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Lipoic acid transfusion preparation and preparing method thereof

A technology of lipoic acid and preparations, which can be used in anti-toxic agents, pharmaceutical formulations, drug delivery, etc., can solve problems such as lipoic acid exposure to light, unstable oxygen, high toxicity of ethylenediamine, and increased patient pain, so as to facilitate the safety of medication , Quality is easy to control, beneficial to the effect of stability

Inactive Publication Date: 2016-02-24
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when this product is injected intramuscularly, each administration site cannot exceed 50 mg, which greatly increases the pain of the patient; intravenous injection requires a slow injection of no more than 50 mg per minute, which is equivalent to the consumption of injection for every 300 mg dose. It takes 6 minutes, which is a big challenge for patients and medical staff. Although the compliance of intravenous infusion is enhanced after compatibility, lipoic acid itself is unstable to light and oxygen, and the compatibility process contains the risk of external pollution. In addition, there is a risk of further degradation
Therefore, it is difficult for the water injection dosage form of the marketed drugs to solve the deficiencies in its clinical drug compliance and safety. At present, there is a clinical need for lipoic acid infusion products with large volumes that can be directly used for intravenous infusion.
[0006] At the same time, in the disclosed prescription of lipoic acid injection, Chinese patent CN102657606A discloses a kind of lipoic acid injection for intravenous administration, its prescription is lipoic acid, co-solvent and water for injection, and its co-solvent is meglumine ; Chinese patent CN103655469A discloses a prescription of lipoic acid injection composition and its preparation process, which is characterized in that the prescription of every 1000ml injection is: lipoic acid, cosolvent ethylenediamine and water for injection; in lipoic acid injection Co-solvents such as tromethamine, ethylenediamine or meglumine are commonly used in prescriptions, which have the problems of large amount of excipients, high drug irritation and low safety
Among them, tromethamine and meglumine are used as injection auxiliary materials, and there has been no clear safety limit and basis, and the use of injections has a relatively high safety risk; ethylenediamine itself is highly toxic, highly corrosive, and flammable and explosive , basically not used in injection excipients

Method used

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  • Lipoic acid transfusion preparation and preparing method thereof
  • Lipoic acid transfusion preparation and preparing method thereof
  • Lipoic acid transfusion preparation and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

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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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...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/385A61K47/04A61P3/10A61P39/06
CPCA61K9/08A61K9/0019A61K31/385A61K47/02
Inventor 牛海岗刘绪贵陈璟李后涛唐欲晓
Owner SHANDONG QIDU PHARMA
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