鈥斺�斺�斺�斺�斺�斺�斺�斺�斺�?/p>
鏂囦欢绫诲埆锛氭妧鏈爣鍑?/p>
1/12
鏂囦欢鍚嶇О
娈嬬暀婧跺墏娴嬪畾娉?/p>
(
鍥涢儴
)
妫�楠屾爣鍑嗘搷浣滆绋?/p>
鏂囦欢缂栧彿锛?/p>
09T-I626-01
璧疯崏浜?/p>
瀹℃牳浜?/p>
鎵瑰噯浜?/p>
鏃ユ湡锛?/p>
鏃ユ湡锛?/p>
鏃ユ湡锛?/p>
棰佸彂閮ㄩ棬锛氳川閲忕鐞嗛儴
鐢熸晥鏃ユ湡锛?/p>
鍒嗗彂閮ㄩ棬锛氳川閲忔帶鍒剁
1.
鐩殑锛?/p>
寤虹珛娈嬬暀婧跺墏娴嬪畾娉?/p>
(
浜岄儴
)
妫�楠屾爣鍑嗘搷浣滆绋嬶紝骞舵寜瑙勭▼杩涜妫�楠岋紝
淇濊瘉妫�楠屾搷浣滆鑼冨寲銆?/p>
2.
渚濇嵁锛?/p>
2.1.
銆婁腑鍗庝汉姘戝叡鍜屽浗鑽吀銆?/p>
2010
骞寸増浜岄儴銆?/p>
3.
鑼冨洿
锛氶�傜敤浜庢墍鏈夌敤娈嬬暀婧跺墏娴嬪畾娉?/p>
(
浜岄儴
)
娴嬪畾鐨勪緵璇曞搧銆?/p>
4.
璐ｄ换
锛氭楠屽憳銆佽川閲忔帶鍒剁涓讳换銆佽川閲忕鐞嗛儴缁忕悊瀵规湰瑙勭▼璐熻矗銆?/p>
5.
姝ｆ枃锛?/p>
5.1.
鑽搧涓殑娈嬬暀婧跺墏绯绘寚鍦ㄥ師鏂欒嵂鎴栬緟鏂欑殑鐢熶骇涓紝
浠ュ強鍦ㄥ埗鍓傚埗澶囪繃绋嬩腑浣?/p>
鐢ㄧ殑锛?/p>
浣嗗湪宸ヨ壓杩囩▼涓湭鑳藉畬鍏ㄥ幓闄ょ殑鏈夋満婧跺墏銆?/p>
鑽搧涓父瑙佺殑娈嬬暀婧跺墏鍙婇檺搴?/p>
瑙侀檮琛?/p>
1
锛岄櫎鍙︽湁瑙勫畾澶栵紝绗竴銆佺浜屻�佺涓夌被婧跺墏鐨勬畫鐣欓檺搴﹀簲绗﹀悎琛?/p>
1
涓殑
瑙勫畾锛涘鍏朵粬婧跺墏锛屽簲鏍规嵁鐢熶骇宸ヨ壓鐨勭壒鐐癸紝鍒跺畾鐩稿簲鐨勯檺搴︼紝浣垮叾绗﹀悎浜у搧瑙?/p>
鑼冦�佽嵂鍝佺敓浜ц川閲忕鐞嗚鑼冿紙
GMP
锛夋垨鍏朵粬鍩烘湰鐨勮川閲忚姹傘�?/p>
5.2.
鏈硶鐓ф皵鐩歌壊璋辨硶锛堥檮褰曗叅
锛ワ級娴嬪畾銆?/p>
5.3.
鑹茶氨鏌?/p>
5.3.1.
姣涚粏绠℃煴锛氶櫎鍙︽湁瑙勫畾澶栵紝鏋佹�х浉杩戠殑鍚岀被鑹茶氨鏌变箣闂村彲浠ヤ簰鎹娇鐢ㄣ�?/p>
5.3.1.1.
闈炴瀬鎬ц壊璋辨煴锛氬浐瀹氭恫涓?/p>
100%
鐨勪簩鐢插熀鑱氱姘х兎鐨勬瘺缁嗙鏌便�?/p>
5.3.1.2.
鏋佹�ц壊璋辨煴锛氬浐瀹氭恫涓鸿仛涔欎簩閱囷紙
PEG-20M
锛夌殑姣涚粏绠℃煴銆?/p>
5.3.1.3.
涓�ц壊璋辨煴锛氬浐瀹氭恫涓猴紙
35%
锛変簩鑻熀
-
锛?/p>
65%
锛夌敳鍩鸿仛纭呮哀鐑枫�侊紙
50%
锛?/p>
浜岃嫰鍩?/p>
-
锛?/p>
50%
锛?/p>
浜岀敳鍩鸿仛纭呮哀鐑枫�?/p>
锛?/p>
35%
锛?/p>
浜岃嫰鍩?/p>
-
锛?/p>
65%
锛?/p>
浜岀敳鍩鸿仛纭呮哀鐑枫�?/p>
锛?/p>
14%
锛?/p>
姘颁笝鍩鸿嫰鍩?/p>
-
锛?/p>
86%
锛変簩鐢插熀鑱氱姘х兎銆?/p>
锛?/p>
6%
锛夋鞍涓欏熀鑻熀
-
锛?/p>
94%
锛変簩鐢插熀鑱氱姘?/p>
鐑风殑姣涚粏绠℃煴绛夈�?/p>
5.3.1.4.
寮辨瀬鎬ц壊璋憋細鏌卞浐瀹氭恫涓猴紙
5%
锛夎嫰鍩?/p>
-
锛?/p>
95%
锛夌敳鍩鸿仛纭呮哀鐑枫�侊紙
5%
锛?/p>
浜岃嫰鍩?/p>
-
锛?/p>
95%
锛変簩鐢插熀纭呮哀鐑风殑姣涚粏绠℃煴绛夈�?/p>