CN101024082A - 一种全面预防和治疗心脑血管疾病复方药及其应用 - Google Patents
一种全面预防和治疗心脑血管疾病复方药及其应用 Download PDFInfo
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- CN101024082A CN101024082A CNA2007102004083A CN200710200408A CN101024082A CN 101024082 A CN101024082 A CN 101024082A CN A2007102004083 A CNA2007102004083 A CN A2007102004083A CN 200710200408 A CN200710200408 A CN 200710200408A CN 101024082 A CN101024082 A CN 101024082A
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Abstract
一种全面预防和治疗心脑血管疾病复方药。属于化学药物领域。其特征为该复方药包括性激素类，降脂类，降压类，降糖类，抗凝类药物，并根据不同人群，在基本组合的基础上，按不同种类，剂量，比例和剂型，适当加减配制。该复方药具有协同增强药效作用，同时最大限度降低副作用发生。使用方便。该复方药应用于更年期女性和成年男性心脑血管疾病一，二级预防和治疗，以及其他疾病如更年期综合征，骨质疏松，子宫内膜癌，老年认知功能减退，糖尿病，代谢综合征等疾病的防治。
Description
技术领域
一种全面预防和治疗心脑血管疾病复方药。属于化学药物领域。
背景技术
2005年12月，我们申请了《一种预防和治疗心脑血管疾病复方药及其应用》的发明专利，专利申请号：2005102008329。此后，大量新的试验证据表明糖尿病高危患者及糖耐量异常患者用药物干预或用特定的降糖药物可以推迟糖尿病的发病时间，降低心脑血管疾病的危险性。因此，在2005年发明专利的基础上，我们增加了降糖药，使新的复方药真正做到了全面预防和治疗心脑血管疾病。现表述如下：
1.心脑血管疾病是威胁人类健康的第一杀手。发病率最高，死亡率最高，并且仍然呈日益增长的趋势。因此寻找新的理想药物和疗法，控制和预防疾病的发展，是当前迫切任务和社会责任。2.女性绝经期前，心脑血管疾病发病率非常低，而绝经期后其发病率和死亡率与男性相同。目前认为可能与女性激素有关。3.大量的动物实验与临床观察表明：性激素尤其雌激素可以减轻炎性因子对血管的损伤，保护受损血管和血管内皮细胞，抑制血管平滑肌细胞增生，减缓粥样斑块发展；可以通过一氧化氮途径扩张血管，降低血压；可以降低低密度脂蛋白胆固醇(LDL_C)，升高高密度脂蛋白胆固醇(HDL_C)；可以降低血液中纤维原激活物；可以增加心肌收缩力，改善心衰心脏的功能和生存率，保护缺血的心肌。此外性激素可以减轻女性更年期综合征的症状，减少骨质疏松，子宫内膜癌，老年认知功能减退，糖尿病的发生等。4.但是性激素也有副作用，如升高甘油三酯，增加血液粘度和血栓形成，尤其是在已经形成血管粥样斑块的情况下。因此目前认为性激素尤其雌激素应该在血管受损的早期应用。此外性激素尤其雌激素可以增加乳腺癌的发生。5.植物雌激素可以选择性的结合雌激素受体，减少雌激素的副作用，如乳腺癌的发生。6.目前大量证据表明随着高血压，高血脂，高血糖及代谢综合症发病率的增加，心脑血管疾病的发病率和死亡率呈相应比例的增加，高血压，高血脂，高血糖及代谢综合症是心脑血管疾病的基础。最新的资料表明心脑血管疾病中70％有糖调节异常，而糖尿病患者中发生心脑血管疾病危险男性是正常人的2-3倍，女性是3-5倍。2003年美国首先提出糖尿病是心脑血管疾病的等危症，引起全世界的关注和赞同。最新的试验表明糖尿病高危患者及糖耐量异常患者用药物干预或用特定的降糖药物可以推迟糖尿病的发病时间，降低今后心脑血管疾病的危险性。因此降低心脑血管疾病的发病率和死亡率，必须严格控制高血压，高血脂，高血糖及代谢综合症的发展，但是单一降低血压或血脂或血糖不能达到最好结果，只有全面控制血压，血脂，血糖于理想状态(血压：115/70mmHg；LDL_C：＜2.6mmol/l；HDL_C：＞1.0mmol/l；血糖：＜6.0mmol/l)才能大幅度减少心脑血管疾病的发生和降低死亡率。7.同样大量的动物实验和大规模临床试验表明降脂药物，降压药物(β受体阻滞剂，血管紧张素转氨酶抑制剂和血管紧张素受体阻滞剂，钙拮抗剂)，降糖药，抗凝剂可以减轻炎性因子对血管的损伤，抑制血管平滑肌细胞增生，降低血压，降低低密度脂蛋白胆固醇(LDL_C)，升高高密度脂蛋白胆固醇(HDL_C)，减缓，稳定和/或逆转血管粥样斑块发展，抑制血小板聚集和血栓形成，减少心脑血管事件的发生等。8.但是降脂药物，降压药物(β受体阻滞剂，血管紧张素转氨酶抑制剂和血管紧张素受体阻滞剂，钙拮抗剂)，降糖药，抗凝剂也有副作用，如他汀类降脂药损害肝脏和平滑肌，β受体阻滞剂减慢心率，抑制心肌收缩力，钙拮抗剂增加心率和交感神经兴奋，血管紧张素转氨酶抑制剂和血管紧张素受体阻滞剂的使用受肾功能影响，抗凝剂引起出血等。这些副作用多数与剂量有关。
发明内容
1.本发明将性激素类，降脂类，降压类，降糖药，抗凝类药物组合成复方药，使它们从不同水平，部位，途经，较全面的，最大限度的，协同发挥心脑血管的保护作用，同时减少剂量，最大限度的降低副作用产生。此外该复方药还可以相互抑制和/或减轻药物的副作用，如β受体阻滞剂和钙拮抗剂合用可以稳定心率，抗凝剂可以减少性激素对凝血系统的影响等。是较为优化的理想组合。2.目前尚无理想(即有疗效又无副作用)的预防心脑血管疾病的药物。因为任何单一的药物都无法胜任防治复杂的心脑血管疾病的任务。不是剂量过大，副作用增加，就是剂量过小，疗效降低，难以成为理想药物。就像治疗爱滋病的“鸡尾酒”疗法一样，只有联合用药才能最大限度的发挥保护心脑血管的作用，同时才能在保证疗效的基础上，最大限度地减少副作用的发生。本复方药集中了当前最有效的保护心脑血管的药物，优化组合，最低剂量，最小副作用，是当前较为理想的防治心脑血管疾病的药物。3.本复方药在基本组合的基础上，适当加减，以适合于不同人群。如较低剂量可用于健康人群，高危人群的一级预防，较高剂量可用于心脑血管疾病患者的二级预防，防止心脑血管事件的进一步发生，增加雌激素，孕激素含量可用于绝经期女性，采用植物雌激素可用于成年男性，调节降压药物含量以适应不同血压人群等。
具体实施方式
实施例1：本复方药由17β雌二醇0.5mg，甲羟孕酮0.3mg，辛伐它汀2.5mg，美托洛尔2.0mg，氨氯地平0.5mg，二甲双胍200mg，阿斯匹林75mg制成组合制剂，按口服制剂(普通片剂，分散片，薄膜包衣片，舌下片，口腔崩解片，肠溶片，缓释片，速释片，控释片，硬胶囊，肠溶胶囊，缓释胶囊等)制备工艺程序进行。用于早期绝经期女性。控制血压，血脂，血糖于理想状态(血压：115/70mmHg；LDL_C：＜2.6mmol/l；HDL_C：＞1.0mmol/l；血糖：＜6.0mmol/l)。控制代谢综合症，监测性激素水平。
实施例2：本复方药由17β雌二醇0.5mg，甲羟孕酮0.3mg，辛伐它T5mg，美托洛尔2.0mg，氨氯地平0.5mg，阿卡波糖20mg，阿斯匹林100mg制成组合制剂，按口服制剂(普通片剂，分散片，薄膜包衣片，舌下片，口腔崩解片，肠溶片，缓释片，速释片，控释片，硬胶囊，肠溶胶囊，缓释胶囊等)制备工艺程序进行。用于晚期绝经期女性。控制血压，血脂，血糖于理想状态(血压：115/70mmHg；LDL_C：＜2.6mmol/l；HDL_C：＞1.0mmol/l；血糖：＜6.0mmol/l)。控制代谢综合症，监测性激素水平。
实施例3：本复方药由大豆异黄酮300mg和/或17β雌激素0.05mg，辛伐它汀2.5mg，美托洛尔2.0mg，氨氯地平0.5mg，吡格列酮10mg，阿斯匹林40mg制成组合制剂，按口服制剂(普通片剂，分散片，薄膜包衣片，舌下片，口腔崩解片，肠溶片，缓释片，速释片，控释片，硬胶囊，肠溶胶囊，缓释胶囊等)制备工艺程序进行。用于成年男性高危人群。控制血压，血脂，血糖于理想状态(血压：115/70mmHg；LDL_C：＜2.6mmol/l；HDL_C：＞1.0mmol/l；血糖：＜6.0mmol/l)。控制代谢综合症，监测性激素水平。
实施例4：本复方药由大豆异黄酮300mg和/或17β雌激素0.05mg，力平脂50mg，美托洛尔2.0mg，氨氯地平0.5mg，罗格列酮3mg，阿斯匹林40mg制成组合制剂，按口服制剂(普通片剂，分散片，薄膜包衣片，舌下片，口腔崩解片，肠溶片，缓释片，速释片，控释片，硬胶囊，肠溶胶囊，缓释胶囊等)制备工艺程序进行。用于成年男性高甘油三脂人群。控制血压，血脂，血糖于理想状态(血压：115/70mmHg；LDL_C：＜2.6mmol/l；HDL_C：＞1.0mmol/l；血糖：＜6.0mmol/l)。控制代谢综合症，监测性激素水平。
实施例5：本复方药由大豆异黄酮300mg和/或17β雌激素0.05mg，辛伐它汀20mg，美托洛尔12.5mg，氨氯地平2.5mg，格列齐特30mg，阿斯匹林80mg制成组合制剂，按口服制剂(普通片剂，分散片，薄膜包衣片，舌下片，口腔崩解片，肠溶片，缓释片，速释片，控释片，硬胶囊，肠溶胶囊，缓释胶囊等)制备工艺程序进行。用于心脑血管疾病的二级预防。控制血压，血脂，血糖于理想状态(血压：115/70mmHg；LDL_C：＜2.6mmol/l；HDL_C：＞1.0mmol/l；血糖：＜6.0mmol/l)。控制代谢综合症，监测性激素水平。
本发明不限于以上所述的实施例。
Claims (10)
1.一种全面预防和治疗心脑血管疾病复方药，其特征为该复方药包括性激素类，降脂类，降压类，降糖药，抗凝类药物。并根据不同人群，在基本组合的基础上，按不同种类，剂量，比例和剂型，适当加减配制。
2.根据权利要求1所述的复方药，应用于更年期女性和成年男性心脑血管疾病一，二级预防和治疗，以及其他疾病如更年期综合征，骨质疏松，子宫内膜癌，老年认知功能减退，糖尿病，代谢综合征等疾病的防治。
3.根据权利要求1，2所述的复方药，其中性激素类包括雌激素(雌二醇，17β雌二醇，苯甲酸雌二醇，戊酸雌二醇，环戊丙酸雌二醇，妊马雌酮，炔雌醇，尼尔雌醇，己烯雌醇，氯烯雌醚，雌三醇等)，孕激素(孕酮，甲羟孕酮，甲地孕酮，氯地孕酮，羟孕酮，炔诺酮，炔诺孕酮，孕三烯酮等)，男性雄激素(丙酸睾酮，甲睾酮，苯丙酸诺龙，达那唑等)，植物雌激素(大豆异黄酮，大豆甙等)。其中雌二醇剂量从0.1-50mg；17β雌二醇剂量从0.1-50mg；苯甲酸雌二醇剂量从0.1-50mg；戊酸雌二醇剂量从0.1-50mg；环戊丙酸雌二醇剂量从0.1-50mg；妊马雌酮剂量从0.05-50mg；炔雌醇剂量从0.1-1000ug；尼尔雌醇剂量从0.1-50mg；己烯雌醇剂量从0.1-50mg；氯烯雌醚剂量从0.1-50mg；雌三醇剂量从0.1-100mg；孕酮剂量从0.1-100mg；甲羟孕酮剂量从0.1-1000mg；甲地孕酮剂量从0.1-50mg；氯地孕酮剂量从0.01-50mg；羟孕酮剂量从0.1-1000mg；炔诺酮剂量从0.05-100mg；炔诺孕酮剂量从0.1-100mg；孕三烯酮剂量从0.1-50mg；丙酸睾酮剂量从0.5-500mg；甲睾酮剂量从0.1-100mg；苯丙酸诺龙剂量从0.1-200mg；达那唑剂量从1-1000mg；大豆异黄酮剂量从0.1-1000mg；大豆甙剂量从0.1-1000mg等。并根据不同人群，按不同剂量，比例，单独和/或联合配制。
4.根据权利要求1，2所述的复方药，其中降脂类包括他汀类药(洛伐他汀，辛伐他汀，普伐他汀，阿托伐他汀，氟伐他汀，西伐他汀等)，贝特类药(非诺贝特，吉非贝齐，苯扎贝特，氯贝特，阿西莫司，普罗布考，力平脂等)，植物类(红曲等)。其中洛伐他汀剂量从0.1-200mg；辛伐他汀从0.1-200mg；普伐他汀剂量从0.1-200mg；阿托伐他汀剂量从0.1-200mg；氟伐他汀剂量从0.1-200mg；西伐他汀剂量从0.1-200mg；非诺贝特剂量从1-2000mg；吉非贝齐剂量从1-2000mg；苯扎贝特剂量从1-2000mg；氯贝特剂量从1-2000mg；阿西莫司剂量从1-2000mg；普罗布考剂量从1-2000mg；力平脂剂量从1-500mg；红曲剂量从1-3000mg。并根据不同人群，按不同剂量，比例，单独和/或联合配制。
5.根据权利要求1，2所述的复方药，其中降压类包括β受体阻滞剂(美托洛尔，比索洛尔，阿替洛尔，普萘洛尔，卡维地洛，噻吗心安，拉贝洛尔、地来洛尔、塞利洛尔、氨磺洛尔、阿尔马尔等)，钙拮抗剂(硝苯地平，氨氯地平，地尔硫，非洛地平，依拉地平，尼卡地平，米伯付地平，维拉帕米，尼索地平，拉西地平等)，血管紧张素受体阻滞剂(氯沙坦，缬沙坦，依贝沙坦，坎地沙坦，依普沙坦，他索沙坦，替米沙坦等)。血管紧张素转氨酶抑制剂(卡托普利，依那普利，苯那普利，赖诺普利，雷米普利，福辛普利，西拉普利，培哚普利，喹那普利，群多普利，地拉普利，咪哒普利等)。其中美托洛尔剂量从0.1-500mg；比索洛尔剂量从0.1-100mg；阿替洛尔剂量从0.1-100mg；普萘洛尔剂量从0.1-100mg；卡维地洛剂量从0.1-100mg；噻吗心安剂量从0.1-100mg；拉贝洛尔剂量从0.1-100mg；地来洛尔剂量从0.1-100mg；塞利洛尔剂量从0.1-100mg；氨磺洛尔剂量从0.1-100mg；阿尔马尔剂量从0.1-100mg；硝苯地平剂量从0.1-200mg；氨氯地平剂量从0.1-100mg；地尔硫剂量从0.1-200mg；非洛地平剂量从0.1-100mg；依拉地平剂量从0.1-100mg；尼群地平剂量从0.1-200mg；尼卡地平剂量从0.1-200mg；尼索地平剂量从0.1-200mg；米伯付地平剂量从0.1-100mg；维拉帕米剂量从0.1-200mg；拉西地平剂量从0.1-100mg；卡托普利剂量从0.1-200mg；依那普利剂量从0.1-100mg；苯那普利剂量从0.1-100mg；赖诺普利剂量从0.1-100mg；雷米普利剂量从0.1-100mg；福辛普利剂量从0.1-100mg；西拉普利剂量从0.1-100mg；培哚普利剂量从0.1-100mg；喹那普利剂量从0.1-100mg；群多普利剂量从0.1-100mg；地拉普利剂量从0.1-100mg；咪哒普利剂量从0.1-100mg等。并根据不同人群，按不同剂量，比例，单独和/或联合配制。
6.根据权利要求1，2所述的复方药，其中降糖药包括磺酰脲类(格列齐特，格列美脲，格列吡嗪，格列喹酮，格列本脲，醋磺己脲，甲苯磺丁脲)，格列奈类(瑞格列奈，那格列奈)，α-葡萄糖苷酶抑制剂(阿卡波糖，米格列醇，伏格列波糖)，双胍类(二甲双胍)，格列酮类(吡格列酮，罗格列酮)。其中格列齐特剂量从5-200mg，格列美脲剂量从0.2-6mg，格列吡嗪剂量从0.5-30mg，格列喹酮剂量从3-120mg，格列本脲剂量从0.3-15mg，醋磺己脲剂量从100-1500mg，甲苯磺丁脲剂量从50-3000mg，瑞格列奈剂量从0.1-16mg，那格列奈剂量从20-1000mg，阿卡波糖剂量从5-200mg，米格列醇剂量从5-100mg，伏格列波糖剂量从0.04-3mg，二甲双胍剂量从50-3000mg，吡格列酮剂量从3-30mg，罗格列酮剂量从1-8mg等。并根据不同人群，按不同剂量，比例，单独和/或联合配制。
7.根据权利要求1，2所述的复方药，其中抗凝剂包括阿斯匹林，华法令等。其中阿斯匹林剂量从10-500mg。华法令从0.1-10mg。并根据不同人群，按不同剂量，比例，单独和/或联合配制。
8.根据权利要求1，2所述的复方药，其特征在于：取主药与填充剂，崩解剂，表面活性剂，助溶剂，粘合剂混合，加湿润剂制软材，制粒，干燥，整粒，加入润滑剂，压片，制成口服普通片，将该口服普通片包薄膜衣或肠溶衣可以进一步制成薄膜衣片或肠溶片；取主药与填充剂，粘合剂混合，加湿润剂制软材，制粒，干燥，整粒，加入矫味剂，润滑剂，压片，制成舌下片。取主药与填充剂，崩解剂，助崩剂，表面活性剂，表面活性剂混合，加入矫味剂，润滑剂，压片，制成分散片，口腔崩解片；取主药和缓释和/或速释和/或控释材料混合，加湿润剂制软材，制粒，干燥，整粒，加入润滑剂，压片，制成缓释片，速释片，控释片。
9.根据权利要求1，2所述的复方药，其特征在于：取主药与填充剂，崩解剂，表面活性剂，助溶剂，粘合剂混合，加湿润剂制软材，制粒，充填入空心胶囊，制成硬胶囊剂，将制备的胶囊用包衣肠溶材料处理，可进一步制成肠溶胶囊；取主药和缓释和/或速释和/或控释材料制成一种或多种缓释和/或速释和/或控释小丸，单独填充或混合后填充空心胶囊，制成缓释和/或速释胶囊或控释胶囊。
10.根据权利要求1，2所述的复方药的辅料：有填充剂，粘合剂，表面活性剂，湿润剂，润湿剂，崩解剂，助崩剂，助悬剂，助流剂，润滑剂，矫味剂，吸附剂，混悬剂，包衣材料，包囊材料，缓释材料，速释材料，控释材料等。其中填充剂包括但不限于乳糖，蔗糖，葡萄糖，甘露醇，山梨醇，硫酸钙，葡萄糖酸钙，磷酸氢钙，碳酸钙，淀粉，羧甲基淀粉，预胶化淀粉，微晶纤维素等。粘合剂包括但不限于淀粉，预胶化淀粉，明胶，糊精，麦芽糖糊精，蔗糖，阿拉伯胶，聚乙烯吡咯烷酮，各种粘度甲基纤维素，低粘度羧甲基纤维素，各种粘度乙基纤维素，各种粘度聚乙烯醇，聚乙二醇6000，5MPAS以下羟丙基甲基纤维素等。崩解剂包括但不限于淀粉，预胶化淀粉，微晶纤维素，海藻酸，纯木质纤维素，羧甲基淀粉钠，瓜耳树胶，交联聚乙烯吡咯烷酮，离子交换树脂，甲基纤维素，羧甲基纤维素钠等；润滑剂包括但不限于硬脂酸镁，硬脂酸钙，硬脂酸锌，滑石粉，单硬脂酸甘油酯，聚乙二醇6000，聚乙二醇8000，苯甲酸钠，己二酸，富马酸，硼酸，氯化钠，三醋酸甘油酯，聚氧乙烯单硬脂酸酯，单月桂蔗糖酸酯，氯化钠，月桂醇硫酸钠，月桂醇硫酸镁等；表面活性剂包括但不限于十二烷基硫酸钠，冶洛沙姆，吐温80，溴化十六烷三甲胺，月桂醇硫酸钠，硬脂醇璜酸钠，聚氧乙烯高级脂肪醇，蔗糖脂，山梨醇脂肪脂，大豆磷脂等；矫味剂包括但不限于甜菊素，果糖，葡萄糖，果葡糖浆，蜂蜜，阿斯巴坦，蛋白糖，木糖醇，甘露醇香精，橘子香精，薄荷香精，茴香，香兰素，柠檬香精，樱桃香精，玫瑰香精等。包衣材料包括但不限于纤维素及其衍生物类，丙烯酸树脂类，乙烯聚合物等。包囊材料包括但不限于明胶，阿拉伯胶，羧甲基纤维素，聚乙烯醇，聚丙烯酸，羟乙基纤维素，聚乳酸，乙基纤维素，聚乙烯，聚酰胺，硬脂酸，硝酸纤维素，硬脂酸甘油酯，虫胶，苯二甲酸醋酸纤维素；缓释，速释，控释骨架材料包括但不限于巴西棕榈腊，氢化蓖麻油，蓖麻腊，氢化蓖麻腊，氢化大豆磷脂，虫胶，明胶，海藻酸钠，甲壳胺，支链淀粉，琼脂，角叉菜胶，瓜耳胶，纤维素衍生物，丙烯酸树脂类，聚乙烯类，高分子材料等。
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| CN101862309A (zh) * | 2009-04-17 | 2010-10-20 | 北京以岭生物工程有限公司 | 格列吡嗪缓释胶囊及其制备方法 |
| CN101869708A (zh) * | 2009-04-24 | 2010-10-27 | 北京奥萨医药研究中心有限公司 | 含有钙通道阻滞剂和双胍类降糖药物的药物组合物及其用途 |
| JP2011505344A (ja) * | 2007-12-03 | 2011-02-24 | ディーエスエム アイピー アセッツ ビー．ブイ． | ステビア抽出物またはステビア抽出物構成物質を含有する新規な栄養補給食品組成物およびその使用 |
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| CN101862309B (zh) * | 2009-04-17 | 2015-10-21 | 北京以岭生物工程技术有限公司 | 格列吡嗪缓释胶囊及其制备方法 |
| CN101869708A (zh) * | 2009-04-24 | 2010-10-27 | 北京奥萨医药研究中心有限公司 | 含有钙通道阻滞剂和双胍类降糖药物的药物组合物及其用途 |
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