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Cefditoren sodium containing-pharmaceutical composition

A technology of cefditoren sodium and its composition, which is applied in the field of pharmaceutical compositions containing cefditoren sodium, can solve the problems of low concentration and poor dissolution effect, and achieve the effects of increasing concentration, improving solubility, and good solubilization

Active Publication Date: 2014-06-18
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The object of the present invention is to overcome the disadvantages of poor dissolving effect and low concentration of active ingredients of cefditoren sodium injection in the prior art, and provide a drug combination containing cefditoren sodium with good dissolving effect and higher concentration when used for preparing injections thing

Method used

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  • Cefditoren sodium containing-pharmaceutical composition
  • Cefditoren sodium containing-pharmaceutical composition
  • Cefditoren sodium containing-pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1 A pharmaceutical composition containing cefditoren sodium, consisting of 0.25 g of cefditoren sodium, 0.15 g of arginine and 0.05 g of citric acid.

[0021] The stability test of the pharmaceutical composition of this example (with reference to the 2010 "Chinese Pharmacopoeia" guidelines for the stability test of raw materials and pharmaceutical preparations): the pharmaceutical composition of this example and the raw material of cefditoren sodium were subjected to high temperature (60°C) and high temperature respectively. Wet (75%) and light test, measure cefditoren sodium content, related substances and polymer respectively after 10 days, test result is shown in Table 1 (each numerical value in Table 1 is the test number of times n≥6 of corresponding test item obtains respectively mean).

[0022] Table 1

[0023]

[0024] As can be seen from the above-mentioned stability test results, the stability of the pharmaceutical composition of this example is equ...

Embodiment 2

[0028] Example 2 A pharmaceutical composition containing cefditoren sodium, consisting of 3 g of cefditoren sodium, 1 g of arginine and 0.33 g of citric acid.

Embodiment 3

[0034] Example 3 A pharmaceutical composition containing cefditoren sodium, consisting of 0.25 g of cefditoren sodium, 0.4 g of arginine and 0.1 g of tartaric acid.

[0035] Dissolve the pharmaceutical composition of this example with 10 mL of water for injection, the concentration of the active ingredient cefditoren sodium in the injection is 0.025 g / mL, and the pH is 6.9.

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Abstract

The invention discloses a cefditoren sodium-containing pharmaceutical composition which is composed of cefditoren sodium and a cosolvent, the cosolvent is a mixture of arginine and a pharmacologically acceptable hydroxyl-containing solid organic acid, and the hydroxyl-containing solid organic acid has 4-12 carbon atoms. The cefditoren sodium-containing pharmaceutical composition compounds the hydroxyl-containing solid organic acid and the arginine to use as the cosolvent, and has a very good cosolubility, the concentration of the cefditoren sodium in an injection is improved, compared with cefditoren sodium raw material, the solubility of the cefditoren sodium-containing pharmaceutical compositioncan be as high as 554.8%; and at the same time, the stability of the cefditoren sodium-containing pharmaceutical composition is good and is equal to that of the cefditoren sodium raw material.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a pharmaceutical composition containing cefditoren sodium. Background technique [0002] Cefditoren sodium is the sodium salt of cefditoren, and cefditoren is the entity form of cefditoren pivoxil currently on the market that works in vivo. Its molecular structure is shown below. [0003] [0004] Cefditoren pivoxil (cefditoren pivoxil) is a third-generation new oral cephalosporin, developed by Japan Meiji Seika Co., Ltd., and first listed in Japan in 1994. In August 2000, cefditoren pivoxil tablets were first approved for marketing in China under the trade name "Meiike", produced by Japan's Meiji Seika and repackaged by Shantou Special Economic Zone Meiji Pharmaceutical Co., Ltd. Studies have shown that cefditoren axetil is effective in the treatment of community-acquired respiratory tract infections caused by five major pathogenic bacteria: Streptococcus pneumoniae, Haemophi...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K47/18A61K47/12A61P31/04
Inventor 李明赵忠琼梁隆王利春沈鑫程志鹏
Owner SICHUAN KELUN PHARMA CO LTD
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