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A pharmaceutical composition comprising imipenem cilastatin sodium and its preparation

A technology of cilastatin sodium and imipenem, which can be used in medical preparations containing active ingredients, medical preparations without active ingredients, antibacterial drugs, etc., can solve problems such as large adverse drug reactions, and reduce the The incidence of central adverse reactions, the improvement of stability, and the effect of reducing central adverse reactions

Active Publication Date: 2016-06-15
CHINA NAT MEDICINES GUORUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to overcome the technical deficiency of the central nervous system adverse drug reaction of the powder injection of imipenem cilastatin sodium in the prior art, the present invention provides a powder of imipenem cilastatin sodium through reasonable compatibility. Injection, when the powder injection is used in clinical treatment, it can effectively reduce the adverse reactions of the central nervous system of the imipenem cilastatin sodium compound preparation, and can significantly improve the stability of the powder injection preparation after reconstitution, so it is suitable for development clinical medicine

Method used

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  • A pharmaceutical composition comprising imipenem cilastatin sodium and its preparation
  • A pharmaceutical composition comprising imipenem cilastatin sodium and its preparation
  • A pharmaceutical composition comprising imipenem cilastatin sodium and its preparation

Examples

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Effect test

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, vacuum-dried, ...

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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Abstract

The invention relates to a pharmaceutical composition containing imipenem cilastatin sodium and a preparation thereof, belonging to the field of medicine. In order to overcome the technical deficiency of the large central adverse reaction of the powder injection of imipenem and cilastatin sodium in the prior art, the present invention provides a powder injection containing imipenem and cilastatin sodium through reasonable compatibility. When the powder injection is used for clinical antibacterial treatment, it can effectively reduce the central adverse reactions of imipenem cilastatin sodium compound preparation, and can significantly improve the stability of the powder injection after reconstitution, so it is suitable for development into clinical treatment drug.

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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4152A61K9/14A61K47/22A61P31/04A61K31/407A61K31/198
Inventor 陈松柳应贵朱三甫蒋敏汪永龙姚磊徐静
Owner CHINA NAT MEDICINES GUORUI PHARMA
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