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Tobramycin inhalation solution and preparing method

A technology of tobramycin and solution, applied in the field of medicine, can solve the problems of limited formation, aggravation of adverse reactions, induction of lung disease patients, etc., and achieve the effect of reducing the incidence of adverse reactions

Inactive Publication Date: 2016-05-04
孙红娟 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The stability of tobramycin is strictly dependent on pH, but the use of pH to inhibit the formation of degradation products is very limited, and the stability of existing products can only be maintained for 28 days at room temperature in the dark
If preservatives and antioxidants are added, although the storage time can be extended, these substances may induce or aggravate adverse reactions in patients with lung diseases

Method used

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  • Tobramycin inhalation solution and preparing method

Examples

Experimental program
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Effect test

Embodiment 1

[0027] Tobramycin inhalation solution of the present invention, every 2ml (1 unit dose vial) contains:

[0028]

[0029]

[0030] The preparation method of above-mentioned tobramycin inhalation solution, the steps are as follows:

[0031] Dissolve 9g of sodium chloride in purified water, stir to fully dissolve, use 98.3wt% concentrated sulfuric acid to adjust the pH, then add 150g tobramycin and 40gL-threonine, and mix until completely dissolved, use 98.3wt% concentrated sulfuric acid Sulfuric acid or 1mol / L sodium hydroxide solution to adjust the pH, and then continue to add purified water to 2L. Finally, it is sufficient to filter the obtained aqueous solution through 0.45 μm and 0.2 μm nylon filters in sequence. The solution was filled into 2 ml polyethylene colorless unit dose vials under a nitrogen purge.

Embodiment 2

[0033] Tobramycin inhalation solution of the present invention, every 2ml (1 unit dose vial) contains:

[0034]

[0035] The preparation method of above-mentioned tobramycin inhalation solution, the steps are as follows:

[0036] Dissolve 9g of sodium chloride in purified water, stir to fully dissolve, adjust pH with 98.3wt% concentrated sulfuric acid, then add 150g tobramycin and 60gL-threonine, and mix until completely dissolved, use 98.3wt% concentrated sulfuric acid Sulfuric acid or 1mol / L sodium hydroxide solution to adjust the pH, and then continue to add purified water to 2L. Finally, it is sufficient to filter the obtained aqueous solution through 0.45 μm and 0.2 μm nylon filters in sequence. The solution was filled into 2 ml polyethylene colorless unit dose vials under a nitrogen purge.

Embodiment 3

[0038] Tobramycin inhalation solution of the present invention, every 2ml (1 unit dose vial) contains:

[0039]

[0040] The preparation method of above-mentioned tobramycin inhalation solution, the steps are as follows:

[0041] Dissolve 9g of sodium chloride in purified water, stir to fully dissolve, adjust pH with 98.3wt% concentrated sulfuric acid, then add 150g tobramycin and 50gL-threonine, and mix until completely dissolved, use 98.3wt% concentrated sulfuric acid Sulfuric acid or 1mol / L sodium hydroxide solution to adjust the pH, and then continue to add purified water to 2L. Finally, it is sufficient to filter the obtained aqueous solution through 0.45 μm and 0.2 μm nylon filters in sequence. The solution was filled into 2 ml polyethylene colorless unit dose vials under a nitrogen purge.

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Abstract

The invention discloses a tobramycin inhalation solution. The tobramycin inhalation solution comprises tobramycin and L-threonine which are dissolved in a 4.5mg / mL sodium chloride water solution, the concentration of tobramycin is 75mg / mL, the concentration of L-threonine is 20-30mg / mL, and pH of the inhalation solution is 5.6-6.0. According to the tobramycin inhalation solution, L-threonine is added, pH adjustment is conducted, and the long-term stability study shows that the inhalation solution is stable at least for 24 months at the indoor temperature in the end and is stable for 6 months on the acceleration condition. The FEV1% predicted value deletion proportion is far higher than that of public products, and the adverse reaction occurrence rate is obviously reduced.

Description

technical field [0001] The invention relates to a tobramycin inhalation solution, in particular to a tobramycin inhalation solution and a preparation method thereof. It belongs to the field of medical technology. Background technique [0002] Cystic fibrosis (CF) is the most common autosomal recessive genetic disease in Western countries. Its cause is that the gene mutation of cystic fibrosis transmembrane conductance regulator (CFTR) causes a large amount of mucus to block the exocrine glands of the whole body. The clinical manifestations are: Sinusitis and bronchiectasis, recurrent respiratory infections, recurrent diarrhea and steatorrhea caused by exocrine pancreatic insufficiency, and congenital absence of the vas deferens in male patients. Patients often present with bronchiectasis or long-term P. aeruginosa colonization or infection in infancy, and mortality is high in infancy and adolescence. However, if diagnosed and treated early, life expectancy is expected to r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K31/702A61P31/04A61K31/198
CPCA61K9/0078A61K9/08A61K31/198A61K31/702A61K47/02A61K2300/00
Inventor 黄群好
Owner 孙红娟
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