A kind of ceftriaxone sodium powder injection preparation and preparation method thereof

A technology for ceftriaxone sodium and injection, which is applied in the field of medicine, can solve problems such as slow dissolution rate, instability, and content reduction, and achieve the effects of product quality improvement, stability improvement, and good solubility

Active Publication Date: 2020-11-24
石药集团中诺药业(石家庄)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Ceftriaxone sodium has poor stability and is unstable to heat, acidic environment, and alkaline environment, and problems such as content reduction and impurity increase will occur
Patent CN201510104263.1 discloses a ceftriaxone sodium powder injection for injection and its preparation method. The ceftriaxone sodium powder for injection obtained by adopting the key production technology of new coupled crystallization has excellent hydrodynamic properties and perfect crystal shape. The particle size distribution is uniform, and the color grade, clarity, purity and stability have been improved, but it is not ideal, and when the injection product is configured into a solution, the dissolution rate is slow, which is not conducive to clinical application

Method used

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  • A kind of ceftriaxone sodium powder injection preparation and preparation method thereof
  • A kind of ceftriaxone sodium powder injection preparation and preparation method thereof
  • A kind of ceftriaxone sodium powder injection preparation and preparation method thereof

Examples

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Effect test

Embodiment 1

[0051] Embodiment 1 prepares ceftriaxone sodium powder injection preparation for injection (0.25g / bottle) of the present invention

[0052] Preparation:

[0053] Step 1: Take 40g of sodium hyaluronate, dissolve it in 6L of distilled water with slow stirring, perform ultrasonic oscillation at 20 kHz for 30 minutes, and 30 kHz for 1 hour, and cool to room temperature to obtain a sodium hyaluronate solution ,spare;

[0054] Step 2: Weigh 1000 g of crude ceftriaxone sodium raw material, add 2 L of distilled water, stir to dissolve, add 4-6% activated carbon to depyrogenate and impurity, stir for 30 minutes, and filter through a microporous membrane to obtain a filtrate;

[0055] Step 3: Add 20% of the sodium hyaluronate solution prepared in step 1 to the filtrate obtained in step 2, stir slowly at 30 rpm for 15 minutes, then add 38% of the sodium hyaluronate solution prepared in step 1, 40 rpm After stirring slowly for 35 minutes, add 26% of the sodium hyaluronate solution prepa...

Embodiment 2

[0059] Embodiment 2 prepares ceftriaxone sodium powder injection preparation for injection (0.5g / bottle) of the present invention

[0060] Preparation:

[0061] Step 1: Take 35g of sodium hyaluronate, dissolve it in 6L of distilled water with slow stirring, perform ultrasonic oscillation at 20 kHz for 30 minutes, and 30 kHz for 1 hour, and cool to room temperature to obtain a sodium hyaluronate solution ,spare;

[0062] Step 2: Weigh 1000 g of crude ceftriaxone sodium raw material, add 2 L of distilled water, stir to dissolve, add 4-6% activated carbon to depyrogenate and impurity, stir for 30 minutes, and filter through a microporous membrane to obtain a filtrate;

[0063] Step 3: Add 20% of the sodium hyaluronate solution prepared in step 1 to the filtrate obtained in step 2, stir slowly at 30 rpm for 15 minutes, then add 38% of the sodium hyaluronate solution prepared in step 1, 40 rpm After stirring slowly for 35 minutes, add 26% of the sodium hyaluronate solution prepar...

Embodiment 3

[0067] Embodiment 3 prepares ceftriaxone sodium powder injection preparation for injection (1.0g / bottle) of the present invention

[0068] Preparation:

[0069] Step 1: Take 45g of sodium hyaluronate, dissolve it in 6L of distilled water with slow stirring, perform ultrasonic oscillation at 20 kHz for 30 minutes, and 30 kHz for 1 hour, and cool to room temperature to obtain sodium hyaluronate solution ,spare;

[0070] Step 2: Weigh 1000 g of crude ceftriaxone sodium raw material, add 2 L of distilled water, stir to dissolve, add 4-6% activated carbon to depyrogenate and impurity, stir for 30 minutes, and filter through a microporous membrane to obtain a filtrate;

[0071] Step 3: Add 20% of the sodium hyaluronate solution prepared in step 1 to the filtrate obtained in step 2, stir slowly at 30 rpm for 15 minutes, then add 38% of the sodium hyaluronate solution prepared in step 1, 40 rpm After stirring slowly for 35 minutes, add 26% of the sodium hyaluronate solution prepared...

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Abstract

The invention relates to a ceftriaxone sodium injection preparation for injection and a preparation method of the ceftriaxone sodium injection preparation, and belongs to the technical field of medicine. The preparation is composed of ceftriaxone sodium and sodium hyaluronate, wherein the sodium hyaluronate is a sodium hyaluronate solution obtained through special treatment of ultrasonic concussion. The sterile ceftriaxone sodium powder for injection is flocculent, the solubleness of the powder injection during fluid preparation is good; the quality of the product is greatly improved, and indexes such as content, single impurity, total impurity and polymer are much higher than the Pharmacopoeia standard and superior to that of the products in the prior art; the stability is significantly improved, through an accelerated test in 6 months, the content is only reduced by 0.1%-0.2%, the single impurity is only reduced by 0.05%-0.06 %, the total impurity is only reduced by 0.10%-0.11%, thepolymer is only reduced by 0.02%, and the stability is obviously superior to that of the products in the prior art.

Description

technical field [0001] The invention relates to a powder preparation for injection, in particular to a ceftriaxone sodium powder preparation for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Ceftriaxone sodium, also known as ceftriaxone or ceftriaxone, is a ceftriaxone derivative. The original manufacturer is Roche in Switzerland, which was first launched in Switzerland in 1982 under the product name "Rocephin". It was launched in the U.S. in December 1984 after FDA review, and in Japan in 1986. It was registered in 28 countries and regions around the world in the early 1990s. It is a "milestone" drug in the development history of cephalosporin antibiotics. In 1995, CFDA approved the production of ceftriaxone sodium produced by Shanghai Roche Company. [0003] Ceftriaxone sodium is a third-generation cephalosporin antibiotic, which has strong activity against Enterobacteriaceae bacteria; The MIC90 o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K47/36A61K31/546A61P31/04
CPCA61K9/0019A61K9/146A61K31/546A61P31/04
Inventor 马慧丽汪涛王晨光
Owner 石药集团中诺药业(石家庄)有限公司
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