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Medium/long-chain fat emulsion injection pharmaceutical composition and preparation method thereof

A technology of long-chain fat emulsion and composition, which is applied in the directions of drug combination, pharmaceutical formulation, emulsion delivery, etc., can solve the problems of high methoxyaniline content, large liquid emulsion particles, impact on yield and production capacity, etc.

Active Publication Date: 2013-10-02
LIAONING HAISCO PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current preparation process has many times of homogenization, large liquid emulsion, high content of methoxyaniline which is harmful to human body in the liquid, long production cycle and high energy consumption, which affects the production and production capacity.

Method used

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  • Medium/long-chain fat emulsion injection pharmaceutical composition and preparation method thereof
  • Medium/long-chain fat emulsion injection pharmaceutical composition and preparation method thereof
  • Medium/long-chain fat emulsion injection pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1 Preparation of Medium / Long Chain Fat Emulsion Injection Pharmaceutical Composition

[0029] Prescription: 50 grams of soybean oil for injection, 50 grams of medium-chain triglycerides for injection, 12 grams of lecithin for injection, 25 grams of glycerin for injection, 0.2 grams of linoleic acid for injection, and water for injection to make up the full amount of the final volume of 1L join in.

[0030]Preparation method: under the protection of nitrogen, weigh the prescription amount of soybean oil and medium-chain triglyceride, stir and mix evenly, heat to 70-75°C, add lecithin and linoleic acid, stir quickly until uniformly dispersed, and prepare the oil Add the prescribed amount of glycerin to water for injection, mix well and filter through a filter membrane to prepare a glycerin aqueous solution (water phase), the temperature is maintained at 60-65°C; under nitrogen protection and rapid stirring, slowly add the above oil phase to the Colostrum is forme...

Embodiment 2

[0031] Example 2 Preparation of Medium / Long Chain Fat Emulsion Injection Pharmaceutical Composition

[0032] Prescription: 100 grams of soybean oil for injection, 100 grams of medium-chain triglycerides for injection, 12 grams of lecithin for injection, 25 grams of glycerin for injection, 0.25 grams of linoleic acid for injection, and water for injection to make up the full amount of the final volume of 1L join in.

[0033] Preparation method: with embodiment 1.

Embodiment 3

[0034] Example 3 Preparation of Medium / Long Chain Fat Emulsion Injection Pharmaceutical Composition

[0035] Prescription: 30 grams of soybean oil for injection, 30 grams of medium-chain triglycerides for injection, 11 grams of lecithin for injection, 18 grams of glycerin for injection, 0.18 grams of linoleic acid for injection, and water for injection to make up the full amount of the final volume of 1L join in.

[0036] Preparation method: with embodiment 1.

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Abstract

The invention relates to a medium / long-chain fat emulsion injection pharmaceutical composition with improved stability and a preparation method thereof. The composition contains soybean oil for injection, medium-chain triglyceride for injection, lecithin for injection, glycerol for injection, linoleic acid for injection and water for injection. The preparation method comprises the steps of oil phase preparation, water phase preparation, initial emulsion preparation, homogenization, filter membrane filtration, filling, sterilization and the like. In the medium / long-chain fat emulsion injection pharmaceutical composition preparation process, the coemulsifier linoleic acid is added to optimize the preparation technique so as to enhance the emulsifying capacity of the system and reduce and stabilize the emulsion particle size, thereby overcoming the defects of floating oil, enlarged emulsion particle and the like in the prior art; and the invention reduces the number of times of homogenization, enhances the productivity, lowers the methoxyaniline value of the product, and improves the stability and safety of the composition.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a medium / long-chain fat emulsion injection pharmaceutical composition and a preparation method thereof. Background technique [0002] Parenteral nutrition plays an important supportive role in the treatment of diseases. Parenteral nutrition plays an important role in maintaining life for patients with functional gastrointestinal diseases, cancer and those patients who need a temporary "rest" of the gastrointestinal tract. Parenteral nutrition enables patients to obtain various nutrients needed for metabolism, thereby avoiding the occurrence of starvation, malnutrition and "nutrition-related complications", and shortening the length of hospital stay. Parenteral nutrition is widely used in the treatment of patients with the following diseases, such as congenital gastrointestinal malformations, moderate to severe malnutrition, gastrointestinal diseases (severe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/48A61K9/107A61K47/12A61P3/02A61K31/685
Inventor 余悦东冯卫王利
Owner LIAONING HAISCO PHARMACEUTICAL CO LTD
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