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Zinc sulfate freeze-dried preparation for injection

A technology of freeze-dried preparations and lipoic acid, which is applied in the direction of freeze-dried transportation, medical preparations containing active ingredients, anti-toxic agents, etc., can solve the problems of lipoic acid instability, limited production and use, etc., and achieve high stability and meet The desired effect of clinical treatment

Inactive Publication Date: 2006-11-01
SHANGHAI INST OF PHARMA IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since lipoic acid itself is very unstable, its production and use are limited

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Under the protection of light and nitrogen, take 3 g of lipoic acid and 0.1 g of sodium sulfite and dissolve them in water for injection, adjust the pH to about 8.5 with sodium hydroxide, add water for injection to 100 ml, filter through a 0.22 μm microporous membrane, and place in a freeze dryer Freeze-dried and sealed to obtain a white to slightly yellow lipoic acid water-soluble powder injection containing 300 mg of lipoic acid per bottle. This product is subjected to 4500lux light, 40, 60 ℃ accelerated 10 days, its content is detected by HPLC method, 10 days irradiated, its content is 92%, 40, 60 ℃ accelerated 10 days, its content is 99%, show that this product is on It is sensitive to light and needs to be stored away from light.

Embodiment 2

[0024] Under the protection of light and nitrogen, take 3 g of lipoic acid, 0.1 g of sodium bisulfite, and 1 g of glycine dissolved in water for injection, adjust the pH to about 8.5 with tromethamine, add water for injection to 100 ml and filter through 0.22 μm microporous Membrane filtration, freeze-drying in a lyophilizer, purging with nitrogen, and sealing to obtain a white to slightly yellow lipoic acid water-soluble powder injection containing 300 mg of lipoic acid in each bottle. This product is subjected to light, 40, 60 ℃ accelerated 10 days, its content is detected by HPLC method, 4500lux irradiated 10 days, its content is 91%, 40, 60 ℃ accelerated 10 days, its content is 98%, show that this product is on It is sensitive to light and needs to be stored away from light.

Embodiment 3

[0026] Under the protection of light and nitrogen, take 3 g of lipoic acid, 0.1 g of sodium sulfite, and 1 g of mannitol dissolved in water for injection, adjust the pH to about 8.5 with tromethamine, add water for injection to 100 ml, and filter through a 0.22 μm microporous membrane , put in a freeze dryer to lyophilize, vent nitrogen, and seal to obtain a white to slightly yellow lipoic acid water-soluble powder injection containing 300 mg of lipoic acid in each bottle. This product is subjected to light, 40, 60 ℃ accelerated 10 days, its content is detected by HPLC method, 4500lux irradiated 10 days, its content is 91.5%, 40, 60 ℃ accelerated 10 days, its content is 98.5%, show that this product is on It is sensitive to light and needs to be stored away from light.

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PUM

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Abstract

A freeze-dried powder injection of thioctic acid contains proprotionally the thioctic acid, antioxidizing agent and pH regulator. Its advantages are high curative effect and high stability.

Description

technical field [0001] The invention relates to a lipoic acid preparation, in particular to a lipoic acid freeze-dried preparation for injection. Background technique [0002] In 1951, lipoic acid (Thioctic Acid; Lipoic Acid; α-Lipoic Acid) was the first natural product isolated from pig liver by Reed, which is the oxidative decarboxylation of α-ketoglutarate in the pyruvate and tricarboxylic acid cycle Coenzyme factor of the reaction. In the past, the understanding of it only stayed in the role of energy metabolism. Modern research shows that it has anti-oxidation effect, prevents and treats many diseases, and is known as a universal antioxidant. [0003] This product has the following characteristics: (1) It is easy to transform in cells. Experiments have proved that lipoic acid (oxidized form) can be reduced to dihydrolipoic acid (reduced form) by lipoamide dehydrogenase in mitochondria after most mammalian cells ingest lipoic acid. And released to the outside of the ce...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/385A61K9/19A61P39/06
Inventor 谢保源陈允发陆敏
Owner SHANGHAI INST OF PHARMA IND CO LTD
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