Ambroxol hydrochloride composition and its preparation method

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.