Ceftriaxone sodium compound prepared by adopting supermolecular mechanism and preparation thereof

A technology of ceftriaxone sodium and its compounds, which is applied in the field of ceftriaxone sodium compounds and its preparations, and can solve the problems of poor product quality, waste of raw materials, instability between batches, etc.

Inactive Publication Date: 2017-01-11
海南顿斯医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existence of these problems leads to poor product quality and instability between batches on the one hand, and also leads to increased production costs and waste of raw materials to a certain extent.

Method used

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  • Ceftriaxone sodium compound prepared by adopting supermolecular mechanism and preparation thereof
  • Ceftriaxone sodium compound prepared by adopting supermolecular mechanism and preparation thereof
  • Ceftriaxone sodium compound prepared by adopting supermolecular mechanism and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Add 50ml of water and 15ml of N,N-dimethylformamide into a jacketed reactor, then add 15.12g of crude ceftriaxone sodium into the above mixture, stir continuously until dissolved, and then adjust the pH value with sulfuric acid 5.5. After the reaction was complete, the liquid was transferred to a jacketed crystallizer, the temperature was lowered to 22°C in a water bath, an elliptical seed crystal was added, and the crystal was grown for 3 hours. Carbon tetrachloride was slowly added to the above solution and filtered. Dissolve the above filtrate in 25ml of water, add 0.2g of activated carbon, stir and absorb for 30min, and filter. Add 100ml of acetone to the filtrate, stir until it is completely precipitated, and filter. The filtrate was washed with 25ml×2 acetone, and dried under vacuum at 40°C for 3h to obtain 14.91g of ceftriaxone sodium.

[0026] X-ray powder diffraction (XRPD) was used to study and characterize the crystalline form of ceftriaxone sodium.

[00...

Embodiment 2

[0033] Add 50ml of water and 15ml of N-methylacetamide into the jacketed reactor, then add 15.04g of crude ceftriaxone sodium into the above mixture, stir continuously until dissolved, and then adjust the pH to 5.2 with hydrochloric acid. After the reaction was complete, the liquid was transferred to a jacketed crystallizer, the temperature was lowered to 25°C in a water bath, an elliptical seed crystal was added, and the crystal was grown for 3 hours. Carbon trichloride was slowly added to the above solution and filtered. Dissolve the above filtrate in 25ml of water, add 0.2g of activated carbon, stir and absorb for 30min, and filter. Add 100ml of acetone to the filtrate, stir until it is completely precipitated, and filter. Wash the filtrate with 25ml×2 acetone, and dry it under vacuum at 35°C for 4h to obtain 14.71g of ceftriaxone sodium.

Embodiment 3

[0035] Add 50ml of water and 15ml of N,N-dimethylformamide into a jacketed reactor, then add 15.10g of crude ceftriaxone sodium into the above mixture, stir continuously until dissolved, then adjust the pH value with hydrochloric acid 6.0. After the reaction was complete, the liquid was transferred to a jacketed crystallizer, cooled to 23° C. in a water bath, and needle-shaped seed crystals were added to grow the crystals for 3 hours. Carbon tetrachloride was slowly added to the above solution and filtered. Dissolve the above filtrate in 25ml of water, add 0.2g of activated carbon, stir and absorb for 30min, and filter. Add 100ml of acetone to the filtrate, stir until it is completely precipitated, and filter; wash the filtrate with 25ml of acetone x 2, and dry it under vacuum at 35°C for 4h to obtain 14.74g of ceftriaxone sodium.

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Abstract

The invention discloses a ceftriaxone sodium compound prepared by adopting a supermolecular mechanism and a preparation thereof, namely ceftriaxone sodium for injection. The 'high-end medicine product refining crystallization technology development and industrialization project' won the second award for national scientific and technological progress in 2015, and the supermolecular mechanism belongs to one of the high-end medicine product refining crystallization technology. According to the structure of the ceftriaxone sodium, five water molecules are contained in the molecule, the crystal system is a monoclinic system, and the space group is P21 / c. The obtained ceftriaxone sodium is low in hygroscopicity, low in impurity content, good in product flowability and stability and high in dissolution rate.

Description

technical field [0001] The invention belongs to the technical field of crystallization, and in particular relates to a ceftriaxone sodium compound prepared by a supramolecular mechanism and a preparation thereof. Background technique [0002] The R&D and industrialization project of refined crystallization technology for high-end pharmaceutical products of one of the inventors, Tianjin University and Xi'an Lijun Pharmaceutical Co., Ltd., won the second prize of the 2015 National Science and Technology Progress Award. [0003] The supramolecular mechanism belongs to one of the refined crystallization technologies of high-end pharmaceutical products. It aims to break through the blockade of related pharmaceutical product crystal forms and crystallization technology patents at home and abroad. The international leading level has promoted the scientific and technological progress of my country's pharmaceutical industry. [0004] The chemical name of Ceftriaxone sodium is (6R,7R)...

Claims

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Application Information

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IPC IPC(8): C07D501/36C07D501/12A61K31/546A61P31/04A61K9/14
CPCC07D501/36A61K9/0019A61K9/14A61K31/546C07B2200/13C07D501/12
Inventor 王坤
Owner 海南顿斯医药科技有限公司
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