CN112641915A - 一种治疗心悸的中药膏方及其制备方法 - Google Patents
一种治疗心悸的中药膏方及其制备方法 Download PDFInfo
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Abstract
本发明属于中药领域,涉及一种治疗心悸的中药膏方及其制备方法,由二十八味药组成,相互作用以达调补阴阳、宁心定悸之效。根据心悸的病因病机和病位的理论认识,即病因乃气血阴阳之虚,水饮、痰火、气滞、血瘀之实;病机不外乎因气血阴阳亏虚,心失所养所致悸;或者因实邪、情志因素扰乱血脉运行,所致心神不宁;病位本在心,又与脾胃关系密切,故平心复脉膏综合虚实病因及发病机制、兼顾心脾,以奏平调阴阳、补虚泄实、调养心脾、通畅气机之功。
Description
技术领域
本发明属于中药领域,具体涉及一种治疗心悸的中药膏方及其制备方法。
背景技术
公开该背景技术部分的信息仅仅旨在增加对本发明的总体背景的理解,而不必然被视为承认或以任何形式暗示该信息构成已经成为本领域一般技术人员所公知的现有技术。
室性早搏是一种常见的心律失常,属中医学“心悸”、“怔忡”、“心动悸”等范畴,既多见于各种器质性心脏病患者:如缺血性心脏病、高血压性心脏病、心脏瓣膜病、心肌病及酸碱失衡、电解质紊乱、洋地黄中毒等。亦常见于无器质性心脏病及烟、酒、茶、咖啡过量或情绪激动的正常人。据统计,冠心病患者发生早搏的概率大约20%,包括了房性早搏、房室交界性早搏及室性早搏三种类型,其中频发室性早搏患者发病率占比较大。临床表现从无症状、有脉搏停顿感、心悸、胸闷到触发恶性心律失常时的晕厥。功能性室早,亦称良性室性早搏,多在健康人身上发生,一般无症状或仅有轻微症状,也无严重后果。多起源于右室。器质性室早,亦称为病理性室早,出现在各种器质性心脏病患者身上,有血液动力学改变,甚至可发生室速或室颤,引起猝死等严重后果,这种室早多起源于左室。因此,研究治疗冠心病频发室性早搏患者的方法有十分重要的临床意义。
中医对心悸的病因不外乎虚实两端,虚责之气血阴阳,实则责之水饮、痰火、气滞、血瘀等因素。病机不外乎因气血阴阳亏虚,心失所养而致悸;或者因实邪、情志因素扰乱血脉运行,而致心神不宁。
发明内容
为了克服上述问题,本发明提供了一种治疗心悸的中药膏方及其制备方法。根据心悸的病因病机和病位的理论认识,即病因乃气血阴阳之虚,水饮、痰火、气滞、血瘀之实;病机不外乎因气血阴阳亏虚,心失所养所致悸;或者因实邪、情志因素扰乱血脉运行,所致心神不宁;病位本在心,又与脾胃关系密切,故平心复脉膏综合虚实病因及发病机制、兼顾心脾,以奏平调阴阳、补虚泄实、调养心脾、通畅气机之功,以达调补阴阳、宁心定悸之效。
为实现上述技术目的,本发明采用如下技术方案:
本发明的第一个方面,提供了一种治疗心悸的中药膏方,由如下重量份的原料组成:阿胶51~102份、炙甘草100~200份、麦冬40~80份、熟地黄25~50份、桂枝100~200份、大枣30~60份、生姜21~42份、火麻仁20~40份、党参30~60 份、醋五味子30~60份、龙骨150~300份、牡蛎150~300份、甘松75~150份、羌活50~100份、燀桃仁50~100份、红花36~72份、桑寄生30~60份、丹参75~150 份、葛根30~60份、黄芪50~100份、茯苓75~150份、炒酸枣仁25~50份、制远志48~96份、炒鸡内金48~96份、六神曲40~80份、陈皮30~60份、麸炒苍术20~40份、生地黄25~50份。
本方中炙甘草甘温、补中益气,以充气血化生之源。党参具有补中益气,生津养血之功效。大枣具有补中益气,养血安神的功效。丹参,有祛瘀、生新、活血。桃仁可破血祛瘀,润肠通便,止咳平喘,其活血化疲之力尤强。红花味辛性温,能活血祛瘀止痛。相互配合补益中气,化生气血,以复脉之本。
阿胶作为常见中药,其滋阴补血、止血、润燥效果均较为显著,能够频繁应用,具有较大的使用范围,在肺燥咳嗽、心烦不眠、眩晕心悸以及血虚萎黄等症状治疗中均能够充分发挥出较好的药理作用。麦冬、火麻仁滋阴养血。熟地滋腻,以养血补血祛瘀血祛、舒畅气机。生地黄味甘、苦,性寒,有清热凉血,养阴生津之功,为补益肝肾之要药。牡蛎,咸,微寒,平肝息风、养阴。甘松芳香开窍,宣泄郁邪。配伍炙甘草、麦冬、五味子等,益气养阴清热,补而不滞,治疗心悸伴有头晕,心烦少寐,面色不华,手足心热等。
黄芪性味甘、微温,入脾、肺经,有补气升阳、益卫固表、托毒生肌、利水消肿之功,适用于肺脾气虚、中气下陷、表虚不固、汗出异常及平素易感冒者。乃益气升阳之要药。生姜具有通阳复脉的功效。葛根以升阳之功。茯苓,健脾利水,渗湿化饮,既能消除已聚之痰饮,又善平饮邪之上逆。桂枝既可温阳化饮,又能化气利水,且可平冲降逆。茯苓、桂枝相合为温阳化气,利水平冲之常用组合,阳气振奋则阴水得散。羌活,味辛、苦、性温。散表寒、祛风湿。桑寄生具有祛风湿,补肝肾,强筋骨,安胎,降血压的功效,在此更偏于调和阴阳,力主阴中求阳,阳中求阴,达到阴平阳秘之意。几味药合用,升阳复脉,健脾祛湿。
酸枣仁味酸性平,归肝、胆、心经,主要用于治疗虚烦不眠、惊悸多梦、体虚多汗、津伤口渴等症。酸枣仁的药理作用主要有镇静、催眠、镇痛、抗惊厥、降温、降血压、降血脂、抗缺氧、增强免疫功能以及对心脏的保护作用。远志具有安神益智、祛痰、消肿的功效,可用于心肾不交引起的失眠多梦、健忘惊悸,神志恍惚等。五味子益气养阴、安神定悸。龙骨,味甘涩、性平,镇惊安神、平肝潜阳、收敛固涩。几味药合用,养心安神。
鸡内金,健胃消食、涩精止遗。六神曲,健脾和胃,消食调中。陈皮,理气健脾,调中,燥湿,化痰主治脾胃气滞之脘腹胀满或疼痛、消化不良。苍术味辛、苦、性温。燥湿健脾、祛风湿、明目。四药合用,消食和胃,理气健脾。
膏方具有药物浓度高、服用量少、口感好、便于坚持服用等优点,但因其制作工艺复杂影响其临床应用。一料膏方的熬制,要经过浸、煎、榨、化、滤、熬、收等七道工序,最少也需要16个小时,而且还需要有经验的老药工全程把控,尤其在最后的收膏阶段,更需要熟练的技巧。这些都严重制约了膏方的大规模推广。中药配方颗粒采用了现代科技手段将传统中药饮片提取、浓缩、瞬间干燥成粉状、颗粒状产品,它组合成汤药可直接冲服,经多年的临床应用,已逐步得到中医药界的认可与肯定,具有疗效确切,质量稳定、均一和可控的优点。若以其作为中药膏方的原料,可缩短及简化膏方制作流程,必将有力推动膏方在临床的大规模应用。
本发明的第二个方面,提供了一种治疗心悸的中药膏方的制备方法,包括:
将龙骨、牡蛎、阿胶单独称量,其余药味饮片按照处方量进行处方调剂;
将龙骨、牡蛎饮片混合,加水,浸泡;将阿胶烊化;将其余药味饮片混合,加水,浸泡;
把浸泡后龙骨、牡蛎上火煎煮0.5~1小时后加入除阿胶外的其他饮片,武火加热至沸腾,后改为文火加热,保持沸腾状态,煎煮2~3小时,过滤,第二次加8~10倍量水煎煮1~1.5小时,过滤,合并滤液,静置;
取上清液浓缩,形成清膏;
向清膏中加入烊化开的阿胶、炼蜜与柠檬酸,熬炼,形成稠膏,冷却,即得。
本发明的第三个方面,提供了一种治疗心悸的中药配方颗粒膏方的制备方法,包括:
将各原料制备成配方颗粒,1g配方颗粒相当于1-60g原药材;
将配方颗粒复溶、熬膏,得清膏;
向清膏中加入炼蜜与柠檬酸,熬膏,得浓膏,冷却,即得。
本发明的有益效果在于:
(1)本发明根据心悸的病因病机和病位的理论认识,即病因乃气血阴阳之虚,水饮、痰火、气滞、血瘀之实;病机不外乎因气血阴阳亏虚,心失所养所致悸;或者因实邪、情志因素扰乱血脉运行,所致心神不宁;病位本在心,又与脾胃关系密切,故平心复脉膏综合虚实病因及发病机制、兼顾心脾,以奏平调阴阳、补虚泄实、调养心脾、通畅气机之功,由二十八味药组成,相互协调,以达调补阴阳、宁心定悸之效。
(2)平心复脉膏其主要功效为调补阴阳、宁心定悸,适用于频发室性早搏,而其他类型的中成药多以单独改善患者症状为主。平心复脉膏从患者气血阴阳不足的根本出发,通过多种机制调节患者机体,全面改善心血管功能,最终通过平调阴阳、补虚泄实、调养心脾、通畅气机,从而实现抗频发室性早搏的治疗效果。
(3)阿胶滋阴补血、止血、润燥效果均较为显著,在肺燥咳嗽、心烦不眠、眩晕心悸以及血虚萎黄等症状治疗中均能够充分发挥出较好的药理作用。阿胶滋腻,有碍脾胃消化功能。服用量过低会导致阴虚,过量的服用会影响脾胃消化功能,患者会出现上火、胀气、食欲下降、消化不良等症状。
(4)人参具有大补元气,补脾益肺,生津安神益智作用,适用于调整血压、恢复心脏功能、神经衰弱及身体虚弱等症,临床表明人参在心血管系统可诱发心律失常、心悸、心率减慢、高血压、甚至心力衰竭。党参和黄芪两种药物同时都具有补气健脾的功效,党参还具有生津养血的作用,黄芪还具有固表,敛汗固脱,托疮生肌,利水消肿的功效。二者合用,对于增强免疫力、扩张血管、降压、改善微循环、增强造血功能都有良好的作用。
(5)鸡内金,健胃消食、涩精止遗。六神曲,健脾和胃,消食调中。陈皮,理气健脾,调中,燥湿,化痰主治脾胃气滞之脘腹胀满或疼痛、消化不良。苍术味辛、苦、性温。燥湿健脾、祛风湿、明目。四药合用,消食和胃,理气健脾。
(6)本发明的制备方法简单、操作方便、实用性强,易于推广。
附图说明
构成本发明的一部分的说明书附图用来提供对本发明的进一步理解,本发明的示意性实施例及其说明用于解释本发明,并不构成对本发明的不当限定。
图1是本申请中药的方剂的实物图。
图2是本发明实施例1中空白组模型组现场图;
图3是本发明实施例1中平心复脉膏对心阴亏虚模型大鼠心电图T波的影响。
具体实施方式
应该指出,以下详细说明都是示例性的,旨在对本发明提供进一步的说明。除非另有指明,本发明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含义。
需要注意的是,这里所使用的术语仅是为了描述具体实施方式,而非意图限制根据本发明的示例性实施方式。如在这里所使用的,除非上下文另外明确指出,否则单数形式也意图包括复数形式,此外,还应当理解的是,当在本说明书中使用术语“包含”和/或“包括”时,其指明存在特征、步骤、操作、器件、组件和/或它们的组合。
一种治疗心悸的中药膏方及其制备方法,
1、中药膏方配方组成:
1.1中草药材配方:
1.2中药配方颗粒配方:
阿胶配方颗粒51g炙甘草配方颗粒100g麦冬配方颗粒24g
熟地黄配方颗粒38g桂枝配方颗粒10g大枣配方颗粒50g
生姜配方颗粒3.4g火麻仁配方颗粒11.5g党参配方颗粒18.2g
醋五味子配方颗粒10g龙骨配方颗粒5g牡蛎配方颗粒5g
甘松配方颗粒15g羌活配方颗粒10g燀桃仁配方颗粒16.7g
红花配方颗粒24g桑寄生配方颗粒10g丹参配方颗粒75g
葛根配方颗粒24g黄芪配方颗粒40g茯苓配方颗粒15g
炒酸枣仁配方颗粒2.5g制远志配方颗粒8g炒鸡内金配方颗粒8g
六神曲配方颗粒8g陈皮配方颗粒30g麸炒苍术配方颗粒20g
生地黄配方颗粒35.7g
1.2.1配方颗粒制法及规格:
阿胶配方颗粒:取阿胶饮片,烊化,制成颗粒,即得。阿胶配方颗粒1g相当于2g原药材。
取处方中其他饮片,加水煎煮,滤过,滤液浓缩成清膏,干燥,制成颗粒,即得。其中:炙甘草配方颗粒1g相当于2g原药材、麦冬配方颗粒1g相当于3.3g 原药材、熟地黄配方颗粒1g相当于1.3g原药材、桂枝配方颗粒1g相当于20g 原药材、大枣配方颗粒1g相当于1.2g原药材、生姜配方颗粒1g相当于12.5g 原药材、火麻仁配方颗粒1g相当于3.5g原药材、党参配方颗粒1g相当于3.3g 原药材、醋五味子配方颗粒1g相当于6g原药材、龙骨配方颗粒1g相当于60g 原药材、牡蛎配方颗粒1g相当于60g原药材、甘松配方颗粒1g相当于10g原药材、羌活配方颗粒1g相当于10g原药材、燀桃仁配方颗粒1g相当于6g原药材、红花配方颗粒1g相当于3g原药材、桑寄生配方颗粒1g相当于6g原药材、丹参配方颗粒1g相当于2g原药材、葛根配方颗粒1g相当于2.5g原药材、黄芪配方颗粒1g相当于2.5g原药材、茯苓配方颗粒1g相当于10g原药材、炒酸枣仁配方颗粒1g相当于20g原药材、制远志配方颗粒1g相当于12g原药材、炒鸡内金配方颗粒1g相当于12g原药材、六神曲配方颗粒1g相当于10g原药材、陈皮配方颗粒1g相当于2g原药材、麸炒苍术配方颗粒1g相当于2g原药材、生地黄配方颗粒1g相当于1.4g原药材。
1.2.1配方颗粒质量的要求:
炙甘草配方颗粒:
(1)每1g含甘草苷(C21H22O9)应为6.5mg~23.0mg,含甘草酸 (C42H62O16)应为12.9mg~60.0mg;
(2)应检出甘草苷、甘草酸等成分;
(3)醇溶性浸出物应不少于40.0%。
麦冬配方颗粒:
醇溶性浸出物应不少于6.0%。
熟地黄配方颗粒:
(1)每1g含毛蕊花糖苷(C29H36O15)应为0.18mg~0.34mg;
(2)应检出洋地黄叶苷C、焦地黄苯乙醇苷A1、毛蕊花糖苷、焦地黄苯乙醇苷B1、异毛蕊花糖苷等成分;
(3)醇溶性浸出物应不少于12.0%。
大枣配方颗粒:
(1)本品每1g含环磷腺苷(C10H12N5O6P)应为0.080mg~0.35mg;
(2)应检出环磷腺苷和5-羟甲基糠醛等成分;
(3)醇溶性浸出物应不少于20.0%。
生姜配方颗粒:
(1)本品每1g含6-姜辣素(C17H26O4)应为5.0mg~15.0mg;
(2)应检出6-姜辣素、6-姜烯酚、8-姜酚等成分;
(3)醇溶性浸出物应不少于10.0%。
火麻仁配方颗粒:
(1)本品每1g含胡芦巴碱(C7H7NO2)应为0.80mg~2.50mg;
(2)应检出α-亚麻酸、亚油酸等成分;
(3)醇溶性浸出物应不少于15.0%。
党参配方颗粒:
(1)应检出党参炔苷成分;
(2)醇溶性浸出物应不少于26.0%。
羌活配方颗粒:
(1)本品每1g含羌活醇应为0.12~0.22mg,异欧前胡素应为0.21~0.39mg。
(2)醇溶性浸出物应不少于15.6%。
燀桃仁配方颗粒:
(1)本品每1g含苦杏仁苷(C20H27NO11)应为21.0mg~70.0mg;
(2)应检出色氨酸、苦杏仁苷等成分;
(3)醇溶性浸出物应不少于17.0%。
红花配方颗粒:
本品每1g的配方颗粒含羟基红花黄色素A(C27H30O15)不得少于0.55mg。
桑寄生配方颗粒:
(1)本品每1g含槲皮苷(C21H20O11)应为3.0mg~15.0mg;
(2)应检出没食子酸、儿茶素、扁蓄苷、槲皮苷等成分;
(3)醇溶性浸出物应不少于17.0%。
丹参配方颗粒:
(1)本品每1g含丹酚酸B(C36H30O16)应为28.0~59.0mg;
(2)应检出丹参素、原儿茶醛、咖啡酸、丹酚酸E、迷迭香酸、紫草酸、丹酚酸B、丹酚酸L等成分;
(3)醇溶性浸出物应不少于9.3%。
葛根配方颗粒:
(1)本品每1g含葛根素(C21H20O9)应为55.0mg~110.0mg;
(2)应检出葛根素、黄豆苷元等成分;
(3)醇溶性浸出物应不少于23.0%。
黄芪配方颗粒:
(1)本品每1g含毛蕊异黄酮葡萄糖苷(C22H22O10)应为0.50mg~2.0mg;每1g含黄芪甲苷(C41H68O14)应为1.20mg~3.50mg。
(2)应检出毛蕊异黄酮葡萄糖苷、毛蕊异黄酮峰、黄芪皂苷Ⅱ、黄芪皂苷Ⅰ等成分;
(3)醇溶性浸出物应不少于18.0%。
陈皮配方颗粒:
(1)本品每1g含橙皮苷(C28H34O15)应为6.5mg~14.5mg;
(2)应检出柚皮芸香苷、橙皮苷、川陈皮素、橘皮素等成分;
(3)醇溶性浸出物应不少于23.0%。
麸炒苍术配方颗粒:
(1)本品每1g含绿原酸(C16H18O9)应为0.086mg~0.650mg;
(2)应检出5-羟甲基糠醛、绿原酸等成分;
(3)醇溶性浸出物应不少于21.0%。
生地黄配方颗粒:
(1)本品每1g含梓醇(C15H22O10)应为6.0mg~48.0mg;每1g含毛蕊花糖苷(C29H36O15)应为0.20mg~0.55mg;
(2)应检出洋地黄叶苷C、焦地黄苯乙醇苷A1、毛蕊花糖苷、焦地黄苯乙醇苷B1、异毛蕊花糖苷等成分;
(3)醇溶性浸出物应不少于12.0%。
2、制法:
2.1中药草药材膏方的制法
2.1.1.处方调剂:
将龙骨、牡蛎、阿胶单独称量。其余药味饮片按照处方量进行处方调剂。
2.1.2.浸泡:
将龙骨、牡蛎饮片单独装入容量相当的不锈钢锅内,加入10倍水,浸泡8 小时。其余药味饮片(除阿胶)放入容量相当的不锈钢锅内,加入10倍水,浸泡8小时。
2.1.3.烊化:
将阿胶,加入2倍量水,隔水蒸30分钟,备用。
2.1.4.煎煮:
把浸泡后龙骨、牡蛎上火煎煮0.5小时后加入除阿胶外的其他饮片,武火加热至沸腾,后改为文火加热,保持沸腾状态,煎煮2小时,过滤,第二次加8 倍量水煎煮1小时,过滤,合并滤液,静置。
2.1.5.静置:
将煎煮好的药液进行静置,温度为4~10℃,沉淀时间12h,取上清液。
2.1.6.浓缩:
将上清液倒入锅中,80℃浓缩,在搅拌到药汁滴在纸上不散开来为度(此时应用阿贝折光仪测定折光率,应为1.46-1.49;密度计测得相对密度1.36-1.38),暂停煎熬,得清膏。
2.1.7.收膏:
把烊化开的阿胶及炼蜜(100g炼蜜/3050g饮片)与柠檬酸(5g柠檬酸/3050g 饮片)等辅料,倒入清膏中,放在小火上慢慢熬炼,不断用铲搅拌,搅拌至提起搅拌棒见药汁“挂旗”,“挂丝”或“滴水成珠”,膏体加热时呈蜂窝状“翻斗云”(此时应用阿贝折光仪测定折光率,应为1.46-1.49;密度计测得相对密度为1.36-1.38;固含量为70%-75%),得稠膏,装入容器,冷却。
2.2配方颗粒膏方的制法:
2.2.1.调剂处方:
应用中药配方颗粒调剂设备按照处方量进行处方调剂配制。
2.2.2.复溶:
在膏方机锅中,加入颗粒总重量1.3倍量的清水,将保温温度与熬膏温度设置为55℃,时间设置为10min,开始加热搅拌,当温度达到50℃以上时,缓缓加入调剂好的中药配方颗粒。
2.2.3.熬膏:
颗粒完全溶解后,将保温温度与熬膏温度设置为80℃,设置时间(34分钟 /500g颗粒),使药液浓缩逐渐变为稠厚的清膏。(此时应用阿贝折光仪测定折光率,应为1.47-1.49;密度计测得相对密度为1.36-1.38)。
2.2.4.收膏:
加入炼蜜(100g炼蜜/500g颗粒)与柠檬酸(5g柠檬酸/500g颗粒)等辅料,盖上盖子,避免在膏体表面形成一层膜。继续80℃加热搅拌熬煮,熬膏时间 (5min/500g颗粒)得膏,(此时应用阿贝折光仪测定折光率,应为1.46-1.49;密度计测得相对密度为1.36-1.38;固含量为70%-75%)。
下面结合具体的实施例,对本发明做进一步的详细说明,应该指出,所述具体实施例是对本发明的解释而不是限定。
实施例1:
膏方工艺研究:
具体考察熬膏时间和收膏参数对膏方工艺的影响。对颗粒熬制膏方的复溶加水量、复溶方式、加水的温度、熬膏温度、熬膏时间、蜂蜜用量、柠檬酸用量等参数进行实验研究及验证。并以主观指标挂旗、吸水纸、冷水测3种常用膏方熬制终点方法为指标确定熬膏时间,由于该3种判定方法主观性强、凭经验,不同的人制备膏方很容易导致质量差异过大,所以将这3种主观指标转化成客观指标固含量、折光率、密度。
1、处方:
2、实验方法:
2.1、加水方式研究
平均称取两份平心复脉膏方配方颗粒,其中一份将称量好的配方颗粒缓缓倒入热水中,搅拌溶解,另一份是将热水缓缓倒入颗粒中,搅拌溶解,观察溶解情况并记录时间,结果见表1-1。
表1-1配方颗粒加水方式考察
加水方式 | 复溶时间(min) | 现象 |
颗粒加到热水中 | 10 | 颗粒全部溶解 |
热水倒入颗粒中 | 大于20 | 颗粒成球,不易溶解 |
结论:加水方式为调剂好的配方颗粒加入到热水中搅拌溶解。
2.2、加水温度考察:
平均称取3份平心复脉膏方配方颗粒,分别将称量好的配方颗粒缓缓倒入30-40℃温水、50-60℃热水、80-90℃热水中,搅拌溶解,观察溶解情况并记录时间,结果见表1-2。
表1-2配方颗粒加水温度考察
加水温度 | 复溶时间(min) | 现象 |
30-40℃ | 大于20 | 不易溶解 |
50-60℃ | 10 | 颗粒全部溶解 |
80-90℃ | 大于20 | 颗粒成球,不易溶解 |
结论:取调剂好的配方颗粒加入到热水50-60℃中搅拌溶解。
2.3、加水量考察:
平均称取4份平心复脉膏方配方颗粒,分别加入0.8、1.0、1.3、1.5倍水考察颗粒溶解度,确定加水量,结果见表1-3。
表1-3配方颗粒复溶加水量
结论:取调剂好的配方颗粒缓缓倒入1.3倍量热水(50-60℃)中搅拌溶解。
2.4、熬膏温度考察:
平均称取两份平心复脉膏方配方颗粒,分别考察不同熬膏温度熬膏情况,最终确定最佳熬膏温度。结果见表1-4。
表1-4熬膏温度考察
结论:熬膏温度控制在80±5℃。
2.5、熬膏时间考察:
取不同量的颗粒,按前面确定的条件熬膏,熬至膏滴在吸水纸不散、“滴水成珠”状态时,测定相对密度与折光率,并分别记录达物理参数一致时所需熬膏时间,最终确定熬膏时间。结果见表1-5
表1-5熬膏时间考察
颗粒量 | 熬膏时间(℃) | 折光率 | 相对密度 |
250 | 17 | 1.4858 | 1.37 |
500 | 34 | 1.4833 | 1.37 |
1000 | 68 | 1.4809 | 1.37 |
结论:熬制时间为34min/500g。
2.6、蜂蜜加入量的确定:
平均称取3份平心复脉膏方配方颗粒,在熬制收膏时分别加入配方颗粒15%、20%、25%蜂蜜,搅拌熬制后,评价该三个膏滋口感,结果见表1-6
表1-6添加不同量蜂蜜口感情况加入炼蜜量
结论:熬膏加入蜂蜜量为配方颗粒的20%。
2.7、柠檬酸加入量考察:
平均称取4份平心复脉膏方配方颗粒,在熬制收膏时加入20%蜂蜜后,再分别加入配方颗粒0%、0.6%、1%、1.2%的柠檬酸,搅拌熬制后,评价该4个膏滋口感情况,结果见表1-7
表1-7添加不同柠檬酸口感情况
结论:熬膏加入柠檬酸量为配方颗粒的1%。
故本处方最终确定的制备方法为:应用中药配方颗粒调剂设备按照处方量进行处方调剂配制。在膏方机锅中,加入颗粒总重量1.3倍量(868.4g)的清水,将保温温度与熬膏温度设置为55℃,时间设置为10min,开始加热搅拌,当温度达到50℃以上时,缓缓加入调剂好的中药配方颗粒。颗粒完全溶解后,将保温温度与熬膏温度设置为80℃,设置时间45.4分钟,使药液浓缩逐渐变为稠厚的清膏。(此时应用阿贝折光仪测定折光率为1.46;密度计测得相对密度为1.36) 加入炼蜜133.6g炼蜜与6.68g柠檬酸,盖上盖子,避免在膏体表面形成一层膜。继续80℃加热搅拌熬煮,熬膏6.7min,得膏,(此时应用阿贝折光仪测定折光率,应为1.47;密度计测得相对密度为1.38;固含量为74%)。
平心复脉膏方治疗心悸的药效学研究
1、材料与试剂
1.1材料与仪器
实验动物:SD大鼠60只,分为5组,雄性,SPF级,体重220-260g,动物在适应期(3d)饲养于明暗循环(light on 8:00)的环境中,室温23±2℃,自由摄食饮水。
主要仪器:Ⅱ导联心电图(深圳邦健生物医疗设备有限公司)、Metler tloedo 电子分析天平(上海梅特勒-特利多有限公司)。
1.2药物及试剂
平心复脉膏低剂量组(1/2临床等效剂量)、平心复脉膏组(临床等效剂量)、平心复脉膏高剂量组(2倍临床等效剂量)、无水氯化钙(上海源叶生物科技有限公司)、戊巴比妥钠盐(美国Sigma公司)、生理盐水(山东华鲁制药有限公司)。
2、方法
2.1心阴亏虚型室性心律失常大鼠模型制作
实验开始时,将大鼠饲养于大鼠笼中,其内分别设置4个直径6.3cm、高5 cm的平台,平台周边注满水,水面低于平台约1.0cm,水温保持在22℃左右, 24h开灯,大鼠在平台上可自由进食饮水,每天换水,心阴亏虚型大鼠模型如下图所示。灌胃给药平心复脉膏30d,于末次30min后,腹腔注射戊巴比妥钠(0.25%, 1.5ml/100g)麻醉,尾静脉推注氯化钙溶液(1.5ml/kg),空白对照组静注相同体积的0.9%生理盐水。
2.2心电图T波和心率检测
戊巴比妥钠(0.25%,1.5ml/100g)麻醉大鼠,将多道生理记录仪的针状电极分别插入四肢皮下,待波形平稳后,记录标准肢体Ⅱ导联心电图。待心电平稳后,取连续测定的6次心电图计算,心率(次/min)=6次心跳×300/6次心跳走纸距离。
2.3数据分析
3、结果
3.1心阴亏虚模型大鼠的状态观察
实验前大鼠精神良好,毛色光泽,活动灵敏,多前肢向上抬举、洗脸、舔足等修饰动作。造模过程中,部分大鼠精神亢奋烦躁,持久站立对峙状,跳跃抓咬,脸部、鼠尾出现明显打斗血痕,毛色白中带黄,另一部分精神萎靡,脱毛,出现活动性降低等行为学改变。
3.2平心复脉膏对心阴亏虚模型大鼠心电图T波的影响
T波可反映心室电刺激恢复期的电压改变。心阴亏虚时,会导致心肌的电生理及形态学的改变。造模给药10天后,心电图改变如图1所示,结果显示,模型组与空白组相比,能显著性降低T波高度(P<0.05),给药平心复脉膏各剂量组后,均能显著性恢复T波高度(P<0.05)(表1)。研究证实,平心复脉膏对于心阴亏虚所致的心肌改变具有明显的治疗作用。
注,与模型组比较,*P<0.05;与空白组比较,#P<0.05。
3.3平心复脉膏对心阴亏虚模型大鼠心率的影响
体重为180~350g的成年大鼠心率约为475次/分(370~580次/分)。麻醉状态下会有所降低。结果显示,心阴亏虚能显著降低模型大鼠心率(P<0.05),平心复脉膏组和高剂量组均能显著恢复其心率(P<0.05)。研究证实,平心复脉膏对于心阴亏虚所致心率异常具有一定的调节作用(表2)。
注,与模型组比较,*P<0.05;与空白组比较,#P<0.05。
3.4平心复脉膏对氯化钙引发的大鼠室性心律失常的影响
灌胃给药平心复脉膏30d,于末次30min后,腹腔注射戊巴比妥钠麻醉,尾静脉推注氯化钙溶液,空白组静注相同体积的生理盐水。氯化钙注射后很快诱发室早(VP)、室速(VT)及室颤(VF),各组在室早、室速及室颤发生率上无显著差异。 (表3)各剂量组均能降低氯化钙诱发的室早发生率,平心复脉膏组和高剂量组均可以降低室颤的发生率。与模型组相比,中药各剂量组的心脏停搏时间均出现延迟(P<0.01),平心复脉膏组和高剂量组大鼠出现VP时间均呈延迟趋势,对于心律失常持续时间均呈现缩短趋势,研究证实,平心复脉膏能够对抗氯化钙所致室性心律失常。(表4)
注,与模型组比较,*P<0.05。
4、结论
平心复脉膏,调补阴阳、宁心定悸,适用于中医(心悸-阴阳两虚型)和西医(心律失常-频发室性早搏)的治疗。该膏方从患者气血阴阳不足的根本出发,通过多种机制调节患者机体,全面改善心血管功能,最终通过平调阴阳、补虚泄实、调养心脾、通畅气机,实现抗频发室性早搏的治疗效果。本研究采用睡眠剥夺法制作心阴亏虚模型,通过尾静脉注射氯化钙,构建心阴亏虚室性心律失常模型。研究证实,平心复脉膏可以明显调节因心阴亏虚所致的心肌改变和心率异常,具有抗氯化钙所致室性心律失常的作用。平心复脉膏组和高剂量组作用能够明显延迟室早发生,缩短持续时间(P<0.05),各剂量组的心脏停搏时间均出现明显延迟(P<0.05),该膏方抗室性心律失常作用明确,值得临床推广应用。
实施例2:
2.1、处方:(与实施例1不同之处在于:阿胶配方颗粒0g)
2.2、制备方法:
2.2.1.调剂处方:
应用中药配方颗粒调剂设备按照处方量进行处方调剂配制。
2.2.2.复溶:
在膏方机锅中,加入颗粒总重量1.3倍量(802.1g)的清水,将保温温度与熬膏温度设置为55℃,时间设置为10min,开始加热搅拌,当温度达到50℃以上时,缓缓加入调剂好的中药配方颗粒。
2.2.3.熬膏:
颗粒完全溶解后,将保温温度与熬膏温度设置为80℃,设置时间42分钟,使药液浓缩逐渐变为稠厚的清膏。(此时应用阿贝折光仪测定折光率为1.48;密度计测得相对密度为1.37)
2.2.4.收膏:
加入炼蜜123.4g炼蜜与6.17g柠檬酸,盖上盖子,避免在膏体表面形成一层膜。继续80℃加热搅拌熬煮,熬膏6.17min,得膏,(此时应用阿贝折光仪测定折光率,应为1.47;密度计测得相对密度为1.36;固含量为72%)。
对比实例1所得的膏滋,实例1膏滋颜色光亮,本次试验膏滋色泽相对暗沉。临床上分三组服用实例1及实例2、及阿胶加倍量样品、每组50人,现象如下:
表1平心复脉膏方加减阿胶对人体影响
实施例3:
3.1、处方:(与实施例1不同之处在于:党参配方颗粒0g、黄芪配方颗粒 0g、人参配方颗粒35g)
3.2、制备方法:
3.2.1.调剂处方:
应用中药配方颗粒调剂设备按照处方量进行处方调剂配制。
3.2.2.复溶:
在膏方机锅中,加入颗粒总重量1.3倍量(838.2g)的清水,将保温温度与熬膏温度设置为55℃,时间设置为10min,开始加热搅拌,当温度达到50℃以上时,缓缓加入调剂好的中药配方颗粒。
3.2.3.熬膏:
颗粒完全溶解后,将保温温度与熬膏温度设置为80℃,设置时间43.8分钟,使药液浓缩逐渐变为稠厚的清膏。(此时应用阿贝折光仪测定折光率为1.49;密度计测得相对密度为1.38)。
3.2.4.收膏:
加入炼蜜129g炼蜜与柠檬酸6.45g柠檬酸,盖上盖子,避免在膏体表面形成一层膜。继续80℃加热搅拌熬煮,熬膏时间6.5min得膏,(此时应用阿贝折光仪测定折光率为1.48;密度计测得相对密度为1.36;固含量为72%)。
平心复脉膏方去掉党参、黄芪,改用人参的药效学研究
SD大鼠30只,SPF级,被随机分为3组,体重220-260g,动物在适应期饲养于明暗循环(light on 8:00)的环境中,室温23±2℃,自由摄食饮水。适应 3d后,平心复脉膏组和平心复脉膏处方加减组每日灌服临床等效剂量的浸膏溶液,空白组给予等量生理盐水,连续灌服4周,检测大鼠体重、肛温和血压变化。研究发现,实验前大鼠精神良好,毛色光泽,活动灵敏,多前肢向上抬举、洗脸、舔足等修饰动作。连续服药后,各组一般体征检测变化不明显,给药组大鼠体重普遍高于空白对照组,差异不具有统计学意义;平心复脉膏组和平心复脉膏处方加减组间比较,后者血压有略高于前者的趋势,差异不显著。(如表1)
实施例4:
4.1、处方:(与实施例1不同之处在于:六神曲配方颗粒0g、陈皮配方颗粒0g、苍术配方颗粒0g、鸡内金配方颗粒0g)
4.2、制备方法:
4.2.1.调剂处方:
应用中药配方颗粒调剂设备按照处方量进行处方调剂配制。
4.2.2.复溶:
在膏方机锅中,加入颗粒总重量1.3倍量(782.6g)的清水,将保温温度与熬膏温度设置为55℃,时间设置为10min,开始加热搅拌,当温度达到50℃以上时,缓缓加入调剂好的中药配方颗粒。
4.2.3.熬膏:
颗粒完全溶解后,将保温温度与熬膏温度设置为80℃,设置时间40.9分钟,使药液浓缩逐渐变为稠厚的清膏。(此时应用阿贝折光仪测定折光率为1.47;密度计测得相对密度为1.36)。
4.2.4.收膏:
加入炼蜜120.4g炼蜜与柠檬酸6.02g柠檬酸,盖上盖子,避免在膏体表面形成一层膜。继续80℃加热搅拌熬煮,熬膏时间6min/得膏,(此时应用阿贝折光仪测定折光率为1.47;密度计测得相对密度为1.38;固含量为73%)。
平心复脉膏方去六神曲、陈皮、苍术、鸡内金的药效学研究
昆明种小鼠30只,被随机分为3组,体重18-22g,动物在适应期饲养于明暗循环(light on 8:00)的环境中,室温23±2℃,自由摄食饮水。平心复脉膏组和平心复脉膏处方加减组灌服临床等效剂量的浸膏溶液,空白组给予等量生理盐水,连续给药3d,末次给药30min后,禁食24h,各组灌服含10%的碳末生理盐水混悬液0.3ml,记录小鼠排黑便时间及6h内排便总数。研究发现,平心复脉膏组和空白对照组比较,具有首次黑便时间缩短和6h内排黑便数目增加的趋势,有明显的通便作用;平心复脉膏处方加减组,因处方改变后,药物刺激胃肠蠕动作用消失,部分大鼠功能甚至弱于空白对照组,但各组间差异未有统计学意义。(如表1)
最后应该说明的是,以上所述仅为本发明的优选实施例而已,并不用于限制本发明,尽管参照前述实施例对本发明进行了详细的说明,对于本领域的技术人员来说,其依然可以对前述实施例所记载的技术方案进行修改,或者对其中部分进行等同替换。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。上述虽然对本发明的具体实施方式进行了描述,但并非对本发明保护范围的限制,所属领域技术人员应该明白,在本发明的技术方案的基础上,本领域技术人员不需要付出创造性劳动即可做出的各种修改或变形仍在本发明的保护范围以内。
Claims (10)
1.一种治疗心悸的中药膏方,其特征在于,由如下重量份的原料组成:阿胶51~102份、炙甘草100~200份、麦冬40~80份、熟地黄25~50份、桂枝100~200份、大枣30~60份、生姜21~42份、火麻仁20~40份、党参30~60份、醋五味子30~60份、龙骨150~300份、牡蛎150~300份、甘松75~150份、羌活50~100份、燀桃仁50~100份、红花36~72份、桑寄生30~60份、丹参75~150份、葛根30~60份、黄芪50~100份、茯苓75~150份、炒酸枣仁25~50份、制远志48~96份、炒鸡内金48~96份、六神曲40~80份、陈皮30~60份、麸炒苍术20~40份、生地黄25~50份。
2.如权利要求1所述的治疗心悸的中药膏方,其特征在于,由如下重量份的原料组成:阿胶76~102份、炙甘草150~200份、麦冬60~80份、熟地黄37.5~50份、桂枝150~200份、大枣45~60份、生姜32.5~42份、火麻仁30~40份、党参45~60份、醋五味子45~60份、龙骨225~300份、牡蛎225~300份、甘松112.5~150份、羌活75~100份、燀桃仁75~100份、红花48~72份、桑寄生45~60份、丹参112.5~150份、葛根45~60份、黄芪75~100份、茯苓112.5~150份、炒酸枣仁37.5~50份、制远志72~96份、炒鸡内金72~96份、六神曲60~80份、陈皮45~60份、麸炒苍术30~40份、生地黄37.5~50份。
3.如权利要求1所述的治疗心悸的中药膏方,其特征在于,由如下重量份的原料组成:阿胶51~76份、炙甘草100~150份、麦冬40~60份、熟地黄25~37.5份、桂枝100~150份、大枣30~45份、生姜21~32.5份、火麻仁20~30份、党参30~45份、醋五味子30~45份、龙骨150~225份、牡蛎150~225份、甘松75~112.5份、羌活50~75份、燀桃仁50~75份、红花36~48份、桑寄生30~45份、丹参75~112.5份、葛根30~45份、黄芪50~75份、茯苓75~112.5份、炒酸枣仁25~37.5份、制远志48~72份、炒鸡内金48~72份、六神曲40~60份、陈皮30~45份、麸炒苍术20~30份、生地黄25~37.5份。
4.如权利要求1所述的治疗心悸的中药膏方,其特征在于,所述中药膏方为配方颗粒膏方,各组分为各原料的配方颗粒。
5.如权利要求4所述的治疗心悸的中药膏方,其特征在于,除阿胶外,其他配方颗粒的制备方法为:取原料药,加水煎煮,滤过,滤液浓缩成清膏,干燥,制成颗粒,即得。
6.如权利要求4所述的治疗心悸的中药膏方,其特征在于,阿胶配方颗粒的制备方法为取阿胶饮片,烊化,制成颗粒,即得。
7.如权利要求4所述的治疗心悸的中药膏方,其特征在于,炙甘草配方颗粒中,1g炙甘草配方颗粒含甘草苷C21H22O9为6.5mg~23.0mg,含甘草酸C42H62O16为12.9mg~60.0mg;检出甘草苷、甘草酸;醇溶性浸出物不少于40.0%;
或,所述麦冬配方颗粒中,醇溶性浸出物不少于6.0%;
或,熟地黄配方颗粒中,每1g熟地黄配方颗粒含毛蕊花糖苷C29H36O15为0.18mg~0.34mg;检出洋地黄叶苷C、焦地黄苯乙醇苷A1、毛蕊花糖苷、焦地黄苯乙醇苷B1、异毛蕊花糖苷;醇溶性浸出物应不少于12.0%;
或,大枣配方颗粒中,每1g大枣配方颗粒含环磷腺苷C10H12N5O6P为0.080mg~0.35mg;检出环磷腺苷和5-羟甲基糠醛;醇溶性浸出物应不少于20.0%;
或,生姜配方颗粒中,每1g生姜配方颗粒含6-姜辣素C17H26O4为5.0mg~15.0mg;检出6-姜辣素、6-姜烯酚、8-姜酚;醇溶性浸出物应不少于10.0%;
或,火麻仁配方颗粒中,每1g火麻仁配方颗粒含胡芦巴碱C7H7NO2为0.80mg~2.50mg;检出α-亚麻酸、亚油酸;醇溶性浸出物应不少于15.0%;
或,党参配方颗粒中,检出党参炔苷;醇溶性浸出物应不少于26.0%;
或,羌活配方颗粒中,每1g羌活配方颗粒含羌活醇为0.12~0.22mg,异欧前胡素应为0.21~0.39mg;醇溶性浸出物应不少于15.6%;
或,燀桃仁配方颗粒中,每1g燀桃仁配方颗粒含苦杏仁苷C20H27NO11为21.0mg~70.0mg;检出色氨酸、苦杏仁苷;醇溶性浸出物应不少于17.0%;
或,红花配方颗粒中,每1g红花配方颗粒含羟基红花黄色素A C27H30O15不得少于0.55mg;
或,桑寄生配方颗粒中,每1g桑寄生配方颗粒含槲皮苷C21H20O11为3.0mg~15.0mg;检出没食子酸、儿茶素、扁蓄苷、槲皮苷;醇溶性浸出物应不少于17.0%;
或,丹参配方颗粒中,每1g丹参配方颗粒含丹酚酸B C36H30O16为28.0~59.0mg;检出丹参素、原儿茶醛、咖啡酸、丹酚酸E、迷迭香酸、紫草酸、丹酚酸B、丹酚酸L;醇溶性浸出物应不少于9.3%;
或,葛根配方颗粒中,每1g葛根配方颗粒含葛根素C21H20O9为55.0mg~110.0mg;检出葛根素、黄豆苷元;醇溶性浸出物应不少于23.0%;
或,黄芪配方颗粒中,每1g黄芪配方颗粒含毛蕊异黄酮葡萄糖苷C22H22O10为0.50mg~2.0mg;含黄芪甲苷C41H68O14为1.20mg~3.50mg,检出毛蕊异黄酮葡萄糖苷、毛蕊异黄酮峰、黄芪皂苷Ⅱ、黄芪皂苷Ⅰ;醇溶性浸出物应不少于18.0%
或,陈皮配方颗粒中,每1g含橙皮苷C28H34O15为6.5mg~14.5mg;检出柚皮芸香苷、橙皮苷、川陈皮素、橘皮素;醇溶性浸出物应不少于23.0%;
或,麸炒苍术配方颗粒中,每1g麸炒苍术配方颗粒含绿原酸C16H18O9为0.086mg~0.650mg;检出5-羟甲基糠醛、绿原酸;醇溶性浸出物应不少于21.0%;
或,生地黄配方颗粒中,每1g生地黄配方颗粒含梓醇C15H22O10为6.0mg~48.0mg;含毛蕊花糖苷C29H36O15为0.20mg~0.55mg;检出洋地黄叶苷C、焦地黄苯乙醇苷A1、毛蕊花糖苷、焦地黄苯乙醇苷B1、异毛蕊花糖苷;醇溶性浸出物应不少于12.0%。
8.一种治疗心悸的中药膏方的制备方法,其特征在于,包括:
将龙骨、牡蛎、阿胶单独称量,其余药味饮片按照处方量进行处方调剂;
将龙骨、牡蛎饮片混合,加水,浸泡;将阿胶烊化;将其余药味饮片混合,加水,浸泡;
把浸泡后龙骨、牡蛎上火煎煮0.5~1小时后加入除阿胶外的其他饮片,武火加热至沸腾,后改为文火加热,保持沸腾状态,煎煮2~3小时,过滤,第二次加8~10倍量水煎煮1~1.5小时,过滤,合并滤液,静置;
取上清液浓缩,形成清膏;
向清膏中加入烊化开的阿胶、炼蜜与柠檬酸,熬炼,形成稠膏,冷却,即得。
9.一种治疗心悸的中药配方颗粒膏方的制备方法,其特征在于,包括:
将各原料制备成配方颗粒,1g配方颗粒相当于1-60g原药材;
将配方颗粒复溶、熬膏,得清膏;
向清膏中加入炼蜜与柠檬酸,熬膏,得浓膏,冷却,即得。
10.如权利要求9所述的治疗心悸的中药配方颗粒膏方的制备方法,其特征在于,所述复溶的具体步骤为:将颗粒加入到50-60℃的热水中,溶解10~20min,加水量为颗粒量的1.2~1.4;
或,所述熬膏的温度控制在80±5℃,熬制时间为30~40min/500g;
或,蜂蜜量为配方颗粒的18~22%
或,柠檬酸量为配方颗粒的0.9~1.1%。
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