Preparation method of ceftriaxone sodium spherical crystals

A technology for ceftriaxone sodium and spherical crystals is applied in the field of preparation of ceftriaxone sodium spherical crystals, which can solve the problems of small particle size and poor fluidity of ceftriaxone sodium, and achieve good fluidity, improved physical properties, and single-pass yield. high effect

Active Publication Date: 2018-08-24
SHENZHEN CHINA RESOURCES GOSUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008] The object of the present invention is to overcome the above-mentioned deficiency of prior art, provide a kind of preparation method of ceftriaxone sodium spherical crystal, aim

Method used

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  • Preparation method of ceftriaxone sodium spherical crystals
  • Preparation method of ceftriaxone sodium spherical crystals
  • Preparation method of ceftriaxone sodium spherical crystals

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preparation example Construction

[0019] The embodiment of the present invention provides a kind of preparation method of ceftriaxone sodium spherical crystal, comprises the following steps:

[0020] S01: Provide ceftriaxone sodium API, bridging agent and dissolution agent;

[0021] S02: dissolving the ceftriaxone sodium bulk drug in a polar solvent to obtain a first ceftriaxone sodium solution;

[0022] S03: mixing the bridging agent with the first ceftriaxone sodium solution to obtain a second ceftriaxone sodium solution;

[0023] S04: mixing the dissolving agent with the second ceftriaxone sodium solution to precipitate spherical ceftriaxone sodium crystals.

[0024] The preparation method of spherical crystals of ceftriaxone sodium provided by the embodiments of the present invention comprises dissolving the bulk drug of ceftriaxone sodium in a polar solvent and adding a suitable bridging agent. The liquid bridging agent coalesces and directly converts the flake crystals produced by elution crystallizati...

Embodiment 1

[0036] Get 22g ceftriaxone sodium crude drug and be dissolved in 44g distilled water, add the saturated sodium chloride solution of 2g again, continue to stir for 10 minutes, filter mixed solution, remove undissolved solid, filtrate is transferred in the crystallizer, and use Wash the filter flask with 3-5ml of distilled water. Continue to add 54 g of methyl acetate into the crystallization mother liquor, mix and stir for 20 minutes, and control the temperature of the system at 15°C. After mixing completely, start to add the dissolution agent acetone dropwise, the dosage of the dissolution agent is 8 times of the raw material drug, and the dissolution agent is controlled to be added dropwise within 4 hours, and the stirring rate is controlled to be 200r / min in this process. After the dissolution agent is added dropwise, keep stirring and continue crystal growth for 1.5 hours. After the crystal growth is completed, filter and wash the filter cake with acetone solvent, and dry ...

Embodiment 2

[0038] Get 22g ceftriaxone sodium crude drug and be dissolved in 44g distilled water, add the saturated potassium chloride solution of 2g again, stir continuously 10 minutes, filter mixed solution, remove undissolved solid, filtrate is transferred in the crystallizer, and use Wash the filter flask with 3-5ml of distilled water. Continue to add 40 g of ethyl acetate solvent into the crystallization mother liquor, mix and stir for 20 minutes, and control the system temperature at 15°C. After mixing completely, start to drop dissolving agent acetone, the consumption of dissolving agent is 8 times of raw material drug, control dissolving agent dropwise within 5 hours, this process control stirring speed is 200r / min. After the dissolution agent was added dropwise, keep stirring and continue growing the crystal for 2 hours. After the crystal growth is completed, filter and wash the filter cake with acetone solvent, and dry the obtained product in a vacuum oven at 30°C for 5 hours. ...

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Abstract

The invention belongs to the technical field of pharmacy, and in particular relates to a preparation method of ceftriaxone sodium spherical crystals. The method comprises the following steps: providing ceftriaxone sodium crude drug, a bridging agent and a solventing-out agent; dissolving the ceftriaxone sodium crude drug into a polar solvent to obtain a first ceftriaxone sodium solution; mixing the bridging agent with the first ceftriaxone sodium solution to obtain a second ceftriaxone sodium solution; mixing the solventing-out agent with the second ceftriaxone sodium solution so as to separate out the ceftriaxone sodium spherical crystals. The preparation method provided by the invention is suitable for aseptic continuous operation of the actual industry, and not only simplifies the production process, has high single-pass yield and is easy in realization of industrial production, but also obtains coalesced particles with good fluidity, compressibility and stability.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a preparation method of spherical ceftriaxone sodium crystals. Background technique [0002] Ceftriaxone sodium (Ceftriaxone sodium), the chemical name is (6R,7R)-7-[[(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3- [[(1,2,5,6-Tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-5-thio Dai-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid disodium salt triple hemihydrate, the molecular formula is: C 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 O, molecular relative mass 661.59, its chemical structure formula is as follows: [0003] [0004] Ceftriaxone sodium belongs to the third-generation cephalosporin antibiotics, which has strong antibacterial activity against Gram-positive bacteria and Gram-negative bacteria. Its original research company is Roche, Switzerland, and it was first listed in Switzerland in 1982. And entered China in 1995. At present, ...

Claims

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Application Information

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IPC IPC(8): C07D501/36C07D501/12
CPCC07B2200/13C07D501/12C07D501/36
Inventor 黄乔吟陈宁高顺清黄权华苏军权
Owner SHENZHEN CHINA RESOURCES GOSUN PHARMA CO LTD
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