Ambroxol hydrochloride atomization inhalant, and preparation method and application thereof

A technology of ambroxol hydrochloride and aerosol inhaler, which is applied in directions such as aerosol delivery, pharmaceutical formulations, respiratory diseases, etc., can solve problems such as unsafe use, instability of ambroxol hydrochloride aerosol inhaler, etc.

Active Publication Date: 2014-09-10
天津药物研究院药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Therefore, the purpose of the present invention is to aim at the instability of current ambroxol hydrochloride atomized inhalation, the deficiency that can not be used safely, provide a kind of ambroxol hydrochloride atomized inhalation and its preparation method and application, the ambroxol hydrochloride Suo aerosol inhalation contains the best stabilizing elements, can be stored stably, and is suitable for safe use by infants and young children

Method used

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  • Ambroxol hydrochloride atomization inhalant, and preparation method and application thereof
  • Ambroxol hydrochloride atomization inhalant, and preparation method and application thereof
  • Ambroxol hydrochloride atomization inhalant, and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Example 1 1000 pieces

[0053] Prescription: Specification 2ml: 15mg

[0054] Ambroxol Hydrochloride 15.0g

[0055] Citric acid 2.0g

[0056] Sodium dihydrogen phosphate 6.0g

[0057] Sodium chloride 15.0g

[0058] Fructose 1.0g

[0059] Sodium sulfite 10.0g

[0060] Add water for injection to 2000ml

[0061] Process:

[0062] (1) Take water for injection at 45°C±5°C with 80% of the prepared amount, add raw and auxiliary materials and stir until completely dissolved, then cool to 25°C±5°C; measure the pH value, add 1mol / L NaOH solution to adjust the pH value to 5.3, Add water to nearly full volume.

[0063] (2) Add medicinal charcoal and stir thoroughly for 30 minutes at 25°C±5°C, filter and decarbonize, and add water to the full amount.

[0064] (3) Filter with a 0.45 μm microporous membrane and then a 0.22 μm microporous membrane, and take samples to determine the pH value and the content of active ingredients.

[0065] (4) Fill and seal ampoule with 2ml e...

Embodiment 2

[0066] Example 2 1000 pieces

[0067] Prescription: Specification 4ml: 30mg

[0068] Ambroxol Hydrochloride 30.0g

[0069] Citric acid 4.0g

[0070] Sodium dihydrogen phosphate 8.0g

[0071] Potassium chloride 34.0g

[0072] Sorbitol 2.0g

[0073] Sodium bisulfite 4.0g

[0074] Add water for injection to 4000ml

[0075] Process:

[0076] (1) Take water for injection at 50°C±5°C with 60% of the prepared amount, add raw and auxiliary materials and stir until completely dissolved, then cool to 35°C±5°C; measure the pH value, add 0.8 mol / L NaOH solution to adjust the pH value to 4.7 , add water to nearly full amount.

[0077] (2) Add medical charcoal and stir thoroughly for 30 minutes at 35°C±5°C, filter and decarbonize, and add water to the full amount.

[0078] (3) Filter with a 0.45 μm microporous membrane and then a 0.22 μm microporous membrane, and take samples to determine the pH value and the content of active ingredients.

[0079] (4) Fill each 4ml ampoule int...

Embodiment 3

[0080] Example 3 1000 pieces

[0081] Prescription: Specification 10ml: 75mg

[0082] Ambroxol Hydrochloride 75.0g

[0083] Citric acid 10.0g

[0084] Sodium dihydrogen phosphate 10.0g

[0085] Sodium chloride 180g

[0086] Fructose 1.0g

[0087] Sodium Metabisulfite 5.0g

[0088] Add water for injection to 10000ml

[0089] Process:

[0090] (1) Take water for injection at 60°C±5°C with 70% of the prepared amount, add raw and auxiliary materials and stir until completely dissolved, then cool to 40°C±5°C; measure the pH value, add 0.6mol / L NaOH solution to adjust the pH value to 4.9 , add water to nearly full amount.

[0091] (2) Add medicinal charcoal and stir thoroughly for 30 minutes at 40°C±5°C, filter and decarbonize, and add water to the full amount.

[0092] (3) Filter with a 0.45 μm microporous membrane and then a 0.22 μm microporous membrane, and take samples to determine the pH value and the content of active ingredients.

[0093] (4) Fill and seal 10ml o...

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Abstract

The invention provides an ambroxol hydrochloride atomization inhalant and a preparation method and application thereof. The ambroxol hydrochloride atomization inhalant uses injection water as a solvent and contains ambroxol hydrochloride with a concentration of 7.5 mg / ml and a pharmaceutically acceptable carrier with a concentration of 18 to 28 mg / ml; the carrier comprises a pH value stabilizing agent which is one or more selected from the group consisting of sodium pyrosulfite, sodium hydrosulphite and sodium hydrogen sulfite. The preparation method comprises the following steps: weighing ambroxol hydrochloride and the pharmaceutically acceptable carrier, adding a proper amount of injection water to dissolve ambroxol hydrochloride and the pharmaceutically acceptable carrier, carrying out cooling, then adjusting a pH value by using the pH value stabilizing agent containing sodium pyrosulfite, sodium hydrosulphite and / or sodium hydrogen sulfite and adding water until a desired total amount is almost obtained; then carrying out full stirring with medicinal carbon, carrying out filtering to remove carbon and adding water until the desired total amount is obtained; carrying out filtering with a microfiltration membrane; and filling each bottle with 2 ml, 4ml, 10 ml or 20 ml of the atomization inhalant, then introducing nitrogen and carrying out autoclaved sterilization. The invention further relates to application of the atomization inhalant in preparation of drugs used for treating diseases of the respiratory system.

Description

technical field [0001] The invention relates to the technical field of chemical pharmacy. It specifically relates to an atomized inhaler and its preparation method and application, in particular to an ambroxol hydrochloride atomized inhaler and its preparation method and application. Background technique [0002] The chemical name of ambroxol hydrochloride is: trans 4-[(2-amino-3,5 dibromo-phenyl) methyl-amino] cyclohexanol, and its structure is as follows: [0003] [0004] Ambroxol hydrochloride is a new generation of airway mucus regulator, which has excellent expectorant effect and can significantly promote the synthesis and secretion of alveolar surfactant. Ambroxol hydrochloride can stimulate bronchial mucous glands to secrete more fluid mucus, dilute sputum, reduce viscosity, and increase the production and secretion of pulmonary surfactant, thereby reducing airway resistance and mucus adhesion. Activates mucociliary blanket function and promotes mucociliary tran...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/12A61K31/137A61P11/10
Inventor 任晓文邹美香孙歆慧李洪起王博郭振华连潇嫣吴疆胡金芳
Owner 天津药物研究院药业有限责任公司
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