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Medicament composition of cefotiam hydrochloride and preparation thereof

A technology for cefotiam hydrochloride and pharmaceutical preparations, applied in the field of pharmaceutical compositions, can solve problems such as unfavorable use, inability to store for a long time, etc., and achieve the effects of low side effects, stable product quality, and overcoming foam

Inactive Publication Date: 2009-10-21
汪娟
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Cefotiam hydrochloride is not absorbed when taken orally. The product of cefotiam hydrochloride currently on the market is the injection powder of cefotiam hydrochloride containing anhydrous sodium carbonate. Since this product uses anhydrous sodium carbonate, when using due to the formation of CO 2 , and a large number of bubbles are produced, which is not conducive to the use of the product. At the same time, during the dissolution process, the solution of the drug turns yellow quickly, the active ingredient decomposes quickly, and cannot be stored for a long time after dissolution; in addition, the product also has serious Adverse reactions, such as serious irritation to patients, causing vascular pain, thrombophlebitis and other reactions

Method used

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  • Medicament composition of cefotiam hydrochloride and preparation thereof
  • Medicament composition of cefotiam hydrochloride and preparation thereof
  • Medicament composition of cefotiam hydrochloride and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Cefotiam Hydrochloride 250g

[0034] Arginine 72.76g

[0035]

[0036] A total of 1000 bottles were made

[0037] Preparation Process:

[0038]Bottle washing: take the qualified vials, put them neatly in the stainless steel turntable, and transfer to the bottle washing station. Rinse with purified water and water for injection in turn, blow off residual moisture with compressed air, and enter a 350°C tunnel oven for drying, sterilization, and cooling. Go to the subpackaging station, and the mixture of cefotiam hydrochloride and arginine is subpackaged into 1000 bottles.

[0039] Plug washing: Take the qualified chlorinated butyl rubber plug, remove the inner and outer packaging, pour it into the cleaning tank, rinse it with purified water for 20 minutes, then rinse it with water for injection for 20 minutes, dry it in a drying oven, and sterilize it at 122 °C for a period of time 40 minutes.

[0040] Sterilization of alu...

Embodiment 2

[0046] Cefotiam Hydrochloride 250g

[0047] Arginine 1455g

[0048]

[0049] A total of 1000 bottles were made

[0050] Preparation process: the preparation method is the same as in Example 1.

Embodiment 3

[0052] Cefotiam Hydrochloride 250g

[0053] Arginine 727.6g

[0054]

[0055] A total of 1000 bottles were made

[0056] Preparation process: the preparation method is the same as in Example 1.

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PUM

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Abstract

The invention discloses medicament composition and a preparation thereof, in particular the medicament composition for injection consisting of the cefotiam hydrochloride and a basic amino acid and the preparation thereof. The invention not only overcomes the technical defects that the product in the prior art is easy to generate foams in clinical use, and has more stable product quality and lower side effect.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a pharmaceutical composition of cefotiam hydrochloride and a preparation thereof. Background technique [0002] The chemical name of cefotiam hydrochloride is: (6R,7R)-7-[[(2-amino-4-thiazolyl)acetyl]amino]-3-[[1-[2-(dimethylamino)ethyl ]-1H-tetrazol-5-yl]thiomethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid dihydrochloride Salt. Chemical Structure: [0003] [0004] Molecular formula: C 18 h 23 N 9 o 4 S 3 · 2HCl; molecular weight: 598.54. [0005] Cefotiam hydrochloride is a second-generation cephalosporin with broad antibacterial activity against both Gram-negative and Gram-positive bacteria. Especially against Escherichia coli, Klebsiella, Proteus mirabilis, influenza bacillus, etc., it shows stronger antibacterial activity. It also shows good antibacterial activity against intestinal bacteria, Citrobacter, indole-positive Proteus vulgaris, Proteu...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/19A61K31/546A61K47/18A61P31/04
Inventor 汪娟
Owner 汪娟
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