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Refining method of high-purity propofol

A refining method and technology of propofol, applied in the field of medicine and chemical industry, can solve problems such as low yield and slow crystallization process

Active Publication Date: 2021-09-10
SHANDONG WEIGAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] In the prior art, the crude product of propofol is frozen without adding or only adding a non-polar solvent, the crystallization process is very slow, the yield is low, and this method is only effective when the impurity content of the crude product is not higher than 0.5%. Crude propofol is not even able to crystallize if the crude impurity content is high

Method used

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  • Refining method of high-purity propofol

Examples

Experimental program
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Effect test

Embodiment 1

[0041] Take 198.2g of propofol crude product, the liquid phase purity is 95.567%, add 60.8g of n-hexane, add 3.1g of water, seal it, shake it evenly, put it into the freezer at -25~-20℃ for 24 hours, take it out, pour it out Or filter the uncrystallized yellow mother liquor, and the remaining ice-like solid melts in a water bath. Add n-hexane and water at the same ratio each time, and then repeat this operation 3 times, then dry the refined product of propofol, distill under reduced pressure at 800pa vacuum, collect fractions at 55-75°C to obtain 129.2g of propofol, The liquid phase purity is 99.987%, and the yield is 65.2%.

[0042] Liquid phase conditions: Porous silica gel packing column (Ptomosil Silica, 5μm, 4.6×200mm); column temperature 25°C; detection wavelength 275nm; n-hexane-acetonitrile-ethanol (990:7.5:1) The flow rate is 1.5ml / min, the same below.

Embodiment 2

[0044] Take 202.5g of propofol crude product, the liquid phase purity is 95.567%. After adding 61.2g of n-hexane, add 3.2g of acetic acid, seal and shake evenly, put it in a freezer at -25~-20℃ for 24 hours, take it out, The yellow mother liquor was decanted and the remaining icy solid was melted in a water bath. Then repeat this operation 3 times, add n-hexane and acetic acid in the same proportion each time, then wash and dry the refined propofol product, distill under reduced pressure at 800pa vacuum, collect fractions at 55-75°C to obtain 139.3g of propofol , liquid phase purity 99.997%, yield 68.8%.

Embodiment 3

[0046] Take 185.6g of propofol crude product, the liquid phase purity is 95.567%. After adding 59.3g of n-hexane, add 2.9g of formic acid, seal it, shake it evenly, put it into the freezer at -25~-20℃ for 24 hours, take it out, The yellow mother liquor was decanted and the remaining icy solid was melted in a water bath. Add n-hexane and formic acid in the same ratio each time, repeat this operation 3 times, then wash and dry the refined propofol product, distill under reduced pressure at 800pa vacuum, collect fractions at 55-75°C to obtain 123.4g of propofol, The liquid phase purity is 99.951%, and the yield is 66.5%.

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Abstract

The invention provides a refining method of high-purity propofol, which comprises the following steps of: adding an organic solvent into an industrial propofol crude product, then adding an inducer, freezing and crystallizing, filtering to remove impurities which are still liquid, heating and melting a filter cake, repeating the step until the requirements of related substances are met, carrying out reduced pressure distillation, and collecting stable fractions to obtain the high-purity propofol. The method is ingenious in conception, simple in process and suitable for industrial production, the single impurity of the prepared propofol is smaller than 0.05%, and the liquid phase purity can reach 99.9% or above.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and in particular relates to a method for refining high-purity propofol. Background technique [0002] Propofol, also known as dipropofol, chemical name 2,6-diisopropylphenol, English name propofol, is a short-acting systemic intravenous anesthetic with rapid onset and is widely used clinically. Its chemical structure is as follows : [0003] [0004] Propofol is a short-acting general intravenous anesthetic with rapid onset, among which propofol / long-chain fat emulsion injection is widely used clinically for induction and maintenance of general anesthesia, and for assisted ventilation in intensive care patients It is used alone or in combination with local anesthetics for sedation during diagnosis and surgery. [0005] The synthesis process of propofol is relatively mature. Generally, phenol is used as a raw material, and it is carried out in a high-pressure and high-temperatur...

Claims

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Application Information

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IPC IPC(8): C07C39/06C07C37/84C07C37/70
CPCC07C37/84C07C37/70C07C39/06
Inventor 王云鹏王帅军王智军赵立伟李晨光
Owner SHANDONG WEIGAO PHARM CO LTD
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