Memantine hydrochloride sustained-release pills and preparation method thereof

A technology of memantine hydrochloride and sustained-release pills is applied in sugar-coated pills, pharmaceutical formulations, and devices that make medicines into special physical or taking forms, etc. Burst release, guaranteed curative effect, good stability

Active Publication Date: 2017-12-15
ZHEJIANG JINGXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this patent solves the risk of sudden release of sustained-release tablets, the capsule is easily affected by the humid environment during long-term storage. Since memantine hydrochloride is a very water-soluble substance, there is a drug-containing layer to slow-release The risk of layer migration, and thus the risk of sudden release
[0005] Patent CN103417491 protects the preparation of memantine hydrochloride sustained-release pellets, mainly protecting the process of the blank pellet core and the memantine hydrochloride drug sustained-release composite layer wrapped in the outer layer, but this process has the same risk of burst release as patent CN103181914

Method used

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  • Memantine hydrochloride sustained-release pills and preparation method thereof
  • Memantine hydrochloride sustained-release pills and preparation method thereof
  • Memantine hydrochloride sustained-release pills and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Embodiment 1: In order to study the impact of the isolation layer on the dissolution of the sustained-release capsule under high humidity conditions, two kinds of pellets were prepared, namely, drug-containing pellet A without isolation layer (or isolation coating layer) and drug-containing pellet B with isolation layer , and then poured into the capsules to form corresponding slow-release capsules A and slow-release capsules B, and put them into a closed container with a relative humidity of 92.5% to investigate the dissolution results in 5 and 10 days.

[0042] One, the preparation of sustained-release capsule A

[0043] (1) Preparation of drug-containing pellets of memantine hydrochloride:

[0044]

[0045] 1.1 Weigh hypromellose E3 into a container filled with purified water at 80°C to 90°C, stir to disperse, then add cold purified water, and stir while adding, to obtain I;

[0046] 1.2 Put polyethylene glycol 6000 and memantine hydrochloride in a container, add...

Embodiment 2

[0083] Embodiment 2: the preparation method of memantine hydrochloride sustained-release capsules:

[0084] (1): Preparation of main drug layer pellets containing memantine hydrochloride (i.e. drug-containing pellets):

[0085]

[0086] 1.1 Weigh hydroxypropyl cellulose and add it to a container filled with purified water at 80°C to 90°C, stir to disperse, then add cold purified water, and stir while adding to obtain I.

[0087] 1.2 Put polyethylene glycol and memantine hydrochloride in a container, add purified water to dissolve, and obtain II.

[0088] 1.3 Then add (I) into (II), stir evenly, then add talcum powder while stirring, stir to disperse the talc powder evenly, pass through an 80-mesh sieve, keep stirring gently with the agitator, and obtain the drug-containing coating solution for later use.

[0089] 1.4 Put the blank pellet core into the material cylinder of the fluidized bed by manual feeding, start heating, and when the temperature of the material is kept a...

Embodiment 3

[0104] Embodiment 3: the preparation method of memantine hydrochloride sustained-release capsules

[0105] (1) Preparation of main drug layer pellets:

[0106]

[0107] 1.1 Weigh hydroxypropyl cellulose and add it to a container filled with purified water at 80°C to 90°C, stir to disperse, then add cold purified water, and stir while adding to obtain I.

[0108] 1.2 Put polyethylene glycol and memantine hydrochloride in a container, add purified water to dissolve, and obtain II.

[0109] 1.3 Then add (I) into (II), stir evenly, then add talcum powder while stirring, and stir to disperse the talcum powder evenly. Pass through an 80-mesh sieve and keep stirring gently with the agitator to obtain a drug-containing coating solution for later use.

[0110] 1.4 Put the blank pellet core into the material cylinder of the fluidized bed by manual feeding, start heating, and when the temperature of the material is kept above 35°C, turn on the atomization pressure (1.6BAR), adjust t...

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Abstract

The invention discloses a sustained release pill of memantine hydrochloride. The filling in the capsule is memantine hydrochloride sustained-release pellets, and the memantine hydrochloride sustained-release pellets sequentially include a blank core, a main drug layer containing memantine hydrochloride, an isolation coating layer and a sustained-release coating layer from the inside to the outside. . The invention has good stability and no sudden release phenomenon, ensures continuous, uniform and slow drug release, and improves the curative effect of the product.

Description

technical field [0001] The invention relates to a memantine hydrochloride slow-release pill and a preparation method thereof, belonging to the technical field of pharmacy. Background technique [0002] With the aging of the world population and the improvement of people's living standards, the average life expectancy is also extended. In 2002, the elderly over the age of 60 accounted for 20% of the world's total population. By 2050, the number of elderly people It is expected to reach 21% of the world's total population. With the aging of the world's population, senile dementia has become the primary problem of human health, and the incidence rate is increasing year by year with the progress of population aging. At present, the number of sick people in the world has exceeded 18 million, and the number of sick people in my country is about 6 million, which is the country with the largest number of sick people in the world. Memantine HCl is used in the treatment of moderate ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K9/22A61K31/13A61J3/06A61P25/28
Inventor 潘裕生胡叶青张利锋俞悦喻颖利徐子金
Owner ZHEJIANG JINGXIN PHARMA
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