Fusidate sodium composition and preparation of its freeze-drying formulation
A technology of sodium fusidate and its composition, applied in the field of pharmaceutical preparations, can solve the problems of poor long-term stability, increase of related substances, increase of foreign matter, etc., and achieve the effects of improving tolerance, strong practicability, and good stability
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Embodiment 1
[0032] Each 1000 vials of lyophilized preparation contains the following ingredients:
[0033] Sodium Fusidate 125g
[0034] Mannitol 20g
[0035] Arginine 5g
[0036] Weigh the prescribed amount of mannitol and arginine, add 2000ml of water for injection, stir to dissolve, the temperature of the solution drops below 60°C, then add the prescribed amount of sodium fusidate, stir continuously to dissolve completely, add the prepared total Amount of 0.5% (W / V) activated carbon for injection, stirred and left for 25 minutes, decarburized by filtration, added water for injection to the full amount and set aside. Fine filter the above solution with a 0.22 μm microporous membrane until the filtrate is clear. After the semi-finished product passes the inspection, it is subpackaged and filled into 1000 10ml vials so that the main drug content is 125mg, and frozen at a low temperature (-40°C). 3 hours, primary drying temperature -25°C for 4 hours, 0°C for 7 hours, 18°C for 7 hours,...
Embodiment 2
[0038] Each 1000 vials of lyophilized preparation contains the following ingredients:
[0039] Sodium Fusidate 125g
[0040] Mannitol 20g
[0041] Arginine 100g
[0042] Disodium edetate 1g
[0043] The raw materials and auxiliary materials of the above prescription were prepared into 1000 bottles of sodium fusidate freeze-dried preparation according to the method of Example 1.
Embodiment 3
[0045]Each 1000 vials of lyophilized preparation contains the following ingredients:
[0046] Sodium Fusidate 125g
[0047] Mannitol 150g
[0048] Arginine 5g
[0049] Disodium edetate 1g
[0050] The raw materials and auxiliary materials of the above prescription were prepared into 1000 bottles of sodium fusidate freeze-dried preparation according to the method of Example 1.
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Abstract
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