A kind of production technology of busulfan injection
A production process and busulfan technology, applied in the field of medicine, can solve problems such as difficult process and condensation of water vapor, and achieve the effect of reducing process process, reducing process steps, and strong controllability
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Embodiment 1
[0038] A production process of busulfan injection, comprising the following steps:
[0039] 1) Dry clean air, N 2 One or more of Ar and Ar pass into the liquid distribution isolator and isolated production line;
[0040] 2) According to the mass, add 67 parts of PEG400 into the liquid preparation tank, pass through dry and clean air, N 2 Add one or more of Ar to PEG400; add 1 part of N,N-dimethylacetamide to PEG400 to obtain a mixed solvent;
[0041] Adding 10 parts of N,N-dimethylacetamide to 0.6 parts of Busulfan bulk drug to obtain a concentrated solution of Busulfan;
[0042] 3) Add concentrated busulfan solution into the mixed solvent, use 12 parts of N,N-dimethylacetamide to rinse the container containing the raw material medicine, stir and filter to obtain the finished product.
Embodiment 2
[0044] A production process of busulfan injection, comprising the following steps:
[0045] 1) Dry clean air, N 2 One or more of Ar and Ar pass into the liquid distribution isolator and isolated production line;
[0046] 2) According to the mass, add 67 parts of PEG400 into the liquid preparation tank, pass through dry and clean air, N 2 Add one or more of Ar to PEG400; add 20 parts of N,N-dimethylacetamide to PEG400 to obtain a mixed solvent;
[0047] Add 1 part of N,N-dimethylacetamide to 0.6 part of Busulfan bulk drug to obtain Busulfan concentrated solution;
[0048] 3) Add concentrated busulfan solution into the mixed solvent, use 12 parts of N,N-dimethylacetamide to rinse the container containing the raw material medicine, stir and filter to obtain the finished product.
Embodiment 3
[0050]A production process of busulfan injection, comprising the following steps:
[0051] 1) Dry clean air, N 2 One or more of Ar and Ar pass into the liquid distribution isolator and isolated production line;
[0052] 2) According to the mass, add 67 parts of PEG400 into the liquid preparation tank, pass through dry and clean air, N 2 Add one or more of Ar to PEG400; add 10 parts of N,N-dimethylacetamide to PEG400 to obtain a mixed solvent;
[0053] Adding 5 parts of N,N-dimethylacetamide to 0.6 parts of Busulfan bulk drug to obtain a concentrated solution of Busulfan;
[0054] 3) Add concentrated busulfan solution into the mixed solvent, use 16 parts of N,N-dimethylacetamide to rinse the container containing the raw material medicine, stir and filter to obtain the finished product.
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