Vinpocetine medicament composition and preparation method thereof

A technology of vinpocetine and composition, applied in the field of vinpocetine pharmaceutical composition and preparation thereof, can solve the problems of increased product cost, high safety risk and the like, and achieves the effects of good stability and high safety in clinical use

Active Publication Date: 2012-07-25
湖北美林药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Vinpocetine is almost insoluble in water and dissolves under acidic conditions. Therefore, vinpocetine injections need to add acidic co-solvents. Vinpocetine is easily oxidized. Antioxidants are generally added to the injections to increase the stabilizer of vinpocetine. Commercially available vinpocetine Vinpocetine injections often add a large amount of excipients to obtain stable vinpocetine injections, but the use of more excipients increases the cost of the product and at the same time makes the product have a higher safety risk

Method used

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  • Vinpocetine medicament composition and preparation method thereof
  • Vinpocetine medicament composition and preparation method thereof
  • Vinpocetine medicament composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Preparation of 2ml:10mg Vinpocetine Injection

[0054] Add 1000ml water for injection into the preparation tank 1, heat to 50~55℃, add 20g of L-malic acid into the preparation tank, stir to dissolve it, take 10g of vinpocetine, add it to the preparation tank, stir to dissolve it, continue Stir for 15 minutes; add 800ml of water for injection to the preparation tank 2,

[0055] Get 40g of polyethylene glycol and add it to the preparation tank and stir for 15 minutes, adjust the pH to 3.0~3.5 with 1mol / L hydrochloric acid; combine the solutions of the preparation tank 1 and the preparation tank 2, use a pH adjuster (1mol / L sodium hydroxide solution) ) Adjust the pH to 3.3~3.7, add water for injection to 2000ml, add 0.15% activated carbon for needles, stir for 25 minutes, filter and decarbonize, check the intermediates, filter and sterilize them with a 0.22μm filter membrane after passing the test, and pour them into the In a 2ml ampoule bottle, fill with nitrogen, melt s...

Embodiment 2

[0057] Preparation of 2ml: 20mg Vinpocetine Injection

[0058] Add 1000ml water for injection into the preparation tank 1, heat to 50-55°C, add 40g of L-malic acid into the preparation tank, stir to dissolve it, take 20g of vinpocetine, add it to the preparation tank, stir to dissolve it, continue Stir for 15 minutes; add 800ml of water for injection to the preparation tank 2,

[0059] Take 400 g of polyethylene glycol and add it to the preparation tank and stir for 15 minutes, adjust the pH to 3.0~3.5 with 1 mol / L hydrochloric acid; combine the solutions of preparation tank 1 and preparation tank 2, use a pH adjuster (1mol / L sodium hydroxide solution) ) Adjust the pH to 3.3~3.7, add water for injection to 2000ml, add 0.15% activated carbon for needles, stir for 25 minutes, filter and decarbonize, check the intermediates, filter and sterilize them with a 0.22μm filter membrane after passing the test, and pour them into the In a 2ml ampoule bottle, fill with nitrogen, melt sea...

Embodiment 3

[0061] The specification is 5ml: the preparation of vinpocetine injection of 30mg

[0062] Add 1000ml of water for injection into the preparation tank 1, heat to 50-55°C, take 24g of L-malic acid and add it to the preparation tank, stir to dissolve it, take 12g of vinpocetine, add it to the preparation tank, stir to dissolve it, continue Stir for 15 minutes; add 800ml water for injection in preparation tank 2,

[0063] Add 48g of polyethylene glycol 400 into the preparation tank and stir for 15 minutes, adjust the pH to 3.0-3.5 with 1mol / L hydrochloric acid; combine the solutions of preparation tank 1 and preparation tank 2, and use a pH regulator (1mol / L sodium hydroxide solution ) to adjust the pH to 3.3-3.7, add water for injection to 2000ml, add 0.15% activated carbon for needles, stir for 25 minutes, filter for decarburization, check the intermediate, filter and sterilize with a 0.22μm filter membrane after passing the test, and pour it into the In a 5ml ampoule bottle, ...

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Abstract

The invention relates to a vinpocetine medicament composition which is prepared from the following raw materials: 10-20g of vinpocetine, 20-40g of L-malic acid, 40-80g of polyethylene glycol400 and 2000ml of WFI (water for injection); and the pH is adjusted to 3.3-3.7. The vinpocetine medicament composition is in the form of injection lyophilized powder or injection. The vinpocetine medicament composition contains less auxiliary materials, is good in stability, and has high safety in clinical use.

Description

technical field [0001] The present invention relates to a vinpocetine pharmaceutical composition and a preparation method thereof. Background technique [0002] Vinpocetine is a vasodilator, which can inhibit the activity of phosphodiesterase, increase the function of vascular smooth muscle relaxation messenger C-GMP, and selectively increase cerebral blood flow. In addition, it can inhibit platelet aggregation, reduce human blood viscosity, and enhance red blood cell deformability. , Improve blood fluidity and microcirculation, promote brain tissue uptake of glucose, increase cerebral oxygen consumption, improve cerebral metabolism and improve various symptoms induced by cerebral infarction sequelae, cerebral hemorrhage sequelae, and cerebral arteriosclerosis. Vinpocetine (Vinpocetine) is an indole alkaloid. Since its launch in 1978, its clinical application is expanding due to its remarkable clinical effect and good safety and tolerance. Medication. Vinpocetine is al...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4375A61K47/12A61K47/10A61P9/10A61P25/00
Inventor 曾艺胡成忠刘键
Owner 湖北美林药业有限公司
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