Injection-grade ambroxol hydrochloride and solution for inhalation of injection-grade ambroxol hydrochloride

A technology of ambroxol hydrochloride and injection grade, applied in the field of injection grade ambroxol hydrochloride and its inhalation solution, can solve the problems of unclear usage and dosage, external use of indications, lack of research materials, etc., and achieves purification process safety, The properties of the preparation are stable and the effect of improving the purity

Inactive Publication Date: 2013-02-13
HC SYNTHETIC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Hospitals usually use injections for aerosol inhalation to treat respiratory diseases, but the instructions for ambroxol hydrochloride injection are only specified for intravenous injection. This kind of usage is due to extern

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Weigh 100g of ambroxol hydrochloride and place it in a three-necked flask, add 700ml of 5% volume ratio ethanol aqueous solution, the temperature of the water bath is 90-100°C, and after heating for 30 minutes, ambroxol hydrochloride is completely dissolved in the solvent ; stop heating, then heat and filter (using suction filtration), collect the filtrate and let it stand to room temperature, place the filtrate in a -4°C environment for crystallization (you can add seeds, stir for crystallization or stand for crystallization), pump Filter and collect the filter cake, and dry the resulting filter cake in an oven to obtain the product.

[0049] Embodiment 2: the preparation of injection grade ambroxol hydrochloride

Embodiment 2

[0050] Weigh 100g of ambroxol hydrochloride and place it in a three-necked flask, add 1200ml of 5% volume ratio ethanol aqueous solution, the temperature of the water bath is 60-80°C, and after heating for 30 minutes, ambroxol hydrochloride is completely dissolved in the solvent stop heating, add gac, the add-on of gac is 5% of ambroxol hydrochloride quality, then heating and filtering (use suction filtration), collect filtrate and leave standstill to room temperature, filtrate is placed in-4 ℃ environment and carry out crystallization (You can add crystal seeds, stir for crystallization or stand for crystallization), filter with suction and collect the filter cake, and dry the obtained filter cake in an oven to obtain the product.

[0051] Embodiment 3: the preparation of injection grade ambroxol hydrochloride

Embodiment 3

[0052] Weigh 100g of ambroxol hydrochloride and place it in a three-necked flask, add 500ml of 10% volume ratio ethanol aqueous solution, the temperature of the water bath is 80-95°C, and after heating for 30 minutes, ambroxol hydrochloride is completely dissolved in the solvent stop heating, add gac, the add-on of gac is 3% of ambroxol hydrochloride quality, then heating and filtering (use suction filtration), collect filtrate and leave standstill to room temperature, filtrate is placed in-4 ℃ of environment and carry out crystallization (You can add crystal seeds, stir for crystallization or stand for crystallization), filter with suction and collect the filter cake, and dry the obtained filter cake in an oven to obtain the product.

[0053] Embodiment 4: the preparation of injection grade ambroxol hydrochloride

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PUM

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Abstract

The invention relates to a method for refining injection-grade ambroxol hydrochloride. The method is characterized by comprising the steps of adding oral-taking-grade ambroxol hydrochloride with the proportion smaller than or equal to 20:1 into ethanol water solution with the volume ratio of 5-20%; performing heating to completely dissolve the oral-taking-grade ambroxol hydrochloride; stopping heating and performing cooling to seed out ambroxol hydrochloride; and filtering solvent to obtain crystals and drying the crystals to obtain the injection-grade ambroxol hydrochloride. The invention further relates to ambroxol hydrochloride solution for inhalation prepared by utilizing the prepared injection-grade ambroxol hydrochloride as the raw material. The atomization inhalation solution comprises the ambroxol hydrochloride, a stabilizer, a pH conditioning agent and an osmotic pressure conditioning agent. By means of the scientific preparation adopting the carrier, fewest degradation products of the atomization inhalation preparation can be produced under the high temperature of 121 DEG C for 15 minutes, the atomization inhalation preparation is stable, and the service life of the atomization inhalation preparation is prolonged to 5 years.

Description

technical field [0001] The invention relates to a method for refining and purifying an injection-grade ambroxol hydrochloride crude drug and its product and application. [0002] The invention relates to an ambroxol hydrochloride solution for inhalation, a preparation method and application thereof. Background technique [0003] Ambroxol Hydrochloride (Ambroxol Hydrochloride) is a new generation of respiratory mucus regulator, also known as bromcycline hydrochloride, which is widely used in clinic for its strong expectorant and lung function improvement. 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 s...

Claims

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Application Information

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IPC IPC(8): C07C215/44C07C213/10A61K9/72A61K9/08A61K31/137A61P11/00
Inventor 杨成强建华陆华龙
Owner HC SYNTHETIC PHARMA CO LTD
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