Method for producing high-purity propofol

A production method and technology of propofol, which is applied in the field of medicine, can solve the problems of high requirements for low-temperature crystallization raw materials, long operation steps, and long processing time, so as to reduce oxidation impurities J and E, improve quality and safety, and shorten the heating time The effect of shortening

Active Publication Date: 2016-05-25
GUANGDONG JIABO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, rectification and purification require a high number of theoretical plates and repeated distillations. Low-temperature crystallization has high requirements for raw materials and requires repeated low-temperature and long-term operations. Esterification and hydrolysis are harsh due to increased reactions and large steric hindrance on propofol.
In summary, the current refining method of propofol has the disadvantages of long operation steps, long processing time, and high equipment requirements, and it is easy to cause oxidation of the impurity E (3,3′,5,5′-tetraisopropylbi Phenol) and J (2,6-diisopropyl-1,4-benzoquinone) exceed the standard, while the oxidized impurities E and J are the core concerns and controlled impurities of medicinal propofol due to their high toxicity

Method used

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  • Method for producing high-purity propofol
  • Method for producing high-purity propofol
  • Method for producing high-purity propofol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036]Open the nitrogen valve of the molecular distillation equipment, make the feed tank 1 replace three times with nitrogen, and put 10.0kg of the crude product of propofol produced into the feed tank 1; the crude product of propofol in the feed tank 1 is input into the The first-stage thin-film distiller 2 is controlled at a vacuum degree of -0.090MPa, the temperature is 45°C, and the feed rate is 2.0kg / h to carry out dehydration and degassing to obtain the first-stage propofol crude product; The crude product of propofol is directly input into the second-stage molecular still 3 through the pump M2, and the low-boiling impurities are separated and removed under the conditions of a vacuum degree of 1500Pa and a temperature of 45°C to obtain the crude product of the second-stage propofol; The crude phenol is directly input into the third-stage molecular still 4 through the pump M3, and the operating conditions are controlled at a vacuum degree of 1500 Pa and a temperature of 7...

Embodiment 2

[0038] Open the nitrogen valve of the molecular distillation equipment, make the feed tank 1 replace three times with nitrogen, and put 10.0kg of the crude product of propofol produced into the feed tank 1; the crude product of propofol in the feed tank 1 is input into the The first-stage thin-film distiller 2 is controlled to carry out dehydration and degassing under the conditions of vacuum degree -0.095MPa, temperature 50°C, and feed rate of 2.5kg / h to obtain the first-stage propofol crude product; The crude phenol is directly input into the second-stage molecular still 3 through the pump M2, and the low-boiling impurities are separated and removed under the conditions of a vacuum degree of 2000 Pa and a temperature of 50° C. to obtain the second-stage propofol crude product; The crude product is directly input into the third-stage molecular still 4 through the pump M3, and the operating conditions are controlled at a vacuum degree of 2000 Pa and a temperature of 80° C. to o...

Embodiment 3

[0040] Open the nitrogen valve of the molecular distillation equipment, make the feed tank 1 replace three times with nitrogen, and put 10.0kg of the crude product of propofol produced into the feed tank 1; the crude product of propofol in the feed tank 1 is input into the The first-stage thin-film distiller 2 is controlled to carry out dehydration and degassing under the conditions of vacuum degree -0.085MPa, temperature 30°C, and feed rate of 1.0kg / h to obtain the first-stage propofol crude product; The crude phenol is directly input into the second-stage molecular still 3 through the pump M2, and the low-boiling impurities are separated and removed under the conditions of a vacuum degree of 100 Pa and a temperature of 30° C. to obtain the second-stage propofol crude product; The crude product is directly input into the third-stage molecular still 4 through the pump M3, and the operating conditions are controlled at a vacuum degree of 100 Pa and a temperature of 65° C. to obt...

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Abstract

The invention belongs to the technical field of medicine, and particularly discloses a method for producing high-purity propofol. The method includes the steps that a propofol crude product serves as a raw material and is separated and purified with a three-stage distillation method; the propofol crude product enters a feeding tank protected by nitrogen and is input into a first-stage film distiller through a pump to be dehydrated and degassed; then the product enters a second-stage molecular distiller, and low-boiling-point impurities are removed; finally, the processed product is input into a third-stage molecular distiller through the pump, high-boiling-point impurities are separated, and the colorless or yellowish high-purity propofol is obtained. The method is simple in technology, easy to operate, convenient and rapid, oxidation can be effectively prevented, the content of toxic oxide impurities E and the content of toxic oxide impurities J are decreased, the quality and the safety of the propofol are improved accordingly, the distillation temperature is low, separating efficiency is high, energy is saved, and the method is environmentally friendly and suitable for mass production and meets the requirement of continuous integration production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a production method of high-purity propofol. Background technique [0002] Propofol is also known as dipropofol, propofol, dipropofol, its molecular formula is: C12H180, its chemical name is: 2,6-diisopropylphenol, and its structure is shown in the following formula: [0003] [0004] Propofol is a rapid and short-acting intravenous anesthetic commonly used clinically for induction of anesthesia, maintenance of anesthesia, sedation of critically ill patients in the ICU, and auxiliary epidural anesthesia. It can almost fully meet the "gold standard" of intravenous anesthetics: rapid onset of action, high plasma clearance rate, rapid decrease in blood concentration, and suitable for continuous infusion administration. Quick and stable recovery after anesthesia, no mental symptoms, rarely cause postoperative nausea and vomiting, complete, less side effects and other...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C37/74C07C39/06
CPCC07C37/74C07C39/06Y02P20/10
Inventor 徐礼锋李庆岳峰袁永强
Owner GUANGDONG JIABO PHARM CO LTD
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