Nsaids-induced gastrointestinal mucosal disorder alleviator and manufacturing method thereof

Abstract

[Problems] The object of the present invention is to provide a Medical Drugs which reduce damage of gastrointestinal mucosal induced by NSAIDs. [Means for Solving Problems] The Medical Drugs that comprises a mixture of NSAIDs and sugar that reduce damage of gastrointestinal mucosal induced by NSAIDs is already known. However the mixture is not enough to suppress damage of gastrointestinal mucosal. The inventors invented new molecular compounds with NSAIDs and trehalose. The new molecular compounds effectively reduce damage of gastrointestinal mucosal induced by NSAIDs.

1 . A Medical Drugs which reduce damage of gastrointestinal mucosal induced by non-steroidal anti-inflammatory Drugs, NSAIDs, the Medical Drugs comprises an intermolecular compound of NSAIDs and a disaccharide; thereby the Medical Drugs has anti-inflammatory effect of the NSAIDs and can alleviate damage induced by the NSAIDs. 
     
     
         2 . The Medical Drugs in accordance with  claim 1 , wherein the NSAIDs is acidic NSAIDs. 
     
     
         3 . The Medical Drugs in accordance with  claim 1 , wherein the NSAIDs is one or more selected from the group of “Aspirin, Sodium salicylate, Salicylamide, Sazapirin, Diflunisal, Ethenzamide, Aluminum aspirin, 5-Amino salicylic acidic, Indomethacin, Etodolac, Sodium diclofenac, sulindac, sodium anfenac, proglumetacin maleate, acemetacin, nabumeton, mofezolac, Ibuprofen, Naproxen, Loxoprofen, Flurbiprofen, Flurbiprofen Axetil, Oxaprozin, Tiaprofenic acidic, Pranoprofen, Aluminoprophen, Zaltoprofen, Mefenamic acidic, TolFenamic acidic, Aluminum flufenamate, Ketophenylbutazone, Clofezone, Bucolome, Piroxicam, Lornoxicam, Tenoxicam, Meloxicam, Ampiroxicam, Epirizole, Tiaramide and Elmofazon” 
     
     
         4 . The Medical Drugs in accordance with  claim 1 , wherein the disaccharide is one or more selected from Trehalose, Maltose, Lactose and Sucrose. 
     
     
         5 . The Medical Drugs in accordance with  claim 1 , wherein the form of the Medical Drugs is tablets, granules, or capsules. 
     
     
         6 . The Medical Drugs in accordance with  claim 1 , wherein the NSAIDs is Indomethacin,
 wherein the disaccharide is Trehalose, and   wherein a DSC curve of the intermolecular compound obtained by the method of differential scanning calorimetry, DSC, has a first peak and a second peak at 80 to 95 degrees Celsius and 260 to 270 degrees Celsius, respectively.   
     
     
         7 . The Medical Drugs in accordance with  claim 1 , wherein the NSAIDs is Ibuprofen,
 wherein the disaccharide is Trehalose, and   wherein a DSC curve of the intermolecular compound obtained by the method of differential scanning calorimetry, DSC, has a third peak and a fourth peak at 175 to 190 degrees Celsius and 130 to 145 degrees Celsius, respectively.   
     
     
         8 . The Medical Drugs in accordance with  claim 1 , wherein the NSAIDs is Aspirin,
 wherein the disaccharide is Trehalose, and   wherein a DSC curve of the intermolecular compound obtained by the method of differential scanning calorimetry, DSC, has a first peak and a second peak at 110 to 120 degrees Celsius and 135 to 145 degrees Celsius, respectively.   
     
     
         9 . The Medical Drugs in accordance with  claim 1 , wherein the NSAIDs is sodium diclofenac,
 wherein the disaccharide is Trehalose, and   wherein a DSC curve of the intermolecular compound obtained by the method of differential scanning calorimetry, DSC, has a first peak and a second peak at 90 to 100 degrees Celsius and 130 to 145 degrees Celsius, respectively.   
     
     
         10 . The Medical Drugs in accordance with  claim 1 , wherein the NSAIDs is Mefenamic acidic,
 wherein the disaccharide is Trehalose,   wherein a DSC curve of the intermolecular compound obtained by the method of differential scanning calorimetry, DSC, has a first peak and a second peak at 225 to 235 degrees Celsius and 90 to 110 degrees Celsius, respectively, and   wherein the absolute values of the first peak and the second peak are larger than absolute values of a peak at 225 to 235 degrees Celsius and a peak at 90 to 110 degrees Celsius in a DSC curve of Mefenamic acidic obtained by the method of DSC, respectively.   
     
     
         11 . The Medical Drugs in accordance with  claim 1 , wherein the NSAIDs is piroxicam,
 wherein the disaccharide is Trehalose,   wherein a DSC curve of the intermolecular compound obtained by the method of differential scanning calorimetry, DSC, has a first peak and a second peak at 90 to 105 degrees Celsius and 195 to 205 degrees Celsius, respectively, and   wherein the absolute values of the first peak and the second peak are smaller than absolute values of a peak at 90 to 105 degrees Celsius and a peak at 195 to 205 degrees Celsius in a DSC curve of piroxicam obtained by the method of DSC, respectively.   
     
     
         12 . The Medical Drugs in accordance with  claim 1 , wherein the Medical Drugs is a Medical Drugs of alleviating damage of gastric mucosal. 
     
     
         13 . A method of manufacturing a Medical Drugs of alleviating damage of gastrointestinal mucosal induced by non-steroidal anti-inflammatory Drugs, NSAIDs, the Medical Drugs being able to bring anti-inflammatory effect of the NSAIDs and being able to alleviate damage induced by the NSAIDs, the method comprising steps of:
 mixing a disaccharide and the NSAIDs so as to obtain a liquid mixture of the disaccharide and the NSAIDs; and   drying the liquid mixture so as to obtain the Medical Drugs.   
     
     
         14 . The method in accordance with  claim 13 , wherein the NSAIDs is acidic NSAIDs. 
     
     
         15 . The method in accordance with  claim 13 , wherein the NSAIDs is one or more selected from the group of “Aspirin, Sodium salicylate, Salicylamide, Sazapirin, Diflunisal, Ethenzamide, Aluminum aspirin, 5-Amino salicylic acidic, Indomethacin, Etodolac, Sodium diclofenac, Sulindac, Sodium Anfenac, Proglumetacin Maleate, Acemetacin, Nabumeton, Mofezolac, Ibuprofen, Naproxen, Loxoprofen, Flurbiprofen, Flurbiprofen Axetil, Oxaprozin, Tiaprofenic acidic, Pranoprofen, Aluminoprophen, Zaltoprofen, Mefenamic acidic, TolFenamic acidic, Aluminum flufenamate, Ketophenylbutazone, Clofezone, Bucolome, Piroxicam, Lornoxicam, Tenoxicam, Meloxicam, Ampiroxicam, Epirizole, Tiaramide and Elmofazon” 
     
     
         16 . The method in accordance with  claim 13 , wherein the disaccharide is one or more selected from trehalose, maltose, lactose and sucrose.