CN1739794A - 一种胸腺素α1的水溶液制剂、其制备方法及应用 - Google Patents
一种胸腺素α1的水溶液制剂、其制备方法及应用 Download PDFInfo
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Abstract
Description
批号 | 时间(天) | 考察项目 | |||||
外观性状 | pH值 | 澄明度 | 澄清度与颜色 | 有关物质(%) | 含量(%) | ||
01 | 0 | 无色澄明 | 6.81 | 符合规定 | 澄清无色 | 0.18 | 99.01 |
5 | 无色澄明 | 5.42 | 符合规定 | 澄清无色 | 0.78 | 83.49 | |
10 | 无色澄明 | 5.10 | 符合规定 | 澄清无色 | 1.44 | 79.23 |
批号 | 时间(天) | 考察项目 | |||||
外观性状 | pH值 | 澄明度 | 溶液的澄清度与颜色 | 有关物质(%) | 含量(%) | ||
01 | 0 | 无色澄明 | 6.84 | 符合规定 | 澄清无色 | 0.20 | 99.14 |
5 | 无色澄明 | 6.32 | 符合规定 | 澄清无色 | 3.85 | 80.56 | |
10 | 无色澄明 | 6.11 | 符合规定 | 澄清无色 | 5.02 | 77.2 |
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01 | 0 | 无色澄明 | 6.83 | 符合规定 | 澄清无色 | 0.19 | 99.27 |
5 | 无色澄明 | 6.37 | 符合规定 | 澄清无色 | 0.64 | 93.10 | |
10 | 无色澄明 | 6.25 | 符合规定 | 澄清无色 | 1.39 | 92.44 |
批号 | 时间(天) | 考察项目 | |||||
外观性状 | pH值 | 澄明度 | 溶液的澄清度与颜色 | 有关物质(%) | 含量(%) | ||
01 | 0 | 无色澄明 | 6.82 | 符合规定 | 澄清无色 | 0.23 | 99.58 |
5 | 无色澄明 | 6.79 | 符合规定 | 澄清无色 | 0.45 | 99.17 | |
10 | 无色澄明 | 6.77 | 符合规定 | 澄清无色 | 1.01 | 98.63 |
批号 | 月 | 考察项目 | ||||||
外观性状 | pH | 澄明度 | 有关物质(%) | 内毒素 | 无菌 | 含量(%) | ||
02 | 0 | 无色澄明 | 6.80 | 符合规定 | 0.22 | 符合规定 | 符合规定 | 100.00 |
1 | 无色澄明 | 6.04 | 符合规定 | 5.86 | - | - | 94.92 | |
2 | 溶液浑浊 | 5.86 | 溶液浑浊 | 9.20 | - | - | 87.41 | |
3 | 溶液浑浊 | 5.59 | 溶液浑浊 | 14.55 | - | - | 81.52 | |
6 | 溶液浑浊 | 4.97 | 溶液浑浊 | 20.64 | - | - | 72.48 |
批号 | 月 | 考察项目 | |||||||
外观性状 | 澄清度与颜色 | pH值 | 澄明度 | 有关物质(%) | 内毒素 | 无菌 | 含量(%) | ||
02 | 0 | 无色澄明 | 澄清无色 | 6.78 | 符合规定 | 0.21 | 符合规定 | 符合规定 | 99.85 |
3 | 无色澄明 | 澄清无色 | 6.76 | 符合规定 | 0.28 | 符合规定 | 符合规定 | 99.74 | |
6 | 无色澄明 | 澄清无色 | 6.74 | 符合规定 | 0.30 | 符合规定 | 符合规定 | 99.70 | |
03 | 0 | 无色澄明 | 澄清无色 | 6.82 | 符合规定 | 0.23 | 符合规定 | 符合规定 | 99.57 |
3 | 无色澄明 | 澄清无色 | 6.77 | 符合规定 | 0.31 | 符合规定 | 符合规定 | 99.46 | |
6 | 无色澄明 | 澄清无色 | 6.75 | 符合规定 | 0.35 | 符合规定 | 符合规定 | 99.21 |
成结数/100淋巴细胞 | 平均成结率(%) | |
阴性对照 | 38.2±4.7 | 38.2 |
01号样品 | 54.6±3.6* | 54.6 |
冻干粉针对照(日达仙) | 55.1±3.1* | 55.1 |
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CN104511013A (zh) * | 2013-09-26 | 2015-04-15 | 长春海悦药业有限公司 | 一种含有胸腺肽的药物组合物及其制剂 |
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CN102233130B (zh) * | 2010-04-28 | 2013-05-01 | 江苏豪森药业股份有限公司 | 稳定的含有胸腺肽1衍生物的药物制剂 |
CN104511013A (zh) * | 2013-09-26 | 2015-04-15 | 长春海悦药业有限公司 | 一种含有胸腺肽的药物组合物及其制剂 |
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