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New cefmetazole sodium for injection

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

Inactive Publication Date: 2018-05-11
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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  • New cefmetazole sodium for injection
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  • New cefmetazole sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1 prepares p-dioxanone-lactide copolymer of the present invention

[0021] 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

[0022] Embodiment 2 prepares cefmetazole sodium for injection according to the present invention, specification: 1.0g

[0023] prescription:

[0024] Cefmetazole Sodium

1000g

gelatin

1135g

gum arabic

1365g

Polyethylene glycol-4000

300g

Polyethylene glycol-6000

100g

p-dioxanone-lactide copolymer (29.3:70.7)

1000g

talcum powder

900g

[0025] The specific steps are:

[0026] Weigh the gelatin, add distilled water, heat at 50-60°C and stir at high speed to dissolve it, then add the prescribed amount of gum arabic and continue stirring to dissolve, finally add the prescribed amount of polyethylene glycol-4000 and polyethylene glycol-6000 to dissolve, Continue heating and stirring in a water bath for 20 minutes, cool to 30°C, add the prescribed amount of cefmetazole sodium and stabilizer p-dioxanone-lactide copolymer (29.3:70.7) during stirring, emulsify with a high-speed dispersing homogenizer, The emuls...

Embodiment 3

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

[0029] prescription:

[0030]

[0031]

[0032] The specific steps are:

[0033] Weigh the gelatin, add distilled water, heat and stir at 50-60°C at high speed to dissolve it, then add the prescribed amount of gum arabic and continue stirring to dissolve, finally add the prescribed amount of polyethylene glycol-4000 to dissolve, continue heating and stirring in a water bath for 20 minutes, Cool to 30°C, add the prescribed amount of cefmetazole sodium and stabilizer p-dioxanone-lactide copolymer (29.3:70.7) while stirring, emulsify with a high-speed dispersing homogenizer to obtain an emulsion, and wait for it to stabilize Afterwards, it is spray-dried to obtain white powdery microcapsules; the anti-tack agent magnesium stearate is added into the microcapsules, mixed evenly, subpackaged, filled with nitrogen and sealed for sterilization.

[0034] The s...

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Abstract

The invention relates to new cefmetazole sodium for injection and a preparation method thereof, and belongs to the technical field of medicines. The new cefmetazole sodium for injection is prepared from 1 part of cefmetazole sodium, 1.13 to 1.18 parts of gelatin, 1.36 to 1.38 parts of arabic gum, 0.4 to 0.5 part of plasticizer, 0.8 to 1.2 parts of stabilizing agent and 0.9 to 1 part of anti-sticking agent. The stabilizing agent dioxanone-lactide copolymer is a copolymer in a special proportion and plays an important function on stability of a preparation. According to an injection, through a slow release effect of a microcapsule, a medicine application method of 2 to 4 times everyday is changed into medicine application for one time, so that medicine application intervals are shortened, the new cefmetazole sodium is convenient to use, the bioavailability is improved, the medicine using amount is reduced, so that the blood concentration is stable to improve a curative effect, and an adverse reaction is reduced. The preparation process of the cefmetazole sodium for injection provided by the invention is simple, is low-cost, and is suitable for large scale production; therefore, the new cefmetazole sodium is a product having market prospect.

Description

technical field [0001] The invention relates to an injection and a preparation method thereof, in particular to a new cefmetazole sodium for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Cefmetazole Sodium (Cefmetazole Sodium), its chemical name is (6R,7R)-7-[2-[(cyanomethyl)thio]acetamido]-7-methoxy-3-[(1-methyl -1H-tetrazol-5-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, Molecular formula is C l5 h 16 N 7 NaO 5 S 3 , the molecular weight is 493.52. Its properties are white to slightly yellow powder; very hygroscopic; easily soluble in water, easily soluble in methanol, slightly soluble in acetone, slightly soluble in ethanol, almost insoluble in ether or dichloromethane. [0003] Cefmetazole sodium is a semi-synthetic cephamycin derivative, similar to other cephalosporins, by affecting the biosynthesis of bacterial cell walls, thus exerting antibac...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K9/52A61K47/34A61K47/42A61K31/546A61P31/04
CPCA61K9/5057A61K9/0019A61K9/5031A61K31/546
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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