Pharmaceutical composition based on a hepatoprotector and a prebiotic, and production and application thereof

Abstract

The invention relates to medicine, hepatology and pharmacology and can be used for producing and using a pharmaceutical composition based on a hepatoprotector and a prebiotic for treating and preventing liver diseases which are caused by lipid-cholesterol exchange and selected from the following group: cholelithiasis mainly with cholesterol stones, alcoholic and non-alcoholic steatohepatitis, biliary cirrhosis, cholesterol imbibition gallbladder and drug-induced and toxic liver damage. The pharmaceutical composition is administered by mouth and contains a hepatoprotector and a prebiotic taken, as an active agent, in therapeutically effective doses. The invention contributes to the liver's functional recovery in a short time and prevents disease recidivation owing to the recovery of cholesterol exchange and intestinal biocenosis as a result of the synergistic interaction of a hepatoprotector and a prebiotic, thereby also preventing hepatoprotector side effects.

What is claimed is: 
     
         1 . A pharmaceutical composition for a treatment and prevention of recurrences of liver diseases in human caused by a disturbance of lipid-cholesterol metabolism, wherein the liver diseases are selected from a group including cholelithiasis with mainly cholesterol stones, alcoholic and nonalcoholic steatohepatitis, primary biliar cirrhosis, gall bladder cholesterosis, and drug-induced and toxic liver injury, the composition, comprising:
 a mixture of a hepatoprotector and a prebiotic combined together in effective doses in a ratio of 1:2 to 1:250 by mass of pure substances,   the mixture being taken by a person orally, the doses leading to a restoration of liver functions and prevention of exacerbations of liver diseases,   wherein the hepaprotector comprises ursodeoxycholic acid (UDCA) and the prebiotic comprises lactulose.   
     
     
         2 . The pharmaceutical composition according to claim  21 , wherein the hepatoprotector further comprises amino acids. 
     
     
         3 . The pharmaceutical composition according to claim  21 , wherein the hepatoprotector further comprises active components of milk thistle plant extracts. 
     
     
         4 . The pharmaceutical composition according to claim  21 , wherein the hepatoprotector further comprises essential phospholipids. 
     
     
         5 . The pharmaceutical composition according to claim  21 , wherein the hepatoprotector further comprises other bile acids or bile acid salts. 
     
     
         6 . The pharmaceutical composition according to claim  25 , wherein the bile acids or bile acid salts are selected from the group consisting of chenodesoxycholic acid (CDCA), desoxycholic acid (DCA), lithochloic acid (LCA), taurodesoxycholic acid (TDCA), hyodeoxycholic acid (HDCA), taurocholic acid (TCA), glycochloic acid (GCA), and combinations thereof. 
     
     
         7 . The pharmaceutical composition according to claim  21 , wherein the prebiotic further comprises fructooligosaccharides. 
     
     
         8 . The pharmaceutical composition according to claim  21 , wherein the prebiotic further comprises maltooligosaccharides. 
     
     
         9 . The pharmaceutical composition according to claim  21 , wherein the prebiotic further comprises galactooligosaccharides. 
     
     
         10 . The pharmaceutical composition according to claim  21 , wherein the prebiotic further comprises xylooligosaccharides. 
     
     
         11 . The pharmaceutical composition according to claim  21 , wherein the prebiotic is lactulose in a ratio of 1:2 by mass of pure substances. 
     
     
         12 . The pharmaceutical composition according to claim  21 , wherein the hepatoprotector further comprises essential phospholipids selected from a group consisting of phosphatidylcholin, phosphatidylethanolamine and phosphatidylinositol, in a ratio of the essential phospholipids and the prebiotic is from 1:0.1 to 1:100 by mass of pure substances. 
     
     
         13 . The pharmaceutical composition according to claim  21 , wherein the hepatoprotector further comprises active components of milk thistle plant extracts selected from silimarin or silibin, and a ratio of the active components of milk thistle plant extracts and the prebiotic is from 1:0.1 to 1:100 by mass of pure substances. 
     
     
         14 . The pharmaceutical composition according to claim  21  made in the form of tablets, granules, globules, powders or capsules, suspensions, pastes, syrups, emulsion, or gels intended for oral administration 2-3 times a day. 
     
     
         15 . The pharmaceutical composition according to claim  21 , wherein the hepatoprotector and the prebiotic are taken in effective doses in a ratio of 1:2 to 1:50 by mass of pure substances. 
     
     
         16 . A method for treating and preventing recurrences of liver diseases in humans caused by a disturbance of lipid-cholesterol metabolism, wherein the liver diseases are selected from a group including cholelithiasis with mainly cholesterol stones, alcoholic and nonalcoholic steatohepatitis, primary biliar cirrhosis, gall bladder cholesterosis, and drug-induced and toxic liver injury, the method comprising:
 administering a composition orally on a patient, wherein the composition comprises a mixture of a hepatoprotector and a prebiotic combined together in effective doses in a ratio of 1:2 to 1:250 by mass of pure substances,   wherein the hepaprotector comprises ursodeoxycholic acid (UDCA) and the prebiotic comprises lactulose, and   delivering the UDCA and lactulose to the patient's liver.   
     
     
         17 . The method of  claim 16 , wherein a therapeutic effect on the patient's liver develops within 1 month. 
     
     
         18 . The method of  claim 16 , wherein a therapeutic effect on the patient's liver develops within 3 months. 
     
     
         19 . The method of  claim 16 , wherein the administering occurs 3 times daily. 
     
     
         20 . The method of  claim 16 , wherein the UDCA:lactulose ratio is between 1:2 and 1:250.