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

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...

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

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