CN106880673A - 一种治疗冠心病的中药组合物及其制备方法 - Google Patents
一种治疗冠心病的中药组合物及其制备方法 Download PDFInfo
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- CN106880673A CN106880673A CN201710148930.5A CN201710148930A CN106880673A CN 106880673 A CN106880673 A CN 106880673A CN 201710148930 A CN201710148930 A CN 201710148930A CN 106880673 A CN106880673 A CN 106880673A
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Abstract
本发明公开了一种治疗冠心病的中药组合物,其包括:唇香草、人参芦、毛节兔唇花、一把伞、甘木通、白果叶、川穹、长管蝙蝠草、茯苓、齿叶橐吾、白乳菇,本发明还公开了上述中药组合物的制备方法。此种中药组合物均以纯中药配制,具有天然药物毒性小、疗效好的特性,对于冠心病疗效明确、标本兼治,尤其适用于气滞血瘀型冠心病的治疗,具有改善微循环、增加冠脉血流量、改善心肌缺血的作用,价格低廉、制作简便,具有良好的应用前景。
Description
技术领域
本发明涉及一种医用配制品,尤其涉及一种用于治疗冠心病的中药组合物及其制备方法。
背景技术
冠状动脉粥样硬化性心脏病是冠状动脉血管发生动脉粥样硬化病变而引起血管腔狭窄或阻塞,造成心肌缺血、缺氧或坏死而导致的心脏病,常常被称为“冠心病”。但是冠心病的范围可能更广泛,还包括炎症、栓塞等导致管腔狭窄或闭塞。世界卫生组织将冠心病分为5大类:无症状心肌缺血(隐匿性冠心病)、心绞痛、心肌梗死、缺血性心力衰竭(缺血性心脏病)和猝死5种临床类型。临床中常常分为稳定性冠心病和急性冠状动脉综合征。
现代医学在药物干预与介入治疗方面获得了明显的进展,但是许多临床问题仍未解决。中医认为冠心病属于胸痹、心痛、气虚血瘀等病症,而中医药的益气活血、去瘀生新等许多治疗法则及临床的有效性,对缓解冠心病和改善生活质量都有很大的潜力。故从中医的角度治疗冠心病是行之有效的方法之一。
发明内容
为了解决上述问题,本发明提供一种具有天然药物毒性小、疗效好的特性,对于冠心病疗效明确、标本兼治、尤其适用于气滞血瘀型冠心病的治疗、具有改善微循环、增加冠脉血流量、改善心肌缺血的作用、价格低廉、制作简便,具有良好的应用前景的中药组合物。
本发明采用的技术方案是:一种治疗冠心病的中药组合物,所述中药组合物的各组份为唇香草、人参芦、毛节兔唇花、一把伞、甘木通、白果叶、川穹、长管蝙蝠草、茯苓、齿叶橐吾、白乳菇。
优选的,各种组份的重量份数比为唇香草25-35份、人参芦15-25份、毛节兔唇花15-25份、一把伞10-20份、甘木通10-20份、白果叶5-15份、川穹5-15份、长管蝙蝠草5-15份、茯苓5-15份、齿叶橐吾5-15份、白乳菇5-15份。
更优选的,各种组份的重量份数比为唇香草30-35份、人参芦20-25份、毛节兔唇花20-25份、一把伞10-15份、甘木通10-15份、白果叶5-10份、川穹5-10份、长管蝙蝠草5-10份、茯苓5-10份、齿叶橐吾5-10份、白乳菇5-10份。
其中,所述中药组合物的剂型为:薄膜衣片剂、丹剂、硬膏剂、糖浆剂、口服液、口含剂、颗粒剂、散剂、注射剂、糖衣片剂、胶囊剂。
本发明还提供了上述中药组合物的制备方法,当所述中药的剂型为胶囊剂时,包括:
第一步,人参芦、毛节兔唇花按比例混合,用相当于混合物质量2-3倍的醇浓度为70-80%的正丙醇回流提取2-4次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1-2次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将一把伞、甘木通、白果叶、川穹用醇浓度为80-90%的正丙醇提取2-3次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2-4倍量的水溶解,静止1-3小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2-3小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2-4倍;
第四步,将上述粉末和淀粉混合,随后进行制粒处理并干燥,得到混合物颗粒,再向混合物颗粒中加入硬脂酸镁,所述硬脂酸镁和所述混合物颗粒质量之比为0.25-100:0.5-100,获得胶囊内容物,将所述的胶囊内容物装入胶囊壳体中即得胶囊剂。
本发明还提供了上述中药组合物的制备方法,当所述中药的剂型为注射剂时,包括:
第一步,人参芦、毛节兔唇花按比例混合,用相当于混合物质量2-3倍的醇浓度为70-80%的正丙醇回流提取2-4次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1-2次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将一把伞、甘木通、白果叶、川穹用醇浓度为80-90%的正丙醇提取2-3次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2-4倍量的水溶解,静止1-3小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2-3小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2-4倍;
第四步,将上述粉末混合,随后将其溶于质量为混合物2-4倍的水,搅拌下加入相对于粉末质量5%-15%的氢氧化钠助溶,过滤,加浓度为1mol/L的盐酸调节pH值为5-6,过滤,沉淀备用,滤液通过聚酰胺柱,先用水洗去杂质,随后用醇浓度为80-90%的正丙醇洗脱,收集正丙醇洗脱液,沉淀用醇浓度为80-90%的正丙醇提取2次,过滤,滤液与上述洗脱液合并,回收正丙醇,减压浓缩至膏体并喷雾干燥成粉末,将获得的粉末加相对于其质量1-2倍的氯化钠及注射用水适量,溶解后再进一步加注射用水至需要的体积,过滤,灌封,灭菌,获得需要的注射液。
唇香草,味辛,性凉,宁心安神;利水清热。主心悸;失眠;水肿;感冒发热;目赤肿痛;疮疡肿毒,主治高血压、冠心病。
人参芦,味甘、微苦,性温,归肺、胃、脾经,能升阳举陷。
毛节兔唇花,味甘,性凉,化瘀止痛;生肌止血。主冠心病;心绞痛;溃疡病;多种出血。
一把伞,味辛、苦、性平,养心安神;清肝明目。主心悸怔忡;神经衰弱;目赤肿痛;冠心病;高血压等。
白果叶,味甘、苦、涩,性平,益心敛肺,化湿止泻。治胸闷心痛,心悸怔忡,痰喘咳嗽,泻痢,白带。
甘木通,味甘、性微凉,镇静,镇痛,降压。主治红眼病,头痛,高血压病。本品对改善高血压所引起的症状,如头痛、头昏、脑胀、四肢麻木,失眠等有较好的疗效。同时初步观察到对冠心病患者和脑血管意外引起的偏瘫患者均有治疗作用。
川穹,味辛、性温,行气开郁,法风燥湿,活血止痛。治风冷头痛旋晕,胁痛腹疼,寒痹筋挛,经闭,难产,产后瘀阻块痛,痈疽疮疡。用于月经不调,经闭痛经,瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。
长管蝙蝠草,味辛,性凉,活血祛瘀,解毒消肿,止痛。用于跌打瘀肿,风湿骨痛,肺结核咳嗽,蛇虫咬伤,痈疮等。
茯苓,味甘、淡,性平,归心、肺、脾、肾经,利水渗湿,健脾,宁心;用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
齿叶橐吾,味辛,性微温,舒筋活血,散瘀止痛。主治跌打损伤,疼痛。
白乳菇,味苦、辛,性温,祛风散寒;舒筋活络。主腰腿疼痛;手足麻木;筋骨不舒;四肢抽搐。
本发明的有益效果:
相对于现有技术中的具有治疗冠心病效果的药物,此种中药组合物均以纯中药配制,具有天然药物毒性小、疗效好的特性,对于冠心病疗效明确、标本兼治,尤其适用于气滞血瘀型冠心病的治疗,具有改善微循环、增加冠脉血流量、改善心肌缺血的作用,价格低廉、制作简便,具有良好的应用前景。
具体实施方式
实施例1:
(一)一种治疗冠心病的中药,由以下原料药按重量份配比而成:
唇香草30份、人参芦25份、毛节兔唇花20份、一把伞15份、甘木通15份、白果叶10份、川穹10份、长管蝙蝠草10份、茯苓10份、齿叶橐吾5份、白乳菇5份。
(二)制备方法:
第一步,人参芦、毛节兔唇花按比例混合,用相当于混合物质量2倍的醇浓度为70%的正丙醇回流提取2次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1-2次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将一把伞、甘木通、白果叶、川穹用醇浓度为80-90%的正丙醇提取2-3次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2倍量的水溶解,静止1小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2倍;
第四步,将上述粉末和淀粉混合,随后进行制粒处理并干燥,得到混合物颗粒,再向混合物颗粒中加入硬脂酸镁,所述硬脂酸镁和所述混合物颗粒质量之比为0.25:0.5,获得胶囊内容物,将所述的胶囊内容物装入胶囊壳体中即得胶囊剂。
实施例2:
(一)一种治疗冠心病的中药,由以下原料药按重量份配比而成:同实施例1。
(二)制备方法:
第一步,人参芦、毛节兔唇花按比例混合,用相当于混合物质量2倍的醇浓度为70%的正丙醇回流提取2次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将一把伞、甘木通、白果叶、川穹用醇浓度为80%的正丙醇提取2次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2倍量的水溶解,静止1小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2倍;
第四步,将上述粉末混合,随后将其溶于质量为混合物2倍的水,搅拌下加入相对于粉末质量5%的氢氧化钠助溶,过滤,加浓度为1mol/L的盐酸调节pH值为5-6,过滤,沉淀备用,滤液通过聚酰胺柱,先用水洗去杂质,随后用醇浓度为80的正丙醇洗脱,收集正丙醇洗脱液,沉淀用醇浓度为80的正丙醇提取2次,过滤,滤液与上述洗脱液合并,回收正丙醇,减压浓缩至膏体并喷雾干燥成粉末,将获得的粉末加相对于其质量2倍的氯化钠及注射用水适量,溶解后再进一步加注射用水至需要的体积,过滤,灌封,灭菌,获得需要的注射液。
实施例3:
1、长期毒性试验过程:
应用Wistar大鼠(北京维通利华实验动物技术有限公司提供)将实验药物设定为高、中、低三个剂量,分别为实施例1配方的胶囊剂8g/kg、4g/kg、2g/kg。按人用剂量0.1g/kg/天片计算,分别为人用有效剂量的80倍、40倍和20倍;另设一对照组,连续灌胃给药90天、180天和部分动物停药10天后,观察对大鼠各项生理、生化指标的影响。实验结果表明:用不同剂量给大鼠连续口服180天,对大鼠的进食量和体重增长均无影响。对肝肾功能均未发现明显毒性作用。对血常规、血生化、尿液生化及骨髓片等均未见明显影响,各组间与对照组比较无明显差异。
2、急性毒性试验过程:
应用ICR小鼠(北京维通利华实验动物技术有限公司提供)40只,体重在25-30克,进行急性毒性实验。小鼠随机分为两组,即对照组、给药组,实验前禁食12小时,然后给予如实施例1制备得到的本发明的中药胶囊剂混悬液(将胶囊剂溶解在水中获得混悬液)灌胃,对给药的半数致死量(LD50)进行了试验测定,但未测到LD50,因此进行了最大耐受量试验。结果:以最大浓度(60%),最大给药量(120ml/kg,一日内份四次给完)100g/kg灌胃,相当于生药量60g/kg,相当于成人临床拟日用剂量的300倍(按75kg),七日内小鼠无一死亡,处死小鼠解剖观察各脏器未发现毒性反应,给药组与对照组小鼠无任何差异。
实施例4:
本发明的临床治疗观察如下:
(一)患者300例,150例为男性,150例为女性,年龄范围45-85岁。
(二)诊断标准:
诊断标准:
所有病例均参照《内科学》中冠心病的诊断标准进行诊断。
(三)治疗方法:1组:采用如实施例1制备方法制得的胶囊剂100g,分成50份,每天早晨空腹服用一份,25天为一个疗程,连续服用两个疗程;2组:采用如实施例2制备方法制得的注射剂100g,分成50份,每天早晨空腹注射一份,25天为一个疗程,连续注射两个疗程;另设一对照组,每日口服复方丹参片2g,连续服用50天。
(四)疗效评定标准:
疗效标准:
整体疗效评定参照《中药新药临床研究指导原则》相关标准:
治愈:冠心病,心绞痛等症状消失,心脏机能恢复正常;
有效:上述症状有所缓解,心脏功能有所恢复;
无效:症状无变化。
(五)治疗结果见表1:
表1治疗结果
组别 | 痊愈 | 有效 | 无效 |
对照组 | 0 | 35 | 65 |
1组 | 98 | 1 | 1 |
2组 | 99 | 1 | 0 |
上述实施例只是为了说明本发明的技术构思及特点,其目的是在于让本领域内的普通技术人员能够了解本发明的内容并据以实施,并不能以此限制本发明的保护范围。凡是根据本发明内容的实质所作出的等效的变化或修饰,都应涵盖在本发明的保护范围。
Claims (6)
1.一种治疗冠心病的中药组合物,其特征在于:所述中药组合物的各组份为唇香草、人参芦、毛节兔唇花、一把伞、甘木通、白果叶、川穹、长管蝙蝠草、茯苓、齿叶橐吾、白乳菇。。
2.如权利要求1所述的中药组合物,其特征在于:各种组份的重量份数比为唇香草25-35份、人参芦15-25份、毛节兔唇花15-25份、一把伞10-20份、甘木通10-20份、白果叶5-15份、川穹5-15份、长管蝙蝠草5-15份、茯苓5-15份、齿叶橐吾5-15份、白乳菇5-15份。
3.如权利要求1所述的中药组合物,其特征在于:各种组份的重量份数比为唇香草30-35份、人参芦20-25份、毛节兔唇花20-25份、一把伞10-15份、甘木通10-15份、白果叶5-10份、川穹5-10份、长管蝙蝠草5-10份、茯苓5-10份、齿叶橐吾5-10份、白乳菇5-10份。
4.如权利要求1-3中任一项所述治疗冠心病的中药组合物,其特征在于,所述中药组合物的剂型为:薄膜衣片剂、丹剂、硬膏剂、糖浆剂、口服液、口含剂、颗粒剂、散剂、注射剂、糖衣片剂、胶囊剂。
5.一种如权利要求1-3中任一项所述治疗冠心病的中药组合物的制备方法,其特征在于:当所述中药的剂型为胶囊剂时,包括:
第一步,人参芦、毛节兔唇花按比例混合,用相当于混合物质量2-3倍的醇浓度为70-80%的正丙醇回流提取2-4次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1-2次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将一把伞、甘木通、白果叶、川穹用醇浓度为80-90%的正丙醇提取2-3次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2-4倍量的水溶解,静止1-3小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2-3小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2-4倍;
第四步,将上述粉末和淀粉混合,随后进行制粒处理并干燥,得到混合物颗粒,再向混合物颗粒中加入硬脂酸镁,所述硬脂酸镁和所述混合物颗粒质量之比为0.25-100:0.5-100,获得胶囊内容物,将所述的胶囊内容物装入胶囊壳体中即得胶囊剂。
6.一种如权利要求1-3中任一项所述治疗冠心病的中药组合物的制备方法,其特征在于:当所述中药的剂型为注射剂时,包括:
第一步,人参芦、毛节兔唇花按比例混合,用相当于混合物质量2-3倍的醇浓度为70-80%的正丙醇回流提取2-4次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1-2次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将一把伞、甘木通、白果叶、川穹用醇浓度为80-90%的正丙醇提取2-3次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2-4倍量的水溶解,静止1-3小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2-3小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2-4倍;
第四步,将上述粉末混合,随后将其溶于质量为混合物2-4倍的水,搅拌下加入相对于粉末质量5%-15%的氢氧化钠助溶,过滤,加浓度为1mol/L的盐酸调节pH值为5-6,过滤,沉淀备用,滤液通过聚酰胺柱,先用水洗去杂质,随后用醇浓度为80-90%的正丙醇洗脱,收集正丙醇洗脱液,沉淀用醇浓度为80-90%的正丙醇提取2次,过滤,滤液与上述洗脱液合并,回收正丙醇,减压浓缩至膏体并喷雾干燥成粉末,将获得的粉末加相对于其质量1-2倍的氯化钠及注射用水适量,溶解后再进一步加注射用水至需要的体积,过滤,灌封,灭菌,获得需要的注射液。
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