Ambroxol hydrochloride injection composition and preparation method thereof

A technology of ambroxol hydrochloride and injection, which is applied in the field of ambroxol hydrochloride injection composition and its preparation, can solve the problems of poor patient compliance, affecting drug efficacy, discomfort, etc., achieve stable drug effect, and increase body resistance , improve the efficacy of the drug

Active Publication Date: 2018-01-09
HEBEI IDEAL & HIGHTECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The main problem in the preparation process of ambroxol hydrochloride injection is that under oxidative or alkaline conditions, it is easy to dissociate ambroxol, thereby increasing the content of related substances in the storage process and affecting drug efficacy.
In the prior art, it is mainly used to control the lower pH value of the injection and add a stabilizer to improve its stability, but the injection with a low pH value will cause discomfort to the human body during injection, and the patient's compliance is poor

Method used

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  • Ambroxol hydrochloride injection composition and preparation method thereof
  • Ambroxol hydrochloride injection composition and preparation method thereof
  • Ambroxol hydrochloride injection composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] prescription:

[0018] Ambroxol Hydrochloride 15g

[0019] Vitamin C 4.5g

[0020] Cysteine ​​3g

[0021] EDTA-2Na 0.2g

[0022] Sodium chloride appropriate amount

[0023] Add water for injection to 2000ml

[0024] Preparation method: add the ambroxol hydrochloride into water for injection, heat to 40-50°C to dissolve, then add EDTA-2Na, stir to dissolve, add the cysteine ​​after cooling to 20-30°C, stir After dissolving, saturate the solution with carbon dioxide, then add vitamin C, stir to dissolve, add sodium chloride to adjust the osmotic pressure, adjust the pH value to 5.5-6.0, potting and sterilizing.

Embodiment 2

[0026] prescription:

[0027] Ambroxol Hydrochloride 15g

[0028] Vitamin C 7.5g

[0029] Cysteine ​​5g

[0030] EDTA-2Na 0.15g

[0031] Sodium chloride appropriate amount

[0032] Add water for injection to 2000ml

[0033] Preparation method: add the ambroxol hydrochloride into water for injection, heat to 40-50°C to dissolve, then add EDTA-2Na, stir to dissolve, add the cysteine ​​after cooling to 20-30°C, stir After dissolving, saturate the solution with carbon dioxide, then add vitamin C, stir to dissolve, add sodium chloride to adjust the osmotic pressure, adjust the pH value to 5.5-6.0, potting and sterilizing.

Embodiment 3

[0035] prescription:

[0036] Ambroxol Hydrochloride 15g

[0037] Vitamin C 5.5g

[0038] Cysteine ​​4g

[0039] EDTA-2Na 0.2g

[0040] Sodium chloride appropriate amount

[0041] Add water for injection to 2000ml

[0042] Preparation method: add the ambroxol hydrochloride into water for injection, heat to 40-50°C to dissolve, then add EDTA-2Na, stir to dissolve, add the cysteine ​​after cooling to 20-30°C, stir After dissolving, saturate the solution with carbon dioxide, then add vitamin C, stir to dissolve it, add glucose to adjust the osmotic pressure, adjust the pH value to 5.5-6.0, potting and sterilizing.

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PUM

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Abstract

The invention discloses an ambroxol hydrochloride injection composition. The ambroxol hydrochloride injection composition contains the following components in parts by weight: 15 parts of ambroxol hydrochloride, 4.5-7.5 parts of vitamin C, 3-5 parts of cysteine, 0.15-0.2 part of EDTA-2Na and a proper amount of an osmotic pressure regulator. The invention further discloses a preparation method of the ambroxol hydrochloride injection composition. The preparation method comprises the steps of adding ambroxol hydrochloride into injection water, heating to 40-50 DEG C until ambroxol hydrochloride is dissolved, adding EDTA-2Na, stirring for dissolving, cooling to 20-30 DEG C, adding cysteine, stirring for dissolving, saturating the solution with carbon dioxide, adding vitamin C, stirring for dissolving, adding the osmotic pressure regulator, regulating the pH value to 5.5-6.0, and carrying out encapsulation and sterilization. The pH value of the ambroxol hydrochloride injection composition is 5.5-6.0, the uncomfortable feel during the injection is reduced, and the quality of the composition is stable.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an ambroxol hydrochloride injection composition and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride is a respiratory mucus regulator, which can promote the elimination of viscous secretions in the respiratory tract and reduce the retention of mucus, thus significantly promoting expectoration and improving respiratory conditions. It is widely used clinically for various acute and chronic respiratory diseases. Thick sputum, difficulty expectoration, etc. Its chemical name is trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, and its structural formula is: [0003] [0004] Ambroxol hydrochloride tastes sharply bitter and numb, with long-lasting bitterness and numbness, and it cannot be masked by adding sweeteners and flavoring agents routinely, and has low oral bioavailability and slow onset, so it is wid...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/22A61K47/18A61K31/137A61K31/375A61P11/10A61P11/00
Inventor 寻冰玉白巧红孙建强娄春晓韩盼盼胡竹梅杨远孙明张文英陈晓彦
Owner HEBEI IDEAL & HIGHTECH PHARMA
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