Ibuprofen liquid injection composition and preparation method thereof
A technology for injection and water for injection, which is applied in the fields of drug combination, drug delivery, pharmaceutical formulation, etc., can solve the problems of unmentioned foreign bodies and insoluble particles, and achieve the effect of improving the inspection items of visible foreign bodies.
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Embodiment 1
[0033] Each 1000 injection preparations contains the following ingredients:
[0034]
[0035] Add water for injection to 4000ml
[0036] Weigh 400g (1.94mol) of ibuprofen and 338g (1.94mol) of arginine according to the prescription, add them to 3200ml of water for injection, stir at room temperature to dissolve completely; adjust the pH value to 8.4 with 5% (W / V) ammonia solution Add activated carbon for needles at 0.05% (W / V), stir at 25°C for 20 minutes, and filter coarsely, then filter the filtrate with a 0.22 μm microporous membrane; then adjust the pH value to 7.4 with 5% (W / V) hydrochloric acid solution, Finally, add water for injection to make the volume to 4000ml; intermediate inspection; nitrogen protection, filling and sealing in 5ml ampoules, 4ml / bottle; 121℃, 15min high-pressure steam sterilization, leak detection; light inspection of ampoules one by one; sampling Full inspection; packing.
Embodiment 2
[0038] Each 1000 injection preparations contains the following ingredients:
[0039]
[0040] Add water for injection to 4000ml
[0041] Weigh 400g of ibuprofen according to the prescribed amount, add 338g of arginine into 3200ml of water for injection, stir at room temperature to dissolve completely; adjust the pH value to 7.8 with 5% (W / V) ammonia solution; press 0.05% (W / V) Add activated carbon for needles, stir at 25°C for 20 minutes, coarsely filter, and then filter the filtrate with a 0.22 μm microporous membrane; then adjust the pH value to 7.0 with 5% (W / V) hydrochloric acid solution, and finally add water for injection to dilute to 4000ml; Intermediate inspection; nitrogen protection, filling and sealing in 5ml ampoules, 4ml / bottle; 121°C, 15min high-pressure steam sterilization, leak detection; light inspection of ampoules one by one; full sampling inspection; packaging.
Embodiment 3
[0043] Each 1000 injection preparations contains the following ingredients:
[0044]
[0045] Add water for injection to 4000ml
[0046] Weigh 400g of ibuprofen according to the prescription, add 338g of arginine into 3200ml of water for injection, stir at room temperature to dissolve completely; adjust the pH value to 9.0 with 5% (W / V) ammonia solution; press 0.05% (W / V) Add activated carbon for needles, stir at 25°C for 20 minutes, coarsely filter, and then filter the filtrate with a 0.22 μm microporous membrane; then adjust the pH value to 8.0 with 5% (W / V) hydrochloric acid solution, and finally add water for injection to dilute to 4000ml; Intermediate inspection; nitrogen protection, filling and sealing in 5ml ampoules, 4ml / bottle; 121°C, 15min high-pressure steam sterilization, leak detection; light inspection of ampoules one by one; full sampling inspection; packaging.
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