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A technology of fludarabine phosphate and fludarabine phosphate wet product, which is applied in the drying field of fludarabine phosphate bulk drug, can solve problems such as the reliability of fludarabine phosphate, and achieve high safety and fast time The effect of shortening
Inactive Publication Date: 2019-07-19
连云港杰瑞药业有限公司
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Problems solved by technology
[0008] Therefore need a kind of new drying method to solve the reliability problem of fludarabine phosphate drying process
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Embodiment 1
[0028] A method for drying fludarabine phosphate crude drug, comprising the steps of:
[0029] Step 1, adding the bulk drug of fludarabine phosphate with larger water content to acetone with 20 times the volume;
[0030] Step 2, stirring at 15°C for 5h;
[0031] Step 3, filtering, drying the filter cake at 55° C. for 3 hours in a vacuum drying oven to obtain the fludarabine phosphate bulk drug with a water content of less than 3% (the product HPLC spectrum is shown in figure 2 ).
Embodiment 2
[0033] A method for drying fludarabine phosphate crude drug, comprising the steps of:
[0034] Step 1, adding the bulk drug of fludarabine phosphate with larger water content to acetone with 30 times the volume;
[0035] Step 2, stirring at 20°C for 3h;
[0036] Step 3, filtering, drying the filter cake in a vacuum drying oven at 50° C. for 3 hours to obtain the fludarabine phosphate raw material with a water content of less than 3%.
Embodiment 3
[0038] A method for drying fludarabine phosphate crude drug, comprising the steps of:
[0039] Step 1, adding the bulk drug of fludarabine phosphate with larger water content to acetone with 25 times the volume;
[0040] Step 2, stirring at 25°C for 5h;
[0041] Step 3, filtering, drying the filter cake in a vacuum drying oven at 60° C. for 5 hours to obtain fludarabine phosphate crude drug with a water content of less than 3%.
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Abstract
The invention discloses a drying method for a bulk drug fludarabine phosphate. The method comprises the following steps: step 1, adding a wet fludarabine phosphate product crystallized from an aqueoussolution into a ketone solvent; step 2, conducting stirring at room temperature for 1-5 h; and step 3, conducting filtering and drying the filter cake in a vacuum oven at 50-60 DEG C for 3-5 h, so asto obtain the bulk drug, namely fludarabine phosphate. The drying method for of the bulk drug fludarabine phosphate is simple in operation, energy-saving and consumption-reducing, suitable for industrial production, and provides a new method for a bulk drug fludarabine phosphate.
Description
technical field [0001] The invention belongs to the technical field of preparation of raw materials, and in particular relates to a method for drying fludarabine phosphate raw materials. Background technique [0002] Fludarabine phosphate, chemical name 9-β-D-arabinofuranosyl-2-fluoroadenine-5'-phosphate, is used for the treatment of chronic lymphocytic leukemia. Its structural formula is: [0003] [0004] Fludarabine phosphate is usually synthesized by using fludarabine as a raw material, reacting with phosphorus oxychloride and preparing it through aqueous solution crystallization. [0005] [0006] Fludarabine phosphate crude drug standards require that the water content be less than 3%, and after crystallization from water, the water content of fludarabine phosphate is generally above 8%, and qualified products must be obtained after drying. [0007] CN105859812A reports that the wet product of water phase crystallization is obtained by vacuum drying; the paper ...
Claims
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