CN1129105A - 预防和治疗偏头痛的偏头痛片 - Google Patents
预防和治疗偏头痛的偏头痛片 Download PDFInfo
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Abstract
本发明涉及一种预防和治疗偏头痛的偏头痛片，它主含咖啡因、盐酸普萘洛尔和苯妥英钠，其1片中各组分含量分别为60-100mg、8-150mg和80-150mg。该发明能拮抗血小板聚集，防止颅内动脉痉挛，增加颅外动脉阻力，阻滞血管扩张，从而缓解偏头痛发作。经临床试用结果表明总有效率达93％以上，是一种预防和治疗偏头痛的固体糖衣片。
Description
本发明涉及一种治疗偏头痛类药，它系一种具有预防和治疗偏头痛的固体糖衣片。
偏头痛是常见病和多发病，平均发病率5-10％。特别是在中国，随着城乡差别的缩小，人民生活节奏的变快，患病率会有增无减。目前治疗偏头痛的药物，如：麦角胺及麦角碱类衍生物，苯噻啶，噻庚啶，普萘洛尔，阿斯匹林及其它非甾体抗炎药，可乐定，安定以及近年来出现的尼莫地平和氟桂嗪等。这些药物治疗偏头痛都不同程度的存在着有效率低或有一定毒副作用的缺点。复方制剂麦角胺咖啡因片亦因长期应用可致毒副作用及药物依赖性或成瘾而受到限制。
本发明的目的是提供一种有效率高，毒性低，副作用小，具有一定安全性治疗偏头痛的药物。
本发明主含咖啡因、盐酸普萘洛尔、苯妥英钠，均为标示量的90.0-110.0％。
其处方：咖啡因 60-100mg
盐酸普萘洛尔 8-15mg
苯妥英钠 80-150mg
20％淀粉浆 30-55mg
硬脂酸镁 5-10mg
制成 1片
制备方法：采用符合“中国药典”八五年版规定的咖啡因、盐酸普萘洛尔、苯妥英钠，依次称取原辅料，分别过筛，混合均匀，用20％淀粉浆作粘合剂制成软材，通过10尼龙筛制粒，在摄氏60度以下烘干4-6小时，自然冷却，再通过14目筛整粒，加硬脂酸镁混合均匀，压片，包衣制成。
下面对各组份的作用及选定说明如下：
1、咖啡因为中枢兴奋药，多年来与麦角胺合用治疗偏头痛，其抗偏头痛作用与其对脑血管的收缩作用有关。它可通过抑制血小板聚集达到治疗偏头痛的作用。
2、盐酸普萘洛尔为β受体阻断剂，其抗偏头痛机理与其β受体阻断防止颅外血管扩张有关。大剂量普萘洛尔可抑制血小板聚集，减少5-HT受体，这些作用与防止颅内收缩而表现抗偏头痛作用有关。
3、苯妥英钠为抗癫痫病药，也用于治疗偏头痛，与其膜稳定作用有关。
偏头痛的发病机理，主要是由于血小板功能异常，释放大量5-HT，引起颅内动脉收缩，以致脑组织缺氧，反应性地使组胺和缓激肽等血管物质增加，同时5-HT迅速被破坏，因而使颅外动脉扩张导致偏头痛发作。因此，凡能拮抗5-HT受体功能，增加颅外动脉阻力或抗血小板聚集的药物都有缓解和预防偏头痛发作的作用。
本发明所含的咖啡因、盐酸普萘洛尔、苯妥英钠均可影响偏头痛发病的某些环节，故三者合用组成的“偏头痛片”在治疗方面可产生下列有益效果：1、抗血小板聚集作用，三药有协同作用，从而防止颅内动脉痉挛；2、防止颅外动脉扩张方面，咖啡因和盐酸普萘洛尔有协同作用，从而增加颅外动脉阻力，缓解偏头痛发作；3、膜稳定作用，盐酸普萘洛尔和苯妥英钠有协同作用，对阻滞血管扩张所致的痛觉传导有有力作用；4、盐酸普萘洛尔和苯妥英钠的中枢抑制作用能被咖啡因所减弱；5、偏头痛片所用剂量大大低于各药单用剂量，偏头痛片每次口服1片，每片最佳含量为咖啡因70mg、盐酸萘洛尔10mg、苯妥英钠100mg，而它们的常用剂量分别为100mg-300mg，80mg-120mg和100mg-200mg，由于偏头痛片所用剂量小，故副作用大大减低。本发明经临床试用结果表明总有效率达93％以上。
偏头痛片与苯噻啶片及安慰剂片经临床试用疗效比较结果见表
表一：三药疗效比较结果
| 药品名称 | 例数 | 治愈 | 显效 | 有 效 | 无效 | ||||
| 例数 | ％ | 例数 | ％ | 例数 | ％ | 例数 | ％ | ||
| 偏头痛片 | 32 | 8 | 25 | 13 | 40.82 | 9 | 28.13 | 2 | 8.25 |
| 苯噻啶片 | 30 | 2 | 6.67 | 7 | 23.33 | 11 | 36.67 | 10 | 33.33 |
| 安慰剂片 | 31 | 0 | 0 | 3 | 8.88 | 8 | 25.80 | 20 | 64.22 |
三种药物副作用比较见表二
表二：三种药物副作用比较结果
| 药品名称 | 例数 | 无副作用 | 头昏 | 口 干 | 睡眠困难 | 倦 怠 | 胃肠道不舒 | 其它副作用 | |||||||
| 例数 | ％ | 例数 | ％ | 例数 | ％ | 例数 | ％ | 例数 | ％ | 例数 | ％ | 例数 | ％ | ||
| 偏头痛片 | 32 | 26 | 81.25 | 1 | 3.12 | 0 | 0 | 3 | 9.3 | 0 | 0 | 1 | 3.12 | 1 | 3.12 |
| 苯噻啶片 | 30 | 20 | 66.68 | 3 | 10 | 1 | 3.33 | 1 | 3.33 | 3 | 10 | 1 | 3.33 | 1 | 3.33 |
| 安慰剂片 | 31 | 28 | 90.31 | 1 | 3.23 | 0 | 3.23 | 1 | 3.23 | 1 | 3.23 | 0 | 0 | 0 | 0 |
本发明的具体实例如下：
最佳实例为：1片中含咖啡因70mg，盐酸普萘洛尔10mg，苯妥英钠100mg。
Claims (4)
1、一种预防和治疗偏头痛的偏头痛片，它是由咖啡因、盐酸普萘洛尔和苯妥英钠组成的固体糖衣片，其1片中各组份的含量分别为60-100mg，8-15mg和80-150mg。
2、根据权利要求1所述的偏头痛片。其特征在于三种组份按比例混合均匀后，用20％淀粉浆作粘合剂制成软材，淀粉浆用量控制在每片30-55mg。
3、根据权利要求2所述的偏头痛片，其特征在于将上述软材经烘干冷却后，加硬脂酸镁混合，压片。
4、根据权利要求3所述的偏头痛片，其特征在于1片中各组份最佳含量为咖啡因70mg，盐酸普萘洛尔10mg和苯妥英钠100mg。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN94116067A CN1049117C (zh) | 1994-09-16 | 1994-09-16 | 预防和治疗偏头痛的偏头痛片 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN94116067A CN1049117C (zh) | 1994-09-16 | 1994-09-16 | 预防和治疗偏头痛的偏头痛片 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1129105A true CN1129105A (zh) | 1996-08-21 |
| CN1049117C CN1049117C (zh) | 2000-02-09 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN94116067A Expired - Lifetime CN1049117C (zh) | 1994-09-16 | 1994-09-16 | 预防和治疗偏头痛的偏头痛片 |
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| Country | Link |
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| CN (1) | CN1049117C (zh) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004075856A3 (en) * | 2003-02-24 | 2005-03-31 | Novacardia Inc | Adenosine a1 receptor antagonist for the treatment of cardiac and renal diseases |
| US7579331B2 (en) | 2003-04-25 | 2009-08-25 | Novacardia, Inc. | Method of improved diuresis in individuals with impaired renal function |
| CN102125522B (zh) * | 2010-01-15 | 2013-01-16 | 复旦大学附属华山医院 | P-糖蛋白单克隆抗体修饰的苯妥英靶向纳米制剂及其制备方法 |
| CN103446156A (zh) * | 2013-08-20 | 2013-12-18 | 云南农业大学 | 咖啡因在制备抗凝血药物中的应用 |
-
1994
- 1994-09-16 CN CN94116067A patent/CN1049117C/zh not_active Expired - Lifetime
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004075856A3 (en) * | 2003-02-24 | 2005-03-31 | Novacardia Inc | Adenosine a1 receptor antagonist for the treatment of cardiac and renal diseases |
| AU2004216133B2 (en) * | 2003-02-24 | 2008-12-04 | Novacardia, Inc. | Adenosine A1 receptor antagonist for the treatment of cardiac and renal diseases |
| US7579331B2 (en) | 2003-04-25 | 2009-08-25 | Novacardia, Inc. | Method of improved diuresis in individuals with impaired renal function |
| CN102125522B (zh) * | 2010-01-15 | 2013-01-16 | 复旦大学附属华山医院 | P-糖蛋白单克隆抗体修饰的苯妥英靶向纳米制剂及其制备方法 |
| CN103446156A (zh) * | 2013-08-20 | 2013-12-18 | 云南农业大学 | 咖啡因在制备抗凝血药物中的应用 |
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| Publication number | Publication date |
|---|---|
| CN1049117C (zh) | 2000-02-09 |
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