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Medium and long chain fat emulsion injection containing olive oil and preparation method of medium and long chain fat emulsion injection

A long-chain fat emulsion and injection technology, applied in the field of medicine, can solve the problems of poor stability, destruction of the emulsion system, and the need to reduce inflammatory response, so as to improve the stability and drug safety, optimize the preparation process, enhance the The effect of emulsifying ability

Active Publication Date: 2017-11-03
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] For fat emulsion supplementation for critically ill and perioperative patients, most of the long-chain oils in the current commercially available medium / long-chain fat emulsion injection formulations are soybean oil, which cannot meet the needs of reducing inflammation; the existing olive oil The fat emulsion injection formula only contains two long-chain oils, olive oil and soybean oil, which cannot meet its needs for rapid energy supply
[0008] Moreover, the stability of the long-chain fat emulsion injection currently available on the market is not good, and it is easily affected by temperature during the process and storage process, and there are cases where emulsion particles larger than 5 μm (PFAT5) are unqualified
On the other hand, the "all-in-one" nutritional preparations commonly used in clinical practice, after mixing olive oil fat emulsion injections with other injections such as electrolyte injections and amino acid injections, are also prone to emulsion system damage, fat particles becoming larger, and phase separation. and other issues

Method used

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  • Medium and long chain fat emulsion injection containing olive oil and preparation method of medium and long chain fat emulsion injection
  • Medium and long chain fat emulsion injection containing olive oil and preparation method of medium and long chain fat emulsion injection
  • Medium and long chain fat emulsion injection containing olive oil and preparation method of medium and long chain fat emulsion injection

Examples

Experimental program
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Effect test

Embodiment 1

[0034] Oil phase preparation: under nitrogen protection, 120 g of refined olive oil, 40 g of soybean oil for injection, and 40 g of medium-chain triglycerides were added to the container. Heat it in a water bath to 65°C, add 9 g of refined egg yolk phospholipids under high-speed stirring at 6000 rpm, and disperse it to prepare an oil phase.

[0035]Water phase preparation: put 751.6g of 67°C water for injection in another container, add 25g of glycerin for injection, 0.225g of sodium oleate, and 1880.225g of poloxamer, stir and mix well, and filter through a 0.45μm filter membrane to prepare an aqueous phase .

[0036] Colostrum preparation: under nitrogen protection, pour the oil phase into the water phase under high-speed stirring at 6000 rpm and stir for 15 minutes to prepare colostrum. Rapidly cool down to about 30°C and perform high-pressure homogenization.

[0037] Homogenization: In a closed container and under nitrogen protection, transfer the prepared colostrum into...

Embodiment 2

[0046] Oil phase preparation: under nitrogen protection, 160 g of refined olive oil, 20 g of soybean oil for injection, and 20 g of medium-chain triglycerides were added to the container. Heat it in a water bath to 70° C., add 12 g of refined egg yolk phospholipids under high-speed stirring at 8000 rpm, and disperse it to prepare an oil phase.

[0047] Water phase preparation: put 750.9g of 67°C water for injection into the container, add 22.5g of glycerin for injection, 0.3g of sodium oleate, and 1880.3g of poloxamer, stir and mix well, and filter through a 0.45μm filter membrane to prepare water Mutually.

[0048] Colostrum preparation: Under nitrogen protection, pour the oil phase into the water phase and stir for 15 minutes under high-speed stirring at 15,000 rpm to make colostrum, quickly cool down to about 40°C and perform high-pressure homogenization.

[0049] Homogenization: In a closed container and under the protection of nitrogen, transfer the prepared colostrum in...

Embodiment 3

[0058] Preparation of the oil phase: under nitrogen protection, 180 g of refined olive oil, 10 g of soybean oil for injection, and 10 g of medium-chain triglycerides were added to the container. Heat it in a water bath to 68° C., add 15 g of refined egg yolk phospholipids under high-speed stirring at 10,000 rpm, and disperse it to prepare an oil phase.

[0059] Water phase preparation: put 742.1g of 69°C water for injection in another container, add 28.1g of glycerin for injection, 0.375g of sodium oleate, and 1880.375g of poloxamer, stir and mix well, and filter through a 0.45μm filter membrane to prepare water Mutually.

[0060] Colostrum preparation: Under nitrogen protection, pour the oil phase into the water phase and stir for 15 minutes under high-speed stirring at 20,000 rpm to make colostrum, quickly cool down to about 45°C and perform high-pressure homogenization.

[0061] Homogenization: In a closed container and under nitrogen protection, transfer the prepared colo...

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Abstract

The invention discloses an olive oil medium and long chain fat emulsion injection composition which can meet the needs of providing energy quickly and reducing inflammatory response of patients during critical and perioperative periods and is stable in quality and a preparation method of the medium and long chain fat emulsion injection and belongs to the technical field of medicines. Every 1000 ml of the fat emulsion injection, disclosed by the invention, contains 120 to 180 g of olive oil, 10 to 40 g of soybean oil, 10 to 40 g of medium chain triglycerides, 6 to 18 g of a compound emulsifier, 15 to 35 g of glycerol, a proper amount of sodium hydroxide and water for injection. The preparation method of the fat emulsion injection, disclosed by the invention, comprises the following steps: preparing an oil phase; preparing a water phase; preparing colostrum; homogenizing; and carrying out fine filtering and filling, external packaging and sterilizing treatment. The fat emulsion injection prepared by the components and the preparation method has uniform particle size and little influence from PFAT5, lysophosphatide, lysophosphatidyl ethanolamine, anisidine value and zeta potential, and further the stability and the medication safety of the composition are improved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an injection containing olive oil and medium / long-chain fat emulsion composition and a preparation method thereof. Background technique [0002] Parenteral nutrition (PN) refers to a method of infusing intravenous nutrition solutions including glucose, amino acids, fat emulsions, electrolytes, trace elements, water-soluble and fat-soluble vitamins through central vein or peripheral vein cannulation. . PN can provide effective nutritional support for critically ill patients and patients with gastrointestinal insufficiency, and plays an active role in improving the nutrition of perioperative patients and improving the success rate of surgery. [0003] Fat emulsion is one of the main ingredients in parenteral nutrition. Intravenous infusion of fat emulsion has two main functions: providing essential fatty acids and serving as a source of energy for the body. Soybean oil long-cha...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/10A61K47/24A61K47/12A61K36/48A61P3/02A61K31/22A61K31/23
CPCA61K9/0019A61K9/107A61K31/22A61K31/23A61K36/32A61K36/48A61K47/10A61K47/12A61K47/24A61K2300/00
Inventor 韩瑶尹冬丽王小飞
Owner HUAREN PHARMACEUTICAL CO LTD
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