Stable inhalation ambroxol hydrochloride solution and preparation method thereof

A technology of ambroxol hydrochloride and solution, which is applied in the field of pharmacy, can solve problems such as instability, and achieve the effects of improving stability, enhancing photostability, and high portability

Active Publication Date: 2018-06-15
SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to overcome the defect that the existing ambroxol hydrochloride solution for inhalation is unstable under light, the present invention finds through research that a specific amount of metal ion complex is added to the ambroxol hydrochloride solution for inhalation as a stabilizer, and a specific amount of metal ion complex is selected at the same time. Temperature is carried out medicinal solution preparation, can significantly improve the stability and inhalation performance (delivery rate, delivery total amount and fine particle dose) of ambroxol hydrochloride solution for inhalation after opening the outer packaging during use

Method used

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  • Stable inhalation ambroxol hydrochloride solution and preparation method thereof
  • Stable inhalation ambroxol hydrochloride solution and preparation method thereof
  • Stable inhalation ambroxol hydrochloride solution and preparation method thereof

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Embodiment 1

[0044]

[0045] Process:

[0046] Add 700ml (prescription amount 70%) of water for injection in the liquid preparation tank, control the temperature at about 40°C, add raw and auxiliary materials and stir to make all dissolve, and the pH is about 5.0. Add water for injection to 1000ml, stir well, filter through a 0.22μm filter membrane, and fill in a 2ml low-density polyethylene bottle to obtain the product.

Embodiment 2

[0048]

[0049] Process:

[0050] Add 700ml (prescription volume 70%) of water for injection in the liquid preparation tank, control the temperature at about 50°C, add raw and auxiliary materials and stir to make all dissolve, and the pH is about 4.7. Add water for injection to 1000ml, stir well, filter through a 0.22μm filter membrane, and fill in a 2ml low-density polyethylene bottle to obtain the product.

Embodiment 3

[0052]

[0053] Process:

[0054] Add 700ml (prescription amount 70%) of water for injection in the liquid preparation tank, control the temperature at about 55°C, add raw and auxiliary materials and stir to make all dissolve, and the pH is about 5.0. Add water for injection to 1000ml, stir well, filter through a 0.22μm filter membrane, and fill in a 2ml low-density polyethylene bottle to obtain the product.

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PUM

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Abstract

The invention discloses a stable inhalation ambroxol hydrochloride solution and a preparation method thereof. The solution comprises 0.5-0.9%(w/v) of ambroxol hydrochloride, 0.5-0.8%(w/v) of an isotonic agent, 0.001-0.003%(w/v) of a metal ion complex as a stabilizer, a pH adjusting agent and a solvent. The stable inhalation ambroxol hydrochloride solution disclosed by the invention is relatively good in portability, remarkably improved in light stability and inhalation performance, capable of greatly improving stability of medicines in the storage process and relatively well applicable to clinical application requirements.

Description

technical field [0001] The invention belongs to the field of pharmacy, in particular to a stable ambroxol hydrochloride solution for inhalation and a preparation method thereof. Background technique [0002] Ambroxol Hydrochloride, also known as bromhexamol hydrochloride, is a new generation of mucus-dissolving agent and the active metabolite of bromhexine, a drug for the respiratory system. Ambroxol hydrochloride was launched in Germany by Boehringer Ingelheim in the late 1970s, and has since been launched in dozens of countries such as Europe, Japan, and China. It is clinically used to treat people with thick and difficult to cough up sputum. Its molecular formula is C 13 h 18 Br 2 N 2 O HCl, the molecular weight is 414.47, the chemical name is trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, and the structural formula is: [0003] [0004] The drug has become a clinically effective expectorant drug with definite clinical curative effect and le...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K31/137A61K47/18A61P11/10
CPCA61K9/0078A61K9/08A61K31/137A61K47/183
Inventor 金方郭升史亚茹
Owner SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD
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