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Lipoic acid composition for injection and preparation method thereof

A technology of lipoic acid and composition, which is applied in the field of lipoic acid composition for injection and its preparation, can solve problems such as no improvement, and achieve the effects of improving efficiency, avoiding degradation, avoiding clinical irritation and medication discomfort

Inactive Publication Date: 2013-05-08
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] None of the existing known technologies propose improvements to the above defects

Method used

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  • Lipoic acid composition for injection and preparation method thereof
  • Lipoic acid composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] prescription:

[0044] Alpha Lipoic Acid 3Kg

[0045] Mannitol 3Kg

[0046] Add water for injection to 60Kg

[0047] Preparation: Put water for injection in a preparation tank, add lipoic acid and mannitol, stir well, and add 1mol / L sodium hydroxide under stirring until lipoic acid is completely dissolved, then adjust pH with 1mol / L hydrochloric acid solution When the value reaches 8.2, add water for injection to the full amount of the prescription and stir evenly;

[0048] Sterile filtration and sub-packaging: filter the above-mentioned lipoic acid solution through a microporous membrane into a sterile room, sub-package in vials, and half stopper;

[0049] Vacuum freeze-drying: put the product in the freeze-drying box, turn it on for refrigeration, and use heat transfer oil to lower the product temperature. When the product temperature reaches –33°C and continue to keep warm for 4 hours, turn on the condenser, and when it condenses to –40°C, turn on the ...

Embodiment 2

[0051] prescription:

[0052] Alpha Lipoic Acid 3Kg

[0053] Mannitol 3Kg

[0054] Add water for injection to 80Kg

[0055] Preparation: Put water for injection in a preparation tank, add lipoic acid and mannitol, stir well, and add 1mol / L sodium hydroxide under stirring until lipoic acid is completely dissolved, then adjust pH with 1mol / L hydrochloric acid solution When the value reaches 8.4, add water for injection to the full amount of the prescription and stir evenly;

[0056] Sterile filtration and sub-packaging: filter the above-mentioned lipoic acid solution through a microporous membrane into a sterile room, sub-package in vials, and half stopper;

[0057] Vacuum freeze-drying: put the product in the freeze-drying box, turn it on for refrigeration, and use heat transfer oil to lower the product temperature. When the product temperature reaches –33°C and continue to keep warm for 4 hours, turn on the condenser, and when it condenses to –40°C, turn on the ...

Embodiment 3

[0059] prescription:

[0060] Alpha Lipoic Acid 3Kg

[0061] Mannitol 6Kg

[0062] Add water for injection to 60Kg

[0063] Preparation: Put water for injection in a preparation tank, add lipoic acid and mannitol, stir well, and add 1mol / L sodium hydroxide under stirring until lipoic acid is completely dissolved, then adjust pH with 1mol / L hydrochloric acid solution When the value reaches 8.6, add water for injection to the full amount of the prescription and stir evenly;

[0064] Sterile filtration and sub-packaging: filter the above-mentioned lipoic acid solution through a microporous membrane into a sterile room, sub-package in vials, and half stopper;

[0065] Vacuum freeze-drying: put the product in the freeze-drying box, turn it on for refrigeration, and use heat transfer oil to lower the product temperature. When the product temperature reaches –33°C and continue to keep warm for 4 hours, turn on the condenser, and when it condenses to –40°C, turn on the ...

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Abstract

The invention relates to a lipoic acid composition for injection and a preparation method thereof. The lipoic acid composition prepared by the method is suitable for treating liver function obstacle, subacutenecrotizingencephalopathy and mushroom poisoning. The lipoic acid composition for injection contains lipoic acid, mannitol and citric acid. The preparation method comprises: 1) preparation, namely weighing citric acid in an amount which is 2 percent based on the weight of the lipoic acid, adding water for injection for dissolving the citric acid, regulating the pH value to 602, adding thelipoic acid and mannitol into the solution according to a weight ratio of 1:(1-3), stirring for dispersion, slowing adding the citric acid solution of which the pH value is 9.0 to 9.3 till complete dissolution, regulating the pH value to 8.2 to 8.6, adding water for injection till total prescription volume, and uniformly stirring; 2) performing sterile filtering, filling separately, and plugging by half; and 3) freezing and drying under vacuum, and obtaining the lipoic acid composition. The formula is simple, the process is advanced, the quality is uniform and stable, the impurity content is low, and the safety of clinic use is high.

Description

technical field [0001] The invention relates to a lipoic acid composition for injection and a preparation method thereof. The lipoic acid composition prepared by the method is suitable for the treatment of liver dysfunction, subacute necrotic encephalopathy and poisonous mushroom poisoning. Background technique [0002] The chemical name for lipoic acid is 5-(1,2-dithiapentyl-3)-pentanoic acid. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 8 h 14 o 2 S 2 [0006] Molecular weight: 206.33 [0007] Lipoic acid (1ipoic acid), also known as α-lipoic acid (LA), is a natural product first isolated from pig liver by Reed in 1951. It participates in the tricarboxylic acid cycle as a coenzyme. Oxidative decarboxylation of a ketoacid. Initially, α-lipoic acid was listed as a vitamin, but subsequent research found that both humans and animals can synthesize it by themselves. For 40 years, its understanding has remained in its role in energy meta...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/385A61K31/047A61K31/194A61K9/19A61P1/16A61P9/10A61P39/02
Inventor 赵俊叶东蔡继兰
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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