CN109010577A - 一种抗凝血抗血小板聚集抗血栓的沙棘组合物及其制备方法 - Google Patents
一种抗凝血抗血小板聚集抗血栓的沙棘组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种抗凝血抗血小板聚集抗血栓的沙棘组合物及制备方法，属于食疗产品、保健品及准字药制备领域。该药食两用品种组合物重量份数组成为：沙棘籽原花青素提取物20‑45，薤白提取物20‑40，炒紫苏子提取物20‑45。上述组合物的制备方法是低温(50℃以下)提取、低温(50℃以下)浓缩、低温(50℃以下)干燥，最大限度保留生物活性成分。本发明组成物全为药食两用品种，安全、可以长期服用。本发明产品能有效抗凝血抗血小板聚集抗血栓，为血脂血粘异常人群，为高脂血症、高血粘症人群，为中老年人预防心脑血管病的发生与预防心脑血管病的加重提供了安全、有效产品。
Description
技术领域：
本发明涉及食疗产品、保健品及准字药领域，具体涉及一种抗凝血抗血小板聚集抗血栓的沙棘药食两用品种组合物及制备方法。
背景技术：
目前，我国心脑血管病人群突破3亿，而且发病人群仍呈上升趋势，年轻化趋势！冠心病的年发病人群突破64‰，最近五年来，脑中风人群正以每年近13％速度上升，有的地区有40％是中年人。大量实验和临床资料表明，冠心病、心肌梗塞、脑梗塞、深部静脉血栓等心脑血管病的发生、发展与血脂、血粘、凝血、血小板聚集及血栓密切相关，特别是凝血及血小板聚集起到关键作用。目前，尽管西医学在心脑血管病的临床治疗上达到了很高的水平，但也只能是治标，冠心病、脑中风都无法治愈。无疑对抗心脑血管病的医学模式必须前移，预防心脑血管病的发生才是明智之举！人每日口服小剂量(50-100mg)阿司匹林是目前公认的有效预防药物，但存在诸多缺点。阿司匹林易造成胃溃疡，损伤消化系统；当机体存在出血或将手术时，必须暂停服用阿司匹林；对该药过敏者及患者有过敏性疾病者，该药受到限制；该药抗栓塞的作用强度也有限。因此，创新研制开发安全、有效抗凝血抗血小板聚集抗血栓的防治血管栓塞的食疗产品、保健品和准字药品是迫切需要的。
目前，采用沙棘籽原花青素提取物、薤白提取物、炒紫苏子提取物药食两用品种组合物抗凝血抗血小板聚集抗血栓的食疗品、保健品及准字药品尚属空白。
发明内容：
本发明的目的在于提供一种抗凝血抗血小板聚集抗血栓的沙棘药食两用品种组合物。
本发明的另一目的是提供上述抗凝血抗血小板聚集抗血栓的沙棘药食两用品种组合制备方法。
本发明通过以下技术方案实现上述目的；
本发明沙棘药食两用品种组合物是由：沙棘籽、薤白、紫苏子组成，其提取物重量份数组成为：沙棘籽提取物20-45，薤白提取物20-40，紫苏子提取物20-45。
最新研究发现，葡萄籽原花青素提取物能明显减少血小板过氧化物的生成，增强NO的释放，抑制血小板的聚集，起到抗血栓形成的作用。目前多项研究显示，原花青素主要是通过过氧化作用，在心脑血管病的防治中具有很好的疗效。而沙棘籽原花青素提取物中的单体不仅含有葡萄籽原花青素一样的儿茶素和表儿茶素，还含有倍儿茶素和表倍儿茶素。而且沙棘籽提取物中含有更多的二聚体、三聚体，沙棘籽原花青素提取物抗氧化效果优于葡萄籽原花青素提取物。为此，沙棘籽原花青素提取物具有比葡萄籽原花青素提取物更强的抗血小板聚集作用。薤白具有理气宽胸、通阳散结之功效，中医临床广泛用于治疗胸痹、心痛等症。现代研究薤白中含有大量的挥发油、腺苷、色氨酸及其衍生物和甾体皂甙等成分。实验研究证实，薤白乙醇提取物及水提取物具有体外抑制血小板聚集和体内抗血栓形成的作用。实验研究表明，酚酸类成分具有抗血小板聚集作用，炒紫苏子中含有较多的多元酚类成分。
本发明沙棘籽提取物三味复合，形成活性成分群，其共同叠加效应起到更有效的抗凝、抗血小板聚集、抗血栓作用，从而有效预防冠心病、脑中风的发生与预防冠心病、脑中风的加重。
本发明所述抗凝血抗血小板聚集抗血栓的沙棘药食两用品种组合物粉剂的制备方法、步骤如下：
1、按比例称取各品种；
2、制备沙棘籽提取物：超临界CO2萃取出沙棘籽油的沙棘籽粕用6-10倍50-70％乙醇浸泡1小时以上；40℃以上超声提取20分钟至1小时，提取2次，300目过滤得提取液；低温(50℃以下)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物30％以上的浓缩液；低温(50℃以下)负压(-0.098MPa)带式干燥机组干燥制得沙棘籽原花青素提取物粉剂；
3、制备薤白提取物：薤白破碎大于20目的颗粒；用6-10倍60-80％乙醇浸泡1小时以上；40℃以上超声提取20分钟至1小时，提取1次，300目过滤得提取液；低温(50℃以下)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物30％以上的浓缩液；以上乙醇提取后的薤白滤渣加8-15倍纯水；40℃以上超声提取20分钟至1小时，提取1次，300目过滤得提取液；低温(50℃以下)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物30％以上的浓缩液；合并两次浓缩液，搅拌均匀，低温(50℃以下)负压(-0.098MPa)带式干燥机组干燥制得薤白提取物粉剂；
4、制备炒紫苏子提取物：冷榨紫苏子油后的紫苏籽粕文火(120℃-150℃)炒制20-30分钟；粉碎至大于20目的颗粒；炒制的紫苏子用6-10倍60-70％乙醇浸泡1小时以上；40℃以上超声提取20分钟至1小时，提取2次，300目过滤得提取液；低温(50℃以下)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物30％以上的浓缩液；低温(50℃以下)负压(-0.098MPa)带式干燥机组干燥制得紫苏子提取物粉剂；
5、组合物粉剂硬胶囊产品制备：将沙棘籽提取物粉剂，薤白提取物粉剂，炒紫苏子提取物粉剂混合均匀，制成0.3-0.4g/粒的硬胶囊产品；
本发明的有效结果：
1、本发明配方全为药食两用品种，无毒副作用，确保了产品的安全性，可以长期服用，为不能服用，不愿意服用阿司匹林的人群提供了抗凝血抗血小板聚集的安全、有效产品。
2、本发明沙棘三味药食两用品种活性成分群的共同叠加作用，起到更有效的抗凝血抗血小板聚集抗血栓的功能作用，为中老年人提供了比阿司匹林安全的预防冠心病、脑中风的发生与预防冠心病、脑中风的加重的有效产品。
3、本发明制备方法中，沙棘籽提取物、薤白提取物的提取、回收乙醇并浓缩及浓缩液干燥，全为低于50℃的低温生产工艺过程，最大限度保留了生物活性成分，大大提高了产品的生物活性作用。
4、本发明采用超声提取，不仅降低了提取温度，而且大大缩短了提取时间，降低了生产成本。
5、本发明中的闭环式热泵蒸发机组的能耗仅为常规的单效蒸发器1/4，节能效果显著，降低生产成本。
具体实施方式：
实施例1：
(1)按比例称取各物料：沙棘籽粕420公斤、薤白500公斤、紫苏子480公斤。
(2)制备沙棘籽提取物：将420公斤沙棘籽粕用8倍65％乙醇浸泡1小时以上；40℃以上第一次超声提取30分钟，第二次超声提起20分钟，300目过滤，合并两次提取液；低温(50℃)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物40％以上的浓缩液；低温(50℃)负压(-0.098MPa)带式干燥机组干燥制得沙棘籽提取物粉剂42公斤备用；
(3)制备薤白提取物：将500公斤薤白破碎大于20目的颗粒；用10倍80％乙醇浸泡1小时以上；45℃超声提取30分钟，300目过滤得提取液；低温(50℃)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物45％的浓缩液；将薤白渣加10倍纯水；45℃超声提取20分钟，300目过滤得提取液；低温(50℃)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物45％的浓缩液；合并两次浓缩液，低温(50℃)负压(-0.098MPa)带式干燥机组干燥制得薤白提取物粉剂30公斤备用；
(4)制备炒紫苏子提取物：将冷榨除由后的480公斤紫苏子粕文火(135℃)炒制25分钟；粉碎至大于20目的颗粒；用10倍65％乙醇浸泡1小时以上；45℃超声提取第一次30分钟，第二次20分钟，300目过滤，合并两次滤液；低温(50℃)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物45％的浓缩液；低温(50℃)负压(-0.098MPa)带式干燥机组干燥制得紫苏子提取物粉剂43.2公斤备用；
(5)组合物粉剂硬胶囊产品制备：将42公斤沙棘籽提取物粉剂，30公斤薤白提取物粉剂，43.2公斤紫苏子提取物粉剂混合均匀，制成0.32g/粒的硬胶囊，理论产量为36万粒。检验、成品。待用。
(6)服用剂量及方法：
每次3粒，每日2次，早晚各一次。
实施例2：
(1)按比例称取各物料：沙棘籽粕840公斤、薤白1000公斤、紫苏子960公斤。
(2)制备沙棘籽提取物：将840公斤沙棘籽粕用8倍65％乙醇浸泡1小时以上；40℃以上第一次超声提取30分钟，第二次超声提起20分钟，300目过滤，合并两次提取液；低温(50℃)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物40％以上的浓缩液；低温(50℃)负压(-0.098MPa)带式干燥机组干燥制得沙棘籽提取物粉剂84公斤备用；
(3)制备薤白提取物：将1000公斤薤白破碎大于20目的颗粒；用10倍80％乙醇浸泡1小时以上；45℃超声提取30分钟，300目过滤得提取液；低温(50℃)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物45％的浓缩液；将薤白渣加10倍纯水；45℃超声提取20分钟，300目过滤得提取液；低温(50℃)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物45％的浓缩液；合并两次浓缩液，低温(50℃)负压(-0.098MPa)带式干燥机组干燥制得薤白提取物粉剂60公斤备用；
(4)制备炒紫苏子提取物：将冷榨除由后的960公斤紫苏子粕文火(135℃)炒制25分钟；粉碎至大于20目的颗粒；用10倍65％乙醇浸泡1小时以上；45℃超声提取第一次30分钟，第二次20分钟，300目过滤，合并两次滤液；低温(50℃)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物45％的浓缩液；低温(50℃)负压(-0.098MPa)带式干燥机组干燥制得紫苏子提取物粉剂86.4公斤备用；
(5)组合物粉剂硬胶囊产品制备：将84公斤沙棘籽提取物粉剂，60公斤薤白提取物粉剂，86.4公斤紫苏子提取物粉剂混合均匀，制成0.32g/粒的硬胶囊，理论产量为72万粒。检验、成品。待用。
(6)服用剂量及方法：
每次3粒，每日2次，早晚各一次。
Claims (4)
1.一种抗凝血抗血小板聚集抗血栓的沙棘组合物，其特征在于由以下品种组成：沙棘籽、薤白、紫苏子，其提取物重量份数组成为：沙棘籽提取物20-45，薤白提取物20-40，炒紫苏子提取物20-45；
(1)、制备沙棘籽提取物：超临界CO2萃取出沙棘籽油的沙棘籽粕用6-10倍50-70％乙醇浸泡1小时以上；40℃以上超声提取20分钟至1小时，提取2次，300目过滤得提取液；低温(50℃以下)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物30％以上的浓缩液；低温(50℃以下)负压(-0.098MPa)带式干燥机组干燥制得沙棘籽原花青素提取物粉剂；
(2)、制备薤白提取物：薤白破碎大于20目的颗粒；用6-10倍60-80％乙醇浸泡1小时以上；40℃以上超声提取20分钟至1小时，提取1次，300目过滤得提取液；低温(50℃以下)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物30％以上的浓缩液；以上乙醇提取后的薤白滤渣加8-15倍纯水；40℃以上超声提取20分钟至1小时，提取1次，300目过滤得提取液；低温(50℃以下)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物30％以上的浓缩液；合并两次浓缩液，搅拌均匀，低温(50℃以下)负压(-0.098MPa)带式干燥机组干燥制得薤白提取物粉剂；
(3)、制备炒紫苏子提取物：冷榨紫苏子油后的紫苏籽粕文火(120℃-150℃)炒制20-30分钟；粉碎至大于20目的颗粒；炒制的紫苏子用6-10倍60-70％乙醇浸泡1小时以上；40℃以上超声提取20分钟至1小时，提取2次，300目过滤得提取液；低温(50℃以下)负压(-0.098MPa)闭环式热泵蒸发机组回收乙醇并浓缩提取液至固形物30％以上的浓缩液；低温(50℃以下)负压(-0.098MPa)带式干燥机组干燥制得紫苏子提取物粉剂；
(4)、组合物粉剂硬胶囊产品制备：将沙棘籽提取物粉剂，薤白提取物粉剂，炒紫苏子提取物粉剂混合均匀，制成0.3-0.4g/粒的硬胶囊产品。
2.根据权利要求1所述抗凝血抗血小板聚集抗血栓的沙棘组合物产品，其特征在于：生产工艺采用低温(50℃以下)超声提取技术；闭环式热泵蒸发机组低温(50℃以下)负压(-0.098MPa)状态下回收乙醇并浓缩提取液；低温(50℃以下)负压(-0.098MPa)带式干燥机组干燥。
3.根据权利要求1所述抗凝血抗血小板聚集抗血栓的沙棘组合物产品可制成各种剂型，包括硬胶囊、软胶囊、丸剂、颗粒剂、粉剂、口服液。
4.根据权利要求1所述抗凝血抗血小板聚集抗血栓的沙棘组合物产品，其特征在于：每100克内包物中，主要功效成分沙棘原花青素≥5g。
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Effective date of registration: 20190926 Address after: 101117 Beijing City Lucheng town Tongzhou District City Industrial Zone No. 15 Applicant after: BEIJING POWDERY HEALTH INDUSTRY CO., LTD. Applicant after: Zou Wei Address before: Room 202, Unit 1, Building 4, Shenxing Binhe District, Xinshibei Road, Qiaoxi District, Shijiazhuang City, Hebei Province Applicant before: Zou Wei |
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Application publication date: 20181218 |