A kind of propofol injection and preparation method thereof
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A technology of propofol and injection, which is applied in the field of medicine and can solve problems such as interference with metabolism
Active Publication Date: 2020-10-20
GUANGDONG JIABO PHARM CO LTD
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[0007] In contrast, physically mixed MCT / LCT contains two different lipids, which can make up for the deficiency of a single form of fat emulsion to a certain extent, but when physically mixed MCT / LCT is used in combination, it will interfere with each other's metabolism
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Embodiment 1
[0039] Embodiment 1, the preparation of structural triglycerides:
[0040] The quality is 879.4g triglycerin trioleate and the quality are 554.9g capric acid triglyceride to mix and then add in the airtight vacuum reaction container, the mixture of the obtained glycerol trioleate and capric triglyceride is vacuum Heat the reaction vessel to 80°C, then add 6.0 g of sodium methoxide to carry out transesterification reaction, stop heating after 50 min, and finally add 140 mL of citric acid aqueous solution with a concentration of 1 mol / L to terminate the reaction to obtain a crude triglyceride. Structural triglycerides are washed with water, centrifuged, and vacuum-dried to obtain the product.
Embodiment 2
[0041] Embodiment 2, a kind of propofol injection
[0042] The propofol injection consists of the following components:
[0043] Propofol 7g, structural triglyceride 70g, egg yolk lecithin 10g, isotonic regulator 20g, water for injection to 1000ml, adding disodium hydrogen phosphate to adjust the pH value to 7.9;
[0044] The preparation method is:
[0045] S1. In a nitrogen environment, weigh structural triglycerides, egg yolk lecithin and propofol, place them in a container, heat to 50°C, and shear until the phospholipids dissolve as oil under high-speed shear at a speed of 8000rpm / min. Mutually;
[0046] S2. In a nitrogen environment, add the isotonic regulator to water for injection with no less than 80% of the prescription amount, mix well, and then filter to form an aqueous phase;
[0047] S3. Under a nitrogen environment, adjust the oil phase and the water phase through a peristaltic pump, so that the volume ratio of the oil phase and the water phase is 1:3, and adju...
Embodiment 3
[0049] Embodiment 3, a kind of propofol injection
[0050] The propofol injection consists of the following components:
[0051] Propofol 10g, structural triglyceride 100g, egg yolk lecithin 12g, isotonic regulator 22.5g, water for injection to 1000ml, adding disodium hydrogen phosphate to adjust the pH value to 7.0;
[0052] The preparation method is similar to Example 2.
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Abstract
The invention belongs to the technical field of medicines and particularly relates to a propofol injection and a preparation method of the injection. A formula of the propofol injection comprises an active ingredient: propofol, and auxiliary materials: structured triglyceride, egg yolk lecithin, an isoosmotic adjusting agent, water for injection and sodium hydrogen phosphate. The propofol injection has the characteristics that the propofol injection is free from a metal ion complexing agent, namely edetate disodium; soybean oil is substituted by structured triglyceride in the auxiliary materials; and sodium hydroxide is substituted by sodium hydrogen phosphate to regulate a pH (potential of hydrogen) value. The propofol injection has the advantages of reasonable compatibility, small stimulation and good stability, and has effects that an injection pain feeling of the traditional propofol injection in a clinical application is relieved and an anesthesia effect of the traditional propofol injection is improved. In addition, the encapsulation efficiency of the propofol injection is better after long-time placement, and quality parameters such as a content and relevant substances of the propofol injection comply with quality standards.
Description
technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a propofol injection and a preparation method thereof. Background technique [0002] Propofol is a short-acting nonbarbiturate intravenous general anesthetic used for the induction and maintenance of anesthesia and sedation. It has the characteristics of rapid onset, no accumulation, definite effect, easy adjustment of the depth of general anesthesia, quick recovery, and no feeling of drunkenness after waking up. Usually, after intravenous injection of a therapeutic dose, the hypnotic effect can be produced within 40 seconds, and the excitatory effect is very small. Since its first listing in 1986, it has been widely used clinically. It has been approved for anesthesia in children in Europe and the United States, and in the United States for anesthesia in neurosurgery. [0003] Propofol injection has been sold in the United States, Germany and other countries by t...
Claims
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