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Novel ceftriaxone disodium and preparation method thereof

A technology of ceftriaxone disodium and sodium alginate, which is applied in the direction of organic chemistry, can solve problems and other problems, and achieve the effects of changing stability, ensuring drug safety, and ensuring product quality

Inactive Publication Date: 2010-08-25
YIPINHONG PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to solve the existing technical problems, provide a new ceftriaxone disodium and its preparation method, solve the problem of ceftriaxone disodium injection clarity, ensure product quality, and ensure public drug safety

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] In the first step, add 80ml of dichloromethane, 10ml of ethanol, 20ml of triethylamine or diisopropylamine, and 10ml of water into a three-neck flask, stir and cool down under nitrogen protection: at a temperature of 5-7°C, add 25g of 7-ACT, 25g of AE- Active ester; stirring reaction, temperature 6-8 ° C; reaction clarification, add hydrochloric acid aqueous solution to adjust the pH to 3.5, stir for 30 minutes, add 2 g of sodium sulfate as a stabilizer, and then add 10 g of salt-forming agent sodium acetate, when the solution becomes cloudy, Adding ceftriaxone disodium powder as seed crystals and carrying out crystal growth treatment, then adding ceftriaxone disodium insoluble organic solvent dichloromethane or ethanol to precipitate crystals, and finally washing and drying conventional crystals to obtain finished products.

[0015] In the second step, during the filling process, use strong pressure nitrogen aseptic filling: vacuum degree (40-60cmHg), compressed air pre...

Embodiment 2

[0018] In the first step, add 80ml of dichloromethane, 10ml of ethanol, 20ml of triethylamine or diisopropylamine, and 10ml of water into a three-neck flask, stir and cool down under nitrogen protection: at a temperature of 5-7°C, add 25g of 7-ACT, 25g of AE- Active ester; stirring reaction, temperature 6-8°C; reaction clarification, adding hydrochloric acid aqueous solution to adjust the pH to 3.5, stirring for 30 minutes, adding 2g of sodium polyacrylate as a stabilizer, and then adding 10g of salt-forming agent sodium acetate, until the solution becomes cloudy , add ceftriaxone disodium powder as seed crystals and then carry out crystal growth treatment, then add ceftriaxone disodium insoluble organic solvent dichloromethane or ethanol to precipitate crystals, and finally process conventional crystallization washing and drying to obtain finished products .

[0019] In the second step, during the filling process, use strong pressure nitrogen aseptic filling: vacuum degree (4...

Embodiment 3

[0022] In the first step, add 80ml of dichloromethane, 10ml of ethanol, 20ml of triethylamine or diisopropylamine, and 10ml of water into a three-neck flask, stir and cool down under nitrogen protection: at a temperature of 5-7°C, add 25g of 7-ACT, 25g of AE- Active ester; stirring reaction, temperature 6-8°C; reaction clarification, adding hydrochloric acid aqueous solution to adjust the pH to 3.5, stirring for 30 minutes, adding 2g of sodium alginate as a stabilizer, and then adding 10g of salt-forming agent sodium acetate, until the solution becomes cloudy , add ceftriaxone disodium powder as seed crystals and then carry out crystal growth treatment, then add ceftriaxone disodium insoluble organic solvent dichloromethane or ethanol to precipitate crystals, and finally process conventional crystallization washing and drying to obtain finished products .

[0023] In the second step, during the filling process, use strong pressure nitrogen aseptic filling: vacuum degree (40-60...

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PUM

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Abstract

The invention provides novel ceftriaxone disodium and a preparation method thereof. The preparation method comprises the steps of: reacting7-ACT with AE-active ester in nitrogen protection, in a solvent, and under the action of an amine intermediate reactant; adding a stabilizer into the reactant; and adding a salt forming agent into the mixture to react and crystallize to prepare the ceftriaxone disodium, wherein the stabilizer is sodium sulfate, sodium polyacrylate or sodium alga acid. Meanwhile, ash residues of halogenated (brominated) butyl rubber plug on a cap are below 35 percent, and the sulfide content is lower than 8 mu g / 20cm<2>, so that the volatile component antioxidant 264 (BHT) in the butyl rubber plug is prevented from migrating to medicament from the rubber plug in a medicament storage process, medicament dissolution is reduced and clearance degree of medicament solution is reduced.

Description

technical field [0001] The invention relates to a novel ceftriaxone disodium and a preparation method thereof. Background technique [0002] Ceftriaxone Disodium (Ceftriaxone Disodium) is a third-generation cephalosporin antibiotic, used for lower respiratory tract infection, urinary tract, biliary tract infection caused by sensitive pathogenic bacteria, as well as abdominal infection, pelvic infection, skin and soft tissue infection, bone And joint infection, sepsis, meningitis, etc. and infection prevention during surgery. At present, the main problem of ceftriaxone disodium for injection sold in the market is that the solution is turbid during the preparation and use process, resulting in possible quality changes. According to the corresponding research, it is found that the main reasons for the turbidity are firstly because the quality of the medicine is unstable, and secondly because of the rubber stopper. Due to the turbidity of the solution caused by the compatibili...

Claims

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Application Information

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IPC IPC(8): C07D501/36C07D501/06
Inventor 李捍雄
Owner YIPINHONG PHARMACEUTICAL CO LTD
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