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Emulsion medicine injection of propofol and preparation process thereof

A technology for propofol and medicine, which is applied to the medicine injection emulsion of propofol and the preparation field thereof, can solve the problems of high substance content, does not solve the problem of propofol oxidation, increase, etc., and achieves obvious combination synergistic effect. Effect

Active Publication Date: 2013-04-03
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Before the present invention, despite the addition of metal ion chelating agent (ethylenediaminetetraacetic acid salt) or cysteine ​​related substances (specific components are 2,6-diisopropylbenzoquinone and 3,3',5 , 5'-tetraisopropyldiphenoquinone) content can be reduced to some extent, but the above inventions do not solve the oxidation problem of propofol as a phenolic hydroxyl structure, resulting in relatively high content of related substances in the prepared samples, especially After the sample is sterilized by high temperature, the content of related substances such as 2,6-diisopropylbenzoquinone and 3,3',5,5'-tetraisopropyldiphenoquinone increases significantly, and a single metal ion chelation method is used to Mixture (ethylenediaminetetraacetic acid salt) or cysteine ​​after sterilization, related substances increase more, etc.

Method used

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  • Emulsion medicine injection of propofol and preparation process thereof
  • Emulsion medicine injection of propofol and preparation process thereof
  • Emulsion medicine injection of propofol and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1: the preparation of injection

[0038] Take 50ml of water for injection, 0.05g of disodium edetate, 0.5g of cysteine ​​hydrochloride and 22.5g of glycerin, mix well, heat to about 40-60°C, add 12g of lecithin and stir to disperse to obtain solution 1; Add 10g of propofol to 100g of soybean oil, stir evenly to obtain solution 2; mix solution 1 and solution 2 to form a primary emulsion, add water to 1000ml, emulsify through a high-pressure homogenizer, adjust the pH value, filter, fill, and roll Cover and sterilize to obtain the injection solution.

Embodiment 2

[0039] Embodiment 2: the preparation of injection

[0040] Take 50ml of water for injection, 0.025g of disodium edetate, 0.25g of cysteine ​​hydrochloride and 22.5g of glycerin, mix them evenly, heat to about 40-60°C, add 12g of lecithin and stir to disperse to obtain solution 1; Add 10g of propofol to 100g of soybean oil, stir evenly to obtain solution 2; mix solution 1 and solution 2 to form a primary emulsion, add water to 1000ml, emulsify through a high-pressure homogenizer, adjust the pH value, filter, fill, and roll Cover and sterilize to obtain the injection solution.

Embodiment 3

[0041] Embodiment 3: the preparation of injection

[0042] Take 50ml of water for injection, 0.1g of pentasodium diethylenetriaminepentaacetic acid, 1.0g of cysteine ​​hydrochloride and 22.5g of glycerin, mix well, heat to about 40-60°C, add 12g of lecithin and stir to disperse to obtain solution 1; Add 10g of propofol into 100g of soybean oil, stir evenly to obtain solution 2; mix solution 1 and solution 2 to form a primary emulsion, add water to 1000ml, emulsify through a high-pressure homogenizer, adjust the pH value, filter, fill, Roll the cap and sterilize to obtain the injection solution.

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Abstract

The present invention relates to emulsion medicine injection of propofol comprising propofol, metal ion chelating agent and cysteine. The present invention solves well the problem of the oxidation of phenol hydroxyl group in effective component propofol to produce degradation product and can ensure safety of clinical administration.

Description

technical field [0001] The invention relates to a drug injection emulsion and a preparation method thereof, in particular to a drug injection emulsion of propofol and a preparation method thereof. Background technique [0002] Propofol, due to its hypnotic properties, induces and maintains general anesthesia and is used for sedation in intensive care units. Before the present invention, despite the addition of metal ion chelating agent (ethylenediaminetetraacetic acid salt) or cysteine ​​related substances (specific components are 2,6-diisopropylbenzoquinone and 3,3',5 , 5'-tetraisopropyldiphenoquinone) content can be reduced to some extent, but the above inventions do not solve the oxidation problem of propofol as a phenolic hydroxyl structure, resulting in relatively high content of related substances in the prepared samples, especially After the sample is sterilized by high temperature, the content of related substances such as 2,6-diisopropylbenzoquinone and 3,3',5,5'-t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K31/05A61P23/00
Inventor 王利春赵忠琼孔繁贵陈倩梁隆程志鹏
Owner SICHUAN KELUN PHARMA CO LTD
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