Propofol medium/long-chain injection emulsion and production method thereof

Fecha de publicación: 05/01/2021
Fuente: Wipo "olive oil"
The invention relates to a propofol medium/long-chain injection emulsion and a production method thereof. Every 100 ml of the injection emulsion contains 0.7-1.2 g of propofol, 3-7g of refined olive oil, 3-7 g of medium-chain triglyceride, 0.8-1.2 g of egg yolk lecithin, 1.85-2.65 g of glycerol, 0.006-0.02 g of oleic acid, 2-5g of sodium hydroxide and the balance of water for injection. The production method comprises the following steps of 1, vacuumizing production equipment, and introducing nitrogen; 2, preparing a water phase; 3, preparing an oil phase; 4, preparing a primary emulsion; 5, performing homogenization: carrying out high-pressure homogenization for multiple times; and 6, performing emulsion filling and sterilization. According to the invention, soybean oil in a traditional injection emulsion is replaced with the refined olive oil, and many unsaturated acids in the refined olive oil improve the oxidation resistance of the propofol, so that impurities in the injection emulsion have no obvious increase trend, and the drug stability is improved; and the amount of the oleic acid in the injection emulsion is adjusted to be 0.1-0.4 mg, so that the possibility of hemolysis caused by excessive use of the oleic acid or sodium oleate is prevented.