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Ilepcimide sustained-release dry suspension and preparation method thereof

A dry suspension and sustained-release technology, which is used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. The problem of poor suspension uniformity, etc., can improve the pungent taste, good suspension uniformity and good sustained release performance.

Pending Publication Date: 2022-07-29
北京斯利安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the poor solubility and strong hydrophobicity of ileximide itself, the ileximide preparation obtained by this technology has the problem of poor suspension uniformity
In addition, this document uses conventional flavoring methods such as adding sweeteners or flavoring agents without masking the spicy taste, and the tester tested that the prescription cannot cover its spicy taste

Method used

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  • Ilepcimide sustained-release dry suspension and preparation method thereof
  • Ilepcimide sustained-release dry suspension and preparation method thereof
  • Ilepcimide sustained-release dry suspension and preparation method thereof

Examples

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preparation example Construction

[0056] The present invention also provides a preparation method of the above-mentioned Ilexiamine sustained-release dry suspension, comprising the following steps:

[0057] heating the slow-release carrier to prepare a melt;

[0058] The molten liquid is mixed with elecilamide and then hot-melt spraying is carried out to prepare elecilamide solid dispersion;

[0059] Mix filler, suspending agent and flavoring agent, carry out wet granulation, and then dry to prepare auxiliary material granules;

[0060] Mix the solid dispersion of elecilamide, auxiliary material particles, pH adjuster and aromatic flavoring agent.

[0061] The invention solves the strong pungent taste brought by ilexiamine itself by screening out the macromolecular suspending agent material and combining with the inclusion effect of the solid dispersion technology, thereby greatly improving the patient's compliance.

[0062] In a specific example, the heating temperature ranges from 70°C to 100°C. Understan...

Embodiment 1

[0073] The present embodiment provides a kind of Ilexiamine sustained-release dry suspension, and its component content is specifically as shown in Table 1:

[0074] Table 1

[0075]

[0076]

[0077] Its preparation method is as follows:

[0078] S1, heating described glycerol monostearate to 85 ℃ melting;

[0079] S2, under stirring state, add ileximine in the molten solution of the glyceryl monostearate of step S1, stir;

[0080] S3. Use MS220 hot melt sprayer, transport it to the second-flow gas spray gun through twin-screw, atomize into mist droplets through compressed air, and solidify into solid powder with low-temperature frozen air (-10 ℃ ~ 15 ℃) to prepare Deyilai Xiamine solid dispersion fine powder;

[0081] S4. Preparation of auxiliary material granules: add the recipe amount of aspartame into water, dissolve it, and use it as a binder for later use. Add sorbitol to the wet granulator, then add sodium carboxymethyl cellulose, start stirring and shearing ...

Embodiment 2

[0085] The present embodiment provides a kind of ilexamide sustained-release dry suspension, and its component content is specifically as shown in Table 2:

[0086] Table 2

[0087] Element content% Ilexamide 15 Stearic acid 40 Sorbitol 40 Xanthan Gum 2 Anhydrous monosodium citrate 2 Sodium Saccharin 0.5 taste essence 0.5

[0088] Its preparation method is as follows:

[0089] S1, the stearic acid is heated to 80 ℃ to melt;

[0090] S2, under stirring state, add ilexiamine in the molten solution of the stearic acid of step S1, stir;

[0091] S3. Use MS220 hot melt sprayer, transport it to the second-flow gas spray gun through twin-screw, atomize into mist droplets through compressed air, and solidify into solid powder with low-temperature frozen air (-10 ℃ ~ 15 ℃) to prepare Deyilai Xiamine solid dispersion fine powder;

[0092] S4. Preparation of auxiliary material granules: adding the prescribed amount of sodium s...

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Abstract

The invention provides an ilepcimide sustained-release dry suspension, which is prepared from the following components in percentage by mass: 10 to 30 percent of ilepcimide, 30 to 60 percent of sustained-release carrier, 10 to 57 percent of filling agent, 1 to 5 percent of suspending aid, 1 to 4 percent of pH (Potential of Hydrogen) regulator, 0.2 to 1 percent of flavoring agent and 0.2 to 1 percent of aromatic flavoring agent, wherein the slow-release carrier is selected from one or two of stearic acid and glyceryl monostearate; the suspending aid is selected from one or more of xanthan gum, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose and sodium alginate. After water is added, the sustained-release dry suspension is good in suspension uniformity, free of precipitation and layering problems, good in sustained-release performance and free of spicy taste.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an ilexamide sustained-release dry suspension and a preparation method thereof. Background technique [0002] Epilepsy is a chronic disorder of the central nervous system that requires long-term medical treatment. The effective rate of antiepileptic drugs currently used clinically is only 70% to 80%. Antiepileptic drugs cannot prevent the formation of epilepsy foci and the progression of the disease course, but can only relieve symptoms. In addition, antiepileptic drugs have many adverse reactions, 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 lymphadenopathy. Moreover, epilepsy patients often need to take long-term medication or take several anti-epileptic drugs at the same time, which will aggrav...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4525A61K47/38A61K47/36A61K47/12A61K47/14A61P25/08
CPCA61K31/4525A61K9/1652A61K9/1617A61P25/08
Inventor 蔡正军张颖然赵欢张蕾杨卓理韩雅慧易斌
Owner 北京斯利安药业有限公司
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