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Download エンドトキシン簡便法講義
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1 Ტᜒ፯Უ ŦǨȳȉȈǭǷȳยܭඥƷؕᄽ Ŧᕤ૾ޅǨȳȉȈǭǷȳᚾ᬴ ŦǨȳȉȈǭǷȳቇ̝ඥƱ̬܍౨ዴ Ŧ̬܍౨ዴ˺૾ඥƱ̅ဇɥƷදॖໜ Ჴ ᲢȇȢƱܱ፼Უ Ŧ̬܍౨ዴ˺ᙌ૾ඥƷȇȢ ŦȗȭȈdzȫᲢଐࠝᚾ᬴Ʒܱ፼ᲣƷᛟଢ Ŧଐࠝᚾ᬴Ʒܱ፼ Ტᜒ፯Უ ŦȈǭǷȎȡȸǿȸƷᢘࣱᚸ̖Ʊໜ౨Ⴘ ᲢLJƱNJᲣ ŦยܭኽௐƷᚐᛟƱᚸ̖ᲢឋွࣖሉᲣ 2 ǨȳȉȈǭǷȳยܭඥƷؕᄽ 3 ぶỈᛶ LPS䛾ᵓ㐀ᶍᘧᅗ ㈇㟁Ⲵ Ỉᛶ ศᏊ㔞⣙2000 4 ǨȳȉȈǭǷȳ КӸ .25 Ʒཎࣉ ỉࣇ ࣇᲢPIǍRIưဃཋࣱ ႆ༏ȷβ၃ࣖሉࣱᲣ ǛᅆƢŵ ỉ᎑ ᎑༏ࣱ éЎˌɥƷʑ༏ưڂƢǔᲣ ỉƋ ƋǒǏǔƱƜǖƴЈྵ ǰȩȠᨏࣱᓏƕƍǔŴ LJƨƸƍƨᚰਗᲣ දݧдƳƲưƸŴǨȳȉȈǭǷȳฆλǛ ሥྸƢǔ࣏ᙲƕƋǔ 5 䝬䜽䝻䝣䜯䞊䝆䜔ᶞ≧⣽⬊ ᰾ 䡷䡮䢀䡲䡮䢙⏘⏕㑇ఏᏊ TLR4 䜶䞁䝗䝖䜻䝅䞁 TLR4 䜶䞁䝗䝖䜻䝅䞁䛿 Tollᵝཷᐜయ䜢䛧䛶 චᢸᙜ⣽⬊䛻స⏝䛩䜛 άᛶ䛧䛯NF-ț% ྛ✀䡷䡮䢀䡲䡮䢙 TNF-Į IL-6 IL-12 IL-1 6 䜶䞁䝗䝖䜻䝅䞁䛾Ỉ⁐ᾮ୰䛷䛾Ꮡᅾ≧ែ 䝎䜲䝬䞊 䝭䝉䝹 䝧䝅䜽䝹 ぢ䛛䛡䛾ศᏊ㔞䠖䠍䡚䠎 ぢ䛛䛡䛾ศᏊ㔞䠖ᩘ䠍䠌䡚䠍䠌䠌 ⏺㠃άᛶ䛾㝖ཤ ⏺㠃άᛶ 㧗ḟᵓ㐀䛾ኚ Ca2+, Mg2+䛺䛹 䠎౯㝧䜲䜸䞁 䜻䝺䞊䝖䚸 ㉸㡢Ἴฎ⌮ 䝷䝯䝷䞊 ⏕≀άᛶ䛾ኚ 7 ᕤ૾ޅǨȳȉȈǭǷȳᚾ᬴ 8 ૾ޅǨȳȉȈǭǷȳᚾ᬴ඥƱƸᲹ $CEVGTKCN'PFQVQZKPU6GUV $'6 ǫȖȈǬȋƷᘉ෩ϹኒǛМဇƠƨ žȩǤǻȸȈᚾᕤſǛဇƍƯŴ ႆ༏ࣱཋឋưƋǔžǨȳȉȈǭǷȳſǛ౨Ј Ƣǔᚾ᬴ŵ ኽௐƸŴEUᲢEndotoxin Unit) ưᘙᅆŵ 9 ȩǤǻȸȈᚾᕤƷӒࣖೞನ Endotoxin(LPS) ȕ-1,3-glucan FactorC άᛶᆺ FactorC ss s s 123 kDa FactorB άᛶᆺ FactorB Proclotting enzyme FactorG άᛶᆺ FactorG Clotting enzyme Coagulogen Coagulin 䠄䝀䝹䚸⃮ᗘቑຍ䠅 Peptide-䡌NA Peptide 䡌NA 䠄㯤ⰍⓎⰍ䠅 10 11 R(t)㏱㐣ග㔞ẚ ㏱㐣ග㔞I(t)䛾ᛂึᮇ䛾 ㏱㐣ග㔞I0䛻ᑐ䛩䜛ྜ 䠄I(t)/I0)㽢100(%) 100% ㏱㐣ග㔞ẚ 䠮䠄䡐䠅 R(th)䠖䛧 䛧䛝䛔್ (94.9 %) Tg:䝀䝹㛫 ᛂ㛫 ᐃ㛤ጞ䛛䜙䚸R(t)䛜R(th)䛻䛺䜛䜎䛷䛾㛫 䜢䝀䝹㛫Tg䛸䛧䛶ㄞ䜏ྲྀ䜛䚹 12 䜹䜲䝛䝔䡤䝑䜽-ẚ⃮ἲ PYROSTAR '5(ȈǭǷȎȡȸǿȸ'6Ǜ̅ဇŵ ήܖႎܭඥƴƓƚǔ౨ዴƷ̊ 13 ᒁ᪉䜶䞁䝗䝖䜻䝅䞁ヨ㦂ἲ䛻䛚䛡䜛 䝞䝸䝕䞊䝅䝵䞁䛾せ௳ 䕺ணഛヨ㦂䛸䛧䛶 䝀䝹ἲ䛷䛿䚸 䜶䞁䝗䝫䜲䞁䝖䛜Ȝ-Ȝ䚸 ගᏛⓗᐃ㔞ἲ䛷䛿䚸 ᳨㔞⥺䛾┦㛵ಀᩘ䛾 ⤯ᑐ್䛜0.980௨ୖ 䠄䠍䠅䜶䞁䝗䝖䜻䝅䞁ᶆ‽ရ䜢 ᐃ䛧䛶䚸ヨ㦂᮲௳ 䛜㐺ษ䛷䛒䜛䛣䛸䜢☜ㄆ䛩䜛䚹 ヨ㦂᮲௳䛸䛿ĺヨ⸆䛾ᛶ⬟䚸⏝ჾල䚸᧯స⪅䛾ᢏ⾡䛺䛹 䠄䠎䠅䜶䞁䝗䝖䜻䝅䞁ᶆ‽ရ䜢ῧຍ䛧䛯ヨᩱ䜢 ᐃ 䛧䚸ヨᩱ䛜 ᐃ䛻ᙳ㡪䛧䛺䛔䛣䛸䜢☜ㄆ䛩䜛䚹 䝀䝹ἲ䛷䛿䚸 ᙳ㡪䛧䛯ሙྜ䛿ヨᩱ䜢ᕼ㔘䛩䜛䛺䛹䛷ᙳ㡪䜢ྲྀ䜚㝖䛟䚹 䜶䞁䝗䝫䜲䞁䝖䛜Ȝ-Ȝ䚸 ගᏛⓗᐃ㔞ἲ䛷䛿䚸 䛯䛰䛧ᕼ㔘ಸᩘ䛿䠩䠲䠠௨ୗ䛸䛩䜛䚹 䕺᪥ᖖヨ㦂䛸䛧䛶 ῧຍ䜶䞁䝗䝖䜻䝅䞁䛾 ᅇ⋡䛜50-200% 䠄䠏䠅ẖᅇ䚸䠄䠍䠅䛸䠄䠎䠅䜢☜ㄆ䛧䛺䛜䜙 ᐃ䛩䜛䚹 14 ᲢήܖႎܭඥƷย૾ܭඥᲣ ෩Ჴᚾ૰๋෩ ෩Ჴᚾ૰๋෩ƴ౨ዴƷɶໜ˄ᡈຜࡇƴƳǔǑƏǨȳȉȈǭǷȳǛ ชьƠƨNjƷᲢࣱᨗᕤдݣༀᲣŵ Ჽ෩Ჴ౨ዴ˺ဇǨȳȉȈǭǷȳ๋෩ ຜࡇˌɥᲣ Ჾ෩ᲴǨȳȉȈǭǷȳᚾ᬴ဇ൦ ᨏࣱݣༀᲣ ᳸Ჾ෩Ǜ PˌɥƷጮǓᡉƠưยܭƢǔ ยܭૠƸӳᚘஜˌɥᲣŵ ᲢӳவˑᲣ Ĭ Ჽ෩ư˺Ơƨ౨ዴƷႻ᧙̞ૠƷዌ͌ݣƕˌɥ ĭ Ჾ෩Ʒยܭኽௐƕᨏࣱ Į Ტ෩Ʒย ͌ܭệ ෩Ʒย͌ܭᲣh෩ƴชьƠƨǨȳȉȈǭǷȳ ຜࡇgƕŴ ệ ᲢᲟᲣƴƋǔ į ෩Ʒย͌ܭƕǨȳȉȈǭǷȳᙹ͌ ŨŨ '7O.சƳƲᲣ ǛƨƢŵ 15 ⾲䠏䚷䜹䜲䝛䝔䜱䝑䜽ẚ⃮ἲ䛻䛚䛡䜛◲㓟䝬䜾䝛䝅䜴䝮ὀᑕᾮ㻔㻡㻜㻜㻌㼙㻹㻕䛾ᛂᖸ΅ᅉᏊヨ㦂ᐇ 䠄䝸䝮䝹䝇㻴㻿㻙㻶䝔䝇䝖䝽䝁䞊䛸䝖䜻䝅䝜䝯䞊䝍䞊䜢⏝䠅 䝀䝹 ῧຍ䡰䢙䢀䢚䢀䡳䡸䢙 䡰䢙䢀䢚䢀䡳䡸䢙⃰ᗘ 㛫 ᅇ⋡㻔㻑㻕 㻔䠄㻮㻙㻭㻕㻛㻜㻚㻜㻢㻞㻡䡔㻝㻜㻜㻕 ᾮ 䠄㻱㼁㻛㼙㼘㻕 㻔㼙㼕㼚㻕 㻪㻢㻜 䠌䠄㻨㻜㻚㻜㻜㻠㻣㻕 㻙 㻪㻢㻜 㻪㻢㻜 㻡㻜㻌㼙㻹 㻜 㻙 㻭 䠌䠄㻨㻜㻚㻜㻜㻠㻣㻕 㻪㻢㻜 㻪㻢㻜 㻝㻜㻜㻌㼙㻹 㻙 䠌䠄㻨㻜㻚㻜㻜㻠㻣㻕 㻪㻢㻜 㻞㻝㻚㻤 㻞㻡㻌㼙㻹 㻜㻚㻜㻢㻢㻟㻞 㻝㻜㻢 㻞㻝㻚㻢 㻞㻟㻚㻢 㻡㻜㻌㼙㻹 㻮 㻜㻚㻜㻡㻟㻜㻞 㻤㻠㻚㻤 㻜㻚㻜㻢㻞㻡㻌㻱㼁㻛㼙㼘 㻞㻟㻚㻞 㻞㻡㻚㻠 㻝㻜㻜㻌㼙㻹 㻜㻚㻜㻠㻜㻤㻣 㻢㻡㻚㻠 㻞㻡㻚㻤 㻟㻤㻚㻜 㻜㻚㻜㻝㻡㻢㻌㻱㼁㻛㼙㼘 㻟㻡㻚㻤 㻟㻥㻚㻠 㻞㻝㻚㻜 㼘㼛㼓㼘㼛㼓㻌㻔㼀㼓㻕㻌㻩 㻯 㻜 㻜㻚㻜㻢㻞㻡㻌㻱㼁㻛㼙㼘 㻞㻝㻚㻠 㻙㻜㻚㻝㻜㻤㻝㼘㼛㼓㻔㻯㻕㻙㻜㻚㻜㻜㻜㻥㻥㻡㻝 㻞㻝㻚㻜 㻝㻡㻚㻜 㼞㻌㻩㻌㻙㻜㻚㻥㻥㻟㻥 㻜㻚㻞㻡㻌㻱㼁㻛㼙㼘 㻝㻠㻚㻠 㻝㻠㻚㻤 㻪㻢㻜 㻰 㻜 㻜 㻪㻢㻜 䠆◲㓟䝬䜾䝛䝅䜴䝮ὀᑕᾮ㻌㻔㻡㻜㻜㻌㼙㻹㻌㻩㻌㻝㻞㻟㻌㼙㼓㻛㼙㼘㻕䛾䜶䞁䝗䝖䜻䝅䞁つ᱁್䛿㻜㻚㻜㻥㻌㻱㼁㻛㼙㼓䛷䛒䜛䚹 㻹㼂㻰㻌㻩㻌䠄㻝㻞㻟㻌㼙㼓㻛㼙㼘䚷䡔䚷㻜㻚㻜㻥㻌㻱㼁㻛㼙㼓㻌䠅㻛㻜㻚㻜㻝㻡㻢㻌㻩㻌㻌㻣㻜㻥㻚㻢㻌ಸ 䡰䢙䢀䢚䢀䡳䡸䢙 ῧຍ⃰ᗘ ◲㓟䝬䜾 䝛䝅䜴䝮 ⃰ᗘ 㻞㻡㻌㼙㻹 ᪥ᖖヨ㦂䜢 ᐇ䛩䜛 ⃰ᗘ䛿䚸ᅇ ⋡䛜75125%䜢᥎ ዡ 16 (&#+PVGTKO)WKFCPEGHQT*WOCPCPF8GVGTPCT[ &TWI2TQFWEVUCPF $KQNQIKECNU -+0'6+%.#.6'%*0+37'5Ტ࠰Უ ă૾ޅƕૢͳƞǕǔƱƱNjƴࢫႸǛኳƑƨƨNJŴ ࠰ƴࡑഥŵ ̬܍౨ዴ̅ဇƴƭƍƯƷᚡ᠍Უ ỉ ̬܍౨ዴƷ˺૾ඥ ᡲዓƠƨଐ᧓Ŵຜ ຜࡇˌɥŴ PˌɥƷǨȳȉȈǭǷȳ ๋෩ǛยܭƠŴࢽǒǕƨμໜǛဇƍƯ˺Ƣǔŵ ౨ዴƷႻ᧙̞ૠƷዌ͌ݣƸˌɥưƋǔƜƱŵ ỉ ࣱᨗݣᝋ ᲽƴǑǔችࡇሥྸ 2% ౨ዴƷɶໜຜࡇƷǨȳȉȈǭǷȳ๋෩ǛׅᛦᙌŴᚾ૰ ƱӷยܭƠŴ̬܍౨ዴǛဇƍƯຜࡇǛምЈƠƨŴ ᲟƴƋǔƜƱŵ 17 䜶䞁䝗䝖䜻䝅䞁つ᱁್ (Endotoxin Limit) タᐃ䛾⪃䛘᪉ 䠄⸆䛾䠅䜶䞁䝗䝖䜻䝅䞁⃰ᗘ䠘䠧್䠋䝠䝖᭱ᢞ㔞䠆 䠆య㔜䠍䡇䡃ᙜ䛯䜚1ᅇ䛾ᢞ㔞 ᪥ᮏ䚸⡿ᅜ䚸Ḣᕞ⸆ᒁ᪉䛷つᐃ䛥䜜䛯K್䠄Ⓨ⇕ㄏ㉳䜶䞁䝗䝖䜻䝅䞁㔞䠅 ᢞ⤒㊰ 䠧್䠄EU/kg) 㟼⬦ෆ 5.0 ᪥ᒁ䛾ሙྜ䚸 㟼⬦ෆ : ᨺᑕᛶ་⸆ရ 2.5 1ᅇᢞ䚸1ே䛒䛯䜚 2.5㽢60 = 150䠡䠱ᮍ‶ ⬨㧊⭍ෆ 0.2 18 ᡫࠝŴӒࣖฏ܇׆ǛᨊƘƨNJƴƸ ᚾ૰ǛࠎƢǔŵ இ̿˴ٻLJưᚾ૰ǛࠎƠƯยܭƠƯNjǑƍƔŵ ᚾ૰๋෩ƷຜࡇƷҥˮƸᙹ͌ƴƑǔƜƱᲛ ǨȳȉȈǭǷȳᙹ͌gᚾ૰๋෩Ʒຜࡇ ᳇᳐ᲾᲷ ဇƍǔย૾ܭඥƷஇ˯౨ЈӧᏡຜࡇᲤ Ფ Dzȫ҄ඥưƸȩșȫᘙᅆज़ࡇ ήܖႎ૾ඥưƸ౨ዴƷஇݱຜࡇ 19 ⬥ ཌ⏕ඛ⏕䜘䜚䛤ㄝ᫂䛔䛯䛰䛝䜎䛩 20 ᪥ᮏ⸆ᒁ᪉䛜䜶䞁䝗䝖䜻䝅䞁ヨ㦂ἲ䛷 つᐃ䛧䛶䛔䜛᪉ἲ ᒁ᪉䛜ồ䜑䜛ಙ㢗ᛶ䝺䝧䝹 䠍䠊ணഛヨ㦂䠄䛒䜙䛛䛨䜑䛩䜉䛝᳨ウ䠅 䠄䠍䠅䝷䜲䝉䞊䝖䝻䝑䝖䛤䛸䛾᳨㔞⥺䛾ಙ㢗ᛶ☜ㄆヨ㦂䠄r=0.980௨ୖ䠅 䠄䠎䠅ᛂᖸ΅ᅉᏊヨ㦂 䠎䠊ᮏヨ㦂䠄ẖ᪥䛾ヨ㦂䠅 䠄䠍䠅䠏⃰ᗘ௨ୖ䛾᳨㔞⥺䠄n=2䠅䜢సᡂ䛧䚸r=0.980௨ୖ 䠄䠎䠅ᛂᖸ΅ᅉᏊヨ㦂䜢ᐇ䛧䠄n=2䠅䚸50-200䠂௨ෆ 䠄䠏䠅䜶䞁䝗䝖䜻䝅䞁ヨ㦂⏝Ỉ䠄n=2䠅䛷䛿䜶䞁䝗䝖䜻䝅䞁䛿᳨ฟ䛥䜜䛺䛔 䠄䠐䠅 ᐃ᳨య䠄n=2䠅 ヨ㦂ᡂ❧ ᮲௳ 21 䜶䞁䝗䝖䜻䝅䞁ヨ㦂䠖䝕䞊䝍䛾ಙ㢗ᛶ䛸⤒῭ᛶ ヨ㦂ἲ ᪥ᮏ⸆ᒁ᪉‽ᣐἲ ᳨㔞⥺䠖䠄㻟⃰ᗘ 㼚㻩㻞㻕 ᳨㔞⥺୰Ⅼ⃰ᗘ㻗㻼㻱㼀⸆䠄㼚㻩㻌㻞㻕 䜶䞁䝗䝖䜻䝅䞁ヨ㦂⏝Ỉ䠄㼚㻩㻌㻞㻕 㻼㻱㼀⸆䠄㼚㻩㻌㻞㻕 ከ䛟䛾㻼㻱㼀タ ᐇ᪉ἲ ᳨㔞⥺䠖䛺䛧 ᳨㔞⥺୰Ⅼ⃰ᗘ㻗㻼㻱㼀⸆䠖䛺䛧 䜶䞁䝗䝖䜻䝅䞁ヨ㦂⏝Ỉ䠖䛺䛧 㻼㻱㼀⸆䠄㼚㻩㻌㻞㻕 ᳨㔞⥺ ᛂᖸ΅ ᅉᏊヨ㦂 ᚲせ䛺 䝷䜲䝉䞊䝖ᮏᩘ 㐺᱁ᛶ☜ㄆ ᵏᵐ ᵐஜ ᵐஜờ ஜờỉἉὅἂἽ ஜờỉ ờỉ ỉἉ ỉἉ Ἁὅ ὅ ὅἂἽ ἘἋἚầ࣏ᙲ ヨ㦂᮲௳ ᐃ㔞 䛷䛝䛺䛔 ☜ㄆ䛺䛧 䠎ᮏ䛷 ᮏ䛷 䛷⤒῭ⓗ 䠎ᮏ䛷⤒῭ⓗ 䛰䛜 䛜ಙ㢗ᛶᏳ ̮᫂ ࣱ̮᫂Ὁኺฎࣱử ࣱ᫂ ࣱ ኺฎࣱử ửɲ ɲᇌẲẺ ᇌẲẺ ̬܍౨ ̬ ܍౨ ዴ ዴử ử ᵮᵣᵲ ᵲӼẬỺὅἛἚỿἉὅૼඥầ࣏ᙲ ᙲ ̅ဇỂẨễẟẦᾎ 22 ᳨㔞⥺ಖᏑ⏝䛾ጇᙜᛶ᳨ウ ಖᏑ᳨㔞⥺䜢⏝䛧䛯ሙྜ䛻ᚓ䜙䜜䜛䜶䞁䝗䝖䜻䝅䞁 ⃰ᗘ䛻䛴䛔䛶䚸┿್䛛䜙䛾㞳䛾⛬ᗘ䜢ྛ⌧ᛶ☜ㄆ ᮲௳䛾ୗ䛷ㄪᰝ䛧䚸᳨㔞⥺䛾ಖᏑ⏝䛾ጇᙜᛶ䜢᳨ウ 䛧䛯䚹 23 䜶䞁䝗䝖䜻䝅䞁᳨㔞⥺䛸సᡂ䛧䛯ಖᏑ᳨㔞⥺ 0.25 N136-1,2,3 Archived Standard Curve 㐃⥆䛩䜛3᪥䛾3ᮏ䛾᳨㔞⥺䝕䞊䝍 䜢⏝䛔䛶䚸1ᮏ䛾ಖᏑ᳨㔞⥺䜢సᡂ Clotting time ((Log-Log) ) 0.2 0.15 0.1 (EU/mL) N136-1 N136-2 N136-3 0.01 42.4 40.0 44.6 42.6 40.8 40.6 0.05 0.1 20.0 20.0 20.6 20.2 19.6 19.8 1 11.0 11.0 11.2 11.2 11.2 11.0 Clotting Time(min) 0 0.01 0.1 1 Endotoxin Conc. ((Log)) 10 24 ಖᏑ᳨㔞⥺䛾ጇᙜᛶ䛾᳨ウ᪉ἲ 0.25 N136-1,2,3 Archived Standard Curve 䐠䜶䞁䝗䝖䜻䝅䞁ᶆ‽⁐ᾮ 0.01䚸0.1䚸1EU/mL⁐ᾮ䜢సᡂ 0.2 0.15 䐟ಖᏑ᳨㔞⥺䜢సᡂ ┿್䛛䜙 䠄3᪥㛫 3ᮏ䛾䝕䞊䝍䛛䜙䠅 䛾㞳 0.1 Clotting time ((Log-Log) ) 䐢ಖᏑ᳨㔞⥺䛻௦ධ 0.01 䝀䝹㛫 43.6 ᐃ(min) 0.1 1 21.2 11.8 䐡䝀䝹㛫䜢 ᐃ 0.05 䐣 ᐃ್䛜ᚓ䜙䜜䜛 0 0.01 0.1 1 Endotoxin Conc. ((Log)) 10 䐤┿್䛛䜙䛾㞳䛷ホ౯ ᅇ⋡䠙 ᳨㔞⥺䛻䜘䜚ᚓ䜙䜜䛯⃰ᗘ ᶆ‽⁐ᾮ䛾⃰ᗘ䠄┿್䠅 X100(%) 25 ಖᏑ᳨㔞⥺䛛䜙ᚓ䜙䜜䛯䜶䞁䝗䝖䜻䝅䞁 ᐃ್䛾 ┿್䛛䜙䛾㞳䠍 䠄䠍䠅ಖᏑ᳨㔞⥺䝕䞊䝍䛾⮬ᕫ௦ධ䛷ᚓ䜙䜜䛯 ᐃ್䛸┿್䛸䛾㞳 䠄䠎䠅ಖᏑ᳨㔞⥺ і ྠ᪥䝕䞊䝍䛾௦ධ 200 200 ಖᏑ᳨㔞⥺ і᳨㔞⥺సᡂ䝕䞊䝍䛾௦ධ 175 175 150 83-115% 125 Revovery(%) 150 85-127% 125 100 100 75 75 50 50 FK Tester FM Tester FY 26 ಖᏑ᳨㔞⥺䛛䜙ᚓ䜙䜜䛯䜶䞁䝗䝖䜻䝅䞁 ᐃ್䛾 ┿್䛛䜙䛾㞳䠎 䠄䠏䠅ಖᏑ᳨㔞⥺ і ู᪥䝕䞊䝍௦ධ 200 Recovery (%) 175 150 86-124% 125 100 75 50 FM1 FM3 FM2 FK2 FK1 FK3 FY1 FY2 FY3 Tester 27 ಖᏑ᳨㔞⥺䛛䜙ᚓ䜙䜜䛯䜶䞁䝗䝖䜻䝅䞁 ᐃ್䛾 ┿್䛛䜙䛾㞳䠏 䠄䠐䠅ಖᏑ᳨㔞⥺ і ู䝻䝑䝖䝷䜲䝉䞊䝖䛾䝕䞊䝍䛾௦ධ 200 175 Recovery (%) 150 125 64-156% 100 75 50 FM N Tester H 28 ಖᏑ᳨㔞⥺䛛䜙ᚓ䜙䜜䛯䜶䞁䝗䝖䜻䝅䞁 ᐃ್䛾 ┿್䛛䜙䛾㞳䠐 䠄䠐䠅䛾タ䛾ಖᏑ᳨㔞⥺ і ྠ䝻䝑䝖䝷䜲䝉䞊䝖䛾䝕䞊䝍䛾௦ධ Table 1-b. Result of the recovery test of the standard solution at substitution in archived standard curves prepared in other facilities. Endotoxin Conc. Recovery rate Lysate Lot (EU/mL) (%) 0.01 88 – 121 132 0.1 89 – 110 1 89 – 116 0.01 88 – 125 136 0.1 88 – 114 1 88 – 114 0.01 86 – 109 137 0.1 89 – 110 1 87 – 124 㻤㻢㻙㻝㻞㻡㻑 29 䜶䞁䝗䝖䜻䝅䞁ヨ㦂䠖䝕䞊䝍䛾ಙ㢗ᛶ䛸⤒῭ᛶ ヨ㦂ἲ ᳨㔞⥺ ᛂᖸ΅ ᅉᏊヨ㦂 ᚲせ䛺 䝷䜲䝉䞊䝖ᮏᩘ ᪥ᮏ⸆ᒁ᪉‽ᣐἲ ᳨㔞⥺䠖䠄㻟⃰ᗘ 㼚㻩㻞㻕 ᳨㔞⥺୰Ⅼ⃰ᗘ㻗㻼㻱㼀⸆䠄㼚㻩㻌㻞㻕 䜶䞁䝗䝖䜻䝅䞁ヨ㦂⏝Ỉ䠄㼚㻩㻌㻞㻕 㻼㻱㼀⸆䠄㼚㻩㻌㻞㻕 ከ䛟䛾㻼㻱㼀タ ᐇ᪉ἲ ᳨㔞⥺䠖䛺䛧 ᳨㔞⥺୰Ⅼ⃰ᗘ㻗㻼㻱㼀⸆䠖䛺䛧 䜶䞁䝗䝖䜻䝅䞁ヨ㦂⏝Ỉ䠖䛺䛧 㻼㻱㼀⸆䠄㼚㻩㻌㻞㻕 ̮᫂ ࣱ̮᫂Ὁኺฎࣱử ࣱ᫂ ኺฎࣱửɲᇌẲẺ ɲᇌẲ Ẻ ỺὅἛἚỿἉὅૼඥỉắ੩క ᵏᵐ ᵐஜ ᵐஜờ ஜờỉἉὅἂἽ ஜờỉ ờỉ ỉἉ ỉἉ Ἁὅ ὅ ὅἂἽ ἘἋἚầ࣏ᙲ ヨ㦂᮲௳ ᐃ㔞 䛷䛝䛺䛔 ☜ㄆ䛺䛧 䠎ᮏ䛷⤒῭ⓗ 䠎ᮏ䛷 ᮏ䛷 䛷⤒῭ⓗ ῭ⓗ ⓗ 䛰䛜 䛜ಙ㢗ᛶ ᛶప䛔 ᳨㔞⥺䜢ẖ᪥సᡂ䛧䛺䛔 ̬܍ ᵒஜᆉࡇ ⮬タ䛷సᡂ 䜎䛯䛿 ᨺ་◊ᥦ♧䜢⏝ 30 ᨺ་◊ཧ⪃ᥦ♧ಖᏑ᳨㔞⥺䜢⏝䛧䛯 䜶䞁䝗䝖䜻䝅䞁ヨ㦂䜢ᐇ䛩䜛䛯䜑䛻 䠍䠊䜶䞁䝗䝖䜻䝅䞁⡆౽ἲᐇ⩦ཷㅮ䛚䜘䜃᳨㔞⥺⏝Ⓩ㘓 䜢䛧䛶ୗ䛥䛔䚹 ᐇ⩦ෆᐜ ಖᏑ᳨㔞⥺సᡂ䛾䝕䝰䞁䝇䝖䝺䞊䝅䝵䞁ཷㅮ љ ಖᏑ᳨㔞⥺⏝䛾䝥䝻䝖䝁䝹సᡂཷㅮ љ 䝃䞁䝥䝹 ᐃᐇ⩦ ಟ 䠎䠊⏝䛩䜛᳨㔞⥺䛜సᡂ䛥䜜䛯䝷䜲䝉䞊䝖䛸ྠ䛨Lot␒ྕ 䛾䝷䜲䝉䞊䝖䜢㉎ධ䞉⏝䛧䛶ୗ䛥䛔䚹 䠏䠊ẖ ᐃ䚸ୗグ䛾᮲௳䜢‶䛯䛩䛸䛝䚸ヨ㦂ᡂ❧䛸䛩䜛䚹 PC䠙䠓䠑䡚䠍䠏䠏䠂 PPC䠙䠑䠌䡚䠎䠌䠌䠂 31 • ȩǤǻȸȈᚾᕤƷȭȃȈƝƱƴ̬܍౨ዴǛ˺ Ƣǔ • ̬܍౨ዴƷࣱ࢘ڲǛᅆƢ Ტ̊ƑƹႻ᧙̞ૠƷዌ͌ݣǛᙹܭƢǔƳƲᲣ • ยܭદ˺ƸȗȭȈdzȫƴӈ݅ƴࢼƬƯᘍƏ • ׅƷยܭவˑƷࣱ࢘ڲǛᅆƢ Ტ̊ƑƹᲽƷׅӓྙǛᙹܭƢǔƳƲᲣ 32 ಖᏑ᳨㔞⥺సᡂ᪉ἲ䛾䝕䝰䞁䝇䝖䝺䞊䝅䝵䞁 䠘 ⏝ヨ⸆䠚 䝸䝮䝹䝇ES-ϩ䝅䞁䜾䝹䝔䝇䝖䝽䝁䞊 䠘ᶆ ᶆ‽ရ䠚 㻯㼛㼚㼠㼞㼛㼘㻌㻿㼠㼍㼚㼐㼍㼞㼐㻌㻱㼚㼐㼛㼠㼛㼤㼕㼚 ヨ㦂⏝Ỉ䠚 䠘ヨ ሯὀᑕ⏝Ỉ 䠘 ⏝ჾᮦ䠚 䞉䝸䝮䝹䝇䝔䝇䝖䝏䝳䞊䝤-S䜰䝹䝭䜻䝱䝑䝥 䞉䝢䝨䝑䝖 䞉䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥䝽䝁䞊1000ϩ 䞉䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥䝽䝁䞊䜶䜽䝇䝔䞁䝗Sϩ 䞉䝍䝑䝏䝭䜻䝃䞊 䞉䝖䜻䝅䝜䝯䞊䝍䞊ET-6000 33 ಖᏑ᳨㔞⥺సᡂ᪉ἲ䛾䝕䝰䞁䝇䝖䝺䞊䝅䝵䞁 䠍䠊㻯㻿㻱⁐ゎ CSE䛾⾲♧ຊ౯䜢ཧ↷䛧䛶⤊⃰ᗘ䛜1000 EU /mL䛸䛺䜛䜘䛖䛻 䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥䛷䜶䞁䝗䝖䜻䝅䞁ヨ㦂⏝Ỉ䜢ຍ䛘䚸 䜃䝂䝮ᰦ䜢䛧䛶ᩘᅇ㌿ಽ᧠ᢾ䛧䛯ᚋ䚸 䝍䝑䝏䝭䜻䝃䞊䛷2ศ㛫⃭䛧䛟᧠ᢾ䛩䜛䚹 ⁐ゎᚋ䛿䝟䝷䝣䜱䝹䝮䜢ᕳ䛔䛶2-10Υ䛷෭ⶶಖᏑ䛩䜛䚹 䠅㻞㻘㻠㻜㻜㻛㼢㼕㼍㼘䛾ሙྜ䚸㻞㻚㻠㼙㻸䛾ヨ㦂⏝Ỉ䜢ຍ䛘㻝㻜㻜㻜㻱㼁㻛㼙㻸䛻ㄪ〇䛩䜛䚹 34 ಖᏑ᳨㔞⥺స సᡂ᪉ἲ䛾䝕䝰䞁䝇䝖䝺䞊䝅䝵䞁 䠎䠊䜶䞁䝗䝖䜻䝅䞁ᶆ‽⁐ᾮ䛾ᕼ㔘 ᕼ㔘䛿ᐊ 䠄10-30Υ䠅䛷⾜䛖䚹 (䜰) 䝸䝮䝹䝇䝔䝇䝖䝏䝳䞊䝤S䜢ヨ㦂⟶❧䛶䛻6ᮏ୪䜉䚸 ┠ⓗ⃰ᗘ䜢グ䛩䚹1 ᮏ䛿㝜ᛶ䝁䞁䝖䝻䞊䝹⏝䛸䛩䜛䚹 (䜲) ྛ䝏䝳䞊䝤䛻ὀᑕ⏝Ỉ䜢ȝ/⏝䝢䝨䝑䝖䛷䚸ȝ/䛪䛴ศὀ䛩䜛䚹 (䜴) 䠍䠊䛷ㄪ〇䛧䛯CSE⁐ᾮ (1000 EU /mL)䜢ᐊ 䛻ᡠ䛧䚸 䝍䝑䝏䝭䜻䝃䞊䛷1ศ㛫⃭䛧䛟᧠ᢾ䛧䛶䛛䜙 䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥䜶䜽䝇䝔䞁䝗䛷ȝL䜢2ᅇὙ䛔㎸䜏䛧䛶䛛䜙 䜚ྲྀ䜚䚸100 EU/mL䛾䝏䝳䞊䝤䛻ຍ䛘䜛䚹 ᡶ䛔ฟ䛧䛾䝢䝨䝑䝖ᢲ䛧ฟ䛧᧯స䛿1 ᅇ䛸䛩䜛䚹 ȝl 100ȝ䡈 100ȝl 100ȝl ⏝䛧䛯䝏䝑䝥䛿ᗫᲠ䛩䜛䚹 100ȝl ᕼ㔘䛧䛯䜶䞁䝗䝖䜻䝅䞁⁐ᾮ䛿䚸 ⏝䜎䛷ᐊ ಖᏑ䛩䜛䚹 ⏝ᮇ㝈䛿ᙜ᪥㝈䜚䛸䛩䜛䚹 35 ಖᏑ᳨㔞⥺సᡂ᪉ἲ䛾䝕䝰䞁䝇䝖䝺䞊䝅䝵䞁 (䜶) 䜰䝹䝭䜻䝱䝑䝥䜢䛧䛶䝍䝑䝏䝭䜻䝃䞊䛷30⛊㛫᧠ᢾ䜢⾜䛖䚹 䛣䛾䚸ෆᐜᾮ䜢䜰䝹䝭䜻䝱䝑䝥䛻᥋ゐ䛥䛫䛺䛔䛣䛸䚹 (䜸) ௨㝆䚸᪂䛧䛔䝏䝑䝥䜢ྲྀ䜚䛡䚸 100EU/mL䛛䜙㡰ḟ䚸0.01EU/mL䜎䛷⧞䜚㏉䛧ᕼ㔘䜢⾜䛖䚹 䝏䝑䝥䛿ẖᅇᚲ䛪䛩䜛䛣䛸 ᕼ㔘䛧䛯䜶䞁䝗䝖䜻䝅䞁⁐ᾮ䛿䚸⏝䜎䛷ᐊ ಖᏑ䛩䜛䚹 ⏝ᮇ㝈䛿ᙜ᪥㝈䜚䛸䛩䜛䚹 36 ಖᏑ᳨㔞⥺సᡂ᪉ἲ䛾䝕䝰䞁䝇䝖䝺䞊䝅䝵䞁 䠏䠊䝖䜻䝅䝜䝯䞊䝍䞊䛻䜘䜛 ᐃ (䜰) ᐃ㛤ጞ䛾20ศ௨ୖ๓䛻ᶵჾ䛾㟁※䜢ධ䜜䛶䛚䛟䚹 ᐃ㛫䛿60ศ䛻タᐃ䛩䜛䚹 (䜲) 䝸䝮䝹䝇ES-ϩ䝅䞁䜾䝹䝔䝇䝖䝽䝁䞊䛾䝷䜲䝉䞊༦ヨ⸆䜢7 ᮏ䚸 ෭ⶶᗜ䛛䜙ྲྀ䜚ฟ䛧䛶ᐊ 䛻ᡠ䛩䠄20ศ⛬ᗘ䠅䚹 (䜴) 䜶䞁䝗䝖䜻䝅䞁ヨ㦂⏝Ỉ䛛䜙䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥䜶䜽䝇䝔䞁䝗䜢 ⏝䛧䛶ȝ/ 䜢2ᅇὙ䛔㎸䜏䛧䛶䛛䜙 䜚ྲྀ䜚䚸 䝷䜲䝉䞊䝖ヨ⸆䛻ຍ䛘䜛䠄䛣䛾᧯స䛿⣙2⛊䛷⾜䛖䠅 䛯䛰䛱䛻⣙5⛊㛫᧠ᢾ䛧 䠄Ἳ䛜䛺䛔䛣䛸䜢☜ㄆ䠅䚸୍㐃䛾᧯స㛤ጞ䛛䜙 ྜィ10⛊ᚋ䛻䝖䜻䝅䝜䝯䞊䝍䞊䛻䝉䝑䝖䛧䚸䝀䝹㛫䛾 ᐃ䜢㛤ጞ䛩䜛䚹 (䜶) 䠎䠊䛷ᕼ㔘䛧䛯䜶䞁䝗䝖䜻䝅䞁⁐ᾮ䛾䛖䛱䚸0.01 EU /mL䜢 20⛊᧠ᢾ䛧䛯ᚋ䚸䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥䜶䜽䝇䝔䞁䝗䜢⏝䛧䛶 ȝ/䜢2ᅇὙ䛔㎸䜏䛧䛶䛛䜙 䜚ྲྀ䜚䚸䝷䜲䝉䞊䝖ヨ⸆䛻ຍ䛘䚸 (䜴) 䛸ྠᵝ䛻䛧䛶䝖䜻䝅䝜䝯䞊䝍䞊䛷 ᐃ䛩䜛䚹 ௨ୖ䛾᧯స䜢2ᅇ⧞䜚㏉䛧䚸n=2䛾 ᐃ䜢ᐇ䛩䜛䚹 37 䞉ヨ㦂⟶䜢ྲྀ䜚ᢅ䛖㝿䛿ぶᣦ䚸 ேᕪ䛧ᣦ䚸୰ᣦ䛾୕ᮏ䛷䛧䛳䛛䜚ᣢ䛴䚹 䞉ヨ㦂⟶䛾ୗ᪉䛿ᥱ䜙䛺䛔䜘䛖䛻䛩䜛䚹 ͤᶵჾ䛻䝉䝑䝖䛧䛯㝿䚸LEDග㊰䛸䛺䜛䛯䜑䚸 ở䜜➼䛻䜘䜚䚸 ᐃ⤖ᯝ䛻ᙳ㡪䜢ཬ䜌䛩ྍ ⬟ᛶ䛜䛒䜛䚹 ở䜜䛯ሙྜ䚸䜽䝸䞊䞁䝹䞊䝮⏝䝽䜲䝟䞊䛷 ở䜜㒊ศ䜢ᣔ䛝ྲྀ䛳䛶䛟䛰䛥䛔䚹 38 䝅䞁䜾䝹䝍䜲䝥䛾ヨ⸆䛻䛿䜰䝹䝭䜻䝱䝑䝥䛸 䝂䝮ᰦ䜢እ䛩䜸䞊䝥䝘䞊䛜ධ䛳䛶䛔䜎䛩䚹 39 ฝᆺ䛾䜰䝹䝭䜻䝱䝑䝥䛻䜸䞊䝥䝘䞊䛾A㒊ศ䜢⿕䛫䚸䛟 䛟䛾Ꮠ䛻ᢡ䜚䚸 䛾እ࿘䜢ᥥ䛟䜘䛖䛻ᢲ䛧ᅇ䛧䛺䛜䜙䚸䜰䝹䝭䜻䝱䝑䝥䛾䜏እ䛧䜎䛩䚹 40 䝂䝮ᰦ䛸ヨ㦂⟶䛾㝽㛫䛻䚸䜸䞊䝥䝘䞊䛾B㒊ศ䜢ᕪ㎸䜏䚸䜖䛳䛟䜚✵䛡䚸 䝂䝮ᰦ䜢እ䛧䛯䜙䚸䜰䝹䝭䜻䝱䝑䝥䛷䛩䛠䛥䜎䜢䛩䜛䚹 ͤヨ㦂⟶䛻䝷䜲䝉䞊䝖ヨ⸆䛜ྵ䜎䜜䛶䛚䜚䚸ヨ㦂⟶ෆ䛜㝜ᅽ䛾䛯䜑䚸 ໃ䛔䜘䛟㛤ᑒ䛩䜛䛸⢊䛜⯙䛖༴㝤䛜䛒䜚䜎䛩䚹 41 䝍䝑䝏䝭䜻䝃䞊䛾ヨ㦂⟶䛾ᣢ䛱᪉ ぶᣦ䚸୰ᣦ䛷ヨ㦂⟶䜢ᣢ䛱䚸 ேᕪ䛧ᣦ䛷䜰䝹䝭䜻䝱䝑䝥䜢ᢲ䛘䜛䚹 䝢䝨䝑䝖䛿ȝ/⏝䜢⏝䛧䚸ศὀ㔞䜢200 䛻タᐃ䛩䜛䚹 42 0ᢿ┠ 䛆䝯䝖䝻䝜䞊䝮 0ᢿ┠䛇 0ᢿ┠ 䝃䞁䝥䝹䜢ヨ㦂⟶䛻ྤ䛝ฟ䛩䚹 ͤヨ㦂⟶䜢ᡭ䛷ᣢ䛳䛶⾜䛳䛯䜋䛖䛜 ḟ䛾᧯స䛻⛣䜚䜔䛩䛔䚹 43 1ᢿ┠ 䛆䝯䝖䝻䝜䞊䝮 2ᢿ┠ 1ᢿ䡚2ᢿ┠䛇 䝢䝨䝑䝖䜢ᢤ䛝䚸䜰䝹䝭䜻䝱䝑䝥䜢䛛䜆䛫䜛䚹 44 䛆䝯䝖䝻䝜䞊䝮3ᢿ䡚7ᢿ┠䛇 䝍䝑䝏䝭䜻䝃䞊䛷5⛊㛫᧠ᢾ䚹 3ᢿ䡚7ᢿ┠ 45 9ᢿ┠ 䛆䝯䝖䝻䝜䞊䝮8ᢿ䡚9ᢿ┠䛇 8ᢿ┠ 䝍䝑䝏䝭䜻䝃䞊䛛䜙ヨ㦂䜢䛿䛪䛧䚸 ẼἻ䛜䛺䛔䛣䛸䜢┠ど☜ㄆ䛩䜛䚹 46 10ᢿ┠ 䛆䝯䝖䝻䝜䞊䝮10ᢿ┠䛇 10ᢿ┠䛷䝖䜻䝅䝜䝯䞊䝍䞊䛻䝉䝑䝖䛩䜛䚹 䠄ዟ䜎䛷ᕪ㎸䜏䚸䝉䝑䝖䛧䛯Pos. 䛾LED䛜Ⅼ⁛䛛䜙Ⅼⅉ䛻ኚ䜟䜚䚸 ḟ䛾Pos.䛾LED䛜Ⅼ⁛䛧䛶䛔䜛䛣䛸䜢☜ㄆ䛩䜛䠅 ͤPos.2 ௨㝆䚸䝖䜻䝅䝜䝯䞊䝍䞊䛻䝉䝑䝖䛩䜛㝿䛻䛾ヨ㦂⟶䛻 ᙜ䛯䜙䛺䛔䜘䛖䛻ὀព䛩䜛䚹 47 Ტᜒ፯Უ Ჴ ŦǨȳȉȈǭǷȳยܭඥƷؕᄽ Ŧᕤ૾ޅǨȳȉȈǭǷȳᚾ᬴ ŦǨȳȉȈǭǷȳቇ̝ඥƱ̬܍౨ዴ Ŧ̬܍౨ዴ˺૾ඥƱ̅ဇɥƷදॖໜ ᲢȇȢƱܱ፼Უ Ŧ̬܍౨ዴ˺ᙌ૾ඥƷȇȢ ŦȗȭȈdzȫᲢଐࠝᚾ᬴Ʒܱ፼ᲣƷᛟଢ Ŧଐࠝᚾ᬴Ʒܱ፼ Ტᜒ፯Უ ŦȈǭǷȎȡȸǿȸƷᢘࣱᚸ̖Ʊໜ౨Ⴘ ᲢLJƱNJᲣ ŦยܭኽௐƷᚐᛟƱᚸ̖ᲢឋွࣖሉᲣ 48 䝕䝰䞁䝇䝖䝺䞊䝅䝵䞁䜢䛤 ぴ䛟䛰䛥䛔 49 䠘┠ ┠ⓗ䠚 ಖᏑ᳨㔞⥺䜢⏝䛔䛯᪥ᖖヨ㦂䛾᪉ἲ䜢⌮ゎ䛩䜛 䠘 ⏝ヨ⸆䠚 䝸䝮䝹䝇ES-ϩ䝅䞁䜾䝹䝔䝇䝖䝽䝁䞊 ᶆ‽ရ䠚 䠘ᶆ 㻯㼛㼚㼠㼞㼛㼘㻌㻿㼠㼍㼚㼐㼍㼞㼐㻌㻱㼚㼐㼛㼠㼛㼤㼕㼚 䠘ヨ ヨ㦂⏝Ỉ䠚 ሯὀᑕ⏝Ỉ 䠘 ⏝ჾᮦ䠚 䞉䝸䝮䝹䝇䝔䝇䝖䝏䝳䞊䝤-S䜰䝹䝭䜻䝱䝑䝥 䞉䝢䝨䝑䝖 䞉䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥䝽䝁䞊1000ϩ 䞉䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥䝽䝁䞊䜶䜽䝇䝔䞁䝗Sϩ 䞉䝍䝑䝏䝭䜻䝃䞊 䞉䝖䜻䝅䝜䝯䞊䝍䞊ET-6000 50 1䠊ୖ㒊䝯䝙䝳䞊䛾᳨㔞⥺䛾䛂⦅㞟䛃䜢䜽䝸䝑䜽 2䠊䛆ᒁ᪉ヨ㦂䛇䜢㑅ᢥ䛧䛂OK䛃䜢䜽䝸䝑䜽 51 3䠊᳨㔞⥺ሗ䜢ධຊ䛧䛂OK䛃䜢䜽䝸䝑䜽 52 ධຊ 53 1䠊⏬㠃ᕥୖ䛻䛒䜛䛂᳨㔞⥺䝕䞊䝍䛃䜢䜽䝸䝑䜽䛩䜛䚹 2䠊⏬㠃ୖ㒊䛻䛒䜛᳨㔞⥺䛾䛂ಖᏑ䛃䜢䜽䝸䝑䜽䛩䜛䚹 54 3䠊᳨㔞⥺䛾ಖᏑඛ䜢☜ㄆ䛧䚸䝣䜯䜲䝹ྡ䠄௵ព䠅䜢ධຊ䛧䛂ಖᏑ䛃䜢䜽䝸䝑䜽䛩䜛䚹 55 1䠊⏬㠃ୖ㒊䛻䛒䜛᳨㔞⥺䛾䛂ㄞ䜏㎸䜏䛃䜢䜽䝸䝑䜽䛩䜛䚹 2䠊䛆ᒁ᪉ヨ㦂䛇䜢㑅ᢥ䛧䛂OK䛃䜢䜽䝸䝑䜽䛩䜛䚹 56 3䠊ㄞ䜏㎸䜐᳨㔞⥺䝣䜯䜲䝹䜢㑅ᢥ䛧䛂㛤䛟䛃䜢䜽䝸䝑䜽䛩䜛䚹 57 1䠊⏬㠃ୖ㒊䛻䛒䜛ุᐃつ᱁䛾䛂ヨ㦂⤖ᯝ䛃䜢䜽䝸䝑䜽䛩䜛䚹 2䠊䛆ᒁ᪉ヨ㦂䛇䜢㑅ᢥ䛧ୗ䛾⾲♧⏬㠃䛸ྠᵝ䛷䛒䜛䛣䛸䜢☜ㄆ䛧䛂OK䛃䜢䜽䝸䝑䜽䛩䜛䚹 ͤ␗䛺䜛ሙྜ䛿䚸ୗ䛾⾲♧⏬㠃䛻䛺䜛䜘䛖䛻タᐃ䛩䜛䚹 58 1䠊⏬㠃ୖ㒊䛻䛒䜛䝃䞁䝥䝹㓄⨨䛾䛂ㄞ䜏㎸䜏䛃䜢䜽䝸䝑䜽䛩䜛䚹 2䠊䛆᪥ᖖヨ㦂䛇䜢㑅ᢥ䛧䛂㛤䛟䛃䜢䜽䝸䝑䜽䛩䜛䚹 59 ᪥ᖖヨ㦂䛾ᐇ⩦ 䠍䠊䝖䜻䝅䝜䝯䞊䝍䞊䛸䝷䜲䝉䞊䝖ヨ⸆䛾‽ഛ (䜰) ᐃ㛤ጞ䛾20ศ௨ୖ๓䛻ᶵჾ䛾㟁※䜢ධ䜜䛶䛚䛟䚹 ಖᏑ᳨㔞⥺䛾䝕䞊䝍䜢ᡭධຊ䛩䜛䚹 ᐃ㛫䛿䚸ಖᏑ᳨㔞⥺䝕䞊䝍䛾⃰ᗘ0.01 EU/mL䛾 ᭱㛗䝀䝹㛫䛻タᐃ䛩䜛䚹 (䜲) 䝸䝮䝹䝇ES-ϩ䝅䞁䜾䝹䝔䝇䝖䝽䝁䞊䛾䝷䜲䝉䞊༦ヨ⸆䜢4 ᮏ䚸 ෭ⶶᗜ䛛䜙ྲྀ䜚ฟ䛧䛶ᐊ 䛻ᡠ䛩䠄20ศ⛬ᗘ䠅䚹 60 ᪥ᖖヨ㦂䛾ᐇ⩦ 䠎䠊䜶䞁䝗䝖䜻䝅䞁ᶆ‽⁐ᾮ䛾ᕼ㔘 (䜰) 䝸䝮䝹䝇䝔䝇䝖䝏䝳䞊䝤S䜢ヨ㦂⟶❧䛶䛻3ᮏ୪䜉䚸ୗᅗ䛻ᚑ䛳䛶 ┠ⓗ⃰ᗘ䜢グ䛩䚹 (䜲) ྛ䝏䝳䞊䝤䛻ὀᑕ⏝Ỉ䜢ȝ/⏝䝢䝨䝑䝖䛷䚸ȝ/䛪䛴ศὀ䛩䜛䚹 (䜴) CSE⁐ᾮ (1000 EU /mL)䜢ᐊ 䛻ᡠ䛧䚸䝪䝹䝔䝑䜽䝇䛷1ศ㛫⃭䛧䛟 ᧠ᢾ䛩䜛䚹䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥䜶䜽䝇䝔䞁䝗䛷ȝL䜢2ᅇὙ䛔㎸䜏䛧䛶䛛䜙 䜚ྲྀ䜚䚸 100 EU/mL䛾䝏䝳䞊䝤䛻ຍ䛘䜛䚹 ᡶ䛔ฟ䛧䛾䝢䝨䝑䝖ᢲ䛧ฟ䛧᧯స䛿1 ᅇ䛸䛩䜛䚹 ⏝䛧䛯䝏䝑䝥䛿ᗫᲠ䛩䜛䚹 (䜶) 䜰䝹䝭䜻䝱䝑䝥䜢䛧䛶䝍䝑䝏䝭䜻䝃䞊䛷30⛊㛫᧠ᢾ䜢⾜䛖䚹 䛣䛾䚸ෆᐜᾮ䜢䜰䝹䝭䜻䝱䝑䝥䛻᥋ゐ䛥䛫䛺䛔䛣䛸䚹 (䜸) ௨㝆䚸᪂䛧䛔䝢䝨䝑䝖䝏䝑䝥䜢ྲྀ䜚䛡䚸 100EU/mL䛛䜙㡰ḟ䚸1EU/mL䜎䛷⧞䜚㏉䛧 ᕼ㔘䜢⾜䛖䚹 61 ᪥ᖖヨ㦂䛾ᐇ⩦ 䠏䠊䠬䠟䚸䠬䠬䠟䚸䝃䞁䝥䝹䛾ㄪ〇 (䜰) 䝸䝮䝹䝇䝔䝇䝖䝏䝳䞊䝤S䜢ヨ㦂⟶❧䛶䛻3ᮏ୪䜉䚸1䛛䜙3 䜎䛷␒ྕ䜢グ䛩䚹 (䜲) ୗ⾲䛻ᚑ䛳䛶䚸ྛ䝏䝳䞊䝤䛻ὀᑕ⏝Ỉ䚸 CSE⁐ᾮ (1 EU/mL䜢20⛊ᨩᢾ) 䚸PET⸆䠄FDG) 䜢ຍ䛘䜛䚹 62 ᪥ᖖヨ㦂䛾ᐇ ᐇ⩦ 䠐䠊䝖䜻䝅䝜䝯䞊䝍䞊䛻䜘䜛 ᐃ (䜰) 䠏䛷ㄪ〇䛧䛯䠬䠟䜢20⛊᧠ᢾ䛧䛯ᚋ䚸䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥䜶䜽䝇䝔䞁䝗䜢 ⏝䛧䛶ȝ/ 䜢2ᅇὙ䛔㎸䜏䛧䛶䛛䜙 䜚ྲྀ䜚䚸 䝷䜲䝉䞊䝖ヨ⸆䛻ຍ䛘䜛䠄䛣䛾᧯స䛿⣙2⛊䛷⾜䛖䠅 䛯䛰䛱䛻⣙5⛊㛫᧠ᢾ䛧 䠄Ἳ䛜䛺䛔䛣䛸䜢☜ㄆ䠅䚸୍㐃䛾᧯స㛤ጞ䛛䜙 ྜィ10⛊ᚋ䛻䝖䜻䝅䝜䝯䞊䝍䞊䛻䝉䝑䝖䛧䚸䝀䝹㛫䛾 ᐃ䜢㛤ጞ䛩䜛䚹 (䜲) ྠ䛨䛟䠏䛷ㄪ〇䛧䛯䠬䠬䠟䜢20⛊᧠ᢾ䛧䛯ᚋ䚸䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥 䜶䜽䝇䝔䞁䝗䜢⏝䛧䛶ȝ/䜢2ᅇὙ䛔㎸䜏䛧䛶䛛䜙 䜚ྲྀ䜚䚸 䝷䜲䝉䞊䝖ヨ⸆䛻ຍ䛘䚸 (䜰) 䛸ྠᵝ䛻䛧䛶䝖䜻䝅䝜䝯䞊䝍䞊䛷 ᐃ䛩䜛䚹 (䜴) ྠ䛨䛟䠏䛷ㄪ〇䛧䛯䝃䞁䝥䝹䜢20⛊᧠ᢾ䛧䛯ᚋ䚸䝞䜲䜸䜽䝸䞊䞁䝏䝑䝥 䜶䜽䝇䝔䞁䝗䜢⏝䛧䛶ȝ/䜢2ᅇὙ䛔㎸䜏䛧䛶䛛䜙 䜚ྲྀ䜚䚸 䝷䜲䝉䞊䝖ヨ⸆䛻ຍ䛘䚸 (䜰) 䛸ྠᵝ䛻䛧䛶䝖䜻䝅䝜䝯䞊䝍䞊䛷 ᐃ䛩䜛䚹 ௨ୖ䛾᧯స䜢2ᅇ⧞䜚㏉䛧䚸n=2䛾 ᐃ䜢ᐇ䛩䜛䚹 63 Ტᜒ፯Უ Ჴ ŦǨȳȉȈǭǷȳยܭඥƷؕᄽ Ŧᕤ૾ޅǨȳȉȈǭǷȳᚾ᬴ ŦǨȳȉȈǭǷȳቇ̝ඥƱ̬܍౨ዴ Ŧ̬܍౨ዴ˺૾ඥƱ̅ဇɥƷදॖໜ ᲢȇȢƱܱ፼Უ Ŧ̬܍౨ዴ˺ᙌ૾ඥƷȇȢ ŦȗȭȈdzȫᲢଐࠝᚾ᬴Ʒܱ፼ᲣƷᛟଢ Ŧଐࠝᚾ᬴Ʒܱ፼ Ტᜒ፯Უ ŦȈǭǷȎȡȸǿȸƷᢘࣱᚸ̖Ʊໜ౨Ⴘ ᲢLJƱNJᲣ ŦยܭኽௐƷᚐᛟƱᚸ̖ᲢឋွࣖሉᲣ 64 ᚨᚘᢘࣱᄩᛐᲢ&&GUKIP3WCNKHKECVKQPᲣ Ўௌೞ֥ƷೞᏡȷࣱᏡˁಮŴೞ֥ȡȸǫȸǁƷᙲ൭ʙǛܭNJǔᚸ̖ ੁ˄ᢘࣱᄩᛐᲢ᳃+PUVCNNCVKQP3WCNKHKECVKQPᲣ ᘺፗƕദƠƘੁƑ˄ƚǒǕƨƔƲƏƔǛᄩᛐ èૼᙹƷኛλŴϐੁ˄ƴNjᘍƏŵ ᆙѣࣱᏡᢘࣱᄩᛐᲢ1RGTCVKQPCN3WCNKHKECVKQPᲣ ᘺፗƴࢳƞǕǔೞᏡŴࣱᏡƕࢽǒǕƯƍǔƜƱǛᄩᛐ èૼᙹƷኛλŴܭໜ౨Ŵ̲ྸࢸƴNjᘍƏŵ ᆙѣᢘࣱᄩᛐᲢ2GTHQTOCPEG3WCNKHKECVKQPᲣ ̅ဇƴࢳƞǕǔኽௐƕࢽǒǕƯƍǔƜƱǛᄩᛐ 65 Ўௌೞ֥Ʒᢘࣱᚸ̖ ᚨᚘᢘࣱᄩᛐᲢ&ᲣƷᙲ൭ǛƨƢᘺፗƕദƠƘੁ Ƒ˄ƚǒǕƨƜƱǛᄩᛐƢǔƷƕ+3Ŵ&3Ʒᙲ൭ǛƨƢ ࣱᏡƕࢽǒǕƯƍǔƜƱǛᄩᛐƢǔƷƕ13ŵ ܱᚾ૰ƴǑǔЎௌƴࢳƞǕǔኽௐƕࢽǒǕƯƍǔƜƱ ǛᄩᛐƢǔƷƕ23ŵ ᢘࣱᚸ̖ǛܱƠƳƚǕƹȷȷȷ ೞ֥ƕႸႎƱƢǔဇᡦƴᢘӳƠƯƍǔƜƱǛᚰଢƢǔƜƱ ƕЈஹƳƍŵɫƭŴЎௌȇȸǿƷࣱ࢘ڲǛᅆƢƜƱƕЈஹ Ƴƍŵ 66 ȐȪȇȸǷȧȳƷ૾ඥ ૨҄ƞǕƨƴࢼƬƯ౨ᚰƠŴࢳƞǕǔኽௐƕࢽǒǕƯƍǔƔǛᄩ ᛐƠŴƦƷኽௐǛᚡƢǔƜƱŵ ২ᘐᎍƷᢘࣱƴƭƍƯ ȐȪȇȸǷȧȳǍȡȳȆȊȳǹǛܱƢǔƴƋƨǓŴ ĬȐȪȇȸǷȧȳƷႸႎȷȷᄩᛐ૾ඥȷኽௐƷӕৢǛദƠƘ ྸᚐƢǔ࣏ᙲƕƋǔŵ ĭೞ֥ƷҗЎƳჷᜤƱྸᚐŴദƠƍ২ᏡǛ̲ࢽƢǔ࣏ᙲƕƋǔŵ ᏋȈȬȸȋȳǰǛᚨƚƯƓǓŴᢘࣱƕƋǔƱLjƳƠƨئӳƴžȡȳ ȆȊȳǹ২ᘐᎍᛐܭſǛႆᘍŵȐȪȇȸǷȧȳƷ૾ඥƕ٭ƞǕƨئ ӳƸŴૼᏋǛܱƢǔŵ 67 ȈǭǷȎȡȸǿȸ Ȉ ǭǷȎȡȸǿȸ ȐȪȇȸǷȧȳȷǵȝȸȈȷǵȸȓǹ Ȑ ȪȇȸǷȧȳȷǵȝȸȈȷǵ ȸȓǹ 68 ͤᮏ ᮏOQ䛻㛵䜟䜛䛶䛾ᩥ᭩䛿ᐃᮇⓗ䛻䝏䜵䝑䜽䛜⾜䜟䜜䜛䛯䜑䚸 ᑗ᮶䛻䜟䛯䜚ᖖ䛻ᨵゞ䛥䜜䜛ྍ⬟ᛶ䛜䛒䜛䚹 䛺䛚䚸OQィ⏬᭩䚸OQᡭ㡰᭩䛚䜘䜃OQᐇሗ࿌᭩䛾ᨵゞ䛾⛣⾜ᮇ㛫䛸䛧䛶䚸 ᨵゞ䛾┤๓䛾∧䛿ᨵゞ∧䛾Ⓨຠ᪥䛾⩣᭶ྠ᪥䜎䛷㐠⏝䛷䛝䜛䚹 69 • ԗภࡇƕéưƋǔƜƱ • ဒ᩿ᘙᅆƷᚨܭภࡇƕéưƋǔƜƱ ൦λǓӒࣖᚾ᬴ሥǛȝǸǷȧȳ ƴǻȃȈƠŴ ภࡇǻȳǵưยܭŴภࡇᙀദ͌ǛᚡƢǔŵ • ӲȝǸǷȧȳƷภࡇǻȳǵƷᘙᅆภࡇƕЎ Ў᧓ˌɥŴ déˌϋưܭܤƠƯƍǔƜƱ • ภࡇᙀദ͌ƕdé • /#:Ʊ/KPƷภࡇࠀƕéˌϋ 70 71 ൦λǓӒࣖᚾ᬴ሥǛȝǸǷȧȳ ƴǻȃȈƠŴఄദฎLjภࡇ ǻȳǵưยܭƢǔŵ 72 μȝǸǷȧȳƴƭƍƯŴᚾ᬴ሥƠƷήƱŴᘺፗ˄ޓ Ʒᚾ᬴ሥư൦ήᲢᔕသ൦ǛO.λǕƨᚾ᬴ሥǛǻȃ ȈƠƨئӳƷήᲣǛยܭƢǔŵ • ᚾ᬴ሥƠƷήย͌ܭƕŴᙌᡯήƷ ᲟˌɥᲟˌɦ • ൦ήƷย͌ܭƕŴᙌᡯήƷᲟˌɥ Ჟˌɦ 73 ᑓ⏝ヨ㦂⟶䛻2mL䛾␃Ỉ䜒䛧䛟䛿䜲䜸䞁Ỉ䜢ศὀ䛩䜛䚹 ⨨䛾㟁※䜢ධ䜜䛶30ศ௨ୖ䜴䜷䞊䝭䞁䜾䜰䝑䝥䛥䛫䜛䚹 䛭䛾㝿䚸Ỉ䜢ධ䜜䛯ᑓ⏝ヨ㦂⟶䜒ຍ 䛧䛶䛚䛟䚹 ͤヨ㦂⟶䛾ୗ㒊䛿ග㊰䛻䛺䜛䛾䛷ở䛥䛺䛔䜘䛖䛻ὀព䛩䜛䚹 74 䝖䜻䝅䝬䝇䝍䞊QC7 䜢㉳ື䛩䜛䚹 䜴䜷䞊䝭䞁䜾䜰䝑䝥䛜⤊䜟䛳䛯䜙䚸タᐃ ᗘ ㏆䛻䛺䛳䛶䛔䜛䛣䛸䜢☜ㄆ䛧䛶䚸ຍ 䛧䛶 䛚䛔䛯ᑓ⏝ヨ㦂⟶䜢ᢤ䛟䚹 䜽䝸䝑䜽䟿 䛆 ᐃ㛤ጞ䛇䜢㑅ᢥ䛩䜛䚹 75 ᐃ㛫䜢60ศ䛻タᐃ䛩䜛䚹 䛆 ᐃ㛤ጞ๓䛻ග㔞䝏䜵䝑䜽䜢ᐇ䛇䛻䝏䜵䝑䜽 䜢䛔䜜䛶䚸䛆 ᐃ㛤ጞ䛇䜢㑅ᢥ䛩䜛䚹 ͤ⮬ືග㔞䝏䜵䝑䜽䛾㝿䛿䚸 ග㒊䜹䝞䞊䜢䛩䜛䛣䛸䚹 76 ⮬ືⓗ䛻ග㔞䝏䜵䝑䜽䛜㛤ጞ䛥䜜䚸䛧䛯䜙䛄ṇᖖ䛅䛸⾲♧䛥䜜䜛䚹 1䝫䝆䝅䝵䞁┠䛾LED䛜⥳Ⰽ䛻Ⅼ⁛ 䛧䛶䛔䜛䛣䛸䜢☜ㄆ䛩䜛䚹 77 ヨ㦂⟶䛾䝬䞊䜹䞊䜢ග※⨨ 䠄Pos.Noഃ䠅䛻ྜ䜟䛫䜛䚹 ヨ㦂⟶䜢Pos.1䛻ᤄධ䛩䜛䚹䝖䜻䝅䝬䝇䝍䞊QC7䛷ᕪಙྕ䜢⾲♧䛩䜛䚹 ᕪಙྕ䛿⾲♧䛜2ᅇኚ᭦䛧䛯್䜢100䛷䛳䛯ᩘᏐ䜢グ㘓䛩䜛䚹 ᑠᩘⅬ௨ୗ䛿ษ䜚ᤞ䛶䜛䚹 䠄䠅29675э296 䛣䛾సᴗ䜢䚸㡰ḟ䚸16䝫䝆䝅䝵䞁⧞䜚㏉䛧⾜䛔䚸 ᐃ䜢⤊䛩䜛䚹 78 ᗘ䚸䝖䜻䝅䝬䝇䝍䞊QC7䛷䛆 ᐃ㛤ጞ䛇䜢㑅ᢥ䛩䜛䚹 䛶䛾䝫䝆䝅䝵䞁䜢䝇䝍䞊䝖䜻䞊䛷 ᐃ㛤ጞ䛩䜛䚹 䝖䜻䝅䝬䝇䝍䞊QC7䛷ᕪಙྕ䜢⾲♧䛩䜛䚹 ᕪಙྕ䛿⾲♧䛜2ᅇኚ᭦䛧䛯್䜢100䛷䛳䛯ᩘᏐ䜢グ㘓䛩䜛䚹 䠄16䝫䝆䝅䝵䞁䛶䠅 ᑠᩘⅬ௨ୗ䛿ษ䜚ᤞ䛶䜛䚹 䠄䠅29675э296 79 ET-6000 ྲྀᢅㄝ᫂᭩ 10䠊ಖᏲ䞉Ⅼ᳨ 10.1䠊ග㔞䝏䜵䝑䜽 80 ET-6000 ྲྀᢅㄝ᫂᭩ 10䠊ಖᏲ䞉Ⅼ᳨ 10.1䠊ග㔞䝏䜵䝑䜽 81 ET-6000 ྲྀᢅㄝ᫂᭩ 10䠊ಖᏲ䞉Ⅼ᳨ 10.1䠊ග㔞䝏䜵䝑䜽 82 ET-6000 ྲྀᢅㄝ᫂᭩ 10䠊ಖᏲ䞉Ⅼ᳨ 10.1䠊ග㔞䝏䜵䝑䜽 83 Ტᜒ፯Უ Ჴ ŦǨȳȉȈǭǷȳยܭඥƷؕᄽ Ŧᕤ૾ޅǨȳȉȈǭǷȳᚾ᬴ ŦǨȳȉȈǭǷȳቇ̝ඥƱ̬܍౨ዴ Ŧ̬܍౨ዴ˺૾ඥƱ̅ဇɥƷදॖໜ ᲢȇȢƱܱ፼Უ Ŧ̬܍౨ዴ˺ᙌ૾ඥƷȇȢ ŦȗȭȈdzȫᲢଐࠝᚾ᬴Ʒܱ፼ᲣƷᛟଢ Ŧଐࠝᚾ᬴Ʒܱ፼ Ტᜒ፯Უ ŦȈǭǷȎȡȸǿȸƷᢘࣱᚸ̖Ʊໜ౨Ⴘ ᲢLJƱNJᲣ ŦยܭኽௐƷᚐᛟƱᚸ̖ᲢឋွࣖሉᲣ 84 ⤖ᯝ䛾ุᐃ (䜰) ಖᏑ᳨㔞⥺䜢⏝䛔䛶⟬ฟ䛧䛯䠬䠟䛾䜶䞁䝗䝖䜻䝅䞁⃰ᗘ䛜䚸 0.075 EU/mL௨ୖ䛛䛴0.133 EU/mL௨ୗ䛷䛒䜛䛣䛸䜢☜ㄆ䛩䜛䚹 (䜲) ಖᏑ᳨㔞⥺䜢⏝䛔䛶⟬ฟ䛧䛯䠬䠬䠟䛾䜶䞁䝗䝖䜻䝅䞁⃰ᗘ䛛䜙 䝃䞁䝥䝹䛾䜶䞁䝗䝖䜻䝅䞁⃰ᗘ䜢ᕪ䛧ᘬ䛔䛯್䛜䚸 0.050 EU/mL௨ୖ䛛䛴0.20 EU/mL௨ୗ䛷䛒䜛䛣䛸䜢☜ㄆ䛩䜛䚹 (䜴) 䠄䜰䠅䛸䠄䜲䠅䛜☜ㄆ䛷䛝䜜䜀䚸 ᐃ䛿᭷ຠ䛷䛒䜛䚹 䝃䞁䝥䝹䛾䜶䞁䝗䝖䜻䝅䞁⃰ᗘ䜢ಖᏑ᳨㔞⥺䜢⏝䛔䛶⟬ฟ䛧䚸 つ᱁ෆ䛛䛹䛖䛛䜢ุᐃ䛩䜛䚹 䠄䛘䜀䚸䝃䞁䝥䝹䛾䜶䞁䝗䝖䜻䝅䞁⃰ᗘ䛜A EU/mL䛸䛺䛳䛯ሙྜ䚸 ⸆ཎᾮ䛾䜶䞁䝗䝖䜻䝅䞁⃰ᗘ䛿䚸A㽢ᕼ㔘ಸᩘ䛸䛺䜛䚹 䛣䜜䛜つ ᱁್ᮍ‶䛷䛒䜛䛛䛹䛖䛛䜢ุᐃ䛩䜛䚹䠅 85 ⤖ᯝ䛾ุᐃ䠄⥆䛝䠅䠄ᮏ᪥䛿ᐇ䛧䛺䛔䠅 (䜶) ಖᏑ᳨㔞⥺䜢⏝䛔䛶⟬ฟ䛧䛯䠬䠟䛾䜶䞁䝗䝖䜻䝅䞁⃰ᗘ䛜䚸 0.075 EU/mL௨ୖ䛛䛴0.133 EU/mL௨ୗ䛷䛺䛛䛳䛯䚸 ௨ୗ䜢☜ㄆ䛧䛶ヨ㦂䛩䜛䚹 э䠟䠯䠡䛾᭷ຠᮇ㝈䚸ಖᏑ᪉ἲ䛻䛿ၥ㢟䛺䛔䛛䠛 э䠟䠯䠡䛾⁐ゎ᪉ἲ䜔ᕼ㔘᪉ἲ䛿ṇ䛧䛔䛛䠛 э ᐃ᧯స䛿䝥䝻䝖䝁䝹䛻䛾䛳䛸䛳䛶䛔䜛䛛䠛 э䝖䜻䝅䝜䝯䞊䝍䞊䛾 ᗘ䚸ග㔞䛿㐺ṇ䛛䠛 (䜸) 䠬䠟䛾䜶䞁䝗䝖䜻䝅䞁⃰ᗘ䛿0.075 EU/mL௨ୖ䛛䛴0.133 EU/mL௨ୗ 䛷䛒䛳䛯䛜䚸䠬䠬䠟䛾䜶䞁䝗䝖䜻䝅䞁⃰ᗘ䛛䜙䝃䞁䝥䝹䛾䜶䞁䝗䝖䜻䝅䞁⃰ᗘ䜢 ᕪ䛧ᘬ䛔䛯್䛜䚸0.050 EU/mL௨ୖ䛛䛴0.20 EU/mL௨ୗ䛷䛺䛛䛳䛯 э䝃䞁䝥䝹䜢䛥䜙䛻ᕼ㔘䛧䛶ヨ㦂䛩䜛䚹 86
