Method for separating the enantiomers of pantoprazole sodium by two-phase recognition fractional distillation extraction
A technology for pantoprazole sodium and enantiomers, which is applied to two-phase identification, fractional distillation, extraction and separation of pantoprazole sodium enantiomers, and uses centrifugal extractor to extract and separate pantoprazole sodium enantiomers through multistage countercurrent reaction extraction. It can solve the problems of excess enantiomer and low yield, and achieve the effects of stable product quality, simple process and easy operation.
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Embodiment 1
[0011] Get 1.0134g pantoprazole sodium enantiomer (racemate) and be dissolved in the NaH of 0.1mol / L 2 PO 4 / NaHPO 4 Regulate pH in the buffer solution (containing the hydroxypropyl-beta-cyclodextrin of certain concentration) be that 8.5 are made into the solution 0.5L of pantoprazole sodium concentration as 5mmol / L as material liquid phase;
[0012] Take 882.6g hydroxypropyl-β-cyclodextrin (HP-β-CD) and dissolve it in 0.1mol / L NaH 2 PO 4 / H 3 PO 4 Adjust the pH in the buffer solution to 8.5 to form a 6L solution with a concentration of 0.1mol / L as the water phase;
[0013] Take 52.46g D-isobutyl tartrate and dissolve it in pure 1,2-dichloroethane organic solvent, and make a 2L solution as the organic phase;
[0014] Connect 10-stage centrifugal extractors in series, use a constant-flow pump to pump the organic phase into the centrifugal extractor first, when the organic phase flows out from the outlet of the extraction phase, pump the water phase into the centrifugal ex...
Embodiment 2
[0016] Get the NaH that 1.0134g pantoprazole enantiomer is dissolved in 0.1mol / L 2 PO 4 / H 3 PO 4 Adjust the pH in the buffer solution (0.1mol / L of hydroxypropyl-β-cyclodextrin) to be 8.5 and prepare a 0.5L solution with a concentration of 5mmol / L as the liquid phase;
[0017] Take 882.6g hydroxypropyl-β-cyclodextrin (HP-β-CD) and dissolve it in 0.1mol / L NaH 2 PO 4 / H 3 PO 4 Adjust the pH in the buffer solution to 8.5 to form a 6L solution with a concentration of 0.1mol / L as the water phase;
[0018] Take 52.46g D-isobutyl tartrate and dissolve it in pure 1,2-dichloroethane organic solvent, and make a 2L solution as the organic phase;
[0019] Connect 20-stage centrifugal extractors in series, use a constant flow pump to pump the organic phase into the centrifugal extractor first, when the organic phase flows out from the outlet of the extraction phase, pump the water phase into the centrifugal extractor from the corresponding inlet, and after a period of time, the two-...
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