Compound preparation of cefotaxime sodium and sulbactam sodium as well as preparation method and application thereof

A technology of cefotaxime sodium and compound preparations, which is applied in the directions of medical preparations containing active ingredients, pharmaceutical formulas, powder delivery, etc. Dispensing, short validity period and other issues, to achieve the effect of easy transportation and long-term storage, improving drug safety and economic benefits, and easy storage

Active Publication Date: 2012-09-26
XIANGBEI WELMAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the procurement process of hospitals, it is generally required to purchase drugs with a remaining validity period of more than 1 year; in the process of warehousing and pharmacy distribution, it often happens that drugs cannot be distributed due to expired or about to expire
The validity period of the compound preparation of cefotaxime sodium and sulbactam sodium is generally 24 months, and the validity period is short, which is prone to problems such as returns and exchanges, and difficulty in sales
[0008] However, the problem of uneven particle size, high temperature stability, especially 60°C high temperature stability and short validity period of the compound preparation of cefotaxime sodium and sulbactam sodium has not been solved so far.

Method used

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  • Compound preparation of cefotaxime sodium and sulbactam sodium as well as preparation method and application thereof
  • Compound preparation of cefotaxime sodium and sulbactam sodium as well as preparation method and application thereof
  • Compound preparation of cefotaxime sodium and sulbactam sodium as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Prescription composition:

[0035] Cefotaxime sodium (calculated as cefotaxime) 1g

[0036]Sulbactam sodium (calculated as sulbactam) 1.5g

[0037] Preparation method: Under GMP aseptic conditions, cefotaxime sodium and sulbactam sodium are respectively micronized with a nano pulverizer, so that the particle size is 2000nm, and the ratio is calculated according to the composition requirements of the prescription before feeding. A high-efficiency mixer with a rotating speed of 17r / min was used for mixing, and the mixing time was 20 minutes. Filling, subpackaging and lamination of film butyl rubber stoppers were carried out under nitrogen filling to obtain the target powder injection.

Embodiment 2

[0039] Prescription composition:

[0040] Cefotaxime sodium (calculated as cefotaxime) 1g

[0041] Sulbactam sodium (calculated as sulbactam) 1.25g

[0042] Preparation method: Under GMP aseptic conditions, cefotaxime sodium and sulbactam sodium are respectively micronized with a nano pulverizer, so that the particle size is 5000nm, and the ratio is calculated according to the composition requirements of the prescription. A high-efficiency mixer with a rotating speed of 15r / min was used for mixing, and the mixing time was 30 minutes. Filling and subpackaging and lamination of film butyl rubber stoppers were carried out under nitrogen filling to obtain the target powder injection.

Embodiment 3

[0044] Prescription composition:

[0045] Cefotaxime sodium (calculated as cefotaxime) 1g

[0046] Sulbactam sodium (as sulbactam) 1g

[0047] Preparation method: Under GMP aseptic conditions, cefotaxime sodium and sulbactam sodium were micronized with a nano pulverizer, so that the particle size was 10000nm, and the ratio was calculated according to the composition requirements of the prescription before feeding. A high-efficiency mixer with a rotating speed of 25r / min was used for mixing, and the mixing time was 25 minutes. Filling and subpackaging and lamination of film butyl rubber stoppers were carried out under nitrogen filling to obtain the target powder injection.

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Abstract

The invention relates to a compound preparation of cefotaxime sodium and sulbactam sodium, as well as a preparation method and application of the compound preparation. The ratio of cefotaxime sodium to sulbactam sodium in the compound preparation is 1: (1.5 to 0.125) in parts by weight of the cefotaxime sodium and the sulbactam sodium; and the grain diameters of cefotaxime sodium and sulbactam sodium are both 2000-100000 nm. According to the invention, a nanometre crushing technology is adopted, and the compound preparation keeps stable at 60 DEG C and has an effective period of 28 months, thus solving the problems of poor high-temperature stability and short effective period, and thus the compound preparation is convenient to transport and store for a long time and is superior to the prior art, and medicine safety and economic benefits are improved.

Description

technical field [0001] The invention relates to the field of drug compound preparations, in particular to a compound preparation of cefotaxime sodium and sulbactam sodium, as well as its preparation method and application. Background technique [0002] The invention relates to a compound preparation of cefotaxime sodium and sulbactam sodium, which is a pharmaceutical composition with stable content of active ingredients for treating infections caused by drug-resistant bacteria such as NDM-1-producing "super bacteria". NDM-1 is the English abbreviation of New Delhi metallo-β-lactamase-1 (New Delhi metallo-β-lactamase-1), an article published in the famous British medical journal "The Infectious Diseases" on August 11, 2010 According to the report, published by Tim Walsh of Cardiford University in the United Kingdom, he named the superbug as "New Delhi metalloproteinase-1", because the bacteria carrying this gene will produce a special β-lactamase, and the activity The part i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K9/14A61P31/04A61K31/43
Inventor 不公告发明人
Owner XIANGBEI WELMAN PHARMA CO LTD
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