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Vinpocetine injection and production method thereof

A technology of vinpocetine and injection, applied in the field of pharmaceutical preparations, can solve problems such as intensified oxidation reaction rate, accelerated degradation products, oxidative degradation, etc., to achieve inhibition of vinpocetine degradation products, good antioxidant performance, and ensure sterility Effect

Active Publication Date: 2014-12-10
HENAN RUNHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] During the production and storage of Vinpocetine injection, it is easy to be oxidized and degraded, resulting in various degradation products. There are four main degradation products of Vinpocetine found so far, and excessive sterilization at 121°C will accelerate the appearance of degradation products.
Currently, the antioxidants often added to vinpocetine injections can effectively ensure that vinpocetine will not be degraded, but it is prone to oxidative degradation under high temperature sterilization conditions, resulting in more degradation products and affecting the clarity of the solution.
[0004] Since the injection needs to use water for injection in the production process, although it has gone through the process of deoxygenation and nitrogen filling, the presence of dissolved oxygen in the water for injection cannot be ruled out.
Moreover, the final sterilization process of the injection needs to be sterilized at 121°C for 15 minutes, and the high heat condition will aggravate the rate of the oxidation reaction.

Method used

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  • Vinpocetine injection and production method thereof
  • Vinpocetine injection and production method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The Vinpocetine injection of the present embodiment consists of:

[0027] Vinpocetine 10g Ascorbic acid 0.3g

[0028] Sodium Metabisulfite 2g Tartaric Acid 6g

[0029] Sorbitol 160g Benzyl Alcohol 20g

[0030] Make injection 2000ml altogether.

[0031] The preparation method is as follows:

[0032] (1) 80% of the water for injection is filtered to remove oxygen, heated to 40°C, added ascorbic acid, tartaric acid and sodium metabisulfite, stirred to dissolve completely;

[0033] (2) Add Vinpocetine, stir, and dissolve completely;

[0034] (3) Add sorbitol, benzyl alcohol, stir and dissolve, make up water for injection, and use 0.3% activated carbon to stir and adsorb;

[0035] (4) Sterilize at a temperature of 121°C for 15 minutes, and fill with nitrogen.

Embodiment 2

[0037] The Vinpocetine injection of the present embodiment consists of:

[0038] Vinpocetine 12g Ascorbic Acid 0.1g

[0039] Sodium Metabisulfite 2g Tartaric Acid 8g

[0040] Sorbitol 160g Benzyl Alcohol 20g

[0041] Make injection 2000ml altogether.

[0042] The preparation method is as follows:

[0043] (1) 80% of the water for injection is filtered to remove oxygen, heated to 40°C, added ascorbic acid, tartaric acid and sodium metabisulfite, stirred to dissolve completely;

[0044] (2) Add Vinpocetine, stir, and dissolve completely;

[0045] (3) Add sorbitol, benzyl alcohol, stir and dissolve, make up water for injection, and use 0.3% activated carbon to stir and adsorb;

[0046] (4) Sterilize for 15 minutes at a temperature of 121°C, and fill with nitrogen.

Embodiment 3

[0048] The Vinpocetine injection of the present embodiment consists of:

[0049] Vinpocetine 20g Ascorbic Acid 0.45g

[0050] Sodium Metabisulfite 2g Tartaric Acid 15g

[0051] Sorbitol 160g Propylene Glycol 20g

[0052] A total of 2000ml of injection was made.

[0053] The preparation method is as follows:

[0054] (1) 80% of the water for injection is filtered to remove oxygen, heated to 40°C, added ascorbic acid, tartaric acid and sodium metabisulfite, stirred to dissolve completely;

[0055] (2) Add Vinpocetine, stir, and dissolve completely;

[0056] (3) Add sorbitol, propylene glycol, stir and dissolve, make up water for injection, and use 0.3% activated carbon to stir and adsorb;

[0057] (4) Sterilize for 15 minutes at a temperature of 121°C, and fill with nitrogen.

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Abstract

The invention discloses a vinpocetine injection and a production method thereof. The vinpocetine injection comprises 10 to 20 parts of vinpocetine, 0.1 to 0.45 parts of ascorbic acid, 1 to 5 parts of one or more antioxidants, 6 to 15 parts of one or more cosolvents, 120 to 180 parts of one or more physical stabilizing agents, 15 to 25 parts of one or more vascular stimulation regulators and 2000 parts of water. Utilization of ascorbic acid in the above components is conducive to the dissolution of alkaline vinpocetine. A lot of experiments prove that the technical scheme of the invention is conducive to the dissolution of alkaline vinpocetine, realizes good antioxidation performances, and can effectively inhibit production of vinpocetine degradation products in production and storage processes.

Description

technical field [0001] The invention relates to a vinpocetine injection and a production method of the vinpocetine injection, belonging to the field of pharmaceutical preparations. Background technique [0002] Vinpocetine is an indole alkaloid with the chemical name ethyl(13as, 13bs)-13a-ethyl-2,3,5,6-13a,13b hexahydro-1H-indole[ 3,2,1-de]pyridine[3,2,1-ij][1,5]naphthyridine-12-carboxylic acid. A large number of scientific studies have confirmed that: Many studies at home and abroad have found that Vinpocetine has a variety of pharmacological effects that are beneficial to the brain, cardiovascular, blood circulation and other systems. (1) Increase cerebral blood flow; (2) Promote the uptake and utilization of glucose and oxygen in the brain, increase ATP, and reduce the production of lactic acid during ischemia and hypoxia; (3) Prevent the excitotoxic death of brain cells (induced by excitatory amino acids Excessive receptor excitation); (4) reduce brain hypoxic damage a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4375A61K47/26A61P9/00A61P25/00A61P9/10A61P39/06A61P9/08
Inventor 吴素林张炜靳勇
Owner HENAN RUNHONG PHARMA
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