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A kind of tobramycin solution for inhalation and preparation method thereof

A technology of tobramycin and solution, applied in the field of medicine, can solve the problems of high probability of bronchospasm and poor stability, and achieve the effects of realizing antioxidant effect, improving stability and improving curative effect.

Active Publication Date: 2019-03-01
HUBEI XINGHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to overcome the poor stability of the existing tobramycin solution for inhalation and the high probability of causing bronchospasm

Method used

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  • A kind of tobramycin solution for inhalation and preparation method thereof
  • A kind of tobramycin solution for inhalation and preparation method thereof
  • A kind of tobramycin solution for inhalation and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0029] Dissolve 0.9g of sodium chloride in 140ml of water for injection at 30°C, stir until completely dissolved and inflate with nitrogen for 20 minutes, then add 15g of tobramycin, stir until completely dissolved, then add 5mol / L sulfuric acid to adjust the pH to 5.8, if necessary, use 1mol / L sodium hydroxide solution to adjust the pH value to 5.8, add water for injection to 200ml, stir for 15min, then filter with a 0.22μm filter, and fill it in a low-density polyethylene bottle to obtain Tobramycin solution for inhalation; the molar osmotic pressure of the tobramycin solution for inhalation obtained in this example is 247 mOsm / l.

Embodiment 2

[0031] Dissolve 0.9g of sodium chloride in 120ml of water for injection at a temperature of 28°C, stir until completely dissolved and inflate with nitrogen for 30 minutes, then inflate with carbon dioxide until the pH of the solution is 5.7, then add 1mg of cysteine ​​and 12g of tobu Mycin, stir until completely dissolved, then add 3mol / L sulfuric acid to adjust the pH value to 5.9, if necessary, use 1mol / L sodium hydroxide solution to adjust the pH value to 5.9, add water for injection to 200ml, stir for 20min, and then use 0.22μm The tobramycin solution for inhalation was obtained by filtering it with a filter and filling it in a low-density polyethylene bottle; the osmotic pressure of the tobramycin solution for inhalation obtained in this example was 232 mOsm / l.

Embodiment 3

[0033] Dissolve 0.9g of sodium chloride in 140ml of water for injection at a temperature of 30°C, stir until completely dissolved and inflate with nitrogen for 20 minutes, then inflate with carbon dioxide gas until the pH of the solution is 5.7, then add 15g of tobramycin, stir until completely dissolved , then add 4mol / L sulfuric acid to adjust the pH value to 6.1, if necessary, use 1mol / L sodium hydroxide solution to adjust the pH value to 6.1, add water for injection to 200ml, stir for 30min, then filter with a 0.22μm filter, and fill The tobramycin solution for inhalation was obtained in a low-density polyethylene bottle; the molar osmotic pressure of the tobramycin solution for inhalation obtained in this example was 243 mOsm / l.

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Abstract

The invention provides a tobramycin solution for inhalation. The tobramycin solution is prepared from tobramycin and a pH regulator, wherein the tobramycin is dissolved in a sodium chloride aqueous solution with concentration of 2.25-4.5mg / ml, the concentration of the tobramycin is 60-75 mg / ml, the pH regulator is sulfuric acid, and pH of the tobramycin solution for inhalation is 5.8-6.2. The tobramycin solution for inhalation is simple in composition, pH of the solution is controlled to be near-neutral and osmotic pressure is near-isotonic by controlling dosage of sulfuric acid, and bronchospasm and cough caused by irritation of the tobramycin solution for inhalation are reduced; after the tobramycin solution for inhalation is stored at room temperature for 1 year, the content of tobramycin is reduced slightly, the content of related substances is lower than 1.0%, requirements of the USP (United States Pharmacopeia) for the tobramycin solution for inhalation are met, the problem thatthe conventional tobramycin solution for inhalation is required to be stored at 2-8 DEG C is solved, drug use for a patient is facilitated, and storage cost and transport cost are reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a tobramycin solution for inhalation and a preparation method thereof. Background technique [0002] Cystic fibrosis (Cystic fibrosis) is a common fatal autosomal recessive genetic disease. The incidence of cystic fibrosis in Europe and North America is about 1 / (2000-3000), and the incidence in Asia is higher than that in Europe and North America. Low in North America, the incidence rate of white infants in the United States is about 1 / 3300, that of black infants is about 1 / 15300, and that of Asian Americans is about 1 / 32000, and 70% of the affected population are children or adolescents. From the analysis of reported cases of cystic fibrosis, it is known that cystic fibrosis has the characteristics of extremely high mortality and short median survival period. Cystic fibrosis results in impaired membrane transport of water, bicarbonate, and the like, resulting in vi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/72A61K9/08A61K31/702A61K47/18A61K47/04A61P31/04A61P11/00
CPCA61K9/0078A61K9/08A61K31/702A61K47/02A61K47/183
Inventor 卢山张传涛陆毅方盼盼蓬国辉潘丽芬洪春雪
Owner HUBEI XINGHUA PHARMA CO LTD
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