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High concentration middle/long fatty milk injection for injection and preparing method thereof

A technology for long-chain fat emulsion and injection, which is applied in the direction of liposome delivery, metabolic diseases, active ingredients of esters, etc. It can solve the problems of blood biochemical indicators such as triglycerides, cholesterol, and phospholipids, and achieve low blood lipid metabolism. Exceptional, well tolerated, broad range of effects

Inactive Publication Date: 2008-08-20
GUANGZHOU FUBANG PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in a large number of clinical studies, it has been found that long-term use of fat emulsion products for energy supply can increase blood biochemical indicators such as triglycerides, cholesterol, and phospholipids in patients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Ingredients: soybean oil (for injection) 150 g / L, medium chain triglyceride (for injection) 150 g / L, lecithin (for injection) 12 g / L, glycerin (for injection) 12 g / L, sodium hydroxide 0.6 g / L, appropriate amount of water for injection.

[0039] Manufacturing method:

[0040] a. Take 150 g / L of soybean oil (for injection) and 150 g / L of medium-chain triglyceride (for injection), put them in a preparation tank, stir for 18 minutes to mix well, slowly heat to 80°C, Add lecithin (for injection) 12 g / L under stirring, stir until dissolved, as the oil phase;

[0041] b. Take 650 grams of water for injection, put it in another preparation tank, add 12 grams / liter of glycerin, stir to dissolve, heat to 80°C, and use it as the water phase. ;

[0042] c. Slowly add the oil phase to the vigorously stirred water phase at 80°C at a constant speed, and keep stirring for 15 minutes to form white colostrum;

[0043] d. Add an appropriate amount of sodium hydroxide solution to adjus...

Embodiment 2

[0049] Ingredients: soybean oil (for injection) 165 g / L, medium chain triglyceride (for injection) 150 g / L, lecithin (for injection) 13 g / L, glycerin (for injection) 18 g / L, sodium hydroxide 0.2 g / L, appropriate amount of water for injection.

[0050] Manufacturing method: a. Get 165 grams / liter of soybean oil (for injection) and 150 grams / liter of medium-chain triglyceride (for injection), and put them in a preparation tank. Stir for 20 minutes to mix well, slowly heat to 60°C, add 13 g / L lecithin under vigorous stirring, stir until dissolved, and use it as the oil phase;

[0051] b. Take 600 grams of water for injection, put it in another preparation tank, add 18 grams / liter of glycerin, stir to dissolve, slowly heat to 60°C, and use it as the water phase. ;

[0052] c. Add the oil phase to the vigorously stirred water phase at 60°C at a uniform speed, and keep stirring for 12 minutes to form white colostrum;

[0053] d. Add an appropriate amount of sodium hydroxide solu...

Embodiment 3

[0059] Ingredients: soybean oil (for injection) 150 g / L, medium chain triglyceride (for injection) 150 g / L, lecithin (for injection) 12 g / L, glycerin (for injection) 17 g / L, sodium oleate 0.3 g / L, sodium hydroxide 0.02 g / L, and appropriate amount of water for injection.

[0060] Manufacturing method: a. Get 150 grams / liter of soybean oil (for injection), 150 grams / liter of medium-chain triglyceride (for injection), and put them in a preparation tank. , stirred for 15 minutes to mix well, slowly heated to 70°C, added 12 g / L of lecithin (for injection) under strong stirring, stirred until dissolved, and used as the oil phase;

[0061] b. Take 650 grams of water for injection, put it in another preparation tank, add 17 grams / liter of glycerin, add 0.3 grams / liter of sodium oleate, stir to dissolve, heat to 70 ° C, and use it as the water phase. ;

[0062] c. Slowly add the oil phase to the vigorously stirred water phase at 70°C at a constant speed, and keep stirring for 10 minu...

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Abstract

The invention relates to a high-concentration medium / long chained fat emulsion injection for injection. The technical proposal is that the components of the injection comprise 135-165g / l long chained triglyceride (soybean oil, for injection), 135-165g / l medium chained triglyceride (for injection), 11-14g / l lecithin (for injection), 15-25g / l glycerol (for injection), a right amount of sodium hydroxide or eunatrol, and the rest being water for injection. The manufacturing method of the medium / long chained fat emulsion is characterized in comprising steps of fat phase preparation, aqueous phase preparation, foremilk preparation, PH value adjustment, high-pressure homogenization, nitrogen-filled bulking and rotating sterilization. The high-concentration medium / long chained fat emulsion injection has the advantages that the invention provides the medium / long chained fat emulsion injection with safety, high energy, low capacity, isotonicity, low PL / TG ratio for patients; and the invention is suitable for the patients who cannot well utilize the long chained triglyceride due to the lack or inactivity of novain enzyme caused by pathological state and more suitable for the patients who need high energy but contemporarily need restriction on the liquid input.

Description

Technical field [0001] The invention relates to an injection and a manufacturing method thereof, in particular to a high-concentration medium / long-chain fat emulsion injection for injection and a manufacturing method thereof. Background technique [0002] Medium / long-chain fat emulsion injection is a new type of fat emulsion for parenteral nutrition, which is composed of medium-chain triglycerides and long-chain triglycerides in a ratio of 1:1. The medium-chain triglycerides in the formula provide suitable energy for human physiological metabolism, and the long-chain triglycerides provide the essential fatty acids needed by the human body, which can improve nitrogen balance, protect liver, lung and immune function, and have few side effects. The osmotic pressure of this product is basically the same as that of blood, and it can be infused through peripheral vein and central vein. It can be mixed with nutrients such as glucose, amino acids, electrolytes, vitamins and trace e...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/23A61P3/02
Inventor 李帼蓉
Owner GUANGZHOU FUBANG PHARMA TECH
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