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Huperzine-A oral cavity disintegration tablet and its preparation method

A technology of orally disintegrating tablets and huperzine A, which is applied in the field of huperzine A orally disintegrating tablets and its preparation, can solve the problems that are unfavorable for the elderly to take and unfavorable for senile dementia patients, and achieve good results, The effect of simple preparation process and good fluidity

Active Publication Date: 2008-01-09
哈尔滨科信必成医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disclosed huperzine A orally disintegrating tablet contains a large amount of sugar as an auxiliary material, which is unfavorable for senile dementia patients, especially unfavorable for the elderly who avoid sugar

Method used

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  • Huperzine-A oral cavity disintegration tablet and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: preparation embodiment

[0027] Huperzine A 0.05 g, Microcrystalline Cellulose Blank Ball Core 40.0 g, Eudradit  E-100 1.0g, mannitol 60g, low-substituted hydroxypropyl cellulose 3.5g, cross-linked polyvinylpyrrolidone 4.7g, microcrystalline cellulose 5.9g, aspartame 0.5g, orange essence 0.5g, stearin Magnesium acid 1.0 grams, the appropriate amount of PVP-K30 and ethanol solution.

[0028] Preparation of huperzine A drug-containing microspheres:

[0029] Will Eudradit  Dissolve E-100 in 30ml of ethanol solution and fully stir to dissolve it, and use it as a coating solution for later use;

[0030] Dissolving huperzine A in the above-mentioned coating solution to make a drug-containing coating solution;

[0031] Place the microcrystalline cellulose blank core in a coating pan, and coat the drug-containing coating solution evenly on the blank core to prepare drug-containing microspheres.

[0032] To prepare mannitol granules:

[0033] Take mannitol,...

Embodiment 2

[0035] Embodiment 2: stability test

[0036] Take the orally disintegrating tablet prepared in Example 1, spread the tablet on a plate, and carry out a strong light irradiation test (illumination: 4500lx±500lx), and continuously irradiate for 10 days;

[0037] Take the orally disintegrating tablet prepared in Example 1, put it in a watch glass, place it in a thermostat at 60°C±2°C for 10 days, and conduct a high temperature stability test;

[0038] Take the orally disintegrating tablet prepared in Example 1, place it in an environment with a relative humidity of 75%±5% for 10 days, and carry out a high humidity stability test;

[0039] Samples were taken on 10 days to check their properties, disintegration time, dissolution rate, related substances and content. The results are shown in Table 1. The results show that all the indicators of the product stability test are in compliance with the regulations.

[0040] Table 1 Stability test results

[0041] category

Embodiment 3

[0042] Embodiment 3: comparative test

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Abstract

An oral disintegrating tablet of huperzine A contains proportionally huperzine A as the cholinesterase depressant, mannitol as diluent and the alcohol solution of PVP-K30 as adhesive. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a huperzine A compound which is a cholinesterase inhibitor, and also relates to an orally disintegrating tablet of huperzine A and a preparation method thereof. Background technique [0002] Huperzine compounds in Huperzaceae plants are highly effective reversible cholinesterase inhibitors with selective anti-acetylcholinesterase activity, which can significantly improve memory loss and Alzheimer's memory and cognitive ability. [0003] CN1306960A and CN1448390A disclose a method for extracting and separating Huperzine A. [0004] The preparation of huperzine A has been studied in tablets, capsules, dropping pills, injections and the like. Since Huperzine A is suitable for the elderly with memory impairment and dementia, and the swallowing function of the elderly is generally poor, it is made into orally disintegrating tablets, and once the drug is put into the mouth, no water or only a small amount of water is required It c...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/435A61K9/20A61P25/28A61P25/00
Inventor 王锦刚
Owner 哈尔滨科信必成医药科技发展有限公司