CN106420963A - 一种药食同源的活力升根制剂（片）及其制备方法 - Google Patents
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Abstract
活力升根制剂（片）是由本发明人用实验证明具有***样作用的药食同源中药火筒杆、葛根等复配而成。旨在为临床目前仅应用有危害性的化学***来治疗更年期综合征，提供一种新的安全有效的天然制剂。本品也有助于中老年回春抗老、“治未病”。还能增强30岁以上男女的青春活力和体能。本发明的技术核心是组方及其制备方法，用醇提法提取组方中各中药的有效成分，制成稠膏，机制成颗粒，干燥，整粒，压片，质量检验，合格品包装。
Description
技术领域
活力升根制剂(片)及其制备方法，为防治更年期综合征、增进中老年男性及女性的青春活力和体能，提供一种男女皆宜、安全可靠的药食同源的天然新制剂。属于医药生物学技术领域。
技术背景
随着人口老龄化和普遍长寿，人的一生约有1/3以上是在更年期渡过的。其中女性50%以上在绝经期及以后会因***水平的不断下降而出现症状，且在年龄上有提前进入更年期的趋势。我国更年期（45~65岁）女性人口已超过1.2亿，这是当前更年期保健的一个必须重视的领域。
女性的青春活力靠***维系。女性体内有400多个部位的组织和器官受***的作用而保持其功能。当更年期的到来，因卵巢功能的衰退、***的下降，这些组织和器官便发生一系列变化。若发生在神经***，便会出现情绪波动、易动、焦虑、消沉抑郁、失眠等；若发生在心血管***，会出现潮热、心悸、血压升高不稳等；若发生在泌尿生殖***，则出现***、***干涩、萎缩或发生***、***减退等；若发生在皮肤骨骼***，则皮肤松弛干瘪、头发稀细，骨质疏松等。男性中老年也会因为内分泌环境的改变而发生活力下降、力不从心、焦虑、注意力不集中、***减退、心脑血管疾病多发等等。
为了治疗更年期综合征，临床使用***替代疗法，有较好疗效，但是用此种类固醇***不仅有副作用和禁忌症，而且有诱发乳腺癌、子宫内膜癌的危险。因此，从天然的中药中寻找安全的也具有***作用的天然制剂替代化学合成品，具有广阔的应用前景和社会经济效益。
目前市场上缺乏一种中老年男女皆宜的既能预防又能治疗女性更年期综合征也可增进中老年男性青春活力的安全可靠的天然制剂（天然药品、天然保健品）。
发明内容
我们用实验筛选出了一组具有***样作用的中药，这就是活力升根制剂（片）中的火筒杆、葛根、茨三味组成的复配中药。实验采用刚断奶的幼鼠（NIH品系）。把这组复配中药的醇提液，给幼鼠涂肤给药，每次0.15ml，每日两次，连续6天后检查幼鼠***脱落细胞。结果显示：中药组9只幼鼠中有8只***出现大量均一的角化细胞，与***组4只幼鼠相同。表明中药组及***组的幼鼠均提前进入动情期。但给生理盐水的对照组7只幼鼠***均未见角化细胞。与此同时，幼鼠子宫的平均重量从生理盐水对照组的8.47±1.96ml，增加至中药组的19.66±2.28mg(p<0.05)，从而证明中药组具有明确的***样作用。另外，皮下注射中药醇提物的8只幼鼠与对照组的比较也得到了同样结果。
火筒杆、葛根、茨这些中药材中所含有的活性成分，如三萜甙类、大豆甙元、刺芒柄花素、金雀异黄酮等，这些成分虽不是***但是具有***样作用，还具有双向调节作用。Lisk E 研究用火筒杆醇提液制剂试制629例更年期综合征患者，连服四周后80%患者的症状明显改善，6~8周后大部分患者的症状完全消失。茨，是国外用于调整男女性功能失调的一种食用草药。Milanov等研究用茨制剂给8男8女服用（3次/日×5天），在8例男性中测得血清睾酮及***增高，而促卵泡激素（FSH）无变化；在8例女性中测得***及FSH升高，而睾酮无变化。并给212例男性不育及***发育不良、性功能障碍者服用30~60天后，发现对***减退、少精和***活动不良的患者有很好的治疗作用，且无不良反应。
活力升根制剂是由上述三味经试验证明具有***样作用的中药，再辅以雪蛤所组成。雪蛤，即中国林蛙、哈士蟆，为中国特有的名贵中药，素有养阴滋肾功用。雪蛤富含人体生命活动所必需的各种营养物质，有助于改善体质、增强体能。这些全营养物质包括必需脂肪酸（ω-3）、必需氨基酸、必需微量元素和维生素，以及核酸、磷脂等。据华特.皮尔鲍利博士研究发现,服用ω-3（DHA、EPA）的老龄鼠，其性行为再度活跃，其寿命也延长。现代医学研究证明ω-3有助于保护心脑血管、降脂、降压、改善神经免疫***的功能，亦能改善更年期各种不适。另外，雪蛤还富含精氨酸，它在体内一氧化氮(NO)合成酶作用下,可生成NO，此亦有助于扩张冠脉及海绵体血管。
保健者应“治未病”。火筒杆、葛根等还兼有改善心脑血管、降低心肌耗氧量、抑制血小板凝聚、降脂、降糖、降压、改善中老年骨质疏松、预防***疾病、抗炎、抗氧化、镇静等作用。这些均有助于“治未病”保护中老年的健康。
活力升根制剂（片）的配方组分及重量配比如下：
火筒杆8~60% 葛根10~70% 茨8~55% 雪蛤8~60%。
活力升根制剂（片）的制备方法如下：
制稠膏：
按配方重量配比称取上述经净化干燥的中药材粗粉碎之；加六倍量70%乙醇浸渍过夜后加热回流，滤取提取液。重复一次，合并两次滤液；回收乙醇，浓缩至稠膏状（四克药材/克稠膏）
制粒、整粒：
取稠膏，加适量赋形剂、湿润剂，混合之，制成软材；进制粒机挤压，使之成湿颗粒；减压干燥，过筛整粒，即得干燥颗粒
压片：
取干颗粒，加润滑剂和崩解剂，混匀；用压片机压片（0.5克/片），包糖衣，质量检查合格，分装。
实施例：
活力升根制剂（片）的制备，以10000片为例
取提取制成的活力升根制剂干颗粒5000克加润滑剂、崩解剂→混匀→压片→包衣，抛光→质量检查→分装。
活力升根制剂（片）主要用于因***水平下降而引起的多器官多组织***功能性失调的病症治疗，特别适用于中老年及更年期综合征的防治；鉴于活力升根片组方的一些中药兼具有保护心脑血管、增强骨骼、美容养颜等多种功效，且均为药食同源之中药，安全性好，因此可供30岁以上亚健康者“治未病”，以改善体质、增强体能、保持机体青春活力和回春抗老。升根片不是化学“伟哥”，但有否温良的女性伟哥样作用值得期待。
Claims (3)
1.一种活力升根制剂（片）及其制备方法，其技术特征之一在于科学的选用经实验证明具有***样作用的复配中药，其配方及重量配比如下所示：火筒杆8~60% 葛根10~70% 茨8~55% 雪蛤8~60%。
2.权利要求1所述活力升根制剂（片）及其制备方法，其技术特征之二在于用醇提法提取其有效成分，然后按现代中药制剂工艺制成片剂：制稠膏：按配方称取中药，经粗粉碎后，加70%乙醇，浸渍后加热回流；趁热滤取，合并两次滤液；浓缩至稠膏状（四克药材/克稠膏）；制粒、整粒：取稠膏与赋形剂、湿润剂混合后制成软材，机制成湿粒；减压干燥；过筛整粒，得干粒；压片：取干粒，加润滑剂、崩解剂混匀后压片（0.5克/片），包糖衣，经质量检验，合格后包装。
3.活力升根制剂（片）及其制备方法的技术特征之三为天然制品，复配的药材均为药食同源之食药材，即可当药品，也可当保健食品食用，安全性好，具有***样作用，适用于更年期综合征的精准防治；也有助于调整和增强30岁以上男女的青春活力和体能，男女皆宜；未成年者不宜。
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