Ambroxol hydrochloride controlled release suspension and preparation method thereof

Abstract

The invention discloses controlled release suspension of ambroxol hydrochloride which is controlled to release in a gastrointestinal tract environment. The preparation contains the ambroxol hydrochloride and pharmaceutically acceptable polymer. The suspension comprises the following components in percentage by weight: 10 to 90 percent of ambroxol hydrochloride and 10 to 90 percent of auxiliary material. The auxiliary material having the controlled-release effect is of one or more of cation exchange resin, methylcellulose, ethylcellulose, acrylic resin and Hydroxypropylmethyl Cellulose. Compared with the rapid-release preparation, the suspension can maintain the valid blood concentration within 24 hours, can improve the treatment effect, has small toxic and side effect, is convenient to take and carry, and can reduce the taking times. Compared with the slow-release preparation, the suspension can maintain more stable blood concentration within 24 hours, can improve the treatment effect, and has small toxic and side effect. The suspension is only required to be taken one time every day. The suspension is used as phlegm medicine clinically.

Description

technical field [0001] The invention relates to a muco-phlegm-dissolving drug ambroxol hydrochloride controlled-release dry suspension and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride (Ambroxol HCL hereinafter referred to as AM) has another name called ambroxol. It is a new mucolytic drug, which is classified as a mucosal lubricant expectorant. It is an active metabolite of hexyl bromide in the body, and its expectorant effect is stronger than that of hexyl bromide. AM increases the volume of airway fluid by promoting the secretion of pulmonary surfactant, performs a protective function on the surface of the airway mucosa, improves the movement of bronchial cilia, enhances the transport function of organ cilia, and makes phlegm easy to cough up. Phlegm medicine. Ambroxol hydrochloride is slightly soluble in water and slightly soluble in organic solvents. The equilibrium solubility (37°C) in artificial gastric juice, water, and pH6.8 p...

AI Technical Summary

Problems solved by technology

[0005] Although controlled-release preparations, particularly controlled-release dry suspensions have advantages relative to common sustained-release preparations and have been paid great attention to by pharmacists and clinicians, the prior art only has the sustained-release preparation of ambroxol hydrochloride, only It can achieve the effect of sustained release in vitro and in vivo, but it cannot achieve the effect of controlled release, which makes the drug release in the body more stable and has fewer adverse reactions. There is no controlled-release preparation of ambroxol hydrochloride, and there is no controlled-release dry suspension of ambroxol hydrochloride. agent

The applicant believes that this is at least in part because certain physical properties of ambroxol hydrochloride are unfavorable for the preparation of conventional controlled-release dry suspensions, and therefore the preparation of controlled-release dry suspensions of ambroxol hydrochloride is of great importance to the art. Technicians have great technical difficulties

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