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Composition of cefotetan acid and sodium citrate

A technology of cefotetan acid and sodium citrate, which is applied in the direction of drug combination, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of high side effects and allergic reactions, ineffective removal of impurities, Secondary injury of patients and other problems, to achieve the effect of low side reaction and allergy rate, excellent water solubility, and improve product quality

Inactive Publication Date: 2012-07-25
国药集团致君(苏州)制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the past, cefotetan disodium used a freeze-drying process, and the freeze-drying process has no crystallization process, no crystal form, and impurities cannot be effectively removed, and must be freeze-dried at a higher pH value, which is unstable and has high impurity content. During clinical use, the side effects and allergic reactions are relatively high, and it is easy to cause secondary harm to patients

Method used

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  • Composition of cefotetan acid and sodium citrate
  • Composition of cefotetan acid and sodium citrate
  • Composition of cefotetan acid and sodium citrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Preparation of powder injection from the composition of cefotetan acid and sodium citrate: in the aseptic ingredient workshop, weigh 50 kg of cefotetan acid and sodium citrate aseptic raw materials according to the proportioning scheme in Table 1, and pour them into the high-efficiency three-dimensional In the motion mixer, set the rotation speed of the three-dimensional powder mixer to 5 rpm, start the powder mixing operation according to the powder mixing packaging standard operating procedures, mix for 60 minutes to 90 minutes until the mixture is uniform, discharge, and pack to obtain powder injections.

[0020] The samples of each ratio were taken to detect the pH value of each sample, and then water for injection was used to prepare a liquid medicine with a concentration for routine infusion of the human body, and the water solubility of each sample solution was tested. The specific experimental results are shown in Table 1.

[0021] The pH value and water-soluble ...

Embodiment 2

[0024] Example 2 Stability Study of Cefotetan Acid and Sodium Citrate Composition

[0025] According to the long-term test (3 months) and the accelerated test (3 months) test operation standard of the drug registration standard, the stability of the cefotetan acid and sodium citrate compositions of the above groups of 2, 4, 5 and 7 is detected , and compared with single cefotetan disodium. Wherein cefotetan acid and the related substance that is transformed into by cefotetan acid adopt high performance liquid chromatography (HPLC) to detect, use waters2487 type high performance liquid chromatography, with octadecylsilane bonded silica gel as packing column; Acetonitrile-methanol-0.1mol / l potassium dihydrogen phosphate-glacial acetic acid (105:105:1200:100) is the mobile phase; the detection wavelength is 254nm. The number of theoretical plates calculated based on the peak of cefotetan disodium should not be less than 2000. The specific experimental results are shown in Table...

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Abstract

The invention discloses a composition with an antibacterial action. The composition is composed of cefotetan acid and sodium citrate and is combined by sterile powders of cefotetan acid and sodium citrate, and sodium citrate is taken as a cosolvent of cefotetan acid, so that the water solubility of cefotetan acid can be effectively improved, the defect that cefotetan acid is inconvenient to use in clinical application can be overcome, cefotetan acid can well play the antibacterial action, the composition obtained by proportioning cefotetan acid and sodium citrate has good stability, the prepared sterile mixed powder of cefotetan acid and sodium citrate can be stored for a long time, antibacterial active ingredient cefotetan acid has a stable structure, impurities with toxic and side effects cannot be produced, and the occurrence rate of side reaction and allergic condition is effectively reduced, thus the composition disclosed by the invention has vitally important social significance.

Description

technical field [0001] The invention relates to a composition, in particular to a composition of antibiotic cefotetan acid and sodium citrate. Background technique [0002] Cefotetan disodium (Cefotetan disodium) was first developed by Japan Fujisawa Company in 1979, the product of Japan Yamanouchi Company It was approved to be listed in Japan in 1993. Astra's product of the same name was approved by the FDA in 2003 for listing in the United States. This product has not been produced or imported in China. The chemical name of cefotetan disodium is: [6R-(6α,7α)]-7-[[[4-(2-amino-1-carboxy-2-oxoethylene)-1,3-dithiophene -2-yl]carbonyl]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxidation-5-thio-1 - Azabicyclo[4,2,0]oct-2-ene-2-carboxylic acid disodium salt. The structural formula is as follows: [0003] [0004] Its active ingredient is cefotetan acid, but because of its low polarity and poor water solubility, it is convenient to use clinically, and its s...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K47/12A61P31/00
Inventor 杨磊史利军胡朝新冯晓燕
Owner 国药集团致君(苏州)制药有限公司
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