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Preparation method of ceftriaxone sodium powder preparation for injection

A technology for ceftriaxone sodium and injection, applied in the field of medicine, can solve problems such as poisoning of production operators and surrounding environment, reduce product purity, aggravate side effects, etc., and achieve the effects of not easy oxidative degradation, good crystal fluidity, and improved quality

Active Publication Date: 2018-12-18
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the 3,4-difluorobenzonitrile used in the operation process of this method is an irritating substance, and dichloromethane is an animal carcinogenic solvent, which has a toxic effect on production operators and the surrounding environment.
[0008] Patent literature CN104370941A discloses a preparation method of ceftriaxone sodium for injection. The method is to dissolve the crude product of ceftriaxone sodium with sterile water, which easily leads to the degradation of ceftriaxone sodium, thereby reducing the purity of the product and causing color grade Elevated, and will aggravate the occurrence of side effects and reduce the efficacy of the drug

Method used

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  • Preparation method of ceftriaxone sodium powder preparation for injection
  • Preparation method of ceftriaxone sodium powder preparation for injection
  • Preparation method of ceftriaxone sodium powder preparation for injection

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preparation example Construction

[0029] A preparation method of ceftriaxone sodium powder preparation for injection, comprising the following steps:

[0030] A. First add the mixed solution of solvent a and water to the reaction tank 1, control the temperature in the reaction tank 1 to be 5-10°C, stir and add the crude product of ceftriaxone sodium and stabilizer until the dissolution is complete, then add the decolorizing agent and filter aid, filter after decolorization to obtain filter cake and filtrate, and finally wash the filter cake with mixed solution to obtain lotion, and the lotion and filtrate are combined to obtain the crude product solution of ceftriaxone sodium, which is then transferred to reaction tank 2; wherein solvent a is methanol or Any one of ethanol, the volume of solvent a in milliliters, the volume of water in milliliters and the weight in grams of crude ceftriaxone sodium are in a ratio of 1 to 2:10 to 20:5; the stabilizer is sodium sulfite and sodium bisulfite Or any one in citric aci...

Embodiment 1

[0047] A preparation method of ceftriaxone sodium powder preparation for injection, comprising the following steps:

[0048] A. Add a mixed solution consisting of 2mL of methanol and 20mL of water to the reaction tank 1, stir well, reserve 2mL of the mixed solution as a washing solution, control the temperature of the reaction tank 1 at 5°C to 6°C, stir and add 0.1g of sodium sulfite and ceftriaxone sodium Crude product 10g is dissolved completely; Add activated carbon 0.5g, filter aid perlite 0.5g, filter after 0.5h of decolorization, wash the filter cake with 2mL lotion, the lotion and filtered filtrate are combined to be ceftriaxone sodium crude product solution, Then transfer to reaction tank 2;

[0049] B. Add 100 mL of acetone to the crystallization tank, control the temperature of the crystallization tank at 15°C to 16°C, control the stirring speed at 150 to 160 rpm, and add the crude ceftriaxone sodium solution in the reaction tank 2 dropwise; add the drop rate accordi...

Embodiment 2

[0058] A preparation method of ceftriaxone sodium powder preparation for injection, comprising the following steps:

[0059] A. Add a mixed solution consisting of 8mL of ethanol and 80mL of water to the reaction tank 1, stir well, reserve 8mL of the mixed solution as a washing liquid, control the temperature of the reaction tank 1 at 9°C to 10°C, stir and add 1g of sodium bisulfite, cephalosporin Trixone sodium crude product 20g to dissolve; Add activated carbon 2g, filter aid diatomite 2g, filter after decolorization 1h, wash the filter cake with 8mL washing liquid, the washing liquid and the filtrate obtained by filtering are combined to be ceftriaxone sodium crude product solution, Then transfer to reaction tank 2;

[0060] B. Add 400 mL of acetonitrile to the crystallization tank, control the temperature of the crystallization tank at 24°C to 25°C, control the stirring speed at 190 to 200 rpm, and add the crude ceftriaxone sodium solution in the reaction tank 2 dropwise; a...

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Abstract

Belonging to the technical field of medicine, the invention discloses a preparation method of a ceftriaxone sodium powder preparation for injection. The method includes: firstly adding a first batch of a solvent b into a crystallization tank during crystallization treatment, then slowly adding a crude ceftriaxone sodium solution into the crystallization tank, and then adding a second batch of thesolvent b; wherein the solvent b is any one of acetone, acetonitrile or isopropanol. The preparation process adopted by the invention is simple, and can effectively improve the product quality. The obtained product ceftriaxone sodium crystal has good flowability, is easy for subpackaging and stable in quality, and the color grade, clarity and purity of the product are also improved.

Description

technical field [0001] The invention relates to a preparation method of medicines, in particular to a preparation method of antibiotics, and belongs to the technical field of medicines. Background technique [0002] Ceftriaxone Sodium (Ceftriaxone Sodium) is a national essential drug, its chemical name is: (6R,7R)-7-[[(2Z)-(2-aminothiazol-4-yl)(methoxyimino)acetyl Base]amino]-3-[[(2-methyl-6-hydroxy-5-oxo-2,5-dihydro-1,2,4-triazin-3-yl)thio]methyl] -8-Oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid disodium salt triple hemihydrate. The structural formula is as follows: [0003] [0004] Ceftriaxone sodium was created by the Swiss Roche (Roche) company. It is an antibiotic with long-acting effects among the third-generation cephalosporins. It has a long half-life, is stable to β-lactamase, and has strong tissue penetration ability. It is synthesized and has bactericidal activity against a wide range of Gram-negative and Gram-positive bacteria. This is the onl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K47/10A61K47/02A61K47/12A61K47/04A61K31/546A61P31/04
CPCA61K9/0019A61K9/143A61K9/145A61K31/546A61P31/04
Inventor 任峰贾全张锁庆田洪年刘树斌魏宝军于亚南贾金焕张素霞
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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