Method for extracting and purifying pravastatin sodium from fermentation liquor
A technology of pravastatin sodium and pravastatin, applied in the field of bio-fermentation pharmaceuticals, can solve the problems of increasing the risk of environmental pollution, large consumption, cumbersome supply and demand, etc., to reduce the risk of safety and environmental protection, and reduce the consumption of organic solvents , Conducive to the effect of recycling and management
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Embodiment 1
[0035] Take 5.0L of fermentation broth, the active ingredient pravastatin in it has a unit of 21238 μg / mL, adjust the pH to 8.5 with 2% (w / v) aqueous sodium hydroxide solution, keep it warm at 40°C, stir for 1.5h, and filter to obtain 5.8L Alkalinization solution: adjust the pH of the alkalization solution to 3.5 with 5mol / L hydrochloric acid, and the total volume of the obtained acidification solution is 6.1L, add 610g of diatomaceous earth, stir evenly, filter to obtain 810g of solid precipitates, and use ethanol to extract once. 2430ml, 1620ml for the second use, solid-liquid extraction at room temperature, stirring time for 1 hour, filter and combine the two extracts to obtain 4160ml, concentrate under reduced pressure at 65°C to 780mL, stir and cool down to crystallize, and separate at 10°C to obtain Puvar Statin tide crystal 115g, the content is 87.6%;
[0036] Add 690mL of ethanol to the tidal crystal, heat it at 70°C, add 0.8g of activated carbon, filter it with a 0.45...
Embodiment 2
[0039] Take 5.0L of fermentation broth, the active ingredient pravastatin in it has a unit of 21238 μg / mL, adjust the pH to 9.5 with 4% (w / v) aqueous sodium hydroxide solution, keep it warm at 50°C, stir for 2.5h, and filter to obtain 6.0L Alkalinization solution: adjust the pH of the alkalization solution to 4.0 with 6mol / L hydrochloric acid, and the volume is 6.2L, add 930g of diatomaceous earth, stir evenly, filter to obtain 1050g of solid precipitates, use ethanol to extract 3150ml once, and use it twice 2100ml, solid-liquid extraction at room temperature, stirred for 1 hour, filtered and combined two extracts to obtain 5280ml, concentrated under reduced pressure at 75°C to 790mL, stirred and cooled to crystallize, separated at 10°C to obtain pravastatin tidal crystals 109g, The content is 88.3%;
[0040] Add 872mL of ethanol to the tidal crystal, heat it at 75°C, add 1.9g of activated carbon, filter it with a 0.45 micron full cardboard to obtain a decolorizing solution, s...
Embodiment 3
[0043] The difference between this embodiment and embodiment 1 is that diatomaceous earth is replaced by perlite powder. Subsequent steps are the same as in Example 1. Finally, 82.8 g of pravastatin sodium finished product was obtained.
[0044] The content of pravastatin sodium is 99.2%, the main impurity 6-eprastatin (impurity A) is 0.09%, the total related substances are 0.23%, and the total yield is 77.97%.
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