Preparation technology of fat emulsion injection product, and fat emulsion injection product

A preparation process and injection technology, which is applied in the direction of emulsion delivery, oil/fat/wax non-active ingredients, inorganic non-active ingredients, etc. It can solve the problems of not fundamentally reducing peroxides and unsafe hidden dangers

Inactive Publication Date: 2017-02-01
威海恒基伟业信息科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these measures are all for clinical use and cannot fundamentally reduce the production of peroxides.
[0005] In addition, in order to prevent the peroxidation of the fat emulsion, the packaging of the fat emulsion is usually a glass bottle wit

Method used

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Effect test

Embodiment Construction

[0025] The present invention: an embodiment of a preparation process of a fat emulsion injection product, the preparation process comprises the following steps:

[0026] (1) oil phase preparation;

[0027] (2) water phase preparation;

[0028] (3) Colostrum preparation;

[0029] (4) High pressure homogenization;

[0030] (5) Anaerobic filling:

[0031] (6) After sterilization, make a fat emulsion injection product;

[0032] The above steps (1) oil phase preparation: in the preparation tank A, add 50-300 g / L soybean oil, 5-15 g / L lecithin, and 0.1-5 g / L oleic acid, and stir and heat to 50 ~90°C, vacuumize and fill with nitrogen, as the oil phase;

[0033] In the preparation of the aqueous phase in the above step (2): add an appropriate amount of water for injection into the preparation tank B, add glycerin and sodium hydroxide, stir and heat to 50-90 ° C, sodium hydroxide is used to adjust the pH value, and make it with Fatty acids form sodium salts, and the pH of the pro...

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PUM

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Abstract

The invention provides a preparation technology of a fat emulsion injection product, and the fat emulsion injection product. The preparation technology is characterized by comprising the following steps: preparing an oil phase; preparing a water phase; preparing colostrum; homogenizing under high pressure; carrying out anaerobic filling; sterilizing, and then preparing the fat emulsion injection product. The water phase is prepared by the steps of adding right amount of water for injection into a preparation tank B, adding glycerin and sodium hydroxide, stirring and heating up to 50-90 DEG C, wherein the sodium hydroxide is used for adjusting the pH value and is enabled to form sodium salt with fatty acid; controlling the pH of the product to be 7.0-12.0 before sterilization, vacuumizing and charging nitrogen to obtain a product which is taken as the water phase. The preparation technology can improve the stability of fat emulsion, and is simple in technology and convenient to operate; under the premise of not adding auxiliary materials such as an antioxidant, the phenomenon that peroxide is formed due to oil oxidation or the peroxide is continuously decomposed so as to generate harmful substances such as aldehyde and ketone seldom occurs.

Description

technical field [0001] The invention relates to the technical field of manufacturing medical injection preparations, in particular to a preparation process of a fat emulsion injection product and the fat emulsion injection product. Background technique [0002] Fat emulsion is one of the important components of total parenteral nutrition (TPN). Through the infusion of various nutritional liquids, the human body can supplement the various nutrients required by the human body to maintain basic and stress conditions when oral intake is not available, so as to maintain the health of patients and save lives. [0003] Fat emulsion is an energy supplement medicine, which provides energy and essential fatty acids for the body. It is used for parenteral nutrition to supplement energy and essential fatty acids, prevent and treat human essential fatty acid deficiency, and is also used for those who cannot maintain and restore normal essential fatty acid levels through oral route. The ...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/02A61K47/10A61K47/44
CPCA61K9/107A61K9/0019A61K47/02A61K47/10A61K47/44
Inventor 吕志
Owner 威海恒基伟业信息科技发展有限公司
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