Dexibuprofen amino acid salt injection and preparation method thereof
An amino acid salt, salt injection technology, applied in anti-inflammatory agents, pharmaceutical formulations, non-central analgesics and other directions, can solve problems such as difficulty in the development of solution-type preparations, and achieve the effect of reducing adverse reactions and reducing dosage.
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Embodiment 1
[0034] Prescription: Dexibuprofen arginine salt: 184.45g (calculated as ibuprofen is 100g)
[0035] Sodium bicarbonate: 6g
[0036] Add water for injection to: 1000ml
[0037] Process: Follow the ordinary small-volume injection process. Dissolve the prescribed amount of dexibuprofen arginine salt and sodium bicarbonate with 80% to 90% of the total amount of water for injection, and then add water for injection to the prescribed amount; after adding activated carbon, place the liquid at 70°C to Insulate and stir at 80°C for 15 minutes to fully absorb, then decarburize; use 0.45μm and 0.22μm microporous membranes for fine filtration in turn; determine the content and pass the relevant substances, and then fill it into 1ml or 2ml ampoules that have been washed, dried and sterilized , melt-sealed; sterilized by autoclaving at 115°C for 30 minutes, and the finished product is obtained after passing the light inspection.
Embodiment 2
[0039] Prescription: Dexibuprofen Lysine Salt: 170.87g (calculated as ibuprofen as 100g)
[0040] Sodium bicarbonate: 6g
[0041] Add water for injection to: 1000ml
[0042] Process: follow the small volume injection process. Weigh the prescribed amount of dexibuprofen lysine salt and sodium bicarbonate, add 80% to 90% of the total amount of prescription water for injection to dissolve, then add water for injection to 1000ml; after adding activated carbon, the liquid medicine is placed at 70°C ~80℃, heat preservation and stirring for 15 minutes, after full adsorption, decarbonization; followed by fine filtration with 0.45μm and 0.22μm microporous membranes; measure the content and pass the relevant substances, fill in 1ml or 2ml that has been washed, dried and sterilized In ampoules, sealed by melting; sterilized by autoclaving at 115°C for 30 minutes, and the finished product is obtained after passing the light inspection.
Embodiment 3
[0044] Prescription: Dexibuprofen: 100g
[0045] Arginine: 85g
[0046] Sodium bicarbonate: 6g
[0047] Add water for injection to: 1000ml
[0048] Process: Operate according to the small volume injection process. Weigh the prescribed amount of arginine and sodium bicarbonate and dissolve them with about 800ml of water for injection, then add the prescribed amount of Dexibuprofen under stirring, stir while adding until completely dissolved, then add water for injection to 1000ml; add activated carbon After the liquid medicine is placed at 70°C to 80°C for 15 minutes, it is kept warm and stirred for 15 minutes. Put it into 1ml or 2ml ampoules that have been treated with bacteria, and melt it; sterilize by autoclaving at 115°C for 30 minutes, and get the finished product after passing the light inspection.
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