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Levocarnitine composition and preparation method thereof

A technology for composition and water for injection, applied in the field of medicine, can solve problems such as poor thermal stability, and achieve the effects of reducing content, improving quality and drug safety, and improving thermal stability

Inactive Publication Date: 2016-08-17
HAINAN HERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] In order to overcome the defects of poor thermal stability proposed above and reduce the content of the undesirable impurity 2(5H)-furanone, the invention provides a composition of levocarnitine, which has thermal stability, thereby greatly reducing the undesirable Content of impurity 2(5H)-furanone

Method used

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  • Levocarnitine composition and preparation method thereof
  • Levocarnitine composition and preparation method thereof
  • Levocarnitine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] prescription:

[0050]

[0051]

[0052] Preparation Process:

[0053] 1) Weigh 0.005g of resveratrol, add 750ml of water for injection at 38°C to dissolve completely, then add 0.02g of egg yolk lecithin, stir to dissolve, and finally add 200g of levocarnitine to dissolve completely;

[0054] 2) Add an appropriate amount of pH regulator, adjust the pH to 4.8, and continue to inject water to the full amount;

[0055] 3) Add activated carbon for injection to decolorize, filter until clear, filter with a filter membrane, and pot it under nitrogen flow, and finally sterilize it in circulating steam at 100°C for 10 minutes.

Embodiment 2

[0057] prescription:

[0058]

[0059] Preparation Process:

[0060] 1) Weigh 0.01g of resveratrol, add 750ml of water for injection at 39°C to completely dissolve, then add 0.04g of egg yolk lecithin, stir to dissolve, and finally add 200g of levocarnitine to completely dissolve;

[0061] 2) Add an appropriate amount of pH regulator, adjust the pH to 5.0, and continue to inject water to the full amount;

[0062] 3) Add activated carbon for injection to decolorize, filter until clear, filter with a filter membrane, pot it under nitrogen flow, and finally sterilize it in circulating steam at 100°C for 15 minutes.

Embodiment 3

[0064] prescription:

[0065]

[0066] Preparation Process:

[0067] 1) Weigh 0.008g of resveratrol, add 750ml of water for injection at 40°C to dissolve completely, then add 0.04g of egg yolk lecithin, stir to dissolve, and finally add 200g of levocarnitine to dissolve completely;

[0068] 2) Add an appropriate amount of pH regulator, adjust the pH to 5.2, and continue to inject water to the full amount;

[0069] 3) Add activated carbon for injection to decolorize, filter until clear, filter with a filter membrane, fill and seal under nitrogen flow, and finally sterilize in circulating steam at 100°C for 20 minutes.

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a levocarnitine composition and a preparation method thereof. The composition is prepared from the following components: 200g of levocarnitine, 0.02-0.10g of egg yolk lecithin, 0.005-0.015g of resveratrol, a proper amount of pH regulator and water for injection which is added until the total volume is 1000ml. The composition has excellent thermal stability, and the content of pyrolyzed impurity 2(5H)-furanone generated in a high-temperature sterilization process can be greatly reduced.

Description

technical field [0001] The invention relates to a composition of levocarnitine, in particular to a composition containing levocarnitine, resveratrol and egg yolk lecithin, belonging to the technical field of medicine. Background technique [0002] Levocarnitine, also known as L-carnitine, chemical name: (R)-3-carboxy-2-hydroxy-N, N, N-trimethyl-1-propylammonium hydroxide, is a widely existing The special amino acid in the body tissue is an essential nutrient for humans and animals. It is a vitamin-like nutrient, which is equivalent to the vitamin B group. Levocarnitine is an essential nutrient whose function is closely related to the metabolism of living organs and tissues. It has also been found that the treatment of certain diseases with exogenous L-carnitine can improve clinical symptoms. As early as the 1960s, D, L-carnitine has been used clinically as a stomach medicine, mainly for aiding digestion and increasing appetite. Later research found that only L-carnitine w...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/205A61K47/24A61K47/10A61P9/10A61P9/02A61P9/00A61P9/06A61P13/12A61P3/10A61P1/16A61P3/06A61P3/04A61P39/00
CPCA61K9/08A61K9/0019A61K31/205A61K47/10A61K47/24
Inventor 钟正明
Owner HAINAN HERUI PHARMA
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