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8銆佸埗鑽敤姘寸殑杈撻€?
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5銆佹煇浜涘彲縐誨姩鐨勮澶囧彲縐誨埌娓呮礂鍖鴻繘琛屾竻媧椼€佹秷姣掑拰鐏弻銆?
6銆佸悓涓€璁懼榪炵畫鍔犲伐鍚屼竴鏃犺弻浜у搧鏃訛紝姣忔壒涔嬮棿瑕佹竻媧楃伃鑿?鍚屼竴璁懼鍔犲伐鍚屼竴闈炵伃鑿屼駭鍝佹椂錛岃嚦灝戞瘡鍛ㄦ垨姣忕敓浜т笁鎵瑰悗榪涜鍏ㄩ潰鐨勬竻媧椼€傜函鍖栨按姘磋川鏍囧噯鐢?shù)闃荤巼锛?xì)鈮?.5M惟.CM錛岀數(shù)瀵肩巼錛氣墹2渭S 姘ㄢ墹0.3渭g/ml 紜濋吀鐩愨墹0.06渭g/ml 閲嶉噾灞炩墹0.5渭g/ml
鍥涖€佸埗鑽敤姘村垎綾誨強(qiáng)姘磋川鏍囧噯錛?
1銆佸埗鑽敤姘村垎綾? (宸ヨ壓鐢ㄦ按錛氳嵂鍝佺敓浜у伐鑹轟腑浣跨敤鐨勬按錛屽寘鎷ギ鐢ㄦ按銆佺函鍖栨按銆佹敞灝勭敤姘?
(1錛夐ギ鐢ㄦ按錛圥otable-Water錛夛細(xì)閫氬父涓鴻嚜鏉ユ按鍏徃渚涘簲鐨勮嚜鏉ユ按鎴栨繁浜曟按錛屽張縐板師姘達(dá)紝鍏惰川閲忓繀欏葷鍚堝浗瀹舵爣鍑咷B5749-85<鐢熸椿楗敤姘村崼鐢熸爣鍑嗐€嬨€傛寜2005涓浗鑽吀瑙勫畾錛岄ギ鐢ㄦ按涓嶈兘鐩存帴鐢ㄤ綔鍒跺墏鐨勫埗澶囨垨璇曢獙鐢ㄦ按銆?
(2錛夌函鍖栨按錛圥urified Water錛夛細(xì)涓哄師姘寸粡钂擱娉曘€佺瀛愪氦鎹㈡硶銆佸弽娓楅€忔硶鎴栧叾浠栭€傚疁鐨勬柟娉曞埗寰楃殑鍒惰嵂鐢ㄧ殑姘淬€佷笉鍚換浣曢檮鍔犲墏銆傜函鍖栨按鍙綔涓洪厤鍒舵櫘閫氳嵂鐗╁埗鍓傜殑婧跺墏鎴栬瘯楠岀敤姘達(dá)紝涓嶅緱鐢ㄤ簬娉ㄥ皠鍓傜殑閰嶅埗閲囩敤紱誨瓙浜ゆ崲娉曘€佸弽娓楅€忔硶銆佽秴婊ゆ硶絳夐潪鐑鐞嗗埗澶囩殑綰寲姘翠竴鑸張縐板幓紱誨瓙姘淬€? 閲囩敤鐗規(guī)畩璁捐鐨勮捀棣忓櫒鐢ㄨ捀棣忔硶鍒跺鐨勭函鍖栨按涓€鑸張縐拌捀棣忔按銆?
(3錛夋敞灝勭敤姘達(dá)紙Water for Injection錛夛細(xì)鏄互綰寲姘翠綔涓哄師姘達(dá)紝緇忕壒孌婅璁＄殑钂擱鍣ㄨ捀棣忥紝鍐峰嚌鍐峰嵈鍚庣粡鑶滆繃婊ゅ埗澶囪€屽緱鐨勬按銆傛敞灝勭敤姘村彲浣滀負(fù)閰嶅埗娉ㄥ皠鍓傜敤鐨勬憾鍓傘€?
(4錛夌伃鑿屾敞灝勭敤姘達(dá)紙Sterile Water for Injection錛夛細(xì)涓烘敞灝勭敤姘翠緷鐓ф敞灝勫墏鐢熶駭宸ヨ壓鍒跺鎵€寰楃殑姘淬€傜伃鑿屾敞灝勭敤姘寸敤浜庣伃鑿岀矇鏈殑婧跺墏鎴栨敞**鐨勭█閲婂墏銆?
2銆佸埗鑽敤姘寸殑姘磋川鏍囧噯
(1錛夐ギ鐢ㄦ按錛氬簲絎﹀悎涓崕浜烘皯鍏卞拰鍥藉浗瀹舵爣鍑?lt;鐢熸椿楗敤姘村崼鐢熸爣鍑嗐€嬶紙GB5749-85錛?
(2錛夌函鍖栨按錛氬簲絎﹀悎<2010涓浗鑽吀銆嬫墍鏀惰澆鐨勭函鍖栨按鏍囧噯銆? 鍦ㄥ埗姘村伐鑹轟腑閫氬父閲囩敤鍦ㄧ嚎媯€(gè)嫻嬬函鍖栨按鐨勭數(shù)闃葷巼鍊肩殑澶у皬錛屾潵鍙嶆槧姘翠腑鍚勭紱誨瓙鐨勬祿搴︺€傚埗鑽涓氱殑綰寲姘寸殑鐢?shù)闃荤巼閫氬父搴斺墺0.5M惟.CM/25鈩?瀵逛簬娉ㄥ皠鍓傘€佹淮鐪兼恫瀹瑰櫒鍐叉礂鐢ㄧ殑綰寲姘寸殑鐢?shù)闃荤巼搴斺?M惟.CM/25鈩冦€?
(3錛夋敞灝勭敤姘達(dá)細(xì)搴旂鍚?005涓浗鑽吀鎵€鏀惰澆鐨勬敞灝勭敤姘存爣鍑嗐€?br /> 綰寲姘磋澶囦腑棰勫鐞嗗繀瑕佹€у強(qiáng)鏂規(guī)硶
涓€銆佺函鍖栨按璁懼鍘熸按澶勭悊鐨勫繀瑕佹€?br /> 鏃犺鏄洿鎺ラ噰鐢ㄧ瀛愪氦鎹㈢郴緇熸垨鑰呭厛鐢ㄧ數(shù)娓楁瀽娉?EDI)錛屽啀鍔犱笂鍙嶆笚閫忕殑緋葷粺錛屾櫘閫氱殑鑷潵姘淬€佸湴涓嬫按鎴栧伐涓氱敤姘村線寰€閮戒笉鑳藉婊¤凍紱誨瓙浜ゆ崲鏍?wèi)鑴傛垨鍙嶆笚閫忚啘瀵圭幏姹＄墿璐ㄧ殑榪涙按瑕佹眰銆傛簮姘村彧鏈夌粡榪囬€傚綋鐨勯澶勭悊鍚庯紝鏂硅兘婊¤凍鍚庨亾鍒舵按鍒跺緋葷粺瀵硅繘姘寸殑姘磋川瑕佹眰銆?br /> 浜屻€佺函鍖栨按璁懼涓父鐢ㄥ師姘撮澶勭悊鏂規(guī)硶
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