CN1785196A - 一种防治心脑血管疾病的复合制剂 - Google Patents
一种防治心脑血管疾病的复合制剂 Download PDFInfo
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Abstract
本发明公开了一种防治心脑血管疾病的复合制剂，该制剂由阿司匹林、叶酸、辛伐他汀、雷米普利组成，加入适量赋形剂制成肠溶片，用于55岁以上的健康或亚健康人群预防和治疗因动脉粥样硬化而引起的高血脂症、高血压病、冠心病、脑中风及糖尿病等。本发明为复方制剂，药物中的四种成分相互提携支持，使疗效得到大幅提升，因而用于心脑血管疾病预防和治疗效果好，不良反应少。
Description
技术领域
本发明涉及心脑血管疾病防治技术，特别是一种防治心脑血管疾病的复合制剂。
背景技术
心脑血管疾病是危机人类生命最常见的疾病，1990年世界范围的前10位的死亡疾病，在发达地区第一位冠心病占24.7％，第二位脑卒中占13.1％；在发展地区冠心病仅次于呼吸道疾病居第二位占9％，脑卒中居第三位占7.5％。心脑血管疾病的病理基础是动脉粥样硬化(以下简称动脉硬化)，动脉硬化多见于40以上的中老年人。动脉硬化的发生与血脂增高和血管内壁损伤有关。动脉硬化的危险因素主要有：
1.高血脂症。研究表明：20-40岁人群，血浆胆固醇浓度超过5.68mmol/L(220mg/dL)时，心肌梗塞的发病率就显著增高，且冠心病死亡危险随胆固醇水平上升而逐步升高。
2.高血压。高血压是引起动脉硬化的一项特别重要的危险因素，如中年男性收缩压大于160mmHg或舒张压大于95mmHg，动脉硬化的危险性要比血压正常的男性人群增高5倍以上；
3.凝血因素。血小板黏附聚集、血栓形成是动脉硬化及其并发症的直接相关因素。凝血因素的变化与急性冠脉综合症、脑血管疾病的发生有密切的关系，血小板在局部黏附是缺血发生的直接原因；
4.同型半胱氨酸(HCY)。HCY是含硫氨基酸的中间代谢产物。血清HCY水平随年龄增加而升高，男性显著高于女性。HCY可引起内皮细胞化学性损伤，HCY与动脉硬化和血栓形成有关。美国健康医生研究表明：HCY是冠心病独立的危险因素。
此外，吸烟及糖尿病等也是心脑血管疾病的危险因素之一。
心脑血管疾病是多种因素综合作用的结果，其防治历来是对其危险因素采取分别对待，孤立处理，血压高了降血压，血脂高了降血脂。但这种防治方法实施的效果一直不够理想。
发明内容
本发明的任务是提供一种新的心脑血管疾病防治制剂，以解决当前心脑血管疾病防治效果普遍不够理想的问题。
本发明因此提出一种防治心脑血管疾病复合制剂，该制剂由阿司匹林、叶酸、辛伐他汀、雷米普利组成，加入适量赋形剂制成肠溶片，每片含阿司匹林50-100mg、叶酸0.5-1.5mg、辛伐他汀10-40mg、雷米普利2.5-10mg。赋形剂为乳糖、糊精或羟基纤维素。其制备工艺为：分别取规定量的阿司匹林、叶酸、辛伐他汀、雷米普利，加入适量的赋形剂，混合均匀，压制成肠衣片，分装，灭菌而成。
本发明的各组分均为防治心脑血管疾病疗效显著的药品，其中：
阿司匹林(乙酰水杨酸)：该药通过抑制环氧化酶介导的前列腺素的合成而抗血小板聚集，防止血栓形成引起的缺血性心脑血管病。对于55-64岁人群，每日口服75mg阿司匹林，应用两年，缺血性心脏事件风险减少32％(23％-40％)，脑卒中风险减少16％(7％-25％)。
叶酸(Falic Acidi，维生素M)：在体内为同型半胱氨酸(HCY)甲基化转化为蛋氨酸过程中，提供甲基(5-甲基四氢叶酸)，从而降低同型半胱氨酸水平，减少同型半胱氨酸对血管内皮细胞损伤等作用。55-64岁人群日服0.8mg叶酸可使HCY水平下降3mmol/L，缺血性心脏病事件风波减少24％(15％-33％)。
辛伐他汀(Simvastatin)：口服吸收后水解为相应的β羟酸结构，该结构主要代谢产物为催化胆固醇合成早期限速酶-3羟基甲基或二酰酶A(HMG-COA)还原酶的特异性抑制剂。辛伐他汀能极有效地降低总胆固醇、低密度脂蛋白(LDL)胆固醇、甘油三酯和极低密度脂蛋白胆固醇及升高低密度脂蛋白胆固醇的血浆浓度。Law等报道55～64岁人群每日口服辛伐他汀40mg或80mg，或者阿伐他汀10mg，2年，可使LDL胆固醇下降1.8mmlo/L(70mg/dl)，IHD事件风险减少61％(51％-71％)，脑卒中风险减少17％(9％-25％)。
雷米普利(Ramipril)：血管紧张速转酶抑制剂(ACEI)，雷米普利较其他血管紧张速转酶抑制剂有更多的优点：半衰期长，更强的溶性，更有效的抑制组织ACE，全面保护脏器(心、肾等)，更强的增加缓激肽促进血管保护作用，抑制血管平滑肌细胞生长、迁移及细胞外基质合成，因此美国FDN批准将雷米普利用于降低心脑血管事件。HOPE(心张结果预防评价)研究：9297例冠状动脉疾病和至少伴有一个其他危险因素和糖尿病的患者，随机接收雷米普利10mg/d，一年后即开始出现危险减少，4.5年后因组合终点(心肌梗、卒中、死于心血管事件)减少22％(P＜0.001)，总死亡率、心肌梗塞、心脏停搏、血管重建分别减少16％、32％、37％、15％，新发糖尿病下降34％(P＜0.001)，亚组分析提示不管是否有糖尿病、高血压、冠状动脉病或年龄大于63岁，雷米普利均有良好作用，独立的使危险下降，且于血压下降无关。HOPE研究还表明在血压下降-3/2mmHg，中风危险性下降32％(Okeefe JH等)。
本发明由于是复合制剂，药物中的四种成分相互提携支持，使药效得到大幅提升，因而防治效果好，不良反应少。本发明具有抗血小板功能、降低血浆同型半胱氨酸水平、降低血脂浓度和降低血压等综合作用，可用于预防和治疗因动脉硬化而引起的心脑血管疾病，适用于55岁以上防治冠心病、高血压症、高血脂症、糖尿病和脑中风的老人。每日1-2片，口服。预测疗效：可减少缺血性心脏病事件≥65％，减少脑卒中事件≥60％。
本发明禁止用于胃及十二指肠溃疡、明显的出血倾向、对乙烯水杨酸类过敏、活动型肝炎或无法解释的持续转氨酶升高、血管神经性水肿、肾动脉狭窄、血流动力学相关的左心室流入、流出障碍及低血压患者。
具体实施方式
实施例1：取阿司匹林5000g、叶酸50g、辛伐他汀1000g、雷米普利250g，加适量乳糖、糊精或羟甲基纤维素等，混合均匀，制成肠溶片剂10万粒，分装，灭菌。
实施例2：取阿司匹林7500g、叶酸100g、辛伐他汀2000g、雷米普利500g，加适量乳糖、糊精或羟甲基纤维素等，混合均匀，制成肠溶片剂10万粒，分装，灭菌。
实施例3：取阿司匹10000g、叶酸500g、辛伐他汀4000g、雷米普利1000g，加适量乳糖、糊精或羟甲基纤维素等，混合均匀，制成肠溶片剂10万粒，分装，灭菌。
Claims (1)
1、一种防治心脑血管疾病的复合制剂，其特征在于：该制剂由阿司匹林、叶酸、辛伐他汀、雷米普利组成，加入适量赋形剂制成肠溶片，每片含阿司匹林50-100mg、叶酸0.5-1.5mg、辛伐他汀10-40mg、雷米普利2.5-10mg。
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009046631A1 (en) * | 2007-09-28 | 2009-04-16 | Beijing Huaanfo Biomedical Research Center, Inc | Pharmaceutical composition containing angiotensin converting enzyme inhibitor and b family vitamins and use thereof |
| CN101897710A (zh) * | 2009-05-27 | 2010-12-01 | 北京奥萨医药研究中心有限公司 | 含有HMG-CoA还原酶抑制剂、阿司匹林、叶酸的药物组合物及其用途 |
| CN101897711A (zh) * | 2009-05-27 | 2010-12-01 | 北京奥萨医药研究中心有限公司 | 含有HMG-CoA还原酶抑制剂、阿司匹林、叶酸、烟酸的药物组合物及其用途 |
| CN102614266A (zh) * | 2012-04-20 | 2012-08-01 | 朱遂勤 | 治疗高血压高血脂的药物 |
| BE1023011B1 (nl) * | 2015-08-05 | 2016-11-04 | Nordic Specialty Pharma Bvba | Acetylsalicylzuur tablet met onmiddellijke afgifte |
| CN106310274A (zh) * | 2016-05-23 | 2017-01-11 | 深圳奥萨制药有限公司 | 一种预防心血管疾病的药物组合物 |
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2004
- 2004-12-10 CN CN 200410098417 patent/CN1785196A/zh active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009046631A1 (en) * | 2007-09-28 | 2009-04-16 | Beijing Huaanfo Biomedical Research Center, Inc | Pharmaceutical composition containing angiotensin converting enzyme inhibitor and b family vitamins and use thereof |
| CN101897710A (zh) * | 2009-05-27 | 2010-12-01 | 北京奥萨医药研究中心有限公司 | 含有HMG-CoA还原酶抑制剂、阿司匹林、叶酸的药物组合物及其用途 |
| CN101897711A (zh) * | 2009-05-27 | 2010-12-01 | 北京奥萨医药研究中心有限公司 | 含有HMG-CoA还原酶抑制剂、阿司匹林、叶酸、烟酸的药物组合物及其用途 |
| CN101897711B (zh) * | 2009-05-27 | 2014-08-13 | 北京奥萨医药研究中心有限公司 | 含有HMG-CoA还原酶抑制剂、阿司匹林、叶酸、烟酸的药物组合物及其用途 |
| CN102614266A (zh) * | 2012-04-20 | 2012-08-01 | 朱遂勤 | 治疗高血压高血脂的药物 |
| BE1023011B1 (nl) * | 2015-08-05 | 2016-11-04 | Nordic Specialty Pharma Bvba | Acetylsalicylzuur tablet met onmiddellijke afgifte |
| CN106310274A (zh) * | 2016-05-23 | 2017-01-11 | 深圳奥萨制药有限公司 | 一种预防心血管疾病的药物组合物 |
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