COMPOSITION CONTAINING AMBROXOL HYDROCHLORIDE AND METHOD FOR PRODUCING IT

摘要

1. A composition containing ambroxol hydrochloride, characterized in that the main ingredients of the composition are 0.1-99.9 weight percent of ambroxol hydrochloride and 99.9-0.1 weight percent of scopolamine. 2. The method of obtaining the composition of the compound using the composition according to claim 1, comprising the following stages: a) adding 0.1-99.9% ambroxol hydrochloride, 99.9-0.1% scopolamine and from 5 to 10 times the amount of mannitol to water for injection, b) stirring until dissolution, adjusting the pH to 5.0 by adding NaOH solution, c) adding 0.1% activated carbon and stirring for 30 minutes, d) removing activated carbon by filtration, followed by filtering the solution through microporous membranes with size pore 0.45 μm and 0.22 μm, d) transfer of the filtrate to a flask or a wide vessel, e) placing it in a lyophilizer, cooling to -40 ° C and keeping at this temperature for 2 hours; g) slow heating to -5 ° C - 0 ° C to lyophilize the liquid, then heating to 35 ° C and holding at this temperature for 3 h, h) extraction from the lyophilizer after lyophilization to obtain a lyophilized powder containing ambroxol hydrochloride and scopolamine, and) grinding the lyophilized powder under sterile conditions, sifting through a 180 mesh sieve to obtain sterile lyophilized powder powder containing ambroxol hydrochloride and scopolamine, ir) preparation of various dosage forms using lyophilized powder as a starting material. 3. A method for preparing a compound of claim 2, wherein the dosage forms include tablets, tinctures, suppositories, capsules, ointments, creams, pastes, ophthalmic preparations, drops, implants, syrups, aerosols, powder and