CN101023956A - 口服葛根素磷脂复合物胶囊及其制备方法 - Google Patents
口服葛根素磷脂复合物胶囊及其制备方法 Download PDFInfo
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- CN101023956A CN101023956A CN 200610008872 CN200610008872A CN101023956A CN 101023956 A CN101023956 A CN 101023956A CN 200610008872 CN200610008872 CN 200610008872 CN 200610008872 A CN200610008872 A CN 200610008872A CN 101023956 A CN101023956 A CN 101023956A
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Abstract
Description
药品名称 | 病症 | ||
冠心病 | 急性缺血性脑血管病 | 清除羟自由基 | |
葛根素注射液 | ++ | + | ++ |
参麦注射液 | + | - | - |
复方丹参注射液 | + | - | - |
去纤酶 | - | ++ | - |
脉络宁 | - | + | - |
丹参注射液 | - | - | + |
川芎嗪注射液 | - | - | + |
果糖二磷酸钠 | + | - | - |
不良反应 | 发生频数 | 构成比(1%) |
发热 | 156 | 79.2 |
变态反应 | 26 | 13.2 |
溶血反应 | 7 | 3.5 |
丙氨酸转氨酶升高 | 2 | 1.0 |
肾绞痛 | 1 | 0.5 |
一过性血红蛋白尿 | 1 | 0.5 |
其它 | 4 | 2.0 |
药物名(注射剂) | 例数 | 构成比(%) | 药物名(注射剂) | 例数 | 构成比(%) |
双黄连 | 36 | 29.0 | 复方丹参 | 2 | 1.6 |
葛根素 | 16 | 12.9 | 大黄藤素 | 2 | 1.6 |
清开灵 | 12 | 9.7 | 鸭胆子油乳 | 2 | 1.6 |
刺五加 | 8 | 6.5 | 肝炎宁 | 1 | 0.8 |
穿琥宁 | 6 | 4.8 | 黄芪 | 1 | 0.8 |
脉络宁 | 5 | 4.0 | 正清风痛灵 | 1 | 0.8 |
茵栀黄 | 5 | 4.0 | β-七叶皂苷钠 | 1 | 0.8 |
生脉 | 5 | 4.0 | 柴胡+庆大酶素 | 2 | 1.6 |
灯盏花素 | 4 | 3.3 | 复方丹参+右旋糖酐 | 4 | 3.3 |
猪苓多糖 | 4 | 3.3 | 灯盏花素+右旋糖酐 | 1 | 0.8 |
参脉 | 3 | 2.4 | 川芎嗪+右旋糖酐 | 1 | 0.8 |
鱼腥草 | 2 | 1.6 | 合计 | 124 | 100 |
水平 | 因素 | ||
A(毫克/毫升) | B(w/w) | C(小时) | |
1 | 100 | 1∶1.8 | 0.5 |
2 | 160 | 1∶1.2 | 1.0 |
3 | 200 | 1∶1 | 2.0 |
批1(040701) | 批2(040702) | 批3(040705) | |
45分钟累积溶出度(%) | 80.67 | 87.18 | 93.27 |
硫酸浓度或饱和盐浓度 | 54% | 48% | 44% | 溴化钠(NaBr) | 氯化钠(NaCl) | 氯化钾(KCl) | 硝酸钾(KNO3) |
RH(%)(25℃) | 30 | 42 | 51 | 56 | 75 | 84 | 92.5 |
样品1吸湿率(%) | -0.277 | 1.314 | 2.262 | 4.149 | 9.787 | 14.428 | 25.123 |
样品2吸湿率(%) | -0.288 | 1.120 | 2.319 | 4.037 | 9.831 | 14.216 | 25.594 |
样品3吸湿率(%) | -0.146 | 1.256 | 2.276 | 3.980 | 10.002 | 14.086 | 26.939 |
平均吸湿率(%) | -0.189 | 1.230 | 2.286 | 4.055 | 9.873 | 14.243 | 25.885 |
试验时间(天) | 性状 | 含量(%) | 溶出度(%)45分钟 | 水分(%) | 分解产物 |
0 | 红色胶囊内装物为浅黄白色粉末 | 94.51 | 96.11 | 0.02 | <2.5% |
5 | 外观无变化内装物略结块 | 94.14 | 86.97 | 0.02 | <2.5% |
10 | 外观无变化内容物略结块 | 95.03 | 89.02 | 0.02 | <2.5% |
试验时间(天) | 性状 | 含量(%) | 溶出度(%)45分钟 | 水分(%) | 分解产物 |
0 | 红色胶囊内装物为浅黄白色粉末 | 94.51 | 96.11 | 0.02 | <2.5% |
5 | 红色胶囊,内容物为浅黄白色粘团状物 | 93.77 | 17.68 | 9.74 | <2.5% |
10 | 囊壳略吸湿,内容物为浅黄白色粘团状物 | 93.54 | 26.91 | 9.66 | <2.5% |
试验时间(天) | 性状 | 含量(%) | 溶出度(%)45分钟 | 水分(%) | 分解产物 |
0 | 红色胶囊内装物为浅黄白色粉末 | 94.51 | 96.11 | 0.02 | <2.5% |
5 | 外观无变化内容物无变化 | 95.92 | 98.40 | 0.02 | <2.5% |
10 | 外观无变化内容物无变化 | 94.78 | 93.86 | 0.02 | <2.5% |
试验时间(天) | 性状 | 含量(%) | 溶出度(%)45分钟 | 水分(%) | 分解产物 |
0 | 红色胶囊内装物为浅黄白色粉末 | 94.51 | 96.11 | 0.02 | <2.5% |
5 | 外观无变化,内容物为浅黄白色粘团状物 | 93.66 | 70.98 | 2.14 | <2.5% |
10 | 外观无变化,内容物为浅黄白色粘团状物 | 94.15 | 30.33 | 5.19 | <2.5% |
累积溶出度 | 1 | 2 | 3 | 4 | 5 | 6 | 平均 |
3分钟 | 13.07 | 24.09 | 24.09 | 24.17 | 23.77 | 23.81 | 21.83 |
5分钟 | 37.92 | 44.53 | 43.56 | 42.61 | 48.15 | 49.98 | 44.46 |
10分钟 | 70.81 | 72.06 | 67.32 | 63.15 | 73.57 | 77.45 | 70.73 |
15分钟 | 86.70 | 86.66 | 81.32 | 79.44 | 86.09 | 88.69 | 84.82 |
20分钟 | 87.56 | 84.95 | 85.97 | 87.24 | 87.52 | 90.17 | 87.24 |
30分钟 | 94.00 | 86.04 | 85.05 | 91.26 | 87.66 | 92.63 | 89.44 |
45分钟 | 92.24 | 85.84 | 88.54 | 99.71 | 85.57 | 85.41 | 89.55 |
累积溶出度 | 1 | 2 | 3 | 4 | 5 | 6 | 平均 |
3分钟 | 42.60 | 46.46 | 46.55 | 46.80 | 46.65 | 52.03 | 46.85 |
5分钟 | 86.91 | 78.37 | 80.47 | 77.59 | 77.33 | 81.44 | 80.35 |
10分钟 | 96.42 | 97.40 | 85.82 | 93.08 | 88.80 | 93.80 | 92.56 |
15分钟 | 94.16 | 94.05 | 91.65 | 90.49 | 92.04 | 93.47 | 92.64 |
20分钟 | 92.36 | 95.92 | 91.35 | 88.63 | 94.35 | 92.97 | 92.60 |
30分钟 | 89.07 | 96.38 | 91.64 | 93.27 | 92.18 | 84.95 | 91.25 |
含T-80处方 | 不含T-80处方 | |||||||
45分钟累积溶出度 | 囊1 | 囊2 | 囊3 | 平均 | 囊1 | 囊2 | 囊3 | 平均 |
41.45 | 18.90 | 23.75 | 28.03 | 81.27 | 64.70 | 107.08 | 84.35 |
批号 | 投料量(千克) | 产量(粒) | 收率(%) | |||
葛根素磷脂复合物 | PVPP | CMS-Na | 微粉硅胶 | |||
040701 | 2.2 | 0.2 | 0.65 | 0.03 | 9530 | 95.3 |
040702 | 2.2 | 0.2 | 0.65 | 0.03 | 9460 | 94.6 |
040705 | 2.2 | 0.2 | 0.65 | 0.03 | 9620 | 96.2 |
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CN105617393A (zh) * | 2016-01-20 | 2016-06-01 | 西安赛邦生物技术有限公司 | 一种水溶性葛根素组合物及制备方法 |
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CN105617393A (zh) * | 2016-01-20 | 2016-06-01 | 西安赛邦生物技术有限公司 | 一种水溶性葛根素组合物及制备方法 |
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