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Injectable composition containing phosphatidylcholine devoid of sodium deoxycholate and preparation method thereof

A technology of phosphatidylcholine and injection composition, applied in the field of injectable composition containing phosphatidylcholine and its preparation, capable of solving safety problems and other problems

Inactive Publication Date: 2014-10-01
AMIFARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, sodium deoxycholate, which is a major component of bile acids, may cause safety concerns when it is administered to body tissues other than the small intestine
In addition, it may cause colorectal cancer

Method used

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  • Injectable composition containing phosphatidylcholine devoid of sodium deoxycholate and preparation method thereof
  • Injectable composition containing phosphatidylcholine devoid of sodium deoxycholate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Solubilization of Phosphatidylcholine Tested Using Various Solubilization Composition Components

[0075] In order to find an injectable composition capable of solubilizing phosphatidylcholine without the use of sodium deoxycholate, unlike conventional phosphatidylcholine-containing injectable compositions, various combinations of phospholipids of additives for intravenous injection were evaluated. Solubilizing ability.

[0076] Phosphatidylcholine, polysorbate 80, and ethanol were mixed with each other in the amounts shown in Table 1 below, and the mixture was stirred at 300 rpm for 30 minutes at 30° C. in a closed space under dark conditions.

[0077] Phosphatidylcholine was purchased from Lipoid GmbH (Germany) (catalogue number 368202, model number: 90G).

[0078] 45 mg of benzyl alcohol was added to the mixture, and various other solubilizers were added. Water for injection was added thereto until a total volume of 5 ml was reached. The resulting solution was...

Embodiment 2

[0085] Solubilization of Phosphatidylcholine Tested Using Various Concentrations of Solubilizing Composition Components

[0086] The components selected in Example 1 were combined with each other to obtain various components and concentrations, and the conditions for obtaining the optimal solubilized injectable composition were determined.

[0087] Phosphatidylcholine, polysorbate 80 and / or polyethylene glycol 15 hydroxystearate, and ethanol were mixed with each other in the amounts shown in Table 2 below, and the mixture was mixed in a closed space under dark conditions. Stir at 300 rpm for 30 minutes at 30°C.

[0088] Propylene glycol and / or benzyl alcohol were added to the mixture in the amounts shown in Table 2 below, and water for injection was added until a total volume of 5 ml was reached. The resulting solution was stirred at 300 rpm at 30° C. for 3 hours in a closed space under dark conditions, thereby preparing an injectable composition.

[0089] Visual observati...

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Abstract

The present invention provides an injectable composition containing phosphatidylcholine, and a preparation method thereof. The composition comprises phosphatidylcholine, ethanol, propylene glycol and / or benzyl alcohol, polysorbate and / or macrogol 15 hydroxystearate, and a balance of water or water for injection. The injectable composition provided by the present invention comprises no sodium deoxycholate which is known as carcinogenic and therefore, the more safe injectable composition of phosphatidylcholine can be prepared.

Description

technical field [0001] The present invention relates to an injectable composition containing phosphatidylcholine without sodium deoxycholate and a preparation method thereof, and more particularly to an injectable composition containing phosphatidylcholine and a preparation method thereof. The composition comprises: phosphatidylcholine; ethanol; propylene glycol and / or benzyl alcohol; polysorbate and / or polyethylene glycol 15 hydroxystearate; and the rest of water or water for injection. Background technique [0002] Phosphatidylcholines are a class of phospholipids that contain choline as the head group. They widely exist in animals, plants, yeast and fungi, also known as lecithin. They are membrane phospholipids of mammals, mainly found in the brain, nerves, blood cells, egg yolk, etc. In plants, phosphatidylcholine occurs in soybeans, sunflower seeds, malt, etc. Phosphatidylcholine generally contains a saturated fatty acid at the 1 position of glycerol and an unsaturat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/661A61K31/66A61K31/675A61K9/08
CPCA61K31/685A61K47/10A61K9/08A61K9/0019A61K47/24A61K47/26A61K9/1075A61P1/16A61P3/06A61K31/661A61K31/66A61K31/675
Inventor 李奇泽李钟赫成一庆
Owner AMIFARM