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Ambroxol hydrochloride atomized inhalation solution and preparation method thereof

A technology of ambroxol hydrochloride and atomized inhalation, which is applied in aerosol delivery, pharmaceutical formulation, spray delivery, etc., can solve the problems of lack of systematic evaluation, etc., achieve good curative effect, good reproducibility, and easy large-scale industrial production Effect

Inactive Publication Date: 2018-11-30
JIANMIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the instructions of Ambroxol Injection only stipulate that it is used for intravenous injection, and there is still a lack of systematic evaluation of relevant evidence on the effectiveness and safety of its use as an aerosol inhalation

Method used

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  • Ambroxol hydrochloride atomized inhalation solution and preparation method thereof

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preparation example Construction

[0032] The embodiment of the present invention provides a kind of preparation method of the above-mentioned ambroxol hydrochloride atomization inhalation solution, and it comprises the following steps:

[0033] (1) Add ambroxol hydrochloride and clenbuterol hydrochloride into a solvent of 50%-80% of the recipe quantity, stir evenly, and the temperature is 50-70°C.

[0034] (2) Add the buffer pair, stir until it is completely dissolved, and the temperature is 50-70°C.

[0035] (3) Add isotonicity regulator and stir until dissolved.

[0036] (4) Add 0.01%-0.1% (w / v) of activated carbon for injection, the temperature is 50-70° C., stir for 15-30 min, and filter for decarburization.

[0037] (5) Add the solvent to the full amount, stir evenly, check the pH and content, and adjust the pH between 4.5-5.5. In this embodiment, a pH adjusting agent is used to adjust the pH value, and the pH adjusting agent includes at least one selected from the group consisting of citric acid, malic...

Embodiment 1

[0049] The present embodiment provides a kind of ambroxol hydrochloride atomization inhalation solution, which adopts the following preparation method to make:

[0050] (1) Add 1 g of ambroxol hydrochloride and 0.05 g of clenbuterol hydrochloride to 80 ml of water for injection, stir evenly, and the temperature is 60°C.

[0051] (2) Add citric acid-sodium citrate, stir until completely dissolved, and the temperature is 60°C.

[0052] (3) Add 2 g of sodium chloride and stir until dissolved.

[0053] (4) 0.05% activated carbon for injection was added, the temperature was 60° C., stirred for 20 min, and filtered for decarburization.

[0054] (5) Add water for injection to a total volume of 100ml, stir evenly, detect pH and content, and adjust pH to be between 5.

[0055] (6) Filter the above-mentioned medicinal liquid through a 1.0 μm titanium filter element, detect the pH value and content of the intermediate, and adjust and control the pH to be between 4 and 101%.

[0056] (...

Embodiment 2

[0060] The present embodiment provides a kind of ambroxol hydrochloride atomization inhalation solution, which adopts the following preparation method to make:

[0061] (1) Add 0.5 g of ambroxol hydrochloride and 0.1 g of clenbuterol hydrochloride into 50 ml of water for injection, stir evenly, and the temperature is 70°C.

[0062] (2) Add citric acid-disodium hydrogen phosphate, stir until completely dissolved, and the temperature is 70°C.

[0063] (3) Add 1 g of magnesium chloride and glucose, and stir until dissolved.

[0064] (4) 0.01% (w / v) of activated carbon for injection was added, the temperature was 70° C., stirred for 30 minutes, and filtered for decarburization.

[0065] (5) Add water for injection to a total volume of 100 ml, stir evenly, detect pH and content, and adjust pH between 5.5.

[0066] (6) Filter the above medicinal liquid through a 1.0 μm titanium filter element, detect the pH value and content of the intermediate, and adjust and control the pH to be...

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Abstract

The invention discloses an ambroxol hydrochloride atomized inhalation solution and a preparation method thereof, and relates to the field of pharmaceutical nanotechnology. According to the ambroxol hydrochloride atomized inhalation solution, every 100ml of ambroxol hydrochloride atomized inhalation solution comprises 0.5-1g of ambroxol hydrochloride, 0.05-0.1g of clenbuterol hydrochloride, a buffer pair and isoosmotic adjusting agents and the balance of solvents. The single-dose specification of the ambroxol hydrochloride atomized inhalation solution is 2ml, measurement is accurate, and the curative effect is good; and the ambroxol hydrochloride atomized inhalation solution has no preservative, stable quality and little side effects. The preparation method of the ambroxol hydrochloride atomized inhalation solution comprises the steps that the ambroxol hydrochloride and the clenbuterol hydrochloride are added to part of the solvents and stirred well; and the buffer pair and the isoosmotic adjusting agents are added and stirred until dissolved, enough solvent is replenished after filtration, and fine filtration is performed. The process has good reproducibility and product stability,and is easy for large-scale industrial production.

Description

technical field [0001] The invention relates to the field of new pharmaceutical dosage forms, and in particular relates to an ambroxol hydrochloride atomized inhalation solution and a preparation method thereof. Background technique [0002] The chemical name of ambroxol hydrochloride is: trans-4-[(2-amino-3,5 dibromo-phenyl)methyl-amino]cyclohexanol. Ambroxol hydrochloride is a new generation of respiratory mucus regulator, which has superior expectorant effect and can significantly promote the synthesis and secretion of alveolar surfactants. Ambroxol hydrochloride can stimulate the bronchial mucous glands to secrete mucus that is easier to flow, dilute the sputum, reduce its viscosity, and increase the production and secretion of pulmonary surfactants, thereby reducing airway resistance and mucus adhesion. Activates mucociliary blanket function and promotes mucociliary transport. Compared with the first-generation and second-generation expectorant drugs, in addition to i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K47/10A61K47/26A61K47/44A61K31/137A61K39/40A61P11/10A61P11/00A61P11/06
CPCA61K39/40A61K47/10A61K47/26A61K47/44A61P11/00A61P11/06A61P11/10A61K9/0073A61K9/08A61K31/137A61K2300/00Y02A50/30
Inventor 任霞赵刚吴雪英余丽花郭平吴木琴方胡彪
Owner JIANMIN PHARMA GRP CO LTD
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