Edaravone injection and preparation method thereof
A technology of edaravone and injection, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, and medical preparations containing active ingredients. Water and other issues
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Embodiment 1
[0082] Embodiment 1: specification: 5ml: 10mg
[0083] formula:
[0084]
[0085] Take a propylene glycol hot water bath and heat to 60-70°C, add Edaravone, and stir until completely dissolved. Separately weigh sodium metabisulfite (0.1%) and pour it into a beaker, add water for injection and stir until completely dissolved. Slowly add the pre-dissolved antioxidant-containing solution to the edaravone propylene glycol solution while stirring, and then slowly add water for injection to 1 / 4 of the total volume while stirring. Then add activated carbon for needles (0.1%), warm and stir for 15 minutes, let stand, filter with suction, and remove carbon. Add the remaining water for injection. Adjust the pH to 4.0 with 0.1mol / L hydrochloric acid, check the intermediate, and fine-filter it with a 0.22μm microporous membrane until it is clear, fill it with nitrogen, fill it in an ampoule, and sterilize it by autoclaving at 115°C for 30 minutes. After three years, all inspections...
Embodiment 2
[0086] Embodiment 2: specification: 5ml: 10mg
[0087] formula:
[0088]
[0089] Take a propylene glycol hot water bath and heat to 60-70°C, add Edaravone, and stir until completely dissolved. Separately weigh sodium metabisulfite (0.15%) and pour it into a beaker, add water for injection and stir until completely dissolved. Slowly add the pre-dissolved antioxidant-containing solution to the edaravone propylene glycol solution while stirring, and then slowly add water for injection to 1 / 4 of the total volume while stirring. Then add activated carbon for needles (0.1%), warm and stir for 15 minutes, let stand, filter with suction, and remove carbon. Add the remaining water for injection. Adjust the pH to 4.2 with 0.1 mol / L hydrochloric acid, check the intermediate, and fine-filter it with a 0.22 μm microporous membrane until it is clear, fill it with nitrogen, fill it in an ampoule, and sterilize it by autoclaving at 115°C for 30 minutes. After three years, all inspecti...
Embodiment 3
[0090] Embodiment 3: specification: 20ml: 30mg
[0091] formula:
[0092]
[0093]Take a propylene glycol hot water bath and heat to 60-70°C, add Edaravone, and stir until completely dissolved. Separately weigh sodium metabisulfite (0.1%) and pour it into a beaker, add water for injection and stir until completely dissolved. Slowly add the pre-dissolved antioxidant-containing solution to the edaravone propylene glycol solution while stirring, and then slowly add water for injection to 1 / 4 of the total volume while stirring. Then add activated carbon for needles (0.1%), warm and stir for 15 minutes, let stand, filter with suction, and remove carbon. Add the remaining water for injection. Adjust the pH to 3.9 with 0.1mol / L hydrochloric acid, check the intermediate, fine filter with a 0.22μm microporous membrane until it is clear, fill it with nitrogen, fill it in an ampoule, and sterilize it by autoclaving at 115°C for 30 minutes. After three years, all inspections meet t...
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