Preparation process of fat emulsion injection products and fat emulsion injection products

Abstract

The invention provides a preparation process of fat emulsion injection products and the fat emulsion injection products, which are characterized in that the preparation process comprises the following steps of: oil phase preparation; aqueous phase preparation; neogala preparation; high-pressure homogenization; oxygen-free filling; and sterilization to prepare the fat emulsion injection products, wherein in the aqueous phase preparation, an appropriate amount of water for injection, glycerol and sodium hydroxide are added into a preparation tank B, and the mixture is stirred and heated to the temperature of between 50 and 90 DEG C; the sodium hydroxide is used for regulating pH values and forming sodium aliphatate with fatty acid; and before the sterilization, the pH values of the products are regulated to between 7.0 and 12.0, and the products are subjected to vacuumization and nitrogenization to prepare an aqueous phase. The preparation process of the fat emulsion injection products can improve the stability of fat emulsion, and have the advantages of simple process and convenient operation; and the phenomena of hyperoxide generated due to oil oxidation or harmful substances such as aldehyde, ketone and the like which are generated due to the continuous decomposition of the hyperoxide occurs rarely under the condition that auxiliary materials such as antioxidant and the like are not added.

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