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Omeprazole sodium microspheric freeze-dried preparation for injection and method for preparing omeprazole sodium microspheric freeze-dried preparation for injection

A technology of omeprazole sodium and freeze-dried preparations, applied in the field of medicine, can solve the problems of short duration of effective concentration, short drug action time, low drug utilization rate, etc., and achieves improved drug stability and high drug load. , sustained release effect and lasting effect

Inactive Publication Date: 2016-10-12
ZHEJIANG YATAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there are a number of domestic pharmaceutical companies producing omeprazole sodium for injection and it has been launched on the market. Most of them are directly freeze-dried and need to be administered daily; low, high total dose

Method used

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  • Omeprazole sodium microspheric freeze-dried preparation for injection and method for preparing omeprazole sodium microspheric freeze-dried preparation for injection
  • Omeprazole sodium microspheric freeze-dried preparation for injection and method for preparing omeprazole sodium microspheric freeze-dried preparation for injection
  • Omeprazole sodium microspheric freeze-dried preparation for injection and method for preparing omeprazole sodium microspheric freeze-dried preparation for injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] The raw and auxiliary material proportioning of present embodiment 1 is as follows:

[0038]

[0039]

[0040] The preparation method of present embodiment 1 is as follows:

[0041] (1) Preparation of water phase: prepare 0.3% PVA aqueous solution, and add appropriate amount of surfactant Span 80.

[0042] (2) Preparation of the oil phase: Weigh 60g of PLGA and dissolve it in 1.5L of ethyl acetate, and weigh 15g of omeprazole sodium in 0.2L of propylene glycol, and mix the two into a homogeneous phase as the oil phase.

[0043] (3) Preparation of emulsion: Slowly add the oil phase into 50L of water, stirring constantly (speed is 1000r min -1 ) for 2 minutes, while keeping the emulsification temperature below 5°C in an ice bath.

[0044] (4) Preparation of microsphere freeze-dried preparation: Stir the emulsion prepared above at low speed for 4 hours, and gradually increase the system temperature to about 30°C, stir to remove the organic solvent until the microsp...

Embodiment 2

[0047] The raw and auxiliary material proportioning of present embodiment 2 is as follows:

[0048]

[0049]

[0050] The preparation method of present embodiment 2 is as follows:

[0051] (1) Preparation of water phase: prepare 0.3% PVA aqueous solution, and add appropriate amount of surfactant Span 80.

[0052] (2) Preparation of the oil phase: Weigh 70g of PLGA and dissolve it in 2L of ethyl acetate, and weigh 20g of omeprazole sodium in 0.2L of propylene glycol, and mix the two into a homogeneous phase as the oil phase.

[0053] (3) Preparation of emulsion: Slowly add the oil phase into 60L of water, stirring constantly (speed is 1000r min -1 ) for 2 minutes, while keeping the emulsification temperature below 5°C in an ice bath.

[0054] (4) Preparation of microsphere freeze-dried preparation: Stir the emulsion prepared above at low speed for 4 hours, and gradually increase the system temperature to about 30°C, stir to remove the organic solvent until the microsphere...

Embodiment 3

[0057] The raw and auxiliary material proportioning of present embodiment 3 is as follows:

[0058]

[0059]

[0060] The preparation method of present embodiment 3 is as follows:

[0061] (1) Preparation of water phase: prepare 0.3% PVA aqueous solution, and add appropriate amount of surfactant Span 80.

[0062] (2) Preparation of the oil phase: Dissolve 100g of PLGA in 3L of ethyl acetate, and weigh 30g of omeprazole sodium in 0.2L of propylene glycol, and mix the two into a homogeneous phase as the oil phase.

[0063] (3) Preparation of emulsion: slowly add the oil phase into 100L of water, and keep stirring (the speed is 1000r min -1 ) for 5 minutes, while keeping the emulsification temperature below 5°C in an ice bath.

[0064] (4) Preparation of microsphere freeze-dried preparation: Stir the emulsion prepared above for 6 hours at a low speed, and gradually increase the system temperature to about 30°C, stir to remove the organic solvent until the microspheres are...

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Abstract

The invention relates to a freeze-dried preparation of omeprazole sodium long-acting slow-release microspheres for injection and a preparation method thereof, comprising 15-30 parts of omeprazole sodium, polylactic-glycolic acid (PLGA) in parts by weight ) 60-100 parts, polyvinyl alcohol (PVA) 50-80 parts and surfactant 1-2 parts. The omeprazole sodium long-acting sustained-release microsphere freeze-dried preparation for injection of the present invention has a long-lasting slow-release time, reduces drug side effects and administration times, and has good drug stability. The carrier material used is biodegradable, has high safety and is freeze-dried. Rapid freeze-drying is adopted in the process, and the product has fine texture and good resolubility.

Description

technical field [0001] The invention relates to a freeze-dried preparation of omeprazole sodium long-acting sustained-release microspheres for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] The chemical name of omeprazole sodium is: 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]-sulfinyl}-1H- Sodium Benzimidazole Monohydrate. Its structural formula is: [0003] [0004] Omeprazole is a racemic mixture of a pair of active optical enantiomers. It reduces the secretion of gastric acid through a highly targeted mechanism of action and is a special inhibitor of the acid pump in gastric parietal cells. This product acts rapidly, and a once-daily dose can reversibly inhibit the secretion of gastric acid. Omeprazole is a weakly alkaline substance that is concentrated and converted into an active substance in the highly acidic environment of the intracellular tubules of the gastric parietal cells,...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/16A61K31/4439A61K47/34A61K47/32A61K47/10A61K47/18A61K47/26A61P25/28
CPCA61K9/19A61K9/0019A61K9/1641A61K31/4439A61K47/10A61K47/183A61K47/26
Inventor 吕旭幸王丽云徐颖冯超敏周亚健戴兴祥
Owner ZHEJIANG YATAI PHARMA
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