CN100353953C - 治疗口腔、咽喉疾病的中药制剂及其制备方法 - Google Patents
治疗口腔、咽喉疾病的中药制剂及其制备方法 Download PDFInfo
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组别 | 动物数(只) | 剂量 | 左右耳片重量差mg(x±SD) | 肿胀抑制率(%) | P值 |
NS | 20 | 0.2ml/10g | 15.6±2.3 | ||
治疗药 | 20 | 0.12g/10g | 10.3±3.0 | 31.6 | 0.05 |
组别 | 扭体反应次数(x±SD) | 扭体反应抑制率(%) |
对照 | 3.2±1.0 | - |
药物140mg/10g | 1.56±0.9 | 52.4 |
药物280mg/10g | 0.96±0.3 | 76.5 |
时间(h) | 体温(℃) | |||||
对照组 | 小剂量组(1.4g/100g) | 大剂量组(2.8g/100g) | ||||
测值 | 增减值 | 测值 | 增减值 | 测值 | 增减值 | |
0 | 37.4±0.10 | - | 37.4±0.15 | - | 37.6±0.15 | - |
1 | 37.9±0.10 | 1.87±0.10 | 37.7±0.15 | 0.36±0.12 | 37.2±0.27 | 0.36±0.20 |
2 | 39.1±0.20 | 1.40±0.30 | 38.2±0.20 | 0.81±0.72 | 38.3±0.24 | 0.76±0.74 |
4 | 38.8±0.20 | 0.31±0.10 | 38.3±0.18 | 0.83±0.16 | 37.7±0.42 | 0.51±0.13 |
6 | 38.8±0.13 | 131±0.13 | 38.6±0.20 | 1.23±0.22 | 38.3±0.17 | 0.54±0.16 |
8 | 37.7±0.05 | 0.52±0.13 | 37.6±0.11 | 0.33±0.16 | 37.7±0.17 | 0.20±0.10 |
菌种 | 样品浓度与结果 | |||||||
原液 | 1/2 | 1/4 | 1/8 | 1/16 | 1/32 | 1/64 | 1/128 | |
金黄色葡萄球菌 | + | + | + | + | + | + | - | - |
表皮葡萄球菌 | + | + | + | + | + | + | + | - |
枯草杆菌 | + | + | + | + | + | + | + | - |
变形杆菌 | + | + | + | + | + | + | + | - |
绿脓杆菌 | + | + | + | + | + | + | + | - |
白色念球菌 | + | + | + | + | + | + | + | - |
组别 | 给药前 | 给药后 | p |
X(平均) | X(平均) | ||
空白对照组 | 19.8g | 22.47g | >0.05 |
试验药小剂量组 | 19.6g | 22.50g | >0.05 |
试验药中剂量组 | 19.5g | 22.23g | >0.05 |
试验药大剂量组 | 19.3g | 22.18g | >0.05 |
组别 | 例数 | 显效 | 有效 | 无效 | 有效率 |
治疗组 | 105 | 56 | 39 | 10 | 90.5% |
对照组 | 35 | 16 | 14 | 5 | 85.7% |
病种 | 组别 | 例数 | 显效 | 有效 | 无效 | 有效率 |
急性咽炎 | 治疗组 | 59 | 40 | 16 | 3 | 94.5% |
对照组 | 28 | 19 | 6 | 3 | 89.2% | |
急性扁桃体炎 | 治疗组 | 45 | 15 | 23 | 7 | 84.4% |
对照组 | 7 | 3 | 2 | 2 | 71.4% | |
扁周围炎 | 治疗组 | 1 | 1 | 0 | 0 | 100% |
对照组 | 0 | 0 | 0 | 0 | 0 |
症状与体征 | 组别 | 治疗前例数 | 治疗后有效例数 | 有效率 |
咽痛 | 治疗组 | 96 | 81 | 84.4% |
对照组 | 32 | 25 | 78.1% | |
发热 | 治疗组 | 34 | 23 | 67.6% |
对照组 | 8 | 5 | 62.5% | |
咽粘膜充血 | 治疗组 | 93 | 78 | 83.8% |
对照组 | 22 | 15 | 68.2% | |
颌下淋巴结肿痛 | 治疗组 | 37 | 20 | 54.1% |
对照组 | 12 | 4 | 33.3% |
组别 | 例数 | 显效 | 有效 | 无效 | 有效率 |
八爪金龙∶山豆根∶蝉蜕(3.13∶3.13∶2.5) | 20 | 8 | 11 | 1 | 95% |
八爪金龙∶山豆根∶蝉蜕(2.5∶2.5∶2.0) | 20 | 12 | 7 | 1 | 95% |
八爪金龙∶蝉蜕(3∶1) | 20 | 4 | 9 | 7 | 65% |
样品 | 投料量(g) | 苦参碱含量(%) | 干膏得率(%) | 苦参碱提取量(%) |
123 | 700700700 | 0.2280.2280.228 | 24.1223.6623.70 | 0.3200.3160.317 |
序号 | 取样量(ml) | 含醇量(%) | 干膏得率(%) | 苦参碱提取量(%) |
1 | 100 | 0 | 24.12 | 0.288 |
2 | 100 | 50 | 16.16 | 0.281 |
3 | 100 | 60 | 14.96 | 0.275 |
4 | 100 | 70 | 13.71 | 0.270 |
5 | 100 | 80 | 12.47 | 0.268 |
6 | 100 | 85 | 12.33 | 0.266 |
序号 | 药液密度 | 含醇量(%) | 干膏得率(%) | 苦参碱提取量(%) |
1 | 1.05 | 80 | 12.66 | 0.291 |
2 | 1.10 | 80 | 12.54 | 0.286 |
3 | 1.15 | 80 | 11.81 | 0.241 |
4 | 1.20 | 80 | 11.43 | 0.231 |
5 | 1.25 | 80 | 11.17 | 0.225 |
6 | 1.30 | 80 | 10.33 | 0.209 |
7 | 1.35 | 80 | 10.05 | 0.204 |
序号 | 冰片量(g) | 甜菊素量(g) | 试用人数 | 结果 |
123456 | 0(原处方)0.010.050.080.090.10 | 0(原处方)0.51.01.52.02.5 | 505050505050 | 苦麻,口感差(100%)差(100%)差(84%)一般(28%)好(96%)冰片味及甜味均较重 |
序号 | 吐温-80用量(ml) | 甘油用量(ml) | 澄明度 | |||
0月 | 1月 | 2月 | 3月 |
12345 | 0(原处方)251015 | 0(原处方)2345 | 澄明澄明澄明澄明澄明 | 产生沉淀产生沉淀澄明澄明澄明 | 增加增加产生沉淀澄明澄明 | 增加增加增加澄明澄明 |
批号 | 041213 | 041217 | 041221 |
药材投料量(kg) | 7.0 | 7.0 | 7.0 |
药材含量(苦参碱)(%) | 0.18 | 0.18 | 0.18 |
灌装量(ml/瓶) | 10 | 10 | 10 |
理论产量(瓶) | 1000 | 1000 | 1000 |
实际产量(瓶) | 972 | 967 | 970 |
成品率(%) | 97.2 | 96.7 | 97.0 |
成品含量(苦参碱)(mg/ml) | 0.284 | 0.292 | 0.288 |
Claims (4)
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Families Citing this family (7)
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CN103040927A (zh) * | 2011-10-13 | 2013-04-17 | 贵州三力制药有限责任公司 | 一种用于治疗咽喉疾病的开喉剑喷雾剂及其制备方法 |
CN104758348B (zh) * | 2015-04-21 | 2019-03-26 | 贵州三力制药股份有限公司 | 一种中药组合物制备用于肿瘤放化疗相关口腔溃疡的用途 |
CN104739922B (zh) * | 2015-04-21 | 2019-03-26 | 贵州三力制药股份有限公司 | 一种中药开喉剑漱口水及其制备方法 |
CN105288009A (zh) * | 2015-10-29 | 2016-02-03 | 林久全 | 一种治疗口腔疾病的药物组合物及其制备方法 |
CN107998177A (zh) * | 2017-12-26 | 2018-05-08 | 贵州三力制药股份有限公司 | 儿童开喉剑喷雾剂及其制备和质量标准检验方法 |
CN110101746A (zh) * | 2019-04-17 | 2019-08-09 | 陕西秦医生优养健康科技有限公司 | 一种维c口腔抑菌药液的制备方法及其喷剂 |
CN115025145B (zh) * | 2022-05-27 | 2023-12-12 | 贵州三力制药股份有限公司 | 改善中药组合物药学性能的方法和组合物及其用途 |
Citations (1)
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CN1502342A (zh) * | 2002-11-26 | 2004-06-09 | 李善祥 | 治疗急慢性咽炎的药物 |
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CN1502342A (zh) * | 2002-11-26 | 2004-06-09 | 李善祥 | 治疗急慢性咽炎的药物 |
Non-Patent Citations (4)
Title |
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八爪金龙为主治疗慢性咽炎的临床疗效观察-附:133例病例报告 项楠.成都中医药大学学报,第19卷第4期 1996 * |
国家中成药标准汇编(中成药地方标准上升国家标准部分) 国家药品监督管理局,68-69,国家药品监督管理局 2002 * |
国家中成药标准汇编(中成药地方标准上升国家标准部分) 国家药品监督管理局,72.73,国家药品监督管理局 2002 * |
开喉剑喷雾剂治疗小儿口腔溃疡 裴方俐.天津中医,第18卷第2期 2001 * |
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