Preparation method of bromhexine hydrochloride glucose injection

Abstract

The invention discloses a preparation method of a bromhexine hydrochloride glucose injection. The preparation method comprises the following steps: dissolving glucose by part of water for injection in a concentrated mixing tank, adding hydrochloric acid to adjust the pH value to 3.8-4.3, adding active carbon which is 0.01-0.1% (g / ml) in general volume, boiling for 10-20 minutes, and filtering and removing carbon to obtain a glucose concentrated liquid; and fully infiltrating bromhexine hydrochloride in prescription amount by water for injection and adding into the glucose concentrated liquid, stirring to dissolve and set the volume to obtain a diluted liquid, and after uniformly mixing, filling, carrying out moist heat sterilization, detecting by lamps and packaging. Compared with other methods of firstly dissolving bromhexine hydrochloride by acid or ethanol and then adding into the glucose concentrated liquid, the preparation method disclosed by the invention is simple, and bromhexine hydrochloride glucose is fully dissolved. Use of ethanol is avoided, so that adverse effects which can happen in clinical use can be avoided. Incomplete dissolution of main medicines and rise of related substances after bromhexine hydrochloride is dissolved by acid in conventional method are avoided. The prepared bromhexine hydrochloride glucose injection is low in content of related substances, and the quality and stability of the product are improved.

Description

technical field [0001] The invention relates to a medical injection, in particular to a preparation method of bromhexine hydrochloride glucose injection. Background technique [0002] Bromhexine hydrochloride, the chemical name is N~(2~amino~3,5~dibromobenzyl)~N~methylcyclohexylamine hydrochloride. Slightly soluble in water and ethanol, soluble in hot ethanol, insoluble in acetone and chloroform, odorless and tasteless, it is a new type of mucus-soluble expectorant synthesized from the active ingredient Panaxenine extracted from the medicinal plant Duckbill flower, It has a strong effect of dissolving mucus, which can crack mucopolysaccharide cellulose or mucin in sputum, and reduce the viscosity of sputum; it also acts on tracheal and bronchial gland cells to secrete small molecule mucin with low viscosity, Improve the rheological properties of secretion and inhibit the synthesis of mucopolysaccharides, so that the sticky sputum is reduced, thereby diluting the sputum and ...

AI Technical Summary

Problems solved by technology

The problem is: this method is to promote the dissolution of bromhexine hydrochloride by reducing the pH value of the solution. The solvent for injection often includes water for sterile injection (pH value is 5.0~7.0), glucose injection (3.2~6.5), chlorine Sodium chloride injection (4.5 ~ 7.0), etc., when the above-mentioned freeze-dried minute needle is added to the above-mentioned solvent, the higher pH value of the solvent will inevitably cause the pH value of the liquid to be higher than the pH when the freeze-dried minute needle is prepared, and the presence of hydrochloric acid will The possibility of bromhexine precipitation, there is a certain risk for patients taking medication

This method directly dissolves the main drug with acid, and it is very easy to add too much acid, and lye must be added to reverse the pH value, resulting in the re-precipitation of bromhexine hydrochloride. Increased content of related substances in the product

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