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Oral disintegration tablet of tramadol hydrochloride and preparation method

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

Inactive Publication Date: 2005-08-31
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 raw materials are all available in the market and easy to buy.

[0023] The preparation method is as follows: Weigh each component according to the prescribed 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 in advance, stir uniformly, and then quench the melt to solidify at low temperature, crush and sieve. Add 120 mg of starch, 20 mg of low-substituted hydroxypropyl cellulose, 8.75 mg of stevioside, wet granulation, and 1.25 mg of magnesium stearate for tableting. The disintegration time limit is 18 minutes, and the taste is relatively bitter.

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%, and magnesium stearate 0.5%. The above-mentioned raw materials are all sold and easily purchased in the market.

[0027] The preparation method is as follows: Weigh each component according to the prescribed 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, and stir evenly, then quench the melt to solidify at low temperature, crush and sieve. Add 112.5 mg of starch, 21.75 mg of low-substituted hydroxypropyl cellulose, 20 mg of stevioside, wet granulation, and 1.25 mg of magnesium stearate for tableting. The disintegration time limit is 16 minutes, and the taste is bitter.

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%, talc 0.3%. The above-mentioned raw materials are all sold and easily purchased in the market.

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

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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 an oral pharmaceutical preparation of tramadol hydrochloride, in particular an oral disintegrating tablet of tramadol hydrochloride 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, 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, molecular weight is 229.84, its structure is as follows: [0003] [0004] Tramadol hydrochloride was researched and developed by Germany Grantai Company. It was first marketed in Germany in 1977 and has been marketed in many countries including my country. This...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/135A61P25/04
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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