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Composition of amino-cephalosporanic acid and arginine

A technology of cephalosporanic acid and composition, applied in the field of pharmaceutical preparation, can solve the problems of poor stability, water insolubility, poor crystal form and the like

Inactive Publication Date: 2010-02-24
CHANGSHA KINGDAY BIO PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The composition of the present invention solves the problem that the active ingredient cephalosporanic acid is insoluble in water. Arginine is added as a cosolvent, which can be directly dissolved in an aqueous solution for use; Not very stable problem, can obviously improve the stability of product; The above-mentioned composition does not contain sodium ion, is suitable for special population to use; Also solved some problems that existing sodium salt preparation of above-mentioned cephalosporins specifically exists: such as cefazolin sodium, Cefnixime sodium and cefotetan disodium are prepared by freeze-drying method, the sterility or pyrogen is easy to exceed the standard, the crystal form is not good, the stability is poor, and the water content is not easy to control; the color of cefuroxime sodium solution is easy to exceed the standard; Polyester sodium needs to add a small amount of sodium carbonate, which is difficult to mix and easy to sink to the bottom.

Method used

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  • Composition of amino-cephalosporanic acid and arginine
  • Composition of amino-cephalosporanic acid and arginine
  • Composition of amino-cephalosporanic acid and arginine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1 Preparation of cefazolin acid arginine composition:

[0018] Take 35.8 kg of sterile cefazolin acid and 14.2 kg of sterile arginine in a sterile environment, put them in a mixer and mix them evenly, then discharge and pack in aluminum barrels. Then it is transferred to the aseptic preparation subpackaging workshop, and is subpackaged into antibiotic glass bottles according to the specifications to obtain the finished preparation.

[0019] The cefazolin acid arginine preparation of embodiment 1 and commercially available cefazolin sodium preparation carry out accelerated test (40 ℃ of temperature, in humidity 75% constant temperature and humidity box), according to 2005 edition " Chinese Pharmacopoeia " cefazolin for injection Method detection under the sodium item, the detection results after 1 month of the test are as follows:

[0020]

[0021] The results show that: the cefazolin acid arginine preparation of the present invention is more stable than t...

Embodiment 2

[0022] Example 2 Preparation of cefuroxime arginine composition:

[0023] Take 35.5 kg of sterile cefuroxime acid and 14.5 kg of sterile arginine in a sterile environment, put them in a mixer and mix them evenly, then discharge and pack in aluminum barrels. Then it is transferred to the aseptic preparation subpackaging workshop, and is subpackaged into antibiotic glass bottles according to the specifications to obtain the finished preparation.

[0024] The cefuroxime arginine preparation of embodiment 2, carry out accelerated test with commercially available cefuroxime sodium preparation (40 ℃ of temperature, in humidity 75% constant temperature and humidity chamber), according to 2005 edition " Chinese Pharmacopoeia " cefuroxime for injection Method detection under the sodium item, the detection results after 1 month of the test are as follows:

[0025]

[0026] The results show that: the cefuroxime arginine preparation of the present invention is more stable than the cef...

Embodiment 3

[0027] Embodiment 3 Preparation of cefamandole acid arginine composition:

[0028] Under the sterile environment, take 36.7kg of sterile cefamandole acid and 13.3kg of sterile arginine, mix them evenly in a mixer, discharge, and pack in aluminum barrels. Then it is transferred to the aseptic preparation subpackaging workshop, and is subpackaged into antibiotic glass bottles according to the specifications to obtain the finished preparation.

[0029] The cefamandole acid arginine preparation of embodiment 3, carry out accelerated test (40 ℃ of temperature, in humidity 75% constant temperature and humidity box) with commercially available cefamandole sodium, press cefamandole sodium quality standard for injection The following method is tested, and the test results after 1 month of testing are as follows:

[0030]

[0031] The result shows: cefamandole acid arginine preparation of the present invention is more stable than cefamandole sodium preparation.

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Abstract

The invention relates to a composition of amino-cephalosporanic acid and arginine, which is characterized in that amino-cephalosporanic acid in the composition comprises cefazolin acid, cefuroxime acid, cefamandole nanfate nitrosate, cefonicid acid and cefotetan acid, and one of the above amino-cephalosporanic acids is combined with arginine to obtain the composition. The invention comprises the following steps: in gnotobasis, scaling asepsis arginine and above amino-cephalosporanic acid which have suitable granularity and specific gravity according to ratio of recipe to serve as asepsis bulkdrugs; pouring the drugs into a mixer to operate according to the standard powder mixing operating instruction; after evenly mixed, discharging and slit charging. The composition of the invention solves the problems that sodium salt agent widely applied in cephems drugs specifically has poor crystal form, solution color is easily out of limits, no bacteria exist or pyrogen is not qualified, wateris hard to control, stability is poor and the like. The invention is predicted to have important clinic application value.

Description

technical field [0001] The invention relates to a group of compositions composed of cephalosporanic acid and arginine, belonging to the technical field of medicine preparation. Background technique [0002] Cephalosporin antibiotics are a class of widely used antibiotics. Cephalosporanic acid is its active ingredient, and its water solubility is generally poor, so its sodium salts such as cefazolin sodium, cefuroxime sodium, cefamandole sodium, and cephalosporins are widely used. Nixie sodium, cefotetan disodium, etc., are all hydrolyzed into cephalosporanic acid in the body to play a role. Among them, cefazolin sodium, cefuroxime sodium, and cefanixime sodium have been widely used in China, and cefotetan disodium is under development. Most of the above-mentioned varieties in China are produced by freeze-drying. [0003] Cefazolin sodium belongs to the first generation of cephalosporin antibiotics, the chemical name is (6R,7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)sulfur]meth...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K47/18A61P31/04
Inventor 周革文唐蓓
Owner CHANGSHA KINGDAY BIO PHARMA TECH
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