3 results about "AMBROXOL HYDROCHLORIDE" patented technology

The application provides an ambroxol oral dissolving film composition, a preparation method and application thereof. The ambroxol oral dissolving film composition comprises an active drug, a film forming material and a taste masking agent, and the active drug is 2-amino-3,5-dibromo-N-(trans-4-hydroxycyclohexyl) benzylamine and / or a pharmaceutically acceptable salt thereof, for example, ambroxol hydrochloride. The ambroxol oral dissolving film composition provided by the application has the advantages of thin thickness, good taste, stable properties, immediate dissolution in the oral cavity without drinking water, and fast oral absorption speed. Moreover, the ambroxol oral dissolving film composition has the advantages of simple process, high drug loading, good drug content uniformity, and good market prospect.

This invention proposes a compound ambroxol sustained-release microsphere and its preparation method. The compound ambroxol sustained-release microsphere comprises ambroxol hydrochloride, clenbuterol hydrochloride, and a cellulose ester sustained-release material, effectively controlling the dissolution differences between ambroxol hydrochloride and clenbuterol hydrochloride, enabling simultaneous and stable release of both drugs and avoiding efficacy fluctuations due to different release rates. Furthermore, the microsphere utilizes a hot-melt extrusion process, ensuring uniform dispersion of the two active pharmaceutical ingredients within the sustained-release material, thus resolving the uniformity issue caused by low clenbuterol hydrochloride content. The preparation process requires no organic solvents, eliminating solvent residues and preventing degradation or reactions of the active pharmaceutical ingredients in solvents, thereby improving product stability.

This invention belongs to the field of organic synthesis technology and provides a method for preparing a key intermediate of ambroxol hydrochloride. The method includes the following steps: methyl 2-aminobenzoate reacts with a brominating reagent under the action of an initiator to generate methyl 2-amino-3,5-dibromobenzoate via a bromination reaction; subsequently, methyl 2-amino-3,5-dibromobenzoate is reduced to 2-amino-3,5-dibromobenzyl alcohol in a reduction system; finally, under the action of an oxidizing agent, 2-amino-3,5-dibromobenzyl alcohol is further oxidized to form the target compound 2-amino-3,5-dibromobenzaldehyde. The optimized process has mild reaction conditions, conforms to green and environmentally friendly principles, significantly improves route safety, uses inexpensive and readily available raw materials, and achieves high product yield and purity, making it suitable for industrial production.