Compositions containing a spiranthes sinensis extract and pharmaceutical applications thereof

Abstract

The present disclosure provides compositions and dosage forms comprising sinetirucallol, and methods of using such compositions, such as to treat an inflammation-associated disease, liver fibrosis, wound healing, and/or an autoimmune disease. In some embodiments, the composition comprises a Spiranthes sinensis extract.

1 . A composition comprising sinetirucallol in an amount effective in reducing an inflammatory response. 
     
     
         2 . The composition of  claim 1 , wherein the composition comprises at least 4.4 μg of sinetirucallol. 
     
     
         3 . The composition of  claim 1 , wherein the sinetirucallol is in an amount between 4.4 μg and 44 μg 
     
     
         4 . The composition of  claim 1 , wherein the composition comprises a  Spiranthes sinensis  extract. 
     
     
         5 . The composition of  claim 1 , wherein reducing an inflammatory response is evidenced by a reduction in expression or activity of one or more biological markers selected from the group consisting of: inducible nitric oxide synthase (iNOS), cyclooxygenase-2 (COX-2), tumor necrosis factor-alpha (TNF-α), prostaglandin E2 (PGE2), interleukin-6 (IL-6), interleukin 1β (IL-1β), interleukin 33 (IL-33), NLRP3, phosphorylated ERK (pERK), NFκB, matrix metalloproteinase-2 (MMP2), and matrix metalloproteinase-9 (MMP9). 
     
     
         6 . The composition of  claim 1 , wherein reducing an inflammatory response is evidenced by a decrease in a level of one or more free radicals in an inflammatory response. 
     
     
         7 . The composition of  claim 6 , wherein the one or more free radicals are selected from the group consisting of: superoxide radical anion (O2-.), hydrogen peroxide (H2O2), hydroxyl radical (.OH), singlet oxygen (1O2), peroxynitrite (ONOO—), nitric oxide (NO), nitrosonium cation (NO+), and nitroxyl anion (NO—). 
     
     
         8 . The composition of  claim 1 , wherein reducing an inflammatory response is evidenced by a reduction in tissue swelling. 
     
     
         9 . The composition of  claim 8 , wherein the tissue is selected from the group consisting of: skin, epithelia, synovial tissue, tendons, cartilage, ligaments, bone, muscle, organs, dura, blood vessels, bone marrow, and extracellular matrix. 
     
     
         10 . A dosage form comprising sinetirucallol formulated for administration to a subject. 
     
     
         11 . The dosage form of  claim 10 , wherein the dosage form is formulated for intravenous, intraarterial, oral, parenteral, buccal, topical, transdermal, rectal, intramuscular, subcutaneous, intraosseous, transmucosal, or intraperitoneal administration. 
     
     
         12 . The dosage form of  claim 10 , wherein the dosage form is formulated for topical administration. 
     
     
         13 . The dosage form of  claim 10 , wherein the dosage form is formulated as a unit dosage in liquid, gel, semi-liquid, semi-solid, or solid form. 
     
     
         14 . The dosage form of  claim 10 , wherein the dosage form comprises at least 4.4 μg of sinetirucallol. 
     
     
         15 . The dosage form of  claim 10 , wherein sinetirucallol is in an amount between 4.4 μg and 44 μg. 
     
     
         16 . The dosage form of  claim 10 , wherein the dosage form comprises a  Spiranthes sinensis  extract. 
     
     
         17 . The dosage form of  claim 10 , wherein the dosage form is formulated as a unit dosage. 
     
     
         18 . The dosage form of  claim 17 , wherein the unit dosage is formulated as a food, beverage, or dietary supplement. 
     
     
         19 .- 39 . (canceled) 
     
     
         40 . A method of reducing an inflammatory response, the method comprising administering to a subject in need thereof a composition comprising sinetirucallol in an amount effective in reducing an inflammatory response, and wherein the composition is formulated for administration to a subject. 
     
     
         41 .- 42 . (canceled) 
     
     
         43 . The method of  claim 40 , wherein the composition comprises a  Spiranthes sinensis  extract.