Composition and great volume injection containing bromhexine salt and the injection preparing process

Abstract

The present invention discloses one kind of composition containing bromhexine salt, great volume injection and the injection preparing process. The composite includes bromhexine salt as the active component in 0.03-0.8 wt%, ethanol as co-solvent in 1.5-36 wt%, and stabilizer in 1.0-40 wt%, and has pH 3.0-7.0. The stabilizer is poloxamer, hydroxypropyl cellulose, hydroxypropyl methyl cellulose and / or hydroxyethyl cellulose. The composition of the present invention has high stability, and may be preserved for long period without bromhexine salt crystal separated out.

Description

technical field [0001] The invention relates to a composition containing bromhexine salt, a large-capacity injection and a preparation method for the injection. Background technique [0002] Bromhexine is a synthetic analogue of orchidine, which has a strong effect of dissolving mucus, can break down the acidic mucopolysaccharide fibers in sputum, and inhibit the synthesis of acidic glycoproteins in mucous glands and goblet cells, so that The content of sialic acid, one of the acidic mucopolysaccharide components in sputum, is reduced, reducing the viscosity of sputum. In addition, bromhexine can also stimulate the gastric mucosa to reflexively increase the secretion of the respiratory glands and dilute the sputum. All of the above effects are conducive to the coughing of sputum. It is the preferred expectorant commonly used at home and abroad. [0003] Experiments have shown that bromhexine can improve the ability of antibiotics such as tetracycline, erythromycin, amoxici...

AI Technical Summary

Problems solved by technology

[0005] Bromhexine currently commonly used is bromhexine hydrochloride, because bromhexine hydrochloride, bromhexine lactate, bromhexine acetate, bromhexine aspartate, bromhexine citrate, etc. are insoluble in water, affected by the pH value , solubilizer and preparation method, etc., the above-mentioned bromhexine salt is easy to precipitate

According to the current technical level, in order to obtain a stable bromhexine salt preparation, it is usually prepared as a small needle or a powder injection, which needs to be diluted or dissolved before intravenous infusion; some manufacturers have prepared a large bromhexine Volumetric injections, but poor stability, easy to precipitate crystals, and content decline, so it is not suitable for large-scale application

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