Imipenem and cilastatin sodium for injection and preparation process of imipenem and cilastatin sodium for injection

A technology for imipenem cilastatin sodium and cilastatin sodium, which is applied in the field of imipenem cilastatin sodium for injection and its production technology, can solve the problems of different quality, great difficulty in mixing, and powder particles. The problem of huge difference in diameter and specific gravity can reduce the influence of particle dust, which is beneficial to uniformity and is not easy to delaminate.

Inactive Publication Date: 2019-02-26
瀚晖制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The imipenem and cilastatin sodium preparations currently on the market are all sterile powders, and their preparation technology is aseptic subpackaging. Packed in glass bottles or infusion bottles, but due to the huge difference in powder particle size and specific gravity between imipenem and cilastatin sodium, it is very difficult to mix evenly, and it is difficult to meet the requirements of 1:1 preparations during the production process. Homogeneous mixing in specific proportions, resulting in uneven drug distribution and variable quality of the finished product, so improvements are made

Method used

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  • Imipenem and cilastatin sodium for injection and preparation process of imipenem and cilastatin sodium for injection
  • Imipenem and cilastatin sodium for injection and preparation process of imipenem and cilastatin sodium for injection

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Embodiment 1

[0030] A kind of imipenem cilastatin sodium for injection, it is made by following production process:

[0031] Mix imipenem, cilastatin sodium and sodium bicarbonate with a mass ratio of 1:1:0.04 in sequence in a sterile room with a humidity less than 40%, and then feed them by screw under the condition that the humidity is less than 40%. The lower portion is packed in sterile glass bottles, and the sterile glass bottle caps are covered with sterilized and dried rubber stoppers and sterilized and dried aluminum caps, and the caps are crimped and sealed.

[0032] Among them, the particle size of imipenem is controlled at 68.8-80.7 microns, that of cilastatin sodium is controlled at 270-320 microns, and that of sodium bicarbonate is controlled at 110-120 microns.

Embodiment 2

[0034] A kind of imipenem cilastatin sodium for injection, it is made by following production process:

[0035] Mix imipenem, cilastatin sodium and sodium bicarbonate with a mass ratio of 1:1:0.04 in sequence in a sterile room with a humidity less than 40%, and then feed them by screw under the condition that the humidity is less than 40%. The lower portion is packed in sterile glass bottles, and the sterile glass bottle caps are covered with sterilized and dried rubber stoppers and sterilized and dried aluminum caps, and the caps are crimped and sealed.

[0036] Among them, the particle size of imipenem is controlled at 68.8-70 microns, that of cilastatin sodium is controlled at 300-320 microns, and that of sodium bicarbonate is controlled at 115-120 microns.

Embodiment 3

[0038] A kind of imipenem cilastatin sodium for injection, it is made by following production process:

[0039] Mix imipenem, cilastatin sodium and sodium bicarbonate with a mass ratio of 1:1:0.04 in sequence in a sterile room with a humidity less than 40%, and then feed them by screw under the condition that the humidity is less than 40%. The lower portion is packed in sterile glass bottles, and the sterile glass bottle caps are covered with sterilized and dried rubber stoppers and sterilized and dried aluminum caps, and the caps are crimped and sealed.

[0040] Among them, the particle size of imipenem is controlled at 76-80.7 microns, that of cilastatin sodium is controlled at 270-280 microns, and that of sodium bicarbonate is controlled at 110-120 microns.

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Abstract

The invention relates to imipenem and cilastatin sodium for injection and a preparation process of the imipenem and cilastatin sodium for injection, and belongs to the field of medicines. The preparation process of the imipenem and cilastatin sodium for injection comprises the following steps: mixing imipenem, cilastatin sodium and sodium bicarbonate under a sterile condition, and separately packing the mixture in sterile glass bottles in a screw feeding mode. The problem that the imipenem and the cilastatin sodium are uniformly mixed difficultly is solved, meanwhile, drugs in the imipenem andcilastatin sodium for injection are uniform, and layering cannot be caused easily. The imipenem and cilastatin sodium prepared by the preparation process of the imipenem and cilastatin sodium for injection comprises the imipenem, the cilastatin sodium and the sodium bicarbonate according to the mass ratio of 1: 1: (0.01-0.1) successively, the quality of the imipenem and cilastatin sodium for injection is stable, the imipenem and the cilastatin sodium are mixed uniformly, and layering is not caused easily.

Description

technical field [0001] The invention relates to the field of medicine, and in particular to imipenem cilastatin sodium for injection and a preparation process thereof. Background technique [0002] Imipenem and cilastatin sodium are carbapenem (penem) compound antibiotics, the main components of which are imipenem and cilastatin sodium. Imipenem is a newest type of β-lactam antibiotic-iminothiamycin, and it is also an amidine derivative with a very broad antibacterial spectrum. Good antibacterial activity. Cilastatin sodium is a specific enzyme inhibitor, which can block the metabolism of imipenem in the kidney, thereby increasing the concentration of the original drug of imipenem in the urinary tract. [0003] Imipenem cilastatin sodium is a very broad-spectrum antibiotic, especially suitable for mixed infections caused by various pathogens and aerobic / anaerobic bacteria, as well as early treatment before the pathogens are not identified. This product is suitable for int...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/02A61K31/407A61K31/198A61P31/04A61J3/02
CPCA61J3/02A61K9/0019A61K9/1611A61K31/198A61K31/407A61P31/04A61K2300/00
Inventor 徐慧娟赵技宇苏春胜王文萍
Owner 瀚晖制药有限公司
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