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

An injection, oxidative technology, applied in the field of pharmacy, can solve the problems such as the dosage does not meet the SFDA safety requirements, the influence of the stability of emulsion particles is not disclosed, the effect of reducing the oxidation of fish oil, etc., to ensure stability and reduce oxidation. , the effect of reducing potential harm

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%, which is not within the scope of protection of this patent) to reduce the effect of oxidation of fish oil in emulsion, but did not disclose the effect of EDTA-Na 2 The effect on the stability of milk particles, when 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 long chain fat emulsion injection and preparation method thereof
  • High oxidation resistance long chain fat emulsion injection and preparation method thereof
  • High oxidation resistance long chain fat emulsion injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Under the protection of nitrogen, weigh 100g of soybean oil for injection, heat to 60°C, add 12g of egg yolk lecithin under high-speed stirring, stir evenly as the oil phase, add 0.05g of calcium sodium edetate and 25g of glycerin for injection into 600ml In 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.

Embodiment 2

[0050] Under the protection of nitrogen, weigh 200g of soybean oil for injection, heat to 60°C, add 12g of egg yolk lecithin under high-speed stirring, stir evenly as the oil phase, add 0.05g of calcium sodium edetate and 25g of glycerin for injection into 600ml In 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.

Embodiment 3

[0052] Under the protection of nitrogen, weigh 300g of soybean oil for injection, heat to 60°C, add 12g of egg yolk lecithin under high-speed stirring, stir evenly as the oil phase, add 0.05g of calcium sodium edetate and 25g of glycerin for injection into 600ml In 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.

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Abstract

The invention provides high oxidation resistance long chain fat emulsion injection and a preparation method thereof. The fat injection consists of soybean oil for active component injection, emulsifier, isoosmotic adjusting agent, metal ion chelation agent and water for injection. The preparation method comprises the following steps: under inert gas environment, adding the emulsifier and coemulsifier into the heated soybean oil for injection, and uniformly stirring the mixture serving as oil phase at high speed; 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 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] Fat emulsion injection is a nutritional supplement that provides energy and essential fatty acids in a very wide range of clinical applications. Oils derived from plants or animals (such as soybean oil, medium-chain triglycerides, olive oil, fish oil, etc. or several oils) mixture) as oil phase, supplemented with phospholipid as emulsifier, glycerin as isotonic regulator, prepared by appropriate emulsification technology. [0003] Since oils derived from plants or animals usually contain a variety of non-glyceride impurities, the use of oil containing impurities to prepare fat emulsion injections may cause adverse reactions such as fever during clinical application, so the oil must be refined to remove impurities before it can be used for preparation Intravenous injection of fat emul...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K36/48A61K31/21A61K35/60A61K36/63A61K36/286A61K36/185A61K47/18A61P3/02
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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