理化和微生物指标/physicochemical and microbial index
检测项/test item 指标/specifications | ||
崩解时限（min）/disintegration time | ≤10 | |
干燥失重/loss on drying | 12.5%-17.5% | |
炽灼残渣/ignition residue | 透明/transparent | ≤2.0% |
着色/opaque | ≤5.0% | |
重金属（ppm）/heavy metal | ≤40 | |
砷（ppm）/arsenic | ≤2 | |
微生物/microbial | 需氧菌总数（cfu/g）/total bacteria count | ≤1000
|
霉菌和酵母菌总数（cfu/g）/total yeast and mold count | ≤100
| |
每1g供试品大肠埃希菌/escherichia coli | 不得检出/absent in 1g | |
每10g供试品沙门菌/salmonella | 不得检出/absent in 10g | |
尺寸和容积/size and specification
型号 size | 长度 ±0.40（mm） length | 壁厚±0.02（mm） wall thicknesst | 口部外径（mm）outer diameter | 囊重差异（mg）weight diffrence | 顶厚（mm）dome thicknoss | 容积（ml）volume | 锁合长±0.5（mm）lock length | 胶囊装量参考（依据药粉密度）（mg）weight lapacity | ||||
00#el | 帽/cap | 12.80 | 0.115 | 8.50-8.60 | ±10.0 | ≥0.12 | 1.0 | 25.3 | 600 | 800 | 1000 | 1200 |
体/body | 21.90 | 0.110 | 8.15-8.25 | |||||||||
00# | 帽/cap | 11.80 | 0.115 | 8.50-8.60 | ±8.0 | ≥0.12 | 0.93 | 23.4 | 558 | 744 | 930 | 1116 |
体/body | 20.10 | 0.110 | 8.15-8.25 | |||||||||
0#el | 帽/cap | 11.80 | 0.110 | 7.64-7.74 | ±7.0 | ≥0.12 | 0.74 | 23.4 | 444 | 592 | 740 | 888 |
体/body | 20.20 | 0.105 | 7.31-7.41 | |||||||||
0# | 帽/cap | 11.00 | 0.110 | 7.61-7.71 | ±7.0 | ≥0.12 | 0.68 | 21.7 | 408 | 544 | 680 | 816 |
体/body | 18.60 | 0.105 | 7.30-7.40 | |||||||||
1# | 帽/cap | 9.90 | 0.105 | 6.90-7.00 | ±6.0 | ≥0.12 | 0.50 | 19.3 | 300 | 400 | 500 | 600 |
体/body | 16.50 | 0.100 | 6.61-6.69 | |||||||||
2# | 帽/cap | 9.00 | 0.095 | 6.32-6.40 | ±5。0 | ≥0.12 | 0.37 | 17.8 | 222 | 296 | 370 | 444 |
体/body | 15.40 | 0.095 | 6.05-6.13 | |||||||||
3# | 帽/cap | 8.10 | 0.090 | 5.79-5.87 | ±4.0 | ≥0.12 | 0.30 | 15.7 | 180 | 240 | 300 | 360 |
体/body | 13.60 | 0.090 | 5.53-5.61 | |||||||||
4# | 帽/cap | 7.20 | 0.090 | 5.28-5.36 | ±3.0 | ≥0.12 | 0.21 | 14.2 | 126 | 168 | 210 | 252 |
体/body | 12.20 | 0.85 | 5.00-5.08 | |||||||||
5# | 帽/cap | 6.40 | 0.090 | 4.87-4.95 | ±3.0 | ≥0.12 | 0.12 | 11.2 | 72 | 96 | 120 | 144 |
体/body | 9.20 | 0.085 | 4.56-4.64 | |||||||||
a# | 帽/cap | 14.40 | 0.105 | 8.50-8.60 | ±7.0 | ≥0.12 | 0.68 | 17.9 | 408 | 544 | 680 | 816 |
体/body | 18.40 | 0.105 | 8.15-8.25 | |||||||||
b# | 帽/cap | 11.00 | 0.105 | 8.50-8.60 | ±6.0 | ≥0.12 | 0.50 | 14.6 | 300 | 400 | 500 | 600 |
体/body | 11.30 | 0.105 | 8.15-8.25 | |||||||||