Preparation method of esomeprazole magnesium
A kind of technology of esomeprazole magnesium, esomeprazole magnesium crude product, is applied in the preparation field of esomeprazole magnesium, can solve undisclosed esomeprazole magnesium purification and purification method, separation and purification difficulty etc. problems, to achieve the effect of meeting pharmaceutical needs, reducing polarity, and morphological stability
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Embodiment 1
[0023] The preparation of embodiment 1 esomeprazole
[0024] According to the method disclosed in CN1157614A, prepare esomeprazole 35.2Kg, HPLC purity is 69.4%, standby.
Embodiment 2
[0025] The preparation of embodiment 2 esomeprazole magnesium
[0026] (1) take Example 1 The prepared esomeprazole 6.5Kg was dissolved into a concentrated solution with 1.7L of methanol, and 1Kg of KOH solid was weighed and dissolved in 6L of purified water;
[0027] (2) Slowly add aqueous potassium hydroxide solution to the methanol solution of esomeprazole being stirred, after adding, stir and react for 1 hour to obtain light yellow transparent esomeprazole potassium salt solution;
[0028] (3) In addition, weigh 1.0Kg of anhydrous magnesium sulfate and dissolve it in 40L of purified water to obtain a clear liquid;
[0029] (4) Slowly add the previously obtained esomeprazole potassium solution dropwise to the mechanically stirred magnesium sulfate aqueous solution, stir and react for 1 hour after the dropwise addition, filter with suction, and dry in vacuum to obtain 6.0Kg esomeprazole Magnesium, HPLC purity 97.8%, water content 6.4%.
Embodiment 3
[0030] The preparation of embodiment 3 esomeprazole magnesium
[0031] (1) take Example 1 The prepared esomeprazole 6.5Kg was dissolved into a concentrated solution with 3.2L of methanol, and 1.2Kg of KOH solid was weighed and dissolved in 5L of purified water;
[0032] (2) Slowly add the methanol solution of esomeprazole into the stirring potassium hydroxide aqueous solution, after the dripping is completed, stir and react for 1 hour to obtain a light yellow transparent potassium salt solution of esomeprazole;
[0033] (3) In addition, 1.5Kg of anhydrous magnesium sulfate was weighed and dissolved in 50L of purified water to obtain a clear liquid;
[0034] (4) Slowly add the previously obtained esomeprazole potassium solution dropwise to the mechanically stirred magnesium sulfate aqueous solution, stir and react for 1 hour after the dropwise addition, filter with suction, and dry in vacuum to obtain 5.9Kg esomeprazole Magnesium, HPLC purity 98.1%, water content 6.1%.
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