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Ambroxol hydrochloride solution for inhalation and preparation method of ambroxol hydrochloride solution

A technology of ambroxol hydrochloride and solution, applied in medical preparations with non-active ingredients, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problem of unguaranteed safety and effectiveness, delayed contact Dermatitis, deficiency and other problems, achieve the effect of preventing allergic reactions and other adverse reactions, improving separation efficiency, and stable and reliable quality

Inactive Publication Date: 2019-03-29
上海禾丰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to their potential irritation, allergic reactions to parabens often result in delayed contact dermatitis
[0006] In addition, although there have been reports on the use of ambroxol hydrochloride injection for aerosol inhalation, experiments have shown that the stability of ambroxol hydrochloride injection for aerosol inhalation is poor, and because there is no relevant preclinical The support of pharmaceutical research data and the lack of support of in vivo and in vitro test data are not reliable, so safety and effectiveness cannot be guaranteed, and there are potential safety hazards

Method used

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  • Ambroxol hydrochloride solution for inhalation and preparation method of ambroxol hydrochloride solution
  • Ambroxol hydrochloride solution for inhalation and preparation method of ambroxol hydrochloride solution
  • Ambroxol hydrochloride solution for inhalation and preparation method of ambroxol hydrochloride solution

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Embodiment 1

[0032] Provide a kind of ambroxol hydrochloride solution for inhalation in the present embodiment, comprise following composition in every 200ml solution:

[0033]

[0034] The specific preparation method of described inhalation ambroxol hydrochloride solution is as follows:

[0035] (1) Add 90% water for injection into the preparation container, and keep the water temperature at 80°C;

[0036] (2) add the ambroxol hydrochloride of formula quantity, stir and dissolve;

[0037] (3) Add the citric acid of formula quantity, stir and dissolve;

[0038] (4) Add the disodium hydrogen phosphate of formula quantity, stir and dissolve;

[0039] (5) Add the sodium chloride of formula quantity, stir and dissolve;

[0040] (6) Test whether the pH value of the solution is within the range of 4.5 to 5.5, if the pH value is within this range, then directly enter the next step; if the pH value is not within this range, add 1% sodium hydroxide or 1% hydrochloric acid to adjust the pH va...

Embodiment 2

[0051] Provide a kind of ambroxol hydrochloride solution for inhalation in the present embodiment, comprise following composition in every 300ml solution:

[0052]

[0053] The specific preparation method of described inhalation ambroxol hydrochloride solution is as follows:

[0054] (1) Add 90% water for injection into the preparation container, and keep the water temperature at 80°C;

[0055] (2) add the ambroxol hydrochloride of formula quantity, stir and dissolve;

[0056] (3) Add the citric acid of formula quantity, stir and dissolve;

[0057] (4) Add the disodium hydrogen phosphate of formula quantity, stir and dissolve;

[0058] (5) Add the sodium chloride of formula quantity, stir and dissolve;

[0059] (6) Test whether the pH value of the solution is within the range of 4.5 to 5.5, if the pH value is within this range, then directly enter the next step; if the pH value is not within this range, then add 1% NaOH or 1% Hcl to Adjust the pH value until the pH valu...

Embodiment 3

[0065] Provide a kind of ambroxol hydrochloride solution for inhalation in the present embodiment, comprise following composition in every 1000ml solution:

[0066]

[0067] Its preparation technology is identical with embodiment 2.

[0068] 2 batches of prepared inhalation ambroxol hydrochloride solutions are carried out quality inspection, and the results are as follows:

[0069] inspection item

[0070] The test results show that the content of related substances and raw materials are all qualified, indicating that the prescription process is stable and reasonable.

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Abstract

The invention provides an ambroxol hydrochloride solution for inhalation and a preparation method of the ambroxol hydrochloride solution. Each 10000ml of the ambroxol hydrochloride solution for inhalation comprises the following components of 75g of ambroxol hydrochloride, 10-40g of citric acid, 12-48g of disodium hydrogen phosphate and 25-75g of sodium chloride. The ambroxol hydrochloride solution for inhalation can realize drug administration by spraying, so that effective components can be directly released to infected parts at high dose.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to an ambroxol hydrochloride solution for inhalation and a preparation method thereof. Background technique [0002] In the late 1970s, German scholars first developed and registered Ambroxol. In 1981, the German company Boehringer Ingelheim developed and listed it under the product name Mucosolvan. It is now on the market in many countries around the world, and it is the main variety of clinical oral expectorant drugs. [0003] Ambroxol hydrochloride is a mucolytic expectorant with various biological effects, which can directly act on bronchial glands, increase the secretion of serous glands in the respiratory mucosa, reduce the secretion of mucous glands, reduce and break up sputum The mucopolysaccharide fiber in the sputum reduces the viscosity of the sputum, makes the sputum thinner, and is easy to cough up. [0004] Inhalation administration is achieved through a nebulizer and pressu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/12A61K47/02A61K31/137A61P11/10A61P11/12
CPCA61K9/007A61K9/08A61K31/137A61K47/02A61K47/12A61P11/10A61P11/12
Inventor 李鹏蒋宇丹郭心怡
Owner 上海禾丰制药有限公司
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