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鎮ㄥソ锛屾杩庤闂亽婧愭満姊板畼鏂圭綉绔欙紒

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鐢熸椿鐢ㄧ焊鑹ソ鐢熶骇瑙勮寖锛圙mp锛?鍚堣鎯呭喌鎺㈣
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浠ュ帹鎴跨敤绾稿拰椁愬肪绾镐富瑕佺殑鍔熻兘鍔╁墏婀垮己鍓備负渚嬶紝鐩墠鍥藉唴鐢ㄤ簬鐢熸椿鐢ㄧ焊鐨勪富瑕佹箍寮哄墏鏄仛閰拌兒鐜哀姘笝鐑锋爲鑴?锛?/span>pae锛夛紝涓昏婀垮己鍓?pae 鍙婂叾娈嬬暀鐨勬祴璇曠粨鏋滆〃鏄?/span>[3-4]锛?/span>pae婀垮己鍓備腑鏈夋満姘唬浣庤仛鐗╃幆姘ф隘涓欑兎 锛?/span>ech锛夈€?/span>1,3-浜屾隘-2-涓欓唶 锛?/span>dcp锛夈€?/span>3-姘?/span>-1锛?/span>2-涓欎簩閱?锛?/span>mcpd锛?涓夎€呬箣鍜岃秴鍑?0. 7% 鐨勫浗瀹舵爣鍑?/span>[5]鍙婃鐩熺敓娲荤敤绾告爣绛炬硶浠よ瀹?/span>[6]鐨勮姹傦紝瀛樺湪杈冧弗閲嶇殑瓒呮爣闂銆傝鎸囧崡涓瀹氱焊宸剧焊姘磋悆鍙栨恫涓?3-mcpd<12 渭g/l鍙?/span>dcp<2 渭g/l 锛堝琛?/span>1鎵€绀猴級锛屽嵆瀵圭焊宸剧焊杩佺щ鍑烘潵鐨?dcp 鍙?mcpd 杩涜浜嗛檺瀹氥€備粠 pae婀垮己鍓傚師娑茬殑娴嬭瘯缁撴灉[3-4]鍙煡锛?/span>dcp銆?/span>mcpd 妫€鍑洪噺杈冨ぇ锛岃€屼笖dcp鐨勬鍑烘祿搴﹁繙瓒呰繃mcpd锛屽洜姝ょ焊宸剧焊鎴愬搧涓?dcp 鐨勬畫鐣欓噺鏇撮珮锛岃€岃鎸囧崡瀵圭焊宸剧焊姘磋悆鍙栨恫涓殑 dcp 闄愬€兼洿涓ワ紝鎵€浠ョ焊宸剧焊鎴愬搧涓?dcp鐨勬畫鐣欓闄╁彲鑳芥€ф洿楂樸€傜焊宸剧焊绛夌敓娲荤敤绾镐笌浜轰滑鏃ュ父鐢熸椿瀵嗗垏鎺ヨе锛屽挨鍏舵槸鐢ㄤ簬鎿︽嫮鍢撮儴銆佽劯閮ㄣ€佹墜閮ㄧ殑闈㈠肪绾搞€侀宸剧焊銆佹墜甯曠焊绛夈€傝繖浜涢噸瑕佺殑浜轰綋閮ㄤ綅鐨偆鏆撮湶浼氭帴瑙﹀埌绾稿肪绾镐腑鐨勬湁瀹崇墿璐?锛堟箍寮哄墏pae娈嬬暀鏈夋満姘唬浣庤仛鐗╋紝灏ゅ叾鏄?dcp锛夛紝闀挎湡鎺ヨе灏嗗浣跨敤鑰呯殑韬綋鍋ュ悍甯︽潵娼滃湪鐨勯闄╅殣鎮c€傜壒鍒槸閽堝鍎跨銆佸┐骞煎効涓撶敤鐨勭焊宸剧焊锛屽瓨鍦ㄧ殑椋庨櫓闅愭偅灏辨洿鍔犻渶瑕佸紩璧烽噸瑙嗐€?br/>

2. 1. 3 鍗板埛娌瑰ⅷ


鍗板埛娌瑰ⅷ鐨勪娇鐢ㄥ簲渚濈収璇ユ寚鍗楅檮褰?/span>2涓殑鐩稿叧瑙勫畾锛屽叾涓寘鍚簡甯哥敤浜庡帹鎴跨敤绾稿拰椁愬肪绾哥殑鍗板埛娌瑰ⅷ涓惈鏈夌殑鐗╄川銆傜敤浜庣敓娲荤敤绾哥殑鍏稿瀷鍗板埛娌瑰ⅷ涓烘按鎬ф补澧紝瀵规补澧ㄧ殑杩炴帴鏂欍€侀鏂欍€佹坊鍔犲墏绛夌粍鍒嗚繘琛岃瀹氾紝鐢熸椿鐢ㄧ焊鐢熶骇浣跨敤鐨勫吀鍨嬭繛鎺ユ枡涓轰笝鐑吀鍜岀敳鍩轰笝鐑吀鏍戣剛锛屽寘鎷嫰涔欑儻鍖栧拰鑱氭皑閰爲鑴傘€傞鏂欎笉寰楀惈鏈夌鐢ㄧ墿璐紝瀵瑰叾涓殑閲嶉噾灞炪€佽姵棣欒兒銆佸姘仈
鑻€佺偔榛戜腑鐢茶嫰鍙悆鍙栫墿鍚噺绛夋湁瀹崇墿璐ㄨ繘琛岄檺瀹氥€傚娣诲姞鍓傚娑堟场鍓傘€佹潃鑿屽墏銆佸绋犲墏绛夋垚鍒嗗強鐢ㄩ噺鑼冨洿杩涜浜嗚瀹氥€?/span>


2. 2 gmp浠嬬粛


gmp 鏄川閲忔帶鍒跺拰浜у搧瀹夊叏淇濊瘉鐨勫熀纭€锛屾彁渚涗簡褰卞搷鍘ㄦ埧鐢ㄧ焊鍜岄宸剧焊璐ㄩ噺浠ュ強閫傜敤鎬у叧閿洜绱犵殑绠$悊鍜屼娇鐢ㄥ缓璁紝鐗瑰埆鏄笌椋熷搧鎺ヨе鐨勫畨鍏ㄦ€э紝娑电洊浜嗕粠鍘熸潗鏂欓噰璐埌浠庡埗閫犲晢鍙戣揣鐨勬墍鏈夌敓浜ч樁娈点€?/span>


gmp鍩轰簬鐩稿叧璐ㄩ噺绠$悊浣撶郴鐨勫師鍒欙紝濡?/span>iso 9000绯诲垪銆傚畠杩樺熀浜庨闄╃鐞嗕綋绯荤殑鐩稿叧鍘熷垯锛屽 hac鈦僀p銆傜鐞嗙郴缁熸兜鐩栫敓浜х殑姣忎釜闃舵锛屽寘鎷師鏉愭枡鐨勯噰璐紝浠ュ強鍔犲伐銆佸埗閫犲拰妫€娴嬨€佸畬宸ャ€佽繍杈撶瓑鐢熶骇鐨勪笉鍚岄樁娈碉紱鍖呮嫭鎵嬪唽銆佺敓浜х▼搴忔枃浠躲€佹娴嬭鑼冿紱澶勭悊銆佸偍瀛樸€佸寘瑁呫€佷繚瀛樸€佷骇鍝佽瘑鍒拰浜や粯锛涗汉鍛樺煿璁紝鍐呴儴瀹℃牳锛涚敓浜у拰璐ㄩ噺璁板綍绛夊唴瀹广€傚叿浣撶殑gmp瑙勫畾瑕佹眰瑙佽〃2銆?/span>

鐩墠鍥藉唴鐢熸椿鐢ㄧ焊浼佷笟鍦ㄧ敓浜ф椂瀛樺湪绾ょ淮鍘熸枡浜ゅ弶姹℃煋鐨勯棶棰橈紝鑵愭祮銆佸皝闂按寰幆瀵艰嚧鐨勫井鐢熺墿婊嬬敓闂锛屽寲瀛﹀姪鍓傜疮绉鑷寸殑瀹夊叏璐ㄩ噺闅愭偅闂锛屽姞宸ャ€佸偍瀛樸€佽繍杈撹繃绋嬪鑷寸殑璐ㄩ噺闂绛夈€傛秷璐硅€呭鐢熸椿鐢ㄧ焊鍗敓璐ㄩ噺鐨勮姹傞珮锛屾瘡涓敓浜ч樁娈甸兘鏈夊彲鑳戒骇鐢熷鑷翠骇鍝佽川閲忛闄╅殣鎮g殑鐢熺墿鐨勫拰/鎴栫墿鐞嗙殑鍜?/span>/鎴栧寲瀛︾殑鍗卞锛屽洜姝ゅ姞寮鸿鑼冪敓浜э紝澧炲己椋庨櫓绠$悊鎰忚瘑锛屾椂鍒昏鎯曞嵄瀹冲彂鐢熺偣锛屾椂鍒诲叧娉ㄩ闄╄閬垮叧閿帶鍒剁偣锛屽強鏃堕噰鍙栭闃茬籂姝f帾鏂斤紝瀵逛繚璇佷骇鍝佽川閲忓畨鍏ㄨ捣鍒伴噸瑕佷綔鐢ㄣ€?/span>


2. 4 璐ㄩ噺瑕佹眰

璇ユ寚鍗椾腑鐨勫帹鎴跨敤绾稿拰椁愬肪绾搁渶瑕佹弧瓒充互涓嬫潯浠躲€傝繖浜涗骇鍝佷腑鐨勬垚鍒嗚縼绉诲埌椋熷搧涓殑閲忎笉鑳藉嵄瀹充汉浣撳仴搴凤紝鎴栬€呴€犳垚椋熷搧涓煇浜涙垚鍒嗗彂鐢熶笉鍙帴鍙楃殑鍙樺寲锛屾垨鑰呴€犳垚鎰熷畼鎬ц川鍔e彉銆?br/>浜у搧涓嶅簲閲婃斁瀵归鍝佹湁鎶楄弻浣滅敤鐨勭墿璐紝搴斿叿鏈夊悎閫傜殑寰敓鐗╁畨鍏ㄦ€э紝杩欎簺閮介渶瑕佽壇濂界殑鐢熶骇鎿嶄綔瑙勮寖鏉ヤ繚璇併€傚帹鎴跨敤绾稿拰椁愬肪绾稿簲绗﹀悎琛?/span>4鍜岃〃5涓殑瑕佹眰銆?/span>


褰撻獙璇佷骇鍝佹槸鍚︾鍚堣瀹氳姹傛椂锛屽簲閬电収璇ユ寚鍗楃 6 閮ㄥ垎涓叧浜庢祴璇曟潯浠跺拰鍒嗘瀽鏂规硶瑙勫畾鐨勫師鍒欒繘琛屻€?/span>


4.png


鍘ㄦ埧鐢ㄧ焊鍜岄宸剧焊鐢熶骇浼佷笟搴斾繚璇佷娇鐢ㄧ敓浜ц繃绋嬩骇鐢熺殑浜屽檨鑻?锛堝姘仈鑻被鍜屼簩鑻苟鍛嬪杻锛?涓哄敖閲忎綆姘村钩鐨勫師鏂欍€?/span>


鐩墠锛屽競闈笂娴侀€氱殑鐢熸椿鐢ㄧ焊澶栧寘瑁呮爣璇嗘爣娉ㄧ鍚堟娲插喅璁?
ap 锛?/span>2002锛?1[2]鐨勬儏鍐碉紝閫氬父鏄熀浜?ap锛?/span>2002锛?1 杩涜娴嬭瘯鎵€寰楃殑鍚堣妫€楠屾姤鍛婏紝涓昏杩涜浜嗛槻鑵愭晥搴斻€佷簩鑻敳閰強 4-鐢插熀浜岃嫰鐢查叜鐗瑰畾杩佺щ銆侀噸閲戝睘 锛堥搮銆侀晧銆佹睘锛夈€佷簲姘嫰閰氥€佽崸鍏夌墿璐ㄧ瓑娴嬭瘯鍙婂悎瑙勮瘎浠枫€傚叾涓噸閲戝睘 锛堥搮銆侀晧銆佹睘锛夈€佷簲姘嫰閰氭槸ap 锛?/span>2002锛?1鏉℃涓殑瑙勫畾锛屽叾浠栭」鐩槸鍏舵妧鏈枃浠剁殑鐩稿叧瑙勫畾銆傝鎸囧崡涓殑璐ㄩ噺瑕佹眰涓?/span>ap 锛?/span>2002锛?1鏉℃涓閲嶉噾灞?锛堥搮銆侀晧銆佹睘锛夈€佷簲姘嫰閰氱殑瑙勫畾涓€鑷淬€?/span>ap 锛?/span>2002锛?1鏄涓庨鍝佹帴瑙︾焊鍜岀焊鏉挎潗鏂欏拰鍒跺搧鐨勭浉鍏宠瀹氾紝鍏惰姹傛瘮鍘ㄦ埧鐢ㄧ焊鍜岄宸剧焊绛夌敓娲荤敤绾镐骇鍝佹洿楂樻洿鍏ㄩ潰銆?/span>


5.png


3 缁?璁?/span>


娆х洘娉曡鍏充簬鍘ㄦ埧鐢ㄧ焊鍜岄宸剧焊鐨勬寚鍗楄姹備繚璇佷簡鍘ㄦ埧鐢ㄧ焊鍜岄宸剧焊鐨勪娇鐢ㄥ畨鍏ㄣ€傝鎸囧崡鍦ㄥ師鏉愭枡銆佸姞宸ユ妧鏈€佷骇鍝佺殑棰勬湡鐢ㄩ€斻€佹毚闇茬殑鐜绛夋柟闈㈠仛浜嗚缁嗙殑瑙勫畾銆傛湰鏂囩潃閲嶅垎鏋愬叾瀵圭敓娲荤敤绾?gmp銆侀闄╄閬垮叧閿帶鍒剁偣绛夎姹傦紝骞跺鎴戝浗鐢熸椿鐢ㄧ焊鐢熶骇杩囩▼涓鍚堟鐩熸硶瑙?gmp 鐨勫悎瑙勭▼搴﹁繘琛屽垵姝ユ帰璁ㄣ€傚垵姝ユ帰绌剁粨鏋滆〃鏄庯紝鐩墠鎴戝浗鍥藉唴瑙勮寖鐨勭敓娲荤敤绾镐紒
涓氬熀鏈兘鍋氬埌鐢熶骇涓嶅悓闃舵鐨?
gmp 瑕佹眰銆備絾鐢变簬鐩墠鎴戝浗鍥藉唴缂轰箯閽堝鐢熸椿鐢ㄧ焊鐢熶骇鐨?gmp 瑙勫畾锛岃繕瀛樺湪鐢熸椿鐢ㄧ焊鐢熶骇棰嗗煙鐢熶骇杩囩▼涓嶈鑼冪殑鐜拌薄銆傛澶栵紝椋庨櫓鍗卞鍒嗘瀽琛ㄦ槑锛屾瘡涓敓浜ч樁娈甸兘鏈夊彲鑳戒骇鐢熷鑷翠骇鍝佽川閲忛闄╅殣鎮g殑鐢熺墿鐨勫拰/鎴栫墿鐞嗙殑鍜?/span>/鎴栧寲瀛︾殑鍗卞锛岄渶瑕佸己鍖栭闄╄閬跨殑鍏抽敭鎺у埗鐐癸紝鍔犲己棰勯槻鎺柦浠ヤ繚闅滅粓绔敓娲荤敤绾镐骇鍝佽川閲忓畨鍏ㄣ€?/span> 


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