Method for preparing mycophenolate mofetil capsule by fusion method
A technology of mycophenolate mofetil and melting method, which can be used in capsule delivery, pharmaceutical formulations, medical preparations with inactive ingredients, etc. Water solubility, stable quality and high production efficiency
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Embodiment 1
[0024] 1500g of polyethylene glycol with a molecular weight of 4000, 1000g of mycophenolate mofetil and 50g of talcum powder were stirred and mixed evenly in a high-shear wet granulator at a speed of 150rpm; the stirring speed was adjusted to 50rpm, and the high-shear wet The granulator is heated in a water bath, and the cutter is turned on after the temperature of the solid mixture in the granulator reaches 55°C. The cutter speed is 1500 rpm, the stirring speed is 150 rpm, and the granulation is performed for 2 minutes; the prepared granules are naturally cooled to room temperature, and the granules are screened with a 1.0mm round hole. After granulation, mix in the conical hopper for 10 minutes, and fill the mixed granules into gelatin hollow capsules with a fully automatic capsule filling machine to obtain mycophenolate mofetil capsules; the mixed granules are evaluated by powder science, and the results are shown in the table 1.
[0025] Table 1 Example 1 Mixed particle po...
Embodiment 2
[0028] 2000g of polyethylene glycol with a molecular weight of 6000, 1000g of mycophenolate mofetil and 150g of talcum powder were stirred and mixed evenly in a high-shear wet granulator at a speed of 150rpm; The granulator is heated in a water bath, and the cutter is turned on after the temperature of the solid mixture in the granulator reaches 65°C, the cutter speed is 2000rpm, the stirring speed is 150rpm, and the granulation is performed for 2 minutes; the prepared granules are naturally cooled to room temperature, and the granules are screened with a 1.0mm round hole After granulation, mix in the conical hopper for 10 minutes, and fill the mixed granules into gelatin hollow capsules with a fully automatic capsule filling machine to obtain mycophenolate mofetil capsules; the mixed granules are evaluated by powder science, and the results are shown in the table 2.
[0029] Table 2 Example 2 Mixed particle powder evaluation
[0030]
Embodiment 3
[0032] 1800g of polyethylene glycol with a molecular weight of 8000, 1000g of mycophenolate mofetil and 100g of talcum powder were set in the high-shear wet granulator to stir and mix evenly; The granulator is heated in a water bath, and the cutter is turned on after the temperature of the solid mixture in the granulator reaches 65°C. The cutter speed is 1500 rpm, the stirring speed is 150 rpm, and the granulation is performed for 2 minutes; the prepared granules are naturally cooled to room temperature, and the granules are screened with a 1.0 mm round hole. After granulation, mix in the conical hopper for 10 minutes, and fill the mixed granules into gelatin hollow capsules with a fully automatic capsule filling machine to obtain mycophenolate mofetil capsules; the mixed granules are evaluated by powder science, and the results are shown in the table 3.
[0033] Table 3 Example 3 Mixed particle powder evaluation
[0034]
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