Carbocisteine oral liquid and preparation method thereof

A technology of carbocisteine ​​and oral solution, applied in the field of medicine, can solve the problems of poor water solubility of carbocisteine, unstable, and the solution is easily oxidized and placed for a long time.

Active Publication Date: 2015-04-15
BEIJING CHENG JI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is: provide a new preparation method of carbocisteine ​​oral solution to solv

Method used

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  • Carbocisteine oral liquid and preparation method thereof
  • Carbocisteine oral liquid and preparation method thereof
  • Carbocisteine oral liquid and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0023] Prescription:

[0024]

[0025] Weigh 200g of carbocisteine, add about 6L of water;

[0026] Slowly add about 0.95L of sodium hydroxide solution (dissolve 45g of sodium hydroxide in 1L of water to obtain a sodium hydroxide solution) into the solution (1), and keep stirring to completely dissolve the carbocisteine ​​(add 1:1 by molar ratio) alkali into salt);

[0027] Get the sodium sulfite of recipe quantity and add in the solution (2) and fully stir, obtain light yellow clear solution;

[0028] Get the sodium acetate of recipe quantity, chitosan and appropriate flavoring agent and add in the solution (3), fully stir to make it dissolve completely, measure the pH of the solution, now the pH of this light yellow clear solution should be 6.9-7.5. Then add water to make up to 10L;

[0029] Filter through a 0.22 μm filter membrane, fill the filtered medicinal solution into a 10ml brown medicinal oral solution bottle, and sterilize it with damp heat at 105°C for 20 min...

example 2

[0031] Prescription:

[0032]

[0033]

[0034] Weigh 500g of carbocisteine, add about 6L of water;

[0035] Slowly add about 0.95L of sodium hydroxide solution (dissolve 112.5g of sodium hydroxide in 1L of water to obtain a sodium hydroxide solution) into the solution (1), and keep stirring to completely dissolve carbocisteine ​​(mole ratio 1:1 Add alkali to form salt);

[0036] Get the sodium metabisulfite of recipe quantity and add in the solution (2) and fully stir, obtain light yellow clear solution;

[0037] Get the sodium succinate of prescription quantity, chitosan and appropriate flavoring agent and add in the solution (3), fully stir to make it dissolve completely, measure the pH of solution, the pH of this light yellow clear solution should be 6.9-7.5 now. Then add water to make up to 10L;

[0038] Filter through a 0.22 μm filter membrane, fill the filtered medicinal solution into a 10ml brown medicinal oral solution bottle, and sterilize it with damp heat ...

example 3

[0040] Prescription:

[0041]

[0042] Weigh 1000g of carbocisteine, add about 6L of water;

[0043] Slowly add about 0.95L of sodium hydroxide solution (dissolve 225g of sodium hydroxide in 1L of water to obtain a sodium hydroxide solution) into the solution (1), and keep stirring to completely dissolve the carbocisteine ​​(add 1:1 by molar ratio) alkali into salt);

[0044] Get the sodium bisulfite of recipe quantity and add in the solution (2) and fully stir, obtain light yellow clear solution;

[0045] Get the sodium succinate of recipe quantity, chitosan and appropriate flavoring agent and add in the solution (3), fully stir to make it dissolve completely, measure the pH of solution, now the pH of this light yellow clear solution should be 6.9-7.5. Then add water to make up to 10L;

[0046] Filter through a 0.22 μm filter membrane, fill the filtered medicinal solution into a 10ml brown medicinal oral solution bottle, and sterilize it with damp heat at 105°C for 20 m...

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PUM

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Abstract

The invention relates to a carbocisteine oral liquid and a preparation method thereof. The oral liquid comprises carbocisteine accounting for 2% to 10% of the oral liquid, sodium hydroxide, an antioxidant, a solution stabilizer composition, and a flavoring agent, and has a pH value of 6.0 to 7.5. The oral liquid is prepared by the following steps: carrying out salt-forming reactions between carbocisteine and a sodium hydroxide solution, then dissolving the salts into water, adding an antioxidant, a solution stabilizer composition, and a flavoring agent, stirring, adding water to a metered volume, filtering, filling the solution into cans, and finally sterilizing the cans so as to obtain the oral liquid; wherein each can contains 10 to 120 mL of oral liquid. The oral liquid is widely used to treat thick phlegm or dys-expectoration caused by chronic bronchitis, bronchus asthma, and the like, and has the characteristics of stable property, long shelf life, and safer clinical application.

Description

technical field [0001] The invention belongs to the field of medicine and relates to a pharmaceutical preparation and a preparation method thereof, in particular to a carbocisteine ​​oral solution and a preparation method thereof. technical background [0002] In view of carbocisteine ​​(carboxymethylcysteine) being a polyacid compound containing two carboxyl groups and an amino group, its solubility in water is only 0.16% (1.6g / L), and the compound preparation Oral solution, the effective drug concentration of this oral solution should be more than 5%, in order to increase the solubility of the compound in water, the present invention adopts the mode of adding alkali to form a salt (molar ratio 1: 1 to form a salt) to realize . And because the compound is a polybasic acid with amino groups, its aqueous solution after salt formation (by adding alkali at a molar ratio of 1:1 to form a salt) is weakly acidic (pH=6.2-6.8), and the weakly acidic aqueous solution should be store...

Claims

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Application Information

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IPC IPC(8): A61K47/36A61K47/12A61K47/04A61K31/198A61K9/08
Inventor 童丰郑玉胜
Owner BEIJING CHENG JI PHARMA
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