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Medium and long-chain fat emulsion injection and preparation method thereof

A technology of injection and fat emulsion, which is applied in the field of medicine, can solve the problems of increasing the risk of sepsis infection in patients, the effect of immunosuppressive damage on the endothelial system, etc., to reduce the level of total cholesterol, solve clinical adverse reactions, and improve high-density lipoprotein cholesterol. horizontal effect

Active Publication Date: 2015-08-26
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Most of the long-chain oils in the existing medium- and long-chain fat emulsion injection formulations on the market are soybean oil, and the content of linoleic acid in ω-6PUFA in soybean oil is 50-55%, and the content of linolenic acid in ω-3PUFA is only 7%. %, excessive intake of linoleic acid in omega-6 PUFA will lead to potential risks of immunosuppression, promotion of inflammation and damage to the endothelial system, and may even increase the risk of sepsis in patients

Method used

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  • Medium and long-chain fat emulsion injection and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0052] In this example, a medium- and long-chain fat emulsion injection is prepared from the following ingredients: each 100ml injection contains 10.2g of refined linseed oil, 10.2g of medium-chain oil (medium-chain triglyceride) for injection, and an emulsifier (Egg Yolk Phospholipid 1.2g + Sodium Oleate 0.03g) 1.23g, Isotonic Regulator (Glycerol for Injection) 2.5g, Antioxidant (Vitamin E) 0.2g, pH Regulator (Sodium Hydroxide) to Regulate the pH of Injection To 5.0-9.0, the balance is water for injection.

[0053] The preparation method of the above-mentioned medium and long-chain fat emulsion injection comprises the following steps:

[0054] (1) Oil phase preparation: under nitrogen protection, heat refined linseed oil and medium-chain oil for injection to 65°C, add emulsifier and antioxidant under high-speed stirring at 6000 rpm to disperse, and obtain an oil phase;

[0055] (2) Water phase preparation: Heat 75.7 g of water for injection to 65°C, add an isotonic regulator...

Embodiment 2

[0068] In this example, a medium- and long-chain fat emulsion injection is prepared from the following ingredients: each 100ml injection contains 10.1g of refined linseed oil, 10.0g of medium-chain oil (medium-chain triglyceride) for injection, and an emulsifier (Egg yolk phospholipid 1.0g + sodium oleate 0.02g + glycerol monooleate 0.03g) 1.05g, isotonicity regulator (sorbitol) 2.6g, antioxidant (anhydrous sodium sulfite 0.03g + edetate disodium 0.1g) 0.13 g. The pH regulator (sodium hydroxide) adjusts the pH of the injection to 8.2, and the balance is water for injection.

[0069] The preparation method of the above-mentioned medium and long-chain fat emulsion injection comprises the following steps:

[0070] (1) Oil phase preparation: under nitrogen protection, heat refined linseed oil and medium-chain oil for injection to 76°C, add emulsifier and antioxidant under high-speed stirring at 8000 rpm to disperse, and obtain an oil phase;

[0071] (2) Water phase preparation: H...

Embodiment 3

[0078] In this example, a medium- and long-chain fat emulsion injection is prepared from the following ingredients: each 100ml injection contains 10.0 g of refined linseed oil, 10.0 g of medium-chain oil (medium-chain triglyceride) for injection, and an emulsifier (Soybean Lecithin 1.5g + Sodium Oleate 0.03g + Poloxamer 0.1g) 1.63g, Isotonic Regulator (Glycerol for Injection) 2.5g, Antioxidant (Vitamin E 0.02g + Edetate Disodium 0.1g) 0.12g 1. A pH regulator (sodium hydroxide) to adjust the pH of the injection to 8.9, and the balance is water for injection.

[0079] The preparation method of the above-mentioned medium and long-chain fat emulsion injection comprises the following steps:

[0080] (1) Oil phase preparation: under nitrogen protection, heat refined linseed oil and medium-chain oil for injection to 62°C, add emulsifier and antioxidant under high-speed stirring at 10,000 rpm to disperse, and obtain an oil phase;

[0081] (2) Water phase preparation: Heat 75.7 g of wat...

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Abstract

The invention discloses medium-chain and long-chain fat emulsion injection and a preparation method thereof. The injection is prepared by the following components: every 1000 ml of injection contains 50-200 g of refined linseed oil, 50-200 g of medium-chain oil for injection, 6-18 g of an emulsifier, 15-35 g of an isoosmotic adjusting agent, 0.1-2 g of an antioxidant, and water for injection in balancing amount, wherein the pH value of the injection is adjusted to be 5.0-9.0 by adopting a pH value conditioning agent, and the medium-chain oil for injection is medium-chain triglyceride. The preparation method comprises oil phase preparation, water phase preparation, elementary fat emulsion preparation, homogenization and fine filtration. The medium-chain and long-chain fat emulsion injection provided by the invention is a fat emulsion for injection containing the linseed oil, and has good stability; due to the low content of linoleic acid and the high content of linolenic acid in the medium-chain and long-chain fat emulsion injection, the adverse clinical reactions caused by high content of the linoleic acid in the existing fat emulsion injection are solved; and the medium-chain and long-chain fat emulsion injection has the important efficacy of maintaining lipoprotein balance, reducing blood fat, regulating cholesterol metabolism, dropping blood pressure, resisting thrombus and preventing canceration.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a medium and long-chain fat emulsion injection and a preparation method thereof. Background technique [0002] Fat is an important nutrient in parenteral nutrition. It mainly provides energy and essential fatty acids for the human body. However, fat cannot be injected directly into the vein, otherwise it will cause fat embolism and endanger the patient's life. Therefore, modern preparation technology and equipment must be used to make stable microemulsion Only capsules can be used for parenteral nutrition. Intravenous fat emulsion preparations have the following characteristics: higher calories, 1g of fat can provide 9.3kcal or 39kJ calories; similar to blood osmotic pressure, can be infused through peripheral veins; can provide essential fatty acids and sufficient choline content to enhance The body's resistance to injury and infection; it is not excreted by the kidneys, does ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K36/55A61K31/202A61P3/02C11B3/00C11B3/06C11B3/10A61K31/201
Inventor 韩瑶李继仁叶芳
Owner HUAREN PHARMACEUTICAL CO LTD
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