Fat emulsion for injection and its preparing process

A fat emulsion and manufacturing method technology, applied in the directions of oil/fat/wax inactive ingredients, emulsion delivery, etc., can solve the problems of elevated plasma cholesterol, phospholipid and triglyceride levels, and achieve the effect of stability assurance

Inactive Publication Date: 2002-10-30
费森尤斯卡比华瑞制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the incidence of clinical side effects of 10% and 20% Intralipid ® is very low, studies have found that long-term use of the above products can increase the levels of plasma cholesterol, phospholipids and triglycerides in patients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0032] The ingredients are 330 grams / liter of purified soybean oil, 3 grams / liter of refined lecithin, 18 grams / liter of anhydrous glycerin, an appropriate amount of sodium hydroxide, and the rest is water for injection.

[0033] Manufacturing method: a. In a preparation tank with heating jacket and stirring equipment, heat 330 g / L of purified soybean oil to about 90°C, add 13 g / L of refined lecithin under strong stirring, and continue stirring until dissolved , forming an oil phase;

[0034] b. Add water for injection into a preparation tank with stirring equipment, then add 18 g / L anhydrous glycerin, stir to dissolve, then rinse the glycerin container with water for injection 4 times, and combine the eluent to glycerin solution , forming an aqueous phase, wherein the ratio of water for injection to anhydrous glycerin is 29 to 1;

[0035] c. Slowly add the oil phase to the vigorously stirred water phase, and continue vigorously stirring for 12 minutes to form colostrum;

[...

example 2

[0041] The ingredients are 290 g / L of purified soybean oil, 12.5 g / L of refined lecithin, 17 g / L of anhydrous glycerin, an appropriate amount of sodium hydroxide, and the rest is water for injection.

[0042] Manufacturing method: a. In a preparation tank with heating jacket and stirring equipment, heat 290 g / L of purified soybean oil to about 85°C, add 12.5 g / L of refined lecithin under strong stirring, and continue stirring until dissolved , forming an oil phase;

[0043] b. Add water for injection into a preparation tank with stirring equipment, then add 17 g / L anhydrous glycerin, stir to dissolve, then rinse the container containing glycerin with water for injection 3 times, and combine the eluent to glycerin solution , forming an aqueous phase, wherein the ratio of water for injection to anhydrous glycerin is 27 to 1;

[0044] c. Slowly add the oil phase to the vigorously stirred water phase, and continue vigorously stirring for 11 minutes to form colostrum;

[0045] d....

example 3

[0053] The ingredients are 320 g / L of purified soybean oil, 12.5 g / L of refined lecithin, 17 g / L of anhydrous glycerin, an appropriate amount of sodium hydroxide, and the rest is water for injection.

[0054] Manufacturing method: a. In a preparation tank with heating jacket and stirring equipment, heat 320 g / L of purified soybean oil to about 75°C, add 12.5 g / L of refined lecithin under strong stirring, and continue stirring until dissolved , forming an oil phase;

[0055] b. Add water for injection into a preparation tank with stirring equipment, then add 17 g / L anhydrous glycerin, stir to dissolve, then rinse the container containing glycerin with water for injection 4 times, and combine the eluent to glycerin solution , forming an aqueous phase, wherein the ratio of water for injection to anhydrous glycerin is 28 to 1;

[0056] c. Slowly add the oil phase to the vigorously stirred water phase, and continue vigorously stirring for 11 minutes to form colostrum;

[0057] d....

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PUM

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Abstract

A fatty emulsion for injection is prepared from purified soybean oil, refined lecithin, anhydrous glycerine, sodium hydroxide and water for injection through heating said purified soybean oil to 70-90 deg.C, dissolving refined lecithin in it while stirring to obtain oil phase, dissolving anhydrous glycerine in the water for injection while stirring to obtain water phase, slowly adding said oil phase to said water phase while stirring, and stirring for 10 mins to obtain early emulsion. Its advantages are high safety and high energy density.

Description

technical field [0001] The invention belongs to a fat emulsion for injection. Background technique [0002] Fat emulsion is an ideal intravenous injection that provides energy, biosynthetic carbon atoms and essential fatty acids. Its osmotic pressure is similar to that of blood, has no stimulation to the vein wall, can be infused through peripheral veins, has the advantages of high calorie, does not require insulin to participate in metabolism, and has no hyperosmolar diuresis. In clinical parenteral nutrition, it can be used together with glucose infusion to provide patients with double energy supply and prevent a series of complications caused by glucose alone. 10% and 20% Intralipid ® have more than 30 years of clinical experience, since the expiration of the patent, many companies have imitated the production. Although the incidence of clinical side effects of 10% and 20% Intralipid ® is very low, studies have found that long-term use of the above products can increase...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K47/44
Inventor 马涛
Owner 费森尤斯卡比华瑞制药有限公司
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