CN110339293A - 一种脉清胶囊配方及制备工艺 - Google Patents
一种脉清胶囊配方及制备工艺 Download PDFInfo
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- CN110339293A CN110339293A CN201910823384.XA CN201910823384A CN110339293A CN 110339293 A CN110339293 A CN 110339293A CN 201910823384 A CN201910823384 A CN 201910823384A CN 110339293 A CN110339293 A CN 110339293A
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Abstract
本发明提供了一种脉清胶囊配方及制备工艺,所述脉清胶囊配方按重量份数比包括以下成分:三七30份、黄连30份、丹参30份、黄芪30份、血偈30份、丹皮30份、川芎30份、瓜蒌皮30份、红景天30份、刺五加30份、葛根30份、桔梗30份、红花30份、党参30份、槐米30份、枸杞30份、山楂30份、绞股蓝20份、罗布麻20份、银杏叶30份、水蛭20份、大黄20份、地黄20份、桃仁20份、黄精20份、玉竹20份、柴胡20份、穿心莲20份、夏枯草20份、决明子20份、泽泻20份、牛膝20份、赤芍20份、白芍20份、栀子20份、首乌20份、麦冬20份、当归10份、甘草10份及冰片10份。本发明提供的一种脉清胶囊配方及制备工艺,具有抗过氧化损伤,降脂、降压及抗衰老调解免疫的作用。
Description
技术领域
本发明是一种清理血管垃圾预防心脑血管疾病的药物,具体地说是以中草药为原料精准提取有效成份中药西制成胶囊药物,本发明还涉及该药物的制备方法。
背景技术
人们生活节奏加快、心理压力的加大,再加上睡眠不足烟酒过度暴饮暴食等不良因素造成血管堵塞和动脉粥样硬化,从而引发冠心病、脑中风等疾病,而心脑血管疾病是人类健康的头号杀手;如何清理血管垃圾(抗凝、抗拴、溶拴)是解决心脑血管问题关键。
中医认为血管堵塞动脉粥样硬化与饮食失调,脾失健运;五志所伤,情志失调;年高体衰,肾精亏损;气血亏耗,心脉失养有关。随着临床实践的深入,逐步认识到血管堵塞动脉粥样硬化的本质是本虚标实:本虚,包括气虚、阳虚、阴虚;标实,包括血瘀、痰浊、气滞、寒凝等范畴。脏腑功能失调,则气血津液运行障碍。若脾胃受损,使脾不健运,输化失常,则水谷精微变为浊脂,进入血液而使血脂升高;浊脂越积越多,不得清化而变为血中之痰浊。人之血液流行于血脉之中,脏腑功能失调则血运不畅,易生瘀滞。痰瘀互结而导致动脉粥样硬化,引发中风、胸痹、真心痛、痴呆等诸病。
现代医学研究证实新脑血管疾病实为动脉粥样硬化斑块由稳定性斑块至易损性斑块,到不稳定斑块破裂,血栓形成而产生的,因而稳定和清除动脉粥样硬化斑块为防治心脑血管疾病的关键。而不稳定斑块的特点是:薄的纤维帽;较大的脂核;较多的炎症细胞浸润、蛋白水解、基质金属蛋白酶等;而粥样硬化斑块中,脂质的增高而致脂质核的扩大、炎症、血栓等为不稳定斑块的重要病理因素,而促使不稳定斑块病变发展的因素有感染、高血压、高血脂、糖尿病、免疫、生物活性物等。大量的临床及实验研究证实了中药可通过多种途径可有效地防治动脉粥样硬化的发生发展,稳定动脉粥样硬化斑块,降低斑块的破裂及血栓形成,防治心脑血管疾病的发生。
祖国医学在辩证施治的过程中,把中药传统功效与中药现代药理作用相结合,并不断发掘研究证实,中药具有:抗凝、溶栓、消炎、抑菌、调脂、抗炎、调解免疫、降压、降血糖等现代药理作用。
但是,目前市场上还没有一种能够充分利用现有的研究成果和理论,能够全面的、综合的、有效的稳定斑块、清楚斑块,最终彻底清理血管垃圾,用于预防和治疗心脑血管疾病的理想药物。
发明内容
以解决上述背景技术中提出的问题,本发明的目的在于提供一种脉清胶囊配方及制备工艺,其遵循中医活血化瘀、祛痰降脂、扶正补虚、滋阳强心、补益肝肾、健脾益气等理论,结合现代中药研究成果(单味药和成方),科学配方、精准提取、中药西制,实现抗凝、抗拴、溶栓、降压、调脂、抑菌、抗炎、抗氧化、调解免疫、改善微循环等现代药理作用,彻底清除血管垃圾(血管斑块),标本兼治,从而达到治疗和预防(治未病)心脑血管疾病的目的。
为解决上述技术问题,本发明提供的技术方案为:
一种脉清胶囊配方,按重量份数比包括以下成分:三七30份、黄连30份、丹参30份、黄芪30份、血偈30份、丹皮30份、川芎30份、瓜蒌皮30份、红景天30份、刺五加30份、葛根30份、桔梗30份、红花30份、党参30份、槐米30份、枸杞30份、山楂30份、绞股蓝20份、罗布麻20份、银杏叶30份、水蛭20份、大黄20份、地黄20份、桃仁20份、黄精20份、玉竹20份、柴胡20份、穿心莲20份、夏枯草20份、决明子20份、泽泻20份、牛膝20份、赤芍20份、白芍20份、栀子20份、首乌20份、麦冬20份、当归10份、甘草10份及冰片10份。
一种应用于权利要求1所述的脉清胶囊配方的制备工艺,包括以下具体步骤:
1)粉碎:将各药材按《中国药典》中粉规格在粉碎机中粉碎;
2)润湿:将粉碎的药材放入不锈钢容器,加入药粉等量的酒精,搅拌均匀,密闭放置8小时,以药粉充分地均匀润湿和膨胀为度;
3)装筒:将药粉装入渗漉筒,注意均匀放入,松紧一致;
4)排气:药粉填装完毕,加入酒精,排除药粉间隙中的空气,保持溶剂始终浸没药粉表面;
5)浸渍:浸渍放置12小时;
6)渗漉:从上方加入酒精,在下方收集保存渗漉液,流速控制每小时流出液应相当于渗漉容器被利用容积的1/25,添加渗漉酒精总量为渗漉容器被利用容积的1.5倍;
7)重渗漉:待酒精渗漉完毕,加95℃纯净水,排除空气,保持温度90℃,浸泡24小时,重复4-6次,流速为每小时渗漉容器被利用容积的1/40,渗漉加液量为渗漉容器被利用容积的2倍;
8)减压浓缩干燥:将两次的渗漉液合并,采用抽真空的方式进行抽真空处理,使用设备降低渗漉液的沸腾温度,使酒精和水快速蒸发乾燥,实现液体和固体分离,得到干燥的提取物固体,并回收酒精;
9)称量计算:按照1:30的浓缩比例计算,如果提取物不足,添加蔗糖到99%重量;。
10)添加敷料:根据计算好的蔗糖量和1%的硬脂酸镁,与干燥的提取物一起粉碎整粒过筛混合均匀;
11)胶囊填充:采用零号胶囊,使用胶囊板或胶囊填充机器填充胶囊;
12)包装:按每瓶100粒装瓶,加入防潮剂加盖密封保存。
作为改进,所述步骤8)中的设备包括浓缩罐、冷凝器、汽液分离器、冷却器及受液桶。
本发明的有益效果是:
抗过氧化损伤:黄芪、绞股蓝、红景天、柴胡;
抑制血管平滑肌增殖:丹皮、葛根、川芎、瓜蒌皮、水蛭;
抗血小板聚集:泽泻、血偈、桃仁、三七、红花、瓜蒌皮、葛根、党参、丹参、白芍、赤芍、大黄、黄连、银杏叶;
降低红细胞聚集:三七、丹皮、葛根、红花、银杏叶、血偈;
抗凝、溶栓:泽泻、桃仁、黄连、红花、当归、川芎、丹皮、槐米、水蛭、赤芍、川芎、丹参、赤芍、银杏叶;
扩张冠脉提高心脑供氧:泽泻、银杏叶、血偈、桃仁、麦冬、黄芪、槐米、红花、瓜蒌皮、葛根、党参、当归、丹皮、刺五加、丹参、三七、川芎、穿心莲、红景天、黄连、山楂;
降脂、降糖作用:栀子、泽泻、玉竹、银杏叶、血偈、夏枯草、麦冬、三七、罗布麻、决明子、桔梗、绞股蓝、黄连、槐米、红花、首乌、葛根、当归、丹参、泽泻、山楂、枸杞、柴胡;
降血压:泽泻、栀子、夏枯草、三七、牛膝、罗布麻、决明子、桔梗、黄芪、黄连、黄精、槐米、红花、葛根、党参、丹皮、川芎、夏枯草、白芍、罗布麻、枸杞、地黄;
扩张血管改善微循环:血偈、桔梗、槐米、葛根、当归、丹皮、川芎、白芍、黄芪、三七、丹参、冰片;
抗氧化、抗衰老:玉竹、银杏叶、血偈、麦冬、罗布麻、绞股蓝、黄精、红景天、首乌、枸杞、葛根、甘草、地黄、丹皮、丹参、刺五加、川芎、白芍、大黄、当归、槐米、人参、三七、黄芪、山楂;
调节免役、抗肿瘤:泽泻、玉竹、麦冬、牛膝、决明子、绞股蓝、黄芪、黄精、枸杞、地黄、党参、当归、丹皮、川芎、柴胡、白芍、刺五加、槐米、首乌、熟地、枸杞、红景天、三七、麦冬、夏枯草;
抗炎、抑菌、抗病毒:栀子、泽泻、夏枯草、红花、当归、丹皮、穿心莲、冰片、首乌、黄连、柴胡、大黄、丹参、甘草、桔梗、牛膝、三七、山楂、麦冬、银杏叶;
本发明在心脑血管疾病的防治中疗效确切,其作用机制主要是通过调节脂质代谢、稳定斑块、调节炎症因子、影响血管重构、保护血管内皮细胞、抗氧化、抗凝血和抑制血栓形成、融解消除血管斑块,能够有效防治动脉粥样硬化的发生和发展,最终彻底清除血管垃圾,有效防治心脑血管疾病;本发明扩张血管、改善微循环、提高心肌和其他组织供氧气,保证了身体个组织器官正常功能;再加上抗衰老、调解免疫、增强抵抗力和抗癌功能,本发明脉清胶囊是防治心脑血管疾病、预防癌症和延年益寿的最理想药品。
具体实施方式
下面用具体实施例说明本发明,并不是对本发明的限制。
实施例
一种脉清胶囊配方,按重量份数比包括以下成分:三七30份、黄连30份、丹参30份、黄芪30份、血偈30份、丹皮30份、川芎30份、瓜蒌皮30份、红景天30份、刺五加30份、葛根30份、桔梗30份、红花30份、党参30份、槐米30份、枸杞30份、山楂30份、绞股蓝20份、罗布麻20份、银杏叶30份、水蛭20份、大黄20份、地黄20份、桃仁20份、黄精20份、玉竹20份、柴胡20份、穿心莲20份、夏枯草20份、决明子20份、泽泻20份、牛膝20份、赤芍20份、白芍20份、栀子20份、首乌20份、麦冬20份、当归10份、甘草10份及冰片10份。
一种应用于权利要求1所述的脉清胶囊配方的制备工艺,包括以下具体步骤:
1)粉碎:将各药材按《中国药典》中粉规格在粉碎机中粉碎。(过细易堵塞,吸附性增强,浸出效果差;过粗不易压紧,溶剂与药材的接触面小,皆不利于浸出)
2)润湿:将粉碎的药材放入不锈钢容器,加入药粉等量的酒精,搅拌均匀,密闭放置8小时,以药粉充分地均匀润湿和膨胀为度。
3)装筒:将药粉装入渗漉筒,注意均匀放入,松紧一致。装得过松,溶剂很快流过药粉,浸出不完全;反之,又会使出液口堵塞,无法进行渗漉。
4)排气:药粉填装完毕,加入酒精,注意最大限度地排除药粉间隙中的空气,保持溶剂始终浸没药粉表面。
5)浸渍:一般浸渍放置12小时。
6)渗漉:从上方加入酒精,在下方收集保存渗漉液。流速控制每小时流出液应相当于渗漉容器被利用容积(下称:总容积)的1/25,添加渗漉酒精总量为总容积的1.5倍。
7)重渗漉:待酒精渗漉完毕,加95水,排除空气,保持温度90,浸泡24小时,(重复4-6过程),流速控制总容积1/40每小时,渗漉加液量为总容积的2倍。
8)减压浓缩干燥:将两次的渗漉液合并,采用抽真空的方式,降低渗漉液的沸腾温度使酒精和水快速蒸发乾燥,有专用设备完成,主要包括浓缩罐、冷凝器、汽液分离器、冷却器、受液桶五部件。实现液体和固体分离,得到干燥的提取物固体,并回收酒精。
9)称量计算:按照1比30的浓缩比例计算,如果提取物不足,添加蔗糖到99%重量。
10)添加敷料:根据计算好的蔗糖量和1%的硬脂酸镁,与干燥的提取物一起粉碎整粒过筛混合均匀。
11)胶囊填充:采用零号胶囊,使用胶囊板或胶囊填充机器填充胶囊。
12)包装:按每瓶100粒装瓶,加入防潮剂加盖密封保存。
上述步骤中的所有使用设备、器皿、作业环境洗消毒流程以及操作人员卫生防护均应符合国家GMP相应标准。
治疗剂量:每次五粒,每日三次,空腹服用;心梗、脑梗急发期剂量可以加大到每次十粒每日三次,空腹口服;间歇用药,连续服药五天停药两天(周末停药)。
保健剂量:每次五粒到十粒,每日一次,睡前口服;间歇用药,连续服药七天停药七天,再继续服用。
长期服用抗凝药如:阿斯匹林或波利维或培林达的患者一经服用本品建议停止使用。
孕妇禁用。尽量避免与其他中药同服。
典型病例:
病例1,魏先生,56岁,44岁发现高血压(100-145mmHg),长期服用阿斯匹林,48岁时(2011年5月18日)突发心梗,服用波利维抗凝治疗,一年后继发心梗,改用培林达抗凝治疗,半年后继续发生心梗,不到两年时间发生三次心梗,心脏里装了四个支架,市场现有抗凝药效果均不理想,作为一个有多个药学文凭的资深药剂师,潜心研究半年,发明了本专利中药配方制造成胶囊,按每天三次,每次10粒治疗,服用三个月后,自我感觉症状(心慌、胸闷、气喘、心区疼痛等)减轻,便停止使用医生的所有处方药品,坚持服用本发明中药胶囊,并根据自己切身的感觉和检查结果反复优化完善配方,使用剂量改为每日两次,每次10粒,继续服用脉清胶囊已经超过六年,没有再次发生心梗事件,目前血压基本正常(85-125mmHg),超声检查,心脏血液灌流良好,全身各处动脉未发现有任何斑块。
病例2,高女士,66岁,冠心病,心脏冠状动脉堵塞严重,冠脉造影堵塞80%,爬楼梯到三楼就气喘吁吁,爬到六楼就心脏因供血不足而感到心脏疼痛,服用脉清胶囊,每天三次,每次10粒,连续服用三个月,感觉症状消失,爬楼到10楼不会感觉心脏疼痛,连续服用半年后,可以爬到18楼不会感觉太费力。甚至可以参加游泳活动。
病例3,王先生,62岁,血压、血脂偏高,B超检查颈部血管和锁骨下动脉均有斑块,每天两次,每次五粒服用脉清胶囊,服用三个月,超声检查斑块明显变小,连续服用两年,斑块基本消失。
病例4,魏女士,64岁,高血压,脑梗患者,经常头疼头昏,四肢无力,下肢水肿,面色晦暗;服用脉清胶囊:每天两次,每次五粒,服用三个月症状改善,连续使用三年,血压基本正常(88—128,不用其他降压药物),自感精力充沛,面色红润,脸上老年斑都消失了。
病例5,吴女士,55岁,体检发现癌胚抗原(CEA)11.0ng/ml,超过正常值(<5.0ng/ml)一倍还多,按保健剂量,每次5粒,每日一次,服用脉清胶囊,间歇用药(服药一周,停药一周,再继续服用),一年后复查CEA为6.0ng/ml,结果基本正常。
以上所述,仅为本发明较佳的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,根据本发明的技术方案及其发明构思加以等同替换或改变,都应涵盖在本发明的保护范围之内。
Claims (3)
1.一种脉清胶囊配方,其特征在于,按重量份数比包括以下成分:三七30份、黄连30份、丹参30份、黄芪30份、血偈30份、丹皮30份、川芎30份、瓜蒌皮30份、红景天30份、刺五加30份、葛根30份、桔梗30份、红花30份、党参30份、槐米30份、枸杞30份、山楂30份、绞股蓝20份、罗布麻20份、银杏叶30份、水蛭20份、大黄20份、地黄20份、桃仁20份、黄精20份、玉竹20份、柴胡20份、穿心莲20份、夏枯草20份、决明子20份、泽泻20份、牛膝20份、赤芍20份、白芍20份、栀子20份、首乌20份、麦冬20份、当归10份、甘草10份及冰片10份。
2.一种应用于权利要求1所述的脉清胶囊配方的制备工艺,其特征在于,包括以下具体步骤:
1)粉碎:将各药材按《中国药典》中粉规格在粉碎机中粉碎;
2)润湿:将粉碎的药材放入不锈钢容器,加入药粉等量的酒精,搅拌均匀,密闭放置8小时,以药粉充分地均匀润湿和膨胀为度;
3)装筒:将药粉装入渗漉筒,注意均匀放入,松紧一致;
4)排气:药粉填装完毕,加入酒精,排除药粉间隙中的空气,保持溶剂始终浸没药粉表面;
5)浸渍:浸渍放置12小时;
6)渗漉:从上方加入酒精,在下方收集保存渗漉液,流速控制每小时流出液应相当于渗漉容器被利用容积的1/25,添加渗漉酒精总量为渗漉容器被利用容积的1.5倍;
7)重渗漉:待酒精渗漉完毕,加95℃纯净水,排除空气,保持温度90℃,浸泡24小时,重复4-6次,流速为每小时渗漉容器被利用容积的1/40,渗漉加液量为渗漉容器被利用容积的2倍;
8)减压浓缩干燥:将两次的渗漉液合并,采用抽真空的方式进行抽真空处理,使用设备降低渗漉液的沸腾温度,使酒精和水快速蒸发乾燥,实现液体和固体分离,得到干燥的提取物固体,并回收酒精;
9)称量计算:按照1:30的浓缩比例计算,如果提取物不足,添加蔗糖到99%重量;。
10)添加敷料:根据计算好的蔗糖量和1%的硬脂酸镁,与干燥的提取物一起粉碎整粒过筛混合均匀;
11)胶囊填充:采用零号胶囊,使用胶囊板或胶囊填充机器填充胶囊;
12)包装:按每瓶100粒装瓶,加入防潮剂加盖密封保存。
3.根据权利要求2所述的一种应用于权利要求1所述的脉清胶囊配方的制备工艺,其特征在于,所述步骤8)中的设备包括浓缩罐、冷凝器、汽液分离器、冷却器及受液桶。
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