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General anesthetic for intravenous injection and preparation method

A technology for intravenous injection and anesthetics, applied in the field of general anesthesia and its preparation, can solve the problems of inability to guarantee the safety of drugs, increase in the particle size of fat emulsions, and no reliable quality assurance

Inactive Publication Date: 2009-07-15
CHENGDU QINGSHAN LIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method cannot be implemented at all in practical applications, because the preparations made by temporary matching and mixing are not allowed to be applied to the human body. There is no sterilization process, no reliable quality assurance, and no guarantee of sterility and no pyrogens. and the particle size of the emulsified product, there is no guarantee that the original inhaled anesthetic composition can be emulsified into its fat emulsion
Because this kind of fat emulsion is oil-in-water type, it is more likely to cause the emulsion particle size of the fat emulsion to increase, or even break the emulsification, and precipitate oil droplets by repeated strong manual operation.
In addition, this method not only cannot ensure that there is no visible foreign matter in the injection, but also increases operational pollution and cannot guarantee the safety of drug use.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] 1) Weigh 100 g of soybean oil and 22 g of isoflurane into a preparation tank, heat to 40° C., add 12 g of egg yolk lecithin, dissolve and stir evenly to form an oil phase.

[0032] 2) Add 25 g of glycerin into an appropriate amount of water for injection, heat to 40° C. and stir evenly to form an aqueous phase.

[0033] 3) Slowly add the oil phase to the water phase and stir at a high speed to form a coarse emulsion, and then emulsify 5 times through a homogenizer with a pressure of 100 MPa and an average particle size of 280 nm, and adjust the pH value to 8.5 with sodium hydroxide solution.

[0034] 4) The emulsion in 3) is adjusted to 1000ml, filled, rotated and sterilized at 121° C., and packaged to obtain 2.2% isoflurane injection.

Embodiment 2

[0036] 1) Weigh 200g of soybean oil and 30g of isoflurane into a preparation tank, heat to 40°C, add 12g of egg yolk lecithin and 1883g of poloxamer, dissolve and stir evenly to form an oil phase.

[0037] 2) Add 25 g of glycerin into an appropriate amount of water for injection, heat to 40° C. and stir evenly to form an aqueous phase.

[0038] 3) Slowly add the water phase to the oil phase and stir at a high speed to form a coarse emulsion, and then emulsify 6 times through a homogenizer with a pressure of 120Mpa and an average particle size of 300nm, and adjust the pH value to 8.8 with sodium hydroxide solution.

[0039] 4) The emulsion in 3) is adjusted to 1000ml, filled, rotated and sterilized at 121° C., and packaged to obtain 3% isoflurane injection.

Embodiment 3

[0041] 1) Weigh 50 g of soybean oil, 50 g of medium chain oil and 60 g of isoflurane into a preparation tank, heat to 60°C, add 15 g of soybean lecithin and 0.3 g of oleic acid, dissolve and stir evenly to form an oil phase.

[0042] 2) Add 25 g of glycerin into an appropriate amount of water for injection containing 0.2 g of sodium cholate, heat to 60° C. and stir evenly to form an aqueous phase.

[0043] 3) Slowly add the oil phase to the water phase and stir at a high speed to form a coarse emulsion, and then emulsify 5 times through a homogenizer with a pressure of 100 MPa and an average particle size of 250 nm, and adjust the pH value to 8.0 with sodium hydroxide solution.

[0044] 4) The emulsion in 3) is adjusted to 1000ml, filled, rotated and sterilized at 121°C, and packaged to obtain sevoflurane injection.

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Abstract

The invention relates to intravenous injection general anesthetic and a preparation method thereof. The general anesthetic contains isoflurane, as well as oil components, isotonic agent and assisting adding components allowed by intravenous injection, wherein the component and the content in each 1000 ml of drugs are as follows: 20-100g of isoflurane, 100-250g of oil components, 22.5-25g of isotonic agent and 10-19g of assisting adding components. The preparation method comprises the following steps: oil-soluble components and water-soluble components are fully and uniformly mixed into oil phase solution and water phase solution which are fully mixed and emulsified until forming emulsion according with the grain diameter requirement, and water is injected for adjustment until reaching the specific volume. The general anesthetic solves various problems of the traditional drug application method of the suction general anesthetic isoflurane, accords with the relative requirement of the pharmacopoeia to the drug application because the quality of the drug is controllable and stable, is favorable to controlling the dosage and the application safety of the clinical application, and is favorable to the industrial production because the preparation process is stable.

Description

technical field [0001] The invention relates to a general anesthetic drug for intravenous injection and a preparation method thereof. Background technique [0002] General anesthetics currently used in medical operations generally can be divided into two categories, i.e. general anesthetics in the form of intravenous injections and general anesthetics in the form of inhalants. Existing general anesthetics in the form of inhalation require a special volatilizer and a special anesthesia machine when used. The operation is very troublesome, the clinical cost is high, and the controllability of the drug inhalation is poor, and accidents are prone to occur. [0003] In order to solve the above problems, Chinese Patent No. 99111465.5 once proposed a method, which uses two preparations of fat emulsion and anesthetic in clinical application, and uses them after temporary mixing according to the required amount by artificial means. This method cannot be implemented at all in practic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/08A61K47/00A61K47/10A61K9/107A61P23/00A61J3/00
Inventor 欧苏崔盛
Owner CHENGDU QINGSHAN LIKANG PHARMA CO LTD
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