Lipoic acid transfusion preparation and preparing method thereof

Abstract

The invention relates to a lipoic acid transfusion preparation and a preparing method thereof. The invention is characterized in that every 1000ml of lipoic acid transfusion solution contains 3-6g of lipoic acid, 0.5-1g of cosolvent, and 0.005-0.05g of sodium hydroxide. The lipoic acid transfusion solution can be directly dosed by intravenous drip, and the problem of adverse effect of traditional intravenous or intramuscular injection of a lipoic acid injection is solved.

Description

technical field

[0001] The invention relates to a lipoic acid transfusion preparation and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique

[0002] Thioctic acid (ThiocticAcid) chemical name is 5-(1,2 dithialenyl-3-)pentanoic acid, molecular formula: C 8 h 14 o 2 S 2 , molecular weight: 206.33, chemical structural formula:

[0003]

[0004] 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 glucose, but also directly med...

Examples

Embodiment 1

[0019] prescription:

[0020] Lipoic acid 3.0g;

[0021] Sodium phosphate 0.5g;

[0022] Sodium hydroxide 0.005g;

[0023] Water for injection 1000ml.

[0024] Preparation Process:

[0025] 3.0 g of lipoic acid and 0.5 g of sodium phosphate were alternately dropped into the water for injection filled with nitrogen and deoxygenated, and stirred to dissolve. Add 0.005g of sodium hydroxide to adjust the pH value to 7.7, and continue nitrogen protection; filter through 0.45 μm and 0.22 μm filter membranes successively, fill and seal under nitrogen protection; sterilize in a water bath at 121°C for 8-12 minutes, and the product is ready.

Embodiment 2

[0027] prescription:

[0028] Lipoic acid 6.0g;

[0029] Sodium phosphate 1.0g;

[0030] Sodium hydroxide 0.05g;

[0031] Water for injection 1000ml.

[0032] Preparation Process:

[0033] Add lipoic acid and sodium phosphate alternately into the water for injection filled with nitrogen and deoxygenated, and stir to dissolve. Add an appropriate amount of sodium hydroxide to adjust the pH value to 8.0, and continue nitrogen protection. Filtered through 0.45μm and 0.22μm filter membranes successively, filled and sealed under nitrogen protection. Sterilize in a water bath at 121°C for 8-12 minutes.

Embodiment 3

[0035] prescription:

[0036] Lipoic acid 6g;

[0037] Sodium phosphate 0.75g;

[0038] Disodium hydrogen phosphate 0.25g;

[0039] Sodium hydroxide 0.01g;

[0040] Water for injection 1000ml.

[0041] Preparation Process:

[0042] Add lipoic acid, sodium phosphate, and disodium hydrogen phosphate alternately into the water for injection that has been filled with nitrogen and deoxygenated, and stir to dissolve. Add an appropriate amount of sodium hydroxide to adjust the pH value to 7.8, and continue nitrogen protection. Filtered through 0.45μm and 0.22μm filter membranes successively, filled and sealed under nitrogen protection. Sterilize at 121°C for 8-12 minutes.

technical field

[0001] The invention relates to a lipoic acid transfusion preparation and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique

[0002] Thioctic acid (ThiocticAcid) chemical name is 5-(1,2 dithialenyl-3-)pentanoic acid, molecular formula: C 8 h 14 o 2 S 2 , molecular weight: 206.33, chemical structural formula:

[0003]

[0004] 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 glucose, but also directly med...

Examples

Embodiment 1

[0019] prescription:

[0020] Lipoic acid 3.0g;

[0021] Sodium phosphate 0.5g;

[0022] Sodium hydroxide 0.005g;

[0023] Water for injection 1000ml.

[0024] Preparation Process:

[0025] 3.0 g of lipoic acid and 0.5 g of sodium phosphate were alternately dropped into the water for injection filled with nitrogen and deoxygenated, and stirred to dissolve. Add 0.005g of sodium hydroxide to adjust the pH value to 7.7, and continue nitrogen protection; filter through 0.45 μm and 0.22 μm filter membranes successively, fill and seal under nitrogen protection; sterilize in a water bath at 121°C for 8-12 minutes, and the product is ready.

Embodiment 2

[0027] prescription:

[0028] Lipoic acid 6.0g;

[0029] Sodium phosphate 1.0g;

[0030] Sodium hydroxide 0.05g;

[0031] Water for injection 1000ml.

[0032] Preparation Process:

[0033] Add lipoic acid and sodium phosphate alternately into the water for injection filled with nitrogen and deoxygenated, and stir to dissolve. Add an appropriate amount of sodium hydroxide to adjust the pH value to 8.0, and continue nitrogen protection. Filtered through 0.45μm and 0.22μm filter membranes successively, filled and sealed under nitrogen protection. Sterilize in a water bath at 121°C for 8-12 minutes.

Embodiment 3

[0035] prescription:

[0036] Lipoic acid 6g;

[0037] Sodium phosphate 0.75g;

[0038] Disodium hydrogen phosphate 0.25g;

[0039] Sodium hydroxide 0.01g;

[0040] Water for injection 1000ml.

[0041] Preparation Process:

[0042] Add lipoic acid, sodium phosphate, and disodium hydrogen phosphate alternately into the water for injection that has been filled with nitrogen and deoxygenated, and stir to dissolve. Add an appropriate amount of sodium hydroxide to adjust the pH value to 7.8, and continue nitrogen protection. Filtered through 0.45μm and 0.22μm filter membranes successively, filled and sealed under nitrogen protection. Sterilize at 121°C for 8-12 minutes.

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