Preparation method 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, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of unsafe hidden dangers and the inability to fundamentally reduce peroxides, etc.

Inactive Publication Date: 2018-12-07
沙玉洁
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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 method of a fat emulsion injection product, and the fat emulsion injection product. The preparation method comprises following steps: oil phase preparation; waterphase preparation; primary emulsion preparation; high pressure homogenization; anoxic filling; and preparation of the fat emulsion injection product after disinfection. In the step of water phase preparation, an appropriate amount of injection water is introduced into a preparation tank B, glycerin and sodium hydroxide are added, an obtained mixture is stirred, and is heated to 50 to 90 DEG C, sodium hydroxide is adopted to adjust the pH value, a sodium salt is prepared from sodium hydroxide and aliphatic acid, before disinfection, product pH value is adjusted to 7.0 to 12.0, vacuum-pumping nitrogen filling is carried out so as to obtain a water phase. The preparation method is capable of improving the stability of fat emulsion; the technology is simple; operation is convenient; and less peroxides generated because of grease oxidation or harmful aldehyde and ketone substances generated because of continue decomposition of the peroxides are generated without adding of accessory ingredients such as anti-oxidant.

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): A61K9/107A61K36/48A61K47/12A61K47/24A61K47/10A61K47/02A61P3/02
CPCA61K9/107A61K9/0019A61K36/48A61K47/02A61K47/10A61K47/12A61K47/24
Inventor 沙玉洁
Owner 沙玉洁
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