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Particle composition as well as preparation method and preparation thereof

A technology for compositions and compound preparations, applied in the field of pharmaceutical preparations, to achieve the effects of improving stability, improving incompatibility difficulties, and overcoming incompatibility taboos

Active Publication Date: 2015-04-29
BEIJING HANMI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

So far, there is no effective solution to the incompatibility between montelukast sodium and levocetirizine hydrochloride, as well as the limited use of mannitol, the preferred excipient in sugar-free preparations

Method used

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  • Particle composition as well as preparation method and preparation thereof
  • Particle composition as well as preparation method and preparation thereof
  • Particle composition as well as preparation method and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] The preparation of embodiment 1 granular composition

[0076] The formulation of the granular composition is shown in Table 1.

[0077] Table 1 Prescription of Granular Composition

[0078]

[0079] Preparation of Montelukast sodium granules: Add purified water into a stainless steel bucket, add meglumine and stir until dissolved; continue stirring and add hydroxypropyl-β-cyclodextrin until dissolved, and finally add Montelukast sodium and stir until dissolved. Dissolve to obtain the first binder solution and set aside. Put the mannitol in a wet granulator after passing through a 26-mesh sieve, put the prepared first binder solution in a wet-process granulator, and make soft materials, which pass through a 26-mesh sieve for granulation, and dry at 45°C for 15 Minutes later, pass through a 26-mesh sieve for granulation, continue to dry until the loss on drying is ≤2.0% (IR90°C, dry for 10 minutes), pass through a 26-mesh sieve for granulation, and obtain montelukast...

Embodiment 2

[0082] The preparation of embodiment 2 granular composition

[0083]The formulation of the granular composition is shown in Table 2.

[0084] Table 2 Prescription of Granular Composition

[0085]

[0086] Preparation of Montelukast sodium granules: Add purified water into a stainless steel bucket, add meglumine and stir until dissolved; continue stirring and add hydroxypropyl-β-cyclodextrin until dissolved, and finally add Montelukast sodium and stir until dissolved. Dissolved to obtain the first binder solution, set aside. Mannitol and microcrystalline cellulose 101 were respectively passed through a 26-mesh sieve, mixed evenly and placed in a wet granulator, and the prepared first binder solution was placed in a wet granulator to make soft materials, and the soft materials were passed through Granulate with a 26-mesh sieve, dry at 45°C for 15 minutes, pass through a 26-mesh sieve for granulation, continue to dry until the drying weight loss ≤ 2.0% (IR90°C, dry for 10 mi...

Embodiment 3

[0089] The preparation of embodiment 3 granular composition

[0090] The formulation of the granular composition is shown in Table 3.

[0091] Table 3 Prescription of Granular Composition

[0092]

[0093]

[0094] Preparation of Montelukast sodium granules: Add purified water into a stainless steel bucket, add meglumine and stir until dissolved; continue stirring and add hydroxypropyl-β-cyclodextrin until dissolved, and finally add Montelukast sodium and stir until dissolved. Dissolved to obtain the first binder solution, set aside. Put the mannitol in a wet granulator after passing through a 26-mesh sieve, put the prepared first binder solution in a wet-process granulator, and make soft materials, which pass through a 26-mesh sieve for granulation, and dry at 45°C for 15 Minutes later, pass through a 26-mesh sieve for granulation, continue to dry until the loss on drying is ≤2.0% (IR90°C, dry for 10 minutes), pass through a 26-mesh sieve for granulation, and obtain m...

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Abstract

A particle composition and a preparation method therefor. The particle composition comprises montelukast sodium particles and levocetirizine particles. The montelukast sodium particles comprise montelukast sodium, a filler, a stabilizer, and an adhesive. The levocetirizine particles comprise levocetirizine, a filler, a stabilizer, and an adhesive. The stabilizers are meglumine, and the adhesives are hydroxypropyl-β-cyclodextrin.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a granular composition, a preparation method and a preparation thereof. Background technique [0002] Allergic rhinitis (allergic rhinitis, AR) is a multifactorial disease induced by the interaction of genes and the environment. It is a mediator mainly mediated by IgE after exposure to allergens in atopic individuals. (mainly histamine) release, and a variety of immune active cells and cytokines involved in the nasal mucosa non-infectious inflammatory disease. There are three necessary conditions for its occurrence: ① specific antigen is the substance that causes the body's immune response; ② atopic individual is the so-called individual difference and allergic constitution; ③ specific antigen meets the atopic individual. Specific antigens are derived from animals, plants, insects, fungi or occupational substances, such as mites, pollen, animal dander, fungal allergens...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/495A61K9/16A61K9/20A61K47/18A61K47/40A61P11/02A61P37/08A61K31/47
CPCA61K9/1623A61K9/2018A61K9/2077A61K31/47A61K31/495A61P11/00A61P11/02A61P11/06A61P27/14A61P37/08A61K2300/00
Inventor 闫学文方翼杨慧君成仁基
Owner BEIJING HANMI PHARMA CO LTD
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