CN104306636B - 洋参苁蓉温肾养肾复方制剂 - Google Patents

洋参苁蓉温肾养肾复方制剂 Download PDF

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CN104306636B
CN104306636B CN201410568654.4A CN201410568654A CN104306636B CN 104306636 B CN104306636 B CN 104306636B CN 201410568654 A CN201410568654 A CN 201410568654A CN 104306636 B CN104306636 B CN 104306636B
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american ginseng
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刘郁
刘连新
刘春杰
董立珉
燕传勇
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Xinjiang life nuclear force high-tech limited company
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Abstract

本发明公开了一种洋参苁蓉温肾养肾复方制剂，属中成药的配方及制备方法。本处方由西洋参、肉苁蓉、熟地黄、枸杞、牛膝、淫羊藿、鹿茸、狗脊、山药、肉桂、附子、牡丹皮、泽泻组成。具有温肾、养肾的作用。西洋参、肉苁蓉具有补肾阳、益精血以及强筋骨的作用，以上二味为君。熟地黄、枸杞、牛膝滋补肾阴，及对腰膝酸痛具有缓解作用，助君补肾，以其为臣。淫羊藿、鹿茸、狗脊、山药、肉桂、附子补火助阳，引火归元，散寒止痛，温通经脉，以其为佐。牡丹皮、泽泻以上二味回阳救逆，补火助阳，散寒止痛，利水渗湿，以其为使。本发明对于肾阳不足，精血亏虚，阳痿不孕，腰膝酸软，筋骨无力，手足冰冷有明显的改善作用。

Description

洋参苁蓉温肾养肾复方制剂
技术领域
本发明涉及一种洋参苁蓉温肾养肾复方制剂，属于中成药的配方及制备方法。主要用于肾阳不足，精血亏虚，阳痿不孕，腰膝酸软，筋骨无力，手足冰冷体征的人，有明显的改善效果。
背景技术
中医理论中，肾是一个非常特殊的脏器。古代医家认为：父母两精交媾，先成胚芽，然后便发育为“肾”，禀受于父母的先天之精(可近似地理解为今人所说的“遗传基因”)即藏之于肾，故有“肾为行天之本”的说法。也许从五行学说中推导而出(肾属水、主冬、水下行而静；冬则蛰藏)，或受启于它因，古医家认为肾有司封藏的功能特点。这具体表现在将“精”(包括先在之精，也包括后天之精)密固于“肾”中而为“肾精”，使这类维系生命的重要物质不致于无谓的耗损或流失，能发挥其促进生长、发育与生殖的功能，故有“肾主藏精，所藏之精主生长、发育与生殖”之说。封藏也表现在肾能协助肺的呼吸，使之不过于浅有，吸入之气可纳入肾中，这称作“肾主纳气”。此外，与现代认识相一致，中医理论强调“肾主小便”，小便是由肾中阳气蒸腾体内津液，留下清的，滤出浊的，并将其暂贮于膀胱，阶段性地排出体外来完成的。再加上脾肺等脏也参与了体内津液的输布，但肺脾等脏的这一功能有赖于肾中阳气的推动，故中医理论中，肾调节并决定着体内津液代谢的平衡，而有“肾主水”之说。
除上述功能外，中医理论认为“腰为肾之府”，肾的位置在于腰部，腰部的慢性伤损、疼痛常与肾有关。肾位于五脏最低位置，生殖器和肛门的病变常也与肾有关，踝膝关节等的某些症状也反映了肾脏的状态。此外，全身的骨、髓、脊髓、头发、齿等都与肾所藏之精密切相关，因为是肾中所藏之精化生成髓，髓灌注在骨腔中以充养骨；充养和滋润脊髓；并上注于脑而为脑髓；充养头发；齿为骨之余；齿亦与肾精息息相关。再者，耳朵与肾有着众多特别紧密的联系，遂有“肾开窍于耳”之说。
中医认为肾阳虚：腰背酸痛，遗精阳痿，多尿或不禁，面色苍白，畏寒肢冷， 下利清谷或五更泄泻，舌质淡胖有齿痕，苔白，脉沉迟。
本发明对于肾阳不足，精血亏虚，阳痿不孕，腰膝酸软，筋骨无力，手足冰冷有明显的改善作用。
发明内容
本发明的目的是提供一种洋参苁蓉温肾养肾复方制剂，对于肾阳不足，精血亏虚，阳痿不孕，腰膝酸软，筋骨无力，手足冰冷有明显的改善作用。
本发明是以如下技术方案实现的：一种洋参苁蓉温肾养肾复方制剂，其特征是：由下述重量份的原料制成：
西洋参8-12份、肉苁蓉8-12份、熟地黄8-12份、枸杞8-12份、
牛膝8-12份、淫羊藿8-12份、鹿茸3-5份、狗脊3-5份、
山药8-12份、肉桂5-7份、附子3-5份、牡丹皮5-7份、
泽泻5-7份。
上述洋参苁蓉温肾养肾复方制剂的制备方法，
(a)按处方称取原料：肉苁蓉、熟地黄、牛膝、淫羊藿、狗脊、附子、牡丹皮和泽泻；
(b)将上述各味药材合并用体积浓度不低于75％的乙醇溶剂浸泡30分钟,然后进行煮沸回流提取2-3次；3次溶剂的用量即乙醇溶剂与药材体积之比分别为10，8，8；煮沸回流的时间从沸腾开始计时，每次回流1个小时；
(c)合并上述提取液，用真空旋转蒸发仪减压浓缩，回收溶剂乙醇，浓缩到密度为1.20-1.25g/ml,得膏状物；
(d)按照处方量，称取西洋参、枸杞、鹿茸、山药和肉桂，干燥，粉碎，过100目筛子，备用；
(e)将步骤(c)的膏状物与步骤(d)药材细粉，以及辅料包括蔗糖、糊精、微晶纤维素和80％的乙醇，16目筛造粒，在电热恒温干燥箱中进行烘干即可，最后整粒；备用；
(f)按照剂型的要求，加入硬脂酸镁制备成片剂、胶囊、颗粒剂。
本发明还可以采用中药制剂学常规工艺制成胶囊剂；采用中药制剂学常规工艺制成片剂、散剂或颗粒剂、口服液。
方解：
西洋参 归心、肺、肾经。补气养阴，清热生津。用于气虚阴亏，虚热烦倦，咳喘痰血，内热消渴，口燥咽干。肉苁蓉 归肾、大肠经。补肾阳，益精血，润肠通便。用于肾阳不足，精血亏虚，阳痿不孕，腰膝酸软，筋骨无力，肠燥便秘。肉苁蓉也叫沙漠人参，主治肾阳不足、温补精血、保肝润燥，有很重要的食疗功效和作用。熟地黄 归肝、肾经。补血滋阴，益精填髓。用于肝肾阴虚，腰膝酸软，骨蒸潮热，盗汗遗精，内热消渴，眩晕。枸杞 归肝、肾经。滋补肝肾，益精明目。用于虚劳精亏，腰膝酸痛，眩晕耳鸣，阳萎遗精，内热消渴，血虚萎黄，目昏不明。枸杞子味甘，性平，归肝肾经，能滋补肾阴，“枸杞味重而纯，擅长补阴，阴中有阳，故能补气，所以滋阴而不致阴衰，助阳能使阳旺。牛膝 苦、甘、酸，平。归肝、肾经。逐瘀通经，补肝肾，强筋骨，利尿通淋，引血下行。用于经闭，痛经，腰膝酸痛，筋骨无力，淋证，水肿，头痛，眩晕，牙痛，口疮，吐血，衄血。淫羊藿 其味辛甘，其气温，归肝、肾经。其性温而不燥，补而不峻，助阳而不伤阴，为平补肾阳之要药。鹿茸 归肾、肝经。壮肾阳，益精血，强筋骨。用于肾阳不足，精血亏虚，阳痿滑精。狗脊 苦、甘，温。归肝、肾经。祛风湿，补肝肾，强腰膝。用于风湿痹痛，腰膝酸软，下肢无力。山药 归脾、肺、肾经。补脾养胃，生津益肺，补肾涩精。肉桂 归肾、脾、心、肝经。补火助阳，引火归元，散寒止痛，温通经脉。用于阳痿宫冷，腰膝冷痛，肾虚作喘，虚阳上浮，眩晕目赤等症状。附子 归心、肾、脾经。回阳救逆，补火助阳，散寒止痛。用于亡阳虚脱，肾阳虚衰，阳痿宫冷，阴寒水肿，阳虚外感，寒湿痹痛。健脾益胃，培元滋肾，主治虚劳损伤，肌体消瘦，腰酸膝软，目暗耳鸣，饮食无味。牡丹皮 归心、肾、脾经。回阳救逆，补火助阳，散寒止痛。用于亡阳虚脱，肢冷脉微，心阳不足，胸痹心痛，虚寒吐泻，脘腹冷痛，肾阳虚衰，阳痿宫冷，阴寒水肿，阳虚外感，寒湿痹痛。清热凉血，活血化瘀。用于热入营血，温毒发斑等。泽泻 归肾、膀胱经。利水渗湿，泄热，化浊降脂。用于小便不利，水肿胀满，泄泻尿少，痰饮眩晕，热淋涩痛，高脂血症。
西洋参、肉苁蓉具有补肾阳、益精血以及强筋骨的作用，以上二味为君。熟地黄、枸杞、牛膝滋补肾阴，及对腰膝酸痛具有缓解作用，助君补肾，以其为臣。淫羊藿、鹿茸、狗脊、山药、肉桂、附子补火助阳，引火归元，散寒止痛，温通 经脉，以其为佐。牡丹皮、泽泻以上二味回阳救逆，补火助阳，散寒止痛，利水渗湿，以其为使。本处方对于肾阳不足，精血亏虚，阳痿不孕，腰膝酸软，筋骨无力，手足冰冷有明显的改善作用。
具体实施方式
下面结合实施例对本发明作进一步说明；
实施例1
组方：
西洋参200g，肉苁蓉200g、熟地黄200g、枸杞200g、牛膝200g、淫羊藿200g、鹿茸80g、狗脊80g、山药200g、肉桂120g、附子80g、牡丹皮120g、泽泻120g。
制备方法
按照处方量，将苁蓉、熟地黄、牛膝、淫羊藿、狗脊、附子、牡丹皮和泽泻各味药材用75％(V/V)的乙醇溶剂，浸泡30分钟,然后进行煮沸，从沸腾开始计时1个小时；如此共提取3次；3次的溶剂用量分别为药材体积的10，8，8倍；合并上述3次提取液；
按照处方量，将西洋参、枸杞、鹿茸、山药和肉桂，干燥，粉碎，过100目筛子得药材细粉，备用。
将合并后的提取液用真空旋转蒸发仪减压浓缩，回收溶剂乙醇，浓缩到密度为1.25g/ml，将浓缩得到的膏状物与上述药材细粉，以及辅料(蔗糖、糊精、微晶纤维素等)和(V/V)80％的乙醇，16目筛造粒，在电热恒温干燥箱中进行烘干即可，最后整粒，即为有效成分，备用。
按照剂型的要求，加入处方量的硬脂酸镁制备成片剂。
实施例2
组方：
西洋参200g，肉苁蓉200g、熟地黄200g、枸杞200g、牛膝200g、淫羊藿200g、鹿茸80g、狗脊80g、山药200g、肉桂120g、附子80g、牡丹皮120g、泽泻120g。
制备方法
按照处方量，将苁蓉、熟地黄、牛膝、淫羊藿、狗脊、附子、牡丹皮和泽泻各味药材用75％(V/V)的乙醇溶剂，浸泡30分钟,然后进行煮沸，从沸腾开始计时1个小时；如此共提取2次；2次的溶剂用量分别为药材体积的10，8倍；合并上述2次提取液；
按照处方量，将西洋参、枸杞、鹿茸、山药和肉桂，干燥，粉碎，过100目筛子得药材细粉，备用。
将合并后的提取液用真空旋转蒸发仪减压浓缩，回收溶剂乙醇，浓缩到密度为1.20g/ml，将浓缩得到的膏状物与上述药材细粉，以及辅料(蔗糖、糊精、微晶纤维素等)和(V/V)80％的乙醇，16目筛造粒，在电热恒温干燥箱中进行烘干即可，最后整粒，即为有效成分，备用。
按照剂型的要求，灌装制备成胶囊剂。
疗效分析
治疗效果
治疗组98例，显效78例(79.6％)，有效53例(54.1％)，无效7例(7.1％)。总有效率为133.7％。对照组85例，显效58例(68.2％)，有效32例(37.6％)，无效16例(18.8％)。总有效率为105.8％。两组总有效率比较，差异显著。
典型案例：
(1)某女：44岁，糖尿病患者，腰膝酸软、乏力倦怠、记忆减退、眩晕、畏寒肢冷、脸色苍白、潮热、多尿等。服每日5-8g，口服。服用6个月后，身体感觉比较轻松，腰膝酸软、乏力倦怠、眩晕、畏寒肢冷、脸色苍白、颧红、潮热、多尿等现象有所改善。现在一直在服用，效果较好。
(2)某男，43岁，工作压力大，经常伴有头痛，睡眠不好，血压偏高，腰膝酸软、乏力倦怠、记忆减退、眩晕、畏寒肢冷、多尿等服用了按照该方制备的胶囊剂，2个月以后，睡眠、腰膝酸软、乏力倦怠、眩晕、畏寒肢冷、多尿状况改善。现在一直在服用，效果明显。
(3)某女：68岁，经常感觉头晕、健忘、神疲乏力、精神不振、活力低下、易疲劳、畏寒怕冷、四肢发凉、身体发沉、腰膝酸痛、腰背冷痛、筋骨萎软等。服用了按照该方制备的胶囊剂，3个月后，精神饱满，睡眠质量，神疲乏力，腰膝酸痛，腰背冷痛，畏寒怕冷、四肢发凉缓解。现在一直在服用，效果很好。

Claims (5)

1.一种洋参苁蓉温肾养肾复方制剂，其特征是：由下述重量份的原料制成：
西洋参8-12份、肉苁蓉8-12份、熟地黄8-12份、枸杞8-12份、
牛膝8-12份、淫羊藿8-12份、鹿茸3-5份、狗脊3-5份、
山药8-12份、肉桂5-7份、附子3-5份、牡丹皮5-7份、
泽泻5-7份。
2.如权利要求1所述的洋参苁蓉温肾养肾复方制剂，其特征是：采用中药制剂学常规工艺制成胶囊剂。
3.如权利要求1所述的洋参苁蓉温肾养肾复方制剂，其特征在于采用中药制剂学常规工艺制成片剂。
4.如权利要求1所述的洋参苁蓉温肾养肾复方制剂，其特征在于采用中药制剂学常规工艺制成散剂或颗粒剂。
5.如权利要求1所述的洋参苁蓉温肾养肾复方制剂，其特征在于采用中药制剂学常规工艺制成口服液。
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