Ambroxol hydrochloride composition, ambroxol hydrochloride injection and their application

Abstract

The invention relates to an ambroxol hydrochloride composition, in particular to an ambroxol hydrochloride composition, an ambroxol hydrochloride injection and their application. The ambroxol hydrochloride composition comprises, by weight, 10-20 parts of ambroxol hydrochloride, 1-4 parts of citric acid monohydrate, 1-5 parts of anhydrous sodium hydrogen phosphate, and 10-20 parts of sodium chloride. The ambroxol hydrochloride composition, the ambroxol hydrochloride injection and their application have the advantages that stability is high, the quantity of impurities is low and the preparationtime is short.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an ambroxol hydrochloride composition and its injection and application. Background technique [0002] Ambroxol hydrochloride (CAS: 23828-92-4), chemical name: trans-4-[(2-amino-3,5-dibromobenzyl) amino] cyclohexanol hydrochloride, English name: Ambroxol Hydrochloride, white to light yellow crystalline powder, almost odorless, its chemical structure is as follows: [0003] [0004] Ambroxol hydrochloride is a mucolytic agent that can stimulate the formation of respiratory surfactants and regulate the secretion of serous and mucus. Adhesive force, promotes the emptying movement of bronchial cilia, further makes sputum easy to cough up, and relieves coughing. Antioxidant and anti-inflammatory and other pharmacological effects, ambroxol hydrochloride is currently the most widely used expectorant in clinical practice. [0005] At present, the preparation types of ambr...

AI Technical Summary

Problems solved by technology

This patent has improved the stability of the injection to a certain extent, but the water for injection was not deoxygenated during the preparation, and the impurities in the prepared sample were high

[0009] Chinese patent CN101416956B discloses a kind of ambroxol hydrochloride injection, and the component of injection comprises: principal agent, pH adjusting agent and stabilizer, this patent adds some components as carrier in order to improve the stability of injection, wherein The stabilizer is also used as a carrier, but the stabilizer involved in the patent includes poloxamer and sodium lauryl sulfate, both of which are surfactants, which will cause certain blood vessel irritation and hemolysis during injection, and there are hidden dangers in drug safety. patients with poor drug compliance

[0010] In the prior art, the stability of ambroxol hydrochloride injection needs to be improved, especially the long-term stability, and impurities are easily produced in the preparation process, and the preparation time is longer

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