Analgesic tramadol hydrochloride oral disintegrating tablet and preparing method thereof

A technology of tramadol hydrochloride and orally disintegrating tablet is applied in the field of analgesic tramadol hydrochloride tablet orally disintegrating tablet and its preparation field, which can solve the problem of inconvenient administration and insufficient release of ordinary tablets and capsules. and other problems, to achieve the effect of short development cycle, alleviation of gastrointestinal discomfort, and small capital investment

Inactive Publication Date: 2004-09-15
周宇
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tramadol hydrochloride is currently available in the domestic market in the form of tablets, capsules, sustained-release tablets and injections. The release of ordinary tablets and capsules is not fast enough, while injections can quickly exert their drug effects but are inconvenient to administer, and long-term use is harmful. The patient causes greater pain, but the orally disintegrating tablet of the present invention avoids this shortcoming

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Suspend 50 g of the main drug tramadol hydrochloride in 75 g of hydroxyethyl cellulose aqueous solution to form solution A. According to the formula in auxiliary material 1, 25 g of gelatin, 645 g of mannitol, 5 g of spices and 250 g of sucrose are mixed and dissolved to form a solution B. Mix the formed solution A with solution B, add an appropriate amount of water to dilute, and mix well, add it to the mold to freeze at low temperature, put it in a freeze dryer to vacuum, sublimate the ice until the material is completely dry, press seal, and pack.

[0032] The total weight of five kinds of auxiliary materials is 1kg, and 1000 tablets are made, each auxiliary material is 1g, and the main drug tramadol hydrochloride is 50mg.

Embodiment 2

[0034] Suspend 100g of the main drug tramadol hydrochloride in 100g of hydroxyethyl cellulose aqueous solution to form solution A, according to the formula in auxiliary material 1, then mix and dissolve 45g of gelatin, 800g of mannitol, 10g of spices and 300g of sucrose to form a solution B. Mix the formed solution A with solution B, add an appropriate amount of water to dilute, and mix well, add it to the mold to freeze at low temperature, put it in a freeze dryer to vacuum, sublimate the ice until the material is completely dry, press seal, and pack.

Embodiment 3

[0036] prescription:

[0037] Tramadol Hydrochloride 50g

[0038] Ethylcellulose 17.45g

[0039] Polyvinylpyrrolidone 4.40g

[0040] Silica 3.65g

[0041] Cross-linked polyvinylpyrrolidone 50.0g

[0042] Granular Mannitol 173.0g

[0043] Mannitol powder 174.0g

[0044] Lemon essence 5.0g

[0045] Aspartame 20.0g

[0046] Magnesium Stearate 2.0g

[0047] Makes 1000 pieces

[0048] Preparation method:

[0049] 1. Dissolve ethyl cellulose in ethanol, add polyvinylpyrrolidone and 1 / 3 amount of silicon dioxide while stirring, and keep stirring (the suspension should be kept stirring during the whole granulation and coating process).

[0050] 2. Put the sieved tramadol hydrochloride raw material and 2 / 3 amount of silicon dioxide into the fluidized bed, heat under the air flow, spray the prepared suspension on the raw material, and granulate.

[0051] 3. When the suspension is sprayed to about 1 / 3 of the volume, take out the raw material granules and sieve through a 500μm ...

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PUM

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Abstract

The present invention relates to an analgesic tramadol hydrochloride oral disintegrant tablet. It is made up by using main medicine tramadol hydrochloride and auxiliary material gelatin and / or mannitol and / or aspartame and / or glucose and / or microcrystal cellulose and / or crosslinked povidone and essence, etc. and adopting freeze-drying or coating, granulating and pressing processes. When it is taken in, it has no need of drinking water, it can be quickly disintegrated in oral cavity, and can be used for curing acute and chronic pain, moderate and light pain due to cancer, pain due to fracture and pain after various operations and toothache, and can obtain good therapeutic effect.

Description

technical field [0001] The invention relates to medicines, in particular to an orally disintegrating tablet of analgesic tramadol hydrochloride and a preparation method thereof. Background technique [0002] Tramadol hydrochloride is a 4-phenylpiperidine analgesic, which is widely used in clinic because of its strong analgesic effect, low addiction, low tolerance and low dependence. This product is a non-opioid central analgesic. Although it can also bind to opioid receptors, its affinity is very weak. The affinity for μ receptors is equivalent to 1 / 6000 of morphine, and the affinity for κ and δ receptors is only 1 / 6000. 1 / 25 of mu receptors. Tramadol hydrochloride is a racemate, its (+) enantiomer acts on opioid receptors, while the (-) enantiomer inhibits the reuptake of norepinephrine by neuronal protrusions and increases extraneuronal 5- The concentration of serotonin can affect the transmission of pain and produce analgesic effect, the strength of which is 1 / 8~1 / 10 of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/135A61P1/02A61P29/00
Inventor 周宇
Owner 周宇
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