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Ceftriaxone sodium powder-injection for injection

A technology for ceftriaxone sodium and injection, which is applied in the field of medicine, can solve problems such as instability, inclusions, and residual solvents, and achieve the effects of high stability, less impurities, and less residual solvents

Active Publication Date: 2015-09-02
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The stability of ceftriaxone sodium is relatively poor, and it is unstable to heat, acidic environment, and alkaline environment. It is manifested in problems such as easy discoloration of appearance, lower content, and occurrence of degradation products. The reason for the occurrence may be that some impurities, Reasons such as residual solvent in the crystal form

Method used

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  • Ceftriaxone sodium powder-injection for injection
  • Ceftriaxone sodium powder-injection for injection
  • Ceftriaxone sodium powder-injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] (1) Accurately weigh 30g of crude ceftriaxone sodium at 20℃, add 50mL of distilled water, start stirring, and completely dissolve in about 10-15 minutes, then add 3g of activated carbon, decolorize for 30 minutes, filter, and use 60ml volume The mixed solvent with a ratio of (acetone:water=3:1) washes the filter residue and the filter bottle twice, and the filtrate enters the crystallization bottle.

[0029] (2) Add the eluent acetone at a stirring speed of 300 revolutions / min at 15℃:

[0030] Time (min)

[0031] (3) After the crystallization is completed, perform suction filtration, wash the filter cake with 20ml*3 times of acetone, put the filter cake in a vacuum drying oven, the temperature of the vacuum drying oven is 40 ℃, vacuum drying, weighing, and packaging.

Embodiment 2

[0033] (1) Accurately weigh 30g of crude ceftriaxone sodium at 20℃, add 50mL of distilled water, start stirring, and completely dissolve in about 10-15 minutes, then add 3g of activated carbon, decolorize for 30 minutes, filter, and use 60ml The mixed solvent with a ratio of (acetone: water = 2:1) washes the carbon and the filter flask twice, and the filtrate enters the crystallization flask.

[0034] (2) Add the eluent acetone at a stirring speed of 300 revolutions / min at 15℃:

[0035] Time (min)

[0036] (3) Filter, wash and dry. After the crystallization is completed, perform suction filtration. Wash the filter cake with 20ml*3 times of acetone, and put the filter cake in a vacuum drying oven. The temperature of the vacuum drying oven is 35℃, vacuum drying, weighing, and packaging .

Embodiment 3

[0038] (1) Accurately weigh 30g of crude ceftriaxone sodium at 20℃, add 50mL of distilled water, start stirring, and completely dissolve in about 10-15 minutes, then add 3g of activated carbon, decolorize for 30 minutes, filter, and use 60ml volume The mixed solvent with a ratio of (acetone:water=2:1) ​​washes the filter residue and the filter bottle twice, and the filtrate enters the crystallization bottle.

[0039] (2) Add the eluent acetone at a stirring speed of 300 revolutions / min at 15℃:

[0040] Time (min)

[0041] (3) After the crystallization is completed, perform suction filtration, wash the filter cake with 20ml*3 times of acetone, and put the filter cake in a vacuum drying oven with a temperature of 35°C, vacuum drying, weighing, and packaging.

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PUM

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Abstract

The invention discloses a ceftriaxone sodium powder-injection for injection. the powder-injection is prepared by the following steps: (1) weighing a ceftriaxone sodium crude raw material at 20 DEG C, adding water, stirring and dissolving, adding active carbon, decolouring, filtering, and washing with mixed solvents; (2) by a particle process crystal product molecular assembly and shape-state optimization technology of North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd., adding a solventing-out agent acetone according to a stream acceleration table at 15 DEG C at the stirring speed of 300 r / min; (3) carrying out suction filtration, washing a filter cake with acetone, putting the filter cake into a vacuum drying oven and carrying out vacuum drying at 30-40 DEG C; and (4) sub-packaging preparations of different specifications, and controlling environmental temperature and humidity until temperature is 20-24 DEG C and humidity is less than 40% so as to obtain the ceftriaxone sodium for injection. In comparison with a traditional technology, ceftriaxone sodium prepared by the above preparation method has advantages of less impurity, high stability and the like.

Description

Technical field [0001] The invention relates to a ceftriaxone sodium powder injection for injection, belonging to the technical field of medicine. Background technique [0002] Ceftriaxone sodium, also known as ceftriaxone, is a new, long-acting, broad-spectrum third-generation semi-synthetic cephalosporin. It belongs to the β-lactam antibiotics and exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls. It has strong antibacterial activity against most gram-positive and negative bacteria. The antibacterial spectrum includes Pseudomonas aeruginosa, Escherichia coli, Pneumoniae, Haemophilus influenzae, Enterobacter aerogenes, Proteus, Dicoccus and Staphylococcus aureus Wait. It is mainly used clinically for meningitis, pneumonia, skin and soft tissue infections, peritonitis, urinary system infections, gonorrhea, liver and gallbladder infections, surgical trauma, sepsis and genital infections. [0003] Ceftriaxone Sodium Molecular Formula C 18 H 16 N 8 Na ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546A61P31/04
Inventor 贾全张文胜张剑楠刘树林蒋晓声张锁庆董伟昌魏宝军马亚松田洪年张立斌姜莉莉傅翠连
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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