CN107854610A - 一种肾阳虚人群用保健的植物组合物及其制备方法 - Google Patents
一种肾阳虚人群用保健的植物组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及中药保健领域，尤其是一种适用于肾阳虚人群保健的植物组合物及其制备方法组合物：原料组合物按重量计，包括人参1‑2份，巴戟天3‑6份；玛咖3‑6份；山药3‑6份；枸杞3‑6份；桑葚3‑6份，覆盆子2‑5份；黄精3‑6份，辣木叶4‑8份，肉桂1‑3份制成，本发明以人参，巴戟天为基础方，提取活性成分并精制的到具有温补肾阳抗衰老防治性功能更减退等功能，本组合物原料采用药食同源和新资源食品原料安全无毒副作用，使用方便，适合肾阳虚人群服用，具有很好的市场前景。
Description
技术领域
本发明涉及一种药物，具体涉及一种肾阳虚人群用保健的植物组合物及其制备方法。
背景技术
中医认为，肾阳虚多因先天不足，肾阳素虚，或年老体弱，命门火衰，或房劳过度，或久病不愈而伤及肾阳，以致元阳虚损，温煦无力，阴寒内生，或气化无权，寒湿内盛所致。中医认为：肾藏精，生髓、主骨，肝藏血而主筋，肾阳虚则真气衰弱，髓不能充，筋骨失养，血气不行，痹阻经络，渐至关节疼痛，僵硬、屈伸不利、肾阳不足、温煦失职、而置畏寒喜暖、手足不温，面色晄白。肾阳衰弱、下无虚惫、故腰膝酸冷无力。
中医认为，肾藏先后天之精，为脏腑阴阳之本，也是人体生长、发育、生殖之源，是生命活动之根本。肾阳能促进人体的新陈代谢，促进精血、津液的化生并使之转化为能量，使人体各种生理活动的进程加快，产热增加，精神振奋。肾阳虚不能简单通过药物治疗，需要通过中药调理来达到标本兼治的目的。
临床表现为腰膝酸痛，畏寒肢冷，尤以下肢为甚，手脚麻木，头目眩晕，精神萎靡，面色白；或黎黑，舌淡胖苔白，脉沉弱；或阳痿，早泄，现代科学证明，当人发生肾虚时，无论肾阴虚还是肾阳虚，都会导致人免疫能力的降低，有更多的证据表明，肾虚发生时，肾脏的免疫能力降低，而肾脏的微循环系统亦会发生阻塞，导致肾络不通。
目前市场上治疗肾阳虚的药物多种多样，但疗程长，疗效差，而且存在一定的副作用。
根据中医理论，针对肾阳虚的发病机理，采用补肾助阳、涩精固脱的治法，进行辩证配伍组方，以达到标本兼治的目的。
发明内容
针对现有技术存在的不足，及中医的基本治疗理论，本发明的目的是提供一种肾阳虚人群用保健的植物组合物；原料组合物按重量计，由人参1-2份，巴戟天3-6份；玛咖3-6份；山药3-6份；枸杞3-6份；桑葚3-6份，覆盆子2-5份；黄精3-6份，辣木叶4-8份，肉桂1-3份制成；
本发明药物的具体制备方法是：
将所述药物煎煮2小时后过滤得滤液，重复煎煮三次，合并滤液，浓缩成为50℃相对密度为1.4-1.55 的稠膏，烘干后加工成120 目的药粉，制备成药物活性组分。
上述药物的活性组分可以制作药剂学上的任何一种口服剂型如片剂、丸剂、颗粒剂，本发明优选片剂。
本发明中药组合物是在传统中医理论和临床经验指导下，精选药物组方。本发明中药组合物中：
人参补肺气，补脾益气，大补元气而益肾壮阳同时益气生津止渴。人参能大补元气，元气充沛，营血必盛，血养心神，则神安智聪，为君药；山药补肺气，益肺阴；入脾经，既补脾气，又益脾阴，且兼涩性；既能补肾，又能固涩为加强人参臣药；巴戟天具有补肾助阳、强筋壮骨、祛风除湿的功效与人参、山药等配伍。 “阳中求阴，阴中求阳”，“阴阳相济”，“阴阳平衡”。既要发挥玛卡补肾阳作用，又要不损伤身体，需要加入一定量的滋阴药，玛卡温肾壮阳，属补阳药；黄精滋阴补肾，柔肝补血，与玛卡配伍，玛卡壮阳，黄精滋阴，阴阳相济，补肾而不热，滋阴而不腻。玛卡配伍巴戟天：巴戟天辛甘而温，功能壮肾阳、祛风湿、提高性欲，有较强的促进性功能的作用。桑椹滋阴补血，枸杞子养肝；滋肾；润肺；补血安神，生津止渴，润肺止咳，覆盆子既能益肾养肝，又善固精缩尿，益肾助阳与枸杞子等同用。辣木叶有除湿、祛寒、壮阳、利尿、消肿之效，为佐药。
肉桂为辛热之品，能补命门之火，引火归元而益阳消阴，偏行血分，有温通经脉之效为使药。
本发明以人参，巴戟天为基础方，提取活性成分并精制得到具有温补肾阳抗衰老防治性功能减退等功能，组分均采用天然的中药原料，其配制简便、药源广、成本低。本发明遵循中医的处方用药原则，经临床应用验证，其疗效显著可靠，药性平和，未出现毒副作用。
本发明所用药物
人参
补气类中药
性味：甘、微苦，平；
归经：归脾、肺、心经；
功效：大补元气，复脉固脱，补脾益肺，生津，安神；
主治：用于体虚欲脱，肢冷脉微，脾虚食少便溏，气短乏力，肺虚喘咳，津伤口渴，内热消渴，久病虚羸，惊悸失眠，阳痿宫冷；心力衰竭，心原性休克。
巴戟天
性味：辛、甘，微温；
归经：归肾经；
功效：补肾助阳，祛风除湿；
主治：用于阳萎尿频，宫冷不孕，风湿痹痛。
玛卡
药性：辛、甘、温、无毒；
归经：归肾、肝、脾经；
功能与主治：温肾壮阳，强筋壮骨，散寒、止痛、调血脉。
玛卡辛甘而温，甘温能补命门火、壮肾阳。辛温可通血脉、祛风湿、疗痹痛。
山药
性味：甘，平；
归经：归脾、肺、肾经；
主治：用于脾虚食少、大便溏泄，肺虚咳喘，遗精尿频，阴虚消渴。
枸杞子
性味：味甘；性平；
归经：归肝经；肾经；肺经；
功能：养肝；滋肾；润肺；
主治：肝肾亏虚；头晕目眩；目视一清；腰膝酸软；阳痿贵精；虚劳咳嗽；消渴引饮，补血安神，生津止渴，润肺止咳。
桑椹
性味：甘，寒；
归经：归心、肝、肾经；
功效：滋阴补血，润肠，生津；
主治：用于阴亏血虚，阴虚消渴，津亏口渴，眩晕耳鸣，肠燥便秘。
覆盆子
性味；甘、酸，温；
归经：归肝、肾经；
功效：固精缩尿，益肾养肝；
主治：用于遗精，尿频，遗尿，阳痿。
黄精
性味：甘，平；
归经：归肺，脾，肾经；
功能主治：滋肾润肺，补脾益气。
辣木叶
性味：味辛，性微温，无毒；
归经：肺、心、胃经；
功能主治：有除湿、祛寒、壮阳、利尿、消肿之效。
肉桂
性味：辛、甘，热；
归经：归肾、脾、心、肝经；
功效：补火助阳，散寒止痛，温通经脉；
主治：用于肾阳不足，阳瘘宫冷，脘腹冷腹，寒痹腰痛，寒疝腹痛，寒凝血瘀，经闭痛经，胸痹心痛。
具体实施方式
实施例1
一种肾阳虚人群用保健的植物组合物：原料组合物按重量计，由人参1份，巴戟天3份，玛咖3份；山药3份；枸杞3份；桑葚3份，覆盆子2份；黄精3份，辣木叶4份，肉桂1份制成；
具体制备方法是：
将所述药物煎煮2小时后过滤得滤液，重复煎煮三次，合并滤液，浓缩成为50℃相对密度为1.4-1.55 的稠膏，烘干后加工成120 目的药粉，制备成药物活性组分。
实施例2
一种肾阳虚人群用保健的植物组合物：原料组合物按重量计，由人参2份，巴戟天6份，玛咖6份；山药6份；枸杞6份；桑葚6份，覆盆子5份；黄精6份，辣木叶8份，肉桂3份制成；
本发明药物的具体制备方法是：
将所述药物煎煮2小时后过滤得滤液，重复煎煮三次，合并滤液，浓缩成为50℃相对密度为1.4-1.55 的稠膏，烘干后加工成120 目的药粉，制备成药物活性组分。
实施例3
一种肾阳虚人群用保健的植物组合物：原料组合物按重量计，由人参1.5份，巴戟天4份，玛咖5份；山药4份；枸杞5份；桑葚5份，覆盆子4份；黄精5份，辣木叶6份，肉桂2份制成；
本发明药物的具体制备方法是：
将所述药物煎煮2小时后过滤得滤液，重复煎煮三次，合并滤液，浓缩成为50℃相对密度为1.4-1.55 的稠膏，烘干后加工成120 目的药粉，制备成药物活性组分。
实施例4
一种肾阳虚人群用保健的植物组合物：原料组合物按重量计，由人参2份，巴戟天3份；玛咖3份；山药6份；枸杞6份；桑葚6份，覆盆子5份；黄精3份，辣木叶4份，肉桂3份制成；
水蜜丸的制备方法是：
将所述药物煎煮2小时后过滤得滤液，重复煎煮三次，合并滤液，浓缩成为50℃相对密度为1.4-1.55 的稠膏，烘干后加工成120 目的药粉，制备成药物活性组分，在药物活性组分中加入适量辅料稀释剂，粘合剂，崩解剂，润滑剂混合均匀，制成片剂。
为了对本发明药物的疗效和安全性进行观察，进行了以下临床试验。
1．患者资料
治疗组150例，其中男75 例，女75例；对照组120例，其中男68 例，女52 例。
2．诊断标准
所观察患者参照卫生部颁布的《中药新药治疗肾阳虚的临床研究指导原则》为诊断标准：
主症：腰膝酸痛，畏寒肢冷，性欲减退，舌质胖大，苔白，脉沉；
次症：精神不振，夜尿频多，下肢浮肿，气短而喘，大便溏，脱发。
3．排除病例标准
（1）有明显兼夹证或合并证者；
（2）年龄在18 岁以下65 岁以上，妊娠或哺乳期妇女，过敏体质及对本药过敏者；
（3）合并有心血管、脑血管、肝、肾、造血系统等严重原发性疾病，精神病患者；
（4）不符合纳入标准，未按规定用药，无法判断疗效，或资料不全等影响疗效或安全性判断者。
4、治疗方法
治疗组口服本发明实施例4的片剂，一日两次，每次10片，空腹服用，对照组口服金贵肾气丸，一日两次，每次一丸，2周之后统计结果。
5、疗效判定标准
1、临床痊愈：肾阳虚的症状，体征消失；
2、显效：肾阳虚的症状、体征明显改善；
3、有效：肾阳虚的症状，体征均有好转；
４、无效：肾阳虚的症状，体征无改善。
6、治疗结果
治疗组150 例患者中临床痊愈73 例，痊愈率48.7% ；显效42 例，显效率28.0% ；有效25例，有效率16.7% ；总有效率达93.4% ；对照组120 例患者中临床痊愈45 例，痊愈率30.0% ；显效28 例，显效率23.3% ；有效26 例，有效率21.7% ；总有效率达82.5%。治疗期间未发生毒副作用。
六、典型病例：
病例1 ：
黄某，女，40 岁。患者自述：腰膝酸软，头晕无力，失眠多梦，夜尿频多。诊见：舌淡苔白，脉沉迟，尺无力。诊为：肾阳虚。服用本发明中药组合物制备的药剂1 个疗程7天，头晕、无力、失眠、夜尿症状得到缓解；继续服2 个疗程，症状及体征均消失，随访半年未复发。
病例2 ：
张某，男，45岁。患者腰膝酸软、畏寒肢冷、精神萎靡、性欲降低，阳痿不举，夜尿频多。服用本发明中药组合物制备的药剂2 个疗程14天，腰酸、肢冷症状减轻；继续服用2 个疗程，症状、体征完全消失，治愈。随访半年未复发。
Claims (5)
1.一种肾阳虚人群用保健的植物组合物；其特征在于：原料组合物按重量计，由人参1-2份，巴戟天3-6份、玛咖3-6份；山药3-6份；枸杞3-6份；桑葚3-6份，覆盆子2-5份；黄精3-6份，辣木叶4-8份，肉桂1-3份制成；
具体制备方法是：
将所述药物煎煮2小时后过滤得滤液，重复煎煮三次，合并滤液，浓缩成为50℃相对密度为1.4-1.55 的稠膏，烘干后加工成120 目的药粉，制备成药物活性组分。
2.根据权利要求1所述的一种肾阳虚人群用保健的植物组合物：其特征在于：原料组合物按重量计，由人参1份，巴戟天3份，玛咖3份；山药3份；枸杞3份；桑葚3份，覆盆子2份；黄精3份，辣木叶4份，肉桂1份制成。
3.根据权利要求1所述的一种肾阳虚人群用保健的植物组合物：其特征在于：由人参2份，巴戟天6份，玛咖6份；山药6份；枸杞6份；桑葚6份，覆盆子5份；黄精6份，辣木叶8份，肉桂3份制成。
4.根据权利要求1所述的一种肾阳虚人群用保健的植物组合物：其特征在于：由人参1.5份，巴戟天4份，玛咖5份；山药4份；枸杞5份；桑葚5份，覆盆子4份；黄精5份，辣木叶6份，肉桂2份制成。
5.根据权利要求1所述的一种肾阳虚人群用保健的植物组合物：其特征在于：由人参2份，巴戟天3份；玛咖3份；山药6份；枸杞6份；桑葚6份，覆盆子5份；黄精3份，辣木叶4份，肉桂3份制成。
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