Ibuprofen sodium chloride injection preparation with pH of 6.0-6.5, and preparation method thereof
A technology of sodium chloride injection and preparation, which is applied in the direction of anti-inflammatory agents, pharmaceutical formulas, non-central analgesics, etc., and can solve the problems of high dosage of acid-base adjustment, low safety, opalescent opacity, etc., and achieve Increase safety and stability, high safety, reduce the effect of dosage
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Embodiment 1
[0036] Embodiment 1: the preparation of ibuprofen sodium chloride injection (4mg / ml)
[0037] Prescription: Ibuprofen 400g
[0038] L-Arginine 310g
[0039] Sodium chloride 850g
[0040] 0.5mol / L L-arginine appropriate amount
[0041] Water for injection up to 100L
[0042] Makes 1000 bottles
[0043] 1) Obtain qualified ibuprofen raw materials, sodium chloride and L-arginine according to the ingredient list;
[0044] 2) Add water for injection with a batch volume of 4% in the batching tank, add the L-arginine of the batch volume, stir and dissolve, add the ibuprofen of the batch volume, stir for 2 hours, add water for injection to 20% of the batch volume, Add sodium chloride and stir to dissolve, add volume 0.05% (W / V) medicinal activated carbon, stir for 30 minutes, filter with titanium rod, add water for injection to 90% of batch volume, add arginine solution to adjust pH to about 6.3, sti...
Embodiment 2
[0049] Embodiment 2: the preparation of ibuprofen sodium chloride injection (4mg / ml)
[0050] Prescription: Ibuprofen 400g
[0051] L-Arginine 330g
[0052] Sodium chloride 820g
[0053] 0.5mol / L L-arginine appropriate amount
[0054] Water for injection up to 100L
[0055] Makes 1000 bottles
[0056] 1) Obtain qualified ibuprofen raw materials, sodium chloride and L-arginine according to the ingredient list;
[0057] 2) Add water for injection with a batch volume of 4% in the batching tank, add the L-arginine of the batch volume, stir and dissolve, add the ibuprofen of the batch volume, stir for 2 hours, add water for injection to 20% of the batch volume, Add sodium chloride and stir to dissolve, add 0.05% (W / V) medicinal activated carbon by volume, stir for 30 minutes, filter with titanium rod, add water for injection to 90% of batch volume, add arginine solution to adjust pH to about 6.4,...
Embodiment 3
[0062] Embodiment 3: the preparation of ibuprofen sodium chloride injection (4mg / ml)
[0063]
[0064] 1) Obtain qualified ibuprofen raw materials, sodium chloride and D-arginine according to the ingredient list;
[0065] 2) Add water for injection with a batch volume of 4% in the batching tank, add the D-arginine of the batch volume, stir and dissolve, add the ibuprofen of the batch volume, stir for 2 hours, add water for injection to 20% of the batch volume, Add sodium chloride and stir to dissolve, add volume 0.05% (W / V) medicinal activated carbon, stir for 30 minutes, filter with titanium rod, add water for injection to 90% of batch volume, add arginine solution to adjust pH to about 6.3, stir well Finally, add water for injection to the full amount, and fine filter with a cartridge filter;
[0066] 3) After the intermediates pass the test, notify the filling section to start filling;
[0067] 4) Put the filled semi-finished product into the sterilization cabinet for ...
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