Decitabine sustained release microsphere and preparation method thereof
A technology of decitabine and sustained-release microspheres, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. It can avoid direct contact, improve effective concentration, and achieve the effect of small loss
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Example Embodiment
[0062] Example 1:
[0063] A decitabine sustained-release microsphere, the preparation process is as follows:
[0064] ① Dissolve chitosan with 1% to 5% acetic acid to prepare a solution of 3.0% to 10.0% (V / W), add 0.15% to 3% (V / W) of decitabine, and stir to disperse it Evenly, adjust the pH value to 5~7 with 0.1mol / L NaOH solution as the water phase;
[0065] ② Formulated with 1.5%~3%(W / W) Span-20, 0.1%~0.2%(W / W) Pluronic F 68 The liquid paraffin solution as the oil phase;
[0066] ③According to the volume ratio of water phase: oil phase 1:8~1:10, add the water phase dropwise to the oil phase, stir at 15~25℃, 1200~1500r / min for 10~30 minutes, and make W / O type Emulsion
[0067] ④ Add a suitable cross-linking agent to the W / O emulsion for cross-linking and curing for 1 to 3 hours;
[0068] ⑤ Wash with an organic solvent 2 to 3 times to remove the oily phase, and wash with a cross-linking agent washing reagent to remove the residual cross-linking agent;
[0069] ⑦ Wash with an organic s...
Example Embodiment
[0074] Example 2:
[0075] A decitabine sustained-release microsphere, the preparation process 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 make it evenly dispersed , Use a suitable alkaline solution to adjust the pH to 5~7 as the water phase;
[0077] ② Take calcium chloride and add water for injection to make a 2.0%~4.0% (W / V) calcium chloride solution as a solidification liquid;
[0078] ③Slowly add the solidified liquid dropwise to the water phase while stirring, and stir for 10-30 minutes under the conditions of 15~25℃ and 1200~1500r / min;
[0079] ④ Suction filtration, suitable for washing with organic solvent or water for injection 3 to 4 times;
[0080] ⑤The obtained product is aseptically freeze-dried to obtain decitabine sustained-release microspheres.
Example Embodiment
[0081] Example 3:
[0082] A decitabine sustained-release microsphere, the preparation process 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 make it evenly dispersed , Use a suitable alkaline solution to adjust the pH to 5~7 as the water phase;
[0084] ②Take calcium chloride and chitosan and add water for injection to make a solution containing calcium chloride 2.0% to 4.0% (W / V) and chitosan 0.1% to 0.3% (W / V);
[0085] ③Slowly add the mixed solution of calcium chloride and chitosan to the water phase with stirring, stirring at 15~25℃, 1200~1500r / min for 10~30 minutes;
[0086] ④ Suction filtration, suitable for washing with organic solvent or water for injection 3 to 4 times;
[0087] ⑤The obtained product is aseptically freeze-dried to obtain decitabine sustained-release microspheres.
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