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Sustained release preparation containing memantine hydrochloride and huperzine A and preparation method thereof

A technology of memantine hydrochloride and huperzine A, applied in the field of medicine, can solve the problems of poor patient compliance, difficulty in patients, short biological half-life of huperzine A and the like

Inactive Publication Date: 2010-06-30
北京利乐生制药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, Huperzine A has a short biological half-life in the body. As a drug for treating senile dementia, it needs to be taken several times a day, which brings certain difficulties to patients, and the patient's compliance is not good, so the slow-release of Huperzine A was developed. Preparation, this compound preparation can be taken once a day, which not only exerts the synergistic effect of two drugs with different mechanisms of action, but also makes the patient's compliance good

Method used

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  • Sustained release preparation containing memantine hydrochloride and huperzine A and preparation method thereof
  • Sustained release preparation containing memantine hydrochloride and huperzine A and preparation method thereof
  • Sustained release preparation containing memantine hydrochloride and huperzine A and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1 memantine hydrochloride A double-layer sustained-release tablet

[0017] prescription:

[0018]

[0019] Preparation Process:

[0020] Pass memantine hydrochloride, huperzine A, calcium hydrogen phosphate dihydrate, and lactose monohydrate through an 80-mesh sieve, and other raw and auxiliary materials through a 60-mesh sieve, and set aside. Take memantine hydrochloride, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose and mix them uniformly in equal amounts, make soft material with water, granulate with 20 mesh, dry, granulate with 20 mesh, add 0.2g magnesium stearate , add croscarmellose sodium, mix well, set aside. Separately take huperzine A, Eudragit RS100, calcium hydrogen phosphate dihydrate, lactose monohydrate, mix uniformly according to the method of equal volume addition, add soft material made of 40% ethanol, granulate with 20 mesh, dry, granulate with 20 mesh, add Magnesium stearate 0.3g and silicon dioxide, mix eve...

Embodiment 2

[0021] Embodiment 2 compound memantine hydrochloride nail film-coated sustained-release tablets

[0022] prescription:

[0023]

[0024] Preparation:

[0025] Take huperzine A, Eudragit RS100, calcium hydrogen phosphate dihydrate, and lactose monohydrate, pass through a 80-mesh sieve, mix evenly according to the method of equal addition, add 40% ethanol to make soft material, granulate at 20 mesh, dry, 20 mesh For granulation, add magnesium stearate and silicon dioxide, mix evenly, and compress into tablets. Place the tablets in the coating pan. Adjust the air inlet temperature, the rotating speed of the coating pan, and the nozzle, and evenly spray it into the water-soluble Opadry gastric-soluble film coating solution containing memantine hydrochloride. Incubate the film coating for about 1 hour, and then discharge.

Embodiment 3

[0026] Example 3 Compound Memantine Hydrochloride Sustained-release Pellet Capsules

[0027] prescription:

[0028]

[0029]

[0030] Preparation:

[0031] Pass memantine hydrochloride, huperzine A, and Eudragit RS100 through a 80-mesh sieve, and other auxiliary materials through a 60-mesh sieve, and set aside. Mix memantine hydrochloride and microcrystalline cellulose evenly, make a soft material with water, extrude strips with a diameter of 12-20 mesh and a length of about 3-5cm, adjust the rotation speed of the bottom turntable to 600-1200rpm, roll into a ball for about 5 minutes, take out and dry , to make quick-release pellets; mix Huperzine A with Eudragit and HPMC-15M evenly, use an appropriate amount of purified water as a binder to prepare soft materials, and prepare slow-release pellets in the same way; the above two pellets After mixing evenly according to a certain ratio, fill it into a capsule shell to obtain the product. Example 4 Compound Memantine Hydr...

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Abstract

The invention relates to sustained release preparation containing memantine hydrochloride and huperzine A and preparation method thereof. The sustained release preparation includes quick release component and slow release component, wherein the memantine hydrochloride is the quick release component which represents the characteristic of quick release in vitro dissolution test and can be released by more 80% 30min later, while huperzine A represents the characteristic of slow release in vitro dissolution test and is released by 10-30% in the first hour, by 40-60% in 6 hours, by 60-80% in 12 hours and by more than 80% in 18 hours. The sustained release preparation is mild, has long-term effect and can reduce the application time (only once a day) and improve the compliance of the patient. The invention further discloses the vitro release characteristic and the preparation method of the sustained release preparation.

Description

technical field [0001] The invention relates to a pharmaceutical preparation with memantine hydrochloride and huperzine A as active ingredients and a preparation method thereof, wherein the memantine hydrochloride is an immediate-release part, and huperzine A is a sustained-release part, belonging to the technical field of medicine. Background technique [0002] Alzheimer's disease (AD) mostly occurs in the elderly over 65 years old, and can cause the loss of memory, judgment, abstract thinking, reasoning ability, cognitive function, emotion, personality and spatial relationship in patients. In the end, they cannot take care of themselves, which brings a heavy burden to the patient's family and society. At present, there are about 6 million Alzheimer's patients in my country, accounting for one-third of the total number of patients in the world. There are about 1.8 million new cases and 1.05 million deaths every year. The incidence situation is very serious. With the gradua...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/439A61K31/13A61P25/28
Inventor 严瑞晶
Owner 北京利乐生制药科技有限公司
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