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Ambroxol hydrochloride oral solution and preparation method thereof

A technology for oral administration of ambroxol hydrochloride and ambroxol hydrochloride is applied in the field of oral ambroxol hydrochloride solution and preparation thereof, and can solve the problems of affecting the normal secretion of gastrointestinal digestive enzymes, reducing the absorption capacity of the small intestine, lack of nutritional value in the human body, and the like. The effect of improving storage stability, improving storage stability, improving safety and stability

Active Publication Date: 2020-08-07
SHANGHAI XINYI JINZHU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

And saccharin sodium is an organic chemical synthesis product, which has no nutritional value to the human body except for the sweet feeling in the taste, and when consumed in large amounts, it will affect the normal secretion of gastrointestinal digestive enzymes, reduce the absorption capacity of the small intestine, and the saccharin sodium Security has been widely debated

Method used

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  • Ambroxol hydrochloride oral solution and preparation method thereof
  • Ambroxol hydrochloride oral solution and preparation method thereof
  • Ambroxol hydrochloride oral solution and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0082] Embodiment 1: a kind of ambroxol hydrochloride oral solution, its composition raw material is: ambroxol hydrochloride: 2g; Sorbitol 150g; Benzoic acid 0.5g; AK sugar 0.5g; Edetate calcium sodium 0.05g; g; mint water 0.05g; purified water added to 1000 parts by volume.

[0083] The preparation method of ambroxol hydrochloride in the present embodiment is:

[0084] Add ambroxol to water 30 times the volume of its weight, heat to 100°C to dissolve it completely, then cool down to 25°C and keep warm, add 0.1mol / L hydrochloric acid solution, in the hydrochloric acid solution, hydrochloric acid and ammonium bromide Equimolar amount of sol, stirred for 6h, filtered while hot, dried at 40°C, recrystallized the dried solid with water and decolorized with activated carbon to obtain ambroxol hydrochloride with a yield of 98.6%.

[0085] The preparation method of the present embodiment ambroxol hydrochloride oral solution is:

[0086] S1, adding hot purified water with a temperat...

Embodiment 2

[0094] Embodiment 2: a kind of ambroxol hydrochloride oral solution, the difference with embodiment 1 is that each raw material component consumption is different, concrete composition is: ambroxol hydrochloride 5g; Sorbitol 250g; Benzoic acid 1g; AK sugar 1.5g; edetate calcium sodium 1g; lemon essence 0.5g; mint water 0.2g; purified water added to 1000 parts by volume.

Embodiment 3

[0095] Embodiment 3: a kind of ambroxol hydrochloride oral solution, the difference with embodiment 1 is that each raw material component consumption is different, concrete composition is: ambroxol hydrochloride 3g; Sorbitol 200g; Benzoic acid 0.7g; AK Sugar 1g; edetate calcium sodium 0.08g; lemon essence 0.3g; mint water 0.1g; purified water added to 1000 parts by volume.

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Abstract

The invention discloses an ambroxol hydrochloride oral solution and a preparation method thereof, and relates to the technical field of phlegm eliminating medicines. The ambroxol hydrochloride oral solution is characterized by comprising the following raw material components in parts by weight: 2-5 parts of ambroxol hydrochloride; 150 to 250 parts by weight of sorbitol; 0.5 to 1 part by weight ofbenzoic acid; 0.5 to 1.5 parts by weight of AK sugar; 0.05 to 1 part by weight of sodium calcium edetate; 0.1 to 0.5 part by weight of lemon essence; 0.05 to 0.2 part by weight of peppermint water; and purified water added to 1000 parts by volume; and when the unit of the weight part is g, the unit of the volume part is mL. The ambroxol hydrochloride oral solution prepared by the formula has the advantages of high safety and good stability.

Description

technical field [0001] The invention relates to the technical field of expectorant drugs, more specifically, it relates to an ambroxol hydrochloride oral solution and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride mainly acts on the secretory cells of the respiratory tract, regulates the secretion of mucus and serous substances, increases the secretion of serous substances, can also crack the polysaccharide fibers of acid glycoproteins in expectorant, and inhibit the acidic proteins in mucous glands and goblet cells. The synthesis of sputum reduces the viscosity of sputum, making the sputum thin and easy to discharge. At the same time, the drug can also increase the movement frequency and intensity of airway cilia, promote the discharge of sputum and the self-purification of the airway. Ambroxol hydrochloride has the advantages of small adverse reactions and quick onset of action. [0003] Ambroxol hydrochloride is developed by Germany B...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/18A61K47/26A61K47/12A61K31/137A61P11/10
CPCA61K9/0095A61K47/183A61K47/26A61K47/12A61K31/137A61P11/10
Inventor 王焕
Owner SHANGHAI XINYI JINZHU PHARMA
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