Ambroxol hydrochloride glucose injection and preparation method thereof

Abstract

The invention discloses an ambroxol hydrochloride glucose injection and a preparation method thereof. The ambroxol hydrochloride glucose injection comprises the following components: ambroxol hydrochloride, glucose, water for injection, and a pH regulator. The preparation method for the injection comprises the following steps of: getting the water for injection, adding glucose for dissolving, adding active carbon to adsorb and decarburizing, putting filtrate to a diluted solution tank, adding ambroxol hydrochloride and all water for injection, stirring and dissolving, regulating the pH value of the solution, filtering the solution through a microfiltration membrane until the solution is clear, filling the clear solution, capping the filled solution and carrying out terminal sterilization; or weighing and adding glucose and ambroxol hydrochloride to a preparation tank; adding all water for injection, stirring and dissolving, regulating the pH value of the solution to a determined range, filtering the solution until the medical solution is clear after that the pH value of the solution and the content of the ambroxol hydrochloride and glucose are qualified, filling, capping and carrying out terminal sterilization to the clear solution to obtain the ambroxol hydrochloride glucose injection. The ambroxol hydrochloride glucose injection has good stability, medication safety and effectiveness and a simple process, and is applicable to large-scale industrial production.

Description

technical field [0001] The invention relates to a composition and a preparation method thereof, in particular to an ambroxol hydrochloride glucose injection and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride chemical name: trans 4-[(2-amino-3,5 dibromo-phenyl) methyl-amino] cyclohexanol, the structure is as follows: [0003] [0004] Ambroxol hydrochloride is a new generation of respiratory mucus regulator with superior expectorant effect. Ambroxol hydrochloride has the characteristics of promoting mucus elimination and dissolving secretions. It can promote the elimination of viscous secretions in the respiratory tract and reduce the retention of mucus, thus significantly promoting expectoration and improving respiratory conditions. It is suitable for acute and chronic respiratory diseases accompanied by abnormal sputum secretion and poor expectoration function. It is one of the widely used expectorant drugs in clinical practice, with...

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Problems solved by technology

In the patent CN 200710059969.6 (a kind of ambroxol hydrochloride injection) a kind of ambroxol hydrochloride small-capacity injection (not containing glucose) is provided, and it adopts the method for controlling solution pH value and adding stabilizer to solve the problem of ambroxol hydrochloride in The problem of the increase of related substances under oxidative or alkaline conditions, but increases the complexity of the formulation, and the addition of surfactants also increases unsafe factors

Patent 200510118511.4 (high-dose ambroxol hydrochloride freeze-dried preparation and preparation method) provides a glucose-free ambroxol hydrochloride freeze-dried preparation. As we all know, the freeze-dried preparation has not been terminally sterilized. High cost, clinical use requires secondary preparation to increase the chance of contamination and inconvenient use. Generally, it is a helpless choice when there is no better solution for unstable samples.

Ambroxol hydrochloride dextrose injection is the most widely used large-volume injection in clinical practice, but its chemical stability is poor, especially when it is sterilized at high temperature, exposed to light and placed for a long time, it is easy to degrade, and its content decreases, related substances increase, or even unqualified , thereby affecting the safety of the product

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