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Novel hydrochloric acid tramadol sustained-release tablet

A technology of tramadol hydrochloride and slow-release tablets, which is applied in the field of medicine, can solve the problem of stable effective blood drug concentration not changing, and achieve the effects of maintaining blood drug concentration, improving stability, and good taste

Active Publication Date: 2008-01-02
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention solves the problems existing in the current prior art, and provides a slow-release tablet that releases tramadol hydrochloride for a long time and can be administered at a relatively long interval of time, and the steady-state effective blood drug concentration of tramadol is almost unchanged agent

Method used

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  • Novel hydrochloric acid tramadol sustained-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1000 tablets, the specification is 90mg.

[0024] prescription:

[0025] Tablet core Film coating

[0026] Tramadol Hydrochloride 90g Hydroxypropyl Methylcellulose 3g

[0027] Chitosan 135g Talc 2g

[0028] Lactose 17.9g Stearic acid 0.5g

[0029] Polyvinylpyrrolidone 5.36g Ethanol 100ml

[0030] Magnesium stearate 1.78g

[0031] Glyceryl monostearate 22.5g

[0032] Proper amount of ethanol

[0033] Preparation:

[0034] a. Preparation of tablet core: Take the prescribed amount of slow-release material, add distilled water, stir in a hot water bath at 70°C to 80°C, take it out after dissolving, quickly emulsify with tramadol hydrochloride, add monostearic acid under constant stirring Glyceride until mixed evenly, adjust the pH value to 5.0-6.0 with 10% hydrochloric acid solution, add distilled water to continue stirring, then place in a cold water bath to cool, add 36% formaldehyde solution and stir for 10min-15min, adjust with 10% sodium hydroxide solution Whe...

Embodiment 2

[0037] 1000 tablets, the specification is 100mg.

[0038] prescription:

[0039] Tablet core Film coating

[0040] Tramadol Hydrochloride 100g Hydroxypropyl Methylcellulose 4.5g

[0041] Xanthan Gum 140g Talc 3g

[0042] Lactose 30.25g Stearic acid 0.75g

[0043] Polyvinylpyrrolidone 9.08g Ethanol 150ml

[0044] Magnesium stearate 3.03g

[0045] Glyceryl monostearate 24g

[0046] Proper amount of ethanol

[0047] The preparation method is the same as in Example 1.

Embodiment 3

[0049] 1000 tablets, the specification is 110mg.

[0050] prescription:

[0051] Tablet core Film coating

[0052] Tramadol Hydrochloride 110g Hydroxypropyl Methylcellulose 6g

[0053] Chitosan 143g Talc 4g

[0054] Lactose 45.2g Stearic acid 1g

[0055] Polyvinylpyrrolidone 13.56g Ethanol 200ml

[0056] Magnesium stearate 4.52g

[0057] Glyceryl monostearate 25.3g

[0058] Proper amount of ethanol

[0059] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention discloses a new type sustained release tablets of tramadol hydrochloride and the preparation method. The sustained release tablets comprise tablet core and membrane clothing sheet. The tablet core contains sustained release capsule of tramadol hydrochloride with its weight being 80-90% of total weight of tablet core, and the sustained release capsule is prepared with tramadol hydrochloride and sustained release material with ratio being 1: 1.2-1.5. The sustained release capsule also contains 10% monoglyceride. The sustained release tablet is characterized by stable effective blood concentration, increased biological utilization rate, reduced side effect, good taste and small intake amount of one time per day.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical preparation, in particular to a preparation method of a novel sustained-release tablet with tramadol or a salt thereof as an active ingredient, and belongs to the technical field of medicine. Background technique [0002] Tramadol is a centrally acting analgesic with a dual mechanism of analgesia, that is, by stimulating the opioid μ receptor and inhibiting the reuptake of central monoaminergic substances (serotonin and norepinephrine). It exerts analgesic effect, and has the characteristics of strong analgesic effect, low drug dependence, low abuse potential, and no typical side effects of many opioid agonists. [0003] Tramadol has a relatively short half-life, so multiple administrations are required. However, in order to maintain an effective amount of blood drug concentration and achieve therapeutic effects, the initial overdose at the initial stage of administration may cause more ...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K9/22A61K9/36A61K9/52A61K47/32
Inventor 郭卫芹张育李国聪王晨光韩婷
Owner CSPC OUYI PHARM CO LTD
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