Preparation method of pidotimod sodium
A technology of pidotimod sodium and solvent, which is applied in the field of medicine, can solve the problems of no pidotimod salt yield and purity research, insufficient heat preservation and stirring, low product yield, etc., and achieve high product yield and purity , low production cost, good water solubility
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Embodiment 1
[0043] (1) Add 30ml of purified water and 30g of pidotimod in sequence to a 500ml four-necked bottle, stir and dissolve for 0.5h, add 11.35g of sodium bicarbonate in batches, adjust the pH to 6.5-7.5, and stir and react at 20°C for 1h to obtain The reaction solution;
[0044] (2) add surfactant cetyltrimethylammonium bromide 0.1g in 180g ethanol, obtain mixed liquor;
[0045] (3) Drop the reaction solution into the mixed solution, control the temperature at 60°C, after the dropwise addition, keep stirring for 1 hour, then lower the temperature to 15°C at a rate of 5°C per 1 hour, keep stirring for 2 hours, and control the stirring speed at 30r / h min, then suction filtered, and rinsed with ethanol to obtain a wet product of pidotimod sodium; put the wet product of pidotimod sodium into a decompression oven, set the temperature at 50°C, and dry to obtain 31.49 g of white uniform particles , the yield was 96.3%, and the purity was 99.54%. For the physical picture of granular pr...
Embodiment 2
[0047] (1) Add 30ml of purified water and 30g of pidotimod in sequence to a 500ml four-necked bottle, stir and dissolve for 0.5h, add 11.35g of sodium bicarbonate in batches, adjust the pH to 6.5-7.5, and stir and react at 30°C for 1h to obtain The reaction solution;
[0048] (2) add surfactant cetyltrimethylammonium bromide 0.1g in 300g acetone, obtain mixed liquor;
[0049] (3) Drop the reaction solution into the mixture, control the temperature at 60°C, after the dropwise addition, keep stirring for 1 hour, then cool down to 20°C at a rate of 5°C per 1 hour, keep stirring for 1 hour, and control the stirring speed at 50r / min, then suction filtered, and rinsed with ethanol to obtain a wet product of pidotimod sodium; put the wet product of pidotimod sodium into a decompression oven, set the temperature at 60°C, and dry to obtain 31.58 g of white uniform particles , the yield is 96.6%, and the purity is 99.63%. The product stability test results are shown in Table 2.
Embodiment 3
[0051] (1) Add 30ml of purified water and 30g of pidotimod in sequence to a 500ml four-neck bottle, stir to dissolve for 0.5h, add 11.35g of sodium bicarbonate in batches, adjust the pH to 6.5-7.5, and stir at 25°C for 1h to obtain The reaction solution;
[0052] (2) Add surfactant cetyltrimethylammonium bromide 0.1g in 300g ethyl acetate, obtain mixed liquor;
[0053](3) Drop the reaction solution into the mixed solution, control the temperature at 60°C, after the dropwise addition, keep stirring for 1 hour, then cool down to 25°C at a rate of 5°C per 1 hour, keep stirring for 2 hours, and control the stirring speed at 60r / min, then suction filtered, and rinsed with ethanol to obtain a wet product of pidotimod sodium; put the wet product of pidotimod sodium into a decompression oven, set the temperature at 70°C, and dry to obtain 31.39 g of white uniform particles , the yield is 96.0%, and the purity is 99.42%. The product stability test results are shown in Table 2.
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