Patent application EP17163030A (EP), filed 2017-03-27
Publication number: EP3225992A1
Title: REAGENT FOR PROTHROMBIN TIME MEASUREMENT AND METHOD FOR PRODUCTION THEREOF
Abstract: [0001]    Disclosed is a reagent for prothrombin time measurement, characterized in that the reagent contains a liposome composition containing a first liposome having a phospholipid layer, a second liposome having a phospholipid layer of a different composition from that of the first liposome, and tissue factor, wherein the tissue factor is associated with the phospholipid layer of at least one of the first liposome and the second liposome; the first liposome contains a phosphatidylcholine compound, a phosphatidylethanolamine compound, and a phosphatidylserine compound; and the second liposome contains at least one phospholipid selected from the group consisting of a phosphatidylcholine compound and a phosphatidylethanolamine compound.
IPC codes: A61K   9/   127            A I
G01N  33/    52            A I
G01N  33/    86            A I
Claims: number: 1
text: A reagent for prothrombin time measurement, characterized in that the reagent contains a liposome composition comprising a first liposome having a phospholipid layer, a second liposome having a phospholipid layer of a different composition from that of the first liposome, and a tissue factor, wherein
the tissue factor is associated with the phospholipid layer of at least one of the first liposome and the second liposome;
the first liposome comprises a phosphatidylcholine compound, a phosphatidylethanolamine compound, and a phosphatidylserine compound; and
the second liposome comprises at least one phospholipid selected from the group consisting of a phosphatidylcholine compound and a phosphatidylethanolamine compound.
number: 2
text: The reagent according to claim 1, wherein the ratio of the mass of the phosphatidylcholine compound to that of the phosphatidylethanolamine compound in the first liposome is less than 3.0.
number: 3
text: The reagent according to claim 1 or 2, wherein the content of the second liposome relative to the total liposome content in the reagent is 20 to 70 mass%.
number: 4
text: The reagent according to any one of claims 1 to 3, wherein the phosphatidylcholine compound is a diacylphosphatidylcholine in which acyl groups have 8 to 20 carbon atoms, the phosphatidylethanolamine compound is a diacylphosphatidylethanolamine in which acyl groups have 8 to 20 carbon atoms, and the phosphatidylserine compound is a diacylphosphatidylserine in which acyl groups have 8 to 20 carbon atoms.
number: 5
text: The reagent according to any one of claims 1 to 4, wherein the phosphatidylcholine compound is dioleoylphosphatidylcholine, the phosphatidylethanolamine compound is dioleoylphosphatidylethanolamine, and the phosphatidylserine compound is dioleoylphosphatidylserine.
number: 6
text: The reagent according to any one of claims 1 to 5, wherein the tissue factor is a recombinant tissue factor.
number: 7
text: The reagent according to claim 6, wherein the recombinant tissue factor is a recombinant human issue factor.
number: 8
text: The reagent according to any one of claims 1 to 7, wherein the reagent further comprises calcium ions.
number: 9
text: A method for producing a reagent for prothrombin time measurement, comprising steps of:
number: 10
text: The method according to claim 9, wherein in step (C), the tissue factor is brought into contact with a mixture of the first liposome obtained in step (A) and the second liposome obtained in step (B).
number: 11
text: The method according to claim 9, wherein in step (C), the tissue factor is brought into contact with the first liposome obtained in step (A) or the second liposome obtained in step (B).
number: 12
text: The method according to any one of claims 9 to 11, wherein the ratio of the mass of the phosphatidylcholine compound to that of the phosphatidylethanolamine compound in the first liposome is less than 3.0.
number: 13
text: The method according to any one of claims 9 to 12, wherein the content of the second liposome relative to the total liposome content in the reagent is 20 to 70 mass%.
number: 14
text: The method according to any one of claims 9 to 13, wherein the phosphatidylcholine compound is a diacylphosphatidylcholine in which acyl groups have 8 to 20 carbon atoms, the phosphatidylethanolamine compound is a diacylphosphatidylethanolamine in which acyl groups have 8 to 20 carbon atoms, and the phosphatidylserine compound is a diacylphosphatidylserine in which acyl groups have 8 to 20 carbon atoms.
number: 15
text: The method according to any one of claims 9 to 14, wherein the phosphatidylcholine compound is dioleoylphosphatidylcholine, the phosphatidylethanolamine compound is dioleoylphosphatidylethanolamine, and the phosphatidylserine compound is dioleoylphosphatidylserine.
Office action: search_report, dated 2017-10-04
Rejection reasons: novelty_epc_54
Prior art cited: ref_id: WO9848283A1
ref_type: patent
severity: background
ref_id: US6203816B1
ref_type: patent
severity: background
ref_id: WO9848283A1
ref_type: patent
severity: background
ref_id: WO9407515A1
ref_type: patent
severity: background
ref_id: WO9208479A1
ref_type: patent
severity: background
ref_id: WO0141740A2
ref_type: patent
severity: background
ref_id: US2002182225A1
ref_type: patent
severity: background
ref_id: WO9208479
ref_type: patent
severity: background
ref_id: WO9407515
ref_type: patent
severity: background
ref_id: WO9848283
ref_type: patent
severity: background
ref_id: US6203816
ref_type: patent
severity: background
ref_id: WO0141740
ref_type: patent
severity: background
ref_id: US2002182225
ref_type: patent
severity: novelty_destroying
Final disposition: pending (2017-10-04)