Propofol injection and its preparing method

A technology of propofol and injection, which is applied in the direction of pharmaceutical formulations, active ingredients of hydroxyl compounds, anesthetics, etc., can solve the problem of blood calcium drop, achieve the effect of small clinical side effects, reduce irritation, and good stability

Inactive Publication Date: 2007-10-03
SHANGHAI INST OF PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the national SFDA has retrieved many domestic and foreign literatures, and believes that edetate disodium can combine with calcium ions in the blood to form a soluble complex, causing a decrease in calcium, and the u

Method used

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Experimental program
Comparison scheme
Effect test

Example Embodiment

[0047] In the preparation method of the present invention, the stirring time is controlled according to needs, and the stirring speed is selected at no less than 1500 revolutions per minute. This choice can be made according to needs. For homogenization by a high-pressure homogenizer, The homogenization conditions and time are well known to those skilled in the art, as long as the homogenized milk particles must not have particles larger than 5 μm, and particles larger than 1 μm should not exceed 3%.

[0048] In the preparation method of the present invention, the choice of inert gas is generally nitrogen.

[0049] In the preparation method of the present invention, the heating temperature is also well known to those skilled in the art, and is generally 65-80°C, preferably 70°C.

Example Embodiment

[0051] Example 1

[0052] Under the protection of nitrogen, weigh 100g soybean oil for injection and heat to 70℃, add 12g egg yolk lecithin and 10g propofol under high-speed stirring, and mix well as the oil phase; add 22.5g glycerol for injection into 600ml water for injection , After mixing, use a 0.45μm filter membrane to filter as the water phase. Add the oil phase to the water phase under high-speed stirring to make colostrum. Measure the pH value to 8.0, add water for injection to 1000ml, repeat homogenization with a high-pressure homogenizer, check the size of the milk particles, and all the particles are less than 1μm in diameter. After the emulsion is filtered, it is filled with nitrogen, fused and sealed, and sterilized in a rotary steam sterilizer. After cooling, the propofol injection is obtained after passing the inspection.

Example Embodiment

[0053] Example 2

[0054]Under the protection of nitrogen, weigh 300g of soybean oil for injection and heat it to 80°C, add 15g of egg yolk lecithin and 12g of propofol under high-speed stirring, and stir evenly as the oil phase; add 25g of glycerol for injection to 600ml of water for injection, After mixing, filter with 0.45μm filter membrane as the water phase. Add the oil phase to the water phase under high-speed stirring to make colostrum. Measure the pH value to be 8.0, add water for injection to 1000ml, homogenize repeatedly with a high-pressure homogenizer, check the size of the milk particles, and all the particles are less than 1μm in diameter. After the emulsion is filtered, it is filled with nitrogen, fused and sealed, and sterilized in a rotary steam sterilizer. Propofol injection is obtained after cooling.

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Abstract

A propofol injection with high safety and stability is prepared from propofol, the oil for injection, emulsifier, isotonic regulator and the water for injection. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to propofol injection and a preparation method thereof, in particular to propofol injection for intravenous injection and a preparation method thereof. Background technique [0002] Propofol injection is a new type of alkylbenzene intravenous anesthetic, which can be used for rapid induction of anesthesia or maintenance of anesthesia and sedation. Its induction of anesthesia is fast and stable, and its excitatory effect is less than that of methynylbital sodium. But higher than thiopental sodium. [0003] The main advantage of propofol injection is that it induces anesthesia quickly, and wakes up and recovers quickly after administration. It is used for induction of anesthesia in a short period of time, and the recovery of consciousness is faster than that of thiopental sodium. Superior to other commonly used intravenous anesthetics. After the patient wakes up, he has no memory ...

Claims

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Application Information

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IPC IPC(8): A61K31/05A61K9/08A61P23/00
Inventor 谢保源陆敏陈允发张兵
Owner SHANGHAI INST OF PHARMA IND
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