Preparation containing tramadol hydrochloride and paracetamol and preparation method of preparation

A technology of paracetamol and tramadol hydrochloride, applied in the field of medicine, can solve the problem of poor quality control of preparation intermediates and final products, complicated prescription of ordinary tablets, and inability to guarantee product safety, effectiveness and reliability, etc. problem, to achieve the effect of simple prescription and guarantee of safety

Active Publication Date: 2016-12-14
SHANXI GOODDOCTOR PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the ordinary tablets of acetaminophen and tramadol dominate the market, but the prescription of ordinary tablets is relatively complicated. During the production process, the quality control of the intermediate products and final products of the preparations is poor, and the safety of the products cannot be guaranteed. , effectiveness and reliability

Method used

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  • Preparation containing tramadol hydrochloride and paracetamol and preparation method of preparation
  • Preparation containing tramadol hydrochloride and paracetamol and preparation method of preparation
  • Preparation containing tramadol hydrochloride and paracetamol and preparation method of preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1 Preparation of preparation containing tramadol hydrochloride and paracetamol

[0045] Feeding amount: 45kg tramadol hydrochloride, 390kg acetaminophen, 12kg lactose, 3.6kg povidone K30, 3.6kg magnesium stearate, each tablet or tablet contains 37.5mg tramadol hydrochloride, 325mg acetaminophen .

[0046] Production Process:

[0047] (1) Pulverizing and sieving: respectively pulverize the tramadol hydrochloride and acetaminophen in the prescribed amount, pass through a 60-mesh sieve, and set aside.

[0048](2) Weighing ingredients: Divide the raw materials of the above prescription into 4 pots for preparation, that is, the ingredients of each pot are tramadol hydrochloride 11.25kg, acetaminophen 97.5kg, and lactose 3kg; hydrochloric acid is weighed according to pot times Tramadol, acetaminophen, lactose.

[0049] (3) Granulation, comprising the following steps:

[0050] A. Preparation of adhesive: 3.6kg of povidone K30 is added to 41.4kg of purified water...

Embodiment 2

[0062] Embodiment 2 Preparation of preparation containing tramadol hydrochloride and paracetamol

[0063] Ingredients: 45kg tramadol hydrochloride, 390kg acetaminophen, 13kg lactose, 3.8kg povidone K30, 3.2kg magnesium stearate, each tablet or tablet contains 37.5mg tramadol hydrochloride, 325mg acetaminophen .

[0064] Production Process:

[0065] (1) Pulverizing and sieving: respectively pulverize the tramadol hydrochloride and acetaminophen in the prescribed amount, pass through a 60-mesh sieve, and set aside.

[0066] (2) Weighing ingredients: Divide the raw materials of the above prescription into 4 pots for preparation, that is, the ingredients of each pot are 11.25kg of tramadol hydrochloride, 97.5kg of acetaminophen, and 3.25kg of lactose; weigh them respectively according to the number of pots Tramadol Hydrochloride, Acetaminophen, Lactose.

[0067] (3) Granulation, comprising the following steps:

[0068] A. Preparation of adhesive: 3.8kg povidone K30 is added to...

Embodiment 3

[0080] Embodiment 3 Preparation of preparation containing tramadol hydrochloride and paracetamol

[0081] Ingredients: 45kg tramadol hydrochloride, 390kg acetaminophen, 15kg lactose, 4kg povidone K30, 4.2kg magnesium stearate, each tablet or tablet contains 37.5mg tramadol hydrochloride, 325mg acetaminophen.

[0082] Production Process:

[0083] (1) Pulverizing and sieving: respectively pulverize the tramadol hydrochloride and acetaminophen in the prescribed amount, pass through a 60-mesh sieve, and set aside.

[0084] (2) Weighing ingredients: Divide the raw materials of the above prescription into 4 pots for preparation, that is, the ingredients of each pot are 11.25kg of tramadol hydrochloride, 97.5kg of acetaminophen, and 3.75kg of lactose; weigh them respectively according to the number of pots Tramadol Hydrochloride, Acetaminophen, Lactose.

[0085] (3) Granulation, comprising the following steps:

[0086] A. Preparation of adhesive: 4.0kg povidone K30 is added to 62....

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PUM

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Abstract

The invention provides a preparation containing tramadol hydrochloride and paracetamol and a preparation method of the preparation. The preparation is prepared from, by weight, 45 parts of tramadol hydrochloride, 390parts ofparacetamol, 10-15parts oflactose, 3.2-4parts ofpovidone K30 and 3-4.2parts ofmagnesium stearate. The preparation method includes the steps of crushing, sieving, weighing, material preparation, granulating, whole mixing, intermediate inspection, filling, polishing or tableting, aluminum-plastic package and the like. The preparation is simple in prescription, the usage amount of the auxiliary materials is small, and it is proved through a long-term test and an acceleration test that the related substance content change in the preparation obtained by adopting the preparation process is small, the tramadol hydrochloride and paracetamol content is basically unchanged, and no p-aminophenol is detected out.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation containing tramadol hydrochloride and acetaminophen and a preparation method thereof. Background technique [0002] Tramadol hydrochloride 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 The affinity is only 1 / 25 of the μ receptor. The chemical name of tramadol hydrochloride is (±)-E-2[(dimethylamino)methyl]-1-(3-methoxyphenyl) cycloethanol hydrochloride, which is a racemate, and its (+ ) enantiomers act on opioid receptors, while (-) enantiomers interfere with the reuptake of norepinephrine in neuronal synapses and increase the concentration of 5-hydroxytryptamine outside neurons, thereby affecting pain transmission and producing analgesia Effect, its strength is 1 / 8-1 / 10 of morphine. [0003] Acet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/167A61K31/137A61K47/32A61K9/48A61K9/20A61P25/04A61P29/00
CPCA61K9/1623A61K9/2027A61K9/4866A61K31/137A61K31/167A61K47/32A61K2300/00
Inventor 刘越飞耿福昌
Owner SHANXI GOODDOCTOR PHARMA CO LTD
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