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Preparation method of fat emulsion, amino acid and glucose injection packed in three-cavity bag

A technology for glucose injection and fat emulsion, which is applied in the directions of emulsion delivery, medical preparations containing active ingredients, and pharmaceutical formulations, etc., can solve problems such as affecting the safety of clinical medication, increasing the size of fat emulsion particles, and affecting the stability of emulsions. , to achieve the effect of increasing drug safety, narrowing the distribution of milk particles, and reducing adverse reactions

Active Publication Date: 2020-02-18
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The inventor finds that electrolyte can affect the stability of emulsion when developing fat emulsion (10%) / amino acid (15) / glucose (20%) injection, makes the milk particle of fat emulsion become bigger, demulsification etc., and this has had a strong impact on Safety of Clinical Drugs

Method used

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  • Preparation method of fat emulsion, amino acid and glucose injection packed in three-cavity bag
  • Preparation method of fat emulsion, amino acid and glucose injection packed in three-cavity bag
  • Preparation method of fat emulsion, amino acid and glucose injection packed in three-cavity bag

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Preparation method of fat emulsion, amino acid and glucose injection packaged in three-chamber bag

[0038] (1) Dosing

[0039] a. Preparation of 10% Fat Emulsion Injection:

[0040] Each 1000ml fat emulsion injection contains 100g soybean oil, 6g lecithin, 12.5g glycerol, 0.15g sodium oleate, appropriate amount of sodium hydroxide and water for injection.

[0041] Oil phase preparation: take 100g soybean oil, heat to 70°C under nitrogen protection, add 6g lecithin, stir and disperse; water phase preparation: add 12.5g glycerol to 250ml water for injection, stir and dissolve and heat to 70°C , introduce nitrogen until the dissolved oxygen content of the water for injection reaches below 3mg / L; mix and stir the oil phase and the water phase, add water for injection to 400ml (40% of the preparation amount), and pass through a high-pressure homogenizer after stirring. The homogenization pressure is 650bar for the primary valve, 120bar for the secondary valve, homogenize ...

Embodiment 2

[0054] Preparation method of fat emulsion, amino acid and glucose injection packaged in three-chamber bag

[0055] (1) Dosing

[0056] a. Preparation of 10% Fat Emulsion Injection:

[0057] Each 1000ml fat emulsion injection contains 100g soybean oil, 12g lecithin, 13.0g glycerol, 0.5g sodium oleate, appropriate amount of sodium hydroxide and water for injection.

[0058] Oil phase preparation: take 100g soybean oil, heat to 90°C under nitrogen protection, add 12g lecithin, stir and disperse; water phase preparation: add 13.0g glycerol to 450ml water for injection, stir and dissolve and heat to 90°C , pass nitrogen until the dissolved oxygen content of water for injection reaches below 3mg / L; mix and stir the oil phase and water phase, add water for injection to 600ml (60% of the preparation amount), stir evenly and pass through a high-pressure homogenizer, The homogenization pressure is 650bar for the primary valve, 120bar for the secondary valve, homogenize 4 times, and th...

Embodiment 3

[0071] Preparation method of fat emulsion, amino acid and glucose injection packaged in three-chamber bag

[0072] (1) Dosing

[0073] a. Preparation of 10% Fat Emulsion Injection:

[0074] Each 1000ml fat emulsion injection contains 100g soybean oil, 6g lecithin, 12.5g glycerol, 0.15g sodium oleate, appropriate amount of sodium hydroxide and water for injection.

[0075] Oil phase preparation: take 100g soybean oil, heat it to 70°C under nitrogen protection; water phase preparation: take 12.5g glycerol and add it to 450ml water for injection, stir and dissolve, heat to 70°C, and pass nitrogen to the level of water for injection. Add 6g of lecithin to the dissolved oxygen below 3mg / L, stir and disperse; mix and stir the oil phase and the water phase, add water for injection to 600ml (60% of the prepared amount), stir evenly, and pass it through a high-pressure homogenizer. The homogenization pressure is 650bar for the primary valve, 120bar for the secondary valve, homogenize...

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Abstract

The invention provides a preparation method of a fat emulsion injection, an amino acid injection and a glucose injection packed in a triple-chamber bag. The preparation method comprises the following steps: (1) preparing liquid; and (2) making the bag and filling the bag with the liquid, and conducting sterilizing. The fat emulsion injection, which is prepared by virtue of the method provided by the invention, is relatively good in emulsion particle uniformity and is relatively narrow in emulsion particle distribution; the stability of the long-term preserved fat emulsion injection in compatibility with such injections as amino acids, vitamins, electrolytes, glucose and the like is enhanced, the quality of the triple-chamber bag packed product (the injection) is improved, adverse reactions of the emulsion are relieved and medication safety is enhanced.

Description

technical field [0001] The invention relates to a preparation method of fat emulsion, amino acid and glucose injection packaged in a three-cavity bag, and belongs to the field of pharmaceutical preparations. Background technique [0002] Provide basic nutrients such as fat, protein and sugar when oral or enteral nutrition cannot, is insufficient or contraindicated, and is provided by intravenous infusion. Clinically, fat emulsion injection, amino acid injection and glucose injection are used to provide fat, protein and sugar respectively. Traditional fat emulsions use soybean oil as raw material. Among the fatty acids in soybean oil are polyunsaturated fatty acids (PUFA), mainly linoleic acid. Excessive PUFA will inhibit the normal inflammatory response of the human body. A number of studies have confirmed that the composition of fatty acids obtained from food or parenteral routes can affect the fatty acid composition of cell membranes to a large extent, thereby affecting t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K33/06A61K31/4172A61K31/405A61K31/401A61K31/198A61K31/7004
Inventor 孔繁贵赵栋王利春王晶翼
Owner SICHUAN KELUN PHARMA CO LTD
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