CN117582450B - 一种防治动脉硬化、冠心病及痛风的药物组合物及制剂 - Google Patents
一种防治动脉硬化、冠心病及痛风的药物组合物及制剂 Download PDFInfo
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Abstract
本发明提供了一种防治动脉硬化、冠心病及痛风的药物组合物及制剂，涉及药物组合物领域，该药物组合物包括枸杞多糖、葡萄糖苷、云杉新苷、木脂素、淫羊藿苷、洋丁香酚苷、女贞苷、藁本内酯、紫云英苷、金丝桃苷、黄芪多糖、黄精多糖、隐丹参酮、山楂黄酮、当药素、香叶木素和金合欢素。本发明的药物组合物及其制得的药物能够有效治疗动脉粥样硬化、痛风和/或冠心病，具有高效、安全的优势。
Description
技术领域
本发明涉及药物组合物领域，具体涉及一种防治动脉硬化、冠心病及痛风的药物组合物及制剂。
背景技术
动脉粥样硬化是冠心病、脑梗死、外周血管病发病的主要原因，其病变基础是脂质代谢障碍，往往受累动脉病变从内膜开始。由于在动脉内膜积聚的脂质外观呈黄色粥样，因此被称为动脉粥样硬化。常见的治疗动脉粥样硬化的中成药有丹萎片、蛭龙活血方以及祛瘀消斑胶囊等（参见书籍：徐燕. 中医良方大典 内科 1卷[M].上海：上海科学普及出版社,2021:27.）。书籍：任建素.赵国定治疗心病临证经验集要[M].上海:上海科学技术出版社,2016:76-78.也谈及年龄、肾虚、肝失疏泄、饮食不节以及毒邪等均是动脉粥样硬化的病因病机，对于动脉粥样硬化应当辨证论治，对于血瘀气滞相应组方有失笑散与四逆散合方，杜宇气虚络瘀有四君子汤与补阳怀五汤合方，对于痰瘀寒结有苓桂术甘汤与通窍活血汤合方等。
痛风是由单钠尿酸盐沉淀所致的晶体相关关节病，与嘌呤代紊乱和/或尿酸排泄减少所致的高尿酸血症直接相关，包括急性发作性关节炎、痛风石形成以及尿酸性尿路结石等，重者可出现关节损伤和肾功能不全。常见的治疗痛风的方剂有薏苡仁、百合和芦根；桑枝、槐枝、椿树枝、桃枝和柳枝；以及红花、白芷、防风和威灵仙等（参见书籍：张振. 药酒药浴 药粥[M].北京：中医古籍出版社, 2022:117.）。
冠心病又称冠状动脉粥样硬化性心脏病，常表现为胸痹或心肌梗死、心律失常或心力衰竭等，其病因多因心阳不足，寒邪袭心，以致寒凝脉涩，拘急收引；或饮食不慎，膏粱厚味变生痰湿，痰湿侵犯、占据清旷之区；或痰热灼络，火性上炎；或气血、津液、阴阳不足，以致虚而血行缓慢；或七情内伤、气机郁滞，均可导致气滞血瘀、血脉瘀阻、郁遏于胸所致。治疗冠心病的相关药物包括宁心膏、熨脐方、菖蒲郁金散或新康锭等（参见书籍：程爵棠.肚脐疗法治百病 第3版[M].郑州：河南科学技术出版社, 2020:66-67）。
对于动脉粥样硬化、痛风以及冠心病，现有技术中部分药物可实现对前述两种或多种疾病的同步性治疗，例如文献：朱永福，蔡彬彬，林崇泽等. 四妙汤加减方辅助治疗痛风合并动脉粥样硬化临床研究[J].新中医，2023，55（19）:69-72.中研究了四妙汤加减方辅助治疗痛风合并动脉粥样硬化的临床疗效，结果发现，四妙汤加减方辅助治疗痛风合并动脉粥样硬化疗效确切，能够降低患者血脂和UA水平，减轻炎症反应。但单纯的中药药物在治疗相关病症时，主要其辅助作用，治疗周期较长，较难在短期内见效。再如专利CN115192574A公开了乌头类生物碱在制备治疗GSDMD相关疾病药物中的应用，以乌头类生物碱作为有效成分有望开发为痛风性关节炎、溃疡性结肠炎、脓毒症、动脉粥样硬化、老年痴呆等炎症疾病的GSDMD抑制剂。但乌头类生物碱具有强烈的神经毒性，对人体中枢神经系统的损害较为严重，因此，在实际临床应用时其安全性有待考证。
针对现有技术存在的问题，寻找一种安全、高效的防治动脉硬化、冠心病及痛风的药物组合物及制剂十分必要。
发明内容
本发明针对现有技术存在的问题，提供了一种防治动脉硬化、冠心病及痛风的药物组合物及制剂，该药物组合物可用于制备相关药物，能够有效治疗动脉粥样硬化、痛风和/或冠心病，具有高效、安全的优势。
为实现上述目的，本发明采用的技术方案如下：
本发明提供了一种药物组合物，包括枸杞多糖、葡萄糖苷、云杉新苷、木脂素、淫羊藿苷、洋丁香酚苷、女贞苷、藁本内酯、紫云英苷、金丝桃苷、黄芪多糖、黄精多糖、隐丹参酮、山楂黄酮、当药素、香叶木素和金合欢素。
进一步地，所述的药物组合物，按重量份数计，包括0.1-2份枸杞多糖、0.2-2份葡萄糖苷、0.2-2份云杉新苷、0.05-1份木脂素、0.05-0.5份淫羊藿苷、0.1-0.5份洋丁香酚苷、0.5-3份女贞苷、0.2-5份藁本内酯、0.1-2份紫云英苷、0.1-2份金丝桃苷、0.5-4份黄芪多糖、0.5-4份黄精多糖、0.1-3份隐丹参酮、0.05-5份山楂黄酮、0.05-0.2份当药素、0.05-1份香叶木素和0.05-0.1份金合欢素。
优选地，所述的药物组合物，按重量份数计，包括0.1-1份枸杞多糖、0.3-1份葡萄糖苷、0.5-1.5份云杉新苷、0.1-0.5份木脂素、0.1-0.4份淫羊藿苷、0.2-0.3份洋丁香酚苷、0.8-2份女贞苷、0.5-3份藁本内酯、0.2-1份紫云英苷、0.2-1份金丝桃苷、1-2份黄芪多糖、1-2份黄精多糖、0.5-2份隐丹参酮、0.1-3份山楂黄酮、0.1-0.2份当药素、0.1-0.5份香叶木素和0.05-0.1份金合欢素。
进一步优选地，所述的药物组合物，按重量份数计，包括0.5份枸杞多糖、0.5份葡萄糖苷、1份云杉新苷、0.4份木脂素、0.3份淫羊藿苷、0.2份洋丁香酚苷、1份女贞苷、0.8份藁本内酯、0.5份紫云英苷、0.5份金丝桃苷、1.5份黄芪多糖、1.5份黄精多糖、1份隐丹参酮、0.5份山楂黄酮、0.1份当药素、0.3份香叶木素和0.1份金合欢素。
进一步地，所述云杉新苷、藁本内酯和隐丹参酮的重量比为（0.5-1.5）:（0.5-3）:（0.5-2）。
优选地，所述云杉新苷、藁本内酯和隐丹参酮的重量比为1:0.8:1。
进一步地，所述药物组合物的制备方法，包括以下步骤：将枸杞多糖、葡萄糖苷、云杉新苷、木脂素、淫羊藿苷、洋丁香酚苷、女贞苷、藁本内酯、紫云英苷、金丝桃苷、黄芪多糖、黄精多糖、隐丹参酮、山楂黄酮、当药素、香叶木素和金合欢素混合即得。
进一步地，本发明提供了一种药物，包括上述的药物组合物。
进一步地，所述药物的剂型包括颗粒剂、丸剂、片剂、口服液、胶囊剂、散剂、粉剂、搽剂和喷雾剂。
进一步地，本发明提供的上述的药物组合物能够用于制备治疗动脉粥样硬化、痛风和/或冠心病的药物。
本发明所取得的技术效果是：
本发明的药物组合物结合科学研究文献与科学实验，以康欣口服液和康欣胶囊为基础方，在康欣口服液和康欣胶囊中的13味药材，如枸杞子、制何首乌、淫羊藿、女贞子、当归、菟丝子、黄芪、黄精（制）、丹参、山楂、酸枣仁、菊花、地骨皮的基础上，以上述各类药材中的部分有效成分如枸杞多糖、葡萄糖苷、云杉新苷、木脂素、淫羊藿苷等为组方，制备得到的药物组合物及其制得的药物能够有效治疗动脉粥样硬化、痛风和/或冠心病，相比于传统的中药组合物存在的有效成分溶出效果差异性、用药精准性差，从而导致的治疗效果差、疗程长等问题，本发明的药物组合物具有高效预防、治疗的作用，同时相比于单一强效成分或者西药具有安全的优势。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。
在进一步描述本发明具体实施方式之前，应理解，本发明的保护范围不局限于下述特定的具体实施方案；还应当理解，本发明实施例中使用的术语是为了描述特定的具体实施方案，而不是为了限制本发明的保护范围。
当实施例给出数值范围时，应理解，除非本发明另有说明，每个数值范围的两个端点以及两个端点之间任何一个数值均可选用。除非另外定义，本文中使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同意义。
值得说明的是，本发明中使用的原料均为普通市售产品，因此对其来源不做具体限定。
表1 本发明药物组合物的原料及其CAS号
实施例1-5
表2 本发明中实施例1-5的组方（单位：份）
上述实施例1-5中药物组合物的制备方法包括以下步骤：将枸杞多糖、葡萄糖苷、云杉新苷、木脂素、淫羊藿苷、洋丁香酚苷、女贞苷、藁本内酯、紫云英苷、金丝桃苷、黄芪多糖、黄精多糖、隐丹参酮、山楂黄酮、酸枣黄素、香叶木素和金合欢素混合即得。
对比例1-5
表3 本发明中对比例1-5的组方（单位：份）
上述对比例1-5中药物组合物的制备方法与实施例1-5的制备方法相近，区别仅在于，根据实际情况，选择是否加入对应原料或替换为其他原料（如没食子酸、正丁烯酰内酯或葛根素）。
一、本发明中药物组合物对高脂饲料及维生素D3联合诱导大鼠动脉粥样硬化模型的作用
1.1 试验动物
120-140g SPF级Wistar大鼠，雄性。
1.2 试验药物
实施例1-5和对比例1-5的药物组合物。
1.3 造模
大剂量维生素D3可明显升高血钙，高血钙可以协同高血脂破坏动脉管壁内皮的完整性，从而有利于血浆脂质对管壁的侵入、损伤和沉积，血钙升高还可以促使钙在主动脉中膜沉积，促使平滑肌细胞变性和钙化。因此，采用高脂饲料及维生素D3联合应用建立大鼠动脉粥样硬化模型。在大鼠自由饮食适应性喂养一周后，将大鼠随即分为2组，一组为空白对照组，共计8只大鼠，另一组为模型组，前者饲喂普通饲料（按质量分数计，包括：50%玉米粉、20%大豆粉、10%麦麸、5%鱼粉、5%骨粉、5%脱脂奶粉、5%维生素和矿物质），后者饲喂高脂饲料（按质量分数计，包括：79.5%普通饲料、10%猪油、5%胆固醇、5%白砂糖、0.5%胆酸钠）同时在腹腔一次性注射6×105IU/kg维生素D3，并按照进食量0.2%灌胃丙基硫氧嘧啶，共计饲喂60天，结束造模。
1.4 试验方法
第60天结束后将造模成功的各组大鼠随机分为11组，每组8只，其中10组为各实施例组和对比例组，分别灌胃给药各实施例组的药物组合物，灌胃量为50mg/kg/d，每天三次，剩余1组为模型对照组，灌胃等量生理盐水，试验期间各组不停止高脂饲料饲喂，30天后各组动物禁食过夜，腹腔注射巴比妥钠麻醉，右股动脉采血并分离血清，剥离主动脉弓、胸主动脉全段及腹主动脉段，采用中性福尔马林钙溶液固定，油红O染色后，照相并分析粥样斑块相对面积，其中相对面积=粥样斑块总面积/主动脉内膜面积。将结果统计至表4中。
1.5 试验结果
试验结果如下表所示：
表4 本发明中各组大鼠粥样斑块相对面积情况
试验结果表明，实施例1-5各组大鼠粥样斑块相对面积相比于模型对照组均明显下降，与模型对照组之间存在显著性差异，表明实施例1-5中药物组合物能够有效抑制粥样斑块的形成，对动脉粥样硬化有着较好的治疗作用。对比例1-3相比于实施例5，组间试验结果存在显著性差异（p＜0.05），组方中部分有效成分发生变动，如将藁本内酯、隐丹参酮替换为等量的云杉新苷，或将云杉新苷、隐丹参酮替换为等量的藁本内酯等，最终的组方对应大鼠粥样斑块的减少程度要差于实施例5中药物组合物，表明在组方中藁本内酯、隐丹参酮和云杉新苷之间存在良好的的协同作用；对比例4和实施例5之间的结果比较表明，特定用量的组方在动脉粥样硬化治疗方面的重要影响；对比例5相比于实施例5的效果显著下降，表明特定原料选择的适用性。
二、本发明中药物组合物对微晶型尿酸钠诱导的急性痛风性关节炎的作用
2.1 试验动物
220-250g SPF级SD大鼠，雌雄各半。
2.2 试验药物
实施例1-5和对比例1-5的药物组合物。
2.3 造模
大鼠自由饮食适应性喂养一周后，将大鼠随即分为2组，一组为空白对照组，共计8只大鼠，另一组为模型组，模型组大鼠腹腔注射35mg/kg戊巴比妥钠麻醉，右踝关节内侧后方为穿刺点，针口斜面朝前上方与胫骨成45°夹角穿入踝关节腔，关节腔注入0.2ml 2.5mg/ml的MSU混悬液，以对侧鼓起为注入标准，诱导AGA模型，空白对照组注射等量生理盐水。造模后大鼠关节红肿，不欲行动，步履蹒跚或者跛行，饮食饮水较空白对照组少，大鼠出现跛行，受试下肢刚触及地面甚至受试下肢离开地面，三足着地行走为造模成功。
2.4 试验方法
将造模成功后的大鼠随机分为11组，每组8只，其中10组为各实施例组和对比例组，分别灌胃给药各实施例组的药物组合物，灌胃量为50mg/kg/d，每天三次，剩余1组为模型对照组，灌胃等量生理盐水，各组均连续给药一周。
以记号笔在踝关节上方约0.5cm处标记测量上限，分别测定致炎前及致炎后1h、3h、5h、24h的足容积，计算关节肿胀度，其中，关节肿胀度=致炎后右后足容积值-致炎前右后足容积值。测量结束后，各组大鼠腹腔注射35mg/kg戊巴比妥钠麻醉，腹部主动脉处取血5mL，离心得到血清，并使用ELISA试剂盒测定大鼠血清中的TNF-α、IL-6、IL-1β和PGE2。将结果统计至表5-6中。
2.5 试验结果
试验结果如下表所示：
表5 本发明中各组大鼠关节肿胀度情况
表6 本发明中各组大鼠炎症因子水平情况
试验结果表明，实施例1-5中药物组合物对微晶型尿酸钠诱导的急性痛风性关节炎有着良好的治疗效果，1h、3h、5h以及24h时各实施例组与模型对照组之间均存在显著性差异。
三、本发明中药物组合物对高脂饮食饲养联合腹腔注射垂体后叶素诱导冠心病的作用
3.1 试验动物
220-250g SPF级Wistar大鼠，雄性。
3.2 试验药物
实施例1-5和对比例1-5的药物组合物。
3.3 造模
在大鼠自由饮食适应性喂养一周后，将大鼠随即分为2组，一组为空白对照组，共计8只大鼠，另一组为模型组，前者饲喂普通饲料（按质量分数计，包括：50%玉米粉、20%大豆粉、10%麦麸、5%鱼粉、5%骨粉、5%脱脂奶粉、5%维生素和矿物质），后者饲喂高脂饲料（按质量分数计，包括：79.5%普通饲料、10%猪油、5%胆固醇、5%白砂糖、0.5%胆酸钠），在饲养第8周的第4天，各模型组腹腔注射垂体后叶素，每次3U/kg，每日一次，连续给药3天，空白对照组灌胃等量生理盐水。第3天注射药物后30min内进行心电图检测，若大鼠心电图存在QRS波群的终点与ST段交接处的J点位移，且位移＞0.1mV，表明大鼠存在心肌缺血，以及心电图ST段抬高＞0.1mV，且心律不齐，即造模成功。
3.4 试验方法
造模成功后将各组大鼠随即分为11组，每组8只，其中10组为各实施例组和对比例组，第9周时分别灌胃给药各实施例组的药物组合物，灌胃量为50mg/kg/d，剩余1组为模型对照组，灌胃等量生理盐水，各组连续给药4周后，各组大鼠腹腔注射35mg/kg戊巴比妥钠麻醉，在大鼠腹部主动脉处取血5mL，离心得到血清，检测血清基质金属蛋白酶-9（MMP-9）和基质金属蛋白酶抑制剂-1（TIMP-1）水平。将结果统计至表7中。
3.5 试验结果
试验结果如下表所示：
表7 本发明中各组大鼠MMP-9和TIMP-1表达水平情况
现有技术中的研究表明MMP-9和TIMP-1是反应冠心病斑块稳定性的重要指标。根据本申请表7的试验结果可知，实施例1-5组的MMP-9与TIMP-1相比于模型对照组存在显著性差异，MMP-9相比于模型对照组下降，TIMP-1相比于模型对照组升高，部分实施例的TIMP-1值甚至更优于空白对照组。也即实施例1-5中药物组合物对于高脂饮食饲养联合腹腔注射垂体后叶素诱导冠心病有着一定的疗效。
注：本发明前述三项试验中，各组显著性差异与标记对应情况如下：
#：与空白对照组相比，p＜0.05；##：与空白对照组相比，p＜0.01；
*：与模型对照组相比，p＜0.05；**：与空白对照组相比，p＜0.01；
a：与对比例1相比，p＜0.05；aa：与对比例1相比，p＜0.01；
b：与对比例2相比，p＜0.05；bb：与对比例2相比，p＜0.01；
c：与对比例3相比，p＜0.05；cc：与对比例3相比，p＜0.01；
d：与对比例4相比，p＜0.05；dd：与对比例4相比，p＜0.01；
e：与对比例5相比，p＜0.05；ee：与对比例5相比，p＜0.01。
Claims (9)
1.一种药物组合物，其特征在于：按重量份数计，包括0.1-2份枸杞多糖、0.2-2份葡萄糖苷、0.2-2份云杉新苷、0.05-1份木脂素、0.05-0.5份淫羊藿苷、0.1-0.5份洋丁香酚苷、0.5-3份女贞苷、0.2-5份藁本内酯、0.1-2份紫云英苷、0.1-2份金丝桃苷、0.5-4份黄芪多糖、0.5-4份黄精多糖、0.1-3份隐丹参酮、0.05-5份山楂黄酮、0.05-0.2份当药素、0.05-1份香叶木素和0.05-0.1份金合欢素。
2.根据权利要求1所述的药物组合物，其特征在于：按重量份数计，包括0.1-1份枸杞多糖、0.3-1份葡萄糖苷、0.5-1.5份云杉新苷、0.1-0.5份木脂素、0.1-0.4份淫羊藿苷、0.2-0.3份洋丁香酚苷、0.8-2份女贞苷、0.5-3份藁本内酯、0.2-1份紫云英苷、0.2-1份金丝桃苷、1-2份黄芪多糖、1-2份黄精多糖、0.5-2份隐丹参酮、0.1-3份山楂黄酮、0.1-0.2份当药素、0.1-0.5份香叶木素和0.05-0.1份金合欢素。
3.根据权利要求2所述的药物组合物，其特征在于：按重量份数计，包括0.5份枸杞多糖、0.5份葡萄糖苷、1份云杉新苷、0.4份木脂素、0.3份淫羊藿苷、0.2份洋丁香酚苷、1份女贞苷、0.8份藁本内酯、0.5份紫云英苷、0.5份金丝桃苷、1.5份黄芪多糖、1.5份黄精多糖、1份隐丹参酮、0.5份山楂黄酮、0.1份当药素、0.3份香叶木素和0.1份金合欢素。
4.根据权利要求1所述的药物组合物，其特征在于：所述云杉新苷、藁本内酯和隐丹参酮的重量比为（0.5-1.5）:（0.5-3）:（0.5-2）。
5.根据权利要求4所述的药物组合物，其特征在于：所述云杉新苷、藁本内酯和隐丹参酮的重量比为1:0.8:1。
6.根据权利要求1所述的药物组合物，其特征在于：所述药物组合物的制备方法包括以下步骤：将枸杞多糖、葡萄糖苷、云杉新苷、木脂素、淫羊藿苷、洋丁香酚苷、女贞苷、藁本内酯、紫云英苷、金丝桃苷、黄芪多糖、黄精多糖、隐丹参酮、山楂黄酮、当药素、香叶木素和金合欢素混合即得。
7.一种药物，其特征在于：包括权利要求1-6任一项所述的药物组合物。
8.根据权利要求7所述的药物，其特征在于：所述药物的剂型包括颗粒剂、丸剂、片剂、口服液、胶囊剂、散剂、粉剂、搽剂和喷雾剂。
9.如权利要求1-6任一项所述的药物组合物在制备治疗动脉粥样硬化、痛风和/或冠心病的药物中的应用。
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