宀涙触涓浗鐜囧厛鎺ㄥ嚭閬椾紶姣掓€ф潅璐∟mba锛圢-凯时国际
2019-07-09銆€銆€2019骞?鏈?鏃ワ紝缇庡浗椋熷搧鍜岃嵂鐗╃鐞嗗眬(fda)鍦ㄥ畼缃戝彂甯冭绠＄揣寮犵礌ii鍙椾綋闃绘粸鍓傦紙arbs锛夎嵂鐗╂隘娌欏潶鐨勮嚜鎰垮彫鍥炲叕鍛婏紝娑夊強鍒板嵃搴etero labs ltd.鐢熶骇鐨?7鎵规隘娌欏潶閽剧墖锛岃€屽鑷磋鍙洖鐨勪富瑕佸師鍥犳槸鍙戠幇鍏朵腑鍚湁n-浜氱鍩?n-鐢插熀-4-姘ㄥ熀涓侀吀锛圢mba锛夋潅璐ㄣ€傜敱浜嶯mba鏄凡鐭ュ姩鐗╁拰娼滃湪浜虹被鐨勮嚧鐧屽寲瀛︾墿璐紝鏄户n鈭掍簹纭濆熀浜岀敳鑳猴紙ndma锛夊拰n鈭掍簹纭濆熀浜屼箼鑳猴紙ndea锛変箣鍚庝笂甯侫rbs鑽墿涓娴嬪埌鐨勭涓夌浜氱鑳虹被閬椾紶姣掓€ф潅璐ㄣ€傛鍚庯紝fda鐩哥户鍏竷浜員eva pharmaceuticals鍜孷ivimed life sciences pvt ltd绛夊埗鑽叕鍙歌嚜鎰垮彫鍥炴秹鍙婃隘娌欏潶閽剧殑63鎵硅嵂鍝侊紝鍏跺師鍥犱负妫€鍑哄惈鏈塏mba銆傚悓鏃讹紝鍔犳嬁澶у崼鐢熼儴锛圚c锛夊強鑻卞浗鍗敓閮紙dhsc锛変篃鍦ㄥ畼缃戜笂鍙戝竷浜嗘隘娌欏潶绫昏嵂鐗╃殑鍙洖鍏憡銆傜洿鑷?019骞?鏈?2鏃ワ紝teva pharmaceuticals浠嶅湪鎵╁ぇ鑷効鍙洖7鎵规鍑篘mba姘矙鍧﹂捑鐗囷紝鍙鑽墿涓殑閬椾紶姣掓€ф潅璐ㄤ粛鍙楀埌鍏紬鍙婅嵂鍝佺洃绠℃満鏋勭殑楂樺害鍏虫敞銆?/p>
銆€銆€鍦‵da宸插叕甯冪殑arbs鑽墿浜氱鑳烘潅璐ㄩ檺搴﹁〃涓紝nmba鐨勬棩鍏佽鎽勫叆閲忔渶澶у€间负0.96ppm銆?fda璇勪及浜嗘毚闇蹭簬9.82ppm姘村钩nmba鐩告瘮浜庣粓鐢熸毚闇蹭簬0.96ppm nmba鐨勬湇鑽按骞筹紝琛ㄦ槑6涓湀鐨勬毚闇查噺涓嶄細瀛樺湪鎮ｇ檶椋庨櫓銆?/p>
n-浜氱鍩?n-鐢插熀-4-姘ㄥ熀涓侀吀锛圢mba锛?br />
n-nitroso-n-methyl-4-aminobutyricacid(nmba)
cas. 61445-55-4
銆€銆€鍥犳锛屼负浜嗙‘淇濇偅鑰呭湪缂撳啿鏈熷彲鑾峰緱姘矙鍧︾被鑽墿锛孎da涓嶅弽瀵瑰惈nmba浣庝簬9.82ppm鐨勬隘娌欏潶淇濇寔閿€鍞€傝杩囨浮缂撳啿鏈烣da璁句负6涓湀锛岀洿鑷崇敓浜т紒涓氭彁渚涗簹纭濊兒鏉傝川绗﹀悎瑕佹眰鐨勬隘娌欏潶鑽墿鏉ュ～琛ュ競鍦恒€?/p>
鐩墠锛屽叧浜庢隘娌欏潶閽句腑nmba鐨勬娴嬫柟娉曞皻鏈鍏紑鎶ラ亾锛屼负鍙婃椂搴斿甯傚満妫€娴嬮渶姹傦紝宀涙触涓浗鐜囧厛鎺ㄥ嚭浜嗗熀浜嶭c-ms/ms鎶€鏈殑妫€娴嬫柟娉曪紝璇ユ柟娉曟搷浣滅畝鍗曪紝鐏垫晱搴﹂珮锛岄€傜敤鎬у己锛屽彲鏈夋晥鐢ㄤ簬姘矙鍧﹂捑涓璑mba鐨勫垎鏋愭娴嬨€?/strong>
1銆?瀹為獙閮ㄥ垎
1.1 浠櫒锛?/strong> lcms-8050涓夐噸鍥涙瀬鏉嗚川璋变华鑱旂敤浠紝鍚湁锛歀c-30ad脳2杈撴恫娉碉紝dgu-20a5r鍦ㄧ嚎鑴辨皵鏈猴紝sil-30ac鑷姩杩涙牱鍣紝cto-30a鏌辨俯绠憋紝cbm-20a绯荤粺鎺у埗鍣紝lcms-8050涓夐噸鍥涙瀬鏉嗚川璋变华锛孡absolutions锛圴ersion 5.82 sp1锛夎壊璋卞伐浣滅珯銆?/p>
1.2 鍒嗘瀽鏉′欢锛?/strong>
娑茬浉鑹茶氨鏉′欢
| 鑹?璋?鏌?/td> | 锛歋him-pack xr-ods ii 2.0 mm i.d.脳 100 mm l., 2.2 渭m | ||
| 娴?鍔?鐩?/td> | 锛欰鐩?0.1%鐢查吀姘存憾娑诧紱b鐩?鐢查唶 | ||
| 娴?閫?/td> | 锛?.3 ml/min | 鏌辨俯 | 锛?0鈩?/td> |
| 杩涙牱浣撶н | 锛? 碌l | 娲楄劚鏂瑰紡 | 锛氭搴︽礂鑴?/td> |
璐ㄨ氨鏉′欢
| 绂诲瓙鍖栨ā寮?/td> | 锛欵si锛屾绂诲瓙妫€娴?/td> | 纰版挒姘?/td> | 锛氭癌姘?270 kpa |
| 闆惧寲姘旀祦閫?/td> | 锛?.0 l/min | 鍔犵儹妯″潡娓╁害 | 锛?00鈩?/td> |
| 鍔犵儹姘旀祦閫?/td> | 锛?0.0 l/min | 骞茬嚗姘旀祦閫?/td> | 锛?0.0 l/min |
| 鎺ュ彛娓╁害 | 锛?00鈩?/td> | 鎵弿妯″紡 | 锛氬鍙嶅簲鐩戞祴(mrm) |
| dl娓╁害 | 锛?50鈩?/td> | mrm鍙傛暟 | 锛氳涓嬭〃 |
1.3 鏍囧噯鍝佹憾娑?/strong>锛氬彇nmba鏍囧噯璐娑诧紝浠ョ函鐢查唶閫愮骇绋€閲婁负0.5銆?銆?銆?銆?0銆?0銆?0銆?00 ng/ml鐨勫叓涓笉鍚屾祿搴︾殑娣峰悎鏍囧噯宸ヤ綔婧舵恫銆?/p>
1.4 鏍峰搧婧舵恫锛氬彇姘矙鍧﹂捑涓夋壒鍘熸枡鑽紙绗﹀悎ep9.0锛?.1 g浜?0 ml瀹归噺鐡朵腑锛屽姞鐢查唶閫傞噺锛岃秴澹? min鑷冲叏閮ㄦ憾瑙ｏ紝鏀惧喎鑷冲娓╋紝鐢ㄧ敳閱囧畾瀹瑰緟娴嬨€?/p>
2銆?缁撴灉
2.1鏍囧噯鍝佽壊璋卞浘
鍥?. nmba鏍囧噯鍝佽壊璋卞浘锛?00 ng/ml锛?br />
锛堥粦鑹?鎬荤瀛愭祦锛涚矇鑹?mrm147.15/117.10锛涜摑鑹?mrm147.15/87.10锛涙鑹?mrm147.15/44.10锛?/p>
2.2 绾挎€у叧绯诲強妫€鍑哄畾閲忛檺
鍥?. nmba鏍囧噯鏇茬嚎
妫€鍑洪檺锛圠od锛?.5 ng/ml(mrm147.15/117.10)锛屽畾閲忛檺锛圠oq锛?.0 ng/ml (mrm147.15/117.10)
2.3 绮惧瘑搴﹀疄楠?/strong>锛?0 ng/ml鏍囧噯婧舵恫涓烘牱鏈繛缁繘鏍凤紝鏃ュ唴鍙婃棩闂翠繚鐣欐椂闂寸浉瀵规爣鍑嗗亸宸綆浜?.1%锛屽嘲闈㈢н浣庝簬1.10%銆?/p>
2.4 鍔犳爣鍥炴敹瀹為獙
鍙?.1 g姘矙鍧﹂捑鏍峰搧浜?0 ml瀹归噺鐡朵腑锛屽姞鍏mba鏍囧噯鍝佹憾娑?鐩稿綋浜?0銆?00銆?00 ng nmba鏍囧噯鍝?锛屾寜鐓?.4涓殑鏂规硶杩涜澶勭悊锛屼笂鏈哄垎鏋愩€傚姞鏍囩殑姘矙鍧﹂捑婧舵恫鑹茶氨鍥撅紙浠?00 ng鍔犳爣閲忎负渚嬶級瑙佸浘3銆備笁涓钩琛屾牱鍝佺殑浣庝腑楂樺钩鍧囧洖鏀剁巼鍒嗗埆涓?8.04%锛?4.40%锛?5.61%銆?/p>
鍥? nmba鍔犳爣閲忎负200 ng鏃舵隘娌欏潶閽炬憾娑茶壊璋卞浘
2.5 妫€娴嬬粨鏋?/strong>锛氫笁鎵规牱鍝佷腑nmba鍧囦綆浜庢渶灏忔鍑洪檺锛圠od锛夈€?/p>
3銆?缁撹
銆€銆€鏈伐浣滃缓绔嬩簡浣跨敤lcms-8050涓夐噸鍥涙瀬鏉嗚川璋辫仈鐢ㄤ华娴嬪畾姘矙鍧﹂捑鍘熸枡鑽腑n-浜氱鍩?n-鐢插熀-4-姘ㄥ熀涓侀吀锛圢mba锛夋潅璐ㄧ殑鏂规硶锛屽湪0.5~100 ng/ml娴撳害鑼冨洿鍐呯嚎鎬у叧绯昏壇濂斤紝妫€鍑洪檺鍜屽畾閲忛檺鍒嗗埆涓?.5 ng/ml鍜?.0 ng/ml銆備娇鐢ㄦ鏂规硶瀵逛笁鎵规姘矙鍧﹂捑鍘熸枡鑽繘琛屼簡娴嬪畾锛岀粨鏋滀负nmba鏈鍑恒€傛湰鏂规硶绠€鍗曘€佸揩閫熴€佺伒鏁忋€佸噯纭紝鍙湁鏁堢敤浜庢隘娌欏潶閽惧師鏂欒嵂涓璑mba鐨勫垎鏋愭娴嬨€?/p>