Busulfan injection and preparation method thereof
A technology of busulfan injection and busulfan injection, which is applied in the field of busulfan injection, can solve the problems of undiscovered stability of busulfan injection, and achieve the effect of improving stability
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Embodiment 1
[0029] The preparation of embodiment 1 busulfan injection of the present invention
[0030] Take 60 mg of Busulfan crude drug and 1 mg of citric acid (accounting for 0.01% w / v of the total amount of the mixed solvent), add 3.3 ml of N,N-dimethylacetamide, and stir to dissolve. Add 0.3% activated carbon by volume of the solution, stir at room temperature for 30 minutes, and filter with a 0.45 μm microporous membrane. Add 6.7ml of polyethylene glycol 400, stir evenly, filter with a 0.22 μm microporous membrane, and aseptically fill.
Embodiment 2
[0031] The preparation of embodiment 2 busulfan injection of the present invention
[0032] Take 60mg of Busulfan crude drug, 20mg of citric acid / sodium citrate (1:1, m / m) (accounting for 0.2%w / v of the total amount of mixed solvent), add 3.3ml N,N-dimethyl Acetamide, stir to dissolve. Add 0.3% activated carbon by volume of the solution, stir at room temperature for 30 minutes, and filter with a 0.45 μm microporous membrane. Add 6.7ml polyethylene glycol 400 and stir well. 0.22μm microporous membrane filtration, aseptic filling.
Embodiment 3
[0033] The preparation of embodiment 3 busulfan injections of the present invention
[0034] Take 60 mg of Busulfan crude drug and 10 mg of citric acid (accounting for 0.1% w / v of the total amount of the mixed solvent), add 3.3 ml of N,N-dimethylacetamide, and stir to dissolve. Add 0.3% activated carbon by volume of the solution, stir at room temperature for 30 minutes, and filter with a 0.45 μm microporous membrane. Add 6.7ml polyethylene glycol 400 and stir well. 0.22μm microporous membrane filtration, aseptic filling.
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