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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 use of edetate disodium in intravenous preparations will lead to a decrease in blood calcium Therefore, it is necessary to pay close attention to and strictly control the dosage of edetate disodium in intravenous preparations

Method used

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preparation example Construction

[0047] In the preparation method of the present invention, the time of stirring is controlled as required, and the speed of stirring is selected at not less than 1500 rpm. This selection can be carried out as required. For homogenization by a high pressure homogenizer, The conditions and time of homogenization 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 the particles above 1 μm shall 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 well known to those skilled in the art, and is generally 65-80°C, preferably 70°C.

Embodiment 1

[0052] Under the protection of nitrogen, weigh 100g of soybean oil for injection and heat it to 70°C. Under high-speed stirring, add 12g of egg yolk lecithin and 10g of propofol, and stir evenly as the oil phase; add 22.5g of glycerin for injection into 600ml of water for injection , and filtered through a 0.45 μm filter membrane as the aqueous phase after mixing. 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 through a high-pressure homogenizer, and check the size of the milk particles. The particle size of all particles is less than 1 μm. After the emulsion is filtered, it is filled with nitrogen, melted and sealed, and sterilized in a rotary steam sterilizer. After cooling, propofol injection is obtained after passing the inspection.

Embodiment 2

[0054]Under the protection of nitrogen, weigh 300g of soybean oil for injection and heat it to 80°C. Under high-speed stirring, add 15g of egg yolk lecithin and 12g of propofol, and stir evenly as the oil phase; add 25g of glycerin for injection into 600ml of water for injection, After mixing, filter with a 0.45 μm filter membrane as the aqueous 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 through a high-pressure homogenizer, and check the size of the milk particles. The particle size of all particles is less than 1 μm. After the emulsion is filtered, it is filled with nitrogen, melted and sealed, and sterilized in a rotary steam sterilizer. Propofol injection was 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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