鍙嶆徊閫忚啘鎶�琛�(sh霉)鍦ㄥ埗钘ヨ妤�(y猫)鐨勬噳(y墨ng)鐢�
渚嗘簮锛�绱旀按瑷�(sh猫)鍌� 浣滆�咃細鍗椾含钀婂紬鐗圭挵(hu谩n)淇濈鎶�鍏徃 鏃ユ湡锛�2018-05-04 12:09:00 鐎忚閲忥細682娆�闅ㄨ憲閱�(y墨)钘ヨ妤�(y猫)鐨勭櫦(f膩)灞�,鍒惰棩 鐢ㄦ按鐨勬按璩�(zh矛)瑕佹眰涔熷湪閫愭鎻愰珮,鍌崇当(t菕ng)鐨勫埗姘村伐钘濆闆㈠瓙浜ゆ彌娉曞凡閬�(yu菐n)閬�(yu菐n)涓嶈兘婊胯冻鍏惰姹�,鐐轰簡閬╂噳(y墨ng)閫欎竴鐧�(f膩)灞曠殑闇�瑕�, 鍗椾含钀婂紬鐗圭挵(hu谩n)?锛熻悕鍔犻偄钖邦倛鐤借鈶惧啑M(j矛n)銆佹湁鏁堢殑姘磋唱(zh矛)鍑堝寲鎶�琛�(sh霉)鈥斺�斿弽婊查�忚啘 鎶�琛�(sh霉)鎳�(y墨ng)鐢ㄥ湪浜嗗埗钘ヨ妤�(y猫)姘磋檿鐞嗙郴绲�(t菕ng)涓�銆�
1 鍙嶆徊閫忚啘鍒嗛洟鍘熺悊鍙婃�ц兘
鑷劧鐣屾湁閫欐ǎ涓�绋嚜鐒剁従(xi脿n)璞�,鐣�(d膩ng)灏囦竴寮靛崐閫忚啘灏囩█钖勬憾娑�(濡傜磾姘�)鑸囩磾鍘氭憾娑�(濡傞菇姘�)闅旈枊,绋�钖勬憾娑叉渻(hu矛)鍚戞績鍘氭憾娑叉徊閫忓苟淇濇寔鐩告噳(y墨ng)鐨勬徊閫忓(瑕嬪湒1),姝ょ従(xi脿n)璞＄ū鐐烘徊閫忕従(xi脿n)璞�,濡傚湪婵冨帤婧舵恫铏曟柦澹撳ぇ浜庤┎婊查�忓鐨勫鍔�,鍓囨績鍘氭憾娑叉渻(hu矛)鍚戠█钖勬憾娑蹭竴鍋�(c猫)婊查��(瑕嬪湒2),姝ょ従(xi脿n)璞＄ū鐐洪��(鍙�)婊查�忕従(xi脿n)璞�,瑭叉妧鍗婇�忚啘琛�(sh霉)鏄洰鍓嶅湅(gu贸) 闅涗笂鍏獚(r猫n)鐨勯珮鏂版妧琛�(sh霉),瀹冨�熷姪澶栧姞澹撳姏鐨勪綔鐢ㄤ娇婧舵恫鐨勬憾鍔戦�忛亷鍗婇�忚啘鑰岄樆鐣欐煇浜涙憾璩�(zh矛),瀹冩槸涓�绋垎闆�,婵冪府鍜屾彁绱旂殑鏈夋晥鎵嬫銆� 鍙嶆徊閫忚啘 琛ㄩ潰寰瓟灏哄涓�鑸湪10A宸﹀彸,瀹冭兘鏈夋晥鍘婚櫎寰矑銆佽啝楂�銆佺窗(x矛)鑿�銆佺啽鍘熷強鏈� 姗�(j墨)鐗╁拰绲曞ぇ閮ㄥ垎闆㈠瓙銆傜洰鍓嶅弽婊查�忚啘鏉愯唱(zh矛)涓昏鐐洪唻绾栬啘,鑺抽鏃忚仛閰拌兒绯讳綆澹撳京(f霉)鍚堣啘鍙婂厛閫�(j矛n)鐨勮秴浣庡寰�(f霉)鍚堣啘,瀹冨�戠殑涓昏鎬ц兘瑕嬭〃1銆�
閱嬬簴鑶滄槸鏃╂噳(y墨ng)鐢ㄧ殑鍙嶆徊閫忚啘 ,浣嗘槸鐢变簬瀹规槗琚窗(x矛)鑿屽悶铦�,pH浣跨敤鑼冨湇绐�,鑴菇鐜囦綆,鐩墠瑭叉潗璩�(zh矛)鑶滃凡閫愭几琚窐姹�,鍙栬�屼唬涔嬫槸楂樿劔楣界巼銆佷綆澹撱�佺┅(w臎n)瀹氭�уソ鐨勫京(f霉)鍚堣啘寤ｆ硾琚娇鐢�銆�
2銆�鍒惰棩 鐢ㄧ磾姘寸殑鍒跺彇宸ヨ棟
2.1銆�鍏ㄩ洟瀛愪氦鎻�(IE)娉�
闆㈠瓙浜ゆ彌绯荤当(t菕ng)鍒跺彇绱旀按鏄垜鍦�(gu贸)鍌崇当(t菕ng)鐨勫埗姘村伐钘�,鍏跺伐钘濇祦绋嬪涓�:
2.2銆�闆绘徊鏋�(ED)+闆㈠瓙浜ゆ彌(IE)娉�
闆绘徊鏋愭槸鍒╃敤闄伴櫧闆㈠瓙浜ゆ彌鑶滃皪(du矛)姘存憾娑蹭腑闄伴櫧闆㈠瓙鐨勯伕鎿囬�忛亷鎬ц�岄仈(d谩)鍒扮墿璩�(zh矛)鍒嗛洟鐨勮檿鐞嗘柟娉�,鍏跺伐钘濇祦绋嬪涓�:
2.3銆�鍙嶆徊閫�(RO)+闆㈠瓙浜ゆ彌(IE)娉�
鍙嶆徊閫忔槸鍒╃敤鍙嶆徊閫忚啘鍙兘閫忛亷姘磋�屼笉鑳介�忛亷婧惰唱(zh矛)鐨勭壒鎬�,寰炲惈鏈夊悇绋劇姗�(j墨)鐗┿�佹湁 姗�(j墨)鐗╁拰寰敓鐗╃殑姘撮珨涓彁鍙栫磾姘寸殑铏曠悊鏂规硶,鍏跺伐钘濇祦绋嬪涓�:
3銆� 鍙嶆徊閫忚啘娉曟按铏曠悊宸ヨ棟鑸囧偝绲�(t菕ng)宸ヨ棟鐨勬瘮杓�
3.1 涓夌ó铏曠悊宸ヨ棟鍎�(y艒u)缂洪粸(di菐n)姣旇純瑕嬭〃2
3.2 涓夌ó铏曠悊宸ヨ棟鐢熺敘(ch菐n)It绱旀按鎵�闇�璨�(f猫i)鐢ㄨ琛�
瑾槑:浠ヤ笂璨�(f猫i)鐢ㄥ寘鎷�:
(1)閰稿牽璨�(f猫i)(鍏朵腑閰搁噰鐢ㄥ伐妤�(y猫)绱旈菇閰�,鍫块噰鐢ㄥ寲瀛�(xu茅)绱旂墖鍫�);
(2) 鍙嶆徊閫忚啘 銆侀浕婊叉瀽鑶溿�侀櫧銆侀櫚妯硅剛鏇存彌璨�(f猫i)鍙婃烤鑺�佽棩鍔戞秷鑰楄不(f猫i);
(3)姘�銆侀浕鍕�(d貌ng)鍔涜不(f猫i),鍏朵腑姘村凡鎸夊埄鐢ㄧ巼鎶樼畻(鍙嶆徊閫忔硶鎸�70percent,闆绘徊鎶樻硶鎸�45percent,鍏ㄩ洟浜ゆ硶鎸�80percent);
(4)浜哄伐璨�(f猫i)鏈▓(j矛)鍏ュ収(n猫i)銆�
4銆�绲�(ji茅)瑾�
缍滀笂鎵�杩�,鍙嶆徊閫忔槸姘磋檿鐞嗕腑楂樻柊鎶�琛�(sh霉),90骞翠唬涓湡鍦ㄦ垜鍦�(gu贸)鐨勯啱(y墨)钘ヨ妤�(y猫)闁嬪寰楀埌浜嗗唬娉涚殑鎳�(y墨ng)鐢�,瀹冪殑浣跨敤澶у湴寤堕暦(zh菐ng)浜嗗偝绲�(t菕ng)鐨勯洟瀛愪氦鎻涜ō(sh猫)鍌欑殑鍐嶇敓鍛ㄦ湡,娓涘皯浜嗛吀鍫挎帓鏀鹃噺,鏈夊姏鍦颁繚璀�(h霉)浜嗙敓鎱�(t脿i)鐠�(hu谩n)澧�銆傞毃钁椼�婅棩鍝佺敓鐢�(ch菐n)璩�(zh矛)閲� 绠� 鐞嗚(gu墨)鑼冦��(GMP)鎶�琛�(sh霉)妯�(bi膩o)婧�(zh菙n)鐨勬繁鍏ヨ搏寰硅垏瀵�(sh铆)鏂姐�傚叏 鍦�(gu贸)瑷卞钘ュ粻鐩哥辜閫�(j矛n)琛屼簡鎶�琛�(sh霉)鏀归��,闄哥簩(x霉)寮曢��(j矛n)鍦�(gu贸)澶栫殑鎶�琛�(sh霉)鍜岃鍌�,浣垮緱 鍙嶆徊閫忚啘鎶�琛�(sh霉)鍦ㄥ埗钘ヨ妤�(y猫)寰楀埌鏇村唬娉涚殑鎳�(y墨ng)鐢�銆傜洰鍓�锛屽弽婊查�忚啘宸插湪澶氬鍒惰棩鍏徃鍔犱互鎳�(y墨ng)鐢ㄥ苟鍙栧緱浜嗚壇濂界殑铏曠悊鏁堟灉銆傚崡浜悐寮楃壒鐠�(hu谩n)淇濈鎶�鏈夐檺鍏徃灏囧啀鎺ュ啀鍘�锛屼笉鏂风爺鍒堕枊鐧�(f膩)鏇撮珮鎶�琛�(sh霉)鍚噺鐨勬柊鑶滃厓浠讹紝浠ユ豢瓒冲埗钘ョ瓑琛屾キ(y猫)鏃ョ泭鎻愰珮鐨勬妧琛�(sh霉)瑕佹眰銆�
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