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A kind of tobramycin inhalation composition and its preparation method and application

A technology of tobramycin and its composition, which is applied in the field of tobramycin inhalation composition and its preparation, can solve the problems of reducing administration time, reducing administration volume, etc., so as to improve curative effect, increase drug concentration, and reduce systemic Toxic effects

Active Publication Date: 2018-08-21
GUANGZHOU JOINCARE RESPIRATORY DRUG ENG TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This technology mainly achieves the effect of reducing the administration time by increasing the concentration of the main drug and reducing the administration volume, and the effect on the stability of tobramycin is not mentioned.

Method used

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  • A kind of tobramycin inhalation composition and its preparation method and application
  • A kind of tobramycin inhalation composition and its preparation method and application
  • A kind of tobramycin inhalation composition and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Weigh 60g of tobramycin, 2.25g of sodium chloride and 4g of citric acid and put it into the liquid irrigation, add water for injection, control the temperature at about 25°C, stir, and dissolve them all, and use 20% (v / v) Take an appropriate amount of sulfuric acid solution, adjust the pH to 6.8, add water for injection to 1000ml, stir well, filter through a 0.22μm filter membrane, fill and seal in a 5ml low-density polyethylene bottle, and obtain.

Embodiment 2

[0044] Weigh 40g of tobramycin, 9g of sodium chloride and 6g of malic acid and put it into the liquid irrigation, add water for injection, control the temperature at about 30°C, stir to dissolve all, and use 20% (v / v) sulfuric acid solution Appropriate amount, adjust the pH to 6.0, add water for injection to 1000ml, stir well, filter through a 0.22μm filter membrane, fill in a 3ml low-density polyethylene bottle, and obtain.

Embodiment 3

[0046] Weigh 80g of tobramycin, 1g of sodium chloride and 1g of tartaric acid, put them into the liquid irrigation, add water for injection, control the temperature at about 10°C, stir to dissolve them all, and add an appropriate amount of 10% (v / v) sulfuric acid solution , adjust the pH to 5.6, add water for injection to 1000ml, stir well, filter through a 0.22μm filter membrane, and fill in a 5ml low-density polyethylene bottle to obtain the product.

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Abstract

The invention relates to a tobramycin inhalation composition and a preparation method and application thereof. The composition is prepared from tobramycin 4%-8% (w / v), sodium chloride 0.1%-0.9% (w / v), weak-reducibility organic weak acid serving as a stabilizer 0.1%-1.0% (w / v), strong acid for regulating the pH value of the composition and the balance water, wherein the pH value of the composition is 5.6-7.5. The tobramycin inhalation composition prepared by adopting the technical scheme has the pH value closer to the physiological pH of a human body and has significantly improved stability at room temperature.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a tobramycin inhalation composition and a preparation method and application thereof. Background technique [0002] Tobramycin inhalation solution is developed by Novartis, and its trade name is TOBI. TOBI is a light yellow sterile, pyrogen-free clear inhalation solution. Use an air-compressed nebulizer to administer the drug. In the United States, TOBI has been approved by the FDA for the treatment of cystic fibrosis patients with chronic lung infection caused by Pseudomonas aeruginosa, and has been approved for use in children over 6 years old. [0003] The active ingredient in TOBI - the chemical formula of Tobramycin is C 18 h 37 N 5 o 9 , its relative molecular weight is 467.52, and its chemical name is O-3-amino-3-deoxy-α-O-glucopyranosyl-(1→6)-O-[2,6-diamino-2,3, 6-trideoxy-α-D-nucleo-hexapyranosyl-(1→4)]-2-deoxy-D-streptomycin, the structural formula is...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/702A61K47/12A61P31/04A61P11/00
CPCA61K9/0078A61K9/08A61K31/702A61K47/12
Inventor 蔡伟惠金方
Owner GUANGZHOU JOINCARE RESPIRATORY DRUG ENG TECH CO LTD
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