CN107334870A - 一种降血压的组合物及其制备方法 - Google Patents
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Abstract
本发明公开了一种降血压的组合物及其制备方法,该组合物由以下重量份的组分组成:金花茶叶1‑5份、荷叶1‑5份、葛根1‑5份、决明子1‑5份、山楂1‑5份、桑叶1‑5份。本发明的组合物具有清泻肝火、平肝潜阳、健脾益气、生津润燥等功效,各药味相互协同,多环节、多靶点、多途径等作用特点,对高血压有较好的疗效,还能提高机体免疫力,无毒副作用,可作为药品或保健食品服用。
Description
技术领域
本发明涉及药品、保健食品领域,具体涉及一种降血压的组合物。
背景技术
随着人们生活水平的不断提高以及饮食结构的变化,高血压、高血脂、高血糖的患者逐年增多。高血压是一种以体循环动脉压增高为主要特点的疾病,是一种在成年人群中常见的心血管疾病,是我国人群脑卒中和冠心病发病及死亡的主要危险因素。目前我国高血患者已达2亿,其中原发性高血压(EH)占95%以上,其严重并发症心、脑、肾的损害,已严重威胁了我国人民群众的生命健康,可见,积极预防和治疗高血压已迫在眉睫。目前,高血压的治疗强调对多种心血管危险因素的综合干预,临床上治疗以西药为主,但尚缺乏根治药物。降压西药种类繁多,其中钙通道拮抗剂(CCB)、血管紧张素转换酶抑制剂(ACEI)、血管紧张素受体拮抗剂(ARB)、β-受体阻滞剂、利尿剂作为一线降压药物虽可有效的控制血压,但单品种降压治疗血压达标率仍不够高,多数高血压患者需要2种以上降压药物联合治疗,也有部分患者因存在禁忌症而无合适的降压方案,而且降压西药在存在副作用大,不良反应发生率高,治标却伤本等问题,影响患者的生活质量。
传统中医理论认为高血压属于“头晕”、“头痛”等范畴,高血压病的本质是“本虚标实”,治疗原则当泻实补虚、调整阴阳,虚实夹杂或因虚致实或由实致虚者当扶正祛邪,临床应分清标本,权衡轻重,酌情施治,达到整体调节、阴阳平衡的目的。控制血压中医药具有多靶点作用、多途径起效的特点,为高血压的治疗提供了广阔的前景。中医药治疗高血压病可明显改善患者症状,着眼于整体调理,防止血压波动平稳降压,减少西药用量及不良反应,能在治本的原则下,同时消除患者不舒服的症状,具有显著优势。而“药食同源”类中药,兼有营养和治疗的双向作用,在治疗高血压方面更是具有一定的优势。本发明利用传统中医理论治疗高血压的原则,研究出一种降血压的组合物,目前尚未见相关报道。
(1)金花茶叶,为金花茶Camellia chrysantha(Hu)Tuyama的叶片,山茶科山茶属金花茶组植物,《广西壮族自治区壮药质量标准》中记载其有清热解毒、利尿利湿等功效。根据中国疾病预防控制中心营养与食品安全所、广西壮族自治区疾病预防控制中心、广西壮族自治区卫生监督检验中心、北京疾病预防控制中心营养与食品安全所、广西壮族自治区分析测试研究中心、广西中医学院、广西农学院实验中心等权威机构检验表明:金花茶功效具有扩张冠状血管、降低高血压、增强心脏收缩或心脏博动数、止渴止痰、抗菌消炎、抗毛细血管脆性和异常透过性、抗肿瘤、保肝利胆、解热镇痛、降低胆固醇、利尿等作用。广西中医学院曾对金花茶叶进行提取分析和药理实验证明,金花茶叶的水浸出物具有降血糖,降血压、降血脂、降血清中胆固醇、抑制肿瘤生长、防止动脉粥样硬化、激活人体多种酶、提高肌体免疫能力、延缓衰老等多种生理功能。
(2)荷叶,为睡莲科植物莲Nelumbo nucifera Gaertn.的干燥叶。收载于中国药典2015
年版:【性味与归经】苦,平。归肝、脾、胃经。【功能与主治】清暑化湿,升发清阳,凉血止血。用于暑热烦渴,暑湿泄泻,脾虚泄泻,血热吐魈,便血崩漏。
(3)葛根,为豆科植物野葛Pueraria lobata(Willd.)Ohwi的干燥根。收载于中国药典2015年版:【性味与归经】甘、辛,凉。归脾、胃、肺经。【功能与主治】解肌退热,生津止渴,透疹,升阳止泻,通经活络,解酒毒。用于外感发热头痛,项背强痛,口渴,消渴,麻疹不透,热痢,泄泻,眩晕头痛,中风偏瘫,胸痹心痛,酒毒伤中。
(4)决明子,为豆科植物决明Cassia obtusifolia L.或小决明Cassia tora L.的干燥成熟种子。收载于中国药典2015年版:【性味与归经】甘、苦、咸,微寒。归肝、大肠经。【功能与主治】清热明目,润肠通便。用于目赤涩痛,羞明多泪,头痛眩晕,目暗不明,大便秘结。
(5)山楂,为蔷薇科植物山里红Crataegus pinnatifida Bge.var.major N.E.Br.或山楂Crataegus pinnatifida Bge.的干燥成熟果实。收载于中国药典2015年版:【性味与归经】酸、甘,微温。归脾、胃、肝经。【功能与主治】消食健胃,行气散瘀,化浊降脂。用于肉食积滞,胃脘胀满,泻痢腹痛,瘀血经闭,产后瘀阻,心腹刺痛,胸痹心痛,疝气疼痛,髙脂血症。
(6)桑叶,为桑科植物桑Morus alba L.的干燥叶。《中国药典》2015年版记载:【性味归经】甘、苦,寒。归肺、肝经。【功能与主治】疏散风热,清肺润燥,清肝明目。用于风热感冒,肺热燥咳,头晕头痛,目赤昏花。
发明内容
本发明的目的是针对高血压患者逐年增多,临床上采用联合用药的方法治疗不良反应多的现状,提供一种降血压的组合物,该组合物无毒副作用,还能提高机体免疫力,可长期服用。
本发明所采用的技术方案如下:
一种降血压的组合物,由以下重量份的组分组成:金花茶叶1-5份、荷叶1-5份、葛根1-5份、决明子1-5份、山楂1-5份、桑叶1-5份。
以上所述降血压的组合物,最佳优选由以下重量份的组分组成:金花茶叶3份、荷叶3份、葛根3份、决明子3份、山楂3份、桑叶3份。
以上所述降血压的组合物,可制备成药品、保健食品上允许的任意剂型,如:茶剂、丸剂、颗粒剂、片剂、胶囊、汤剂、煎膏剂、口服液、糖浆剂等,优选制成茶剂。
一种以上所述降血压的组合物制成茶剂的方法,包括以下步骤:
S1.分别取金花茶叶、荷叶、葛根、决明子、山楂、桑叶,洗净,干燥;
S2.按照以下重量份称取原料:金花茶叶1-5份、荷叶1-5份、葛根1-5份、决明子1-5份、山楂1-5份、桑叶1-5份;
S3.取步骤S2称量好的药材,分别粉碎成细粉,过筛;
S4.取步骤S3细粉,混匀,分装,即得。
进一步的,步骤S3项下所述过筛步骤所用的筛网优选为80-100目,最佳优选为90目。
以上所述降血压的组合物,在制备降血压的食品、药品中的用途。
本发明降血压的组合物,根据传统中医药理论,结合现代中医的辩证疗法,以国家***公布的药食同源目录品种为原料,组方科学严谨,兼具营养和治疗的双向作用,可长期服用,安全健康。
高血压病隶属于中医学中“眩晕”“头痛”等证范畴,病位在清窍,或脑髓空虚,清窍失养,或痰火上逆,扰动清窍,与肝、脾、肾关系密切。其病因与情志、饮食、劳逸失常相关,病机多属本虚标实,虚实夹杂。虚者多以内伤为主,气血亏虚,肾精不足,脑髓失养;实者多因本虚标实,可为肝肾阴虚,肝阳偏亢,风阳上扰清窍;或脾虚不运,痰湿中阻和瘀血痹阻清窍,主要治疗方法为滋补肝肾,平肝潜阳,清泻肝火,健脾燥湿等。
本发明以金花茶清热解毒、利尿利湿;荷叶清暑化湿,升发清阳,凉血止血;葛根解肌退热,生津止渴,透疹,升阳止泻,通经活络;决明子清热明目,润肠通便;山楂消食健胃,行气散瘀,化浊降脂;桑叶疏散风热,清肺润燥;上述组合物合用共凑清泻肝火、平肝潜阳、健脾益气、生津润燥之功,在治疗高血压上具有相互协同、多环节、多靶点、多途径等作用特点,既调节人体阴阳平衡,又调节血压调控***的生理平衡,对高血压有良好的疗效。
本发明的有益效果是:
1.原料药均取自食品和“药食同源”品种,使用安全。
2.组方严谨,药少力专,具有清泻肝火、平肝潜阳、健脾益气、生津润燥等功效,具有各药味相互协同,多环节、多靶点、多途径等作用特点,既调节人体阴阳平衡,又调节血压调控***的生理平衡,对高血压有良好的疗效,治疗总有效率达96%以上。
3.克服了西药在治疗高血压疾病联合用药时服药种类多,副作用大,不良反应多等缺点,可作为药品和保健食品长期使用,安全有效。
具体实施方式
下面结合具体实施例对本发明作进一步描述,但不限制本发明的保护范围和应用范围:
一、降血压的组合物茶剂的制备
实施例1
一种降血压的组合物制成茶剂的方法,包括以下步骤:
S1.分别取金花茶叶、荷叶、葛根、决明子、山楂、桑叶,洗净,干燥;
S2.按照以下重量份称取原料:金花茶叶1000g、荷叶1000g、葛根1000g、决明子1000g、山楂1000g、桑叶1000g;
S3.取步骤S2称量好的药材,分别粉碎成细粉,过80目筛;
S4.取步骤S3细粉,混匀,分装,即得。
实施例2
一种降血压的组合物制成茶剂的方法,包括以下步骤:
S1.分别取金花茶叶、荷叶、葛根、决明子、山楂、桑叶,洗净,干燥;
S2.按照以下重量份称取原料:金花茶叶3000g、荷叶3000g、葛根3000g、决明子3000g、山楂3000g、桑叶3000g;
S3.取步骤S2称量好的药材,分别粉碎成细粉,过90目筛;
S4.取步骤S3细粉,混匀,分装,即得。
实施例3
一种降血压的组合物制成茶剂的方法,包括以下步骤:
S1.分别取金花茶叶、荷叶、葛根、决明子、山楂、桑叶,洗净,干燥;
S2.按照以下重量份称取原料:金花茶叶5000g、荷叶5000g、葛根5000g、决明子5000g、山楂5000g、桑叶5000g;
S3.取步骤S2称量好的药材,分别粉碎成细粉,过100目筛;
S4.取步骤S3细粉,混匀,分装,即得。
以下通过动物试验来说明本发明组合物的功效。
二、动物试验
1.降血压功能试验
1.1试验材料
1.1.1样品:实施例1产品,同时以市售卡托普利片为阳性对照。
1.1.2试验动物:成年自发性高血压大鼠(SHR)大鼠、SD大鼠,雄性,12周龄,体重180g±20g。
1.1.3仪器:RBP-1型大鼠血压计。
以尾脉搏法测定血压,每次测量间隔一定时间,记录心率变化≤10次/min、血压变化<6mmHg的连续3次读数,取其均数。从给予受试动物开始每天测定血压和心率一次,连续45d。
1.2试验方法
1.2.1受试样品溶液的制备
试验组供试品溶液的制备:取实施例1产品内容物80g,加煮沸的纯化水浸泡,待冷却室温后过滤,滤液定容至200ml,即为0.4g/ml,此为高剂量组;然后取高剂量组溶液100ml加纯化水至200ml,即为中剂量组;最后取中剂量组溶液100ml加纯化水至200ml,即为低剂量组。灌胃体积为10ml/kg·BW。
阳性对照供试品溶液的制备:取卡托普利片150mg,加纯化水使溶解并定容至200ml,即为0.75mg/ml。
1.2.2分组与给药
将32只SHR大鼠随机分成4组:高、中、低三个剂量治疗组,阳性对照(卡托普利)组,每组8只;以SD大鼠及SHR作为对照,为正常组和SHR组。高、中、低三个治疗组给药剂量分别为4g/kg·bw、2g/kg·bw、1g/kg·bw,阳性对照(卡托普利组)剂量为15mg/kg·bw,SHR组均给予同体积的纯化水,正常组给予4g/kg·bw(高剂量),每天1次,共治疗45d。
1.3统计学处理
各组数据用SPSS13.0统计软件处理,计量资料以x±s表示,多组间比较采用单因素方差分析(ANOVA),两组间比较采用q检验。
1.4结果
1.4.1各组大鼠给药前后的血压对比
结果见表1。
表1各组大鼠给药前后的血压对比(x±s,n=8)
注:△△表示与正常组比较P<0.01;#,##表示与给药前比较P<0.05,P<0.01
由表1可知,给药后,与模型组相比,3个剂量组及卡托普利组大鼠的舒张压、收缩压均显著下降(P<0.01或P<0.05);与给药前相比,3个剂量及卡托普利组均可显著降低大鼠的收缩压及舒张压(P<0.01或P<0.05)。表明本发明实施例1与卡托普利均具有显明的降血压作用。
1.4.2各组大鼠给药前后心率的比较
结果见表2。
表2各组大鼠给药前后心率的对比(x±s,n=8)
由表2可知,给药前、后各组心率差异均无统计学意义,说明本发明组合物对心率的影响作用不大。
三、临床应用试验
1.治疗高血压
1.1病例选择标准
原发性高血压患者,未用药,或服用高血压药物但停药两两周后,舒张压≥90mmHg,收缩压≥140mmHg,满足两者任一项即可。
排除标准
(1)年龄在18岁以下或65岁以上者;
(2)妊娠期或哺乳期妇女;
(3)合并有心、脑、肝、肾和造血***等严重全身性疾病患者、精神病患者;
(4)继发性高血压患者;
(5)过敏体质或对多种药物过敏者。
1.2给药方法
将符合上述标准的152例高血压患者(其中男89例,女63例)按就诊顺序随机分为实施例组和阳性对照组,每组76例。
(1)实施例组:将上述制备好实施例1-3样品,用于临床试验。口服,取样品2包,加水500-1000ml煮沸3-5分钟,分早晚喝完。疗程:用药6周。
(2)对照组:卡托普利片。口服,第1-3天:每次12.5mg;第4-7天,每次25mg(1片),每日2-3次;第2周:每次50mg(2片),每日2-3次。疗程:用药6周。
1.3疗效判定标准
(1)显效:舒张压下降10mmHg以上,并达到正常范围;或收缩压虽未降至正常水平但已下降20mmHg或以上。
(2)有效:舒张压下降不及10mmHg,但已达到正常范围;或舒张压较治疗前下降10-19mmHg,但未达到正常范围;收缩压较治疗前下降30mmHg以上(具备任一项)。
(3)无效:未达到以上标准者。
1.4治疗结果
结果见表3。
表3本发明实施例1-3及卡托普利治疗高血压患者用药前后疗效评价情况
在以上试验过程中,对受试者试验前后的血常规、尿常规、心肝肾功能等指标进行了检查,实施例组均未发现异常,而且无一病例出现过敏等不适反应;而对照组有5例患者出现皮肤瘙痒、发热、心悸等不良反应。
由表3可见,实施例组与对照组治疗后的降压效果比较,有显著性差异(P<0.05)。服用本发明实施例组样品6周后,血压有明显的下降,对高血压的治疗总有效率达到96%以上,高于对照组,而且试验过程中未出现任何不良反应,说明本发明组合物具有很好的降血压作用,使用安全有效。以下是典型的例子:
典型例子1:李某,男,63岁,三年前因头晕到医院就诊,确诊为原发性高血压。服用降压西药一年多,由于副作用大停服,停服西药后,经常感觉胸闷、心慌、气短、睡眠不好。服用本发明实施例2样品,每天取样品2包,加水500-1000ml煮沸3-5分钟,分早晚喝完,服用3天后,症状减轻,测血压收缩压由157mmHg降至148mmHg,舒张压由86mmHg降至78mmHg。再继续服用12天后,测血压收缩压为138mmHg,舒张压为73mmHg,连续服用完6周后,血压一直维持在正常范围至一年后回访未出现血压升高现象。
典型例子2:农某,女,58岁,头晕10多年,到医院体检时发现是原发性高血压。几乎服用过所有的降压西药,但血压一直没能降至正常。服用本发明实施例1样品15天,每天取样品2包,加水500-1000ml煮沸3-5分钟,分早晚喝完,复查结果高血压由服用本发明实施例样品前的147降至107,低压由95降至89,连续服用完6周后,血压维持在正常范围至一年后回访未出现血压升高现象。
典型例子3:苏某,男,56岁,诊断为原发性高血压5年。服用降压西药2年,因为降压效果不好且副作用大等原因,寻求中药治疗。服用本发明实施例3样品,每天取样品2包,加水500-1000ml煮沸3-5分钟,分早晚喝完,服用10天后,测血压收缩压由167mmHg降至158mmHg,舒张压由101mmHg降至92mmHg。再继续服用20天后,测血压收缩压为145mmHg,舒张压为89mmHg,连续服用完6周后,血压一直维持在正常范围至一年后回访未出现血压升高现象。
Claims (10)
1.一种降血压的组合物,其特征在于,由以下重量份的原料组成:金花茶叶1-5份、荷叶1-5份、葛根1-5份、决明子1-5份、山楂1-5份、桑叶1-5份。
2.根据权利要求1所述降血压的组合物,其特征在于,由以下重量份的原料组成:金花茶叶3份、荷叶3份、葛根3份、决明子3份、山楂3份、桑叶3份。
3.根据权利要求1或2所述降血压的组合物,其特征在于,所述组合物制成食品或药品领域可接受的任意剂型。
4.根据权利要求3所述降血压的组合物,其特征在于,所述组合物制成茶剂、丸剂、颗粒剂、片剂、胶囊、汤剂、煎膏剂、口服液、糖浆剂。
5.根据权利要求4所述降血压的组合物,其特征在于,所述组合物制成茶剂。
6.一种根据权利要求5所述降血压的组合物制成茶剂的方法,其特征在于,包括以下步骤:
S1.分别取金花茶叶、荷叶、葛根、决明子、山楂、桑叶,洗净,干燥;
S2.按照以下重量份称取原料:金花茶叶1-5份、荷叶1-5份、葛根1-5份、决明子1-5份、山楂1-5份、桑叶1-5份;
S3.取步骤S2称量好的药材,分别粉碎成细粉,过筛;
S4.取步骤S3细粉,混匀,分装,即得。
7.根据权利要求6所述降血压的组合物制成茶剂的方法,其特征在于,所用原料水分含量≤8.5%。
8.根据权利要求6所述降血压的组合物制成茶剂的方法,其特征在于,步骤S3所述过筛步骤所用的筛网为80-100目。
9.根据权利要求8所述降血压的组合物制成茶剂的方法,其特征在于,步骤S3所述过筛步骤所用的筛网为90目。
10.根据权利要求1-9中任一所述降血压的组合物,其特征在于,所述组合物在制备降血压的食品、药品中的用途。
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