Flunitrazepam sublingual tablet preparation and preparation method thereof

A technology of flunitrazepam and sublingual tablet, applied in the field of flunitrazepam sublingual tablet preparation and preparation thereof, can solve the problems of being difficult to achieve rapid onset of effect, irritating, troublesome intramuscular injection, etc. And easy to carry, easy to take, complete and rapid effect

Active Publication Date: 2016-06-08
SHANGHAI MEDICILON INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the drug is absorbed quickly, it is still difficult to achieve rapid onset of action, and intramuscular injection is relatively cumbersome and irritating, so it has great application value to prepare it as a sublingual tablet

Method used

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  • Flunitrazepam sublingual tablet preparation and preparation method thereof
  • Flunitrazepam sublingual tablet preparation and preparation method thereof

Examples

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Effect test

preparation example Construction

[0041] In a more specific example, the preparation method of flunitrazepam sublingual tablet comprises the following steps:

[0042] Step 1: Mix sorbitol and polyethylene glycol 6000 evenly, and pass through a sieve of 80 mesh or 100 mesh;

[0043] Step 2: Dissolving polyvinylpyrrolidone K30 and caprylic capric acid polyethylene glycol glyceride in an appropriate amount of water to form a solution, the concentration of polyvinylpyrrolidone K30 in the aqueous solution can be 15-40 g / mL;

[0044] The third step: dissolving flunitrazepam in the second step solution, adding the above-mentioned powder to prepare soft material, crossing an appropriate mesh screen (such as 20 mesh sieve) to make granules, oven or fluidized bed drying (drying) The temperature is, for example, 40-60°C) and then sizing (for example, sizing through a 20-mesh sieve);

[0045] Step 4: Add magnesium stearate to the dry granules, mix well, and press into tablets.

[0046] Adopt technology of the present in...

Embodiment 1

[0053] Flunitrazepam

[0054] Magnesium stearate

[0055] Mix sorbitol and polyethylene glycol 6000 evenly; dissolve polyvinylpyrrolidone K30 and caprylic capric acid macrogolglyceride in 20mL water to form solution A, then dissolve flunitrazepam in solution A, add the above powder Prepare the soft material in the middle, pass through a 20-mesh sieve to make granules, dry at 40-60°C, granulate with a 20-mesh sieve, add magnesium stearate to the dry granules, mix well, and press into tablets.

Embodiment 2

[0057] Flunitrazepam

[0058] Mix sorbitol and polyethylene glycol 6000 evenly; dissolve polyvinylpyrrolidone K30 and caprylic capric acid macrogolglyceride in 20mL water to form solution A, then dissolve flunitrazepam in solution A, add the above powder Prepare the soft material in the middle, pass through a 20-mesh sieve to make granules, dry at 40-60°C, sieve the 18-mesh sieve, add magnesium stearate to the dry granules, mix well, and press into tablets.

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Abstract

The invention relates to a flunitrazepam sublingual tablet preparation and a preparation method thereof. Every 1000 sublingual tablets contain 1-3g of flunitrazepam, 5-10g of polyvinylpyrrolidone K30, 30-50g of polyethylene glycol 6000, 30-60g of sorbitol, 2-10g of labrasol, and 0.5-2g of magnesium stearate. According to the invention, by utilizing the characteristics that sublingual mucosa is non-cornified, capillaries are abundant, and blood flows fast, and directed at the disadvantages that drug administration of flunitrazepam through gastrointestinal tract needs time and intramuscular injection is relatively troublesome, flunitrazepam is prepared into a sublingual tablet that can be absorbed through sublingual mucosa and directly enter blood circulation through jugular vein and superior vena cava. The sublingual tablet takes effect fast and guarantees the curative effect, does not need water during taking, is for sublingual administration, is convenient to take orally, and has good taste.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a flunitrazepam sublingual tablet preparation which is used for sedation and hypnosis and takes effect rapidly through sublingual mucosal absorption and a preparation method thereof. Background technique [0002] There are relatively serious sleep disorders in modern society. Nearly 1 / 4 of the people in the world are troubled by insomnia, and the occurrence of insomnia increases with age. Its treatment has attracted more and more people's attention. Insomnia is usually caused by heavy psychological burden, lack of a good sleeping environment, physical pain, and mental diseases such as anxiety and depression. The clinical manifestations of insomnia mainly include difficulty in falling asleep, poor sleep, excessive night awakenings and early awakening. In the drug treatment of insomnia, it is important to correctly diagnose and determine the etiology. According to the etiology, duration ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/5513A61K47/34A61K47/32A61P25/20
Inventor 黄冲李国栋刘月庆陈春麟程萍夏秦刘彦君
Owner SHANGHAI MEDICILON INC
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