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The preparation method of theophylline sustained-release tablet

A technology for sustained-release tablets and theophylline, which is applied in the field of medicine, can solve the problems of poor reproducibility of sustained-release tablets, differences in release rate and dissolution, and achieve the effects of improving use value, stable quality, and avoiding toxic and side effects.

Active Publication Date: 2016-01-20
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The purpose of the present invention is to solve the problem of poor reproducibility in the release process of sustained-release tablets and large differences in the release and dissolution of each batch. The present invention has simple process and good process stability, and the quality of the produced product can be guaranteed. Control, in line with GMP requirements, safe, effective and stable relief of patients' pain

Method used

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  • The preparation method of theophylline sustained-release tablet
  • The preparation method of theophylline sustained-release tablet
  • The preparation method of theophylline sustained-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Table 1 The raw materials and proportions of theophylline sustained-release tablets (100mg)

[0034]

[0035] The preparation method is as follows:

[0036] (1) Add ethyl cellulose, hydroxypropyl methyl cellulose and 80% ethanol of recipe quantity in the wet mixing granulator, stir and shear at normal temperature for 30 minutes, and make a uniformly dispersed binder for subsequent use;

[0037] (2) Add theophylline, binding agent, starch and mannitol of recipe quantity in granulator again, make soft material;

[0038] (3) After replacing the granulator with a 16-mesh stainless steel mesh, use the granulator to granulate;

[0039] (4) The prepared wet granules are pumped into the fluidized bed, and the wet granules are vacuum pumped into the fluidized bed to dry to a moisture content of 4%, and then the granules are sized with a crushing and sizing machine, and magnesium stearate is added to mix evenly and then pressed The tablets are dried to obtain theophylline su...

Embodiment 2

[0041] Table 2 Theophylline Sustained-release Tablets (125mg) Raw Materials and Proportioning

[0042]

[0043]

[0044] The preparation method is as follows:

[0045] (1) Add povidone K30, methyl cellulose and 80% ethanol of recipe quantity in the wet mixing granulator, stir and shear at normal temperature for 25 minutes, make the uniformly dispersed adhesive for subsequent use;

[0046] (2) Add theophylline, binding agent, starch and mannitol of recipe quantity in granulator again, make soft material;

[0047] (3) After replacing the granulator with 18-mesh stainless steel mesh, use the granulator to granulate;

[0048] (4) The prepared wet granules are pumped into the fluidized bed, and the wet granules are vacuum pumped into the fluidized bed to dry to 5% moisture, and then the granules are sized with a crushing and sizing machine, and magnesium stearate is added to mix evenly and then pressed The tablets are dried to obtain theophylline sustained-release tablets. ...

Embodiment 3

[0050] Table 3 The raw materials and proportions of theophylline sustained-release tablets (200mg)

[0051] raw material

Dosage / kg

Theophylline

5

starch

4

Ethyl cellulose

0.25

carbomer

0.1

Hypromellose

0.5

Magnesium stearate

0.01

stearic acid

0.075

80% ethanol

4

A total of 25,000 pieces were made

[0052] The preparation method is as follows:

[0053] (1) Add sodium alginate, hydroxypropyl methylcellulose and 80% ethanol in the wet mixing granulator, stir and shear at room temperature for 30 minutes, and make a uniformly dispersed adhesive for subsequent use;

[0054] (2) Add theophylline, binding agent, starch and mannitol of recipe quantity in granulator again, make soft material;

[0055] (3) After replacing the granulator with a 19-mesh stainless steel mesh, use the granulator to granulate;

[0056] (4) The prepared wet granules are pumped into the...

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Abstract

The invention belongs to the technical field of medicines and relates to a method for preparing theophylline sustained release. The method comprises the following preparation steps: (1) adding a retardant into a wet type granulator, adding a solvent of the retardant to prepare an adhesive, and stirring and shearing at normal temperature; (2) adding theophylline, an adhesive and a filler and preparing a soft material; (3) replacing a 16-20-mesh stainless steel mesh in the granulator, and granulating through the granulator; and (4) pumping the wet granules into a fluidized bed for drying in a vacuum mode, granulating through a crushing granulator, mixing and laminating to obtain the theophylline sustained release by adding a lubricating agent. The theophylline sustained release can be released at a constant speed, the quality is stable, the pain of the asthmatic is safely, effectively and stably solved, the pain of a patient is relieved, the process is simple, and the process stability is high.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a preparation method of theophylline sustained-release tablets. Background technique [0002] Theophylline is a methylpurine drug. It has the effects of strengthening the heart, diuresis, expanding coronary arteries, relaxing bronchial smooth muscle and stimulating the central nervous system. Mainly used for the treatment of bronchial asthma, emphysema, bronchitis, cardiac dyspnea. [0003] Bronchial asthma (abbreviation: asthma) is a kind of common disease, frequently-occurring disease. At present, there are about 300 million asthmatics in the world, and about 30 million asthmatics in China. The onset of asthma is characterized by attacks within minutes and hours to days. Due to the long attack time of asthma, irregularity, instability and predictability, common preparations cannot immediately solve the patient's pain and bring pain to the patient. Asthma is an important dise...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/522A61P11/06A61P11/00
Inventor 何茂群苗得足黄京山王玉广杨本军
Owner REYOUNG PHARMA
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