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Compound pharmaceutical composition of tapentadol hydrochloride and dexketoprofen trometamol

A technology of dexketoprofen trometamol and tapentadol hydrochloride, which is applied in the field of analgesic pharmaceutical compositions, and can solve problems such as no medicinal use

Inactive Publication Date: 2014-12-10
ANHUI YIXINMING PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] A compound composed of tapentadol hydrochloride and dexketoprofen trometamol has no clinical application

Method used

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  • Compound pharmaceutical composition of tapentadol hydrochloride and dexketoprofen trometamol
  • Compound pharmaceutical composition of tapentadol hydrochloride and dexketoprofen trometamol
  • Compound pharmaceutical composition of tapentadol hydrochloride and dexketoprofen trometamol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1 37.5mg / 12.5mg Tapentadol Hydrochloride Dexketoprofen Tromethamine Tablets

[0026] 1. Prescription

[0027] Table 1 Composition of 37.5mg / 12.5mg tapentadol hydrochloride dexketoprofen tromethamine tablets prescription (1000 tablets)

[0028]

[0029] 2. Preparation process

[0030] (1) Tapentadol hydrochloride passed through a 80-mesh sieve, lactose monohydrate, microcrystalline cellulose, and hydroxypropyl methylcellulose passed through a 60-mesh sieve, and put into a V-type mixer and mixed evenly;

[0031] (2) Put the above mixed powder into the wet mixing granulator, add purified water slowly, and shear granulate;

[0032] (3) Dry the granules at 60°C;

[0033] (4) The dried granules were sieved with 24 meshes to obtain granule 1;

[0034] (5) Dexketoprofen trometamol is passed through an 80-mesh sieve and silicon dioxide is put into a V-type mixer and mixed evenly;

[0035] (6) After passing through a 60-mesh sieve, cornstarch and sodium carboxym...

Embodiment 2

[0039] Example 2 75mg / 25mg Tapentadol Hydrochloride Dexketoprofen Tromethamine Tablets

[0040] 1. Prescription

[0041] Table 2 75mg / 25mg tapentadol hydrochloride dexketoprofen tromethamine tablets prescription composition (1000 tablets)

[0042]

[0043] 2. Preparation process

[0044](1) Tapentadol hydrochloride passed through a 80-mesh sieve, lactose monohydrate, microcrystalline cellulose, and hydroxypropyl methylcellulose passed through a 60-mesh sieve, and put into a V-type mixer and mixed evenly;

[0045] (2) Put the above mixed powder into the wet mixing granulator, add purified water slowly, and shear granulate;

[0046] (3) Dry the granules at 60°C;

[0047] (4) The dried granules were sieved with 24 meshes to obtain granule 1;

[0048] (5) Dexketoprofen trometamol is passed through an 80-mesh sieve and silicon dioxide is put into a V-type mixer and mixed evenly;

[0049] (6) After passing through a 60-mesh sieve, cornstarch and sodium carboxymethyl cellu...

Embodiment 3

[0053] Example 3 37.5mg / 12.5mg Tapentadol Hydrochloride Dexketoprofen Tromethamine Capsules

[0054] 1. Prescription

[0055] Table 3 37.5mg / 12.5mg Tapentadol Hydrochloride Dexketoprofen Tromethamine Capsules Prescription Composition (1000 capsules)

[0056]

[0057] 2. Preparation process

[0058] (1) Tapentadol hydrochloride passed through a 80-mesh sieve, lactose monohydrate, microcrystalline cellulose, and hydroxypropyl methylcellulose passed through a 60-mesh sieve, and put into a V-type mixer and mixed evenly;

[0059] (2) Put the above mixed powder into the wet mixing granulator, add purified water slowly, and shear granulate;

[0060] (3) Dry the granules at 60°C;

[0061] (4) The dried granules were sieved with 24 meshes to obtain granule 1;

[0062] (5) Pass dexketoprofen trometamol through a 80-mesh sieve, pass through a 60-mesh sieve with cornstarch and sodium carboxymethylcellulose, and mix them evenly in a V-type mixer;

[0063] (6) Put the above mixed...

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PUM

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Abstract

The invention relates to a compound pain-relieving pharmaceutical composition which comprise the active ingredients of tapentadol hydrochloride and dexketoprofen trometamol. The invention also relates to a preparation method and application of a compound preparation of the pharmaceutical composition, wherein a dosage form of the compound preparation is an oral solid preparation. Tapentadol hydrochloride and dexketoprofen trometamol have a synergistic effect on the curative effect and antagonism on the toxicity, so that the compound pain-relieving pharmaceutical composition refers to a quick-acting, powerful and low-addiction compound pain-relieving preparation.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an analgesic pharmaceutical composition, a compound preparation comprising active ingredients tapentadol hydrochloride and dexketoprofen trometamol and uses thereof. Background technique [0002] Tapentadol hydrochloride is a new type of strong central analgesic with dual action modes of opioid receptor agonism and norepinephrine reuptake inhibition. On January 23, 2008, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application for Tapentadol Hydrochloride Immediate Release Tablets for the treatment of moderate to severe acute pain. The results of the study show that tapentadol does not rely on metabolic activation and has no active metabolites. It has good effects on acute, inflammatory and chronic neuropathic pain models, and its potency is between morphine and tramadol. Satisfactory blood drug concentration can be obtained, and it is ...

Claims

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Application Information

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IPC IPC(8): A61K31/192A61P29/00A61P25/04A61K31/137
Inventor 徐奎刘经星
Owner ANHUI YIXINMING PHARMA TECH
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