CN107362236A - 一种具有辅助降血压功能的组合物及其制备方法 - Google Patents
一种具有辅助降血压功能的组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种具有辅助降血压功能的组合物及其制备方法。该组合物是由杜仲叶、罗布麻叶、绿茶提取物按一定重量配比制备而成,它可以被制成任何一种常用制剂,优选口服制剂。本发明组方简单,配伍合理,各原料间协同增效作用明显,通过实验证实其具有降血压作用,且制备工艺简单、稳定,产品质量稳定可控。
Description
技术领域
本发明涉及一种具有辅助降血压功能的组合物及其制备方法,属于保健食品的技术领域。
背景技术
随着人们生活水平的提高,心脑血管疾病已经成为危害人类健康的头号杀手,而高血压是引起心脑血管疾病极高的危险因素。高血压是一种以动脉血压持续升高为主要表现的慢性疾病,主要发病原因之一是由于人体外周小动脉痉挛,使人体外周小动脉阻力加大,从而造成血压增高,形成高血压,常引起心、脑、肾等重要器官的病变并出现相应的后果。目前,高血压无论患病率及其死亡率和致残率都在快速增长,其发展趋势令人十分担忧。2015年中国心血管病报告指出,我国十五岁及以上人口高血压患病率高达26.39%,估计高血压患者接近亿。特别值得指出的是,高血压患者的年龄呈现年轻化。流行病学调查表明,25岁到34岁年龄段患病率达25.19%。因此,我国高血压发展趋势很不乐观,其防治任务十分繁重。
在高血压的治疗中,人们广泛使用各种西药降压药,其虽可满足一般的降压要求,但也有明显的副作用。由于西药降压都是以扩张血管为主,而血管在不断的扩张过程中,其自身弹性变弱并硬化,因此,长期使用降压药的人容易引起血管硬化和破裂,并导致脑血管栓塞、中风等疾病。因此,西药不适合长久使用。
发明内容
本发明目的是提供了一种具有辅助降血压功能的组合物。
本发明的另外一个目的是提供了该组合物的制备方法。
本发明是通过以下技术方案实现的:
本发明是由下述重量份的原料制成的:
杜仲叶100-700份、罗布麻叶300-900份、绿茶提取物30-90份。
优选为:
杜仲叶300-500份、罗布麻叶500-700份、绿茶提取物50-70份。
进一步优选为:
杜仲叶400份、罗布麻叶600份、绿茶提取物60份。
本发明涉及一种组合物,它是在现有中医理论的基础上,进行科学配伍,发挥药物之间相互协同的作用,从而筛选出能辅助降血压的组方。
本发明中各原料药的作用机理如下:
杜仲:甘,温。归肝、肾经。具有补肝肾的功效,用于治疗腰脊酸疼、足膝痿弱、小便余沥、阴下湿痒、高血压等。现代研究表明,杜仲中的黄酮类物质主要包括槲皮素和芦丁,其中槲皮素具有舒张血管的作用,并且根据浓度的高低,其舒张作用的具体机制也有所不同;槲皮素对动脉平滑肌细胞(ASMC)血管紧张素转化酶(ACE)活性及血管紧张素(AngⅡ)生成有持久的抑制作用;槲皮素还可通过抑制血管平滑肌细胞(VSMC)的增生途径来降低血压。芦丁的舒血管作用主要是通过促进血管内皮细胞释放NO来实现。
罗布麻:甘、苦,凉。归肝经。具有平抑肝阳、清热利尿的功效,可治疗头晕目眩和水肿,小便不利。研究表明,每日用罗布麻叶1~2钱,开水泡当茶喝,或早晚定时煎服,共治596例,其中单用罗布麻叶169例;用其他降压药效果不稳定而改用罗布麻,或降压药与罗布麻同用,血压下降到一定程度后再用罗布麻巩固者计427例。结果症状消失或显着减轻者254例,减轻212例;其中血压下降至140/90毫米汞柱以下者143人,收缩压或舒张压下降20毫米汞柱以上者268人。有效率达88.59%。服用罗布麻茶时间越长则疗效越高,超过半年的可达93.3%。对头痛、眩晕、脑胀、失眠多梦和浮肿有较好的缓解作用;或作为治疗高血压病的辅助剂,对改善症状有较好疗效。
绿茶提取物:茶多酚是茶叶中的类黄酮物质,包括黄烷醇,又称为儿茶素,黄酮醇,酚酸和缩酚酸类以及其他多酚类,茶多酚中儿茶素约占80%。大量研究表明,茶及茶多酚具有良好的降血压效果。
关于原发性高血压的发病机制普遍认为是由于受肾素和血管紧张素类物质的控制所引起,即有肾素刺激产生的血管紧张素Ⅰ在ACE作用下转化为具有强升压活性的血管紧张素Ⅱ,从而导致血压升高。因此通常认为抑制ACE活性可起到降血压的效果。茶叶具有降血压的作用早有报道,关于茶叶的降血压机理,日本学者研究认为主要是茶叶中儿茶素类化合物和ACE活性的抑制作用;此外,研究还发现茶叶中的咖啡碱和儿茶素类能使血管壁松弛,增加血管的有效直径,通过血管舒张而使血压下降。
为了使本发明组合物能发挥更大的功效,还可以加入天麻、葛根、三七、绞股蓝中的一种或一种以上配伍使用,可以相互协同增效,共同发挥降血压的作用。
本发明组分可以采用中药制剂的常规方法制备成任何常规的制剂,包括口服制剂,外用制剂,注射剂等。例如可以将这些原料药研成粉末混合均匀;可以将所述重量份的原料药分别加水或不同浓度的乙醇提取,提取液浓缩干燥得粗提物,或采用精制方法,例如,水提醇沉法、有机溶剂萃取法、柱层析法、二氧化碳超临界萃取法、水蒸气蒸馏法进行精制得到精提物。
在使用上述药物时,既可以采用以相当于所述重量配比的药物为原料分别净选,干燥、粉碎、混合得到符合制剂要求粒度的颗粒或粉末直接服用。也可以采用以相当于所述重量配比关系的药物为原料经过适当处理后添加药用辅料,根据需要将其制成各种制剂。由上述原料药制备成制剂的过程中,上述原料药可以采用如下方法进行处理:将所述重量份的原料药直接粉碎得药材粉末;或分别加水或不同浓度的乙醇提取或采用水提醇沉法、离心法、水蒸气蒸馏法提取得提取物;在对上述有效药用成分进行提取时可采用的具体操作和/或使用方法,既可以是以所述的各比例量的药物成分为原料,分别提取其有效药用成分后再混合的方式,也可以采用按所说比例量的各药物原料混合后再共同提取的方式。采用不同的提取手段、设备及提取时所需的理想或最佳的提取温度、溶剂用量、提取时间、提取次数等具体条件,则可根据实际情况通过试验被筛选和找到。
以上任意一种方法均可以制备得到本发明组合物的活性成分,制得的活性成分可以直接入药服用或加入药剂学上可接受的辅料按常规工艺制备成所需制剂。如可以制成常用的片剂(分散片、泡腾片、口腔崩解片、含片、咀嚼片、泡腾片)、胶囊剂(硬胶囊、软胶囊剂)、颗粒剂、丸剂(滴丸剂)、散剂等固体制剂形式的口服药物,也可以制成糖浆、口服液、袋装茶剂、袋泡茶剂等液体制剂形式的口服药物;还可以制成膏剂、凝胶剂、软膏剂、巴布剂、贴膏剂、搽剂、洗剂、涂膜剂等外用制剂形式的外用药物。因此,该药物组合物中除有效成分外,还可以含有药学上可以接受的辅料。
这里所述的辅料,可以根据不同的制剂有所不同,如在片剂、胶囊剂、颗粒剂等固体制剂中常用的稀释剂、崩解剂、赋形剂、粘合剂、润滑剂、表面活性剂、填充剂等;在糖浆、口服液等液体制剂形式中常用的表面活性剂、稀释剂、防腐剂、稳定剂、矫味剂、增稠剂、助流剂等;在凝胶剂、软膏剂等外用制剂形式中常用的药用油性基质、水性基质、防腐剂、抗氧剂、保湿剂、透皮吸收促进剂、表面活性剂等。
其常用辅料如淀粉、乳糖、糊精、麦芽糊精、糖粉、微晶纤维素、甘露醇、木糖醇、聚乙二醇、硫酸钙、磷酸氢钙、碳酸钙、改良淀粉、β-环糊精、一水柠檬酸、柠檬酸钾、山梨醇、聚乙烯吡咯烷酮、重质碳酸镁、羧甲基纤维素钠、羟丙甲基纤维素、甲基纤维素、乙基纤维素、羧甲淀粉钠、羟丙基纤维素、聚维酮K30、白陶土、预胶化淀粉、硬脂酸镁、滑石粉、微粉硅胶、蔗糖、甜叶菊苷、甜菜碱、阿司帕坦、甘草甜素、糖精钠、枸橼酸、酒石酸、碳酸氢钠、碳酸钠、卡拉胶、琼脂、明胶、海藻酸钠、黄原胶、瓜耳豆胶、西黄耆胶、阿拉伯胶、槐豆胶、刺梧桐胶、硬脂酸、单硬脂酸甘油酯、聚丙烯酰胺、交联型聚丙烯酸钠、聚乙烯醇、卡波姆、山梨酸、山梨酸钾、羟苯乙酯、苯甲醇、尼泊金、硫柳汞、二甲基亚砜、氮酮、三乙醇胺、氢氧化钠、甘油、丙二醇、十二烷基硫酸钠、吐温类、司盘类等。
为了使该组合物的各组分能更好的发挥药效,优选对本发明所述重量份配比的组分采取如下的制备方法,但不能用于限制本发明的保护范围。
本发明组合物颗粒剂的制备方法如下:
取所述重量份的杜仲叶、罗布麻叶,加5-20倍量水提取1-3次,每次1-3小时,过滤,合并滤液,减压浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,减压干燥,粉碎成细粉,与所述重量份的绿茶提取物、适量辅料混匀,制粒,干燥,整粒,即得。
本发明组合物颗粒剂的制备方法优选为:
取所述重量份的杜仲叶、罗布麻叶,加水提取2次,每次1小时,第一次加14倍量水提取,第二次加12倍量水提取,过滤,合并滤液,减压浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,减压干燥,粉碎成细粉,所述重量份的绿茶提取物、适量辅料混匀,制粒,干燥,整粒,即得。
本发明组合物颗粒剂的制备方法还可以为:
取所述重量份的杜仲叶、罗布麻叶,加5-20倍量20-95%乙醇提取1-3次,每次1-3小时,过滤,合并滤液,减压回收乙醇至无醇味,继续浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,减压干燥,粉碎成细粉,与所述重量份的绿茶提取物、适量辅料混匀,制粒,干燥,整粒,即得。
以上制备方法中涉及的辅料是指β-环糊精、一水柠檬酸、柠檬酸钾、糊精、麦芽糊精、淀粉、预胶化淀粉、甘露醇、微晶纤维素、乳糖、阿司帕坦、甜菜碱、蔗糖、枸橼酸、酒石酸中的一种或一种以上;优选β-环糊精、一水柠檬酸、柠檬酸钾。
以上制备方法中涉及的绿茶提取物是通过购买市售品或者通过以下任一方法得到:
(1)取绿茶加4-20倍量20-95%乙醇提取1-4次,每次1-3小时,提取液合并,过滤,滤液减压回收乙醇至无醇味,继续浓缩,干燥,粉碎成细粉,即为绿茶提取物;
(2)取绿茶加4-20倍量水回流提取1-4次,每次1-3小时,提取液合并,过滤,滤液浓缩,干燥,粉碎成细粉,即为绿茶提取物。
以下通过实施例形式的具体实施方式,对本发明的上述内容作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实施例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
实施例1
杜仲叶400g、罗布麻叶600g、绿茶提取物60g
取所述重量份的杜仲叶、罗布麻叶,加水提取2次,每次1小时,第一次加14倍量水提取,第二次加12倍量水提取,过滤,合并滤液,减压浓缩至60℃测相对密度1.10~1.15的浸膏,冷藏,离心,取上清液继续减压浓缩至60℃测相对密度1.30~1.35的稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量β-环糊精、一水柠檬酸、柠檬酸钾,混匀,制粒,干燥,整粒,即得。
实施例2
杜仲叶300g、罗布麻叶700g、绿茶提取物70g
取所述重量份的杜仲叶、罗布麻叶,加水提取2次,每次1.5小时,第一次加12倍量水提取,第二次加10倍量水提取,过滤,合并滤液,减压浓缩至60℃测相对密度1.10~1.15的浸膏,冷藏,离心,取上清液继续减压浓缩至60℃测相对密度1.30~1.35的稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量β-环糊精、一水柠檬酸、柠檬酸钾,混匀,制粒,干燥,整粒,即得。
实施例3
杜仲叶500g、罗布麻叶500g、绿茶提取物50g
取所述重量份的杜仲叶、罗布麻叶,加水提取2次,每次2小时,第一次加10倍量水提取,第二次加8倍量水提取,过滤,合并滤液,减压浓缩至60℃测相对密度1.10~1.15的浸膏,冷藏,离心,取上清液继续减压浓缩至60℃测相对密度1.30~1.35的稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量β-环糊精、枸橼酸、柠檬酸钾,混匀,制粒,干燥,整粒,即得。
实施例4
杜仲叶100g、罗布麻叶900g、绿茶提取物90g
取所述重量份的杜仲叶、罗布麻叶,加20倍量水提取1次,提取3小时,过滤,滤液减压浓缩至60℃测相对密度1.10~1.15的浸膏,冷藏,离心,取上清液继续减压浓缩至60℃测相对密度1.30~1.35的稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量β-环糊精、柠檬酸钾、阿司帕坦,混匀,制粒,干燥,整粒,即得。
实施例5
杜仲叶700g、罗布麻叶300g、绿茶提取物30g
取所述重量份的杜仲叶、罗布麻叶,加5倍量水提取3次,每次1小时,过滤,合并滤液,减压浓缩至60℃测相对密度1.10~1.15的浸膏,冷藏,离心,取上清液继续减压浓缩至60℃测相对密度1.30~1.35的稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量微晶纤维素、酒石酸,混匀,制粒,干燥,整粒,即得。
实施例6
杜仲叶450g、罗布麻叶550g、绿茶提取物55g
取所述重量份的杜仲叶、罗布麻叶,加水提取2次,每次1.5小时,第一次加14倍量水提取,第二次加10倍量水提取,过滤,合并滤液,减压浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量甘露醇、麦芽糊精、蔗糖,混匀,制粒,干燥,整粒,即得。
实施例7
杜仲叶400g、罗布麻叶600g、绿茶提取物60g
取所述重量份的杜仲叶、罗布麻叶,加12倍量水提取2次,每次2小时,过滤,合并滤液,减压浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量乳糖、糊精,混匀,制粒,干燥,整粒,加入适量硬脂酸镁,混匀,压片,包衣,即得。
实施例8
杜仲叶350g、罗布麻叶650g、绿茶提取物65g
取所述重量份的杜仲叶、罗布麻叶,加8倍量水提取3次,每次2小时,过滤,合并滤液,减压浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量β-环糊精、柠檬酸钾,混匀,制粒,干燥,整粒,装胶囊,即得胶囊剂。
实施例9
杜仲叶480g、罗布麻叶500g、绿茶提取物50g
取所述重量份的杜仲叶、罗布麻叶,加12倍量水提取2次,每次1小时,过滤,合并滤液,减压浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量辅料,混匀,制成丸剂。
实施例10
杜仲叶600g、罗布麻叶400g、绿茶提取物40g
取所述重量份的杜仲叶、罗布麻叶,加14倍量水提取2次,每次1小时,过滤,合并滤液,减压浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量甘露醇、糊精、微晶纤维素,混匀,制粒,干燥,整粒,加入适量硬脂酸镁,混匀,压片,即得。
实施例11
杜仲叶200g、罗布麻叶800g、绿茶提取物80g
取所述重量份的杜仲叶、罗布麻叶,加12倍量水提取2次,每次2小时,过滤,合并滤液,减压浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,加入所述重量份的绿茶提取物、适量的混悬剂、调味剂、防腐剂,混匀,加水定容,滤过,分装,制成口服液体制剂。
实施例12
杜仲叶400g、罗布麻叶600g、绿茶提取物60g
取所述重量份的杜仲叶、罗布麻叶,加水提取2次,每次1小时,第一次加14倍量水提取,第二次加12倍量水提取,过滤,合并滤液,减压浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物,混匀,制成散剂。
实施例13
杜仲叶400g、罗布麻叶600g、绿茶提取物60g
取所述重量份的杜仲叶、罗布麻叶,加70%乙醇提取2次,每次1小时,第一次加14倍量水提取,第二次加12倍量水提取,过滤,合并滤液,减压回收乙醇至无醇味,继续浓缩至60℃测相对密度1.10~1.15的浸膏,冷藏,离心,取上清液继续减压浓缩至60℃测相对密度1.30~1.35的稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量β-环糊精、一水柠檬酸、柠檬酸钾,混匀,制粒,干燥,整粒,即得。
实施例14
杜仲叶300g、罗布麻叶700g、绿茶提取物70g
取所述重量份的杜仲叶、罗布麻叶,加20倍量95%乙醇提取1次,提取3小时,过滤,滤液减压回收乙醇至无醇味,继续浓缩至60℃测相对密度1.10~1.15的浸膏,冷藏,离心,取上清液继续减压浓缩至60℃测相对密度1.30~1.35的稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量阿司帕坦、麦芽糊精、柠檬酸钾,混匀,制粒,干燥,整粒,即得。
实施例15
杜仲叶500g、罗布麻叶500g、绿茶提取物50g
取所述重量份的杜仲叶、罗布麻叶,加20倍量95%乙醇提取1次,提取3小时,过滤,滤液减压回收乙醇至无醇味,继续浓缩至60℃测相对密度1.10~1.15的浸膏,冷藏,离心,取上清液继续减压浓缩至60℃测相对密度1.30~1.35的稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量预胶化淀粉、糊精、甜菜碱,混匀,制粒,干燥,整粒,即得。
实施例16
杜仲叶400g、罗布麻叶600g、绿茶提取物60g
取所述重量份的杜仲叶、罗布麻叶,加水提取2次,每次1小时,第一次加14倍量水提取,第二次加12倍量水提取,过滤,合并滤液,减压浓缩至60℃测相对密度1.10~1.15的浸膏,冷藏,离心,取上清液继续减压浓缩至60℃测相对密度1.30~1.35的稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量柠檬酸钾,混匀,按常规方法制成袋装茶剂、袋泡茶剂。
实施例17
杜仲叶400g、罗布麻叶600g、绿茶提取物60g
取所述重量份的杜仲叶、罗布麻叶直接粉碎成粗粉,加入所述重量份的绿茶提取物,混匀,按常规方法制成袋装茶剂、袋泡茶剂。
以上实施例1-17中涉及的绿茶提取物是通过购买市售品或者通过以下任一方法得到:
(1)取绿茶加4-20倍量20-95%乙醇提取1-4次,每次1-3小时,提取液合并,过滤,滤液减压回收乙醇至无醇味,继续浓缩,干燥,粉碎成细粉,即为绿茶提取物;
(2)取绿茶加4-20倍量水回流提取1-4次,每次1-3小时,提取液合并,过滤,滤液浓缩,干燥,粉碎成细粉,即为绿茶提取物。
根据上述内容,在不脱离本发明基本技术思想前提下,按照本领域的普通技术知识和惯用手段,显然还可以作出其他多种形式的修改、替换和变更。
通过以下实验进一步阐述本发明所述组合物的有益效果:
一、试验方法
采用自身对照及组间对照法,选择符合试验条件的志愿受试者服用本发明受试物45天,观察期间原用药物种类和剂量不变。共观察100名受试者,随机分为试食组、对照组各50名。在试食结束时试食组1名和对照组2名没有参加检查。试食组男性28名,女性22名,平均年龄45.28±9.57岁,平均病程(年)5.36±2.48;对照组男性24名,女性26名,平均年龄46.06±8.81岁,平均病程(年)5.28±9.33,试食前两组患者年龄、病程、用药情况均无明显差异,具有可比性。试食前后,受试者精神状况、睡眠状况、饮食、大小便状况未见异常。
二、功效观察
1、症状观察
服用受试物45天,试食组临床症状有明显改善,与自身试验前及对照组比较,差异有显著性(P<0.05)。试食后试食组与对照组主要症状改善总有效率分别为31.25%、77.55%,二者有显著性差异(P<0.05)。见表1、2。
表1 临床症状积分统计(±s)
组别 | 试食前 | 试食后 |
对照组 | 10.58±3.22 | 10.45±2.96 |
试食组 | 10.60±3.08 | 9.01±2.57*# |
注:*与试食前比较P<0.05;#与对照组比较P<0.05
表
2
临床症状改善情况
注:#与对照组比较P<0.05
2、血压测定观察
试食组试食后收缩压、舒张压与试食前自身比较及与对照组试食后比较,差异有显著性(P<0.05);试食后试食组收缩压下降幅度为14.11,与对照组比较,差异有显著性(P<0.05);试食后试食组舒张压下降幅度为12.56,与对照组比较,差异有显著性(P<0.05)。见表3。
表
3
试食前后血压变化情况(
mmHg
,±
s
)
注:*与试食前比较P<0.05;#与对照组比较P<0.05
服用受试物45天,试食组降血压总有效率为61.22%,与对照组比较,差异有显著性(P<0.05)。见表4。
表4 降血压总有效率观察
组别 | 例数 | 有效 | 无效 | 总有效率 |
对照组 | 48 | 6 | 42 | 12.50 |
试食组 | 49 | 30 | 19 | 61.22# |
注:#与对照组比较P<0.05
3、心率测定观察
各组试食前后心率未见明显改变(P>0.05)。
三、安全性观察
1、尿常规、大便常规、血常规及生化指标检测
食用受试物45天后,试食组和对照组尿常规、大便常规、血常规及生化指标均在正常范围内,提示本发明受试物对机体健康无明显损害。
2、心电图、腹部B超、胸透检查,均在正常范围内。
3、试食期间未见明显不良反应。
四、结论
人体试食试验结果表明,试食组试食后主要临床症状有改善,总有效率为77.55%,试食组临床症状积分与自身比较及与对照组试食后比较,差异均有显著性(P<0.05);试食组试食后收缩压、舒张压与试食前自身比较及与对照组试食后比较,差异有显著性(P<0.05);试食后试食组收缩压下降幅度为14.11,与对照组比较,差异有显著性(P<0.05);试食后试食组舒张压下降幅度为12.56,与对照组比较,差异有显著性(P<0.05)。试食前后尿常规、大便常规、血常规、生化等检测指标均在正常范围内,试食期间未见明显不良反应。根据《保健食品检验与评价技术规范》(2003年版)评价标准,表明本发明组合物具有辅助降血压功能。
Claims (10)
1.一种具有辅助降血压功能的组合物,其特征在于,按重量份计,制成该组合物的原料药为:杜仲叶100-700份、罗布麻叶300-900份、绿茶提取物30-90份。
2.根据权利要求1所述的组合物,其特征在于,按重量份计,制成该组合物的原料药为:杜仲叶300-500份、罗布麻叶500-700份、绿茶提取物50-70份。
3.权利要求1或2所述组合物的制备方法,其特征在于,它是这样制备的:
取所述重量份的杜仲叶、罗布麻叶直接粉碎成粉末;加水或不同浓度的乙醇提取,提取液浓缩干燥得粗提物;或进一步采用水提醇沉法、有机溶剂萃取法、柱层析法、二氧化碳超临界萃取法、水蒸气蒸馏法的一种或几种联合使用进行适当精制后得精提物;上述药材粉末或粗提物或精提物与所述重量份的绿茶提取物混合,不加或者加入适量辅料,按常规工艺制成药剂学上可接受的制剂。
4.根据权利要求3所述的制备方法,其特征在于,所述的制剂是指片剂、颗粒剂、胶囊剂、丸剂、散剂、口服液体制剂、袋装茶剂、袋泡茶剂。
5.根据权利要求4所述的制备方法,其特征在于,所述的制剂是指颗粒剂。
6.根据权利要求5所述的制备方法,其特征在于,颗粒剂是这样制备的:
取所述重量份的杜仲叶、罗布麻叶,加5-20倍量水提取1-3次,每次1-3小时,过滤,合并滤液,减压浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量辅料,混匀,制粒,干燥,整粒,即得。
7.根据权利要求6所述的制备方法,其特征在于,颗粒剂是这样制备的:
取所述重量份的杜仲叶、罗布麻叶,加水提取2次,每次1小时,第一次加14倍量水提取,第二次加12倍量水提取,过滤,合并滤液,减压浓缩至浸膏,冷藏,离心,取上清液继续减压浓缩至稠膏,减压干燥,粉碎成细粉,加入所述重量份的绿茶提取物、适量辅料,混匀,制粒,干燥,整粒,即得。
8.根据权利要求6或7所述的制备方法,其特征在于,所述的辅料是指β-环糊精、一水柠檬酸、柠檬酸钾、糊精、麦芽糊精、淀粉、预胶化淀粉、甘露醇、微晶纤维素、乳糖、阿司帕坦、甜菜碱、蔗糖、枸橼酸、酒石酸中的一种或一种以上。
9.根据权利要求8所述的制备方法,其特征在于,所述的辅料是指β-环糊精、一水柠檬酸、柠檬酸钾。
10.权利要求1或2所述组合物用于制备具有辅助降血压功能的保健食品中的应用。
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