CN117771198A - 一种黄蜀葵复方养心丸及其制备方法 - Google Patents
一种黄蜀葵复方养心丸及其制备方法 Download PDFInfo
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Abstract
本发明涉及中药技术领域,公开了一种黄蜀葵复方养心丸及其制备方法,其方法包括以下步骤:预混:取黄蜀葵、薤白、桂枝、丹参与酸枣仁作为原料混匀,加入至多功能提取罐中,加入溶剂溶解;提取:向多功能提取罐中通入蒸汽进行加热,加热温度为60‑100℃,加热时间为1‑2h,降温后打开多功能提取罐的料阀排出药液,过滤后移入贮存罐;真空浓缩:将所述药液泵入浓缩器中抽真空,抽真空时温度设置为50‑75℃,得到浓缩液;所述浓缩液经过一次干燥、造粒、二次干燥后,进行包装或压片,即可所述黄蜀葵复方养心丸。本发明配伍的中药材,经提取制备工艺,制成的中药协同增效并更加安全与有效。
Description
技术领域
本发明涉及中药技术领域,具体而言,涉及一种黄蜀葵复方养心丸及其制备方法。
背景技术
我国心血管病现患人数3.3亿,其中脑卒中1300万,冠心病1139万,心力衰竭890万,肺源性心脏病500万,心房颤动487万,风湿性心脏病250万,先天性心脏病200万,外周动脉疾病4530万,高血压2.45亿。且中国心血管病患病率处于持续上升阶段。随着人口老龄化及城镇化进程的加速,我国心血管病危险因素趋势呈明显上升态势,导致了心血管病的发病人数持续增加。高患病率为心血管用药带来巨大的市场需求。2022年我国心血管疾病用药行业市场规模为2590.1亿元,同比2021年的2542.3亿元增长了1.88%。
随着心血管疾病的发病人群不断增加,如何开发一种用于养心的中药创新药成为当下亟待解决的问题。
发明内容
鉴于此,本发明提出了一种黄蜀葵复方养心丸及其制备方法,旨在为当前心血管疾病的患病人群提供一种养心的调理方式。
一方面,本发明提出了一种黄蜀葵复方养心丸的制备方法,包括以下步骤:
预混:取黄蜀葵、薤白、桂枝、丹参与酸枣仁作为原料混匀,加入至多功能提取罐中,加入溶剂溶解;
提取:向多功能提取罐中通入蒸汽进行加热,加热温度为60-100℃,加热时间为1-2h,降温后打开多功能提取罐的料阀排出药液,过滤后移入贮存罐;
真空浓缩:将所述药液泵入浓缩器中抽真空,抽真空时温度设置为50-75℃,得到浓缩液;
所述浓缩液经过一次干燥、造粒、二次干燥后,进行包装或压片,即可所述黄蜀葵复方养心丸。
进一步地,所述预混步骤中,所述原料的质量比为黄蜀葵:薤白:桂枝:丹参:酸枣仁为10:2:2:3:3。
进一步地,所述预混步骤中,溶剂为水或酒精,所述酒精浓度为40-80%。
进一步地,所述提取步骤中,所述预混步骤重复进行1-3次。
进一步地,所述提取步骤中,所述降温达到50℃后,打开多功能提取罐的料阀排出所述药液。
进一步地,所述真空浓缩步骤中,所述药液的浓度浓缩至密度1.1-1.2g/cm3时,获得浓缩液。
进一步地,所述一次干燥为喷雾干燥,将所述浓缩液泵入干燥器进行干燥,得到提取物干粉;
所述二次干燥为干燥箱干燥,控制水分含量小于5%。
进一步地,所述造粒包括:取所述提取物干粉加入辅料与粘合剂,混合制粒得到湿颗粒;所述辅料为糊精和/或乳糖。
另一方面,本发明还提出了一种黄蜀葵复方养心丸,其通过上述制备方法得到。
与现有技术相比,本发明的有益效果在于:
本发明的黄蜀葵复方养心丸,一是能够软化血管,抗动脉硬化;二是能够软化血管壁上的斑块,有效融化、缩小斑块,预防心肌的坏死;三是可以促进侧支循环的建立;四是可改善传导系统纤维化,稳定心率,预防心律失常的发生;五是抗心肌的纤维化,预防心衰;六是可以改善全身神经血管的功能;七是中医对于治疗心脏病的效果较好,其优点是可以根据患者症状特点进行辨证施治,同时中医治疗可以延缓病情进展,减少西药用量、减轻西药副作用。另外,本发明的黄蜀葵复方养心丸以临床应用安全有效的传统中药为基础,适应现代医药制造业的工艺技术和质量标准。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
在本申请的一些实施例中,本实施例提供了一种黄蜀葵复方养心丸的制备方法,包括:预混、提取、真空浓缩、一次干燥、造粒与二次干燥后,进行包括或压片,即得黄蜀葵复方养心丸。
具体地,制备方法为:
预混:将黄蜀葵、薤白、桂枝、丹参、酸枣仁原料精选或选择合格的中药饮片;根据配方将中药材称重,混合均匀;
提取:将混合后的药材投入到多功能提取罐中,加入8-10倍溶剂,溶剂为水或食用酒精,酒精浓度为40-80%,优选为55-75%。
提取罐通入蒸汽加热,温度60-100℃,保温1-2h。降温至50℃时,打开放料阀放出药液至贮存罐内。提取罐再加入8倍溶剂按前述方法进行第二次提取,提取完成后,过滤、药液放入贮存罐。
需要说明的是,将混合后的药材投入提取罐,为后续提取过程提供原始材料,确保整个提取过程的开始。溶剂的加入有助于将草药中的有效成分溶解出来,形成药液。溶剂的选择和加入量直接影响提取效率,水或酒精的使用能有效提取不同类型的药用成分。蒸汽加热有助于加速溶剂中有效成分的提取,提高提取效率。控制温度和时间,确保在适宜的条件下实现最大程度的成分提取,保留药物的活性成分。通过降温和打开放料阀,将提取液收集至贮存罐中,便于后续处理,降温有助于减少可能对活性成分的热敏感影响,同时放出药液至贮存罐,便于后续处理和分装。进行第二次提取有助于充分提取草药中剩余的有效成分,提高提取效率。通过多次提取,确保充分利用原料中的有效成分,提高了制备物质的活性。过滤有助于去除固体残渣,确保提取液的纯净度。将提取液过滤后放入贮存罐,为后续步骤提供清洁的提取物,保证最终制备的药物质量。
真空浓缩:将提取液泵入浓缩器中抽真空,保持50~75度温度真空浓缩,将药液浓缩至密度1、1~1.2,得浓缩液。
需要说明的是,通过抽真空,可以减低提取液的沸点,降低溶剂蒸发温度,提高浓缩效率。抽真空有助于在较低的温度下实现液体的蒸发,防止在高温下对活性成分的热敏感影响。限制浓缩温度范围,有助于在较低的温度下保留草药中的活性成分,减少热敏感物质的损失。通过在相对较低的温度下进行浓缩,有助于确保提取液中的有效成分得以保存,同时降低溶剂残留。控制浓缩至特定密度范围,有助于保留所需的活性成分,同时去除多余的溶剂。控制浓缩度可以调整制备物质的浓缩程度,确保活性成分的适当浓度,同时提高制备物质的稳定性。得到浓缩液是为后续制备步骤提供基础,是制备高浓缩药液或干燥制品的关键步骤。浓缩液中含有相对较高浓度的活性成分,为后续步骤提供了具备一定活性的基础材料。
一次干燥:将浓缩液泵入干燥器以喷雾形式干燥得到提取物干粉。
混合制粒:取一定量提取物干粉,加入的辅料和粘合剂。辅料为糊精、乳糖等混合制粒得到湿颗粒。
二次干燥:将湿颗粒置于干燥箱中干燥,控制水分,含量小于5%。
颗粒包装:干燥好的颗粒,置颗粒包装机中分装,即得颗粒剂成品。
压片:将干燥好的颗粒置于V型混合机中,加入润滑剂混合15-30秒,转入压片机中压片,即得片剂成品,经检验合格后即可包装为成品。
需要说明的是,首先,一次干燥步骤通过将浓缩液以喷雾形式干燥,迅速将药液转化为提取物干粉。这有益于降低水分含量,减轻药物的质量,提高稳定性和延长保存期。喷雾形式的干燥能够形成细小颗粒,增加表面积,有助于后续步骤的混合和吸收。接着,混合制粒阶段将提取物干粉与辅料、粘合剂混合,形成湿颗粒。这一步骤的作用在于确保颗粒中各成分的均匀分布,同时加入的辅料和粘合剂如糊精和乳糖有助于提高颗粒的可加工性。湿颗粒的制备为后续加工和造粒提供了良好的基础。随后,通过二次干燥将湿颗粒放置于干燥箱中,控制水分含量小于5%。这一步骤有益于进一步减少水分,确保颗粒的稳定性和质量。水分的控制对防止微生物滋生、防止颗粒吸湿以及提高药物的稳定性都至关重要。最后,颗粒包装阶段将经过二次干燥的颗粒通过颗粒包装机进行分装,即得到颗粒剂成品。这个步骤不仅有益于保护药物免受外部环境的影响,确保了药品的长期贮存和使用的稳定性,同时也方便了患者的使用和管理。这些步骤的协同作用确保了从提取到最终制剂的每一步都能够维持黄蜀葵复方养心丸的药效成分,同时确保了产品的稳定性和可用性。这种细致的制备过程有助于提高制品的质量、一致性和药物的治疗效果。颗粒包装与压片的区别在于所制得的成品形式不同,其成分与功效是相同的。
本发明各成分的药理作用为:
黄蜀葵花为君药:占50%。黄蜀葵花中的主要化学成分为黄酮类、有机酸类、鞣酸类及长链烃类等化合物。现代药理学研究表明,黄蜀葵花的黄酮类成分具有保护心、脑缺血,改善肾功能以及修复口腔黏膜溃疡等作用,能治疗多种口腔炎症、慢性支气管炎,止痛效果显著。金丝桃苷对心肌缺血再灌,脑缺血再灌,脑梗塞都显示良好的保护作用。
对心肌缺血缺氧损伤及缺血再灌注损伤的保护作用:TFA能不同程度减轻缺血再灌注损伤模型的心肌损伤程度,降低心律失常的发生率,显著降低心肌组织和血清中MDA含量,同时增强SOD、GSH-Px活性,抑制血清中肌酸磷酸激酶和乳酸脱氢酶的产生和释放,上调bc l-2mRNA的表达,下调缺血心肌组织中I CAM-1mRNA的表达,降低心肌细胞凋亡率。说明TFA可能是通过抑制心肌脂质过氧化及心肌炎症反应、抑制心肌细胞凋亡以及改善心肌能量代谢来发挥其保护作用。
薤白、桂枝为臣药:各占10%。
薤白为葱蒜属植物,该属植物有类似芥子的作用,欧洲民间过去常用该属植物缓解肺部炎症引起的刺激症状,如(胸痛),又实验证明口服葱蒜的提出物后,平滑肌的反应先是短暂兴奋,继而抑制。这对于理解薤自治疗胸痹(胸膜炎、心绞痛等)所以有效,有一定帮助;薤白所含大蒜辣素的主要成分为硫化丙烯,有降脂作用,且性味辛温,能温阳散结,可用于治疗高胆固醇和高血脂症;薤白所含的大蒜辣素能杀菌消炎,对多种细菌有明显的抑制作用,对感染疾病有治疗效果。薤白的药理作用:降血脂和抗动脉粥样硬化,高胆固醇血症家兔持续服用其提取物,血浆总脂、总胆固醇和β-脂蛋白明显低于对照组。病人服用薤白有效成分,其血浆总胆固醇和β-脂蛋白也明显降低。家兔服用后主动脉脂质斑块的面积、厚度、斑块内泡沫细胞数和平滑肌细胞的增生程度等均有显著的降低,冠状动脉的损害也有明显的减轻。薤白的临床应用:治疗高脂血症和冠心病。
桂芝:性味归经辛、甘,温,入肺、心、膀胱经。辛温,可祛风寒,能治疗感冒风寒、发热恶寒等。化学成分:含桂枝皮醛、桂皮酸等挥发油,还含有酚类、有机酸、苷类、香豆精等成分;药理作用:桂枝煎剂有降温、解热作用;煎剂及醇浸也对金黄色葡萄球菌、伤寒杆菌、流感病毒等均有抑制作用;所含挥发油能刺激汗腺、扩张血管,还能利尿、强心、止咳、祛痰等;所含桂皮醛有镇痛、镇静、抗惊厥作用;现代运用:现代临床以本品配伍他药,可治疗妇女子宫肌瘤等妇科疾病、前列腺炎、脑梗死、肺心病、冻疮、坐骨神经痛、过敏性鼻炎等多种疾病。
丹参为佐药:占15%。丹参具有活血散淤、消肿止血、消炎止痛、调经止痛、扩张冠状动脉、改善心肌缺血状况、降低血压、安神静心、降血糖和抗菌等功效,对心烦失眠、心绞痛等病症有较好疗效。
近代的医学实验证明,丹参还具有抗血小板凝聚、降低血液黏度及调节内外凝血系统的功能,是一种安全又可靠的治疗心脏血管疾病的天然中药。副作用:丹参片是活血化瘀、理气止痛的中成药。主要用于心绞痛、高血压、颈椎病以及胸中憋闷等病症。而且其药效可靠、副作用小,但也不能吃的过于频繁。因长期服用复方丹参片可能会引起血钾含量降低,产生低血钾症。
酸枣仁为使药:占15%。酸枣仁入心经,有养心安神、益气敛汗作用。其性味甘、酸,性平。主要功效:养心补肝,宁心安神,敛汗,生津;临床应用:现代用于神经衰弱、失眠、室性早搏、心律失常等;药理作用:镇静、催眠作用,以及镇痛、抗惊厥、降温作用;对心血管系统的影响:酸枣仁可引起血压持续下降,心传导阻滞;酸枣仁含有一定数量的脂肪油和蛋白质,并含甾醇、三萜类、酸枣仁皂甙、多量维生素C,有镇静、催眠、镇痛、抗惊厥作用,以及一定的降压作用。
综上所述,本发明配伍的中药材都是药食同源植物,均无历史记载毒副作用,药品的稳定性、针对性与协同增效性强,且安全、有效,是一种能满足不同消费者对预防、保健、治疗和康复的多功能和个性化治疗的养心中药。以中医药理论为基础,遵循中药方剂的配伍理论与原则,经对配伍中药材有效成分的分类提取和配伍,创新并组分的现代中药制剂,药效物质明确、作用机理清晰、临床适应病症确切,具有较强的针对性,且相对安全有效,质量可控并适于产业化推广。
最后应当说明的是:以上实施例仅用以说明本发明的技术方案而非对其限制,尽管参照上述实施例对本发明进行了详细的说明,所属领域的普通技术人员应当理解:依然可以对本发明的具体实施方式进行修改或者等同替换,而未脱离本发明精神和范围的任何修改或者等同替换,其均应涵盖在本发明的权利要求保护范围之内。
Claims (9)
1.一种黄蜀葵复方养心丸的制备方法,其特征在于,包括以下步骤:
预混:取黄蜀葵、薤白、桂枝、丹参与酸枣仁作为原料混匀,加入至多功能提取罐中,加入溶剂溶解;
提取:向多功能提取罐中通入蒸汽进行加热,加热温度为60-100℃,加热时间为1-2h,降温后打开多功能提取罐的料阀排出药液,过滤后移入贮存罐;
真空浓缩:将所述药液泵入浓缩器中抽真空,抽真空时温度设置为50-75℃,得到浓缩液;
所述浓缩液经过一次干燥、造粒、二次干燥后,进行包装或压片,即可所述黄蜀葵复方养心丸。
2.根据权利要求1所述的黄蜀葵复方养心丸的制备方法,其特征在于,所述预混步骤中,所述原料的质量比为黄蜀葵:薤白:桂枝:丹参:酸枣仁为10:2:2:3:3。
3.根据权利要求1所述的黄蜀葵复方养心丸的制备方法,其特征在于,所述预混步骤中,溶剂为水或酒精,所述酒精浓度为40-80%。
4.根据权利要求1所述的黄蜀葵复方养心丸的制备方法,其特征在于,所述提取步骤中,所述预混步骤重复进行1-3次。
5.根据权利要求1所述的黄蜀葵复方养心丸的制备方法,其特征在于,所述提取步骤中,所述降温达到50℃后,打开多功能提取罐的料阀排出所述药液。
6.根据权利要求1所述的黄蜀葵复方养心丸的制备方法,其特征在于,所述真空浓缩步骤中,所述药液的浓度浓缩至密度1.1-1.2g/cm3时,获得浓缩液。
7.根据权利要求1所述的黄蜀葵复方养心丸的制备方法,其特征在于,所述一次干燥为喷雾干燥,将所述浓缩液泵入干燥器进行干燥,得到提取物干粉;
所述二次干燥为干燥箱干燥,控制水分含量小于5%。
8.根据权利要求7所述的黄蜀葵复方养心丸的制备方法,其特征在于,所述造粒包括:取所述提取物干粉加入辅料与粘合剂,混合制粒得到湿颗粒;所述辅料为糊精和/或乳糖。
9.一种黄蜀葵复方养心丸,其特征在于,采用权利要求1-8任一项所述的方法制备得到。
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