A method for improving the stability of ambroxol hydrochloride

A technology of ambroxol hydrochloride and stability, applied in the field of preparation of ambroxol hydrochloride, can solve problems such as ambroxol hydrochloride solubility defects

Inactive Publication Date: 2011-11-30
江西川奇药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The object of the present invention is to overcome the defect of ambroxol hydrochloride solubility in wat

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] A kind of method improving the stability of ambroxol hydrochloride, every making 1000ml, the weight portion of its main component is as follows: ambroxol hydrochloride 6g, propylene glycol 100~400g, surplus is, get propylene glycol and add 100ml~500ml boiled water and mix, Add ambroxol hydrochloride to dissolve, add to the above-mentioned auxiliary material solution, add water to 1000ml, mix well, fill, and obtain.

Embodiment 2

[0017] The present invention is further described in conjunction with specific examples as follows: the above materials, take sorbitol, sodium benzoate, citric acid, sucralose, add water and boil for 10-30 minutes, let cool to 40-80 °C; take propylene glycol and add 100ml-500ml boiling water Mix, add ambroxol hydrochloride to dissolve, add to the above-mentioned auxiliary material solution, add essence, add water to 1000ml, mix well, fill, and obtain.

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PUM

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Abstract

The invention relates to a method for improving the stability of ambroxol hydrochloride. The main component, ambroxol hydrochloride, is slightly soluble and unstable. Both glycerol and propylene glycol can be used for effective solubilization. The stability has a great influence, and the product obtained by the preparation method of the propylene glycol formula has good stability. It has been proved by the accelerated stability and long-term stability test that the formula and preparation method have better stability compared with the same product in the market. stability.

Description

technical field [0001] The invention relates to a preparation method of ambroxol hydrochloride. Background technique [0002] Ambroxol hydrochloride (ambroxol hydrochloride), also known as bromcycline hydrochloride, is a new generation of mucus-dissolving agent, which can promote the emptying of bronchial cilia and facilitate the discharge of airway secretions. It is mainly used clinically for acute and chronic respiratory diseases , especially in the expectorant treatment of chronic bronchitis. Existing ambroxol hydrochloride has poor stability in related dosage forms with water as solution. Contents of the invention [0003] The purpose of the present invention is to overcome the defect of ambroxol hydrochloride solubility in water and provide a kind of formula and preparation method that can improve the stability of ambroxol hydrochloride. [0004] The specific technical scheme of the present invention uses propylene glycol as an auxiliary material to greatly improve ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/10A61K31/137A61K47/10A61P11/10
Inventor 章志红姚方程胡丰
Owner 江西川奇药业有限公司
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