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Refining process for crude product of ceftriaxone sodium

A ceftriaxone sodium and process technology, applied in the field of preparing ceftriaxone sodium fine products, can solve the problems of a large amount of process solvent, rapid product color change, low product yield, etc., and achieve a reduction in the amount of solvent used and low production cost. , the effect of poor solvent toxicity

Inactive Publication Date: 2008-10-22
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For the refined preparation of the existing ceftriaxone sodium crude product, most of the eluents selected are acetone mixed solvent, and the crystals are separated out with the acetone mixed solvent. The cost is high, the product yield is low, and the color of the product changes quickly

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The refining technique of ceftriaxone sodium of the present invention, is recorded as follows by operation time:

[0035] (1) Weigh 30 g of crude Trixone Sodium, add 50 ml of water and stir to dissolve for 10 min; add 4 g of activated carbon to decolorize for about 20 min.

[0036] (2) vacuum filter the above solution. First use filter paper to filter out activated carbon, and then use membrane filter to remove tiny impurities. During the filtration process, wash the filter bottle and filter cake with 50 ml of water-isopropanol solution with a volume ratio of 1:1, and pour the washing liquid into the crystallizer together.

[0037] (3) After controlling the solution in the crystallizer to reach the temperature in the water bath, start adding an appropriate amount of dissolution agent dropwise, add the seed crystal after the solution reaches the metastable zone, and continue to add isopropanol dropwise after growing the crystal for 30 minutes, and add isopropyl alcohol ...

Embodiment 2

[0041] The refining technique of ceftriaxone sodium of the present invention, is recorded as follows by operation time:

[0042] (1) Weigh 30 g of crude Trixone Sodium, add 50 ml of water and stir to dissolve for 10 min; add 4 g of activated carbon to decolorize for about 20 min.

[0043] (2) vacuum filter the above solution. First use filter paper to filter out activated carbon, and then use membrane filter to remove tiny impurities. During the filtration process, wash the filter bottle and filter cake with 50 ml of water-isopropanol solution with a volume ratio of 1:1, and pour the washing liquid into the crystallizer together.

[0044] (3) After controlling the solution in the crystallizer to reach the temperature in the water bath, start adding an appropriate amount of dissolution agent dropwise, add the seed crystal after the solution reaches the metastable zone, and continue to add isopropanol dropwise after growing the crystal for 30 minutes, and add isopropyl alcohol ...

Embodiment 3

[0048] The refining technique of ceftriaxone sodium of the present invention, is recorded as follows by operation time:

[0049] (1) Weigh 30 g of crude Trixone Sodium, add 50 ml of water and stir to dissolve for 10 min; add 4 g of activated carbon to decolorize for about 20 min.

[0050] (2) vacuum filter the above solution. First use filter paper to filter out activated carbon, and then use membrane filter to remove tiny impurities. During the filtration process, wash the filter bottle and filter cake with 50 ml of water-isopropanol solution with a volume ratio of 1:1, and pour the washing liquid into the crystallizer together.

[0051] (3) After controlling the solution in the crystallizer to reach the temperature in the water bath, start adding an appropriate amount of dissolution agent dropwise, add the seed crystal after the solution reaches the metastable zone, and continue to add isopropanol dropwise after growing the crystal for 30 minutes, and add isopropyl alcohol ...

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PUM

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Abstract

The invention relates to an art for refining a ceftriaxone sodium crude product, which includes the following steps: the ceftriaxone sodium crude product is put into injection water to dissolve till clarification; the insoluble organic solvent of the ceftriaxone sodium is added after the solution is sterilized and filtered; then an aseptic ceftriaxone sodium crystal seed is added, and a crystal nourishing treatment is carried out after a crystal is precipitated; the insoluble organic solvent of the ceftriaxone sodium is added continuously; and finally the ceftriaxone sodium finished product is obtained after normal crystallization, washing and drying. The art for refining the ceftriaxone sodium crude product is characterized in that: the insoluble organic solvent of the ceftriaxone sodium is isopropanol. By adopting a single isopropanol solvent, the art for refining the ceftriaxone sodium crude product reduces the use amount of the solvent sharply, which is 57 percent of the former art, and has the advantages of convenient operation, easy control, short production cycle (shortened by 4 hours compared with the former art), low labor strength, low production cost, and stable color which is weaker than the color of the mixed solvent crystal by 0.5 to 1 size. Meanwhile, the art for refining the ceftriaxone sodium crude product can improve the production yield by 2 percent with the yield being 98 percent, and reduces the damage of the solvent to the operators owing to the weak solvent toxicity.

Description

technical field [0001] The invention relates to a process for refining crude ceftriaxone sodium, which is used for preparing fine ceftriaxone sodium. Background technique [0002] Ceftriaxone sodium is the third-generation broad-spectrum cephalosporin, which is widely used in respiratory tract infections and urinary system infections sensitive to this product, including pyelonephritis and gonorrhea, sepsis, meningitis, burn infection, postoperative infection, bone and joint, Soft tissue, skin and wound infection, abdominal infection (peritonitis, bile duct and gastrointestinal tract infection), etc., and infection prevention during surgery. The refinement of crude products usually adopts the method of dissolution and crystallization. Solventing-out refers to adding a certain solvent to reduce the solubility of the solute dissolved in water or other organic solvents, forming a supersaturated solution and crystallization. Method, its mechanism is: the solute is first dissolve...

Claims

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Application Information

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IPC IPC(8): C07D501/36
Inventor 赵玉山苗得足王龙科孔霁红吕含富
Owner REYOUNG PHARMA
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