CN113425806B - 治疗心脑血管疾病的茶色素组合物及制备方法 - Google Patents
治疗心脑血管疾病的茶色素组合物及制备方法 Download PDFInfo
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Abstract
本发明属于治疗心脑血管疾病的中药治疗领域,具体涉及一种具有治疗心脑血管疾病的茶色素组合物及制备方法和应用。所述组合物的原料包括如下组分:茶色素5‑10份、蛇床子5‑10份、三七10‑15份、西洋参5‑10份、泽兰10‑15份、玉竹10‑15份、山茱萸5‑10份、麦冬10‑15份和瓜蒌10‑15份。制备方法为先将蛇床子、瓜蒌、西洋参和玉竹提取挥发油,药渣再与三七、泽兰、山茱萸和麦冬醇提,纯化,最后将各提取物与茶色素和辅料混合即得。本发明各药味有机配伍,对调血脂、改善血液流变学有较好的功效。
Description
技术领域
本发明属于中药治疗领域,具体涉及一种具有治疗心脑血管疾病的茶色素组合物及制备方法和应用。
背景技术
心脑血管疾病就是心脏血管和脑血管的疾病统称。泛指由于高脂血症、血液粘稠、动脉粥样硬化和高血压等所导致的心脏大脑以及全身组织发生的缺血性或出血性的疾病。抗动脉粥样硬化(AS)的病因与发病机制极为复杂,至今为止仍然没有确定其确切的病因及发病机制,现公认的危险因素和发病机制如下:(1)脂质代谢紊乱;血清中胆固醇的升高与AS的发生呈正相关。随着对脂蛋白研究的深入,发现主要是LDL的水平与AS的发生呈正相关,其机制是LDL能通过载脂蛋白B-100与细胞外基质相互作用而沉积在动脉内膜形成粥样斑块。而高密度脂蛋白(HDL)能将胆固醇逆向转运至肝,可降低机体胆固醇水平,从而起到抗AS的作用。(2)炎症与免疫反应;有研究结果提示AS实质为血管受损后的一种慢性炎症性过程,在AS起始阶段,血液中的单核细胞和淋巴细胞迁移,在炎性因子的作用下黏附聚集。大量的细胞因子参与其中,不仅可以直接损伤周围的细胞,而且通过自分泌和旁分泌的形式作用于自身和其他纽胞,生成更多的细胞因子以及炎性介质,形成恶性循环,促AS的发生发展。(3)氧化应激;氧化应激直接对血管壁细胞造成损伤,并通过影响血管壁细胞转录因子的水平,调节基因的表达,参与AS的发生发展。
目前用于治疗动脉粥样硬化的药物以调节血脂为主,主要治疗药物有他汀类(辛伐他汀、阿托伐他汀等)、贝特类(苯扎贝特、非诺贝特等),除此之外还有抗氧化类药物(维生素C、β-胡萝卜素等)、抗血小板聚集类药物(阿司匹林等)和抗高血压类药物(维拉帕米、地尔硫等)。但是化学药治疗需终身服用,且治标不治本,效果单一,副作用大。
中医并无AS这一病名,但根据其临床表现可涉及中医学眩晕、头痛、健忘、痴呆、中风和胸痹等疾病。中药整体施治,对于AS这类复杂疾病具有独特的优势。中药抗AS主要从调节脂质代谢,抗炎、免疫调节,抗氧化、保护EC,抑制SMC的增殖与迁移、稳定斑块、改善凝血纤溶系统上进行改善。
中国发明专利申请CN106177433A公开了一种含有青钱柳叶、葛根和玉竹的保健组合物,其中三者的重量百分比可以为1-98%:1-98%:1-98%。所述保健组合物中还可以包含选自由桑叶、枸杞子、黄精、昆布、乌梅、桑白皮、人参、三七、女贞子、山茱萸、川芎、苍术、玄参、生地黄、白芍、当归、红景天、西洋参、芦荟、五味子、麦门冬、制大黄、知母、蒺藜、银杏叶、黄芪、绞股蓝、苦瓜、苦荞麦、南瓜、魔芋、芹菜、玉米须、银耳、猴头菇和大蒜所组成的组中的一种或更多种。声称具有降血糖、降血压或降血脂的效果,但是处方冗杂,临床适应性差,对于抗动脉粥样硬化的疗效并不明确。
中国发明专利CN101461896B公开了一种辅助降血脂的中药组合物及其制备方法,组合物由灵芝4g,西洋参2g,三七3g,葛根4g,山楂2g,黄精2g和玉竹2g组成,该方法有一定的降血脂作用,但对抗动脉粥样硬化治疗中的抗氧化性和抗炎效果有待进一步提高。
发明内容
针对现有技术存在的不足,本发明的目的是提供一种疗效确切,具有调血脂、抗氧化性及抗炎作用较强的中药组合物,用于抗动脉粥样硬化的治疗。
本发明的目的是通过以下技术方案实现的:
一种具有抗动脉粥样硬化的茶色素组合物,按照重量份数计,组合物的原料包括如下组分:茶色素5-10份、蛇床子5-10份、三七10-15份、西洋参5-10份、泽兰10-15份、玉竹10-15份、山茱萸5-10份、麦冬10-15份和瓜蒌10-15份。
方中西洋参味甘、微苦,补气养阴,清热生津,三七,归肝、胃经,化瘀止血、活血定痛;泽兰,归肝、脾经,活血祛瘀,利水消肿,三药为君药,益气养阴,活血化瘀;蛇床子与山茱萸补益肝肾,,助力君药益气扶正固本,为臣药;玉竹归肺、胃经,养阴润燥,生津止渴,麦冬归心、肺、胃经,养阴生津,润肺清心,瓜蒌,甘、微苦、寒,清热涤痰,宽胸散结,合为佐药,增强君药益气固本,活血化瘀、清热祛痰之功效。
优选地,所述组合物的原料包括如下组分:茶色素8-10份、蛇床子5-8份、三七12-15份、西洋参5-10份、泽兰10-12份、玉竹10-12份、山茱萸5-8份、麦冬10-15份和瓜蒌10-12份。
优选地,所述组合物还包括药学上可接受的辅料。
优选地,药学上可接受的辅料为淀粉和硬脂酸镁。
本发明的再一目的是提供上述茶色素组合物的制备方法,包括如下步骤:
(1)将蛇床子、瓜蒌、西洋参和玉竹加水提取挥发油,过滤得挥发油、滤液a和滤渣a;将挥发油加β-环糊精包合,得挥发油包合物;
(2)将滤渣a、三七、泽兰、山茱萸和麦冬加25-50%乙醇提取,得滤液b和滤渣b;
(3)将滤液a和滤液b混合,用大孔吸附树脂吸附,用10-20%乙醇洗脱去除,再依次用50-70%乙醇、85-95%乙醇、65-75%丙酮洗脱,收集洗脱液,浓缩干燥得提取物;
(4)将挥发油包合物、提取物、茶色素和药学上可接受的辅料混合即得。
优选地,步骤(1)中所述水的质量与蛇床子、瓜蒌、西洋参和玉竹总质量的比为8-10:1;所述提取的时间为3-5h。
优选地,步骤(1)中所述挥发油与β-环糊精的质量比为1:5.5-7.5;所述包合的时间为1-3h,所述包合的温度为55-65℃。
优选地,步骤(2)中所述提取为在pHpH7-9、60-65℃下提取0.5-1h,过滤得滤液1和药渣1,在药渣1中加入25-50%乙醇加热回流提取1-2h,过滤得滤液2和药渣2,合并滤液得滤液b,药渣2即为滤渣b。
优选地,步骤(2)中所述25-50%乙醇的加入的体积为滤渣a、三七、泽兰、山茱萸和麦冬总质量的5-10倍。
优选地,步骤(3)中所述洗脱为先用2-3倍柱体积的10-20%乙醇洗脱去除,再依次用3-5倍柱体积的50-70%乙醇、1-3倍柱体积的85-95%乙醇、2-5倍柱体积的65-75%丙酮洗脱,控制洗脱液的流速为1-1.5mL/min。
本发明还有一个目的是提供上述茶色素组合物在制备心脑血管疾病药物中的应用;
优选地,上述茶色素组合物在制备抗动脉粥样硬化药物中的应用。
相比于现有技术,本发明的有益效果:
(1)本发明各药味有机配伍,经研究发现,蛇床子和三七在方中与其他药味配伍,具有明显的协同作用,对调血脂、改善血液流变学有较好的功效;
(2)本发明进一步对组合物的制备方法进行研究,发现了提取药材的关键质量属性参数,发现了最佳包合工艺,最佳提取溶剂及pH,制得的组合物包合率高,药效成分纯度高,治疗效果明显提升。
具体实施方式
下面结合具体实施例进一步阐述本发明。
实施例1
一种治疗心脑血管疾病的茶色素组合物,原料组分如下:茶色素5份、蛇床子5份、三七10份、西洋参5份、泽兰10份、玉竹10份、山茱萸5份、麦冬10份和瓜蒌10份。
制备方法如下:
(1)将蛇床子、瓜蒌、西洋参和玉竹加8倍量水提取挥发油3h,过滤得挥发油、滤液a和滤渣a;将β-环糊精加水制成0.5g/mLβ-环糊精水溶液,将挥发油与β-环糊精溶液混合,在55℃恒温下200r/min磁力搅拌1h,冷却,抽滤,干燥得挥发油包合物;挥发油与β-环糊精的质量比为1:5.5。
(2)将滤渣a、三七、泽兰、山茱萸和麦冬加5倍量的25%乙醇在pH至7.5、60℃下提取0.5h,过滤得滤液1和药渣1,然后在药渣1中加入5倍量的25%乙醇加热回流提取1h,过滤得滤液2和药渣2,合并滤液得滤液b,药渣2即为滤渣b。
(3)将滤液a和滤液b混合,用AB-8大孔吸附树脂吸附,先用2倍柱体积的10%乙醇洗脱去除,再依次用3倍柱体积的70%乙醇、1倍柱体积的85%乙醇、2倍柱体积的75%丙酮水溶液洗脱,控制洗脱液的流速为1.5mL/min,收集洗脱液,浓缩干燥得提取物;
(4)将挥发油包合物、提取物、茶色素和药学上可接受的辅料混合即得。
实施例2
一种治疗心脑血管疾病的茶色素组合物,原料组分如下:茶色素10份、蛇床子8份、三七15份、西洋参10份、泽兰15份、玉竹15份、山茱萸8份、麦冬15份和瓜蒌15份。
制备方法如下:
(1)将蛇床子、瓜蒌、西洋参和玉竹加10倍量水提取挥发油5h,过滤得挥发油、滤液a和滤渣a;将β-环糊精加水制成0.5g/mLβ-环糊精水溶液,将挥发油与β-环糊精溶液混合,在65℃恒温下200r/min磁力搅拌3h,冷却,抽滤,干燥得挥发油包合物;挥发油与β-环糊精的质量比为1:7.5。
(2)将滤渣a、三七、泽兰、山茱萸和麦冬加10倍量的50%乙醇在pH至8.5、65℃下提取1h,过滤得滤液1和药渣1,在药渣1中加入10倍量的50%乙醇加热回流提取1.5h,过滤得滤液2和药渣2,合并滤液得滤液b,药渣2即为滤渣b。
(3)将滤液a和滤液b混合,用AB-8大孔吸附树脂吸附,先用3倍柱体积的20%乙醇洗脱去除,再依次用5倍柱体积的50%乙醇、3倍柱体积的85%乙醇、5倍柱体积的65%丙酮水溶液洗脱,控制洗脱液的流速为1mL/min,收集洗脱液,浓缩干燥得提取物;
(4)将挥发油包合物、提取物、茶色素和药学上可接受的辅料混合即得。
实施例3
一种治疗心脑血管疾病的茶色素组合物,原料组分如下:茶色素8份、蛇床子5份、三七15份、西洋参8份、泽兰12份、玉竹10份、山茱萸8份、麦冬10份和瓜蒌12份。
制备方法如下:
(1)将蛇床子、瓜蒌、西洋参和玉竹加8倍量水提取挥发油3h,过滤得挥发油、滤液a和滤渣a;将β-环糊精加水制成0.5g/mLβ-环糊精水溶液,将挥发油与β-环糊精溶液混合,在60℃恒温下200r/min磁力搅拌2h,冷却,抽滤,干燥得挥发油包合物;挥发油与β-环糊精的质量比为1:6。
(2)将滤渣a、三七、泽兰、山茱萸和麦冬加5倍量的25%乙醇在pH至8、60℃下提取0.5h,过滤得滤液1和药渣1,在药渣1中加入10倍量的50%乙醇加热回流提取1h,过滤得滤液2和药渣2,合并滤液得滤液b,药渣2即为滤渣b。
(3)将滤液a和滤液b混合,用AB-8大孔吸附树脂吸附,先用2倍柱体积的10%乙醇洗脱去除,再依次用3倍柱体积的50%乙醇、3倍柱体积的90%乙醇、3倍柱体积的70%丙酮洗脱,控制洗脱液的流速为1mL/min,收集洗脱液,浓缩干燥得提取物;
(4)将挥发油包合物、提取物、茶色素和药学上可接受的辅料混合即得。
对比例1
本对比例与实施例3的区别是,方中不含蛇床子,三七份数为20,其余与实施例3保持一致。
对比例2
本对比例与实施例3的区别是,方中不含三七,蛇床子份数为20,其余与实施例3保持一致。
对比例3
本对比例与实施例3的区别是,将蛇床子调整为牛膝,泽兰调整为红花,西洋参调整为黄芪,其余与实施例3保持一致。
对比例4
本对比例与实施例3的区别是,制备方法不同,具体如下:
一种治疗心脑血管疾病的茶色素组合物,原料组分如下:茶色素8份、蛇床子5份、三七15份、西洋参8份、泽兰12份、玉竹10份、山茱萸8份、麦冬10份和瓜蒌12份。
制备方法如下:
(1)将蛇床子、瓜蒌、西洋参和玉竹加8倍量水提取挥发油3h,过滤得挥发油、滤液a和滤渣a;将β-环糊精加水制成0.5g/mLβ-环糊精水溶液,将挥发油与β-环糊精溶液混合,在60℃恒温下200r/min磁力搅拌2h,冷却,抽滤,干燥得挥发油包合物;挥发油与β-环糊精的质量比为1:6。
(2)将滤渣a、泽兰和麦冬加5倍量水煎煮2次,每次煎煮1h,过滤浓缩干燥得提取物1;
(3)将三七和山茱萸加入10倍量的50%乙醇加热回流提取2次,每次提取1h,过滤得滤液b;
(4)将滤液b用AB-8大孔吸附树脂吸附,先用2倍柱体积的10%乙醇洗脱去除,再依次用3倍柱体积的50%乙醇、3倍柱体积的80%乙醇、3倍柱体积的95%乙醇洗脱,控制洗脱液的流速为1mL/min,收集洗脱液,浓缩干燥得提取物2;
(4)将挥发油包合物、提取物1、提取物2、茶色素和药学上可接受的辅料混合即得。
试验例1本发明组合物对模型大鼠血液流变学的影响
1.1动物分组:
雄性SD大鼠,体重200±20g,按照随机数字表随机分为10组,分别为正常组、模型组、阳性对照组、实施例1至实施例3组,对比例1至对比例4组。
1.2动物模型的建立
将各组大鼠自由喂养1周,各组大鼠自然摄食基础饲料,同时除正常组大鼠之外的各组大鼠每天上午喂食高脂乳剂配方,喂食3周。高脂乳剂的组成为吐温-80 50%+食用油18%+胆固醇10%+胆酸钠5%+丙基硫氧嘧啶0.2%,余量为水;制备方法为:将食用油用热水分散,依次加入胆固醇、丙基硫氧嘧啶、胆酸钠、吐温-80,剧烈搅拌,然后加热水至100mL搅拌制成高脂乳化液,即得。
1.3试验方法
灌胃给药。将实施例1-3组、对比例1-4组给予相应组制备得到的组合物,给药剂量按生药量10g/kg计,组合物加水溶解分散,给药体积2mL/100g;正常组和模型组给药同等容量的生理盐水;阳性组给药辛伐他汀混悬液1.5mg/kg。给药3周后,禁食不禁水12h,眼底静脉丛取血,分离血浆,测定血脂水平和血液流变学指标。
1.4结果与分析
1.4.1用ELISA法测定总胆固醇、甘油三酯、低密度脂蛋白、高密度脂蛋白的水平。结果见表1。
表1 各组大鼠血脂水平
注:同一列不同字母代表相应组间比较,具有统计学差异,P<0.05。
1.4.2采用全自动血流变检测仪测定大鼠全血高切粘度(ηH)、全血低切粘度(ηL)、血浆粘度(ηp)及红细胞压积(HCT),结果见表2。
表2 各组大鼠血液流变学检测
注:同一列不同字母代表相应组间比较,具有统计学差异,P<0.05。
综上可知,大鼠经喂食基础饲料与高脂肪乳剂配方三周后,模型组大鼠的血脂水平、血液流变学参数明显改变,与正常组大鼠具有显著的统计学差异(P<0.05);经本发明组合物灌胃给药3周后,大鼠的血脂水平明显下降,其中甘油三酯、高密度脂蛋白水平、改善血液流变学状态优于阳性对照辛伐他汀;提示本发明组合物具有良好的改善动脉粥样硬化的作用,市场前景广阔。
上述详细说明是针对本发明其中之一可行实施例的具体说明,该实施例并非用以限制本发明的专利范围,凡未脱离本发明所为的等效实施或变更,均应包含于本发明技术方案的范围内。
Claims (11)
1.一种抗动脉粥样硬化的茶色素组合物,其特征在于,按照重量份数计,所述组合物的原料由如下组分组成:茶色素5-10份、蛇床子5-10份、三七10-15份、西洋参5-10份、泽兰10-15份、玉竹10-15份、山茱萸5-10份、麦冬10-15份和瓜蒌10-15份;
所述的茶色素组合物的制备方法,包括如下步骤:
(1)将蛇床子、瓜蒌、西洋参和玉竹加水提取挥发油,过滤得挥发油、滤液a和滤渣a;将挥发油加β-环糊精包合,得挥发油包合物;
(2)将滤渣a、三七、泽兰、山茱萸和麦冬加25-50%乙醇提取,得滤液b和滤渣b;
(3)将滤液a和滤液b混合,用大孔吸附树脂吸附,用10-20%乙醇洗脱去除,再依次用50-70%乙醇、85-95%乙醇、65-75%丙酮洗脱,收集洗脱液,浓缩干燥得提取物;
(4)将挥发油包合物、提取物、茶色素和药学上可接受的辅料混合即得。
2.根据权利要求1所述的茶色素组合物,其特征在于,所述组合物的原料由如下组分组成:茶色素8-10份、蛇床子5-8份、三七12-15份、西洋参5-10份、泽兰10-12份、玉竹10-12份、山茱萸5-8份、麦冬10-15份和瓜蒌10-12份。
3.根据权利要求1所述的茶色素组合物,其特征在于,所述组合物还包括药学上可接受的辅料。
4.根据权利要求1所述的茶色素组合物,其特征在于,所述药学上可接受的辅料为淀粉和硬脂酸镁。
5.一种权利要求1-4任意一项所述的茶色素组合物的制备方法,其特征在于,包括如下步骤:
(1)将蛇床子、瓜蒌、西洋参和玉竹加水提取挥发油,过滤得挥发油、滤液a和滤渣a;将挥发油加β-环糊精包合,得挥发油包合物;
(2)将滤渣a、三七、泽兰、山茱萸和麦冬加25-50%乙醇提取,得滤液b和滤渣b;
(3)将滤液a和滤液b混合,用大孔吸附树脂吸附,用10-20%乙醇洗脱去除,再依次用50-70%乙醇、85-95%乙醇、65-75%丙酮洗脱,收集洗脱液,浓缩干燥得提取物;
(4)将挥发油包合物、提取物、茶色素和药学上可接受的辅料混合即得。
6.根据权利要求5所述的制备方法,其特征在于,步骤(1)中所述水的质量与蛇床子、瓜蒌、西洋参和玉竹总质量的比为8-10:1;所述提取的时间为3-5h。
7.根据权利要求5所述的制备方法,其特征在于,步骤(1)中所述挥发油与β-环糊精的质量比为1:5.5-7.5;所述包合的时间为1-3h,所述包合的温度为55-65℃。
8.根据权利要求5所述的制备方法,其特征在于,步骤(2)中所述提取为在pH7-9、60-65℃下提取0.5-1h,过滤得滤液1和药渣1,在药渣1中加入25-50%乙醇加热回流提取1-2h,过滤得滤液2和药渣2,合并滤液得滤液b,药渣2即为滤渣b。
9.根据权利要求5所述的制备方法,其特征在于,步骤(2)中所述25-50%乙醇的加入的体积为滤渣a、三七、泽兰、山茱萸和麦冬总质量的5-10倍。
10.根据权利要求5所述的制备方法,其特征在于,步骤(3)中所述洗脱为先用2-3倍柱体积的10-20%乙醇洗脱去除,再依次用3-5倍柱体积的50-70%乙醇、1-3倍柱体积的85-95%乙醇、2-5倍柱体积的65-75%丙酮洗脱,控制洗脱液的流速为1-1.5mL/min。
11.一种权利要求1-4任意一项所述的茶色素组合物在制备抗动脉粥样硬化药物中的应用。
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