Stable ambroxol theophylline acetate solution for inhalation

Abstract

The invention provides a stable ambroxol theophylline acetate solution for inhalation and belongs to the field of chemical pharmaceuticals. The stable ambroxol theophylline acetate solution comprises theophylline acetic acid, ambroxol hydrochloride, a surfactant, an antioxidant, and a preservative. Furthermore, 100 ml of solvent contains 0.1-0.3 g of theophylline acetic acid, 0.1-0.3 g of ambroxol hydrochloride, and the surfactant accounting for 3-6% of the theophylline acetic acid by weight, and pH of the solution is 2.0-5.8. The stable ambroxol theophylline acetate solution for inhalation in the invention is good in stability and long in storage time. This solution may have no significant change in active ingredients after being stored at room temperature for one year.

Description

technical field [0001] The invention belongs to the field of chemical medicine and relates to a theophylline ambroxol acetate solution, in particular to a stable theophylline ambroxol acetate solution for inhalation. Background technique [0002] As we all know, theophylline ambroxol acetate, also known as theophylline acetate bromide, is theophylline derivatives, molecular formula: C 22 h 28 Br 2 N 6 o 5 , is a double salt formed by equimolar ambroxol and theophylline acetic acid, so it has the pharmacological and clinical effects of both ambroxol and theophylline acetic acid, and is a kind of product that promotes expectoration, improves respiratory conditions, and has obvious anti-inflammatory effects. Novel drug with anti-inflammatory ability; the existing theophylline ambroxol acetate has poor stabilizing effect and short storage time. [0003] The prior art mostly uses dimethylformamide as a solvent, theophylline acetic acid and ambroxol base react in this solvent...

AI Technical Summary

Problems solved by technology

This kind of preparation in the prior art uses chemical solvents, which directly leads to high production costs, and the use of a large amount of ethyl acetate and dimethylformamide leads to environmental pollution, which does not conform to the concept of sustainable development

Simultaneously, the theophylline ambroxol acetate prepared by the prior art has a poor stabilizing effect, is easily decomposed, has a short storage time, and the active ingredient decomposes seriously, and the use effect is greatly reduced

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