CN101219140B - 盐酸苄达明可溶片及其制备方法 - Google Patents
盐酸苄达明可溶片及其制备方法 Download PDFInfo
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- CN101219140B CN101219140B CN2007100932025A CN200710093202A CN101219140B CN 101219140 B CN101219140 B CN 101219140B CN 2007100932025 A CN2007100932025 A CN 2007100932025A CN 200710093202 A CN200710093202 A CN 200710093202A CN 101219140 B CN101219140 B CN 101219140B
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- benzydamine hydrochloride
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- benzydamine
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Description
批号 | 实验天数(天) | 外观 | 崩解时限 | 增失重(%) | 标示含量(%) | 有关物质(%) |
060901 | 0 | 类白色片 | 1′40″ | - | 97.92 | 0.27 |
5 | 类白色片 | 1′20″ | -0.09 | 97.89 | 0.24 | |
10 | 类白色片 | 1′25″ | -0.09 | 97.96 | 0.24 |
批号 | 实验天数(天) | 外观 | 崩解时限 | 增失重(%) | 标示含量(%) | 有关物质(%) |
060901 | 0 | 类白色片 | 1′40″ | - | 97.92 | 0.27 |
5 | 类白色片 | 1′21″ | -3.15 | 98.27 | 0.26 | |
10 | 类白色片 | 1′27″ | -5.18 | 97.40 | 0.25 |
批号 | 实验天数(天) | 外观 | 崩解时限 | 增失重(%) | 标示含量(%) | 有关物质(%) |
060901 | 0 | 类白色片 | 1′40″ | - | 97.92 | 0.27 |
5 | 类白色片 | 1′23″ | -1.00 | 98.58 | 0.26 | |
10 | 类白色片 | 1′22″ | -9.84 | 97.34 | 0.27 |
批号 | 实验天数(天) | 外观 | 崩解时限 | 增失重(%) | 含量(%) | 有关物质(%) |
060901 | 0 | 类白色片 | 1′40″ | - | 97.92 | 0.27 |
5 | 类白色片 | 1′27″ | 1.02 | 99.56 | 0.26 | |
10 | 类白色片、略膨胀 | 1′26″ | 2.17 | 99.52 | 0.24 |
批号 | 实验天数(天) | 外观 | 崩解时限 | 增失重(%) | 含量(%) | 有关物质(%) |
060901 | 0 | 类白色片 | 1′40″ | - | 97.92 | 0.27 |
5 | 类白色片 | 1′26″ | 7.15 | 99.28 | 0.26 | |
10 | 类白色片、膨胀破裂 | 1′25″ | 20.12 | 98.48 | 0.26 |
批号 | 试验月数 | 性状 | 崩解时限 | 有关物质(%) | 标示含量(%) |
061101 | 0 | 光洁、白色片 | 1′40″ | 0.29 | 97.44 |
1 | 光洁、白色片 | 1′20″ | 0.32 | 97.72 | |
2 | 光洁、白色片 | 1′25″ | 0.33 | 97.31 | |
3 | 光洁、白色片 | 1′40″ | 0.35 | 98.34 | |
6 | 光洁、白色片 | 1′42″ | 0.42 | 97.52 |
061102 | 0 | 光洁、白色片 | 1′40″ | 0.29 | 101.88 |
1 | 光洁、白色片 | 1′33″ | 0.29 | 102.06 | |
2 | 光洁、白色片 | 1′25″ | 0.34 | 101.48 | |
3 | 光洁、白色片 | 1′30″ | 0.35 | 101.96 | |
6 | 光洁、白色片 | 1′37″ | 0.42 | 101.76 | |
061103 | 0 | 光洁、白色片 | 1′45″ | 0.27 | 99.45 |
1 | 光洁、白色片 | 1′27″ | 0.27 | 99.82 | |
2 | 光洁、白色片 | 1′40″ | 0.31 | 98.87 | |
3 | 光洁、白色片 | 1′34″ | 0.31 | 99.18 | |
6 | 光洁、白色片 | 1′49″ | 0.40 | 98.71 |
批号 | 试验月数 | 性状 | 崩解时限 | 有关物质(%) | 标示含量(%) |
061101 | 0 | 光洁、白色片 | 1′40″ | 0.29 | 97.44 |
3 | 光洁、白色片 | 1′34″ | 0.29 | 97.61 | |
6 | 光洁、白色片 | 1′35″ | 0.30 | 97.84 | |
061102 | 0 | 光洁、白色片 | 1′40″ | 0.29 | 101.88 |
3 | 光洁、白色片 | 1′42″ | 0.28 | 101.47 | |
6 | 光洁、白色片 | 1′44″ | 0.31 | 102.22 |
061103 | 0 | 光洁、白色片 | 1′45″ | 0.27 | 99.45 |
3 | 光洁、白色片 | 1′38″ | 0.28 | 99.60 | |
6 | 光洁、白色片 | 1′48″ | 0.26 | 100.22 |
刺激反应 | 分值 | 分值 | |
红斑 | 水肿 | 0 | |
无红斑 | 0 | 无水肿 | 0 |
勉强可见 | 1 | 勉强可见 | 1 |
明显可见 | 2 | 明显隆起轮廓清楚 | 2 |
严重红斑 | 3 | 隆起1mm并有范围扩大 | 4 |
紫红色红斑并有焦痂形成 | 4 | 最高总分值 | 8 |
强度评价 | 分值 |
无刺激性 | <0.5 |
轻度刺激 | <2.99 |
中度刺激 | <6 |
强刺激 | >6 |
组别 | 完整皮肤 | 破损皮肤 | ||||||
药物及赋形剂 | 盐酸苄达明可溶片 | 赋形剂 | 盐酸苄达明可溶片 | 外涂赋形剂 | ||||
剂量(mg/kg) | 528 | 等量 | 528 | 等量 | ||||
体重变化(g.x±SD) | 药前 | 107.4±6.9 | 111.0±7.6 | 111.5±6.0 | 112.9±10.4 | |||
药后7天 | 147.6±15.6 | 153.2±14.2 | 148.1±14.5 | 151.4±22.7 | ||||
药后14天 | 175.4±19.4 | 174.8±16.9 | 162.9±7.7 | 162.6±6.7 | ||||
药后反应平均值(n=10) | 红斑 | 水肿 | 红斑 | 水肿 | 红斑 | 水肿 | 红斑 | 水肿 |
0 | 0 | 0 | 0 | 0.9±0.7 | 0.2±0.4 | 1.3±0.5 | 0.3±0.5 | |
0 | 0 | 0 | 0 | 0.3±0.5 | 0 | 0.3±0.5 | 0.9±0.7 | |
0 | 0 | 0 | 0 | 0.1±0.3 | 0 | 0.2±0.4 | 0 | |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
组别 | 完整皮肤 | 破损皮肤 | |||||||
药物及赋形剂 | 赋形剂 | 盐酸苄达明可溶片 | 赋形剂 | 盐酸苄达明可溶片 | |||||
剂量(mg/kg.d) | 2g/kg | 285.3 | 2g/kg | 285.3 | |||||
体重变化(g.x±SD) | 药前 | 282.2±8.83 | 281.76±8.38 | 284.9±8.19 | 281.8±8.54 | ||||
药后7天 | 313.9±9.6 | 311.7±11.3 | 316.8±8.39 | 306.1±5.4 | |||||
药后14天 | 342.3±17.6 | 344.0±16 | 343.2±15.2 | 342.2±12.7 | |||||
末次涂后刺激反应平均值(n=5) | 红斑 | 水肿 | 红斑 | 水肿 | 红斑 | 水肿 | 红斑 | 水肿 | |
1h | 0 | 0 | 0 | 0 | 0.83±0.8 | 0.17±0.4 | 0.83±0.8 | 0.33±0.5 | |
24h | 0 | 0 | 0 | 0 | 0.5±0.5 | 0 | 0.5±0.5 | 0 | |
48h | 0 | 0 | 0 | 0 | 0 | 0 | 0.3±0.5 | 0 | |
72h | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
组别 | 完整皮肤 | 破损皮肤 | ||||
药物及赋形剂 | 盐酸苄达明可溶片剂 | 赋形剂 | 盐酸苄达明可溶片剂 | 外涂赋形剂 | ||
剂量(mg/kg) | 165 | 涂等体积 | 165 | 涂等体积 | ||
停药后皮肤刺激反应评分值 | 1h | 红斑 | 0.5±0.6 | 0.25±0.5 | 1.5±0.6 | 1.25±0.5 |
水肿 | 0.25±0.5 | 0 | 0.5±0.6 | 0.5±0.6 | ||
24h | 红斑 | 0 | 0 | 1.5±0.6 | 1.25±0.5 | |
水肿 | 0 | 0 | 0 | 0.5±0.6 | ||
48h | 红斑 | 0 | 0 | 0 | 0 | |
水肿 | 0 | 0 | 0 | 0 | ||
72h | 红斑 | 0 | 0 | 0 | 0 | |
水肿 | 0 | 0 | 0 | 0 |
皮肤反应 | 分值 | 分值 | |
红斑形成: | 水肿形成: | ||
无红斑 | 0 | 无水肿 | 0 |
轻度红斑 | 1 | 轻度水肿 | 1 |
中度红斑 | 2 | 中度水肿 | 2 |
重度红斑 | 3 | 重度水肿 | 3 |
水肿性红斑 | 4 | 积分 | 7 |
致敏率(%) | 分级 | 反应强度 |
0-8 | 1 | 弱致敏性 |
9-28 | 2 | 轻度致敏性 |
29-64 | 3 | 中度致敏性 |
65-80 | 4 | 强致敏性 |
81-100 | 5 | 极强致敏 |
试验组别 | 10%赋形剂 | 1%盐酸苄达明可溶片 | 1%二硝基氯代苯 | |
动物数(只) | 10 | 10 | 10 | |
不同时间皮肤过敏反应平均值(h) | 0 | 0 | 0 | 6.4±0.8 |
24 | 0 | 0 | 5.0±0.7 | |
48 | 0 | 0 | 3.3±1.1 | |
72 | 0 | 0 | 1.5±0.8 | |
致敏率(%) | 0 | 0 | 100 | |
体重变化(g.x±SD) | 0d | 264.9±9.9 | 266.5±10.3 | 269.7±10.6 |
14d | 311.4±19.6 | 310.5±17.1 | 300.0±16.1 | |
28d | 372.2±20.8 | 346.9±32.9 | 355.7±18.1 |
Claims (4)
Priority Applications (1)
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CN2007100932025A CN101219140B (zh) | 2007-12-24 | 2007-12-24 | 盐酸苄达明可溶片及其制备方法 |
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CN2007100932025A CN101219140B (zh) | 2007-12-24 | 2007-12-24 | 盐酸苄达明可溶片及其制备方法 |
Publications (2)
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CN101219140A CN101219140A (zh) | 2008-07-16 |
CN101219140B true CN101219140B (zh) | 2011-06-01 |
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Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1143909A (zh) * | 1994-03-01 | 1997-02-26 | 方济各安吉利克化学联合股份有限公司 | 含有镇咳药和苄达明的镇咳组合物 |
US6913759B2 (en) * | 2003-03-11 | 2005-07-05 | Curatek Pharmaceuticals Holding, Inc. | Gel composition and method for treatment of vaginal infections |
CN1957928A (zh) * | 2005-09-26 | 2007-05-09 | 北京吉厚成科技有限公司 | 临床治疗用药物的缓释制剂及其制备方法 |
-
2007
- 2007-12-24 CN CN2007100932025A patent/CN101219140B/zh active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1143909A (zh) * | 1994-03-01 | 1997-02-26 | 方济各安吉利克化学联合股份有限公司 | 含有镇咳药和苄达明的镇咳组合物 |
US6913759B2 (en) * | 2003-03-11 | 2005-07-05 | Curatek Pharmaceuticals Holding, Inc. | Gel composition and method for treatment of vaginal infections |
CN1957928A (zh) * | 2005-09-26 | 2007-05-09 | 北京吉厚成科技有限公司 | 临床治疗用药物的缓释制剂及其制备方法 |
Non-Patent Citations (1)
Title |
---|
张强、武凤兰主编.无.《药剂学》.北京大学医学出版社,2005,(第1版),173-176. * |
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Owner name: CHONGQING LAIMEI MEDICINE TECHNOLOGY CO., LTD. Free format text: FORMER OWNER: GUANGXI HUAHONG PHARMACEUTICAL CO., LTD. Effective date: 20110322 |
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Assignee: CHONGQING SUCCEWAY PHARMACEUTICAL CO., LTD. Assignor: Chongqing City laimei Pharmaceutical Technology Co., Ltd. Contract record no.: 2012500000031 Denomination of invention: Benzydamine Hcl soluble tablet and method for preparing the same Granted publication date: 20110601 License type: Exclusive License Open date: 20080716 Record date: 20120507 |
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Effective date of registration: 20120528 Address after: 402566 Jinlong Industrial Zone, Tongliang County, Chongqing Patentee after: CHONGQING SUCCEWAY PHARMACEUTICAL CO., LTD. Address before: 400041, Chongqing high-tech zone standard workshop J block 7 Building Patentee before: Chongqing City laimei Pharmaceutical Technology Co., Ltd. |
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Application publication date: 20080716 Assignee: CHONGQING SUCCEWAY PHARMACEUTICAL CO., LTD. Assignor: Chongqing City laimei Pharmaceutical Technology Co., Ltd. Contract record no.: 2012500000031 Denomination of invention: Benzydamine Hcl soluble tablet and method for preparing the same Granted publication date: 20110601 License type: Exclusive License Record date: 20120507 |
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