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Lipoic acid injection liquid and preparation method thereof

A technology of lipoic acid and injection, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., and can solve problems such as allergic reactions

Inactive Publication Date: 2016-06-01
PENGLAI NUOKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although the addition of antioxidants can significantly improve product quality, since antioxidants in injections can cause adverse reactions such as allergic reactions, the country has strictly controlled the addition of antioxidants, and it is not recommended to add antioxidants.

Method used

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  • Lipoic acid injection liquid and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1: Preparation of Lipoic Acid Injection (10L)

[0030]Add 300g of tromethamine into 6000ml of water for injection, the temperature of the water for injection is 29°C, stir and mix evenly. Add 250g lipoic acid to the above solution and mix well. Use an ultrafiltration column with a molecular weight cut-off of 5K to remove pyrogens, measure the concentration of the sample, and calculate the constant volume. Dilute to the final volume with water for injection, filter the sample after mixing evenly, pass helium gas into the bottom of the sample to remove oxygen, keep the sample solution stirring continuously, the stirring speed is subject to the vortex generated by the liquid surface, and measure the oxygen content of the sample solution to be 0.21mg / L. Fill and sterilize under the protection of helium. Before filling, the liquid is filled with helium and deoxygenated so that the oxygen content is 0.20mg / L, and the stirring speed is subject to the vortex gene...

Embodiment 2

[0031] Embodiment 2: Preparation of Lipoic Acid Injection (10L)

[0032] Add 200g of tromethamine into 8000ml of water for injection, the temperature of the water for injection is 25°C, stir and mix evenly. Add 250g lipoic acid to the above solution and mix well. Use an ultrafiltration column with a molecular weight cut-off of 5K to remove pyrogens, measure the concentration of the sample, and calculate the constant volume. After making up to the final volume with water for injection, filter the sample after mixing evenly, pass nitrogen gas into the bottom of the sample to remove oxygen, keep the sample solution stirring continuously, the stirring speed is based on the vortex generated by the liquid surface, and measure the oxygen content of the sample solution to be 0.19mg / L, filled and sterilized under nitrogen protection. Before filling, the liquid is filled with nitrogen and deoxygenated so that the oxygen content is 0.20mg / L, and the stirring speed is subject to the vo...

Embodiment 3

[0033] Embodiment 3: Preparation of Lipoic Acid Injection (10L)

[0034] Add 70g of ethylenediamine to 7000ml of water for injection, the temperature of the water for injection is 31°C, stir and mix evenly. Add 250g lipoic acid to the above solution and mix well. Use an ultrafiltration column with a molecular weight cut-off of 5K to remove pyrogens, measure the concentration of the sample, and calculate the constant volume. Dilute to the final volume with water for injection, filter the sample after mixing evenly, pass helium gas into the bottom of the sample to remove oxygen, keep the sample solution stirring continuously, the stirring speed is based on the vortex generated by the liquid surface, and measure the oxygen content of the sample solution to be 0.35mg / L, filled and sterilized under the protection of helium. Before filling, the liquid is filled with helium to deoxygenate to make the oxygen content 0.36mg / L, and the stirring speed is subject to the vortex generate...

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Abstract

The present invention provides a lipoic acid injection liquid and a preparation method thereof, the preparation method comprises the following steps: (1) first a co-solvent is dissolved in part of water for injection, and lipoic acid is added and dissolved; (2) a solution obtained by the step (1) is ultrafiltered for removal of pyrogen; (3) water for injection is added into a solution obtained by the step (2) for volume fixing to a final volume, the solution is evenly mixed and then filtered, and an inert gas is introduced to remove oxygen; and (4) under inert gas protection, the lipoic acid injection liquid is filled and sterilized. The preparation method does not take any antioxidant, the content of oxidation products formed by degradation of lipoic acid still can be effectively controlled, and the product quality is, more stable.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations and relates to a pharmaceutical preparation of lipoic acid and a preparation method thereof, in particular to a lipoic acid injection with less impurities, stable quality and good safety and a preparation method thereof. Background technique [0002] Lipoic acid is mainly used clinically for the treatment of diabetic microangiopathy. In Europe, lipoic acid injection is the only confirmed and marketed drug for the treatment of diabetic multiple microcirculation lesions; in my country, the drug was approved for import in 2000. In November 2009, α-lipoic acid injection was included for the first time in the new national medical insurance catalog as a medical insurance class B drug for regulating blood sugar. [0003] The main dosage forms of lipoic acid listed are oral preparations and injections. The oral preparation of the drug has a strong first-pass effect, and in addition to the extr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/385A61P3/10A61P9/14
Inventor 刘星刘宏大王宏英薛雁邸伟庆孙殷赵凯华宁静薛百忠
Owner PENGLAI NUOKANG PHARMA CO LTD
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