Ambroxol hydrochloride composition and its preparation method

摘要

An ambroxol hydrochloride composition and a preparation method therefor. 0.1%-99.9% by mass of ambroxol hydrochloride and 99.9%-0.1% by mass of scopolamine serving as main ingredients and mannitol are added into water for injection; dissolve, then adjust to pH 5.0; add 0.1% of activated carbon with stirring; filter out the activated carbon, and then filter the liquid; send into a lyophilizer, cool to −40° C., and hold the temperature for 2 hours; warm to −5° C. to 0° C. slowly to lyophilize the liquid, heat to 35° C., and hold the temperature for 3 hours; take out of the lyophilizer to obtain a lyophilized powder injection containing ambroxol hydrochloride and scopolamine; crush the lyophilized powder injection under sterile conditions, and sieve to obtain sterile lyophilized powder containing ambroxol hydrochloride and scopolamine; and prepare various dosage forms by using the lyophilized powder as a raw material.

主权项

1. A method, for preparing a composition, comprising the steps of:
a) adding 0.1%-99.9% of ambroxol hydrochloride, 99.9%-0.1% of scopolamine and 5 to 10 times main ingredients of mannitol to water to form a compound solution for injection; b) stirring to dissolve the compound solution and adjusting pH of the compound solution to 5.0 by adding an NaOH solution; c) adding 0.1% of activated carbon to the compound solution and stirring the compound solution for 30 minutes; d) filtering out the activated carbon from the compound solution, and then filtering the compound solution with 0.45 μm and 0.22 μm microporous filter membranes; e) filling the filtered compound solution into a large plate or vial; f) sending the filtered compound solution into a lyophilizer, cooling to a first temperature of −40° C., and holding the first temperature for 2 hours; g) warming the filtered compound solution slowly to −5 ° C. to 0 ° C. to lyophilize the filtered compound solution, heating the filtered compound solution to a second temperature of 35 ° C., and holding the second temperature for 3 hours; h) taking the filtered compound solution out of the lyophilizer after lyophilizing to obtain a lyophilized powder injection containing ambroxol hydrochloride and scopolamine; i) crushing the lyophilized powder injection under a sterile condition, sieving the lyophilized powder injection with a 180-mesh sieve to obtain a sterile lyophilized powder containing ambroxol hydrochloride and scopolamine; and j) preparing various dosage forms by using the sterile lyophilized powder as a raw material.