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Tablet containing roflumilast as active ingredients and preparation method of tablet

An active ingredient, a technology of roflumilast, which is applied to the field of tablets containing roflumilast as an active ingredient and the preparation thereof, can solve the problems of complex process, slow dissolution rate and high operation cost, and achieves simple process and cost saving Effect

Inactive Publication Date: 2013-01-16
CHINA RESOURCES SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to provide a tablet containing roflumilast as an active ingredient and a preparation method thereof, so as to overcome the disadvantages of slow dissolution rate, complicated process and high operating cost in the existing preparation method

Method used

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  • Tablet containing roflumilast as active ingredients and preparation method of tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The tablet containing roflumilast as an active ingredient described in the embodiments of the present invention contains:

[0023] A: Roflumilast (through a 150-mesh sieve) 0.5 mg;

[0024] B: Lactose monohydrate 99.32 mg;

[0025] C: Corn starch 26.78 mg;

[0026] D: Hydroxypropyl methylcellulose (viscosity 4~6mP·s) 1 mg;

[0027] E: water 3 mg;

[0028] F: Ethanol 22 mg;

[0029] End result: 128.2 mg / tablet.

[0030] The preparation method of the tablet containing roflumilast as the active ingredient described in the embodiment of the present invention comprises the following steps:

[0031] (1) Mix all pharmaceutical excipients except hydroxypropyl methylcellulose;

[0032] (2) Dissolve or suspend hydroxypropyl methylcellulose and roflumilast respectively in the mixed solution of ethanol and water;

[0033] (3) The mixture obtained in step (1) and the solution obtained in (2) were granulated in a wet granulator, and the wet granules were dried and sized befo...

Embodiment 2

[0035] The tablet containing roflumilast as an active ingredient described in the embodiments of the present invention contains:

[0036] A: Roflumilast (through a 150-mesh sieve) 0.5 mg;

[0037] B: Lactose monohydrate 99.32 mg;

[0038] C: Corn starch 26.78 mg;

[0039] D: Hydroxypropyl methylcellulose (viscosity 4~6mP·s) 1 mg;

[0040] E: Water 3.6 mg;

[0041] F: Ethanol 18 mg;

[0042] End result: 128.2 mg / tablet.

[0043] The preparation method of the tablet containing roflumilast as the active ingredient described in the embodiment of the present invention comprises the following steps:

[0044] (1) Mix all pharmaceutical excipients except hydroxypropyl methylcellulose;

[0045] (2) Dissolve or suspend hydroxypropyl methylcellulose and roflumilast respectively in the mixed solution of ethanol and water;

[0046] (3) The mixture obtained in step (1) and the solution obtained in step (2) were granulated in a wet granulator, and the wet granules were dried and siz...

Embodiment 3

[0048] The tablet containing roflumilast as an active ingredient described in the embodiments of the present invention contains:

[0049] A: Roflumilast (through a 150-mesh sieve) 0.5 mg;

[0050] B: Microcrystalline cellulose 105.32 mg;

[0051] C: Pregelatinized starch 20.18 mg;

[0052] D: Hydroxypropyl methylcellulose (viscosity 40~60mP·s) 0.5 mg;

[0053] E: water 2 mg;

[0054] F: 30 mg ethanol;

[0055] End result: 126.5 mg / tablet.

[0056]The preparation method of the tablet containing roflumilast as the active ingredient described in the embodiment of the present invention comprises the following steps:

[0057] (1) Mix all pharmaceutical excipients except hydroxypropyl methylcellulose;

[0058] (2) Dissolve or suspend hydroxypropyl methylcellulose and roflumilast respectively in the mixed solution of ethanol and water;

[0059] (3) The mixture obtained in step (1) and the solution obtained in step (2) are granulated in a fluidized bed granulator, and the wet...

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Abstract

The invention discloses a tablet containing roflumilast as active ingredients and a preparation method of the tablet. The tablet comprises binders, other drug excipients, humectants, drug-loading solvents and the roflumilast, wherein the binders are hydroxypropyl methyl cellulose, and the humectants and drug preparations are mixed solution of ethanol and water. The tablet and the preparation method thereof have the advantages that the mixed solution of the ethanol and the water serves as the drug-loading solvents, and dissolved states of the active ingredients not subjected to micronization are controlled by utilizing difference of solubility of the roflumilast in the ethanol and the water and adjusting the proportion of the ethanol and the water; the roflumilast is dissolved out fast from preparations to achieve pharmacological action by using the hydroxypropyl methyl cellulosas as the binders and conjunctively adjusting and controlling the dissolution rate of the roflumilast from the tablets, the whole process does not need pretreatment and can be achieved by normal granulation and tabletting, and the technical process is simple while cost is saved.

Description

technical field [0001] The invention relates to the field of medical technology, in particular to a tablet containing roflumilast as an active ingredient and a preparation method thereof. Background technique [0002] Chronic obstructive pulmonary disease (Chronic obstructive pulmonary diseases, COPD) is a serious chronic respiratory disease with a large number of patients and a high mortality rate. Due to its slow progressive development, it seriously affects the working ability and quality of life of patients. COPD After the acute attack period, the patient's clinical symptoms are relieved, but his lung function continues to deteriorate, and due to the decrease of his own defense and immune function and the influence of various harmful factors outside, the attack often occurs repeatedly, and gradually develops various symptoms. Cardiopulmonary disease, the current standard of care is B 2 Adrenergic receptor agonists, glucocorticoids, and antibiotics. [0003] Roflumilast...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/44A61K47/38A61P11/00
Inventor 关津张国松蒋玲敏何凤娟杨琰王文峰
Owner CHINA RESOURCES SAIKE PHARMA
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