Production method of high-purity propofol

Abstract

The invention discloses a production method of high-purity propofol. The specific operation steps are as follows: step one, screening and filtering a propofol crude product under a vacuum state; steptwo, detecting impurities contained in the filtered propofol crude product under a vacuum state by utilizing a high-performance liquid chromatography (HPLC) method to obtain the data of impurity species and content, and recording the data; and step three, putting the detected propofol crude product into glassware with a vacuum state, then heating the whole glassware, heating and stirring the propofol crude product to a molten state, then filtering out the impurities in the liquid by a reverse osmosis membrane, and adsorbing impurities by activated carbon. According to the production method provided by the invention, the propofol crude product is heated; the impurities with low boiling points are removed by the reverse osmosis membrane and the activated carbon; high-temperature distillationis utilized to distill out impurities with different boiling points first; then the temperature gradually increases, and the propofol is separated out by distillation when the temperature reaches theboiling point of the propofol; remained impurities with high boiling points are removed; and then the prepared propofol has a high purity.

Description

technical field [0001] The invention relates to the field of production methods of high-purity propofol, in particular to a production method of high-purity propofol. Background technique [0002] Although crude propofol introduces a variety of relatively toxic process impurities, in order to meet drug safety, countries have put forward high requirements for the purity of medical propofol, and also put forward strict restrictions on the content of each single impurity . Therefore, purifying the crude propofol with a purity of 60-75% to more than 99% high-purity propofol, that is, the refining of propofol has become a research hotspot. The current refining methods include: rectification purification, low temperature crystallization purification, column chromatography and esterification hydrolysis. However, rectification and purification require a high number of theoretical plates and repeated distillations. Low-temperature crystallization has high requirements for raw mater...

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. Lipidation 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 impurities 3,3',5,5'-tetraisopropylbiphenol and 2,6-diisopropyl-1,4-benzoquinone exceeds the standard, and oxidized impurities are the core concerns and controlled impurities of medicinal propofol due to their high toxicity, and the utensils used for propofol purification during the purification process are as follows: The metal material will also affect the oxidation of internal substances and affect the purification