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A kind of desloratadine citrate capsule and its preparation method and application

A desloratadine and loratadine technology, applied in the field of pharmaceutical preparations, can solve the problem that the substance content of desloratadine cannot be well solved, and achieves improved dissolution rate and stability, improved stability, Well-formulated effect

Active Publication Date: 2022-03-25
HEFEI IND PHARMA INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] But so far, the content of related substances in desloratadine has not been well resolved

Method used

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  • A kind of desloratadine citrate capsule and its preparation method and application
  • A kind of desloratadine citrate capsule and its preparation method and application
  • A kind of desloratadine citrate capsule and its preparation method and application

Examples

Experimental program
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Effect test

Embodiment 1

[0028]

[0029]

[0030] The preparation method is:

[0031] (1) take by weighing desloratadine citrate, ascorbic acid, calcium hydrogen phosphate, microcrystalline cellulose and pregelatinized starch of recipe quantity, 60 mesh sieves, premix;

[0032] (2) Weigh the PVP k30 of the recipe quantity, add the recipe quantity purified water to prepare the binder solution, and add it to the mixture prepared in step (1), granulate with a 30-mesh sieve, and dry in a fluidized bed to moisture≤5.0%, After granulating with a 24-mesh sieve, adding silicon dioxide and mixing to obtain desloratadine citrate granules;

[0033] (3) Filling the desloratadine citrate granules into gelatin hollow capsules (No. 3) to obtain 1000 desloratadine citrate capsules.

Embodiment 2

[0035] Raw material name Prescription amount desloratadine citrate 8.8g Calcium hydrogen phosphate 45g microcrystalline cellulose 65g silica 1.2g Povidone (PVP k30) 1.5g ascorbic acid 1g purified water 20g

[0036] The preparation method is:

[0037] (1) take by weighing the desloratadine citrate, ascorbic acid, calcium hydrogen phosphate and microcrystalline cellulose of the recipe quantity, sieve with 60 meshes, premix;

[0038] (2) Weigh the PVP k30 of the recipe quantity, add the recipe quantity purified water to prepare the binder solution, and add it to the mixture prepared in step (1), granulate with a 30 mesh sieve, and dry in a fluidized bed to moisture≤5.0%, After granulating with a 24-mesh sieve, adding silicon dioxide and mixing to obtain desloratadine citrate granules;

[0039] (3) Filling the desloratadine citrate granules into hollow gelatin capsules (No. 4) to obtain 1000 desloratadine citrate capsules....

Embodiment 3

[0041] Raw material name Prescription amount desloratadine citrate 8.8g Calcium hydrogen phosphate 40g pregelatinized starch 70g silica 1.2g Povidone (PVP k30) 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 recipe quantity, 60 mesh sieves, premix;

[0044] (2) Weigh the PVP k30 of the recipe quantity, add the recipe quantity purified water to prepare the binder solution, and add it to the mixture prepared in step (1), granulate with a 30 mesh sieve, and dry in a fluidized bed to moisture≤5.0%, After granulating with a 24-mesh sieve, adding silicon dioxide and mixing to obtain desloratadine citrate granules;

[0045] (3) Filling the desloratadine citrate granules into hollow gelatin capsules (No. 4) to obtain 1000 desloratadine citrate capsules.

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Abstract

The invention provides a desloratadine citrate capsule, a preparation method and application thereof. Described capsule is made up of desloratadine citrate granule and hollow capsule, and described desloratadine citrate granule contains desloratadine citrate, ascorbic acid, filler, lubricant and binding agent, and percentage by weight is respectively (5‑12): (1‑3): (80‑150): (0.5‑2): (0.5‑3). The invention also provides a preparation method of the desloratadine citrate capsule and its application in the preparation of medicines for treating rhinitis and urticaria. The desloratadine citrate capsule of the invention has a reasonable formula and a simple and convenient production process; the dissolution rate and stability of the desloratadine citrate capsule are significantly improved by adding ascorbic acid components.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a desloratadine citrate capsule and a preparation method and application thereof. Background technique [0002] Desloratadine is a non-sedative long-acting tricyclic antihistamine, an active metabolite of loratadine, which can relieve seasonal allergic rhinitis by selectively antagonizing peripheral H1 receptors or associated symptoms of chronic idiopathic urticaria. In addition, desloratadine inhibited histamine release from human mast cells in vitro. Animal studies suggest that desloratadine does not easily cross the blood-brain barrier. However, due to the well-known instability and low water solubility of desloratadine, it encountered great difficulties in formulation, and many literatures reported different solutions. For example, US2002 / 123504, WO2006 / 020534, CN1246794 and the like. [0003] For another example, CN201410104158.3 discloses a desloratadine capsu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/4545A61K47/22A61P11/02A61P17/00A61P37/08
CPCA61K9/1617A61K31/4545A61P11/02A61P37/08A61P17/00
Inventor 何广卫李丰刘为中苏峰毕东辉
Owner HEFEI IND PHARMA INST CO LTD
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