CN1055634C - 降低血粘度的贴剂 - Google Patents
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Abstract
本发明公开了一种降低血粘度的贴剂即清血贴，属于药物组合物的发明。该贴剂由洋葱提取物、茶多酚、烟酸、亚油酸、月桂氮酮、医用压敏胶等组合而成。配制的药胶混合乳液于专利设备盘旋式药膜涂布机制膜而得。用于治疗血粘度、血脂、血糖增高的患者，经动物试验和临床试用取得满意效果。
Description
本发明涉及一种药物组合物，特别是一种降低血粘度的贴剂。
随着生活水平的提高，高糖、高脂的饮食习惯不可避免的造成血脂、血粘度、血糖、血压、胆固醇的提高，甚至形成血栓，过早动脉硬化。近年来降血脂的药物不断出现，多种口服药物剂型应用于临床如降血脂药脉通(Beniol)常因烟酸和亚油酸组分导致恶心呕吐等副作用。
中国专利CN 1095596 A公开了“一种降血脂涂皮液”是在磷脂、无水乙醇液中加入维生素E，搅匀呈乳状液，涂抹于清洁后的腹部及四肢皮肤，达到患者易接受，有效降低血脂的目的。
中国专利CN 10099266 A公开了一种“用齐敦果酸琥珀酸半脂制备的一种降血脂药”，可分别制成片剂、胶囊剂等口服剂型，达到降低人血中甘油三脂和胆固醇含量，升高高密度脂蛋白含量。
本发明的目的是为了提供一种通过透皮给药降低血粘度皮肤贴剂，因此本发明是有区别于现有技术的。
本发明的处方依据：
洋葱提取物·洋葱具有提高纤维蛋白的溶解活性作用，可预防高血压、脑溢血、血管静脉炎以及防治糖尿病有非常好的疗效。其有效成份在挥发油部分，主要是烯丙基丙基二硫化合物、二烯丙基二硫化合物及环蒜氨酸Cyololliin，但在消化道内吸收率仅为21％-30％，故此采用洋葱提取物透皮给药。
烟酸·烟酸的降脂作用一方面是抑制脂肪组织中的脂解作用，降低游离脂肪酸；另一方面还能减少肝中的极低密度脂蛋白的合成。
亚油酸·为不饱和脂肪酸，能与血中胆固醇结合成脂，并可进而促使胆固醇降为胆酸，排出体外。并有降低甘油三脂作用，可预防和治疗动脉硬化症。
茶多酚(TP)·是从茶叶中提出脱咖啡因的高度天然药效成份，有显著清除自由基，抑制由于自由基诱发的人体低密度脂蛋白脂质过氧化现象，具有良好的降低纤维蛋白原效能，改善血液流变性，调解血脂。在处方中还有保护亚油酸不饱和双键，防止被氧化的作用。
月桂氮酮·是近代透皮给药常用的透皮促进剂。
医用压敏胶·保证贴膜药物有效粘附在皮肤表面，能形成药物从贴膜缓释透皮到血液进行全身治疗作用。
本发明药物是由下述重量份的药物组合而成。
洋葱提取物 35-40份
茶 多 酚 85-90份
烟 酸 80-83份
亚 油 酸 95-98份
月桂氮酮 12份
医用压敏胶 2600份
本发明药物组合中，主要药物理想的重量份配比：
洋葱提取物 40份
茶 多 酚 90份
烟 酸 80份
亚 油 酸 95份
本发明药物的制备方法：
1.洋葱提取物：洋葱搅碎成洋葱浆，经水蒸气蒸馏为油状物。
2.洋葱提取物溶于月桂氮酮中，搅拌制成1号混合药液。
3.将烟酸溶于亚油酸中，搅匀制成2号混合药液。
4.另将茶多酚溶于适量乙醇中，搅匀制成3号混合药液。
5.分别将1、2、3号混合药液顺序加入医用压敏胶中，搅匀制成药胶混合乳液。
6.将药胶混合乳液于专利设备盘旋式药膜涂布机制膜即可。
本发明膜药毒性LD50测定结论为：按《食品安全性毒理学评价程序》本发明样品属无毒。
本发明皮肤刺激试验结论为：本膜药对大耳白兔皮肤无刺激作用。
按以上方案制备的降低血粘度的贴剂，经动物体外透皮吸收试验、动物体内药效学试验、临床药效学试验，达到设计要求。
由于透皮给药，有着如下优点：
1.可避免肝脏“首过效应”与肠道干扰的影响，血药浓度持久、恒定，避开不必要的血药浓度“峰谷”现象，生物利用度高。
2.可控制释药速度，随意调整药物用量，作用缓和，性能稳定。
3.能提供一个治疗所需要的接近零级的释药速率。
4.在发生问题时可简单迅速地停止给药，可减少给药频率，同时减轻副作用。
5.使用方便，不污染衣物，病人易于接受。
本发明贴剂的用法用量：
每日一贴，12贴为一疗程，贴于清洁后胸前区皮肤。
本发明贴剂的适应症：
血粘度、血脂、血糖增高患者。
下面结合实施例及附图对本发明贴剂描述之。
附图为本发明工艺流程图。
称取洋葱提取物400克溶于月桂氮酮120克，搅拌制成1号混合药液；再将烟酸800克溶于亚油酸950克中，搅匀制成2号混合药液；用适量75％乙醇溶解茶多酚900克，搅匀制成3号混合药液，最后分别将1、2、3号混合药液按顺序加入医用压敏胶26000克中，制成药胶混合液。药胶混合液经专利设备盘旋式药膜涂布机制膜，干燥成药胶膜材，紫外线灯消毒后复保护硅纸收卷，药胶卷材经膜切机按标准剪裁可得35×45×0.3mm贴片10000贴，密封、包装、入库、备用。
动物体内药效学试验：
| 试验方法 | 使用药物 | 使用量 | 血糖值下降比例 |
| 实验家兔每kg体重投给1g葡萄糖后使用不同药物贴膜与对照组比较 | 洋葱提取物 | 0.125g/kg | 10％左右P＜0.05 |
| 甲苯磺丁脲 | 0.25g/kg | 20％左右P＜0.01 |
临床药效学试验：
| 试验品种 | 例数 | 纤维蛋白溶解活性单位(优球蛋白溶解时间） | |||
| 平均变化 | 平均值偏差 | P值 | |||
| 乙醚提取物(0.25g/贴） | 对照组试验组 | 66 | 634.1 | 28.1 | P＜0.01 |
| 水蒸汽蒸馏(0.125g/贴) | 对照组试验组 | 66 | 3.845.2 | 41.4 | P＜0.01 |
| 环蒜氨酸(0.125g/贴) | 对照组试验组 | 55 | 4.618 | 13.4 | P＜0.01 |
| 测定项目 | 脂肪食 | 脂肪食+贴清血贴 | P值 | ||
| 空腹前 | 饭后 | 空腹前 | 饭后 | ||
| 血清胆固醇 | 221 | 237 | 228 | 225 | P＜0.05 |
| 血浆纤维蛋白原 | 249 | 320 | 366 | 272 | P＜0.01 |
| 全血凝固时间 | 4′15″ | 3′41″ | 4′11″ | 4′36″ | P＜0.01 |
| 纤维蛋白溶解活性 | 83.7 | 43.1 | 80.1 | 93.1 | P＜0.01 |
Claims (2)
1.一种降低血粘度的贴剂，其特征在于该贴剂是由以下重量份的药物组合而成：
洋葱提取物 35-40份
茶 多 酚 85-90份
烟 酸 80-83份
亚 油 酸 95-98份
月桂氮酮 12份
医用压敏胶 2600份
2.根据权利要求1所述的贴剂，其特征在于该贴剂主要药物理想的重量份配比是：
洋葱提取物 40份
茶 多 酚 90份
烟 酸 80份
亚 油 酸 95份
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97119158A CN1055634C (zh) | 1997-10-22 | 1997-10-22 | 降低血粘度的贴剂 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97119158A CN1055634C (zh) | 1997-10-22 | 1997-10-22 | 降低血粘度的贴剂 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1184666A CN1184666A (zh) | 1998-06-17 |
| CN1055634C true CN1055634C (zh) | 2000-08-23 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN97119158A Expired - Fee Related CN1055634C (zh) | 1997-10-22 | 1997-10-22 | 降低血粘度的贴剂 |
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| Country | Link |
|---|---|
| CN (1) | CN1055634C (zh) |
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|---|---|---|---|---|
| WO2020041787A1 (en) * | 2018-08-24 | 2020-02-27 | North Carolina State University | Microneedle-array patches with glucose-responsive matrix for closed-loop insulin delivery |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1075637A (zh) * | 1992-02-28 | 1993-09-01 | 郭如明 | 将蔬菜洋葱开发为新药 |
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1997
- 1997-10-22 CN CN97119158A patent/CN1055634C/zh not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1075637A (zh) * | 1992-02-28 | 1993-09-01 | 郭如明 | 将蔬菜洋葱开发为新药 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1184666A (zh) | 1998-06-17 |
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