( )
... 1... 6... 6... 9... 12... 13... 19... 21... 23... 26... 27 2001... 28 2001 I
... 34 2002... 36... 44... 51... 65... 66... 68... 69... 71... 73 ( )... 89 II
... 104 863... 108 ()... 109...117...117...119...119... 131... 131 5... 145 55.65... 145... 146... 147... 150... 152 1... 155... 157... 158 III
... 158... 161... 163... 164... 166... 167... 170... 172... 174... 176... 177... 178... 179... 180... 182... 185... 187 IV
... 187 2000... 190... 192... 192... 196... 197... 198... 199... 202... 205... 207... 207... 208 V
2001-2-28 2001-4-1 2001220 68 1
2
3
1999 4
200141 5
2000-12-11 ( ) 10 2001-2-28 2001-4-1 6
2001220 68 4% 7
8
1 30 200141 9
B1 B2 B E(5mg) B4 B6 B12 C D2 10
D3 ( )( ) ( )( ) (1) ( )(2) (3) (4) (17) (18F) (3H) 11
(1) (2) (3) (4) ( ) 2000-12-15 83 43.4% 12
[2000]42 20012005 13
14
15
16
17
18
2000-12-11 19
1. ( ) 7 ( ) GMP GMP 2. 3 20
3. (2001 220 68 ) 12 1. 2. 21
3. 4. 5. 6. 7. 8. 9. 10. 22
11. 12. K1 ( ) 23
( II VI IX X) (1) (2) (3) ( ) ( ) K3 K4 ( ) ( ) 24
() ( ) ( ) ( ) 25
70 ( )( ) 26
( ) / ( ) ( ) ( ) ( ) () ( ) 2000-12-14 27
1130 13 66. 2001 2001-4-26 200136 2001 [2001]12 2001 28
1 2 3 4 5 1 29
2 3 4 1 20 2 15 2001 30
() 10139001130 ( ) 14001630 ( ) () 10149001130 14001630 ( ) 31
( ) [ ] 2000 2000 32
33 200165-69 3 / 6 65687030 65688039 38 62091715
64287072 11 3 www.bjpta.gov.cn www.bjda.gov.cn 2001 2001-4-19 34
2001 6 3 2 3+2 5 35
www.sda.gov.cn; www.bjp.gov.cn zhou.g.y@bjda.gov.cn 2002 2002-4-10 2002-4-24 [2002]35 36
2002 [2002]14 [2001]49 2002 37
1012 9:00-11:30 2:00-4:30 1013 38
9:00-11:30 2:00-4:30 1 20 2 15 39
11988 10 21990 8 3199941 2002424 428 8:30-16:30 11 40
6 65688039 11 64286989 38 62091715 41
418 www.bjpta.gov.cn 2001 42
2001 2002 16898100 (www.bjpta.gov.cn) 43
2000-12-20 44
45
46
1 2 1 2 3 100 100 47
30 48
49
50
2001-3-19 [2001]19 51
2001220 68 1978104 ( ) 52
53
y 200141 200141 2001331 54
25 20 55
2001331 60% 56
35 45 70 35 45 70 1%2%4.8% 4.3% 57
200141 1998630 200 19987 1 100 58
1300 650 50% 5 59
90 90 180 270 90 180 90 50% 60
1231 11 61
62
1988550 1988 63
550 200141 64
2001319 2000 2001-2-28 200118 (2001 220 68 ) 65
2001228 2000 2001-2-28 66
200117 (2001 220 68 ) 67
2001-2-28 [2001]26 68
2001 220 68 2001-2-28 [2001] 13 69
?? 2001 220 68 70
2001-2-28 200116 2001 220 68 71
4% 72
73
[2001]211 74
75
76
10 30 IP 77
IP 30 78
79
80
81
30 30 82
83
84
85
30 86
87
20 88
( ) [2001]211 89
90
91
10 30 92
IP IP 30 93
94
95
96
30 30 97
98
99
100
30 101
102
103
20 2001-2-20 [2000]562 104
105
1 2 3 4 5 6 3 106
2000334 20017120046 30 2004630 107
2001 200149 13 7409 200162 2001630 863 2000-12-1 108
863 20 20 863 50 K-001 () 2000-12-28 () 1 ( Amoxicillin ) 109
2 ( Ampicillin Sodium ) 3 ( Oxacillin Sodium ) 4 ( Cloxacillin Sodium ) 5 [ ]Benzylpenicillin[Sodium Potassium] 6 V Phenoxymethylpenicillin Potassium 7 Cefalexin 8 Cefradine 9 Cefotaxine Sodium 10 Cefazoline Sodium 11 ( Amikacin Sulfate ) 12 Gentamicin Sulfate 110
13 Chloramphenicol 14 Tetracycline Hydrochloride 15 ( Doxycycline Hydrochloride ) 16 Erythromycin 17 Lincomycin Hydrochloride 18 Compound Sulfamethoxazole 19 Sulfadiazine 20 [ Ciprofloxacin ] HydrochlorideLactate 21 ( ) Norfloxacin 22 ( ) Ofloxacin 23 Metronidazole 24 ( )Nitrofurantoin 25 Furazolidone; Nifurazolidone 111
26 Methenamine 27 ( )Berberine Hydrochloride 28 Sodium Aminosalicylate 29 Rifampicin 30 Streptomycin Sulfate 31 Ethambutol Hydrochloride 32 ( ) Isoniazid 33 Dapsone 34 Acedapsone 35 Nysfungin 36 Aciclovir 37 ( Ribavirin ) 38 Praziquantel 39 Bithionol 40 Diethylcarbamazine Citrate 41 Quinine Sulfate 112
42 Primaquine Phosphate 43 Chloroquine Phosphate 44 Dihydroartemisinin 45 Mebendazol 46 Levamisole Hydrochloride 47 Pentamidine 48 Sodium Stibogluconate 49 Aspirin 50 Ibuprofen 51 Somedon 52 Allopurinol 53 Colchicine 54 Enflurane 55 Isoflurane 56 Thiopental sodium 57 Ketamine Hydrochloride 58 Lidocaine Hydrochloride 113
59 Bupivacaine Hydrochloride 60 Tetracaine Hydrochloride 61 Procaine Hydrochloride *62 Fentanyl *63 Morphine Hydrochloride *64 Pethidine Hydrochloride 65 Suxamethonium Chloride 66 Ephedrine Hydrochloride 67 Naloxone Hydrochloride 68 Calcium Gluconate 69 B1 Vitamin B1; Thiamine 70 B12 Vitamin B12; Cyanocobalamin 71 B6 Vitamin B6;Pyridoxine 72 C Vitamin C; Ascorbic Acid 73 D3 Vitamin D3; Cholecalciferol 74 Arginine Hydrochloride 114
75 Fat Emulsion 76 Corticotrophin 77 Desmopressin 78 Chorionic Gonadotrophin 79 Dexamethasone Acetate 80 Prednisone 81 Hydrocortisone 82 Nandrolone Phenylpropionate 83 Testosterone Propionate 84 Methyltestosterone 85 Diethylstilbestrol 86 Medroxyprogesterone Acetate 115
87 Progesterone 88 [ Insulin ] 89 Neutral Insulin 90 Protamine Zinc Insulin 91 Glibenclamide 92 Metformin Hydrochloride 93 Thyroid Tablets 94 ( Compound Iodine ) 95 Propylthiouracil 96 ( ) Thiamazole 97 Tripterysium Glucosides 98 Azathioprine 99 Cyclophosphamide 100 Thiotepa 116
2000-12-22 2001-1-8 2001-1-8 117
118
2000-10-31 101920 FDA 2001 6 22 119
120
121
122
123
124
125
126
127
128
10 129
130
2001101 131
132
133
10 22 134
135
136
137
138
139
140
20% 141
142
143
144
2001 9 1 5 2000-12-18 5 1365 300 55.65 2001-1-4 145
1215 115929 55.65 5 768 2600 ( ) ( ) 146
( ) ( ) ( ) 2001 70-80% ( ) ( ) ( ) ( ) ( ) 2000-12-22 147
1121 5 3 15 3 18 10 148
472 1130 1200 600 1536 657.2 10 GB-1993 ( )115929 55.65 10098 28.97 7000 149
2000-12-12 150
3 17 151
2000-12-4 2001 ( ) 152
153
12 2001 154
1 2000-11-28 19 155
10373 28.16% 334 9.50% 25 56.25% 1 1. 3 2. 19 3 13.96% 99.7% 3. 9 8159 78.67% 156
4. 2000-12-18 157
2000-12-8 111617 2 2000-11-27 158
1114 50 159
1/3 ( ) ( ) 160
2000-11-27 1018 161
162
2000-10-27 28 163
2000-12-4 112228 164
( ) GMP 165
2000-10-31 1011 6 6 166
1200 600 500 93 768 52 300 GMP 8 GMP 2000-10-26 167
1018 1200 168
169
2000-12-1 () 170
100 20013 17 171
2000-12-9 1115 172
30 2000 173
2000-12-9 1121 17 17 5 3 427 1130 1200 174
500 93 768 98 2600 175
176 1123 4 10 200 500 2 5000 80 40 170 83.56 3 18 10
2000-12-21 126 5 5 177
3 2000-10-26 178
2000-12-28 179
29 2 2000-12-25 11 110 80 4 180
3 10 123 40 40 124 88 30 100 4 12 1 2 181
140 4 4 1026 28 2.6 6 10 110 80 2000-12-5 182
2000 11 28 85 183
WTO 184
2000-12-7 300 21 2b 185
186
18 60 14 187
( ) (1994) Z-B-0093 20062 ( ) (1994) X-B-0021 20012 ( ) (1994) X-A-0087 10058 ( ) (1994) Z-B-0013 20019 ( ) (1994) Z-B-0011 20016 ( ) (1994) 188
X-A-0047 10028 (1994) 10103 ( ) (1994) X-B-0135 20132 ( ) Z-C-0038 ( ) (1994) X-B-0114 20136 ( ) X-A-0155 (1995) 387514 (1993) 189
387507 (1994) 387508 2000 2001-1-4 2000 2000 10070 973 9.66 6.06 3.45 7.9013.84 190
9.414.936.454.03 143 112 146 18 19 25 1504 403 320 6 191
383 500 40 2000-12-7 1128 192
6 () 193
0791-6217821 194
GMPGSP 195
2000-12-11 196
2001 2001-1-2 2001-1-2 2001-11-2 10 35 12 197
() 10 35 2000-12-6 198
1120 2000-12-6 1013 1120 199
200
201
2000-12-6 1120 202
1. 2. 203
3. 204
2001-1-10 205
2001-1-10 30 50 206
2000-11-1 1019 33 55 2000 6 24 2000 8 1 207
2000 6 27 2000 6 24 208
209
210
211
212
213
8 214
215
216
217
218
219
( 220
221
10 15 222
5 3 5000 10 223
1 5 224
225
2000 8 1 226