A kind of preparation method and product of decitabine freeze-dried preparation
A technology of freeze-dried preparations and citabine, which is applied in the field of medicine to achieve the effects of shortening the dissolution time, avoiding the reduction of curative effect, and avoiding hidden dangers
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[0013] In the embodiment of the present invention, the present invention relates to a kind of preparation method of decitabine freeze-dried preparation, described method comprises the following steps:
[0014] a) Put the prescribed amount of water for injection in the batching tank, add the prescribed amount of pH regulator into it, stir and dissolve, and then turn on the freezer to keep the obtained pH buffer solution at 0-8°C;
[0015] b) Transfer 50% of the above pH buffer solution, add the prescribed amount of decitabine into the above batching tank under stirring conditions, keep the temperature in the tank at 0~8°C, use a high-speed milk homogenizer, stir When the speed is greater than or equal to 10000rpm, stir and disperse it evenly;
[0016] c) Transfer the transferred pH buffer solution back to the batching tank, and continue to stir until it is completely dissolved to obtain the medicinal solution;
[0017] d) The medicinal liquid is filtered, filled with half stop...
Embodiment 1
[0028] Prescription of decitabine lyophilized preparation:
[0029] Decitabine 25g
[0030] Potassium dihydrogen phosphate 34g
[0032] Water for injection 5L
[0033] A total of 1000 bottles were made
[0034] The preparation technology of decitabine freeze-dried preparation:
[0035] a) Add the prescribed amount of potassium dihydrogen phosphate and sodium hydroxide to the prescribed amount of water for injection, stir until completely dissolved, and turn on the refrigerator to keep the obtained pH buffer at 1-4°C;
[0036] b) Transfer 50% of the above pH buffer solution, add the prescribed amount of micronized decitabine (average particle size is 2-10 μm) into the above-mentioned batching tank under the condition of stirring, and keep the temperature in the tank at 1-10 μm. At 4°C, use a high-speed homogenizer to stir and disperse evenly at a stirring rate of 10,000 rpm;
[0037] c) Transfer the transferred pH buffer solution back to t...
Embodiment 2
[0040] The prescription is the same as in Example 1. Add the prescribed amount of potassium dihydrogen phosphate and sodium hydroxide to the prescribed amount of water for injection, stir until completely dissolved, and turn on the refrigerator to keep the obtained pH buffer solution at 1~4°C; Prepare 50% of the above pH buffer solution, add the prescribed amount of decitabine fine powder passing through a 60-mesh sieve into the above batching tank under the condition of stirring, keep the temperature in the tank at 1~4°C, and use high-speed milk to homogenize Machine, stir and disperse evenly at a stirring rate of 25000rpm; transfer the transferred pH buffer solution back to the batching tank, continue to stir until completely dissolved, and obtain a medicinal solution, the pH of the medicinal solution is 6.8; the medicinal solution is passed through Filtration, filling and half-stoppering, freeze-drying (filled with nitrogen 5 minutes before the end of freeze-drying), vacuum ...
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