Lipoic acid injection for intravenous administration

A lipoic acid and injection technology, which is applied in the directions of pharmaceutical formulation, drug combination, drug delivery, etc., can solve problems such as being unable to tolerate terminal sterilization

Active Publication Date: 2012-09-12
JIANGSU SHENLONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Internationally, it is unanimously stipulated that the SAL of the moist heat sterilization method shall not be greater than 10 -6 , that is, the probability of microorganism survival after sterilization should not be greater than one in a million; while the products using aseptic production process, their SAL can only reach 10. -3 , so it is limited to products that are clinically necessary for injection and cannot withstand terminal sterilization
The aseptic production process is only applicable to powder injections or some small-volume injections

Method used

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  • Lipoic acid injection for intravenous administration
  • Lipoic acid injection for intravenous administration
  • Lipoic acid injection for intravenous administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Prescription (1000 formulation units):

[0046] Alpha Lipoic Acid 300g

[0047] Meglumine 90g

[0048] Add water for injection to 12000ml

[0049] Preparation process: Add lipoic acid to 11500ml of water for injection, add meglumine during continuous stirring, until the pH value of the solution is 8.02 after clarification, add 6g of activated carbon, stir for 20 minutes, filter and decarbonize with a 0.80μm microporous membrane , add water for injection to 12000ml, filter through a 0.22μm microporous membrane, potting, and autoclave at 115°C for 30min to obtain the product.

Embodiment 2

[0051] Prescription (1000 formulation units):

[0052] Alpha Lipoic Acid 300g

[0053]Meglumine 105g

[0054] Add water for injection to 12000ml

[0055] Preparation process: Add lipoic acid to 11000ml of water for injection, add meglumine during continuous stirring, until the pH value of the solution is 8.13 after clarification, add 5.5g of activated carbon, stir for 20 minutes, filter with a 0.80μm microporous membrane to remove Charcoal, add water for injection to 12000ml, filter through a 0.22μm microporous membrane, potting, and autoclave at 115°C for 30min to obtain the product.

Embodiment 3

[0057] Prescription (1000 formulation units):

[0058] Alpha Lipoic Acid 300g

[0059] Meglumine 120g

[0060] Add water for injection to 12000ml

[0061] Preparation process: Add lipoic acid to 11,500ml of water for injection, add meglumine during continuous stirring, until the pH value of the solution is 8.22 after clarification, add 6g of activated carbon, stir for 20 minutes, filter and decarbonize with a 0.80μm microporous membrane filter , add water for injection to 12000ml, filter through a 0.22μm microporous membrane, potting, and autoclave at 115°C for 30min to obtain the product.

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Abstract

The invention discloses a lipoic acid injection for intravenous administration and a preparation method thereof. Per 1000ml of the injection comprises the following components: 25g of lipoic acid, 7.5 to 12.5g of cosolvent, and the balance of injection water. The lipoic acid injection has the advantages of stable quality, hot-press resistance, sterilization and high aseptic guarantee level. The invention also provides a prescription and a process preparation method of the injection, and the process has the advantages of convenience, high efficiency and controllable quality.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a lipoic acid injection for intravenous administration and a preparation method thereof. Background technique [0002] Thioctic Acid (Thioctic Acid) chemical name is 5-(1,2 dithialenyl-3-)pentanoic acid [0003] Chemical Structure: [0004] [0005] Molecular formula: C 8 h 14 o 2 S 2 [0006] Molecular weight: 206.33 [0007] Lipoic acid was first isolated from pig liver as a kind of vitamin, and it can be obtained by chemical synthesis at present. Lipoic acid is a cofactor of pyruvate dehydrogenase, which is mostly found in the liver, kidney and heart. It is an indispensable substance in the conversion of pyruvate into acetyl-CoA, generation of FADH, and participation in the tricarboxylic acid cycle. It plays an important role in energy metabolism play an important role. Studies in recent years have shown that lipoic acid not only participates in the metabolism of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/385A61K47/18A61P3/10A61P39/06
Inventor 徐成秦勇苏晋金春段绪红胡传良
Owner JIANGSU SHENLONG PHARMA
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