Pharmaceutical composition containing imipenem cilastatin sodium and preparation thereof

Abstract

The invention relates to a pharmaceutical composition containing imipenem cilastatin sodium and preparation thereof, belongs to the field of medicine and aims at overcoming the technical shortcoming that an imipenem cilastatin sodium powder injection in the prior art causes large adverse effect on the centre. The invention provides a powder injection containing the imipenem cilastatin sodium through reasonable compatibility. The powder injection can effectively reduce the adverse effect on the centre of an imipenem cilastatin sodium compound preparation when being used for clinic antibacterial treatment, the stability of the re-dissolved powder injection can be remarkably improved, and therefore, the pharmaceutical composition is suitable for development of clinic treatment medicine.

Description

technical field

[0001] The invention relates to a pharmaceutical composition containing imipenem cilastatin sodium and a preparation thereof, belonging to the field of medicine. Background technique

[0002] Imipenem is a carbapenem antibiotic, which has antibacterial effect on Gram-positive and negative aerobic and anaerobic bacteria. The antibacterial spectrum includes Streptococcus, Staphylococcus aureus, E. coli, Klebsiella, and Part of the strains of Actinobacillus, Haemophilus influenzae, Proteus, Serratia, Pseudomonas aeruginosa, etc. Imipenem is especially suitable for mixed infections caused by various pathogens and aerobic / anaerobic bacteria, as well as early treatment before the pathogens are not identified. Clinically, this product is used for various infections caused by allergenic bacteria, especially for various bacterial joint infections and mixed infections of aerobic and anaerobic bacteria, such as peritonitis, liver and gallbladder infection, intra-abdomi...

Examples

Embodiment 1

[0024] Embodiment 1 Powder injection of the present invention

[0025] Prescription composition:

[0026]

[0027] Preparation Process:

[0028] Weigh the prescribed amount of imipenem, cilastatin sodium, edaravone and auxiliary materials; add sodium bicarbonate and mannitol into an appropriate amount of water for injection, stir and dissolve, add the prescribed amount of imipenem, cilastatin For statin sodium and edaravone, heat and boil to dissolve the drug completely and use sodium hydroxide to adjust the pH value of the drug solution to 7.0-8.5. Add 0.1% activated carbon to the drug solution and stir for 15 minutes. 0.45 μm and 0.22 μm filter to remove activated carbon, after the filtrate was cooled to room temperature, add 6 times the volume of absolute ethanol to the drug solution, a precipitate formed in the solution, after stirring for 30 minutes, use a 0.45 μm filter to obtain an off-white solid. The off-white solid is washed with absolute ethanol, dried in vacuu...

Embodiment 2

[0029] Embodiment 2 powder injection of the present invention

[0030] Prescription composition:

[0031]

[0032] The preparation method is the same as Example 1 of the present invention except that the prescription is different.

Embodiment 3

[0033] Embodiment 3 powder injection of the present invention

[0034] Prescription composition:

[0035]

[0036] The preparation method is the same as Example 1 of the present invention except that the prescription is different.

technical field

[0001] The invention relates to a pharmaceutical composition containing imipenem cilastatin sodium and a preparation thereof, belonging to the field of medicine. Background technique

[0002] Imipenem is a carbapenem antibiotic, which has antibacterial effect on Gram-positive and negative aerobic and anaerobic bacteria. The antibacterial spectrum includes Streptococcus, Staphylococcus aureus, E. coli, Klebsiella, and Part of the strains of Actinobacillus, Haemophilus influenzae, Proteus, Serratia, Pseudomonas aeruginosa, etc. Imipenem is especially suitable for mixed infections caused by various pathogens and aerobic / anaerobic bacteria, as well as early treatment before the pathogens are not identified. Clinically, this product is used for various infections caused by allergenic bacteria, especially for various bacterial joint infections and mixed infections of aerobic and anaerobic bacteria, such as peritonitis, liver and gallbladder infection, intra-abdomi...

Examples

Embodiment 1

[0024] Embodiment 1 Powder injection of the present invention

[0025] Prescription composition:

[0026]

[0027] Preparation Process:

[0028] Weigh the prescribed amount of imipenem, cilastatin sodium, edaravone and auxiliary materials; add sodium bicarbonate and mannitol into an appropriate amount of water for injection, stir and dissolve, add the prescribed amount of imipenem, cilastatin For statin sodium and edaravone, heat and boil to dissolve the drug completely and use sodium hydroxide to adjust the pH value of the drug solution to 7.0-8.5. Add 0.1% activated carbon to the drug solution and stir for 15 minutes. 0.45 μm and 0.22 μm filter to remove activated carbon, after the filtrate was cooled to room temperature, add 6 times the volume of absolute ethanol to the drug solution, a precipitate formed in the solution, after stirring for 30 minutes, use a 0.45 μm filter to obtain an off-white solid. The off-white solid is washed with absolute ethanol, dried in vacuu...

Embodiment 2

[0029] Embodiment 2 powder injection of the present invention

[0030] Prescription composition:

[0031]

[0032] The preparation method is the same as Example 1 of the present invention except that the prescription is different.

Embodiment 3

[0033] Embodiment 3 powder injection of the present invention

[0034] Prescription composition:

[0035]

[0036] The preparation method is the same as Example 1 of the present invention except that the prescription is different.

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