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High-dissolving-rate ilepcimide drug composition and preparation method thereof

A technology of composition and medicine, which is applied in the field of eleximide pharmaceutical composition with high dissolution rate and its preparation, can solve problems such as high cost, difficult industrial production, and complexity, and achieve good absorption, improved bioavailability, high dispersion effect

Active Publication Date: 2014-11-05
黑龙江童医生儿童生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For improving bioavailability, the above-mentioned methods all have the defects of being too complicated, difficult to industrialized production, and high in cost.

Method used

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  • High-dissolving-rate ilepcimide drug composition and preparation method thereof
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  • High-dissolving-rate ilepcimide drug composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Embodiment 1: Ileximide Capsules

[0057]

[0058] Preparation Process:

[0059] (1) Pass the raw and auxiliary materials through a 100-mesh sieve for later use;

[0060] (2) Weigh according to the prescription amount, mix eleximine and starch evenly, add ethanol (50%) in an appropriate amount to moisten, and make a soft material;

[0061] (3) Pass the soft material through a 40-mesh sieve to granulate, dry at 45-55°C, granulate with a 40-mesh sieve, then add the prescribed amount of magnesium stearate, and mix well;

[0062] (4) Intermediate detection;

[0063] (5) Capsule filling, polishing, and packaging to obtain Ileximide capsules with a specification of 25 mg (calculated as Ileximide).

Embodiment 2

[0065] Ileximide Capsules Prescription:

[0066]

[0067] Preparation Process:

[0068] (1) Pass the raw and auxiliary materials through a 100-mesh sieve for later use;

[0069] (2) Weigh according to the prescription amount, mix eleciamine and lactose evenly, add ethanol (50%) to moisten it in an appropriate amount, and make a soft material;

[0070] (3) Pass the soft material through a 40-mesh sieve to granulate, dry at 45-55°C, granulate with a 40-mesh sieve, then add the prescribed amount of micro-powder silica gel and mix well;

[0071] (4) Intermediate detection;

[0072] (5) Capsule filling, polishing, and packaging to obtain Ileximide capsules, with a specification of 50 mg (calculated as Ileximide).

Embodiment 3

[0074] Ileximine dry suspension (suspension granules) prescription:

[0075]

[0076] Preparation Process:

[0077] (1) Pass the raw and auxiliary materials through a 100-mesh sieve for later use;

[0078] (2) Weigh according to the prescription amount, mix eleximine, sucrose, mannitol, and xanthan gum evenly, add ethanol (50%) to moisten it in an appropriate amount, and make a soft material;

[0079] (3) Pass the soft material through a 40-mesh sieve to granulate, dry at 45-55°C, granulate with a 40-mesh sieve, then add the prescribed amount of micro-powder silica gel and mix well;

[0080] (4) Intermediate detection;

[0081] (5) Filling and packaging, that is, deleximide dry suspension (suspension granules), with a specification of 50 mg (calculated as ileximide).

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Abstract

The invention relates to a high-dissolving-rate ilepcimide drug composition and a preparation method thereof. The drug composition mainly comprises ilepcimide of 80 to 120 meshes, and particles of 30 to 50 meshes, which are prepared from pharmaceutically acceptable first auxiliary material; and the dissolution rate of the drug composition is 70% to 85%. The two preferred forms of the drug composition provided by the invention are dry suspension and capsule. The invention has the benefits that compared with the traditional tablets, the high-dissolving-rate ilepcimide drug composition disperses quickly and is well absorbed in gastrointestinal fluid, the bioavailability is improved by 10% to 15%, and the patient compliance is good; when being made into capsules, the drug composition is neat and beautiful, is easy to swallow, and reduces the irritation to the pharynx and the throat; and when being made into dry suspension, the drug composition is very suitable for being taken by the old, children and other patients having difficulty in swallowing. Meanwhile, the preparation method provided by the invention is simple in process and is suitable for industrialized production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an eleximide pharmaceutical composition with a high dissolution rate and a preparation method thereof. Background technique [0002] Ileximide, one of the derivatives of piperine, is an antiepileptic drug extracted from white pepper, a traditional Chinese antiepileptic medicine prescription. Ileximide is a broad-spectrum antiepileptic drug. Pharmacological experiments and clinical experiments on a large number of animal models have confirmed that its antiepileptic effect is remarkable and its toxic and side effects are small. The pharmacological mechanism may be related to the increase of 5-hydroxytryptamine content in the brain of animals. [0003] Ilecilamine is white or light yellow crystalline powder; odorless and tasteless; easily soluble in chloroform and ether, soluble in ethanol and carbon tetrachloride, insoluble in water. At present, only tablets...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4525A61K9/16A61K9/14A61K9/48A61P25/08
Inventor 王世岭李孟广张超
Owner 黑龙江童医生儿童生物制药有限公司
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