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Novel ceftriaxone sodium for injection

A technology for ceftriaxone sodium and injection, which is applied in the field of medicine, can solve the problems of staying in the microcapsule technology, not being converted into commercial products, and being few in number, etc., and achieves the effects of shortening the medication interval, low cost, and simple preparation process.

Inactive Publication Date: 2018-05-04
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

There are some microcapsule products in my country's pharmaceutical industry, but they are few in number. There are also a small number of products in the food industry, but they are still in their infancy. Most of the microcapsule technology is still in laboratory research and patent documents, and has not been transformed into commercial products.

Method used

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  • Novel ceftriaxone sodium for injection
  • Novel ceftriaxone sodium for injection
  • Novel ceftriaxone sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1 prepares p-dioxanone-lactide copolymer of the present invention

[0022] P-dioxanone and lactide are put into a three-necked flask according to the weight ratio, and catalyst stannous octoate (3.56% of the lactide monomer quality) and initiator lauryl alcohol (lactide) are added under the protection of nitrogen. 2.72% of the monomer mass), vacuumed to 10Pa, heated to 185°C under stirring, reacted for 1.5h, stopped stirring, kept vacuum for 4h, and then naturally cooled to room temperature. Dissolve the product with a small amount of dichloromethane, then settle with petroleum ether 3 times the volume of the solution, and filter with suction, repeating this process 3 times, and finally the obtained copolymer product is dried under reduced pressure at 40°C for 3 hours in a vacuum drying oven to obtain different proportions The finished product of dioxanone-lactide copolymer.

Embodiment 2

[0023] Embodiment 2 prepares ceftriaxone sodium for injection according to the present invention, specification: 1.0g

[0024] prescription:

[0025] Ceftriaxone Sodium

1000g

Ethyl cellulose

333g

acetone

20L

p-dioxanone-lactide copolymer (29.3:70.7)

667g

Magnesium stearate

267g

Span-80

889ml

liquid paraffin

80L

[0026] The specific steps are:

[0027] 1. Firstly crush ethyl cellulose and ceftriaxone sodium respectively, and pass through 100-mesh and 80-mesh sieves. 2. Dissolve the prescribed amount of ethyl cellulose in the prescribed amount of acetone, add the prescribed amount of ceftriaxone sodium and the stabilizer p-dioxanone-lactide copolymer (29.3:70.7), stir for 20 minutes, Suspension A is obtained. 3. Add the prescribed amount of surfactant Span-80 into the prescribed amount of liquid paraffin, heat in a water bath at 35°C and stir for 20 minutes to obtain solution B. 4. Add suspension A...

Embodiment 3

[0028] Embodiment 3 prepares ceftriaxone sodium for injection according to the present invention, specification: 0.5g

[0029] prescription:

[0030] Ceftriaxone Sodium

500g

Ethyl cellulose

150g

acetone

12L

p-dioxanone-lactide copolymer (29.3:70.7)

300g

talcum powder

150g

Span-80

450ml

liquid paraffin

35L

[0031] The specific steps are:

[0032] 1. Firstly crush ethyl cellulose and ceftriaxone sodium respectively, and pass through 100-mesh and 80-mesh sieves. 2. Dissolve the prescribed amount of ethyl cellulose in the prescribed amount of acetone, add the prescribed amount of ceftriaxone sodium and the stabilizer p-dioxanone-lactide copolymer (29.3:70.7), stir for 20 minutes, Suspension A is obtained. 3. Add the prescribed amount of surfactant Span-80 into the prescribed amount of liquid paraffin, heat in a water bath at 35°C and stir for 20 minutes to obtain solution B. 4. Add suspension A to so...

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Abstract

The invention relates to novel ceftriaxone sodium for injection and a preparation method thereof, and belongs to the technical field of medicines. The novel ceftriaxone sodium for injection consists of 1 part of ceftriaxone sodium, 0.30 to 0.33 part of ethyecellulose, 0.60 to 0.72 part of a stabilizer, 0.80 to 0.90 part of a surfactant, 70 to 80 parts of liquid paraffin and 0.27 to 0.30 part of ananti-sticking agent. The stabilizer p-dioxanone-lactide copolymer is a copolymer with a specific proportion, and plays an important role in preparation stability. According to the injection, the drugdelivery application twice every day becomes once administration through slow-release effect of a micro-capsule, the dosing interval is shortened, the injection is convenient to use, the biological availability is improved, the using amount of medicine is reduced, the curative effect is improved since the blood concentration is smooth, and the untoward effect is reduced. The novel ceftriaxone sodium for injection, provided by the invention, is simple in preparation technology and low in cost, is applicable for large-scale production, and is a product with very good market prospects.

Description

technical field [0001] The invention relates to an injection and a preparation method thereof, in particular to a new ceftriaxone sodium for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Ceftriaxone Sodium (Ceftriaxone Sodium) is a third-generation cephalosporin antibiotic with strong activity against Enterobacteriaceae bacteria. The MIC90 for Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Citrobacter freundii, indole-positive Proteus, Pruvidenella and Serratia is between 0.12 and 0.25mg / Between L. Enterobacter cloacae, Acinetobacter and Pseudomonas aeruginosa were less sensitive to the drug. It has strong antibacterial effect on Haemophilus influenzae, Neisseria gonorrhoeae and Neisseria meningitidis, and also has good effect on hemolytic streptococcus and pneumococcus. It is clinically used for the prevention of lower respiratory tract infection, urinary tract and biliary tract ...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/546A61K9/50A61K47/38A61P31/04
CPCA61K31/546A61K9/0019A61K9/5042
Inventor 马慧丽王荣端康辉王晨光
Owner 石药集团中诺药业(石家庄)有限公司
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