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    • 1. 发明申请
    • Lubricant for wear testing of joint replacements and associated materials
    • US20080214417A1
    • 2008-09-04
    • US12069280
    • 2008-02-07
    • Jan-M BrandtKory D. CharronLin ZhaoJohn B. MedleySteven J. MacDonald
    • Jan-M BrandtKory D. CharronLin ZhaoJohn B. MedleySteven J. MacDonald
    • C10M125/24
    • A61K35/16C12N9/6462C12Y304/21073
    • The present invention relates to an artificial synovial fluid composition that mimics the tribological properties of human, osteoarthritic synovial fluid (SF) for the main purpose of in vitro wear testing. There is described an artificial synovial fluid composition comprising: a) a mammalian serum having i) a total protein concentration of from about 10 to about 45 g/L; ii) an albumin fraction of from about 55% to about 80% w/w %; iii) an α-1 globulin fraction of from about 3% to about 6% w/w %; iv) an α-2 globulin fraction of from about 5% to about 10% w/w %; v) a β-globulin fraction of from about 3% to about 20% w/w %; vi) a γ-globulin fraction of from about 5% to about 20% w/w %; vii) a calcium (Ca) concentration of from about 0.1 mmol/L to about 3 mmol/L; viii) a magnesium (Mg) concentration of from about 0.05 mmol/L to about 0.8 mmol/L; ix) an inorganic phosphate (P) concentration of from about 0.1 mmol/L to about 1.5 mmol/L; x) an iron (Fe) concentration of from about 0.001 mmol/L to about 0.1 mmol/L; xi) a peptide concentration at a 2,000 Da molecular weight cut-off of from about 0.005 g/L to about 10 g/L; xii) a maximal transition midpoint temperature, Tm-cp-max, of from about 330 K to about 350 K at a concentration molality of from about 0.005 to about 0.15 mmol/L measured at a scan rate of from about 20 K/hour to about 100 K/hour; xiii) a total enthalpy change, ΔH, of from about 650 kJ mol−1 to about 1200 kJ mol−1 at a set concentration molality of 0.05 mmol/l measured at a scan rate of 60 K/hour; xiv) a total entropy change, ΔS, of from about 1.5 kJ mol−1 K−1 to about 4 kJ mol−1 K−1 at a concentration molality of from about 0.005 mmol/l to about 0.15 mmol/l and a scan rate from about 20 K/hour to 100 K/hour; wherein the ratio of albumin to total globulin (α-1 globulin+α-2 globulin+β-globulin+γ-globulin fractions) in solution is from about 1.5 to about 3; b) a buffer for maintaining a solution osmolality of from about 200 mmol/kg to about 400 mmol/kg; c) hyaluronic acid (HA) at a concentration of from about 0.1 g/L to about 6 g/L; d) hyaluronic acid (HA) with a molecular weight of from 1 MDa to 4 MDa; and e) a pH level of about 7 to about 8.