Composition comprising the extract of herbal combination for preventing or treating diabetic peripheral neuropathy

Abstract

Disclosed are a pharmaceutical composition and a health functional food for the prevention and treatment of diabetic peripheral neuropathy, comprising an herb extract of a mixture of 3.5:1 Dioscorea Rhizoma:Dioscorea nipponica (w/w). Having the ability to synergistically increase in vivo levels of nerve growth factor, compared to the extracts from the herbs alone or herb mixtures of other weight ratios, the mixed herb extract is effective for preventing the apoptosis of nerve cells and promoting nerve regeneration. Thus, it can be applied to pharmaceutical compositions and health functional foods preventive and curative of diabetic peripheral neuropathy.

1 . A method for treating a diabetic peripheral neuropathy in a subject in need thereof, comprising administering to the subject an effective amount of a pharmaceutical composition comprising an extract of a mixture comprising Dioscorea Rhizoma and a rhizome of Dioscorea nipponica. 
     
     
         2 . The method of  claim 1 , wherein the diabetic peripheral neuropathy exhibits a symptom selected from the group consisting of a burning discomfort, a stingy ache, soreness, a straining feeling, loss of tactile sensation, vibratory sensation or temperature sensation, and a combination thereof. 
     
     
         3 . (canceled) 
     
     
         4 . The method of  claim 1 , wherein the Dioscorea Rhizoma is a rhizome of Dioscorea batatas Decaisne or Dioscorea japonica Thunberg. 
     
     
         5 . The method of  claim 1 , wherein the rhizome of Dioscorea nipponica is a rhizome of Dioscorea nipponica Makino. 
     
     
         6 . The method of  claim 1 , wherein the pharmaceutical composition comprises a suitable carrier, excipient or diluent selected from the group consisting of lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and mineral oil. 
     
     
         7 . The method of  claim 1 , wherein the pharmaceutical composition is in a solid form. 
     
     
         8 . The method of  claim 1 , wherein the pharmaceutical composition is in a liquid form. 
     
     
         9 . The method of  claim 4 , wherein the Dioscorea Rhizoma is steamed and dried. 
     
     
         10 . The method of  claim 1 , wherein the Dioscorea Rhizoma and the rhizome of Dioscorea nipponica are present in the mixture at a ratio of 3.5:1. 
     
     
         11 . The method of  claim 1 , wherein the pharmaceutical composition comprises:
 (a) 100 mg of the extract;   (b) 3.0 mg of sodium metabisulfite;   (c) 0.8 mg of methylparaben; and   (d) 0.1 mg of propylparaben;   wherein the pharmaceutical composition is in an injectable form.   
     
     
         12 . The method of  claim 1 , wherein the pharmaceutical composition comprises:
 (a) 100 mg of the extract;   (b) 100 mg of lactose;   (c) 100 mg of starch; and   (d) a pharmaceutically acceptable amount of magnesium stearate;   wherein the pharmaceutical composition is in a tablet form.   
     
     
         13 . The method of  claim 1 , wherein the pharmaceutical composition comprises:
 (a) 100 mg of the extract;   (b) 50 mg of lactose;   (c) 50 mg of starch;   (d) 2 mg of talc; and   (e) a pharmaceutically acceptable amount of magnesium stearate;   wherein the pharmaceutical composition is in a capsule form.   
     
     
         14 . The method of  claim 1 , wherein the pharmaceutical composition comprises:
 (a) 100 mg of the extract;   (b) 20 mg of sugar;   (c) 20 mg of isomeroase; and   (d) a pharmaceutically acceptable amount of lemon flavor;   wherein the pharmaceutical composition is in a liquid form.   
     
     
         15 . The method of  claim 1 , wherein the pharmaceutical composition is administered at a dose from 0.01 g/kg to 10 g/kg. 
     
     
         16 . The method of  claim 1 , wherein the pharmaceutical composition is administered orally, intrarectally, intravenously, intramuscularly, hypodermically, endometrially, or intracerebroventicularly. 
     
     
         17 . A pharmaceutical composition comprising an extract of a mixture comprising Dioscorea Rhizoma and a rhizome of Dioscorea nipponica, wherein the mixture is at a weight ratio of 3.5:1 (w/w) of the Dioscorea Rhizoma and the rhizome of Dioscorea nipponica. 
     
     
         18 . The pharmaceutical composition of  claim 17 , which is capable of treating a diabetic peripheral neuropathy. 
     
     
         19 . A health functional food comprising an extract of a mixture comprising Dioscorea Rhizoma and a rhizome of Dioscorea nipponica and a food additive, wherein the mixture is at a ratio of 3.5: 1 (w/w) of the Dioscorea Rhizoma and the rhizome of Dioscorea nipponica. 
     
     
         20 . A method of preparing the pharmaceutical composition of  claim 1  comprising:
 (a) providing a mixture comprising dried Dioscorea Rhizoma and a rhizome of Dioscorea nipponica; and 
 (b) precipitating an extract from the mixture. 
 
     
     
         21 . The method of  claim 20 , wherein the Dioscorea Rhizoma and the rhizome of Dioscorea nipponica (w/w) are present at a ratio of 3.5:1.