Medicinal composition of cefmenoxime hydrochloride

A technology of cefmenoxime hydrochloride and composition, which is applied in the field of pharmaceutical compositions containing the active ingredient cefmenoxime hydrochloride, and can solve problems such as increased impurities, poor stability, and impact on drug safety and effectiveness

Active Publication Date: 2015-06-17
ZHEJIANG WHITESON PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, anhydrous sodium carbonate is added to the product as a co-solvent, but in clinical use, the solubility is still very poor, and due to the difference in crystallization between batches of raw material production, the solubility between batches is also very different. In clinical use, some medicines cannot be completely dissolved after 20 minutes by medical staff, and in good cases, it takes 5 minutes to completely dissolve
[0013] 2. The stability of cephalosporin products in the solution is poor, and they should be used immediately after the solution is prepared. Due to the long dissolution time, the cefmenoxime will be degraded and the impurities will increase. Particles are easy to form embolism in the human body, leading to adverse reactions such as vasculitis, which seriously affects the safety and effectiveness of clinical medication, and brings inconvenience to clinical use

Method used

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  • Medicinal composition of cefmenoxime hydrochloride
  • Medicinal composition of cefmenoxime hydrochloride
  • Medicinal composition of cefmenoxime hydrochloride

Examples

Experimental program
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Effect test

Embodiment 1

[0078] Cefmenoxime hydrochloride 1000g, sodium carbonate 533g, ethylenediamine 267g.

[0079] Preparation method: The cefmenoxime hydrochloride raw material is pulverized with a jet pulverizer using low-temperature inert gas (nitrogen) under sterile conditions. The pulverized cefmenoxime hydrochloride and auxiliary materials were mixed in a three-dimensional mixer for 30 minutes until uniformly mixed; the uniformly mixed aseptic mixed powder was packed in sterilized 20ml vials under aseptic conditions, and pressed Stoppering, capping, full inspection, packaging after passing the test, respectively to obtain 1000 bottles of powder injection.

Embodiment 2

[0081] Cefmenoxime hydrochloride 1000g, sodium carbonate 516g, ethylenediamine 284g.

[0082] Preparation method: The cefmenoxime hydrochloride raw material is pulverized with a jet pulverizer using low-temperature inert gas (nitrogen) under sterile conditions. The pulverized cefmenoxime hydrochloride and auxiliary materials were mixed in a three-dimensional mixer for 30 minutes until uniformly mixed; the uniformly mixed aseptic mixed powder was packed in sterilized 20ml vials under aseptic conditions, and pressed Stoppering, capping, full inspection, packaging after passing the test, respectively to obtain 1000 bottles of powder injection.

Embodiment 3

[0084] Cefmenoxime hydrochloride 1000g, sodium carbonate 485g, ethylenediamine 315g.

[0085] Preparation method: The cefmenoxime hydrochloride raw material is pulverized with a jet pulverizer using low-temperature inert gas (nitrogen) under sterile conditions. The pulverized cefmenoxime hydrochloride and auxiliary materials were mixed in a three-dimensional mixer for 30 minutes until uniformly mixed; the uniformly mixed aseptic mixed powder was packed in sterilized 20ml vials under aseptic conditions, and pressed Stoppering, capping, full inspection, packaging after passing the test, respectively to obtain 1000 bottles of powder injection.

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PUM

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Abstract

The invention belongs to the technical field of medicines, discloses a medicinal composition of cefmenoxime hydrochloride, and in particular relates to a medicinal composition containing cefmenoxime hydrochloride, sodium carbonate and ethylenediamine. The medicinal composition is obtained by a screening test, and dissolution speed tests, clarity and medicine stability tests indicate that a powder injection prepared from the medicinal composition is high in re-dissolution speed and has qualified clarity and small content of impurities and cefmenoxime polymer and high quality.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition containing cefmenoxime hydrochloride as an active ingredient. Background technique [0002] Cefmenoxime hydrochloride, chemical name: (6R, 7R)–7-[(Z)–2–(2-amino-4-thiazolyl)-2-methoxyiminoacetamido]-3-[[[1 -Methyl-1H-tetrazol-5-yl]-thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid Hydrochloride (2:1). [0003] Chemical Structure: [0004] [0005] Molecular formula: (C 16 h 17 N 9 o 5 S 3 ) 2 HCl [0006] Molecular weight: 1059.58 [0007] Cefmenoxime hydrochloride is the third-generation cephalosporin developed by Takeda Pharmaceutical Co., Ltd. in Japan. It has antibacterial effects on both Gram-negative and positive aerobic and anaerobic bacteria. It has the same antibacterial effect as other third-generation cephalosporins. Very strong antibacterial activity. Among Gram-negative bacteria, the ant...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/546A61K47/02A61K47/18A61P31/04
Inventor 芦红代
Owner ZHEJIANG WHITESON PHARMA
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