Ambroxol hydrochloride liquid preparation and preparation method thereof
A technology of ambroxol hydrochloride and liquid preparations, which is applied in the field of ambroxol hydrochloride liquid preparations and its preparation, can solve the problems affecting the health of the infusion population, allergies, pyrogens, tumor-like reactions, and pollution particles The incidence of adverse reactions, the effect of improving the level of sterility assurance and reducing the introduction of impurities
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Embodiment 1
[0047] Embodiment 1: the preparation of ambroxol hydrochloride injection, totally 1000ml.
[0048] One, the preparation of ambroxol hydrochloride injection
[0049] In the sterile operating room, 15 g of ambroxol hydrochloride was dissolved in water for injection at 80° C., then 18 g of sodium chloride was added, stirred until fully dissolved, 200 ml of propylene glycol was added, and stirred evenly to obtain solution I.
[0050] Adjust the pH value to 3.6 with a mixed solution of 10% glacial acetic acid and citric acid.
[0051] In the aseptic operation room, the temperature of the above solution I was lowered to 40° C., and the solution I was filtered with a 0.22 μm pore size filter to obtain the filtrate a.
[0052] Filtrate a was ultrafiltered with an ultrafilter with a molecular weight cutoff of 10,000 Daltons to obtain filtrate b.
[0053] The filtrate b was made up to 1000 ml with water for injection, and then filtered with a 0.22 μm pore size filter to obtain filtrat...
Embodiment 2
[0095] Embodiment 2: the preparation of ambroxol hydrochloride injection, altogether 1000ml.
[0096] The preparation process and filling process are carried out under the local level 100 of the 10,000-level clean area.
[0097] One, the preparation of ambroxol hydrochloride injection
[0098] In a sterile operating room, dissolve 30 g of ambroxol hydrochloride in water for injection at 50° C., then add 20 g of mannitol, stir until fully dissolved, add 100 ml of propylene glycol, and stir evenly to obtain a solution.
[0099] Adjust the pH value to 3.8 with a mixed solution of 10% glacial acetic acid and citric acid.
[0100] In the aseptic operation room, the temperature of the above solution I was lowered to 45° C., and then the solution I was filtered with a 0.22 μm pore size filter to obtain the filtrate a.
[0101] Filtrate a was ultrafiltered with an ultrafilter with a molecular weight cutoff of 10,000 Daltons to obtain filtrate b.
[0102] The filtrate b was made up ...
Embodiment 3
[0128] Embodiment 3: the preparation of ambroxol hydrochloride injection, altogether 1000ml.
[0129] The preparation process and filling process are carried out under the local level 100 of the 10,000-level clean area.
[0130] One, the preparation of ambroxol hydrochloride injection
[0131] In the sterile operating room, dissolve 50 g of ambroxol hydrochloride in water for injection at 60° C., then add 50 g of xylitol, stir until fully dissolved, add 250 ml of Tween-80, and stir evenly to obtain solution I.
[0132] Adjust the pH to 3.7 with 10% phosphate buffer.
[0133] In the aseptic operation room, the temperature of the above solution I was lowered to 42° C., and then the solution I was filtered with a 0.22 μm pore size filter to obtain the filtrate a.
[0134] Filtrate a was ultrafiltered with an ultrafilter with a molecular weight cutoff of 10,000 Daltons to obtain filtrate b.
[0135] The filtrate b was made up to 1000 ml with water for injection, and then filter...
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