绗竴绔?/p>
鑽搧璐ㄩ噺鐮旂┒鐨勫唴瀹逛笌鑽吀姒傚喌
(
鍚华璁?/p>
)
涓�銆佸～绌洪
1
锛?/p>
涓浗鑽吀鐨勪富瑕佸唴瀹圭敱
鍑′緥銆?/p>
_
姝ｆ枃
銆侀檮褰?/p>
銆佸紩绱?/p>
鍥涢儴鍒嗙粍鎴愩�?/p>
2
锛?/p>
鐩墠鍏鐨勫叏闈㈡帶鍒惰嵂鍝佽川閲忕殑娉曡鏈?/p>
GLP
銆?/p>
GMP
銆?/p>
GSP
銆?/p>
GCP
銆?/p>
3
锛?/p>
鈥滅簿瀵嗙О瀹氣�濈郴鎸囩О鍙栭噸閲忓簲鍑嗙‘鑷虫墍鍙栭噸閲忕殑
鍗冨垎涔嬩竴
锛?/p>
鈥滅О瀹氣�濈郴鎸囩О鍙栭噸閲忓簲鍑嗙‘鑷虫墍鍙栭噸閲忕殑
鐧惧垎涔嬩竴
锛涘彇鐢ㄩ噺涓衡�滅害鈥?/p>
鑻ュ共鏃讹紝绯绘寚鍙栫敤閲忎笉寰楄秴杩囪瀹氶噺鐨?/p>
卤
10%
銆?/p>
4
锛?/p>
鑽墿鍒嗘瀽涓昏鏄噰鐢?/p>
鍖栧
鎴?/p>
鐗╃悊鍖栧
銆佺敓鐗╁寲瀛︾瓑鏂规硶鍜屾妧鏈紝鐮旂┒鍖栧缁撴瀯宸茬煡鐨勫悎鎴愯嵂鐗╁拰澶╃劧鑽墿鍙婂叾鍒跺墏鐨勭粍鎴愩�?/p>
鐞嗗寲鎬ц川銆佺湡浼壌鍒�佺函搴︽鏌ヤ互鍙婃湁鏁堟垚鍒嗙殑鍚噺娴嬪畾绛夈�傛墍浠ワ紝鑽墿鍒嗘瀽鏄竴闂?/p>
鐮旂┒涓庡彂灞曡嵂鍝佽川閲忔帶鍒?/p>
鐨勬柟娉曟�у绉戙�?/p>
5
锛?/p>
鍒ゆ柇涓�涓嵂鐗╄川閲忔槸鍚︾鍚堣姹傦紝蹇呴』鍏ㄩ潰鑰冭檻涓夎�?/p>
_
閴村埆銆佹鏌ャ�佸惈閲忔祴瀹?/p>
_
鐨勬楠岀粨鏋溿�?/p>
6
锛?/p>
鑽墿鍒嗘瀽鐨勫熀鏈换鍔℃槸妫�楠岃嵂鍝佽川閲忥紝淇濋殰浜烘皯鐢ㄨ嵂
_
鍚堢悊銆佹湁鏁堛�?/p>
瀹夊叏
_
銆佺殑閲嶈鏂归潰銆?/p>
浜屻�侀�夋嫨棰?/p>
1
锛?/p>
銆婁腑鍥借嵂鍏搞�嬩粠鍝勾鐨勭増鏈紑濮嬪垎涓轰笁閮紝绗笁閮ㄦ敹杞界敓鐗╁埗鍝侊紝棣栨灏?/p>
(
鐢熺墿鍒跺搧瑙勭▼
)
骞跺叆鑽吀
(A)1990
鐗?/p>
(B)1995
鐗?/p>
(C)2000
鐗?/p>
(D)2005
鐗?/p>
(E)2010
鐗?/p>
2
锛?/p>
ICH
锛?/p>
浜虹敤鑽搧娉ㄥ唽鎶�鏈姹傚浗闄呭崗璋冧細
锛夋湁鍏宠嵂鍝佽川閲忕殑鎶�鏈姹傛枃浠剁殑鏍囪瘑浠ｇ爜鏄?/p>
()
(A)E
锛堣嵂鍝佹湁鏁堟�х殑鎶�鏈姹傦級
(B)M
锛堣嵂鍝佺殑缁煎悎鎶�鏈姹傦級
(C)P
(D)Q
(E)S
锛堣嵂鍝佸畨鍏ㄦ�х殑鎶�鏈姹傦級
3
锛?/p>
銆婅嵂鍝佷复搴婅瘯楠岃川閲忕鐞嗚鑼冦�嬪彲鐢?/p>
()
琛ㄧず銆?/p>
(A)GMP
锛堣嵂鍝佺敓浜ц川閲忕鐞嗚鑼冿級
(B)GSP
锛堣嵂鍝佺粡钀ヨ川閲忕鐞嗚鑼冿級
(C)GLP
锛堣嵂鍝侀潪涓村簥鐮旂┒璐ㄩ噺绠＄悊瑙勮寖锛?/p>
(D)GAP
锛堜腑鑽?/p>
鏉愮敓浜ц川閲忕鐞嗚鑼冿紙璇曡锛?/p>
锛?/p>
(E)GCP
4
锛?/p>
鐩墠锛?/p>
銆婁腑鍗庝汉姘戝叡鍜屽浗鑽吀銆嬬殑鏈�鏂扮増涓?/p>
()
(A)2000
骞寸増
(B)2003
骞寸増
(C)2010
骞寸増
(D)2007
骞寸増
(E)2009
骞寸増
5
锛?/p>
鑻卞浗鑽吀鐨勭缉鍐欑鍙蜂负
()
銆?/p>
(A)GMP
(B)BP
(C)GLP (D)RP
锛?/p>
HPLC (E)TLC
6
锛?/p>
缇庡浗鍥藉澶勬柟闆嗙殑缂╁啓绗﹀彿涓?/p>
()
銆?/p>
(A)WHO (B)GMP (C)INN
(D)NF
(E)USP
7
锛?/p>
GMP
鏄寚
()
(A)
鑽搧闈炰复搴婄爺绌惰川閲忕鐞嗚鑼?/p>
(
B)
鑽搧鐢熶骇璐ㄩ噺绠＄悊瑙勮寖
(C)
鑽搧缁忚惀璐ㄩ噺绠＄悊瑙勮寖
(D)
鑽搧涓村簥璇曢獙璐ㄩ噺绠＄悊瑙勮寖
(E)
鍒嗘瀽璐ㄩ噺绠＄悊
8
锛?/p>
鏍规嵁鑽搧璐ㄩ噺鏍囧噯瑙勫畾锛岃瘎浠蜂竴涓嵂鍝佺殑璐ㄩ噺閲囩敤
()
(A)
閴村埆锛屾鏌ワ紝璐ㄩ噺娴嬪畾
(B)
鐢熺墿鍒╃敤搴?/p>
(C)
鐗╃悊鎬ц川
(D)
鑽悊浣滅敤
涓夈�侀棶绛旈
1
锛?/p>
鑽搧鐨勬蹇碉紵瀵硅嵂鍝佺殑杩涜璐ㄩ噺鎺у埗鐨勬剰涔夛紵
绛?/p>
: 1)
鑽搧鏄寚鐢ㄤ簬棰勯槻銆佹不鐤椼�佽瘖鏂汉鐨勭柧鐥咃紝鏈夌洰鐨勫湴璋冭妭浜虹殑鐢熺悊鏈鸿兘骞惰瀹氭湁閫傚簲璇佹垨鑰呭姛鑳戒富娌汇�佺敤娉曠敤閲忕殑鐗╄川锛屾槸骞垮ぇ浜?/p>
姘戠兢浼楅槻鐥呮不鐥呫�佷繚鎶ゅ仴搴峰繀涓嶅彲灏戠殑鐗规畩鍟嗗搧銆傜敤浜庨闃叉不鐤楄瘖鏂汉鐨勭柧鐥呯殑鐗规畩鍟嗗搧銆?/p>
2)
瀵硅嵂鍝佺殑杩涜璐ㄩ噺鎺у埗鐨勬剰涔夛細淇濊瘉鑽搧璐?/p>
閲忥紝淇濋殰浜烘皯鐢ㄨ嵂鐨勫畨鍏ㄣ�佹湁鏁堝拰缁存姢浜烘皯韬綋鍋ュ悍
2
锛?/p>
鑽墿鍒嗘瀽鍦ㄨ嵂鍝佺殑璐ㄩ噺鎺у埗涓媴浠荤潃涓昏鐨勪换鍔℃槸浠�涔堬紵
绛?/p>
:
淇濊瘉浜轰滑鐢ㄨ嵂瀹夊叏銆佸悎鐞嗐�佹湁鏁堬紝瀹屾垚鑽搧璐ㄩ噺鐩戠潱宸ヤ綔銆?/p>
3
锛?/p>
甯歌鐨勮嵂鍝佹爣鍑嗕富瑕佹湁鍝簺锛屽悇鏈変綍鐗圭偣锛?/p>
绛?/p>
:
鍥藉鑽搧鏍囧噯
(
鑽吀
)
锛涗复搴婄爺绌剁敤鑽川閲忔爣鍑嗭紱鏆傝鎴栬瘯琛岃嵂鍝佹爣鍑嗭紱浼佷笟鏍囧噯銆?/p>
4
锛?/p>
涓浗鑽吀
(2005
骞寸増
)
鏄�庢牱缂栨帓鐨勶紵
绛?/p>
:
鍑′緥銆佹鏂囥�侀檮褰曘�佺储寮曘�?/p>
5
锛?/p>
浠�涔堝彨鎭掗噸锛?/p>
浠�涔堝彨绌虹櫧璇曢獙锛?/p>
浠�涔堝彨鏍囧噯鍝併�?/p>
瀵圭収鍝侊紵
绛?/p>
:
鎭掗噸鏄緵璇曞搧杩炵画涓ゆ骞茬嚗鎴栫伡鐑у悗鐨勯噸閲忓樊寮傚湪
0.3mg
浠ヤ笅鐨勯噸閲忥紱
绌虹櫧璇曢獙鏄笉鍔犱緵璇曞搧鎴栦互绛夐噺婧跺墏浠ｆ浛渚涜瘯娑茬殑鎯呭喌涓嬶紝鍚屾硶鎿嶄綔鎵�寰楃殑缁撴灉锛涙爣鍑嗗搧銆佸鐓у搧鏄敤浜庨壌鍒�佹鏌ャ�佸惈閲忔祴瀹氱殑鐗╄川銆?/p>
6
锛?/p>
甯哥敤鐨勮嵂鐗╁垎鏋愭柟娉曟湁鍝簺锛?/p>
绛?/p>
:
鐗╃悊鐨勬柟娉曘�佸寲瀛︾殑鏂规硶銆?/p>
7
锛?/p>
鑽搧妫�楠屽伐浣滅殑鍩烘湰绋嬪簭鏄粈涔?/p>
?
绛?/p>
:
鍙栨牱銆佹楠?/p>
(
閴村埆銆佹鏌ャ�佸惈閲忔祴瀹?/p>
)
銆佽褰曞拰鎶ュ憡銆?/p>
8
锛?/p>
涓浗鑽吀鍜屽浗澶栧父鐢ㄨ嵂鍏哥殑鐜拌鐗堟湰鍙婅嫳鏂囩缉鍐欏垎鍒槸浠�涔堬紵
绛?/p>
:
涓崕浜烘皯鍏卞拰鍥借嵂鍏革細
Ch.P
銆佹棩鏈嵂灞�鏂?/p>
:JP
銆佽嫳鍥借嵂鍏?/p>
:BP
銆佺編鍥?/p>
鑽吀
:USP
銆佹娲茶嵂鍏?/p>
:Ph.Eur
銆佸浗闄呰嵂鍏革細
Ph.Int