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Vinpocetine freeze-dried preparation for injection and preparation method thereof

A technology of freeze-dried preparations and vinpocetine, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve the problems of many preparation process steps, poor particle stability, and large amount of excipients. problems, to achieve the effects of low toxic and side effects, improved stability, and fewer excipients

Active Publication Date: 2016-05-04
GUANGZHOU YIPINHONG PHARMA +4
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process has many steps and is difficult to control, the stability of the particles is poor, and the amount of auxiliary materials is also large

Method used

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  • Vinpocetine freeze-dried preparation for injection and preparation method thereof
  • Vinpocetine freeze-dried preparation for injection and preparation method thereof
  • Vinpocetine freeze-dried preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1

[0021]

[0022] Preparation method: Weigh 1g of vinpocetine, add vinpocetine to 10ml of acetone, heat to 80°C to dissolve to obtain a drug solution, then disperse the drug solution in 200ml of water for injection, stir at high speed to form a suspension solution, add Cholesterol, mannitol, and L-malic acid were intermittently dispersed three times with a high-pressure milk homogenizer at a pressure of 80 MPa. Finally, acetone was removed by rotary evaporation, filtered through a 0.22 μm microporous membrane, and freeze-dried to obtain a lyophilized powder preparation for injection.

[0023] The average particle diameter of the freeze-dried powder after reconstitution is 75nm.

Embodiment 2

[0025]

[0026] Preparation method: Weigh 1g of vinpocetine, add vinpocetine to 30ml of dichloromethane, heat to 60°C to dissolve to obtain a drug solution, then disperse the drug solution in 200ml of water for injection, stir at high speed to form a suspension solution , add egg yolk lecithin, albumin, phosphoric acid, disperse intermittently three times with a high-pressure milk homogenizer, the milk uniform pressure is 60MPa, and finally remove methylene chloride by rotary evaporation, filter through a 0.22μm microporous membrane, freeze-dry to obtain a lyophilized powder for injection injection preparations.

[0027] The average particle diameter of the freeze-dried powder after reconstitution is 148nm.

Embodiment 3

[0029]

[0030] Preparation method: Weigh 3g of vinpocetine, add vinpocetine to 30ml of acetone, heat to 80°C to dissolve to obtain a drug solution, then disperse the drug solution in 500ml of water for injection, stir at high speed to form a suspension solution, add Soybean lecithin, glucose, and lactic acid were intermittently dispersed three times with a high-pressure milk homogenizer at a pressure of 40 MPa. Finally, acetone was removed by rotary evaporation, filtered through a 0.22 μm microporous membrane, and freeze-dried to obtain a lyophilized powder for injection.

[0031] The average particle size of the lyophilized preparation after reconstitution was 89 nm.

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Abstract

The invention relates to a vinpocetine freeze-dried preparation for injection and a preparation method thereof. The vinpocetine preparation for injection belongs to a medicine application system and is prepared from, by weight, 1-10 parts of vinpocetine, 5-30 parts of organic solvent, 0.1-20 parts of a surface active agent, 0.1-15 parts of a freezing and drying protecting agent, 0.01-1 part of a pH conditioning agent and the balance water for injection. The vinpocetine freeze-dried preparation can be used for preparing medicine for treating multiple types of insufficient blood supply symptoms and can be further used for treating multiple types of cerebrovascular circulation disorder diseases such as cerebral infarction, cerebral hemorrhage and cerebral arteriosclerosis.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a vinpocetine nanoparticle freeze-dried preparation for injection and a preparation method thereof, belonging to the field of medicine. Background technique [0002] Vinpocetine, also known as apovincine ethyl ester, is a natural medicine extracted from periwinkle, belongs to indole alkaloid, is a vasodilator, can inhibit the activity of phosphodiesterase, and acts on vascular smooth muscle PDE-1 receptors, two-way regulation of vascular tension, improve blood supply, improve red blood cell deformability, enhance hemoglobin oxygen release ability, improve tissue oxygen supply, increase vascular smooth muscle C-GMP (cyclic guanosine monophosphate) concentration, selectively Increase cerebral blood flow and reduce cerebrovascular resistance. Vinpocetine is highly fat-soluble and easily enters brain tissue through the blood-brain barrier. It can inhibit platelet aggregation, reduce b...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K47/24A61K47/28A61K31/4375A61P9/10
CPCA61K9/0019A61K9/145A61K31/4375
Inventor 李捍雄杨冬玲刘凡
Owner GUANGZHOU YIPINHONG PHARMA
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