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Alprazolam sustained-release preparation and preparation method thereof

A technology of alprazolam and sustained-release preparations, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problems that alprazolam sustained-release tablets have not been listed yet , to achieve the effect of easy drug withdrawal, convenient administration and wide distribution

Inactive Publication Date: 2011-06-29
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The Pharmacopoeia of the People's Republic of China, 2000 Edition, Part II has recorded alprazolam raw materials and tablets, but there is no alprazolam sustained-release tablet on the market in China.

Method used

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  • Alprazolam sustained-release preparation and preparation method thereof
  • Alprazolam sustained-release preparation and preparation method thereof
  • Alprazolam sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Preparation:

[0029] (1) Take alprazolam (Shandong Qilu Xinghua Pharmaceutical Factory), hypromellose K15MP (Shanghai Colorcon Coating Technology Co., Ltd.), lactose Granulac200 (Shanghai Representative Office of German Magile Company), hard Magnesium fatty acid (Yingkou Aoda Pharmaceutical Co., Ltd.), respectively crosses 80 mesh sieves, for subsequent use;

[0030] (2) Alprazolam, hydroxypropyl methylcellulose K15MP (Shanghai Colorcon Coating Technology Co., Ltd.), and lactose Granulac200 were weighed and mixed according to the principle of equal mixing;

[0031] (3) get the mixture of step (2) gained, stamp large piece with 12mm die;

[0032] (4) the large pieces of step (3) gained are broken, cross 26 mesh sieves, and granulate;

[0033] (5) take by weighing the magnesium stearate of recipe quantity, add in the granule of step (4) gained, mix, measure intermediate content, calculate sheet weight, tabletting, measure hardness, control hardness 70N;

[0034...

Embodiment 2

[0037] Preparation:

[0038] (1) Get alprazolam, hypromellose K100LV (Shanghai Kalekang Coating Technology Co., Ltd.), microcrystalline cellulose 101 (Germany JRS Shanghai Fenghong Pharmaceutical Co., Ltd.), magnesium stearate, respectively Pass through a 80-mesh sieve and set aside;

[0039] (2) Alprazolam, hydroxypropyl methylcellulose K100LV, and microcrystalline cellulose 101 of the prescribed amount were weighed respectively and mixed uniformly according to the principle of equal mixing;

[0040] (3) get the mixture of step (2) gained, stamp large sheet with 10mm die;

[0041] (4) the large pieces of step (3) gained are broken, cross 26 mesh sieves, and granulate;

[0042] (5) take by weighing the magnesium stearate of recipe quantity, add in the granule of step (4) gained, mix, measure intermediate content, calculate sheet weight, tabletting, measure hardness, control hardness 60N;

[0043] (6) Weigh the Opadry (Shanghai Colorcon Coating Technology Co., Ltd.) o...

Embodiment 3

[0046] Preparation:

[0047] (1) Take Alprazolam, Hypromellose K4M (Shanghai Colorcon Coating Technology Co., Ltd.), Hypromellose E5 (Shanghai Colorcon Coating Technology Co., Ltd.), microcrystalline fiber Plain 101, magnesium stearate, cross 80 mesh sieves respectively, for subsequent use;

[0048] (2) Alprazolam, hydroxypropylmethylcellulose K4M, hydroxypropylmethylcellulose E5, and microcrystalline cellulose 101 of the prescribed amount were weighed and mixed uniformly according to the principle of equal mixing;

[0049] (3) get the mixture of step (2) gained, stamp large piece with 12mm die;

[0050] (4) the large pieces of step (3) gained are broken, cross 26 mesh sieves, and granulate;

[0051] (5) take by weighing the magnesium stearate of recipe quantity, add in the granule of step (4) gained, mix, measure intermediate content, calculate sheet weight, compress tablet, measure hardness, control hardness 65N;

[0052] (6) Weigh the prescribed amount of Surelease (Shan...

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Abstract

The invention relates to alprazolam sustained-release preparation and the preparation method thereof. The alprazolam sustained-release preparation is characterized in that alprazolam, framework material, filling agent, lubricating agent and film-forming material are mainly included. The invention belongs to the technical field of medicinal preparations and aims at providing the alprazolam sustained-release preparation with favorable compliance, small side effects, durable drug effect and stable curative effect and the preparation method of the alprazolam sustained-release preparation. The alprazolam sustained-release preparation stably and stably releases the drug, avoids the phenomenon that the peak valley is easy to generate when the general preparation releases the drug, has more durable drug effect, stably exists in the blood for 24 hours and can be widely distributed on the whole body; and the alprazolam sustained-release preparation has the characteristics of high bioavailability, low toxic or side effects, stable curative effect, low administration frequency, long administration time, and the like and is convenient for administration; and the abuse is avoided and the alprazolam sustained-release preparation is easily stopped administrating.

Description

technical field [0001] The invention relates to an alprazolam sustained-release preparation and a preparation method thereof, characterized in that the alprazolam sustained-release preparation is composed of the main drug alprazolam, a skeleton material, a filler, a lubricant, and a film-forming material. composition. It belongs to the technical field of pharmaceutical preparations. Background technique [0002] Alprazolam is a benzodiazepine receptor agonist, and the benzodiazepine receptor is a functional supramolecular functional unit, also known as a component of the benzodiazepine-GABA receptor-chloride ion complex. The receptor complex is located in the nerve cell membrane, regulates cell discharge, and mainly functions as the threshold valve (gating) of the chloride channel. GABA receptor activation leads to the opening of chloride channels, allowing chloride ions to flow through the nerve cell membrane, causing post-synaptic neuron hyperpolarization, and inhibiting...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/30A61K31/519A61K47/38A61P21/02A61P25/08A61P25/20A61P25/24A61P25/22
Inventor 李育巧林鹏郑顺利
Owner COSCI MED TECH CO LTD
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