楂樻晥閬庢烤鍣ㄧ殑閬庢烤鏁堢巼鑸囩従(xi脿n)鍫存婕忔脯瑭︾殑闂滅郴
闅ㄨ憲鏂扮増GMP鐨勯爳甯冨鏂斤紝楂樻晥閬庢烤鍣�銆侀珮婧珮鏁堥亷婵惧櫒銆佽秴楂樻晥閬庢烤鍣ㄧ殑瀹屾暣鎬ф脯瑭﹀凡缍�(j墨ng)閫愭鎺ㄥ唬鎳夌敤锛岀従(xi脿n)鍦ㄩ亷婵惧櫒鐢熺敘(ch菐n)寤犲晢鎳夌敤鏈€鐐哄唬娉涚殑鏄噰鐢�MPPS锛堟渶鏄撶┛閫忕矑寰戯級鏂规硶妾㈡脯閬庢烤鍣ㄦ晥鐜囷紝鑰屽湪閬庢烤鍣ㄥ畨瑁濈従(xi脿n)鍫翠竴鑸噰鐢�DOP娉曢€茶妾㈡脯锛屼竴鑸殑瑙€榛炴槸楂樻晥閬庢烤鍣ㄧ殑娉勬紡鐜囩瓑浜庢笡鍘婚亷婵惧櫒閬庢烤鏁堢巼锛屽叾瀵﹀叐鑰呬箣闁撳苟涓嶆槸閫欏€嬬啊鍠殑鏁�(sh霉)瀛稿叕寮�銆備笅闈㈠氨鍏╃ó鏂规硶涔嬮枔鐨勫崁(q奴)鍒ュ拰鑱�(li谩n)绯婚€茶鍒嗘瀽瑷庤珫锛�
涓€銆侀珮鏁堥亷婵惧櫒鐨勬娓垏椹楁敹鍦嬪妯欐簴
楂樻晥閬庢烤鍣ㄧ殑妾㈡脯鑸囬鏀跺湅瀹舵婧栨湁涓夊€�锛屽寘鎷€�GB\T 6165-2008楂樻晥绌烘埃閬庢烤鍣ㄦ€ц兘瀵﹂鏂规硶鐨勬晥鐜囧拰闃诲姏銆嬨€併€�GB-T 13554-2008楂樻晥绌烘埃閬庢烤鍣ㄣ€�锛屽湅澶栨婧栨湁cGMP銆佺編鍦嬬殑銆�IEST-RP-CC034銆�锛屾瓙鐩熺殑銆�EN1822銆�,銆�ISO14644-3娼斿噲瀹ゅ強鍏跺彈鎺х挵(hu谩n)澧冭▓閲忓拰娓│鏂规硶銆�锛屾瘡鍊嬫婧栦腑鎻愬嚭浜嗛珮鏁堥亷婵惧櫒鐨勬婕忔柟娉曞強椹楁敹妯欐簴鏈変笉鍚�锛屽湪cGMP鍜岀編鍦嬨€�IEST-RPCC034銆嬫婧栦腑瑕�(gu墨)瀹氶珮鏁堥亷婵惧櫒鐝�(xi脿n)鍫存婕忛€忛亷鐜�0.3渭m 锛屽厜搴﹁▓鎺冩弿鎾挎紡娉曠偤0.01%銆傛瓙鐩熺殑銆�EN1822銆嬭(gu墨)瀹氾細妾㈡紡MPPS娓│H13绱氶珮鏁堥亷婵惧櫒绺芥晥鐜囩偤99.995%锛屽眬閮ㄩ€忛亷鐜囩偤0.025%銆傛垜鍦嬪湪銆�GB 5059-2010娼斿噲瀹ゅ強椹楁敹瑕�(gu墨)鑼冿紙闄勬鏂囪鏄庯級銆嬪強銆�GB/T 13554-2008楂樻晥绌烘埃閬庢烤鍣ㄣ€嬩腑瑕�(gu墨)瀹氶珮鏁堥亷婵惧櫒娉勬紡鐜囨婧栧畾鐐哄皬浜庣瓑浜�0.01%
浜�銆侀珮鏁堥亷婵惧櫒鏁堢巼鐨勮▓绠楁柟娉�
楂樻晥閬庢烤鍣ㄩ亷婵炬晥鐜囨€ц兘瑭﹂鐨勬柟娉曚竴鑸湁閳夌劙娉�銆佹补闇ф硶鍜岃▓鏁�(sh霉)娉�銆傞毃钁楃鎶€鐨勯€叉锛屼汉鍊戠櫦(f膩)鐝�(xi脿n)鏈€瀹规槗绌块€忛亷婵惧櫒鐨勭矑瀛愬苟涓嶆槸0.3渭m 锛岃€屾槸鍦�0.1~0.2渭m 锛屾墍浠ョ従(xi脿n)鍦ㄤ竴鑸噰鐢�MPPS(鏈€鏄撶┛閫忕矑寰�)瑷堟暩(sh霉)鏂规硶锛屽嵆灏嶉亷婵惧櫒涓嬫柟閫茶鎺冩弿寰楀嚭鍚勭矑寰戜笅鐨勬晥鐜�锛岄噰鐢ㄦ渶瀹规槗绌块€忛亷婵惧櫒鐨勭矑瀛愰€茶鍒嗘瀽锛屽緱鍒伴珮鏍¢亷婵惧櫒鐨勯亷婵炬晥鐜囥€�
瑷堢畻鍏紡濡備笅锛�
A1----涓婃父姘f憾鑶犵矑瀛愶紙绮�/绔嬫柟绫筹級
A2----涓嬫父姘f憾鑶犵矑瀛愶紙绮�/绔嬫柟绫筹級
R----鐩搁棞绯绘暩(sh霉)
E----閬庢烤鍣ㄧ殑閬庢烤鏁堢巼銆�%
閫茶鎺冩弿鍚庡緱鍑洪亷婵惧櫒鍦ㄤ笉鍚岀矑寰戜笅鐨勯亷婵惧櫒鏁堢巼锛屽苟绻埗鍦栬〃濡備笅鍦�2鎵€绀猴細
寰炲湒2鍙互鐪嬪嚭锛岃┎鐗囬珮鏁堥亷婵惧櫒鐨�MPPS榛炵偤0.18渭m,瑭茬矑寰戠殑閬庢烤鏁堢巼鐐�99.992%銆�
涓夛細绺芥晥鐜囪垏灞€閮ㄦ晥鐜囩殑鍗€(q奴)鍒�
楂樻晥閬庢烤鍣ㄤ竴鑸彧妯欏畾閬庢烤鍣ㄧ殑绺芥晥鐜�锛屽閬庢烤鍣ㄩ姌鐗屼笂妯欏畾鏋滅矑姗欐晥鐜�99.97%锛屽嵆鐐鸿┎閬庢烤鍣ㄧ殑绺芥晥鐜�銆傚湒3鏄婧栥€�EN1822銆嬩腑鍒楀嚭鐨勪笉鍚岀礆鍒ラ亷婵惧櫒鐨勭附鍊艰垏灞€閮ㄥ€间箣闁撶殑鏁�(sh霉)鍊�銆傚眬閮ㄥ€兼槸鎸囧湪閬庢烤鍣ㄤ笅鏂归€茶閫愰粸鎺冩弿寰楀嚭鐨勬晥鐜�锛岀附鍊兼槸閫愰粸鎺冩弿鍚庡彇绠楄骞冲潎鍊煎緱鍒扮殑锛屽湒3涓眬閮ㄥ€肩殑鏁�(sh霉)鍊兼槸浠�MPPS锛堟渶鏄撶┛閫忕矑寰戯級閫茶瑷堟暩(sh霉)鐨勩€�
EN1822-1:1998 9/17 閬庢烤鍣ㄦ婧栬姹�
閬庢烤鍣ㄧ礆鍒�
|
绺藉€�
|
灞€閮ㄥ€�
|
鏁堢巼锛�%锛�
|
閫忛亷鐜囷紙%锛�
|
鏁堢巼锛�%锛�
|
閫忛亷鐜囷紙%锛�
|
|
H10
H11
H12
H13H
H14
U15
U16
U17
|
85
95
99.5
99.95
99.995
99.9995
99.99995
99.999995
|
15
5
0.5
0.05
0.005
0.0005
0.00005
0.000005
|
-
-
-
99.75
99.975
99.9975
99.99975
99.9999
|
-
-
-
0.25
0.025
0.0025
0.00025
0.0001
|
|
鍦�3 绺藉€艰垏灞€閮ㄥ€兼瘮杓�
寰炲湒3涓彲浠ョ湅鍑哄眬閮ㄩ€忛亷鐜囨渶澶у€煎ぇ浜庣附鏁堢巼銆備緥濡�H13鐨勯珮鏁堥亷婵惧櫒绺芥晥鐜囧叾绺芥晥鐜囩偤99.95%锛岃€屽眬閮ㄦ晥鐜囧彲浠ョ偤99.75%锛屽叾閫愰粸鎺冩弿鐨勬渶澶ч€忛亷鐜囩偤0.025%
鍥�銆佸厜瑷堝害娉曠従(xi脿n)鍫存婕忔脯瑭�
鎸夌収2011鐗�GMP瑕佹眰锛岄珮鏁堥亷婵惧櫒鎳夌稉(j墨ng)閬庡畬鏁存€ф脯瑭�?锛孎(xi脿n)鍫存娓敱浜庡彈鍒拌ō鍌欏拰寤犳埧鐨勯檺鍒�锛屼笉鑳界洿鎺ユ娓亷婵惧櫒鏁堢巼锛屼絾鍙互妾㈡脯閬庢烤鍣ㄧ殑灞€閮ㄦ硠婕忓€�锛屾噳鐢ㄦ瘮杓冨唬娉涚殑鏄厜瑷堝害娉曠殑涓€绋�锛�DOP妾㈡紡娉曞師鐞嗘槸閲囩敤鐓欓湩鐧�(f膩)鐢熷櫒鍦ㄩ亷婵惧櫒涓婃父鐧�(f膩)濉�锛屽啀浣跨敤鍏夊害瑷堟娓烤鍣ㄦ娓亷婵惧櫒涓婁笅娓告埃婧惰啝婵冨害渚嗗垽瀹氭烤鍣ㄦ槸鍚︽湁娉勬紡銆傚叾妾㈡脯鍘熺悊鍦栧涓嬶細
鍥犳棭鏈熺厵闇ч噰鐢ㄩ劙鑻簩鐢查吀浜岃緵閰紙閫氱敤鍚嶇偤di-octyl-phthalatc锛夌敤浜庢娓珮鏁堥亷婵惧櫒锛屾墍鏈夌ū鐐�DOP娉�銆傞劙鑻簩鐢查吀浜岃緵閰�锛屽彲浠ョ偤鑷寸檶鐗╄唱锛屾敼PAO锛堣仛-a-鐑兇锛夌墿璩€茶鐧�(f膩)鐓�銆傜櫦(f膩)鐓欐柟娉曠偤鐔辩櫦(f膩)鐓欏拰鍐风櫦(f膩)鐓欏叐绋紝鐔辩櫦(f膩)鐓欐槸鍒╃敤钂哥櫦(f膩)鍐峰嚌鐨勫師鐞�锛岃闇у寲鐨勬埃婧惰啝绮掑瓙鐢ㄥ姞鐔卞櫒钂哥櫦(f膩)锛屽苟鍦ㄧ壒瀹氭浠朵笅鍐峰嚌鎴愬井灏忔恫婊�锛岀啽鐧�(f膩)鐓欐瘮杓冪┅(w臎n)瀹�锛岀厵闇х洿寰戜竴鑸湪0.3渭m宸﹀彸銆傚喎鐧�(f膩)鐓欐槸鎸囧绺┖姘e湪娑查珨涓紦姘f场锛岀稉(j墨ng)鍣寸椋涙亢鐢�(ch菐n)鐢熺墿鎱�(t脿i)鐨勫鍒嗘暎鐩告埃婧惰啝锛屽垎甯冭唱閲忎腑寰戝湪0.65渭m宸﹀彸銆�
鐝�(xi脿n)鍦ㄥ皪閬庢烤鍣ㄩ€茶鎺冩弿妾㈡紡鏅�锛岀稉(j墨ng)甯告槸浣跨敤鍐风櫦(f膩)鐓欐柟娉曪紝鐧�(f膩)鐓欐績搴﹀湪GB/T13554-2008涓偤10-20渭g/1,鑰屽湪銆�GB50591-2010娼斿噲瀹ゆ柦宸ュ強椹楁敹瑕�(gu墨)鑼冦€嬭姹傛績搴︾偤20鈥�80渭g/1銆傛婕忓剙鍣ㄤ竴鑸噰鐢ㄧ編鍦�ATI鐢熺敘(ch菐n)鐨勬娓剙閫茶妾㈡脯锛屾娓剙鍣ㄤ竴鑸偤姘f憾鑶犲厜搴﹁▓锛屼富瑕佹槸妾㈡脯閬庢烤鍚庣矑瀛愮殑閲嶉噺銆傚湪鍏╁€嬪湅妯欓悩閮芥彁鍑洪€忛亷鐜囧ぇ浜�0.01%鍗宠獚鐐烘槸婊叉紡銆�
绺戒箣锛屽緸浠ヤ笂鎻忚堪鍙互鐪嬪嚭锛岀従(xi脿n)鍫存娓垏鐝�(xi脿n)鍫存娓噰鐢ㄧ殑DOP娉曞叾瀵︽槸灏嶉亷婵惧櫒鐨勪笅鏂归€茶閫愰粸鎺冩弿锛屾娓殑鏄亷婵惧櫒鐨勫眬閮ㄦ晥鐜�锛岃€屾巸鎻忕殑绮掑緫鐐�0.3渭m锛涙瓙娲叉婧栥€�EN1822銆嬩腑鎻愬嚭鐨勫眬閮ㄩ€忛亷鐜囩偤MPPS榛炰笅鐨勫眬閮ㄩ€忛亷鐜囷紝閫氬父MPPS榛炲湪0.1-0.2渭m锛屽鏋�MPPS榛炵殑灞€閮ㄦ晥鐜囪秺楂�锛岄偅涔堝湪0.3渭m涓嬬殑灞€閮ㄦ晥鐜囦篃灏辫秺楂�銆備緥濡傞噰鐢�H13绱氬垾鐨勯珮鏁堥亷婵惧櫒锛屽緸鍦�3涓緱鍒扮附鏁堢巼鐐�99.95%锛屽叾MPPS灞€閮ㄩ€忛亷鐜囦縿鏃�0.25%锛屽鏋滈噰鐢ㄨ搵绱氬垾閬庢烤鍣ㄩ€茶DOP娉曠従(xi脿n)鍫存婕忔脯瑭﹀皣鏈冨嚭鐝�(xi脿n)娉勬紡鍊间竴瀹氭渻灏忎簬0.25%锛屼絾涓嶈兘淇濊瓑鑳介仈鍒�0.01%锛屽皪浜�H14绱氶珮鏁堥亷婵惧櫒锛屽叾绺芥晥鐜囩偤99.95%锛�MPPS灞€閮ㄩ€忛亷鐜囩偤0.025%锛岄€茶DOP鐝�(xi脿n)鍫存婕忔脯瑭﹀叾娉勬紡鍊兼墠鍙兘鏈冨皬浜�0.01%銆�
鍏嶈铂鑱叉槑锛� 鏈枃鍍呬唬琛ㄤ綔鑰呭€嬩汉瑙€榛�锛岃垏 缍犺壊绡€(ji茅)鑳界挵(hu谩n)淇濈恫(w菐ng) 鐒¢棞銆傚叾鍘熷壍(chu脿ng)鎬т互鍙婃枃涓櫝杩版枃瀛楀拰鍏�(n猫i)瀹规湭缍�(j墨ng)鏈珯璀夊锛� 灏嶆湰鏂囦互鍙婂叾涓叏閮ㄦ垨鑰呴儴鍒嗗収(n猫i)瀹广€佹枃瀛楃殑鐪熷鎬�銆佸畬鏁存€с€佸強鏅傛€ф湰绔欎笉浣滀换浣曚繚璀夋垨鎵胯锛岃珛璁€鑰呭儏 浣滃弮鑰�锛屽苟璜嬭嚜琛屾牳瀵︾浉闂滃収(n猫i)瀹广€�