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Tobramycin inhalation solution and preparation method thereof

A tobramycin and solution technology, 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: 2019-06-04
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 preparation method thereof
  • Tobramycin inhalation solution and preparation method thereof
  • Tobramycin inhalation solution and preparation method thereof

Examples

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Effect test

Embodiment 1

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

[0028]

[0029]

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

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

Embodiment 2

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

[0034]

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

[0036] 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 of tobramycin and 60g of L-threonine, and mix until completely dissolved, using 98.3wt% of Adjust the pH with concentrated sulfuric acid or 1mol / L sodium hydroxide solution, and then continue to add purified water to 2L. Finally, filter the resulting aqueous solution through 0.45μm and 0.2μm nylon filters in sequence. Under nitrogen purge, the solution was filled into a 2 ml polyethylene colorless unit dose vial.

Embodiment 3

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

[0039]

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

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

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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 the gene mutation of cystic fibrosis transmembrane conductance regulator (CFTR), which causes a large amount of mucus to block the exocrine glands throughout the body. Clinical manifestations Sinusitis and bronchiectasis, repeated respiratory infections, recurrent diarrhea and steatorrhea caused by pancreatic exocrine insufficiency, and congenital vas deferens loss can also occur in male patients. Patients often see a doctor due to bronchiectasis or long-term colonization or infection of Pseudomonas aeruginosa in childhood, and the mortality rate is high during childhood and adolescence. But if diagnosed and treated early, life ex...

Claims

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Application Information

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