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Huperzine A double-layer osmotic pump controlled release tablets and preparation method thereof

An osmotic pump controlled release and huperzine A technology is applied in the field of Huperzine A double-layer osmotic pump controlled release tablet and its preparation, which can solve the problems of pain, too fast drug release, complicated preparation process and the like, and achieves convenient application. , The effect of stable blood concentration and reducing the number of doses

Inactive Publication Date: 2009-07-22
普尔药物科技开发(深圳)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Existing huperzine A oral and injection preparations have the following defects: (1) avoid gastrointestinal adverse reactions, but regular injections are required, causing inconvenience and pain for patients; Fast; (3) The preparation process is complicated and the quality stability is difficult to control

Method used

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  • Huperzine A double-layer osmotic pump controlled release tablets and preparation method thereof
  • Huperzine A double-layer osmotic pump controlled release tablets and preparation method thereof
  • Huperzine A double-layer osmotic pump controlled release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] prescription:

[0081]

[0082] Preparation process: a. Pass huperzine A raw material, red iron oxide, and yellow iron oxide through 80-mesh sieve respectively, and pass the remaining auxiliary materials through 60-mesh sieve respectively. The other medicinal materials are mixed through a 60-mesh sieve, and then the mixture is gradually mixed with the main drug and pigment, and placed in a mixer for mixing;

[0083] b. The obtained mixed powder is dry-pressed into large tablets, the set pressure is 6.0-6.5MPa, the feed speed is 2rpm, the roller shaft speed is 2.3-2.5rpm, and the particles between 20-60 meshes are sieved;

[0084] c. Compress the double-layer tablet core, set the pressure to 4.5MPa;

[0085] d. Prepare the controlled-release coating solution to completely dissolve and clarify, and set aside;

[0086] e. The tablet core is coated with a controlled-release coating film, set the tablet bed weight to 5.0Kg, the rotation speed to 10rpm, the inlet air tem...

Embodiment 2

[0091] prescription:

[0092]

[0093] Preparation process: with embodiment 1. The weight gain of coating film during coating is: 20mg.

Embodiment 3

[0095] prescription:

[0096]

[0097]

[0098] Preparation process: with embodiment 1. The weight gain of coating film during coating is: 26mg.

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Abstract

The invention discloses a huperzine A double-layer osmotic pump controlled-release tablet. The tablet comprises a double-layer tablet core consisting of a drug containing layer and a pushing layer, and a semipermeable coating membrane coating the double-layer tablet core, wherein one side of the drug containing layer of the coating membrane is provided with a drug release hole; the drug containing layer of the tablet core contains huperzine, a suspending agent, osmotic pressure active matters and pharmaceutical excipients which are all in effective dosage; the pushing layer contains an expanding agent, a permeation enhancer, and a binder; and the coating membrane contains polyethylene glycol used as a plasticizer, the weight gain of the coating membrane against the weight of the tablet core is between 8 and 20 percent, and the aperture of the drug release hole on the surface of the drug containing layer of the coating membrane is between 0.2 and 2.0 millimeters. The invention also discloses a method for preparing the controlled-release tablet. After patients take the controlled-release tablet, the blood concentration of the patients is relatively stable; the accumulated drug release rate in 12 hours reaches more than 90 percent, thereby greatly reducing the drug taking frequency of the patients; and the invention provides a novel formulation which is safer, more effective, stable, controllable and convenient for application in clinically treating senile dementia.

Description

technical field [0001] The invention relates to a medicine containing huperzine A component and a preparation method thereof, in particular to a huperzine A osmotic pump controlled-release preparation and a preparation method thereof. Background technique [0002] Huperzine A (Huperzine A) is a lycopodium alkaloid extracted from Huperziaserrata (Thunb) Trev, a plant of the Huperzaceae family. It has remarkable effects in enhancing learning and memory, improving spatial memory impairment, etc., and has become one of the research hotspots of global concern. In recent years, the research on the pharmacological effects of huperzine A has continued to deepen and expand, showing multi-directional and multi-angle anti-aging and nootropic effects. The main manifestations are: inhibiting the activity of acetylcholinease, regulating the oxygen free radical system, protecting the brain from hypoxic-ischemic damage, and improving the ability of learning and memory. Both animal experim...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/439A61P25/28
Inventor 何元田王文苹刘姹杨大坚陈新滋
Owner 普尔药物科技开发(深圳)有限公司
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