A kind of preparation method of indapamide capsule
A technology for indapamide and capsules, which is applied in the field of preparation of indapamide capsules, can solve the problems that high-temperature adhesives are unfavorable for mass production operations by production personnel, hidden dangers of GMP environmental safety for production personnel, and pollution of the environment and operators. , to reduce the influence of manual operation, shorten the preparation time, and reduce the hidden danger of production safety.
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Embodiment 1
[0043] Example 1 Preparation of Indapamide Capsules (Specification: 2.5mg)
[0044]
[0045] Preparation of granulation solution: Dissolve the prescribed amount of hypromellose E5 in ethanol aqueous solution, make HPMC-ethanol aqueous solution, stir to dissolve, then put the prescribed amount of indapamide into HPMC-ethanol aqueous solution, stir well to a lump-free suspension.
[0046] 2. Granulation: Put the weighed cornstarch, lactose, and povidone K90 into the fluidized bed in sequence, and use top spray granulation. The parameters set in the fluidized bed at different times are shown in the table below:
[0047]
[0048] After spraying the granulation liquid on the top, it is dried, and the drying parameters are set: the material temperature is 40°C, the air inlet temperature is 55°C, and the air volume of the fan is 600m 3 / h. Moisture is controlled below 3.0%.
[0049] 3. Total mixing: Put the 40-mesh sieved granules and the prescribed amount of silicon dioxide...
Embodiment 2
[0051] Example 2 Preparation of Indapamide Capsules (Specification: 2.5mg)
[0052]
[0053] Preparation of granulation solution: Dissolve the prescribed amount of hypromellose E5 in ethanol aqueous solution, make HPMC-ethanol aqueous solution, stir to dissolve, then put the prescribed amount of indapamide into HPMC-ethanol aqueous solution, stir well to a lump-free suspension.
[0054] 2. Granulation: Put the weighed cornstarch, lactose, and povidone K90 into the fluidized bed in sequence, and use top spray granulation. The parameters set in the fluidized bed at different times are shown in the table below:
[0055]
[0056] After spraying the granulation liquid on the top, it is dried, and the drying parameters are set: the material temperature is 45°C, the air inlet temperature is 60°C, and the air volume of the fan is 900m 3 / h. Moisture is controlled below 3.0%.
[0057] 3. Total mixing: Put the 40-mesh sieved granules and the prescribed amount of silicon dioxide...
Embodiment 3
[0059] Example 3 Preparation of Indapamide Capsules (Specification: 2.5mg)
[0060]
[0061] 1. Material preparation: Weigh the raw and auxiliary materials with the required weight and set aside.
[0062] Preparation of granulation solution: Dissolve the prescribed amount of hypromellose E5 in ethanol aqueous solution, make HPMC-ethanol aqueous solution, stir to dissolve, then put the prescribed amount of indapamide into HPMC-ethanol aqueous solution, stir well to a lump-free suspension.
[0063] 2. Granulation: Put the weighed cornstarch, lactose, and povidone K90 into the fluidized bed in sequence, and use top spray granulation. The parameters set in the fluidized bed at different times are shown in the table below:
[0064]
[0065] After spraying the granulation liquid on the top, it is dried, and the drying parameters are set: the material temperature is 50°C, the air inlet temperature is 65°C, and the air volume of the fan is 1200m 3 / h. Moisture is controlled b...
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