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Medicinal composition of cefotetan disodium

A technology of cefotetan disodium and composition, applied in the field of pharmaceutical composition of cefotetan disodium

Active Publication Date: 2010-09-29
SHENZHEN LIJIAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004]At present, due to limited raw materials or technical difficulties, the development of cephamycin antibiotics is relatively weak
The curative effect of cefotetan disodium is clinically recognized, but because cefotetan disodium salt is very unstable, it is easy to degrade when it encounters water during production, storage and use, and the related substances will increase rapidly, resulting in unqualified products. way to use, which brings great difficulties to production, storage and use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] According to the above components, the 500mg / bottle of cefotetan disodium for injection was prepared by freeze-drying technology. The specific process is: dissolving cefotetan disodium in the aqueous solution of glucose, adding activated carbon for needles and stirring, and filtering to remove the activated carbon, then performing sterile filtration, filling, and then placing it in a freeze dryer to freeze-dry to make a finished product .

[0023] After dosing according to the prescription, filter the filtrate to detect related substances, and compare it with the prescription without adding glucose. The result shows that the related substances of the filtrate after the prescription without adding glucose are 5.4%, while the related substances of adding glucose are 3.5%. Visible glucose can significantly enhance the stability of cefotetan disodium in water.

[0024] Example 2:

[0025] In this example, the specific content of each component of the pharmaceutical...

Embodiment 2

[0028] According to the above components, 500 mg / bottle of cefotetan disodium for injection was obtained by using freeze-drying technology. The specific process is: dissolving cefotetan disodium in the aqueous solution of glucose, adding activated carbon for needles and stirring, and filtering to remove the activated carbon, then performing sterile filtration, filling, and then placing it in a freeze dryer to freeze-dry to make a finished product .

[0029] After dosing according to the prescription, filter the filtrate to detect related substances, and compare it with the prescription without adding glucose. The result shows that the related substances in the filtrate after the prescription without adding glucose are 5.4%, while those with adding glucose are 3.7%. Visible glucose can significantly enhance the stability of cefotetan disodium in water.

[0030] Example 3:

[0031] In this example, the specific content of each component of the pharmaceutical composition...

Embodiment 3

[0034] According to the above components, 500 mg / bottle of cefotetan disodium for injection was obtained by using freeze-drying technology. The specific process is: dissolving cefotetan disodium in the aqueous solution of glucose, adding activated carbon for needles and stirring, and filtering to remove the activated carbon, then performing sterile filtration, filling, and then placing it in a freeze dryer to freeze-dry to make a finished product .

[0035] After dosing according to the prescription, filter the filtrate to detect related substances, and compare it with the prescription without adding glucose. The results show that the related substances in the filtrate after the prescription without adding glucose are 5.4%, while the related substances in the adding glucose are 3.2%. Visible glucose can significantly enhance the stability of cefotetan disodium in water.

[0036] Example 4:

[0037] In this example, the specific content of each component of the pharmac...

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PUM

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Abstract

The invention discloses a medicinal composition of cefotetan disodium, which comprises the cefotetan disodium, and also comprises minor ingredients; the percentage by mass of the cefotetan disodium is 50 to 99 percent; and the percentage by mass of the minor ingredients is 1 to 50 percent. The medicinal composition of the cefotetan disodium is added with the minor ingredients capable of strengthening the stability of the cefotetan disodium to inhibit the quick degradation of the cefotetan disodium when the cefotetan disodium meets water in the processes of production, storage and use and improve the stability of the cefotetan disodium, so that a high-efficiency and stable medicinal composition product of the cefotetan disodium is obtained.

Description

technical field [0001] The invention relates to a medicine, in particular to a pharmaceutical composition of cefotetan disodium for injection. Background technique [0002] At present, many cephalosporin antibiotics have been listed and widely used in clinical practice, playing an important role in the treatment of infectious diseases. But analysis, the cephalosporin antibiotics that have been listed are mostly cephalosporin (Cephalosporin) class. From the first generation of cephalexin and cefadroxil to the new generation of cefotaxime, ceftriaxone, cefpirome, etc., although each generation of cephalosporin antibiotics has its own characteristics, the common deficiency of these antibiotics is the The β-lactamase produced by some bacteria is unstable, so the treatment effect on infections caused by some strains that can produce β-lactamase is affected. Since the discovery of Cephamycin C (Cephamycin C) in Streptomyces (S.Lactamdurans), some cephamycin antibiotic drugs have...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/10A61K31/546A61P31/04A61K47/02A61K47/26
Inventor 杨鹏博宋珊珊何成光陈茂胜褚广武张超
Owner SHENZHEN LIJIAN PHARM CO LTD
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