Metformin hydrochloride controlled-release tablet and preparation method thereof

A technology of metformin hydrochloride and controlled-release tablets, applied in the field of medicine, can solve the problems of sudden release, uneven dissolution and release, etc.

Inactive Publication Date: 2020-10-30
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This invention provides a controlled-release or sustained-release pharmaceutical tablet with only a homogeneous osmotic core, wherein the osmotic core component can be prepared by conventional tablet compression technology, but its dissolution and release are not uniform, and there is a problem of burst release

Method used

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  • Metformin hydrochloride controlled-release tablet and preparation method thereof
  • Metformin hydrochloride controlled-release tablet and preparation method thereof
  • Metformin hydrochloride controlled-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Example 1: metformin hydrochloride controlled-release tablets, see Table 1 for the weight ratio of each component.

[0074] The weight proportion of each component of table 1

[0075]

[0076]

[0077] The preparation of metformin hydrochloride controlled-release tablet comprises the following steps:

[0078] (1) First, the metformin hydrochloride raw material, lactose, stearyl alcohol, and polyethylene oxide are pulverized through a 100-mesh sieve; the powder sieved is added to a wet granulator, and after stirring at a low speed, add 5% povidone K30 aqueous solution, Made into soft materials, granulated with a 12-mesh oscillating granulator, with a granulating frequency of 40-50Hz;

[0079] (2) Dry the wet granules at 60°C, control the water content to 2.5%-3.5%, take out the 16-mesh swing-type granulator and granulate, the granulation frequency is 30-40Hz;

[0080] (3) Mix uniformly for tableting, control the tableting pressure 10-20KN during tableting, the ta...

Embodiment 2

[0084] See Table 2 for the proportioning by weight of each component of the metformin hydrochloride controlled-release tablet.

[0085] The proportioning by weight of each component of table 2

[0086]

[0087] The preparation of metformin hydrochloride controlled-release tablet comprises the following steps:

[0088] (1) First, the metformin hydrochloride raw material, pregelatinized starch, stearyl alcohol, and polyethylene oxide are pulverized through an 80-mesh sieve; the powder sieve is added to the wet granulator, and after stirring at a low speed, add 3% hypromell Cellulose aqueous solution, made into soft materials, granulated with a 12-mesh oscillating granulator, with a granulation frequency of 40-50Hz;

[0089] (2) Dry the wet granules at 60°C, control the water content to 2.5%-3.5%, take out the 16-mesh swing-type granulator and granulate, the granulation frequency is 30-40Hz;

[0090] (3) Mix uniformly for tableting, control the tableting pressure 10-20KN dur...

Embodiment 3

[0094] See Table 3 for the proportioning by weight of each component of the metformin hydrochloride controlled-release tablet.

[0095] The weight ratio of each component of table 3

[0096]

[0097] The preparation method of metformin hydrochloride controlled-release tablet comprises the following steps:

[0098] (1) Metformin hydrochloride, starch, stearyl alcohol, and polyethylene oxide are pulverized and mixed through a 100-mesh sieve; a 5% aqueous solution of hydroxypropylmethylcellulose is prepared, and the powder sieved is mixed with a binder to make a soft material , Swing type granulator 12 mesh granulation, granulation frequency 50Hz;

[0099] (2) Dry the wet granules at 60°C, control the water content to 1.5%-4.0%, take out the 16-mesh swing-type granulator to granulate, and granulate the granules at a frequency of 35Hz;

[0100] (3) Mix uniformly for tableting, control the tableting pressure 10-20KN during tableting, the tableting speed 5-100,000 tablets / h, th...

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Abstract

The invention discloses a metformin hydrochloride controlled-release tablet and a preparation method thereof. The metformin hydrochloride controlled-release tablet comprises a tablet core, a coating aqueous dispersion forms a controlled-release coating film outside the tablet core, and the tablet core is prepared from, by weight, 80-120 parts of metformin hydrochloride, 10-14 parts of a tablet core controlled-release material, 2-4 parts of filler and 0.2-1.2 parts of an adhesive, and the aqueous dispersion is prepared from the following raw materials in parts by weight: 2 to 6 parts of coatingslow-release material, 1.2 to 1.6 parts of plasticizer, 1.2 to 1.6 parts of pore-foaming agent, 0.4 to 0.8 part of anti-sticking agent and 0.1 to 0.5 part of emulsifying agent. The controlled-releasetablet provided by the invention is coated by adopting the aqueous dispersion, so that the pollution of an organic solvent to the environment is avoided, and the potential safety hazard is reduced. According to the invention, a double controlled release technology of tablet core slow release and membrane controlled coating is adopted, the release degree in the second hour is 10%-35%, the releasedegree in the sixth hour is 40%-70% and the release degree in the twelfth hour is more than 80% in an in-vitro release degree test, constant-speed release is realized, swallowing is easy, and the compliance of a patient is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular, the invention relates to a metformin hydrochloride controlled-release tablet and a preparation method thereof. Background technique [0002] With the development of pharmacy, the therapeutic advantages of oral sustained and controlled release preparations over ordinary immediate release preparations have been widely recognized. The release time of sustained and controlled release preparations is longer and the drug release is more stable. After taking the medicine, the plasma drug concentration in the patient's body fluctuates. It is very small, which not only reduces the number of times of taking medicine, but also improves the therapeutic effect and reduces the occurrence of side effects. Therefore, during the research and development of pharmaceutical preparations, more and more drugs for the treatment of chronic diseases are designed as sustained and controlled release dosage ...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/22A61K31/155A61K47/38A61K47/10A61P3/10
CPCA61K9/2013A61K9/2031A61K9/2095A61K9/2866A61K9/2893A61K31/155A61P3/10
Inventor 陈用芳胡延贵吴奇财樊竞洁郑勇杨绪凤何伟薛云梅
Owner CHONGQING CONQUER PHARML
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