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

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 ...

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 with good sealing performance. However, although the glass bottle can reduce the peroxidation of the fat emulsion during storage, it is open-ended Infusion, air needs to be introduced during the infusion process, which has certain unsafe hidden dangers