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A kind of ambroxol hydrochloride solution for inhalation and preparation method thereof

A technology of ambroxol hydrochloride and solution, applied in the field of medicine, can solve the problems of lack of uniform standards for drug concentration and course of treatment, lack of effective evidence for respiratory system safety, inconvenience for clinical use and the like

Active Publication Date: 2020-11-13
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] But because ambroxol hydrochloride aerosol inhalation has problems such as safety and solution stability are not clear, there is no ambroxol hydrochloride aerosol inhalation to go on the market so far at home and abroad, but domestic many clinicians will formulate ambroxol hydrochloride injection Dissolve appropriate amount of normal saline or lyophilized powder injection in appropriate amount of normal saline for aerosol inhalation to treat respiratory diseases
Ambroxol hydrochloride injection directly replaces the atomized inhalation solution dosage form to carry out atomization treatment, and there are many problems as follows: first, lack the uniform standard of drug concentration and course of treatment, clinically use ambroxol hydrochloride injection dosage form to carry out the preparation concentration of atomization inhalation treatment There is no unified standard for the course of treatment, lack of stability and maximization of curative effect
Secondly, lack of safety, ambroxol hydrochloride injection still lacks effective evidence on the safety of the nasal cavity and the whole respiratory system
Finally, the lack of convenience
Ambroxol hydrochloride injection or injection needs to be prepared by adding an appropriate amount of normal saline before aerosol inhalation, which is not convenient for clinical use

Method used

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  • A kind of ambroxol hydrochloride solution for inhalation and preparation method thereof
  • A kind of ambroxol hydrochloride solution for inhalation and preparation method thereof
  • A kind of ambroxol hydrochloride solution for inhalation and preparation method thereof

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Embodiment 1

[0034] Embodiment 1 a kind of ambroxol hydrochloride solution for inhalation

[0035] Described inhalation uses ambroxol hydrochloride solution, comprises following composition in every 2000ml water for injection: the ambroxol hydrochloride of 12.0g, the disodium hydrogen phosphate of 1.2g, the citric acid of 1.0g, 10.2g sodium chloride, stable Agent 0.5g and surfactant 0.8g.

[0036] The stabilizer is composed of chitosan and sodium metabisulfite in a weight ratio of 1:7.

[0037] The surfactant is composed of tyloxapol and lecithin in a weight ratio of 6:5.

[0038]The preparation method of described suction ambroxol hydrochloride solution, described preparation method may further comprise the steps:

[0039] S1. Weigh 60% of the water for injection, add disodium hydrogen phosphate, citric acid, ambroxol hydrochloride and surfactant in turn, stir to dissolve, after the dissolution is complete, add sodium chloride and stabilizer, stir Until completely dissolved, mixed solu...

Embodiment 2

[0044] Embodiment 2 a kind of ambroxol hydrochloride solution for inhalation

[0045] Described inhalation uses ambroxol hydrochloride solution, comprises following composition in every 2000ml water for injection: the ambroxol hydrochloride of 15.0g, the disodium hydrogen phosphate of 2.88g, the citric acid of 2.0g, 14.4g sodium chloride, stable Agent 1.0g and surfactant 2.0g.

[0046] The stabilizer is composed of chitosan and sodium metabisulfite in a weight ratio of 2:5.

[0047] The surfactant is composed of tyloxapol and lecithin in a weight ratio of 10:3.

[0048] The preparation method of described suction ambroxol hydrochloride solution, described preparation method may further comprise the steps:

[0049] S1. Weigh 60% of the water for injection, add disodium hydrogen phosphate, citric acid, ambroxol hydrochloride and surfactant in turn, stir to dissolve, after the dissolution is complete, add sodium chloride and stabilizer, stir Until completely dissolved, mixed s...

Embodiment 3

[0054] Embodiment 3 a kind of ambroxol hydrochloride solution for inhalation

[0055] Described inhalation uses ambroxol hydrochloride solution, comprises following composition in every 2000ml water for injection: the ambroxol hydrochloride of 18.0g, the disodium hydrogen phosphate of 4.0g, the citric acid of 3.6g, 16.5g sodium chloride, stable Agent 1.2g and surfactant 2.6g.

[0056] The stabilizer is composed of chitosan and sodium metabisulfite in a weight ratio of 3:4.

[0057] The surfactant is composed of tyloxapol and lecithin in a weight ratio of 11:1.

[0058] The preparation method of described suction ambroxol hydrochloride solution, described preparation method may further comprise the steps:

[0059] S1. Weigh 60% of the water for injection, add disodium hydrogen phosphate, citric acid, ambroxol hydrochloride and surfactant in turn, stir to dissolve, after the dissolution is complete, add sodium chloride and stabilizer, stir Until completely dissolved, mixed so...

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Abstract

The invention belongs to the technical field of medicines, and discloses an ambroxol hydrochloride solution for inhalation, which comprises the following components in every 2000ml of water for injection: 12.0-18.0 g of ambroxol hydrochloride, 1.2-4.0 g of disodium hydrogen phosphate, 1.0-3.6 g of citric acid, and 10.2-16.5 g of sodium chloride. The ambroxol hydrochloride solution for inhalation provided by the invention can be absorbed through the lung, is strong in targeting effect, high in local concentration and small in dosage, can be well tolerated by patients in the treatment process, and is high in safety, free of preservatives, stable in quality and free of side effects.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to an ambroxol hydrochloride solution for inhalation and a preparation method thereof. Background technique [0002] Respiratory diseases are generally manifested as cough, phlegm, wheezing, and inflammation, especially increased sputum volume and difficulty in expectoration are symptoms of many respiratory diseases such as chronic obstructive pulmonary disease (COPD), bronchial asthma, and cystic pulmonary fibrosis (CF). Common symptoms, children and the elderly often have difficulty spitting, which interferes with people's daily life in mild cases, and even endangers the lives of patients in severe cases. At the same time, in the case of thoracic and abdominal operations, patients often produce a large amount of sputum, which can block the respiratory tract, easily cause coughing, wheezing, and even difficulty in breathing. Sputum obstructs the respiratory tract, leading to une...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/72A61K9/08A61K47/02A61K47/12A61K31/137A61P11/10
CPCA61K9/0078A61K31/137A61K47/02A61K47/12A61P11/10
Inventor 李贞黄红叶姜锋李玲玲钱海峰庄卫红
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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