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Sodium fusidate pharmaceutical composition for injection, and preparation method thereof
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A technology of sodium fusidate and composition, which is applied in the field of pharmaceutical composition of sodium fusidate for injection and preparation thereof, and achieves the effects of simplifying production links, being beneficial to product quality, and easy to control product quality
Active Publication Date: 2020-04-17
SICHUAN HAISCO PHARMA CO LTD
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Problems solved by technology
[0020] Aiming at the many defects and problems existing in the existing sodium fusidate pharmaceutical composition for injectio
Method used
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Embodiment 1
[0056] Prescription of pharmaceutical composition of sodium fusidate for injection per 1000 vials:
[0057]
[0058] Preparation:
[0059] (1) Dissolve arginine in 60% of the water for injection of the recipe, adjust the pH value to 8.0-8.7 with hydrochloric acid, add sodium fusidate, stir to dissolve, and replenish water to the full amount, i.e. 4000mL after the dissolution is complete;
[0060] (2) Filter through the microporous membrane in the sterile room, fill the semi-finished product to the corresponding filling amount after passing the inspection, and then half-press the plug;
[0061] (3) Freeze drying, nitrogen filling, plugging, unboxing, and capping to obtain the finished product.
[0062] product instructions:
[0063] (1) Confirm the product information after opening the outer packaging of the product, and remove the outer packaging after confirmation;
[0064] (2) Use a disposable sterile syringe to draw 10 mL of a ready-to-use compatible diluent such as 0...
Embodiment 2
[0067] Prescription of pharmaceutical composition of sodium fusidate for injection per 1000 vials:
[0068]
[0069] Preparation method: same as Example 1.
[0070] Product use method: same as Example 1.
Embodiment 3
[0072] Prescription of pharmaceutical composition of sodium fusidate for injection per 1000 vials:
[0073]
[0074] Preparation method: same as Example 1.
[0075] Product use method: same as Example 1.
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Abstract
The invention provides a sodium fusidate pharmaceutical composition for injection, and a preparation method thereof, wherein the composition comprises sodium fusidate, basic amino acid and a proper amount of an acid for adjusting pH value, and is prepared through a freeze-drying process. According to the invention, the composition product does not need to be provided with a special buffer salt solvent, and cannot generate precipitation or turbidity after direct compatibility with 0.9% sodium chloride injection or 5% glucose injection and the like during use, so that the preparation link for the special buffer salt solvent is omitted in production so as to substantially simplify the production process, improve the operation compliance of medical staff, reduce the safety risk in the medicinecompatibility process and improve the use safety of the product.
Description
technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition of sodium fusidate for injection and a preparation method thereof. Background technique [0002] Fusidic Acid (also known as fusidic acid) is a fusidic acid antibiotic. It was first extracted from the fat globule fungus (Fusidium coccineum fungus) in 1962 by the Danish pharmaceutical company Leo. Its antibacterial mechanism is to interfere with elongation factor G by inhibiting the translocation of ribosomes, thereby hindering the synthesis of bacterial proteins. Because of its unique mechanism of action, it avoids cross-resistance with other antibacterial drugs, so it is widely used in clinical practice at home and abroad. Fusidic acid maintains strong antibacterial activity and a low resistance rate against most Staphylococcus strains, especially in the current situation where resistance to Staphylococcus aureus infections is b...
Claims
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