Decitabine sustained release microsphere and preparation method thereof
A technology of decitabine and sustained-release microspheres, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, and medical preparations containing active ingredients. Poor and other problems, to avoid direct contact, increase the effective concentration, the effect of small loss
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Embodiment 1
[0063] A kind of decitabine sustained-release microspheres, the process of its preparation is as follows:
[0064] ①Dissolve chitosan with 1%~5% acetic acid to prepare a 3.0%~10.0% (V / W) solution, add 0.15%~3% (V / W) drug decitabine, stir to disperse Evenly, use 0.1mol / L NaOH solution to adjust the pH value to 5-7 as the water phase;
[0065] ②Preparation containing 1.5%~3% (W / W) Span-20, 0.1%~0.2% (W / W) Pluronic F 68 The liquid paraffin solution is used as the oil phase;
[0066] ③According to the water phase: oil phase volume ratio 1:8~1:10, add the water phase to the oil phase dropwise, stir for 10~30 minutes at 15~25℃, 1200~1500r / min, and make W / O type Emulsion;
[0067] ④ adding a suitable crosslinking agent to the W / O emulsion for crosslinking and curing for 1 to 3 hours;
[0068] ⑤ Wash with an organic solvent for 2 to 3 times to remove the oil phase, and wash with a cross-linking agent washing reagent to remove the residual cross-linking agent;
[0069] ⑦ Wash with...
Embodiment 2
[0075] A kind of decitabine sustained-release microspheres, the process of its preparation is as follows:
[0076] ① Dissolve sodium alginate with water for injection to make a 1.0%-6.0% (W / V) sodium alginate solution, add 0.15%-3% (V / W) drug decitabine, stir to disperse evenly , using a suitable alkaline solution to adjust the pH value to 5-7 as the water phase;
[0077] ② Take calcium chloride and add water for injection to make a 2.0% to 4.0% (W / V) calcium chloride solution as a solidification solution;
[0078] ③Slowly add the solidified solution dropwise into the water phase under stirring, and stir for 10-30 minutes at 15-25°C and 1200-1500r / min;
[0079] ④ Suction filtration, suitable for washing with organic solvent or water for injection 3 to 4 times;
[0080] ⑤ The obtained product is aseptically freeze-dried to obtain decitabine sustained-release microspheres.
Embodiment 3
[0082] A kind of decitabine sustained-release microspheres, the process of its preparation is as follows:
[0083] ① Dissolve sodium alginate with water for injection to make a 1.0%-6.0% (W / V) sodium alginate solution, add 0.15%-3% (V / W) drug decitabine, stir to disperse evenly , using a suitable alkaline solution to adjust the pH value to 5-7 as the water phase;
[0084] ② Take calcium chloride and chitosan, add water for injection to make solutions containing calcium chloride 2.0% to 4.0% (W / V) and chitosan 0.1% to 0.3% (W / V);
[0085] ③ Slowly add the mixed solution of calcium chloride and chitosan into the water phase under stirring, and stir for 10-30 minutes at 15-25°C and 1200-1500r / min;
[0086] ④ Suction filtration, suitable for washing with organic solvent or water for injection 3 to 4 times;
[0087] ⑤ The obtained product is aseptically freeze-dried to obtain decitabine sustained-release microspheres.
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