CN107496876A - 一种消栓通脉中药制剂及其制备方法 - Google Patents
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- CN107496876A CN107496876A CN201710847324.2A CN201710847324A CN107496876A CN 107496876 A CN107496876 A CN 107496876A CN 201710847324 A CN201710847324 A CN 201710847324A CN 107496876 A CN107496876 A CN 107496876A
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Abstract
本发明公开了一种消栓通脉中药制剂及其制备方法，该中药制剂的中药组分为：天麻100‑300g、紫丹参300‑1000g、西洋参100‑300g、南方人参300‑1000g、壮三七100‑300g、大蒜1000‑3000g、生姜1000‑3000g和柠檬1000‑3000g。制备方法为：分别制备天麻、紫丹参、西洋参和南方人参的提取物，另外制备三七、生姜和柠檬挥发油，然后将制备提取物所得滤渣加水和大蒜，煎煮两次，得到滤液，将滤液和挥发油混合后得到母液，加入辅料制得口服液，片剂、颗粒剂或胶囊。本发明制剂对高粘血症、心慌、心痛、胸背酸痛，头昏头痛、手脚麻木有较好的治疗作用，对心脑血管有重要的保护作用。
Description
技术领域
本发明涉及中药制剂技术领域，具体为一种消栓通脉中药制剂及其制备方法。
背景技术
血栓是血流在心血管系统血管内面剥落处或修补处的表面所形成的小块。在可变的流体依赖型(variable flow dependent patterns)中，血栓由不溶性纤维蛋白,沉积的血小板,积聚的白细胞和陷入的红细胞组成。据统计，根据目前已有的流行病学资料推测，到2020年，人类疾病死因中冠心病和脑卒中将是人类死因的前两位，据估计，到时全球冠心病死亡人数将上升至1100万人，脑卒中死亡人数将增至770万人。而且随着社会发展加快，大多人的工作方式将超负荷运作，作息不规律，脑力劳动加强，工作压力进一步加大，心脑血管疾病发生逐渐年轻化，将成为危害人类健康的主要疾病，更是未来人类致死的头号杀手。
目前，抗血栓药可分为抗凝血药、抗血小板聚集药和溶血栓药三大类：1、抗凝血药(anticoagulants）是一类干扰凝血因子，阻止血液凝固的药物，主要用于血栓栓塞性疾病的预防与治疗；2、抗血小板聚集药分为三代：阿司匹林为第一代，噻氯匹啶为第二代，血小板糖蛋白Ⅱb/Ⅲa受体拮抗剂为第三代；3、凝血中形成的纤维蛋白，可经纤溶酶作用从精氨酸-赖氨酸键上分解成可溶性产物，使血栓溶解。第一代的溶栓药链激酶(SK）和尿激酶(UK）至今仍然是国内外使用最广泛的品种，随着尿激酶原(Pro-UK）等新一代溶栓药的问世，这类药物正在临床逐渐推广应用。而西药对血栓的治疗快速而有效，但同时伴随而来的是副作用及抗性问题，因此西药需要不断更新换代来适应引起血栓的病因。
而对于血栓中医论证与治疗有“治未病”的思想，血栓如果能早期预防，或发生后能预防复发，则更有价值和意义，中医学西汉帛书《五十二病方》，对血栓多属于“血瘀”症范畴，因此临床上多使用活血化瘀药物来防止血栓形成。其中，红花、丹参、当归、三七、水蛭为代表治疗药物。治疗该项疾病的中西药虽然很多种，但在临床应用中发现多数药物存在服用时间长、剂量大、见效缓慢等弊端，临床疗效也不够理想，如何根据中药的“四气五味”合理配伍，让其达到较好的效果才更具意义。
发明内容
本发明针对现有技术存在的上述不足，提供了一种消栓通脉中药制剂及其制备方法，该中药制剂对治疗高粘血症的冠心病，脂肪肝，对心慌、心痛、胸背酸痛、头昏头痛、手脚麻木有较好的治疗和改善。
本发明技术方案是这样实现的：
本发明所述消栓通脉中药制剂，由中药组分及辅料组成，所述中药组分为：天麻100-300g、紫丹参300-1000g、西洋参100-300g、南方人参300-1000g、壮三七100-300g、大蒜1000-3000g、生姜1000-3000g和柠檬1000-3000g。
所述消栓通脉中药制剂的制备方法为：先将中药组分加工成母液，再加入相关辅料制成口服液、片剂、胶囊或颗粒剂。
所述母液的制备方法如下：
（1）取天麻、紫丹参粉碎，加体积分数为70%的乙醇回流提取2-4h，滤过，所得滤液回收乙醇，得到的溶液A备用。
（2）取西洋参、南方人参粉碎，加入体积分数为50-70%的乙醇回流提取2-4h，滤过，所得滤液回收乙醇，得到的溶液B备用。
（3）取壮三七粉碎，生姜、柠檬打碎，水蒸气蒸馏提取挥发油，备用。
（4）步骤（1）、（2）、（3）所剩药渣加水及大蒜，煎煮两次，每次2-4h，收集两次滤液，备用。
（5）将步骤（4）收集的滤液与步骤（1）、（2）得到的滤液A、滤液B及步骤（3）得到的挥发油混合，得到母液。
口服液的制备方法为：取步骤（5）制得的母液，加入5000-50000ml米醋，调节pH到2，加入蜂蜜调节口感即得。
片剂的制备方法为：将步骤（5）制得的母液经浓缩处理加入淀粉、葡萄糖、羧甲基纤维素，搅拌吸附，气流粉碎后，压片制得片剂。
胶囊的制备方法为：将步骤（5）制得的母液经浓缩处理加入聚乙烯醇、聚乙二醇6000，搅拌吸附后，干燥、粉碎，制成胶囊。
颗粒剂的制备方法：将步骤（5）制得的母液经浓缩处理加入淀粉、葡萄糖、羧甲基纤维素，蔗糖，搅拌吸附后，气流粉碎后挤压造粒制成颗粒剂。
本发明消栓通脉中药制剂在制备降血脂、改善血液粘稠度以及消除血栓的药物中的应用。
本发明所述的消栓通脉中药制剂中的有效成分分析如下：
天麻：为兰科植物天麻（Gastrodia elata Blume.）的干燥块茎，【别名】赤箭、木浦、明天麻、定风草根、白龙皮等。【性味】甘，平。【归经】归肝经。【功能主治】平肝息风止痉。用于头痛眩晕，肢体麻木，小儿惊风，癫痫抽搐，破伤风。
紫丹参：为唇形科植物丹参（salvia miltiorrhiza Bunge.）的干燥根及根茎，【别名】丹参、红根、大红袍、血参根、血山根、红丹参等。【性味】苦，微寒。 【归经】归心、肝经。【功能主治】祛瘀止痛，活血通经，清心除烦。用于月经不调，经闭痛经，症瘕积聚，胸腹刺痛，热痹疼痛，疮疡肿痛，心烦不眠；肝脾肿大，心绞痛。
西洋参：为五加科植物西洋参（panax quinquefolium.L,）的干燥根。【别名】花旗参、洋参、西洋人参。【性味与归经】甘、微苦，凉。归心、肺、肾经。【功能与主治】补气养阴，清热生津。用于气虚阴亏，内热，咳喘痰血，虚热烦倦，消渴，口燥咽干。
南方人参：即绞股蓝，为葫芦科绞股蓝属植物绞股蓝（Gynostemma pentaphyllum (Thunb.) Makino）的全草。【别名】七叶胆、小苦药、公罗锅底等。【性味】味苦；微甘；性凉。【归经】归肺；脾；肾经。【功能主治】清热；补虚；解毒。主体虚乏力；虚劳失精；白细胞减少症；高脂血症；病毒性肝炎；慢性胃肠炎；慢性气管炎。绞股蓝主要有效成份是绞股蓝皂甙、绞股蓝糖甙(多糖)、水溶性氨基酸、黄酮类、多种维生素、微量元素、矿物质等。有保肝解毒、降血压、降血脂血糖的功效。
壮三七：拉丁学名：Panax pseudoginseng Wall. var. notoginseng (Burkill)Hoo et Tseng，为伞形目五加科人参属多年生草本植物，根状茎短，肉质根圆柱形，掌状复叶，伞形花序顶生，花黄绿色；萼杯状。根部入药，其性温，味辛，具有显著的活血化瘀、消肿定痛功效，有“金不换”、“南国神草”之美誉。
生姜：为姜科植物姜（Zingiber officinale Roscoe）的新鲜根茎，别名有姜根、百辣云、勾装指、因地辛、炎凉小子、鲜生姜、蜜炙姜。【性味】辛，微温。【归经】归肺、脾、胃经。【功能主治】解表散寒，温中止呕，化痰止咳。用于风寒感冒，胃寒呕吐，寒痰咳嗽。
大蒜：为百合科植物大蒜（Allium sativum L.）的鳞茎。【别名】蒜头、大蒜头、胡蒜、葫、独蒜、独头蒜，是蒜类植物的统称。【性味与归经】 辛，温。归脾、胃、肺经。【功能与主治】 解毒消肿，杀虫，止痢。用于痈肿疮疡，疥癣，肺痨，顿咳，泄泻，痢疾。
柠檬：为芸香科柑橘属植物柠檬（Citrus limonia Osbeck）的果实。【别名】黎檬、黎檬子、宜母子、宜母子、里木子、黎檬干、药果、梦子、宜母果、柠果。【性味】酸；甘；凉。【归经】肺；胃经。【功能主治】生津，止渴，祛暑，安胎。咽痛口干，胃脘胀气，高血压，心肌梗塞，不思饮食。
心脑血管病的病理基础为气虚血瘀，本发明溯本求源，在活血通络的基础上益气扶正，同时补益肝肾、降脂降压，达到标本兼治的目的。其中紫丹参、壮三七能够活血化瘀、通经活络，用为君药；天麻、西洋参补气祛邪，破血逐淤，同为臣药；南方人参、柠檬降脂降压，俱为佐药；生姜、大蒜辛温解表，用为使药。全方共奏益气活血，疏通血脉，溶栓疗瘫之功效。能从根本上整体调理治疗，达到恢复健康的目的。
本发明的有益效果：
1、本发明的消栓通脉中药制剂具有降血脂、改善血液粘稠度，消除血栓、扩张和畅通血管功能；经临床观察对治疗高粘血症的冠心病，脂肪肝，对心慌、心痛、胸背酸痛，头昏头痛、手脚麻木有较好的治疗和改善，对心脑血管有重要的保护作用。
2、本发明相对西药毒副作用小，成本低，适用人群广，经发明人验证，对各年龄段人群均有较好的治疗效果。
3、本发明的消栓通脉中药制剂各组分常见易得，制备工艺流程简单，无复杂环节，便于实现工业化生产，便于推广和应用。
具体实施方式
实施例1 消栓通脉口服液的制备
中药原料配比组成：
制备方法为：
（1）取天麻、紫丹参粉碎，加体积分数为70%的乙醇回流提取3h，滤过，所得滤液回收乙醇，得到的溶液A备用。
（2）取西洋参、南方人参粉碎，加入体积分数为50%的乙醇回流提取3h，滤过，所得滤液回收乙醇，得到的溶液B备用。
（3）取壮三七粉碎，生姜、柠檬打碎，水蒸气蒸馏提取挥发油，备用。
（4）步骤（1）、（2）、（3）所剩药渣加水及大蒜，煎煮两次，每次2h，收集两次滤液，备用。
（5）将步骤（4）收集的滤液与步骤（1）、（2）得到的滤液A、滤液B及步骤（3）得到的挥发油混合，得到母液。
（6）将米醋加入到母液中，调节pH到2，加入蜂蜜，搅拌均匀，即得。
实施例2 消栓通脉片剂的制备
中药原料配比组成：
制备方法为：母液的制备同实施例1-4，在母液中经浓缩处理按配方比例加入淀粉、羧甲基纤维素或葡萄糖，充分搅拌吸附后，进入气流粉碎机粉碎至200目，在压片机中压片，干燥，即得。
实施例3 消栓通脉颗粒剂的制备
中药原料配比组成：
制备方法为：母液的制备同实施例1-4，在母液中经浓缩处理按配方比例加入淀粉、羧甲基纤维素或葡萄糖，充分搅拌吸附后，进入气流粉碎机粉碎至200目，挤压造粒，控制每颗粒重0.2-0.23g，干燥，即得。
实施例4 消栓通脉胶囊的制备
中药原料配比组成：
制备方法为：母液的制备同实施例1-4，在母液中经浓缩处理按配方比例加入聚乙烯醇和聚乙二醇充分搅拌吸6000，充分吸附后，进入气流粉碎机粉碎至200目，制成胶囊，即得。
实施例5
为表明本发明的药物对心脑血管疾病的治疗效果，本发明人对300例病例临床观察，其中男性152人，女性148人，年龄40岁--80岁，病程2--5年，其中高血压65例，高血脂90例，脑动脉硬化80例，冠心病65例。通过服用本发明的药物，一般用药2-3个疗程，270人治愈，治愈率达90%，285人有效，有效率为95%。
以下是本发明临床应用几个典型实施例：
病例1：王某，男83岁，症状：犯有经常性头痛，头晕，有高血压史20余年，同时犯有四肢麻木等症状。临床诊断：1、高血压病；2、脑动脉硬化；3、脑出血。入院治疗20天后，症状好转，但仍伴有四肢无力，头晕头痛症状。随后服用本发明实施例1口服液，每次30-50ml，每天3次，一周为一个疗程，服用3个疗程后，症状明显减轻，四肢有力，头痛减轻。
病例2：魏某，女，58岁，农民，经常性头晕目眩，记忆力差，四肢无力，经医院检查，犯有中度高血压，血脂偏高，诊断为脑梗前兆，建议住院治疗，20天后症状减轻，但回家后断药后1周，头痛加重，血压升高。之后服用本发明实施例1口服液，每次30-50ml，每天3次，一周为一个疗程，服用2个疗程后，症状明显减轻，继续服用4个疗程后，血压稳定。
病例3：孙某，女，66岁。语言不清伴左侧肢体活动障碍5个月，患有高血压15年，并伴有糖尿病8年，医院诊断为脑梗伴有糖尿病。服用本发明实施例5，每次2片，每天3次，4个疗程后症状减轻，血压控制稳定，身体轻松，睡眠良好。
病例4：吉某，男，82岁，患有发作性胸闷、胸痛、气短15年，加重7天入院，位于心前区，呈压榨样钝痛，伴出汗，无放射，持续数分钟，患有脑血栓，脑梗塞。医院诊断为：“冠状动脉心脏病、急性下壁右室心肌梗死”。服用本发明实施例13，每次服用2g，每天2次，5个疗程后不良症状可缓解，无头晕、黑蒙。
病例5：李某，女54岁，既往身体健康，在劳动中突然左侧偏瘫，经医院检查为，右侧基底节脑梗塞，经脱水、降压、营养脑细胞等治疗后10天，病情稳定但未有好转，复查头颅CT，右侧基底节脑梗塞，左侧强袭性脑梗塞，继续治疗5天后，仍未有好转。在住院期间服用本发明实施例4口服液，4个疗程后，患者左下肢肌力恢复到4级，血压稳定，下肢疼痛得到控制。
Claims (4)
1.一种消栓通脉中药制剂，所述制剂由中药组分及辅料组成，其特征在于：所述中药组分为：天麻100-300g、紫丹参300-1000g、西洋参100-300g、南方人参300-1000g、壮三七100-300g、大蒜1000-3000g、生姜1000-3000g和柠檬1000-3000g。
2.权利要求1所述消栓通脉中药制剂的制备方法，其特征在于：所述制备方法为：先将中药组分加工成母液，再加入相关辅料制成口服液、片剂、胶囊或颗粒剂。
3.根据权利要求2所述的消栓通脉中药制剂的制备方法，其特征在于：所述母液的制备方法如下：
（1）取天麻、紫丹参粉碎，加体积分数为70%的乙醇回流提取2-4h，滤过，所得滤液回收乙醇，得到的溶液A备用；
（2）取西洋参、南方人参粉碎，加入体积分数为50-70%的乙醇回流提取2-4h，滤过，所得滤液回收乙醇，得到的溶液B备用；
（3）取壮三七粉碎，生姜、柠檬打碎，水蒸气蒸馏提取挥发油，备用；
（4）步骤（1）、（2）、（3）所剩药渣加水及大蒜，煎煮两次，每次2-4h，收集两次滤液，备用；
（5）将步骤（4）收集的滤液与步骤（1）、（2）得到的滤液A、滤液B及步骤（3）得到的挥发油混合，得到母液。
4.权利要求1所述消栓通脉中药制剂在制备降血脂、改善血液粘稠度以及消除血栓的药物中的应用。
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