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Pharmaceutical composition with cefminox sodium sterile mixed powder form

A technology of cefminox sodium and its composition, which is applied in the field of pharmaceutical compositions in the form of cefminox sodium aseptic mixed powder, can solve the problems of increased risk of allergic reactions, increased polymer content, etc. Safety and effectiveness, improved stability, good thermal stability effect

Active Publication Date: 2013-03-20
HAINAN HERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Above-mentioned method has solved the problem of product stability to a certain extent, but because cefminox sodium often degrades and polymerizes in storage process, along with the prolongation of storage time in production, storage and use process, its high polymerization Increased content of the substance increases the risk of allergic reactions in the human body

Method used

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  • Pharmaceutical composition with cefminox sodium sterile mixed powder form
  • Pharmaceutical composition with cefminox sodium sterile mixed powder form
  • Pharmaceutical composition with cefminox sodium sterile mixed powder form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] [Example 1] Cefminox Sodium Sterile Powder for Injection

[0041] Specification:

[0042] Preparation:

[0043] 1. Inner packaging material treatment

[0044] Antibiotic glass bottles, rubber stoppers, and aluminum caps are cleaned, dried, and sterilized according to the conventional process, and set aside;

[0045] 2. Specific steps

[0046] (1) Weigh the prescribed amount of anhydrous sodium carbonate, anhydrous sodium carbonate, and sodium benzoate, and mix them evenly in a sterile container;

[0047] (2) Inspection of intermediate products;

[0048] (3) Aseptic subpackaging according to specifications;

[0049] (4) Plugging and capping;

[0050] (5) Packaging, full inspection, and storage.

Embodiment 2

[0051] [Example 2] Cefminox Sodium Sterile Powder Injection

[0052] Specification:

[0053] Preparation method: same as preparation example 1.

Embodiment 3

[0054] [Example 3] Cefminox Sodium Sterile Powder Injection

[0055] Specification:

[0056] Preparation method: with embodiment 1.

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Abstract

The invention relates to a pharmaceutical composition with a cefminox sodium sterile mixed powder form, and the pharmaceutical composition comprises cefminox sodium, anhydrous sodium carbonate and sodium benzoate, wherein the mass ratio of the cefminox sodium, the anhydrous sodium carbonate and the sodium benzoate is 100g:(0.1-0.5)g:(0.1-1.0)g. Due to the combined application of the cefminox sodium, the anhydrous sodium carbonate and the sodium benzoate, the heat stability of the cefminox sodium can be greatly improved, and the stability of the cefminox sodium in a solution state can be improved, so that the clinical use safety is improved. Furthermore, the invention also relates to a preparation method of the pharmaceutical composition, and the preparation method is simple and practicable in technology, thus being suitable for large-scale production.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a pharmaceutical composition in the form of cefminox sodium aseptic mixed powder, which contains anhydrous sodium carbonate and sodium benzoate. Background technique [0002] Cefminox sodium, the English name is Cefminox Sodium, the chemical name is (6R,7S)-7β-[(S)-2-[(2-amino-2-carboxyethyl)sulfur]acetamido]-7α-methanol Oxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]octyl- 2-ene-2-carboxylic acid sodium salt heptahydrate is a cephalosporin widely used clinically, and its structural formula is: [0003] [0004] Molecular formula: C 16 h 20 N 7 NaO 7 S 3 .7H 2 O, molecular weight: 667.66. [0005] Cefminox sodium is a third-generation cephalosporin antibiotic developed by Japan's Meiji Company. It has broad-spectrum antibacterial activity against Gram-positive and Gram-negative bacteria, especially Escherichia coli, Klebsiella, and influenza. H...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K47/02A61K47/12A61K9/14A61P31/04
Inventor 朱正兵
Owner HAINAN HERUI PHARMA
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