CN1742748A - 甲钴胺分散片及其制备方法 - Google Patents
甲钴胺分散片及其制备方法 Download PDFInfo
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- CN1742748A CN1742748A CN 200510105797 CN200510105797A CN1742748A CN 1742748 A CN1742748 A CN 1742748A CN 200510105797 CN200510105797 CN 200510105797 CN 200510105797 A CN200510105797 A CN 200510105797A CN 1742748 A CN1742748 A CN 1742748A
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- mecobalamin
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Abstract
Description
时间 | 0天 | 5天 | 10天 |
外观 | 光洁 | 光洁 | 光洁 |
片重 | 0.1056 | 0.1039 | 0.1046 |
分散时限 | 53″ | 56″ | 55″ |
有关物质 | 1.34% | 1.81% | 1.92% |
含量 | 100.01% | 99.00% | 98.74% |
时间 | 0天 | 5天 | 10天 |
外观 | 光洁 | 表面粗糙 | 表面粗糙 |
片重 | 0.1056 | 0.1209 | 0.1368 |
分散时限 | 53″ | 49″ | 46″ |
有关物质 | 1.34% | 1.53% | 1.55% |
含量 | 100.01% | 99.38% | 99.10% |
时间 | 考察前 | 考察后 |
外观 | 光洁 | 光洁 |
片重 | 0.1056 | 0.1052 |
分散时限 | 53″ | 55″ |
有关物质 | 1.34% | 4.06% |
含量 | 100.01% | 95.14% |
时间 | 0天 | 30天 |
外观 | 光洁 | 光洁 |
片重 | 0.1056 | 0.1058 |
分散时限 | 53″ | 56″ |
有关物质 | 1.34% | 1.54% |
含量 | 100.01% | 100.00% |
实施例产品 | 崩解时限 | 分散均匀性 |
1 | 2分15秒内崩解完全 | 3分钟内崩解完全,可以均匀混悬,过2号筛 |
2 | 2分28秒内崩解完全 | 3分钟内崩解完全,可以均匀混悬,过2号筛 |
3 | 2分15秒内崩解完全 | 3分钟内崩解完全,可以均匀混悬,过2号筛 |
4 | 2分18秒内崩解完全 | 3分钟内崩解完全,可以均匀混悬,过2号筛 |
实施例 | 性状 |
1 | 淡红色片 |
2 | 淡红色片 |
3 | 淡红色片 |
实施例 | 批号 | 波长1 | 波长2 | 波长3 |
1 | 030805 | 267 | 342 | 523 |
2 | 030806 | 266 | 342 | 522 |
3 | 030807 | 267 | 342 | 521 |
实施例 | 杂质峰总面积 | 对照溶液主峰面积 | 有关物质含量 |
1 | 22658 | 39977 | 1.70% |
2 | 20832 | 38523 | 1.62% |
3 | 19981 | 40487 | 1.48% |
实施例 | 1 | 2 | 3 | |
每片标示含量(%) | 1 | 100.38 | 106.59 | 102.39 |
2 | 99.05 | 99.89 | 99.63 | |
3 | 99.62 | 100.75 | 97.25 | |
4 | 101.66 | 97.05 | 99.58 |
5 | 103.05 | 105.40 | 100.21 | |
6 | 104.99 | 98.86 | 97.78 | |
7 | 104.31 | 103.61 | 102.49 | |
8 | 102.48 | 102.67 | 104.00 | |
9 | 101.34 | 102.02 | 100.36 | |
10 | 104.13 | 98.90 | 106.05 | |
平均值 | 102.10 | 101.57 | 100.97 | |
S | 2.042 | 3.054 | 2.749 | |
A+1.80S | 5.776 | 7.067 | 5.918 | |
结论 | 合格 | 合格 | 合格 |
加入量(mg) | 峰面积 | 测得量(mg) | 回收率(%) | 平均回收率(%) | RSD(%) | |
低浓度 | 10.311.811.1 | 185252092319231 | 10.5011.8610.91 | 100.99100.5598.25 | 100.33±1.35 | 1.35 |
中浓度 | 16.617.917.6 | 298463151331114 | 16.9217.8717.64 | 99.96101.83100.25 | ||
高浓度 | 20.220.820.6 | 359273608136650 | 20.3720.4620.78 | 100.8698.37100.89 | ||
对照品5.28μg/ml 37244 |
溶出时间(分钟) | 1 | 2 | 3 | 4 | 5 | 6 | 平均 |
3 | 88.69 | 89.98 | 84.97 | 86.98 | 87.43 | 92.23 | 88.26 |
5 | 101.10 | 103.42 | 99.22 | 100.34 | 100.99 | 106.65 | 101.95 |
10 | 100.98 | 103.87 | 99.74 | 101.18 | 101.00 | 105.71 | 102.08 |
溶出时间(分钟) | 1 | 2 | 3 | 4 | 5 | 6 | 平均 |
3 | 93.17 | 85.25 | 91.86 | 91.15 | 88.45 | 88.29 | 89.69 |
5 | 104.56 | 96.10 | 99.42 | 99.56 | 95.87 | 98.58 | 99.02 |
10 | 104.85 | 96.64 | 100.58 | 100.92 | 98.12 | 102.04 | 100.52 |
溶出时间(分钟) | 1 | 2 | 3 | 4 | 5 | 6 | 平均 |
3 | 81.27 | 85.98 | 76.94 | 80.07 | 77.85 | 75.31 | 79.57 |
5 | 86.71 | 89.71 | 89.71 | 88.53 | 90.96 | 89.12 | 89.12 |
10 | 105.30 | 97.42 | 104.62 | 102.14 | 99.18 | 98.13 | 101.13 |
溶出时间(分钟) | 1 | 2 | 3 | 4 | 5 | 6 | 平均 |
3 | 94.50 | 86.63 | 89.43 | 90.17 | 84.27 | 86.98 | 88.66 |
5 | 102.79 | 104.82 | 103.61 | 102.41 | 96.91 | 98.48 | 101.50 |
10 | 100.02 | 103.42 | 106.05 | 105.71 | 98.20 | 103.27 | 102.78 |
第一组 |
取样时间(分) | 溶出度(%) | ||||||
1 | 2 | 3 | 4 | 5 | 6 | 平均 | |
3 | 82.38 | 85.64 | 92.13 | 90.26 | 85.73 | 88.73 | 87.48±3.561 |
5 | 90.50 | 95.27 | 105.39 | 102.83 | 97.86 | 98.67 | 98.42±5.311 |
10 | 92.46 | 95.70 | 104.55 | 98.79 | 96.48 | 100.67 | 98.11±4.216 |
第二组 | |||||||
取样时间(分) | 溶出度(%) | ||||||
1 | 2 | 3 | 4 | 5 | 6 | 平均 | |
3 | 94.09 | 86.92 | 81.75 | 86.16 | 90.42 | 91.65 | 88.50±4.773 |
5 | 105.32 | 97.22 | 98.48 | 93.33 | 99.91 | 100.34 | 99.10±3.954 |
10 | 104.43 | 99.23 | 95.38 | 92.25 | 99.74 | 101.79 | 98.21±4.390 |
第三组 | |||||||
取样时间(分) | 溶出度(%) | ||||||
1 | 2 | 3 | 4 | 5 | 6 | 平均 | |
3 | 88.77 | 86.16 | 90.68 | 91.47 | 90.58 | 83.65 | 88.55±3.066 |
5 | 99.08 | 93.61 | 103.36 | 102.73 | 97.20 | 95.47 | 98.57±3.916 |
10 | 98.24 | 94.62 | 102.91 | 101.54 | 96.48 | 94.85 | 98.11±3.476 |
第四组 | |||||||
取样时间(分) | 溶出度(%) | ||||||
1 | 2 | 3 | 4 | 5 | 6 | 平均 | |
3 | 88.78 | 91.00 | 88.53 | 92.42 | 85.45 | 90.24 | 89.40±2.413 |
5 | 99.41 | 106.40 | 101.82 | 104.11 | 94.16 | 100.86 | 101.13±4.214 |
10 | 100.94 | 100.46 | 105.82 | 101.99 | 94.50 | 99.83 | 100.59±3.664 |
第五组 | |||||||
取样时间(分) | 溶出度(%) | ||||||
1 | 2 | 3 | 4 | 5 | 6 | 平均 | |
3 | 94.69 | 90.15 | 89.48 | 91.48 | 85.01 | 88.28 | 89.85±3.230 |
5 | 107.56 | 101.44 | 102.39 | 101.72 | 94.73 | 96.43 | 100.71±4.590 |
10 | 106.31 | 102.86 | 103.58 | 101.30 | 95.61 | 97.99 | 101.27±3.900 |
第六组 | |||||||
取样时间(分) | 溶出度(%) | ||||||
1 | 2 | 3 | 4 | 5 | 6 | 平均 | |
3 | 82.53 | 87.34 | 92.51 | 95.59 | 91.48 | 91.92 | 90.23±4.602 |
5 | 92.44 | 99.89 | 105.95 | 103.31 | 105.84 | 104.24 | 101.94±5.154 |
10 | 92.82 | 100.24 | 105.29 | 101.59 | 104.85 | 103.74 | 101.42±4.638 |
实施例1 | |||||||
取样时间(分) | 溶出度(%) | ||||||
1 | 2 | 3 | 4 | 5 | 6 | 平均 | |
3 | 88.78 | 91.00 | 88.53 | 92.42 | 85.45 | 90.24 | 89.40±2.413 |
5 | 99.41 | 106.40 | 101.82 | 104.11 | 94.16 | 100.86 | 101.13±4.214 | |
10 | 100.94 | 100.46 | 105.82 | 101.99 | 94.50 | 99.83 | 100.59±3.664 | |
实施例2 | ||||||||
取样时间(分) | 溶出度(%) | |||||||
1 | 2 | 3 | 4 | 5 | 6 | 平均 | ||
3 | 86.66 | 91.59 | 91.17 | 84.99 | 90.25 | 85.74 | 88.40±2.934 | |
5 | 98.90 | 101.07 | 102.33 | 99.07 | 106.42 | 98.96 | 102.33±2.945 | |
10 | 99.61 | 99.35 | 105.00 | 98.07 | 104.55 | 96.77 | 100.56±3.423 | |
实施例3 | ||||||||
取样时间(分) | 溶出度(%) | |||||||
1 | 2 | 3 | 4 | 5 | 6 | 平均 | ||
3 | 87.46 | 88.47 | 84.94 | 92.42 | 91.68 | 90.68 | 89.27±2.841 | |
5 | 97.99 | 98.10 | 97.38 | 105.43 | 99.63 | 101.99 | 100.09±3.098 | |
10 | 98.21 | 100.45 | 98.08 | 103.72 | 99.57 | 100.93 | 100.16±2.088 |
取样时间(分) | 3 | 5 | 10 |
实施例1 | 89.40 | 101.13 | 100.59 |
实施例2 | 88.40 | 102.33 | 100.56 |
实施例3 | 89.27 | 100.09 | 100.16 |
平均溶出(%) | 89.02±0.54 | 101.18±1.12 | 100.44±0.24 |
RSD(%) | 0.61 | 1.10 | 0.24 |
实施例 | 1 | 2 | 3 |
溶出量% | 100.94100.46105.82101.9994.5099.83 | 99.6199.35105.0098.07104.5596.77 | 98.21100.4598.08103.7299.57100.93 |
平均值 | 100.59%±3.664 | 100.56%±3.423 | 100.16%±2.088 |
实施例 | 1 | 2 | 3 |
结果 | 1分30秒崩解 | 1分45秒崩解 | 1分30秒崩解 |
结论 | 符合规定 | 符合规定 | 符合规定 |
实施例 | 1 | 2 | 3 |
细菌数(个/g)霉菌数(个/g)大肠杆菌活螨结论 | 40<10未检出未检出符合规定 | 60<10未检出未检出符合规定 | 30<10未检出10未检出符合规定 |
浓度C(μg/ml) | 3.472 | 34.72 | 69.44 | 138.88 | 277.76 | 434 |
峰面积A | 11672 | 116062 | 229544.5 | 457632.5 | 906422 | 1423171.5 |
回归方程 | A=3271.6C+1577.7 r=0.9999 |
加入量(mg) | 峰面积 | 测得量(mg) | 回收率(%) | 平均回收率(%) | RSD(%) | |
低浓度 | 34.935.231 | 567859.5589113.5509594 | 34.3535.6330.82 | 98.42101.2399.43 | 99.61±0.90 | 0.90 |
中浓度 | 42.644.440.3 | 694672.5732887.5661477.5 | 59.2758.7358.82 | 98.78101.2599.19 | ||
同浓度 | 48.251.648.6 | 802864847985799837.5 | 48.5651.2948.38 | 100.7599.4099.54 | ||
对照品202μg/ml 715821.5 |
时间(min) | 0 | 30 | 60 | 90 | 120 |
峰面积A | 621057.5 | 629182 | 623860.5 | 614323.5 | 601047 |
A±SD | 617894.1±10835.1 | ||||
RSD% | 1.75% |
实施例 | 平均片重(g) | 含量(标示量%) |
1 | 0.1045 | 100.24 |
2 | 0.1073 | 101.36 |
3 | 0.1059 | 99.14 |
时间(天) | 外观色泽 | 有关物质% | 溶出度(%) | 分散均匀性 | 含量(标示量%) |
0510 | 淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整 | 1.685.1610.61 | 符合规定符合规定符合规定 | 符合规定符合规定符合规定 | 100.3786.0178.13 |
时间(天) | 外观色泽 | 有关物质% | 溶出度(%) | 分散均匀性 | 含量(标示量%) |
05 | 淡红色片,表面光滑完整淡红色片,表面光滑完整 | 1.682.73 | 符合规定符合规定 | 符合规定符合规定 | 100.3799.60 |
10 | 淡红色片,表面光滑完整 | 2.74 | 符合规定 | 符合规定 | 101.15 |
时间(天) | 外观色泽 | 有关物质% | 溶出度(%) | 分散均匀性 | 吸湿(%) | 含量(标示量%) |
0510 | 表面光滑完整表面光滑完整吸潮变松 | 1.681.561.82 | 符合规定符合规定符合规定 | 符合规定符合规定符合规定 | -0.932.14 | 100.3799.19100.30 |
实施例 | 时间(月) | 外观色泽 | 有关物质(%) | 溶出度(%) | 分散均匀性 | 含量(标示量%) |
1 | 01236 | 淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整 | 1.681.661.712.042.24 | 符合规定符合规定符合规定符合规定符合规定 | 符合规定符合规定符合规定符合规定符合规定 | 100.3799.5499.94100.22101.09 |
2 | 01236 | 淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整 | 1.561.891.882.462.18 | 符合规定符合规定符合规定符合规定符合规定 | 符合规定符合规定符合规定符合规定符合规定 | 98.4698.8798.2599.1899.39 |
3 | 01236 | 淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整 | 1.761.901.811.802.23 | 符合规定符合规定符合规定符合规定符合规定 | 符合规定符合规定符合规定符合规定符合规定 | 102.14102.00102.03101.44101.88 |
实施例 | 时间/月 | 外观色泽 | 有关物质% | 溶出度(%) | 分散均匀性 | 含量(标示量%) |
1 | 0369 | 淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整 | 1.681.741.661.60 | 符合规定符合规定符合规定符合规定 | 符合规定符合规定符合规定符合规定 | 100.37100.54100.72100.21 |
2 | 0369 | 淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整 | 1.561.861.561.58 | 符合规定符合规定符合规定符合规定 | 符合规定符合规定符合规定符合规定 | 98.4698.8898.8599.95 |
3 | 0369 | 淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整淡红色片,表面光滑完整 | 1.781.771.811.92 | 符合规定符合规定符合规定符合规定 | 符合规定符合规定符合规定符合规定 | 102.14100.99102.05100.53 |
给药量(ug) | Tmax(h) | Cmax(pgml-1) | ΔCmax(pg·ml-1) | ΔCmax%(%) | ΔAUC12 0(pgh·ml-1) | t1/2(h) |
120 | 2.8±0.2 | 743±47 | 37±15 | 5.1±2.1 | 168±58 | 计算不出 |
1500 | 3.6±0.5 | 972±55 | 255±51 | 36.0±7.9 | 2033±51 | 12.5 |
Claims (4)
Priority Applications (1)
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CNB2005101057972A CN100348201C (zh) | 2005-09-29 | 2005-09-29 | 甲钴胺分散片及其制备方法 |
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