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Lipoic acid injection and preparation method thereof

A technology of lipoic acid and injection, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, and pharmaceutical formulas, etc., can solve problems such as inability to tolerate terminal sterilization, and achieve good market value and technology. Simple, Inexpensive Effects

Active Publication Date: 2015-03-04
YUANSHENG SUYUANG BIOLOGICAL SCI TECH BEIJING
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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 and preparation method thereof
  • Lipoic acid injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Prescription (100 preparation units, 12ml):

[0042] Alpha Lipoic Acid 30g

[0043] Ethylenediamine 7.7g

[0044] Add water for injection to 1200ml

[0045] Preparation Process:

[0046] Fill the water for injection with nitrogen for deoxygenation, and check the oxygen content in the water to be qualified (oxygen content in water <50ug / ml). Measure water for injection of 3 / 4 of the total amount of dosing. Add ethylenediamine according to the prescription ratio and stir evenly. Slowly add the prescribed amount of lipoic acid while continuing to stir, and stir evenly. Add water to the full amount, add medicinal charcoal, and stir for 30 minutes. Decarburization by coarse filtration through Φ3μm titanium rod filter (5 cores). The initial pH value was 8.2. Then go through a 0.45 μm polyethersulfone pleated filter membrane core for primary filtration, and a 0.22 μm polyethersulfone pleated filter membrane core for primary sterilization filtration. Then p...

Embodiment 2

[0048] Prescription (100 preparation units, 6ml):

[0049] Alpha Lipoic Acid 15g

[0050] Ethylenediamine 3.87g

[0051] Add water for injection to 600ml

[0052] Preparation process: The water for injection is filled with nitrogen and deoxidized, and the oxygen content in the water is tested to be qualified (the oxygen content in the water is <50ug / ml). Measure 3 / 4 of the total amount of water for injection. Add ethylenediamine according to the prescription ratio and stir evenly. Slowly add the prescribed amount of lipoic acid while continuing to stir, and stir evenly. Add water to the full amount, add medicinal charcoal, and stir for 30 minutes. Decarburization by coarse filtration through Φ3μm titanium rod filter (5 cores). The initial pH value was 8.15. Then go through a 0.45 μm polyethersulfone pleated filter membrane core for primary filtration, and a 0.22 μm polyethersulfone pleated filter membrane core for primary sterilization filtration. Then pass throu...

Embodiment 3

[0054] Prescription (100 preparation units, 6ml):

[0055] Alpha Lipoic Acid 15g

[0056]Ethylenediamine 3.85g

[0057] Add water for injection to 600ml

[0058] Preparation process: The water for injection is filled with nitrogen and deoxidized, and the oxygen content in the water is tested to be qualified (the oxygen content in the water is <50ug / ml). Measure water for injection of 3 / 4 of the total amount of dosing. Add ethylenediamine according to the prescription ratio and stir evenly. Slowly add the prescribed amount of lipoic acid while continuing to stir, and stir evenly. Add water to the full amount, add medicinal charcoal, and stir for 30 minutes. Decarburization by coarse filtration through Φ3μm titanium rod filter (5 cores). The initial pH value was 8.2. Then go through a 0.45 μm polyethersulfone pleated filter membrane core for primary filtration, and a 0.22 μm polyethersulfone pleated filter membrane core for primary sterilization filtration. Then pa...

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Abstract

The invention discloses a prescription and a preparation technology of a lipoic acid injection combination. Each 1000 ml of injection comprises the components as follows: 25 g of lipoic acid, 5-8 g of a cosolvent ethanediamine and the balance of water for injection. The disclosed lipoic acid injection is stable in quality and resistant to hot pressure for sterilization, and the sterility level is high. The invention further provides the prescription and the preparation technology of the lipoic acid injection. The technology is simple, convenient and efficient, and the quality can be controlled.

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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/385A61K47/18A61P3/10
Inventor 门毅
Owner YUANSHENG SUYUANG BIOLOGICAL SCI TECH BEIJING