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Ilepcimide-containing controlled release tablet as well as preparation method and application thereof

A technology of controlled-release tablets and content, which is applied in the field of medicine, can solve the problems of poor patient compliance, high blood drug concentration side effects, poor children's compliance, etc., reduce the number of times and doses taken, reduce the fluctuation of blood drug concentration, and improve drug use. safety effect

Active Publication Date: 2021-11-02
北京斯利安健康科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] (2) Ileximine is derived from pepper, which has a strong spicy taste of pepper, and patients, especially children, have poor compliance
It has the following disadvantages: ① It is inconvenient to take, and the patient’s compliance is poor; ② The therapeutic window of antiepileptic drugs is generally narrow, and the blood drug concentration of ordinary tablets fluctuates greatly, and the blood drug concentration is too high, especially when the patient is a child. If the drug concentration is too low, the ideal curative effect cannot be achieved; ③The total dosage of ordinary tablets is relatively large, especially for children, the potential risk of harm is great
[0007] At present, there is no relevant report on eleximide controlled-release tablets in the prior art, so it is imminent to develop eleximide controlled-release tablets

Method used

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  • Ilepcimide-containing controlled release tablet as well as preparation method and application thereof
  • Ilepcimide-containing controlled release tablet as well as preparation method and application thereof
  • Ilepcimide-containing controlled release tablet as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0146] prescription:

[0147]

[0148]

[0149] Preparation Process:

[0150] (1) Preparation of chelates: pulverizing the ileximide and crossing a 100-mesh sieve;

[0151] Weigh β-cyclodextrin sulfobutyl ether sodium according to the prescription amount, and add it into water according to the mass ratio of 2:1 to obtain an aqueous solution of β-cyclodextrin sulfobutyl ether sodium; Mix the sodium butyl ether aqueous solution, stir evenly, filter, dry, and sieve through a 100-mesh sieve to obtain the sodium butyl ether chelate (ie, ECH-(SBE)7m-β-CD ,1:2), spare.

[0152] (2) drug-containing layer: mix eleximide-β-cyclodextrin sodium sulfobutyl ether chelate with colloidal silicon dioxide and poloxamer passed through a 60-mesh sieve, mix evenly according to the prescription amount, add mass The soft material is made from an aqueous solution of povidone with a fraction of 10%, granulated with a 24-mesh sieve, dried at 45°C for 12 hours, sized with a 24-mesh sieve, then ...

Embodiment 2

[0156] prescription:

[0157]

[0158]

[0159] Preparation Process:

[0160] (1) Preparation of chelates: pulverizing the ileximide and crossing a 100-mesh sieve;

[0161] Weigh according to the prescription amount, add β-cyclodextrin sulfobutyl ether sodium into water at a mass ratio of 1.5:1 to obtain an aqueous solution of β-cyclodextrin sulfobutyl ether sodium; add elexinamine to β-cyclodextrin Mix the aqueous solution of sodium sulfobutyl ether, stir evenly, filter, dry, and sieve through a 100 mesh sieve to obtain the sodium sulfobutyl ether chelate (ie ECH-(SBE)7m-β- CD,1:1.5), spare.

[0162] (2) drug-containing layer: mix eleximide-β-cyclodextrin sodium sulfobutyl ether chelate with colloidal silicon dioxide and poloxamer passing through a 60-mesh sieve, mix evenly according to the prescription amount, add mass Fractionally add 10% povidone aqueous solution to make a soft material, granulate with a 24-mesh sieve, dry at 45°C for 12 hours, granulate with a 24...

Embodiment 3

[0166] prescription:

[0167]

[0168] Preparation Process:

[0169] (1) Preparation of chelates: pulverizing the ileximide and crossing a 100-mesh sieve;

[0170] Weigh according to the prescription quantity, add β-cyclodextrin sulfobutyl ether sodium into water at a mass ratio of 1:1 to obtain an aqueous solution of β-cyclodextrin sulfobutyl ether sodium; add elexinamine to β-cyclodextrin Mix the aqueous solution of sodium sulfobutyl ether, stir evenly, filter, dry, and sieve through a 100 mesh sieve to obtain the sodium sulfobutyl ether chelate (ie ECH-(SBE)7m-β- CD,1:1), spare.

[0171] (2) drug-containing layer: mix eleximide-β-cyclodextrin sodium sulfobutyl ether chelate with colloidal silicon dioxide and poloxamer passed through a 60-mesh sieve, mix evenly according to the prescription amount, add mass The soft material is made from an aqueous solution of povidone with a fraction of 10%, granulated with a 24-mesh sieve, dried at 45°C for 12 hours, sized with a 24-...

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Abstract

The invention discloses a controlled release tablet containing ilepcimide and a preparation method and application thereof. The controlled release tablet containing ilepcimide comprises a tablet core and a semi-permeable membrane layer coating the outer surface of the tablet core; the tablet core comprises a medicine-containing layer and a boosting layer; the medicine-containing layer and the boosting layer are arranged in a stacked mode. The drug-containing layer comprises ilepcimide and a solubilizing chelating agent; the boosting layer comprises a permeation promoting polymer; the semi-permeable membrane layer is made of a semi-permeable membrane material; and the semipermeable membrane layer is provided with small drug release holes. Compared with a common normal release preparation, the ilepcimide-containing controlled release tablet provided by the invention has the advantages that the taking times and dosage are reduced, the ilepcimide-containing controlled release tablet can be taken 1-2 times per day, the blood concentration fluctuation of the medicine in a human body can be reduced, the toxic and side effects are reduced, the medication safety is improved, and the curative effect of the ilepcimide on diseases such as senile dementia is enhanced.

Description

technical field [0001] The application relates to a controlled-release tablet containing ileximide and its preparation method and application, belonging to the technical field of medicines. Background technique [0002] Epilepsy is a chronic disorder of the central nervous system that requires long-term drug treatment. Currently, the effective rate of antiepileptic drugs used clinically is only 70% to 80%. Antiepileptic drugs cannot prevent the formation of epileptic foci and the progression of the disease, but can only relieve symptoms. In addition, there are many adverse reactions of antiepileptic drugs, involving multiple systems of the human body. Common adverse reactions include rash, dizziness, nausea, anorexia, abnormal mental behavior, abnormal liver and kidney function, endocrine system dysfunction, and enlarged lymph nodes. Moreover, patients with epilepsy often need to take drugs for a long time or take several antiepileptic drugs at the same time, which will agg...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/44A61K31/4525A61K9/36A61K9/22A61K47/69A61K47/10A61K47/38A61K47/02A61P25/08
CPCA61K9/205A61K9/2086A61K9/2054A61K9/2031A61K9/2009A61K9/2866A61K31/4525A61P25/08
Inventor 孙彦辉岳玉荣易斌韩雅慧
Owner 北京斯利安健康科技有限公司
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