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Cefotiam-hydrochloride-containing medicine preparation and preparation method thereof

A technology of cefotiam hydrochloride and pharmaceutical preparations, which is applied in the field of preparation of pharmaceutical preparations, can solve the problems of high sodium carbonate content, achieve the effects of less dosage, avoid alkalosis, and expand the scope of use

Inactive Publication Date: 2012-12-19
SHANGHAI NEW ASIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The technical problem to be solved by the present invention is to provide a pharmaceutical preparation containing cefotiam hydrochloride, which has a lower sodium carbonate content, so that its quality is stable Controllable, less adverse reactions and simple process

Method used

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  • Cefotiam-hydrochloride-containing medicine preparation and preparation method thereof
  • Cefotiam-hydrochloride-containing medicine preparation and preparation method thereof
  • Cefotiam-hydrochloride-containing medicine preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1 injection cefotiam hydrochloride

[0039] prescription:

[0040]

[0041] The preparation process is as follows:

[0042] Bottle washing: The glass bottle is first washed with ultrasonic waves, then washed with purified water, washed with water for injection, rinsed with compressed air, and finally sterilized in a tunnel oven to remove pyrogens.

[0043] Washing, drying and sterilization of rubber stoppers: wash the rubber stoppers with purified water and water for injection respectively, then steam sterilize and dry with hot air for later use.

[0044] Powder mixing: After mixing the proportioned cefotiam hydrochloride, anhydrous sodium carbonate and arginine in a mixer, samples are taken for intermediate inspection.

[0045] Packing: Aseptically pack the mixed powder into vials according to the results of the intermediate test, cap and crimp the cap.

Embodiment 2

[0046] Embodiment 2 injection cefotiam hydrochloride

[0047] prescription:

[0048]

[0049] The preparation process is as follows:

[0050]Bottle washing: The glass bottle is first washed with ultrasonic waves, then washed with purified water, washed with water for injection, rinsed with compressed air, and finally sterilized in a tunnel oven to remove pyrogens.

[0051] Washing, drying and sterilization of rubber stoppers: wash the rubber stoppers with purified water and water for injection respectively, then steam sterilize and dry with hot air for later use.

[0052] Powder mixing: After mixing the proportioned cefotiam hydrochloride, anhydrous sodium carbonate and arginine in a mixer, samples are taken for intermediate inspection.

[0053] Packing: Aseptically pack the mixed powder into vials according to the results of the intermediate test, cap and crimp the cap.

Embodiment 3

[0054] Embodiment 3 injection cefotiam hydrochloride

[0055] prescription:

[0056]

[0057] The preparation process is as follows:

[0058] Bottle washing: The glass bottle is first washed with ultrasonic waves, then washed with purified water, washed with water for injection, rinsed with compressed air, and finally sterilized in a tunnel oven to remove pyrogens.

[0059] Washing, drying and sterilization of rubber stoppers: wash the rubber stoppers with purified water and water for injection respectively, then steam sterilize and dry with hot air for later use.

[0060] Subpackaging: Aseptically subpackage the proportioned cefotiam hydrochloride, anhydrous sodium carbonate and arginine respectively into vials, cap and crimp the cap.

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PUM

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Abstract

The invention discloses a cefotiam-hydrochloride-containing medicine preparation which is composed of an active component cefotiam hydrochloride, basic amino acid, and anhydrous sodium carbonate. The weight ratio of cefotiam hydrochloride (calculated according to cefotiam) to basic amino acid to anhydrous sodium carbonate is 1:0.4-0.6:0.05-0.15. A preparation method provided by the invention is substantially advantaged in that: (1) vacuum pumping is not needed after product sub-packaging, such that processes are reduced; (2) when the medicine is dissolved, the generation of a large amount of carbon dioxide is prevented, such that the danger for cefotiam medicine liquid to be sprayed from a bottle is avoided; (3) when the cefotiam preparation is diluted into various fluid replacements (including glucose solutions, electrolyte solutions or amino acid preparations), the amount of generated carbon dioxide is extremely low, such that clarity observation of intravenous infusion is not affected; (4) the dosage of anhydrous sodium carbonate is low, such that the possibility of alkalosis is avoided; and (5) the dosage of sodium ions is reduced, such that the preparation is suitable for patients with cardiac or renal insufficiency, edema patients, neonates, pregnant women, and the aged. Therefore, the application scope of the preparation is expended.

Description

technical field [0001] The invention relates to a pharmaceutical preparation containing cefotiam hydrochloride, which is used for treating infection, belongs to the field of pharmaceutical preparations, and also relates to a preparation method of the pharmaceutical preparation containing cefotiam hydrochloride. Background technique [0002] Cephalosporins, also known as cephalosporins, are a class of broad-spectrum semi-synthetic antibiotics. The first cephalosporins came out in the 1960s. At present, there are more than 60 varieties on the market, and the output accounts for more than 60% of the antibiotic production in the world. Compared with penicillin, cephalosporin has the advantages of wider antibacterial spectrum, resistance to penicillinase, high curative effect, low toxicity, and less allergic reaction, and occupies a very important position in anti-infection therapy. [0003] The chemical name of cefotiam hydrochloride is: (6R-trans)-7-[[(2-amino-4-thiazolyl)acety...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546A61K47/18A61P31/04
Inventor 黄君勤袁晖郑玉林张晓航商鼎初秀海尹大全
Owner SHANGHAI NEW ASIA PHARMA
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