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Novel ampicillin sodium used for injection

A technology for ampicillin sodium and injection, which is used in injections and its preparation. The new field of ampicillin sodium for injection and its preparation can solve the problems of not being converted into commercial products, microcapsule technology stays, and a small number, etc., and achieve cost The effect of low, shortened medication interval, and simple preparation process

Inactive Publication Date: 2018-04-20
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 ampicillin sodium used for injection
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  • Novel ampicillin sodium used for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1 Preparation of p-dioxanone-lactide copolymer according to the present invention

[0023] 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

[0024] Example 2 Preparation of Ampicillin Sodium for Injection according to the present invention, specification: 1.0g

[0025] prescription:

[0026] Ampicillin Sodium

1000g

xanthan gum

6000g

Sodium carboxymethyl cellulose

3500g

Soy Lecithin

1800g

Poloxamer

1000g

p-dioxanone-lactide copolymer (29.3:70.7)

1200g

talcum powder

800g

Polyethylene glycol-4000

35000g

[0027] The specific steps are:

[0028] Weigh xanthan gum and sodium carboxymethylcellulose, stir and dissolve in water at about 30°C, add ampicillin sodium and emulsifier, and stir with a homogenizer to obtain an emulsion; then add anti-sticking agent talcum powder and stabilizer to the emulsion Dioxanone-lactide copolymer (29.3:70.7), stir to disperse evenly, and spray dry to obtain white powdery microcapsules; mix the microcapsules with the prepared solvent polyethylene glycol- 4000, mix well, dispense, fill with nitrogen and ...

Embodiment 3

[0030] Example 3 Preparation of Ampicillin Sodium for Injection according to the present invention, specification: 0.5g

[0031] prescription:

[0032]

[0033]

[0034] The specific steps are:

[0035] Weigh xanthan gum and sodium carboxymethylcellulose, stir and dissolve in water at about 30°C, add ampicillin sodium and emulsifier, and stir with a homogenizer to obtain an emulsion; then add anti-sticking agent talcum powder and stabilizer to the emulsion Dioxanone-lactide copolymer (29.3:70.7), stir to disperse evenly, and spray dry to obtain white powdery microcapsules; mix the microcapsules with the prepared solvent polyethylene glycol- 4000, mix well, dispense, fill with nitrogen and seal for sterilization.

[0036] The spray drying conditions are as follows: inlet temperature 160° C., feed rate 6.6 ml / min.

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Abstract

The invention relates to novel ampicillin sodium used for injection and a preparation method thereof, and belongs to the technical field of medicines. The novel ampicillin sodium used for injection comprises the following ingredients in parts by weight: 1 part of ampicillin sodium, 5.5-6 parts of xanthan gum, 3.5-3.7 parts of sodium carboxymethylcellulose, 2.8-2.9 parts of an emulsifying agent, 0.8-1 part of an anti-sticking agent, 1.1-1.2 parts of a stabilizing agent and 30-35 parts of a solvent, wherein the stabilizing agent dioxy-cyclohexanone-lactide copolymer is a copolymer with a specific ratio and has a crucial effect on the stability of the preparation. Through a slow-release effect of a micro-capsule, the injection preparation is administrated once instead of twice to four times every day, and the dosing interval is shortened, so that the injection preparation is convenient in use; the bioavailability is improved, and the dosage is reduced, so that the blood concentration is stable, the curative effect is improved, and the adverse reaction is reduced. The ampicillin sodium used for injection provided by the invention is simple in preparation process and low in cost, so that the ampicillin sodium is suitable for large-scale production and is a product having a good market prospect.

Description

technical field [0001] The invention relates to an injection and a preparation method thereof, in particular to a novel ampicillin sodium for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Ampicillin Sodium (Ampicillin Sodium) is a broad-spectrum semi-synthetic penicillin antibiotic drug, which exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls, and has a strong antibacterial effect on hemolytic streptococcus, Streptococcus pneumoniae and non-penicillinase-producing Staphylococcus. Ampicillin also has a good antibacterial effect on Streptococcus viridans, and its effect on Enterococcus and Listeria is better than that of penicillin. Ampicillin sodium can be injected intramuscularly or intravenously. Clinically, it is mainly used to treat upper and lower respiratory tract infections, gastrointestinal tract infections, urinary tract infections, skin and soft tissue infection...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K47/38A61K47/36A61K47/34A61K31/43A61P31/04
CPCA61K9/5042A61K9/0019A61K9/5031A61K9/5036A61K31/43
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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