Desloratadine citrate disodium capsules as well as preparation method and application thereof
A technology of desloratadine and loratadine, which is applied in the field of pharmaceutical preparations, can solve the problems that the substance content of desloratadine cannot be solved well, so as to improve the dissolution rate and stability, improve the dissolution behavior, Effect of inhibiting the growth of related substances
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Embodiment 1
[0028]
[0029]
[0030] The preparation method is:
[0031] (1) Desloratadine citrate, ascorbic acid, calcium hydrogen phosphate, microcrystalline cellulose and pregelatinized starch are taken by weighing the prescription amount, sieved and premixed with 60 meshes;
[0032] (2) Weigh the PVP k30 of the prescribed amount, add the prescribed amount of purified water to prepare a binder solution, and add it to the mixture prepared in step (1), granulate with a 30-mesh sieve, and dry in a fluidized bed until the moisture content is ≤5.0%. After sizing through a 24-mesh sieve, add silicon dioxide for total mixing to obtain desloratadine citrate granules;
[0033] (3) Fill the desloratadine citrate granules into gelatin hollow capsules (No. 3) to prepare 1000 desloratadine citrate capsules.
Embodiment 2
[0035] Name of raw material Prescription amount desloratadine citrate 8.8g Calcium hydrogen phosphate 45g microcrystalline cellulose 65g silica 1.2g Povidone (PVPk30) 1.5g ascorbic acid 1g purified water 20g
[0036] The preparation method is:
[0037] (1) take desloratadine citrate, ascorbic acid, calcium hydrogen phosphate and microcrystalline cellulose of prescription quantity, 60 mesh sieve, premix;
[0038] (2) Weigh the PVP k30 of the prescribed amount, add the prescribed amount of purified water to prepare a binder solution, and add it to the mixture prepared in step (1), granulate with a 30-mesh sieve, and dry in a fluidized bed until the moisture content is ≤5.0%. After sizing through a 24-mesh sieve, add silicon dioxide for total mixing to obtain desloratadine citrate granules;
[0039] (3) Fill the desloratadine citrate granules into gelatin hollow capsules (No. 4) to prepare 1000 desloratadine citrate capsu...
Embodiment 3
[0041] Name of raw material Prescription amount desloratadine citrate 8.8g Calcium hydrogen phosphate 40g pregelatinized starch 70g silica 1.2g Povidone (PVPk30) 1.5g ascorbic acid 3g purified water 20g
[0042] The preparation method is:
[0043] (1) take by weighing desloratadine citrate, ascorbic acid, calcium hydrogen phosphate and pregelatinized starch of prescription quantity, 60 mesh sieve, premix;
[0044] (2) Weigh the PVP k30 of the prescribed amount, add the prescribed amount of purified water to prepare a binder solution, and add it to the mixture prepared in step (1), granulate with a 30-mesh sieve, and dry in a fluidized bed until the moisture content is ≤5.0%. After sizing through a 24-mesh sieve, add silicon dioxide for total mixing to obtain desloratadine citrate granules;
[0045] (3) Fill the desloratadine citrate granules into gelatin hollow capsules (No. 4) to prepare 1000 desloratadine citrate cap...
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