璨蜂綆婧亽婧亽婵曡│椹�(y脿n)绠辫獚(r猫n)婧�(zh菙n)鍓�(chu脿ng)娓鎶€
绶婇毃甯傚牬闇€姹傚苟绲�(ji茅)鍚堢溇澶氬悓椤炵敘(ch菐n)鍝佺壒榛�(di菐n)锛屽壍(chu脿ng)娓鎶€鏀归潻鍓�(chu脿ng)鏂帮紝鐧�(f膩)灞曠鍚堝競鍫撮渶姹傜殑鐢�(ch菐n)鍝併€傜稉(j墨ng)閵风殑浣庢韩鎭掓韩鎭掓繒瑭﹂(y脿n)绠辫嚜鎶曟斁甯傚牬浠ヤ締锛岀敘(ch菐n)閵烽噺骞村勾鏀€鍗囷紝娣卞彈寤ｅぇ闇€姹傜兢楂旂殑濂借⿻鑸囦俊璩淬€傞噸鎱跺壍(chu脿ng)娓鎶€鏈夐檺鍏徃绉夎憲鈥滆拷姹傗€濆拰鈥滅敤鎴惰嚦涓娾€濈殑缍�(j墨ng)鐕熺悊蹇碉紝绔獱鐐哄鎴舵彁渚涘劒(y艒u)鐣扮殑鐢�(ch菐n)鍝佸拰鏈嶅嫏(w霉)銆�
浣庢韩鎭掓韩鎭掓繒瑭﹂(y脿n)绠�鏄弮鐓� 銆奊B10586-2006婵曠啽绠辨妧琛�(sh霉)姊濅欢銆嬪埗閫犮€傜壒鍒ラ仼鐢ㄤ簬浣庢韩浣庢繒鐨勭壒娈婅│椹�(y脿n)姊濅欢锛屽悓鏅�(sh铆)涔熸豢瓒矴MP,FDA,ICH鍘熷墖涓(gu墨)瀹氱殑鎶€琛�(sh霉)姊濅欢锛屾豢瓒冲ぇ杓告恫绛夌壒娈婅棩椤炵殑 40.0鈩�,20.0%R.H锛�25.0鈩�,40.0%R.H锛�5.0鈩�,40%R.H, 10.0鈩�,60%R.H绛変綆婵曞害鐨勮│椹�(y脿n)姊濅欢銆� 闄や簡浣庢韩鎭掓韩鎭掓繒瑭﹂(y脿n)绠�锛屾垜鍊戠殑鐢�(ch菐n)鍝侀倓鏈夐珮婧│椹�(y脿n)绠憋紝楂樹綆婧│椹�(y脿n)绠憋紝婧繒搴﹁│椹�(y脿n)绠憋紝婧害娌栨搳瑭﹂(y脿n)绠憋紝婧害蹇畩瑭﹂(y脿n)绠憋紝婧繒搴︿氦璁婅│椹�(y脿n)绠憋紝楣介湩瑭﹂(y脿n)绠憋紝姘欑噲姘ｅ€欑绛夈€� 鐢�(ch菐n)鍝佹秹鍙婂埌鐢熺墿锛岄啱(y墨)钘ワ紝鍖栧伐锛岄浕瀛愶紝姗�(j墨)姊帮紝鍏靛伐鍙婅埅绌鸿埅澶╃瓑闋�(l菒ng)鍩熴€傜敘(ch菐n)鍝佹豢瓒冲悇椤炶妤�(y猫)鐨勭挵(hu谩n)澧冭│椹�(y脿n)鑸囧彲闈犳€ц│椹�(y脿n)妯�(bi膩o)婧�(zh菙n)浠ュ強鐩搁棞(gu膩n)鐨勬(bi膩o)婧�(zh菙n)鍜岃妤�(y猫)妯�(bi膩o)婧�(zh菙n)銆侴B銆丟JB銆丼AE銆両SO銆丄STM銆両EC銆丏IN绛夈€� 鎴戝€戞湁钁楀骞村緸浜嬬挵(hu谩n)澧冨(sh铆)椹�(y脿n)瑷�(sh猫)鍌欑殑缍�(j墨ng)椹�(y脿n)锛屽€熼憭骞跺惛鏀跺湅鍏�(n猫i)澶栫挵(hu谩n)澧冭│椹�(y脿n)瑷�(sh猫)鍌欏粻瀹剁殑鎶€琛�(sh霉)锛屽厠鏈嶅湪琛屾キ(y猫)涓亣鍒扮殑闆ｉ粸(di菐n)锛屽姏鐖湪鍦嬪収(n猫i)鍒堕€犲嚭绌�(w臎n)瀹氬彲闈狅紝鐠�(hu谩n)淇濈瘈(ji茅)鑳斤紝鎬у児(ji脿)姣旈珮鐨勭悊鎯崇挵(hu谩n)澧冨(sh铆)椹�(y脿n)瑷�(sh猫)鍌欍€�
瀹㈡埗婊挎剰鏄垜鍊戜笉鎳堢殑杩芥眰銆傜偤鐢�(ch菐n)鍝佽兘澶犲畨鍏ㄥ揩鎹风殑閫侀仈(d谩)鍒板鎴舵墜涓婏紝鍓�(chu脿ng)娓鎶€閲囩敤闄搁亱(y霉n);鍏矾閬�(y霉n)杓�?sh霉)纭粸缍栨ň鏋ㄧ瑫鍚巜閫�(j矛n)琛屼綆婧亽婧亽婵曡│椹�(y脿n)绠辩殑閰嶉€侊紝閬�(y霉n)璨�(f猫i)璨疯常闆欐柟鍗�(xi茅)鍟嗭紝瀹㈡埗涔熷彲閫氶亷鐝�(xi脿n)閲戞敮浠�;閵€琛岃綁(zhu菐n)璩殑鏂瑰紡鏀粯璨ㄦ銆傛垜鍙告啈鍊熸垚鐔熺殑鐮旂櫦(f膩)鎶€琛�(sh霉)銆佸劒(y艒u)鐣扮殑鐢�(ch菐n)鍝併€佸畬鍠勭殑鏈嶅嫏(w霉)鐐洪渶姹傜兢楂旀彁渚涘叿鏈夊児(ji脿)鍊肩殑渚涙噳(y墨ng)骞宠嚭锛屼互淇濋殰瀹㈡埗鐨勯渶姹傘€�
鍓�(chu脿ng)娓鎶€鏄泦鐢熺敘(ch菐n)銆佽部(m脿o)鏄撲簬涓€楂旂殑澶氱ó缍�(j墨ng)鐕熺稉(j墨ng)婵�(j矛)瀵�(sh铆)楂旓紝鎶€琛�(sh霉)鎴愮啛銆佽ō(sh猫)鍌欓綂鍏ㄣ€佸(sh铆)鍔涢泟鍘氥€傚叕鍙镐互鏁堢巼楂樸€佷俊璀�(y霉)濂戒絿绔嬪湪妾㈡脯瑷�(sh猫)鍌欏競鍫寸稉(j墨ng)婵�(j矛)澶ф疆涓€傚叕鍙歌睛瀵�(sh铆)浜嬨€佹眰瀵�(sh铆)鏁堬紝鍓�(chu脿ng)鑹ソ鏈嶅嫏(w霉)锛屾ü浼佹キ(y猫)褰㈣薄銆傜敓鐢�(ch菐n)閵峰敭鐨勪綆婧亽婧亽婵曡│椹�(y脿n)绠卞搧璩�(zh矛)鍎�(y艒u)鑹紝缍�(j墨ng)涔呰€愮敤锛屼富瑕佺敤浜庣挵(hu谩n)澧冪敓鐢�(ch菐n)鑸囧彲闈犳€ц│椹�(y脿n)銆�
鍏徃绔嬪織鈥滄ü鑹ソ浼佹キ(y猫)褰㈣薄锛屽壍(chu脿ng)鍝佽唱(zh矛)鑹ソ宸ョ▼鈥濄€傚湪鏃ョ泭婵€鐑堢殑甯傚牬绔剁埈涓紝鍏徃灏囩辜绾�(x霉)鍔犲ぇ绉戞妧鎶曞叆锛屽毚(y谩n)鏍艰(gu墨)鑼冧紒妤�(y猫)绠＄悊锛屽姏鐖互鍎�(y艒u)鐣扮殑浣庢韩鎭掓韩鎭掓繒瑭﹂(y脿n)绠憋紝妯圭珛鍎�(y艒u)鐣颁紒妤�(y猫)褰㈣薄锛屽苟涓斿幓鐖彇鏇村唬闂婄殑甯傚牬銆傚壍(chu脿ng)娓鎶€鍕囦簬璺ㄨ秺锛岃拷姹傦紝瑾犳懐姝¤繋鍚勫€嬩紒妤�(y猫)鐢ㄦ埗鑸囨垜鍙告敎鎵嬪悎浣溿€�
姝¤繋闆昏┍鑱�(li谩n)绯绘垜鍊戜簡瑙ｆ湁闂�(gu膩n)锛屼綆婧亽婧亽婵曡│椹�(y脿n)绠变綆鍍�(ji脿)鎵圭櫦(f膩)锛屼綆婧亽婧亽婵曡│椹�(y脿n)绠辩殑鏇村淇℃伅瑭虫儏銆�
