Method used

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  • Fudosteine injection and preparation method thereof
  • Fudosteine injection and preparation method thereof
  • Fudosteine injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] 1000 sticks

[0032] prescription:

[0033] Fordosteine

200g

citric acid

0.2g

sodium citrate

0.6g

Add water for injection to

2000ml

[0034] Process:

[0035] Weigh the prescribed amount of fudosteine, citric acid and sodium citrate into a beaker, add 1500ml of water for injection, stir at room temperature to dissolve, add 1mol / L hydrochloric acid or 1mol / L sodium hydroxide to adjust the pH to 3-6. Add 0.1% activated carbon, stir at room temperature for 20 minutes, filter to remove carbon, measure the content of intermediates, add water for injection to make up for fine filtration with a 0.22μm filter membrane, fill with 2ml each, and sterilize at 121°C for 15 minutes to obtain Defudos Tan injection.

Embodiment 2

[0036] 1000 sticks

[0037] prescription:

[0038] Fordosteine

400g

Mannitol

400g

Add water for injection to

1000ml

[0039] Process:

[0040] First add 800ml of water for injection into the container, add fudosteine ​​and mannitol and stir to dissolve at room temperature for about 30 minutes, add 0.2% activated carbon, stir at room temperature for 20 minutes, decarburize, use 0.22μm microporous membrane to filter bacteria, measure the middle Add water for injection to make up, subpackage by 1ml per bottle, pre-freeze for 2 hours, dry under reduced pressure for 12 hours under freezing, and dry for 3 hours after the sample temperature reaches room temperature to obtain a white loose block. Seal the seal to get fodosteine ​​freeze-dried powder injection.

Embodiment 3

[0041] 50 bottles

[0042] prescription:

[0043] Fordosteine

10g

potassium chloride

110g

Disodium phosphate

2g

Add water for injection to

12500ml

[0044] Process:

[0045] Add 10000ml of water for injection in the container, add fudosteine, potassium chloride and disodium hydrogen phosphate and stir to dissolve, stir and dissolve at room temperature for about 30 minutes, add 1mol / L phosphoric acid to adjust the pH to 3-6, add 0.2% activated carbon, and keep at room temperature Stir for 20 minutes, decarburize, measure the content of intermediates, add water for injection to make up, use 0.22μm microporous membrane filter, pack in 250ml per bottle, and sterilize at 115°C for 15 minutes to obtain Defodosteine ​​Injection.

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PUM

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Abstract

The invention relates to medicinal preparations, specifically to a fudosteine injection. The fudosteine injection is a stable pharmaceutical composition composed of the active component fudosteine and pharmaceutically acceptable adjuvant materials which comprises excipient, a pH value regulating agent, an osmotic pressure regulating agent, injection water and the like. According to the invention, since above-mentioned carriers are used and scientific preparation is carried out, the quality and medication safety and stability of a freeze-dried powder injection, a small-needle injection and a transfusion preparation are ensured, and application of the freeze-dried powder injection, the small-needle injection and the transfusion preparation in treatment of the symptoms of excessive phlegm and distressed cough of all respiratory system diseases including bronchitis is guaranteed.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation, more specifically, an expectorant-fudosteine ​​injection. Background technique: [0002] The chemical name of fudosteine ​​is: (-)-(R)-2-amino-3-(3-hydroxypropylthio)propionic acid. Its structure is as follows: [0003] [0004] Fudosteine ​​(Fudosteine) is a new type of expectorant, a new generation of mucolytic drugs, belonging to cysteine ​​derivatives. It alters the composition and rheological properties of secretions, reduces sputum viscosity, and improves depressed respiratory function. Its clinical effective rate for treating various inflammations of respiratory congestion and infection is much higher than that of ambroxol, carbocisteine ​​and other varieties currently used clinically. It was first launched in Japan on December 17, 2001, produced by SSP and Mitsubishi Welfide. The indications of fudosteine ​​almost cover the symptoms of excessive phlegm and difficult cough of all res...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/19A61K31/198A61K47/02A61K47/10A61K47/12A61P11/10
Inventor 李洪起王博连潇嫣任晓文
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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