¡¡¡¡1¡¢ÎÒ‡øŒ¦Ê³Æ·Ìí¼Ó„©Ã÷ÄzÉú®a¼°Ê¹ÓõĹÜÀí
¡¡¡¡Ã÷ÄzÊÇÎÒ‡øÔÊÔSʹÓõÄʳƷÌí¼Ó„©£¬Ö÷Òª¹¦ÄÜžéÔö³í„©¡£×÷žéʳƷÌí¼Ó„©Ê¹ÓõÄÃ÷Äz£¬±Øíš·ûºÏ¡¶Ê³Æ·Ìí¼Ó„© Ã÷Äz¡·£¨GB6783£©ÒŽ¶¨Ù|Á¿ÒŽ¸ñÒªÇó¡£°´ÕÕÔ“˜ËœÊÒŽ¶¨£¬×÷žéʳƷÌí¼Ó„©µÄÃ÷Äz±ØíšÒÔ„ÓÎïµÄƤ¡¢¹ÇÒÔ¼°ëì¡¢÷[µÈ×÷žéÔÁÏ£¬²¢Ìá³öÁ˾ßówµÄ¼¼ÐgÖ¸˜ËºÍ™zòž·½·¨µÄÒªÇó¡£Í¬•r£¬á˜Œ¦Ê³Æ·Ìí¼Ó„©Ã÷ÄzµÄÉú®aß^³ÌÒªÇó£¬ÎÒ‡ø߀Öƶ¨ÁË¡¶Ê³Æ·Ìí¼Ó„©Ã÷ÄzÉú®aÆó˜IÐlÉúÒŽ·¶¡·£¨Ðl±O¶½°l[2005]535Ì–£©£¬ÆäÖÐŒ¦ÓÚʳƷÌí¼Ó„©Ã÷ÄzµÄÉú®aÔÁÏßMÐÐÁËßMÒ»²½¼š»¯£¬¾ßówƒÈÈݞ飺“ʳƷÌí¼Ó„©Ã÷ÄzÉú®a¿ÉÒÔʹÓõÄÔÁÏ£º£¨1£©ÍÀÔ׈ö¡¢Èâ“S¡¢¹Þî^S¡¢²ËÊЈöµÈÌṩµÄ½›™zÒߺϸñµÄÐÂõrÅ£¡¢Øi¡¢ÑòµÈÉüÐóµÄƤºÍ¹Ç£»£¨2£©ÖƸï÷·Öƹ¤Ë‡Ç°£¬¼ôÇÐÏµĎ§Ã«ß…Ƥ»òÆÊϵăȌÓƤ£¬Ë×·Qžéë߅Ƥ¡¢¶þŒÓƤ¡¢ÈýÇåƤµÈÉúƤ£»£¨3£©¹ÇÁ£¼Ó¹¤SÕûÀí¼Ó¹¤µÄÇå¹ÇÁ£ºÍÖ±½ÓÊÕÙµÄ×ÔÈ»ïL¸ÉµÄ¹ÇÁÏ¡£½ûֹʹÓÃÒÔÏÂÔÁÏ£º£¨1£©ÖƸïS÷·ÖƺóµÄÈκÎUÁÏ£»£¨2£©Ÿo™zòž™zÒߺϸñ×CÃ÷µÄÅ£¡¢Øi¡¢ÑòµÈÉüÐóµÄƤºÍ¹Ç¡£”
¡¡¡¡ÎÒ‡ø¡¶Ê³Æ·°²È«‡ø¼Ò˜ËœÊ ʳƷÌí¼Ó„©Ê¹Óؘʡ·£¨GB2760-2011£©ÒŽ¶¨£¬Ã÷Äz×÷žéÔö³í„©¿ÉÒÔÔÚ³ý¸½±íËùÁÐʳƷî„eÖ®ÍâµÄ¸÷îʳƷÖÐʹÓ㨸½±íÔ”ÒŠºó£©£¬Ê¹ÓÃÁ¿žé°´ÕÕÉú®aÐèÒªßmÁ¿Ê¹Óᣰ´ÕÕÔ“˜ËœÊÒŽ¶¨£¬Ã÷Äz×÷žéÔö³í„©²»ÄÜÓÃÓÚ°l½ÍÈ飬¿ÉÒÔÓÃÓÚïLζ°l½ÍÈé¡£
¡¡¡¡2¡¢‡øëHÉÏêPÓÚʳƷÌí¼Ó„©Ã÷ÄzµÄ°²È«ÐÔÔuƒrºÍʹÓÃÇé›r
¡¡¡¡Â“ºÏ‡ø¼ZÞr½M¿—/ÊÀ½çÐlÉú½M¿—“ºÏʳƷÌí¼Ó„©Œ£¼Òί†T•þ£¨JECFA£©Œ¦Ê³ÓÃÃ÷ÄzµÄ°²È«ÐÔßMÐÐÁËÔuƒr£¬ÆäÿÈÕÔÊÔS”zÈëÁ¿£¨ADI£©²»ÐèÒªÏÞ¶¨¡£¼ÓÄôóµÈ‡øÔÊÔSÃ÷Äz×÷žéʳƷÌí¼Ó„©Ê¹Ó㬾ßówʹÓÃÒŽ¶¨ÈçÏ£º
¼ÓÄôó£º
|
¹¦ÄÜ
|
ʹÓ÷¶‡ú
|
ʹÓÃÁ¿
|
|
È黯„©¡¢Ôö³í„©ºÍ·€¶¨„©
|
ëçÈâ¡¢¹ÞÑbµÄÇÝÈâ¡¢ÄÌÓÍ¡¢ÈâîÕ³ºÏ„©¡¢ÈâÃÓ¾í¡¢¾«ÖÆ»ðÍÈ¡¢Ã“Ö¬Ä̵È
|
GMP
|
|
ËÉÜ›¸ÉÀÒ¡¢¼ÓÄÌÓ͵ÄËÉÜ›¸ÉÀÒ¡¢±ùä¿ÁÜ¡¢ÄÌÓͱùä¿ÁܵÈ
|
0.5%
|
|
|
±ùƒö¹û×Ó¶
|
0.75%
|
|
|
ËáÄÌÓÍ
|
0.5%
|
|
|
ÄÌÓ͸ÉÀÒ¡¢¼Ó¹¤µÄÜ›¸ÉÀÒ¡¢µÍœØ¹ÞÑbÌŽÀíµÄ¸ÉÀÒʳƷµÈ
|
0.5%
|
|
|
³ÎÇå„©
|
Æ¡¾Æ¡¢ÌO¹û¾Æ¡¢ÆÏÌѾÆ
|
GMP
|
|
ʳƷ·ÖîÌ–
|
ʳƷÃû·Q
|
|
01.01.01
|
°ÍÊÏš¢¾úÈé
|
|
01.01.02
|
œç¾úÈé
|
|
01.02.01
|
°l½ÍÈé
|
|
01.03.01
|
Èé·ÛºÍÄÌÓÍ·Û
|
|
01.05.01
|
Ï¡ÄÌÓÍ
|
|
02.01
|
»ù±¾²»º¬Ë®µÄÖ¬·¾ºÍÓÍ
|
|
02.02.01.01
|
üSÓͺÍâ¿süSÓÍ
|
|
04.01.01
|
ÐÂõrË®¹û
|
|
04.02.01
|
ÐÂõrÊß²Ë
|
|
04.02.02.01
|
ÀäƒöÊß²Ë
|
|
04.02.02.06
|
°l½ÍÊß²ËÖÆÆ·
|
|
04.03.01
|
ÐÂõrʳÓþúºÍÔåî
|
|
04.03.02.01
|
ÀäƒöʳÓþúºÍÔåî
|
|
06.01
|
Ô¼Z
|
|
06.02
|
´óÃ×¼°ÆäÖÆÆ·
|
|
06.03.01
|
Сûœ·Û
|
|
06.03.02.01
|
ÉúñÃæÖÆÆ·£¨Ãæ—l¡¢ïœ×ÓƤ¡¢ðQï‚Ƥ¡¢ŸýûœÆ¤£©
|
|
06.03.02.02
|
Éú¸ÉÃæÖÆÆ·£¨’ìÃ棩
|
|
08.01
|
Éú¡¢õrÈâ
|
|
09.01
|
õrË®®a
|
|
09.03
|
îAÖÆË®®aÆ·£¨°ë³ÉÆ·£©
|
|
10.01
|
õrµ°
|
|
10.03.01
|
Óˮµ°ÖÆÆ·£¨Èçµ°°×·Û¡¢µ°üS·Û¡¢µ°°×Ƭ£©
|
|
10.03.03
|
Àäƒöµ°ÖÆÆ·£¨Èç±ùµ°£©
|
|
11.01
|
ʳÌÇ
|
|
11.01.02
|
ÆäËûÌǺÍÌÇ{£¨Èç¼tÌÇ¡¢³àÉ°ÌÇ¡¢±ùƬÌÇ¡¢ÔÌÇ¡¢ÌÇÃÛ¡¢²¿·ÖÞD»¯ÌÇ¡¢éʘäÌÇ{µÈ£©
|
|
11.03.01
|
·äÃÛ
|
|
12.01
|
û}¼°´úû}ÖÆÆ·
|
|
12.09
|
ÏãÐÁÁÏî
|
|
13.01
|
‹ëÓ׃ºÅ䷽ʳƷ
|
|
13.02
|
‹ëÓ׃ºÝoÖúʳƷ
|
|
13.03
|
ÌØÊâátŒWÓÃ;Å䷽ʳƷ£¨13.01ÖÐÉæ¼°Æ··N³ýÍ⣩
|
|
14.01.01
|
ï‹ÓÃÌìÈ»µVȪˮ
|
|
14.01.02
|
ï‹ÓüƒƒôË®
|
|
14.01.03
|
ÆäËûï‹ÓÃË®
|
|
14.02.01
|
¹ûÊßÖ£¨{£©
|
|
14.02.02
|
â¿s¹ûÊßÖ£¨{£©
|
|
15.03.01
|
ÆÏÌѾÆ
|
|
16.02
|
²èÈ~¡¢¿§·È
|
