銆€銆€鏍规嵁銆�椋熷搧瀹夊叏娉�銆嬭瀹氾紝瀹¤瘎鏈烘瀯缁勭粐涓撳瀵�鎶楀潖琛€閰�妫曟閰搁叝锛堥叾娉曪級绛�3绉�椋熷搧娣诲姞鍓傛柊鍝佺銆�杈f娌规爲鑴�绛�8绉�椋熷搧娣诲姞鍓�鎵╁ぇ浣跨敤鑼冨洿銆佸瘜纭�閰垫瘝椋熷搧钀ュ吇寮哄寲鍓傛墿澶т娇鐢ㄨ寖鍥寸殑瀹夊叏鎬ц瘎浼版潗鏂欏鏌ュ苟閫氳繃銆�
銆€銆€鐗规鍏憡銆�
銆€銆€闄勪欢锛�1. 鎶楀潖琛€閰告姒堥吀閰紙閰舵硶锛夌瓑3绉嶉鍝佹坊鍔犲墏鏂板搧绉�
銆€銆€2. 杈f娌规爲鑴傜瓑8绉嶉鍝佹坊鍔犲墏鎵╁ぇ浣跨敤鑼冨洿
銆€銆€3. 瀵岀閰垫瘝椋熷搧钀ュ吇寮哄寲鍓傛墿澶т娇鐢ㄨ寖鍥�
銆€銆€鍥藉鍗敓璁$敓濮�
銆€銆€2016骞�7鏈�22鏃�
銆€銆€闄勪欢1
銆€銆€鎶楀潖琛€閰告姒堥吀閰紙閰舵硶锛夌瓑3绉�
椋熷搧娣诲姞鍓傛柊鍝佺涓€銆� 鎶楀潖琛€閰告姒堥吀閰紙閰舵硶锛�
鑻辨枃鍚嶇О锛歛scorbyl palmitate (enzymatic)
鍔熻兘鍒嗙被锛氭姉姘у寲鍓�
锛堜竴锛� 鐢ㄩ噺鍙婁娇鐢ㄨ寖鍥�
椋熷搧鍒嗙被鍙�
|
椋熷搧鍚嶇О
|
鏈€澶т娇鐢ㄩ噺/(g/kg)
|
澶囨敞
|
02.0
|
鑴傝偑锛屾补鍜屼钩鍖栬剛鑲埗鍝�
|
0.2
|
|
02.01
|
鍩烘湰涓嶅惈姘寸殑鑴傝偑鍜屾补
|
锛堜簩锛夎川閲忚鏍艰姹�
1鑼冨洿
鏈川閲忚鏍艰姹傞€傜敤浜庝互妫曟閰革紙鎴栨姒堥吀涔欓叝锛夊拰鎶楀潖琛€閰镐负鍘熸枡锛岀粡鑴傝偑閰跺偓鍖栧弽搴斿埗寰楃殑椋熷搧娣诲姞鍓傛姉鍧忚閰告姒堥吀閰€�
鍏朵粬鎶€鏈姹傛墽琛屻€婇鍝佹坊鍔犲墏 L-鎶楀潖琛€閰告姒堥吀閰€嬶紙GB 16314-1996锛夈€�
浜屻€� 3-{1-[(3,5-浜岀敳鍩�-1,2-鍣佸攽-4-鍩猴級鐢插熀]-1H-鍚″攽 -4-鍩簘-1-(3-缇熷熀鑻勫熀锛夊挭鍞戝晧-2,4-浜岄叜
鑻辨枃鍚嶇О: 3-{1-[(3,5-dimethyl-1,2-oxazol-4-yl)methyl]-1H-pyrazol-4-yl}-1-(3-hydroxybenzyl)imidazolidine-2,4-dione
鍔熻兘鍒嗙被锛氶鍝佺敤棣欐枡
锛堜竴锛� 鐢ㄩ噺鍙婁娇鐢ㄨ寖鍥�
閰嶅埗鎴愰鍝佺敤棣欑簿鐢ㄤ簬鍚勭被椋熷搧锛圙B2760-2014琛˙.1椋熷搧绫诲埆闄ゅ锛夛紝鐢ㄩ噺涓烘寜鐢熶骇闇€瑕侀€傞噺浣跨敤銆�
锛堜簩锛� 璐ㄩ噺瑙勬牸瑕佹眰
1 鑼冨洿
鏈川閲忚鏍艰姹傞€傜敤浜庝互N,N-浜岀敳鍩虹敳閰拌兒銆佷箼鍩哄悺鍞�-4-缇ч吀涔欓叝銆佸彅涓佸熀浜岀敳鍩烘隘纭呯兎銆丯, N-浜屽紓涓欏熀涔欒兒銆佷笁涔欓叞姘у熀纭兼阿鍖栭挔鍜屽洓姘㈠憢鍠冧负鍘熸枡锛岀粡鍖栧鍙嶅簲鍒跺緱鐨勯鍝佹坊鍔犲墏3-{1-[(3,5-浜岀敳鍩�-1,2-鍣佸攽-4-鍩�)鐢插熀]-1H-鍚″攽-4-鍩簘-1-(3-缇熷熀鑻勫熀)鍜攽鍟�-2,4-浜岄叜銆�
2 鍖栧鍚嶇О銆佸垎瀛愬紡銆佺粨鏋勫紡銆佸垎瀛愰噺
2.1鍖栧鍚嶇О
3-{1-[(3,5-浜岀敳鍩�-1,2-鍣佸攽-4-鍩�)鐢插熀]-1H-鍚″攽-4-鍩簘-1-(3-缇熷熀鑻勫熀)鍜攽鍟�-2,4-浜岄叜
2.2鍒嗗瓙寮�
C19H19N5O4
2.3缁撴瀯寮�

2.4鐩稿鍒嗗瓙璐ㄩ噺
354.42锛堟寜2007骞村浗闄呯浉瀵瑰師瀛愯川閲忥級
3 鎶€鏈姹�
3.1鎰熷畼瑕佹眰锛氬簲绗﹀悎琛�1鐨勮瀹氥€�
琛�1 鎰熷畼瑕佹眰
椤� 鐩�
|
瑕� 姹�
|
妫€楠屾柟娉�
|
鑹叉辰
|
鐧借壊
|
灏嗚瘯鏍风疆浜庝竴娲佸噣鐧界焊涓婏紝鐢ㄧ洰娴嬫硶瑙傚療
|
鐘舵€�
|
绮夋湯
|
|
棣欐皵
|
娓╁拰棣欐皵
|
GB/T 14454.2
|
3.2 鐞嗗寲鎸囨爣锛氬簲绗﹀悎琛�2鐨勮瀹氥€�
琛�2 鐞嗗寲鎸囨爣
椤� 鐩�
|
鎸� 鏍�
|
妫€楠屾柟娉�
|
鍚噺锛�w /% ≥
|
99.0
|
闄勫綍A
|
鐔旂偣/鈩�
|
145锝�150
|
GB/T 14457.3
|
闄勩€€褰曘€€A
椋熷搧娣诲姞鍓�3-{1-[(3,5-浜岀敳鍩�-1,2-鍣佸攽-4-鍩�)鐢插熀]-1H-鍚″攽-4-鍩簘-1-(3-缇熷熀鑻勫熀)
鍜攽鍟�-2,4-浜岄叜鐨勬祴瀹�
A.1銆€浠櫒鍜岃澶�
A.1.1 鑹茶氨浠細鎸塆B/T 27579—2011涓5绔犵殑瑙勫畾銆�
A.1.2 鏌憋細鍙嶇浉娑茬浉鑹茶氨鏌便€�
A.1.3 妫€娴嬪櫒锛氫簩鏋佺闃靛垪妫€娴嬪櫒銆�
A.2銆€娴嬪畾鏂规硶
鍐呮爣娉曪細鎸塆B/T 27579—2011涓9绔犳祴瀹氬惈閲忋€�
A.3銆€閲嶅鎬у強缁撴灉琛ㄧず
鎸夌収GB/T 27579—2011涓9.2鏉¤瀹氳繘琛屻€�
3-{1-[(3,5-浜岀敳鍩�-1,2-鍣佸攽-4-鍩�)鐢插熀] -1H-鍚″攽-4-鍩簘-1-(3-缇熷熀鑻勫熀)鍜攽鍟�-2,4-浜岄叜鐨勯珮鏁堟恫鐩歌壊璋卞浘鍙傝闄勫綍B銆�
闄� 褰� B
椋熷搧娣诲姞鍓�3-{1-[(3,5-浜岀敳鍩�-1,2-鍣佸攽-4-鍩�)鐢插熀]-1H-鍚″攽-4-鍩簘-1-(3-缇熷熀鑻勫熀)
鍜攽鍟�-2,4-浜岄叜鐨勯珮鏁堟恫鐩歌壊璋卞浘
锛堝唴鏍囨硶锛�
B.1 椋熷搧娣诲姞鍓�3-{1-[(3,5-浜岀敳鍩�-1,2-鍣佸攽-4-鍩�)鐢插熀]-1H-鍚″攽-4-鍩簘-1-(3-缇熷熀鑻勫熀)鍜攽鍟�-2,4-浜岄叜鐨勯珮鏁堟恫鐩歌壊璋卞浘
椋熷搧娣诲姞鍓�3-{1-[(3,5-浜岀敳鍩�-1,2-鍣佸攽-4-鍩�)鐢插熀] -1H-鍚″攽-4-鍩簘-1-(3-缇熷熀鑻勫熀)鍜攽鍟�-2,4-浜岄叜鐨勯珮鏁堟恫鐩歌壊璋卞浘瑙佸浘B.1銆�

鍥� B.1 椋熷搧娣诲姞鍓�3-{1-[(3,5-浜岀敳鍩�-1,2-鍣佸攽-4-鍩�)鐢插熀]-1H-鍚″攽-4-鍩簘-1-(3-缇熷熀鑻勫熀)鍜攽鍟�-2,4-浜岄叜鐨勯珮鏁堟恫鐩歌壊璋卞浘
B.2 鎿嶄綔鏉′欢
B.2.1 鏌憋細鍙嶇浉娑茬浉鑹茶氨鏌憋紙Φ 4.6 mm ×150 mm锛岀矑寰�4 μm锛夈€�
B.2.2 娴佸姩鐩窤锛�0.1%鐢查吀姘存憾娑层€�
B.2.3 娴佸姩鐩窧锛�0.1%鐢查吀涔欒厛婧舵恫銆�
B.2.4 娴侀€燂細1 mL/min銆�
B.2.5 妫€娴嬫尝闀匡細230 nm銆�
B.2.6 杩涙牱閲忥細1 μL銆�
B.2.7 鏌辨俯锛�25°C銆�
B.2.8 姊害娲楄劚鏉′欢锛氳琛� B.1銆�
琛� B.1 姊害娲楄劚鏉′欢
鏃堕棿锛坢in锛�
|
娴佸姩鐩窤锛�%锛�
|
娴佸姩鐩窧锛�%锛�
|
0
|
95
|
5
|
20
|
5
|
95
|
25
|
5
|
95
|
27
|
95
|
5
|
30
|
95
|
5
|
涓夈€� 4-姘ㄥ熀-5-[3-(寮備笝鍩烘皑鍩�)-2,2-浜岀敳鍩�-3-姘т唬涓欐哀鍩篯-2-鐢插熀鍠瑰晧-3-缇ч吀纭吀鐩�
鑻辨枃鍚嶇О锛�
4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy) -2- methylquinoline-3-carboxylic acid sulfate
鍔熻兘鍒嗙被锛氶鍝佺敤棣欐枡
锛堜竴锛� 鐢ㄩ噺鍙婁娇鐢ㄨ寖鍥�
閰嶅埗鎴愰鍝佺敤棣欑簿鐢ㄤ簬鍚勭被椋熷搧锛圙B2760-2014琛˙.1椋熷搧绫诲埆闄ゅ锛夛紝鐢ㄩ噺涓烘寜鐢熶骇闇€瑕侀€傞噺浣跨敤銆�
锛堜簩锛夎川閲忚鏍艰姹�
1銆€鑼冨洿
鏈川閲忚鏍艰姹傞€傜敤浜庝互寮備笝鑳恒€佸紓涓欏熀姘寲闀併€佺敳鍩虹緹鍩轰笁鐢插熀涔欓吀鐩愬拰涔欓叞涔欓吀涔欓叝涓哄師鏂欙紝缁忓寲瀛﹀弽搴斿埗寰楃殑椋熷搧娣诲姞鍓�4-姘ㄥ熀-5-[3-(寮備笝鍩烘皑鍩�)-2,2-浜岀敳鍩�-3-姘т唬涓欐哀鍩篯-2-鐢插熀鍠瑰晧-3-缇ч吀纭吀鐩愩€�
鍖栧鍚嶇О銆佸垎瀛愬紡銆佺粨鏋勫紡鍜岀浉瀵瑰垎瀛愯川閲�
2.1 鍖栧鍚嶇О
4-姘ㄥ熀-5-[3-(寮備笝鍩烘皑鍩�)-2, 2-浜岀敳鍩�-3-姘т唬涓欐哀鍩篯-2-鐢插熀鍠瑰晧-3-缇ч吀纭吀鐩�
2.2 鍒嗗瓙寮�
C19H28N3O7S0.5
2.3 缁撴瀯寮�

2.4 鐩稿鍒嗗瓙璐ㄩ噺
426.47锛堟寜2007骞村浗闄呯浉瀵瑰師瀛愯川閲忥級
鎶€鏈姹�
3.1 鎰熷畼瑕佹眰:搴旂鍚堣〃1鐨勮瀹氥€�
琛�1 鎰熷畼瑕佹眰
椤� 鐩�
|
瑕� 姹�
|
妫€楠屾柟娉�
|
鑹叉辰
|
鐧借壊鑷虫祬榛勮壊
|
灏嗚瘯鏍风疆浜庝竴娲佸噣鐧界焊涓婏紝鐢ㄧ洰娴嬫硶瑙傚療
|
鐘舵€�
|
绮夋湯
|
|
棣欐皵
|
娓╁拰棣欐皵
|
GB/T 14454.2
|
3.2 鐞嗗寲鎸囨爣:搴旂鍚堣〃2鐨勮瀹氥€�
琛�2 鐞嗗寲鎸囨爣
椤� 鐩�
|
鎸� 鏍�
|
妫€楠屾柟娉�
|
鍚噺锛�w/% ≥
|
98.0
|
闄勫綍A
|
闄勩€€褰曘€€A
椋熷搧娣诲姞鍓� 4-姘ㄥ熀-5-[3-(寮備笝鍩烘皑鍩�)-2,2-浜岀敳鍩�-3-姘т唬涓欐哀鍩篯-2-鐢插熀鍠瑰晧-3-缇ч吀
纭吀鐩愮殑娴嬪畾
A.1 浠櫒鍜岃澶�
A.1.1 鑹茶氨浠細鎸塆B/T 27579—2011涓5绔犵殑瑙勫畾銆�
A.1.2 鏌憋細鍙嶇浉娑茬浉鑹茶氨鏌便€�
A.1.3 妫€娴嬪櫒锛氫簩鏋佺闃靛垪妫€娴嬪櫒銆�
A.2 娴嬪畾鏂规硶
鍐呮爣娉曪細鎸塆B/T 27579—2011涓9绔犳祴瀹氬惈閲忋€�
A.3 閲嶅鎬у強缁撴灉琛ㄧず
鎸夌収GB/T 27579—2011涓9.2鏉¤瀹氳繘琛屻€�
4-姘ㄥ熀-5-[3-(寮備笝鍩烘皑鍩�)-2,2-浜岀敳鍩�-3-姘т唬涓欐哀鍩篯-2-鐢插熀鍠瑰晧-3-缇ч吀纭吀鐩愮殑楂樻晥娑茬浉鑹茶氨鍥惧弬瑙侀檮褰旴銆�
闄� 褰� B
椋熷搧娣诲姞鍓� 4-姘ㄥ熀-5-[3-(寮備笝鍩烘皑鍩�)-2,2-浜岀敳鍩�-3-姘т唬涓欐哀鍩篯-2-鐢插熀鍠瑰晧-3-缇ч吀纭吀鐩愮殑楂樻晥娑茬浉鑹茶氨鍥�
锛堝唴鏍囨硶锛�
B.1 椋熷搧娣诲姞鍓�4-姘ㄥ熀-5-[3-(寮備笝鍩烘皑鍩�)-2,2-浜岀敳鍩�-3-姘т唬涓欐哀鍩篯-2-鐢插熀鍠瑰晧-3-缇ч吀纭吀鐩愮殑楂樻晥娑茬浉鑹茶氨鍥�
4-姘ㄥ熀-5-[3-(寮備笝鍩烘皑鍩�)-2,2-浜岀敳鍩�-3-姘т唬涓欐哀鍩篯-2-鐢插熀鍠瑰晧-3-缇ч吀纭吀鐩愮殑楂樻晥娑茬浉鑹茶氨鍥捐鍥綛.1銆�

鍥綛.1 椋熷搧娣诲姞鍓� 4-姘ㄥ熀-5-[3-(寮備笝鍩烘皑鍩�)-2,2-浜岀敳鍩�-3-姘т唬涓欐哀鍩篯-2-鐢插熀鍠瑰晧-3-缇ч吀纭吀鐩愮殑楂樻晥娑茬浉鑹茶氨鍥�
B.2 鎿嶄綔鏉′欢
B.2.1 鏌憋細鍙嶇浉娑茬浉鑹茶氨鏌憋紙Φ 4.6 mm ×150 mm锛岀矑寰�4 μm锛夈€�
B.2.2 娴佸姩鐩窤锛�0.1%鐢查吀姘存憾娑层€�
B.2.3 娴佸姩鐩窧锛�0.1%鐢查吀涔欒厛婧舵恫銆�
B.2.4 娴侀€燂細1 mL/min銆�
B.2.5 妫€娴嬫尝闀匡細230 nm銆�
B.2.6 杩涙牱閲忥細1 μL銆�
B.2.7 鏌辨俯锛�25°C銆�
B.2.8 姊害娲楄劚鏉′欢锛氳琛� B.1銆�
琛� B.1 姊害娲楄劚鏉′欢
鏃堕棿锛坢in锛�
|
娴佸姩鐩窤锛�%锛�
|
娴佸姩鐩窧锛�%锛�
|
0
|
95
|
5
|
20
|
5
|
95
|
25
|
5
|
95
|
27
|
95
|
5
|
30
|
95
|
5
|

闄勪欢2
杈f娌规爲鑴傜瓑8绉嶉鍝佹坊鍔犲墏鎵╁ぇ浣跨敤鑼冨洿
搴忓彿
|
鍚嶇О
|
鍔熻兘
|
椋熷搧鍒嗙被鍙�
|
椋熷搧鍚嶇О
|
鏈€澶т娇鐢ㄩ噺锛坓/kg锛�
|
澶囨敞
|
1.
|
杈f娌规爲鑴�
|
澧炲懗鍓傘€佺潃鑹插墏
|
04.04.01.02
|
璞嗗共绫�
|
鎸夌敓浜ч渶瑕侀€傞噺浣跨敤
|
-
|
09.04.02
|
缁忕児璋冩垨娌圭偢鐨勬按浜у搧
|
|||||
2.
|
杈f绾�
|
鐫€鑹插墏
|
04.04.01.02
|
璞嗗共绫�
|
鎸夌敓浜ч渶瑕侀€傞噺浣跨敤
|
-
|
09.04.02
|
缁忕児璋冩垨娌圭偢鐨勬按浜у搧
|
|||||
3.
|
寮傞害鑺介叜绯�
|
鐢滃懗鍓�
|
05.01.02
|
宸у厠鍔涗笌宸у厠鍔涘埗鍝侊紝闄�05.01.01浠ュ鐨勫彲鍙埗鍝�
|
鎸夌敓浜ч渶瑕侀€傞噺浣跨敤
|
-
|
05.01.03
|
浠e彲鍙剛宸у厠鍔涘強浣跨敤鍙彲鑴備唬鐢ㄥ搧鐨勫阀鍏嬪姏绫讳技浜у搧
|
|||||
05.03
|
绯栨灉鍜屽阀鍏嬪姏鍒跺搧鍖呰。
|
|||||
06.10
|
绮鍒跺搧棣呮枡
|
|||||
07.04
|
鐒欑儰椋熷搧棣呮枡鍙婅〃闈㈢敤鎸傛祮
|
|||||
4.
|
灞辨ⅷ閰搁捑
|
闃茶厫鍓�
|
09.03.02
|
鑵屽埗姘翠骇鍝�(浠呴檺鍗抽娴疯渿)
|
1.0
|
浠ュ北姊ㄩ吀璁�
|
5.
|
鐒︿簹纭吀閽�
|
闃茶厫鍓傘€佹姉姘у寲鍓�
|
09.01
|
椴滄按浜э紙浠呴檺浜庢捣姘磋櫨锜圭被鍙婂叾鍒跺搧锛�
|
0.1
|
鏈€澶т娇鐢ㄩ噺浠ヤ簩姘у寲纭畫鐣欓噺璁�
|
09.02
|
鍐峰喕姘翠骇鍝佸強鍏跺埗鍝侊紙浠呴檺浜庢捣姘磋櫨锜圭被鍙婂叾鍒跺搧锛�
|
|||||
6.
|
绱兌(鍙堝悕铏兌)
|
鐫€鑹插墏
|
16.03
|
鑳跺師铔嬬櫧鑲犺。
|
鎸夌敓浜ч渶瑕侀€傞噺浣跨敤
|
-
|
7.
|
鑱氫簩鐢插熀纭呮哀鐑峰強鍏朵钩娑�
|
椋熷搧宸ヤ笟鐢ㄥ姞宸ュ姪鍓傦紙娑堟场鍓傦級
|
-
|
钖被鍔犲伐宸ヨ壓
|
鎸夌敓浜ч渶瑕侀€傞噺浣跨敤
|
-
|
8.
|
杈涳紝鐧搁吀鐢樻补閰�
|
椋熷搧宸ヤ笟鐢ㄥ姞宸ュ姪鍓傦紙闃查粡鍓傦級
|
-
|
宸у厠鍔涘拰宸у厠鍔涘埗鍝佸姞宸ュ伐鑹�
|
0.08
|
-
|
闄勪欢3
瀵岀閰垫瘝椋熷搧钀ュ吇寮哄寲鍓傛墿澶т娇鐢ㄨ寖鍥�
搴忓彿
|
鍚嶇О
|
鍔熻兘
|
椋熷搧鍒嗙被鍙�
|
椋熷搧鍚嶇О
|
浣跨敤閲�
|
澶囨敞
|
1.
|
瀵岀閰垫瘝
|
椋熷搧钀ュ吇寮哄寲鍓�
|
01.03.02
|
璋冨埗涔崇矇锛堝効绔ョ敤涔崇矇闄ゅ锛�
|
140μg/kg ~ 280μg/kg
|
浠ョ璁�
|
璋冨埗涔崇矇锛堜粎闄愬効绔ョ敤涔崇矇锛�
|
60μg/kg ~ 130μg/kg
|
|||||
06.02
|
澶х背鍙婂叾鍒跺搧
|
140μg/kg ~ 280μg/kg
|
||||
06.03
|
灏忛害绮夊強鍏跺埗鍝�
|
140μg/kg ~ 280μg/kg
|
||||
06.04
|
鏉傜伯绮夊強鍏跺埗鍝�
|
140μg/kg~ 280μg/kg
|
||||
07.01
|
闈㈠寘
|
140μg/kg ~ 280μg/kg
|
||||
07.03
|
楗煎共
|
30μg/kg ~ 110μg/kg
|