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Ambroxol hydrochloride medicine combination for injection

A technology of ambroxol hydrochloride and composition, which is applied in the field of medicine in the field of medicine, and can solve the problems of inconvenient use, storage and transportation, etc.

Inactive Publication Date: 2012-10-10
天津梅花药品销售有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0021] The ambroxol hydrochloride injection produced by the prior art has very strict requirements on storage and light protection, and it is inconvenient to use, store and transport

Method used

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  • Ambroxol hydrochloride medicine combination for injection
  • Ambroxol hydrochloride medicine combination for injection
  • Ambroxol hydrochloride medicine combination for injection

Examples

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Comparison scheme
Effect test

Embodiment 1

[0110] Every 1000 described ambroxol hydrochloride pharmaceutical compositions, its formula consists of:

[0111] Ambroxol Hydrochloride 15g

[0112] Sodium chloride 18g

[0113] Glacial acetic acid 10g

[0114] Sodium acetate 2.52g

[0115] Add water for injection to 2L.

[0116] Preparation process: Take 90% of the prescribed amount of water for injection, at a temperature of 55-65°C, add the prescribed amount of glacial acetic acid and sodium acetate, and stir to dissolve; add the prescribed amount of ambroxol hydrochloride, stir until dissolved, and add to the solution Add the prescribed amount of sodium chloride and stir until it dissolves completely; measure the initial pH value, adjust the pH value range to 3.5-4.5 with 10% acetic acid solution or 10% sodium hydroxide solution according to the initial pH value; add medicinal charcoal to 0.05%, stirring, standing for 30 minutes; suction filtration, adding water for injection to the full amount, mixing evenly; fine fi...

Embodiment 2

[0118] Every 1000 described ambroxol hydrochloride pharmaceutical compositions, its formula consists of:

[0119] Ambroxol Hydrochloride 30g

[0120] Sodium chloride 36g

[0121] Glacial acetic acid 20g

[0122] Sodium acetate 5.1g

[0123] Add water for injection to 4L.

[0124] Preparation process: Take 90% of the prescribed amount of water for injection, at a temperature of 55-65°C, add the prescribed amount of glacial acetic acid and sodium acetate, and stir to dissolve; add the prescribed amount of ambroxol hydrochloride, stir until dissolved, and add to the solution Add the prescribed amount of sodium chloride and stir until it dissolves completely; measure the initial pH value, adjust the pH value range to 3.5-4.5 with 10% acetic acid solution or 10% sodium hydroxide solution according to the initial pH value; add medicinal charcoal to 0.05%, stirring, standing for 30 minutes; suction filtration, adding water for injection to the full amount, mixing evenly; fine fil...

Embodiment 3

[0126] Every 1000 described ambroxol hydrochloride pharmaceutical compositions, its formula consists of:

[0127] Ambroxol Hydrochloride 30g

[0128] Sodium chloride 36g

[0129] Glacial acetic acid 20g

[0130] Sodium acetate 5.1g

[0131] Add water for injection to 2L.

[0132] Preparation process: Take 90% of the prescribed amount of water for injection, at a temperature of 55-65°C, add the prescribed amount of glacial acetic acid and sodium acetate, and stir to dissolve; add the prescribed amount of ambroxol hydrochloride, stir until dissolved, and add to the solution Add the prescribed amount of sodium chloride and stir until it dissolves completely; measure the initial pH value, adjust the pH value range to 3.5-4.5 with 10% acetic acid solution or 10% sodium hydroxide solution according to the initial pH value; add medicinal charcoal to 0.05%, stirring, standing for 30 minutes; suction filtration, adding water for injection to the full amount, mixing evenly; fine fil...

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Abstract

The invention discloses an ambroxol hydrochloride medicine combination for injection. The ambroxol hydrochloride injection is composed of ambroxol hydrochloride, sodium chloride, glacial acetic acid and sodium acetate, wherein each ambroxol hydrochloride injection is composed of 15-30mg of ambroxol hydrochloride, 18-36mg of sodium chloride, 10-20mg of glacial acetic acid and 2.52-5.1g of sodium acetate. The preparing method includes: taking 90% of water for injection as the prescription amount; adding the glacial acetic acid and the sodium acetate as the prescription amount for stirring to dissolve the glacial acetic acid and the sodium acetate at the temperature of 55-65 DEG C; adding the ambroxol hydrochloride as the prescription amount, stirring to dissolve the ambroxol hydrochloride, adding the sodium chloride as the prescription amount in the solution, and stirring to totally dissolve the sodium chloride; measuring the initial pH value, regulating the pH value to be within the range of 3.5-4.5 with 10% glacial acetic acid solution; adding 0.05% of medical carbon in the solution, stirring and standing for 30 minutes; performing suction filtration, replenishing injection water to full amount, and evenly mixing; performing fine filtering; filling; sterilizing for 15 minutes under hot pressure at the temperature of 121 DEG C; performing lamp inspection; warehousing; and obtaining the ambroxol hydrochloride injection. The ambroxol hydrochloride medicine combination is good in photo-stability and stability, improves product yield, reduces cost, achieves industrialization, can be better applied to clinical medicine and has obvious advantages.

Description

technical field [0001] The invention relates to medicines in the medical field, in particular to an ambroxol hydrochloride pharmaceutical composition for injection that is stable to light, does not produce insoluble particles, and has good stability and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride is a mucus dissolving agent, also known as bromcycline hydrochloride, which is widely used in clinical practice due to its strong effect on eliminating phlegm and improving lung function. The drug can act on secretory cells, regulate the secretion of serous and mucus, increase serous secretion, dissolve and dilute mucus, strengthen the swing of cilia, increase the clearance ability of mucus transport system, and make sputum easy to discharge. Ambroxol hydrochloride is also a protective agent for the respiratory system, which has anti-oxidation, inhibits the release of inflammatory mediators, relaxes airway smooth muscle, and promotes the synthe...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/12A61K47/20A61K47/04A61P11/10A61P11/00A61P39/06A61P29/00
Inventor 梅开忠黄欣
Owner 天津梅花药品销售有限公司
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