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Oral disintegration tablet of tramadol hydrochloride and preparation method

A technology for tramadol hydrochloride and orally disintegrating tablets, which is applied in the field of tramadol hydrochloride orally disintegrating tablets and its preparation, and can solve problems such as inconvenience, accidents, and failure to achieve rapid onset of action

Inactive Publication Date: 2007-11-14
HENAN UNIVERSITY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When patients take this medicine, they must be taken with boiled water. When taking it for the elderly, children and patients with dysphagia, they often feel very inconvenient, and even accidents may occur. For patients who go out, it will be even more inconvenient if there is no water. convenient
Moreover, this common oral tablet often does not achieve the effect of rapid onset of action

Method used

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  • Oral disintegration tablet of tramadol hydrochloride and preparation method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The present invention is prepared by adopting the following proportioning formula.

[0022] Tramadol hydrochloride 5%, polyethylene glycol 6000 (PEG6000) 35%, starch 48%, low-substituted hydroxypropyl cellulose (L-HPC) 8%, stevioside 3.5%, magnesium stearate 0.5%. The above-mentioned raw materials are all available in the market, and are easy to buy.

[0023] The preparation method is as follows: weighing each component according to the specified amount in the above formula. First heat and melt the weighed polyethylene glycol 600087.5 mg, add 12.5 mg of tramadol hydrochloride powder that has been crushed through a 100-mesh sieve, stir evenly, then quench and solidify the melt at low temperature, crush and sieve. Add 120 mg of starch, 20 mg of low-substituted hydroxypropyl cellulose, and 8.75 mg of stevioside, wet granulate, add 1.25 mg of magnesium stearate, and press into tablets to obtain the product. Its disintegration time limit is 18 minutes, and the taste is rel...

Embodiment 2

[0025] The present invention is prepared by adopting the following proportioning formula.

[0026] Tramadol hydrochloride 10%, polyethylene glycol 4000 (PEG4000) 27.8%, starch 45%, low-substituted hydroxypropyl cellulose (L-HPC) 8.7%, stevioside 8%, magnesium stearate 0.5%. The above-mentioned raw materials are all available in the market and easily purchased.

[0027] The preparation method is as follows: weighing each component according to the specified amount in the above formula. First heat and melt the weighed polyethylene glycol 400069.5 mg, add 25 mg of tramadol hydrochloride powder that has been crushed through a 100-mesh sieve in advance, stir evenly, then quench and solidify the melt at low temperature, crush and sieve. Add 112.5 mg of starch, 21.75 mg of low-substituted hydroxypropyl cellulose, and 20 mg of stevioside, wet granulate, add 1.25 mg of magnesium stearate, and press into tablets to obtain the product. Its disintegration time limit is 16 minutes, and t...

Embodiment 3

[0029] The present invention is prepared by adopting the following proportioning formula.

[0030] Tramadol hydrochloride 15%, polyethylene glycol 4000 (PEG4000) 38.8%, polyethylene glycol 6000 (PEG6000) 13.9%, microcrystalline cellulose (MCC PH102) 12%, low-substituted hydroxypropyl cellulose (L- HPC) 8%, stevioside 12%, talcum powder 0.3%. The above-mentioned raw materials are all available in the market and easily purchased.

[0031] The preparation method is as follows: weighing each component according to the specified amount in the above formula. First, polyethylene glycol 4000 97 mg and polyethylene glycol 6000 34.75 mg were heated and melted, and 37.5 mg of tramadol hydrochloride powder crushed through a 100-mesh sieve was added, stirred evenly, and then the melt was quenched and solidified at low temperature. Crush and sieve. Add 30 mg of microcrystalline cellulose (MCCpH102), 20 mg of low-substituted hydroxypropyl cellulose, and 30 mg of stevioside, wet granulate,...

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Abstract

An orally disintegrating tablet of tramadol hydrochloride is prepared through preparing the dispersed solid from tramadol hydrochloride and dispersing solid carrier, mixing it with filler, disintegrant, flavouring and lubricant, stirring and tabletting.

Description

technical field [0001] The invention relates to a tramadol hydrochloride oral pharmaceutical preparation, in particular to a tramadol hydrochloride orally disintegrating tablet and a preparation method thereof. Background technique [0002] Tramadol hydrochloride, English name: Tramadol, Hydrochloride, chemical name: (±)-E-2[(=methylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride , This product is white crystal or crystalline powder; odorless, bitter taste; hygroscopic. It is very soluble in water, easily soluble in ethanol or chloroform, slightly soluble in acetone, and insoluble in ether. Its melting point is 179-182°C. The molecular formula of this product is: C 16 h 25 NO 2 HCl, the molecular weight is 229.84, its structural formula is as follows: [0003] [0004] Tramadol hydrochloride was researched and developed by Germany's Granta, and was first launched in Germany in 1977. It has been listed in many countries including my country. This product ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/135A61K9/20A61P25/04
Inventor 陈洪轩肖衍宇陈志鹏张克军刘伟芬王艳丽芦秀琴
Owner HENAN UNIVERSITY
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