Methods and compositions employing red rice fermentation products

Abstract

Methods and compositions are disclosed which comprise red rice fermentation products, that can be used as natural dietary supplements and/or medicaments for the treatment or prevention of hyperlipidemia and associated disorders and symptoms, such as cardiovascular diseases, cerebrovascular diseases, diabetes, hypertension, obesity, asthenic breathing, chronic headache, chest pain and tightness, limb swelling and distention, loss of appetite and excess expectoration. The methods and compositions are effective in lowering both the serum cholesterol and serum triglyceride levels in humans, and can be used for maintaining cardiovascular health. The invention also encompasses particular Monascus strains that yield fermentation products with the desired biological activities.

What is claimed:  
     
         1 . A composition for treating elevated serum cholesterol and/or triglycerides, said composition comprising: 
 a red rice product containing at least about 0.05% lovastatin by weight.    
     
     
         2 . The composition of  claim 1 , wherein said red rice product is the product of a process comprising: 
 culturing a lovastatin-producing Monascus strain in a culture medium comprising rice;    removing said culture medium to provide a solid residue; and    sterilizing said solid residue to provide said red rice product.    
     
     
         3 . The composition of  claim 2 , wherein said Monascus strain comprises a stain selected from the group consisting of  Monascus albidus  Sato AS 3.570, AS 3.4440, CGMCC No. 0317;  Monascus pilosus  Sato AS 3.4444, AS 3.4633, AS 3.4646, AS 3.4647;  Monascus pubigerus  Sato AS 3.4445;  Monascus ruber  van Tieghem AS 3.549, CGMCC No. 0315, CGMCC No. 0316;  Monascus paxii  Lingelsheim AS 3.4453;  Monascus fuliginosus  Sato AS 3.569, AS 3.1098, AS 3.2091, AS 3.2093, AS 3.2134, IFFI 05035, and  Monascus purpureus  Went CGMCC No. 0272.  
     
     
         4 . The composition of  claim 2 , wherein said process further comprises: 
 extracting said solid residue with ethanol.    
     
     
         5 . A method for producing improved red rice, said method comprising: 
 providing a lovastatin-producing Monascus strain;    culturing said Monascus strain in a culture medium comprising rice at a temperature of about 15° C. to about 35° C. for a period of about 2 to about 20 days to provide crude red yeast rice; and    drying said crude red rice to provide improved red rice.    
     
     
         6 . The method of  claim 5 , wherein said Monascus strain comprises a strain selected from the group consisting of  Monascus albidus  Sato AS 3.570, AS 3.4440, CGMCC No. 0317;  Monascus pilosus  Sato AS 3.4444, AS 3.4633, AS 3.4646, AS 3.4647;  Monascus pubigerus  Sato AS 3.4445;  Monascus ruber  van Tieghem AS 3.549, CGMCC No. 0315, CGMCC No. 0316;  Monascus paxii  Lingelsheim AS 3.4453;  Monascus fuliginosus  Sato AS 3.569, AS 3.1098, AS 3.2091, AS 3.2093, AS 3.2134,IFFI 05035, and  Monacus purpureus  Went CGMCC No. 0272.  
     
     
         7 . The method of  claim 5 , wherein said culture medium further comprises: 
 about 2% to about 6% sugar;    about 2% to about 7% additional carbon source selected from the group consisting of glycerine, malt, potato juice;    about 0% to about 3% peptone;    about 0% to about 3% thick beef juice; and    about 2% to about 4% defoamer.    
     
     
         8 . The method of  claim 5 , wherein said strain is cultured at about 30° C. to about 34° C. for about 2 to about 4 days, and is then cultured at about 20° C. to about 25° C. for at least about 4 days.  
     
     
         9 . The method of  claim 5 , which further comprises: 
 extracting said improved red rice with an ethanol solution to provide an ethanol extract; and    drying said extract.    
     
     
         10 . The method of  claim 9 , wherein said ethanol solution comprises about 75% to about 95% aqueous ethanol.  
     
     
         11 . A Monascus strain capable of producing about 0.5% lovastatin upon culturing.  
     
     
         12 . The  Monacus purpureus  Went strain of  claim 11 , wherein said strain is selected from the group consisting of  Monascus albidus  Sato AS 3.570, AS 3.4440, CGMCC No. 0317;  Monascus pilosus  Sato AS 3.4444, AS 3.4633, AS 3.4646, AS 3.4647;  Monascus pubigerus  Sato AS 3.4445;  Monascus ruber  van Tieghem AS 3.549, CGMCC No. 0315, CGMCC No. 0316;  Monascus paxii  Lingelsheim AS 3.4453;  Monascus fuliginosus  Sato AS 3.569, AS 3.1098, AS 3.2091, AS 3.2093, AS 3.2134, IFFI 05035, and  Monascus purpureus  Went CGMCC No. 0272.  
     
     
         13 . A method of treating or preventing cardiovascular disorders in a mammal which comprises: 
 administering to a mammal an effective amount of a red rice fermentation product comprising 0.5% lovastatin.    
     
     
         14 . The method of  claim 13  wherein said red rice fermentation product is produced from the fermentation of at least one lovastatin-producing Monascus strain.  
     
     
         15 . The method of  claim 13  wherein said cardiovascular disorder is selected from the group consisting of myocardial infarction, coronary heart disease, hypertension, hypotension, atherosclerosis and arteriosclerosis.  
     
     
         16 . A method of treating or preventing stroke, cerebral thrombosis which comprises administering an effective amount of a red rice fermentation product.  
     
     
         17 . A method of treating or preventing fatty liver conditions in a human which comprises administering to a human an effective amount of a red rice fermentation product.  
     
     
         18 . A method of reducing serum cholesterol and triglyceride levels to normal levels in a human in need of such therapy which comprises administering an effective amount of a red rice fermentation product.  
     
     
         19 . A pharmaceutical or nutritional formulation for treating elevated serum cholesterol and/or triglyceride levels, said formulation comprising: 
 an effective amount of a red rice product; and    a pharmaceutically acceptable excipient.    
     
     
         20 . The formulation of  claim 19 , wherein said formulation comprises about 10 mg lovastatin.