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Sub-microemulsion preparation for levocarnitine injection and preparation method thereof

A technology for milk preparations and injections, which is applied in the field of medicine, can solve the problems of unstable and unstable product quality, and achieve the effect of simple and easy preparation process, good stability and convenient use

Inactive Publication Date: 2009-06-24
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, levocarnitine injection products are on the market, but the product quality is very unstable. The present invention prepares levocarnitine into a submicron emulsion freeze-dried preparation, which can effectively solve the problem of instability

Method used

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  • Sub-microemulsion preparation for levocarnitine injection and preparation method thereof
  • Sub-microemulsion preparation for levocarnitine injection and preparation method thereof
  • Sub-microemulsion preparation for levocarnitine injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] L-Carnitine 500g

[0031] soybean oil 500g

[0032] Soy Lecithin 1000g

[0033] Butylated hydroxytoluene 30g

[0034] Sodium bisulfite 20g

[0035] Glucose 1000g

[0036] Phosphate buffer solution to pH 5.0-6.5

[0037] Water for injection 5000ml

[0038] Preparation Process:

[0039] (1) Weigh 500g of levocarnitine and evenly disperse it in 500g of soybean oil, add 1000g of soybean lecithin and 30g of dibutyl hydroxytoluene, heat to 50°C, and stir evenly to obtain an oil phase;

[0040] (2) Weigh 1000g of glucose and 20g of sodium bisulfite and dissolve them in water for injection, stir and dissolve to obtain an aqueous phase;

[0041] (3) Mix the prepared oil phase and water phase, heat to 50° C., stir evenly to obtain colostrum, and then further emulsify with a high-pressure homogenizer to obtain levocarnitine emulsion;

[0042] (4) The emulsion was adjusted to 5.8 with phosphate buffer, filtered through a microporous membrane, and freeze-dried to obtain a fr...

Embodiment 2

[0044] L-Carnitine 1000g

[0045] Peanut oil 3000g

[0046] Vitamin E-Polyethylene Glycol 1000 Succinate 5000g

[0047] Tocopherol 400g

[0048] Ascorbic acid 600g

[0049] Sorbitol 9000g

[0050] Amount of citric acid and sodium citrate buffer to pH 5.0-6.5

[0051] Water for injection 20000ml

[0052] Preparation Process:

[0053] (1) Weigh 1000g of levocarnitine and evenly disperse it in 3000g of peanut oil, add 5000g of vitamin E-polyethylene glycol 1000 succinate and 400g of tocopherol, heat to 60°C, and stir evenly to obtain an oil phase;

[0054] (2) Take 9000g sorbitol and 600g ascorbic acid and dissolve in water for injection, stir and dissolve to obtain the aqueous phase;

[0055] (3) Mix the prepared oil phase and water phase, heat to 60°C, stir evenly to obtain colostrum, and then further emulsify with a high-pressure homogenizer to obtain levocarnitine emulsion;

[0056] (4) The emulsion was adjusted to 5.9 with citric acid and sodium citrate buffer, filtere...

Embodiment 3

[0058] L-Carnitine 500g

[0059] Olive oil 3000g

[0060] Yolk Lecithin 5000g

[0061] Butylated hydroxytoluene 30g

[0062] Ascorbic acid 20g

[0063] Glucose 5000g

[0064] Acetate buffer to pH 5.0-6.5

[0065] Water for injection 10000ml

[0066] The preparation process was the same as that in Example 1, the acetate buffer was adjusted to 5.7, and freeze-dried to obtain a freeze-dried preparation of levocarnitine submicroemulsion.

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Abstract

The invention relates to a submicroemulsion preparation for injecting levocarnitine and a preparation method thereof. Proper auxiliary materials and preparation method are selected, so the emulsion has large drug loading, good stability and long storage period, and can prepare emulsions with different contents. The emulsion can be directly used for intravenous injection, has curative effect superior to that of the prior water injection preparation formulation, particularly has good drug stability at the same time, and is applicable to the mass preparation and industrialized production of the submicroemulsion preparation for injecting the levocarnitine.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of levocarnitine, in particular to a submicron emulsion preparation for injection of levocarnitine and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] L-carnitine, also known as L-carnitine, is a special amino acid that widely exists in human body tissues. It is an essential nutrient for humans and animals. It is a vitamin-like nutrient, which is equivalent to vitamin B group. Studies have found that L-carnitine is a compound related to fatty acid metabolism in animals, and its basic function is to assist long-chain fatty acids to penetrate the mitochondrial inner membrane for β-oxidation. 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. Engel reported...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/205A61P9/00A61P1/16A61P3/00
Inventor 邱民
Owner HAINAN LINGKANG PHARMA CO LTD
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