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1. 发明申请

US20080214417A1 Lubricant for wear testing of joint replacements and associated materials 审中-公开
公开(公告)号：US20080214417A1
公开(公告)日：2008-09-04
申请号：US12069280
申请日：2008-02-07
申请人： Jan-M Brandt , Kory D. Charron , Lin Zhao , John B. Medley , Steven J. MacDonald
发明人： Jan-M Brandt , Kory D. Charron , Lin Zhao , John B. Medley , Steven J. MacDonald
IPC分类号： C10M125/24
CPC分类号： A61K35/16 , C12N9/6462 , C12Y304/21073
摘要： 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.

2. 发明申请

US20120266699A1 LUBRICANT FOR WEAR TESTING OF JOINT REPLACEMENTS AND ASSOCIATED MATERIALS 审中-公开
标题翻译：润滑剂用于联接更换和相关材料的磨损测试
公开(公告)号：US20120266699A1
公开(公告)日：2012-10-25
申请号：US13274088
申请日：2011-10-14
申请人： Jan-M. Brandt , Kory D.J. Charron , Lin Zhao , John B. Medley , Steven J. MacDonald
发明人： Jan-M. Brandt , Kory D.J. Charron , Lin Zhao , John B. Medley , Steven J. MacDonald
IPC分类号： C10M141/10 , G01N33/00
CPC分类号： A61K35/16 , C12N9/6462 , C12Y304/21073
摘要： The present invention relates to an artificial synovial fluid composition that mimics the tribological and biochemical properties of human, osteoarthritic synovial fluid for in vitro testing of implantable materials. The artificial synovial fluid comprises new-born calf serum or alpha-calf serum (iron-free or iron-supplemented) that contains a specific total protein concentration, specific protein constituent fractions (albumin, α-1 globulin, α-2 globulin, β-globulin, and γ-globulin), specific trace element concentrations (Ca, Mg, inorganic P, and Fe), and a specific low-molecular weight peptide concentration important for in vitro testing of implantable materials. In addition, the artificial synovial fluid contains a hyaluronic acid concentration and level of osmolality (preferably using phosphate buffered-saline solution) to mimic the thermal stability (transition mid-point temperature, enthalpy, and entropy) and pH level as measured clinically.
摘要翻译：本发明涉及人造滑液组合物，其模拟人骨关节炎滑液的摩擦学和生物化学性质，用于体外测试可植入材料。人造滑液包含含有特定总蛋白浓度的新生小牛血清或α-小牛血清（无铁或铁补充），特异性蛋白质组分（白蛋白，α-1球蛋白，α-2球蛋白，bgr ; - 球蛋白和γ-球蛋白），特异性微量元素浓度（Ca，Mg，无机P和Fe）以及对可植入材料的体外测试重要的特异性低分子量肽浓度。此外，人造滑液含有透明质酸浓度和渗透压水平（优选使用磷酸盐缓冲盐水溶液）以模拟临床测定的热稳定性（转变中点温度，焓和熵）和pH水平。

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