High oxidation resistance medium/long chain fat emulsion injection and preparation method thereof

A long-chain fat emulsion and oxidative technology, which is applied in the field of pharmacy, can solve the problems of reducing the effect of emulsion lipid oxidation, the enlargement of emulsion particles, and the dosage not meeting the safety requirements, so as to reduce the degree of oxidation and reduce potential hazards , to ensure the effect of stability

Inactive Publication Date: 2010-08-11
SHANGHAI INST OF PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Anne-Mette Haahr et al. (Eur.J.Lipid Sci.Technol.2008, 110(10):940-961) investigated edetate disodium (EDTA-Na 2 , the dosage is 0.019%, not within the scope of protection of this patent) to reduce the effect of lipid oxidation in the emulsion, but did not reveal the effect of EDTA-Na 2 Effect on the stability of milk grains, because EDTA-Na 2 Excessive dosage will destroy the electric double layer on the surface of the emulsion, causing the emulsion to become larger and finally delaminated
In addition, for intravenous injection of fat emulsion, its dosage obviously does not meet the safety requirements of SFDA

Method used

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  • High oxidation resistance medium/long chain fat emulsion injection and preparation method thereof
  • High oxidation resistance medium/long chain fat emulsion injection and preparation method thereof
  • High oxidation resistance medium/long chain fat emulsion injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Under nitrogen protection, weigh 100g of soybean oil for injection, 100g of medium-chain triglyceride, heat to 60°C, add 12g of egg yolk lecithin under high-speed stirring, stir well as the oil phase, and add edetate calcium sodium 0.05 g. Add 25 g of glycerin for injection into 600 ml of water for injection, mix well and filter with a 0.45 μm filter membrane as the water phase. Add the oil phase to the water phase under high-speed stirring to make colostrum, adjust the pH value to 9.0-10.0 with NaOH, add water for injection to 1000ml, and repeatedly homogenize through a high-pressure homogenizer to check the size of the milk particles. The diameter is less than 1 μm. After the emulsion is filtered, it is filled with nitrogen, plugged, capped, sterilized in a rotary steam sterilizer, and cooled to obtain the high antioxidant fat emulsion injection of soybean oil and medium-chain triglyceride.

Embodiment 2

[0041] Under nitrogen protection, weigh 100g of soybean oil for injection, 100g of medium-chain triglycerides, and 0.2g of oleic acid, heat to 60°C, add 12g of egg yolk lecithin under high-speed stirring, and stir evenly as the oil phase. Add 0.1 g of disodium diacetate and 25 g of glycerin for injection into 600 ml of water for injection, mix well, and filter with a 0.45 μm filter membrane as the water phase. Add the oil phase to the water phase under high-speed stirring to make colostrum, adjust the pH value to 9.0-10.0 with NaOH, add water for injection to 1000ml, and repeatedly homogenize through a high-pressure homogenizer to check the size of the milk particles. The diameter is less than 1 μm. After the emulsion is filtered, it is filled with nitrogen, plugged, capped, sterilized in a rotary steam sterilizer, and cooled to obtain the high antioxidant fat emulsion injection of soybean oil and medium-chain triglyceride.

Embodiment 3

[0043] Under nitrogen protection, weigh 100g of soybean oil for injection and 100g of medium-chain triglycerides, heat to 60°C, add 12g of egg yolk lecithin under high-speed stirring, and stir evenly as the oil phase. Add calcium sodium edetate 0.005 g. Add 0.05 g of sodium oleate and 25 g of glycerin for injection into 600 ml of water for injection, mix well and filter with a 0.45 μm filter membrane as the water phase. Add the oil phase to the water phase under high-speed stirring to make colostrum, adjust the pH value to 9.0-10.0 with NaOH, add water for injection to 1000ml, and repeatedly homogenize through a high-pressure homogenizer to check the size of the milk particles. The diameter is less than 1 μm. After the emulsion is filtered, it is filled with nitrogen, plugged, capped, sterilized in a rotary steam sterilizer, and cooled to obtain the high antioxidant fat emulsion injection of soybean oil and medium-chain triglyceride.

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Abstract

The invention provides high oxidation resistance medium/long chain fat emulsion injection (C8-C24) and a preparation method thereof. The fat injection consists of soybean oil for active component injection, median chain triglyceride oil, emulsifier, isoosmotic adjusting agent, metal ion chelation agent and water for injection. The method comprises the following steps: under inert gas environment, adding the emulsifier and the coemulsifier into the heated soybean oil for injection and the median chain triglyceride oil, and uniformly stirring the mixture at high speed serving as oil phase; uniformly mixing the isoosmotic adjusting agent and the metal ion chelation agent with proper water for injection, and filtering the solution serving as water phase; in high speed stirring, combining the oil phase and the water phase, continuously stirring the mixture to foremilk at high speed, adjusting the pH of the foremilk to be between 9.0 and 10.0, adding the water for injection to the volume of 1,000ml; homogenizing the foremilk after the foremilk is uniformly mixed by a high pressure homogenizer until the milk particles are qualified; and preparing the medium/long chain fat emulsion injection through filling, nitrogen introducing, plugging, capping, sterilizing and cooling after filtration.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a high antioxidant fat emulsion injection and a preparation method thereof. Background technique [0002] Medium / Long Chain Fat Emulsion Injection (C 8 ~C 24 ) is a nutritional supplement that provides energy and essential fatty acids in a very wide range of clinical applications. It uses soybean oil for injection and medium-chain triglycerides as the oil phase, supplemented by phospholipids as emulsifiers, and glycerin as an isotonic regulator. Prepared by proper emulsification techniques. [0003] Since natural injection oil usually contains a variety of non-glyceride impurities, fat emulsion injection prepared from oil containing impurities may cause adverse reactions such as fever during clinical application, so it must be refined to remove impurities before it can be used for preparation of intravenous injection Fat emulsion, but as the degree of refining increases, the content of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/23A61K47/16A61K47/44A61P3/02
Inventor 谢保源陈允发何军陈辰张兵孙润梅
Owner SHANGHAI INST OF PHARMA IND
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