CN105664143A - 一种强身壮阳的药物组合物及其制备方法 - Google Patents
一种强身壮阳的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种强身壮阳的药物组合物,它由以下组分按重量份配比制成:水蛭5~20份、淫羊霍80~110、肉丛蓉15~28份、鹿鞭20~30份、鹿茸8~12份、蛤蚧18~28份、蛤蚧雄睾1~3份、人参15~30份、海马15~28份、锁阳12~25份、东革阿里15~28份、牡蛎15~30份、党参20~26份、分心木2~4份、茯苓15~26份、桂圆10~16份、甘草22~36份、蚓激酶12~18份。其制备方法是加入辅料制成胶囊剂。本发明通过药物的合理配伍,达到强身健体、补肾壮阳、提高人体免疫力的目的。
Description
技术领域
本发明涉及制药技术领域,特别是一种强身壮阳的药物组合物及其制备方法。
背景技术
随着现代生活节奏的加快,长期无规律、疲劳过度、压力过大的生活,容易导致人的肌体功能失调,表现为肾阳不足、精血亏虚、腰膝酸痛、四肢寒冷、体倦乏力、阳痿早泄、须发早白等症状。人们为了强身健体、补肾壮阳,会选择一些补肾壮阳的药品或保健品来服用,但是,现今中医或西医研制而成的壮阳药品种繁多,但由于壮阳药市场鱼龙混杂,壮阳药的成分不明确,使得很多的使用者对于壮阳药和补肾药都存有疑虑。
发明内容
本发明提供了一种强身壮阳的药物组合物及其制备方法,制得的中药制剂可以强身健体、补肾壮阳、提高人体免疫力。
为实现上述目的,本发明的技术方案为:
一种强身壮阳的药物组合物,它主要由以下组分按重量份配比制成:
水蛭5~20份、淫羊霍80~110、肉丛蓉15~28份、鹿鞭20~30份、鹿茸8~12份、蛤蚧18~28份、蛤蚧雄睾1~3份、人参15~30份、海马15~28份、锁阳12~25份、东革阿里15~28份、牡蛎15~30份、党参20~26份、分心木2~4份、茯苓15~26份、桂圆10~16份、甘草22~36份、蚓激酶12~18份。
以上所述的强身壮阳的药物组合物,优选主要由以下组分按重量份配比制成:
水蛭12份、淫羊霍105、肉丛蓉22份、鹿鞭25份、鹿茸10份、蛤蚧23份、蛤蚧雄睾2份、人参23份、海马23份、锁阳19份、东革阿里23份、牡蛎24份、党参23份、分心木3份、茯苓22份、桂圆13份、甘草31份、蚓激酶15份。
以上所述药物组合物可以按药剂学方法加入常规辅料制成临床接受的任意剂型;作为优选所述剂型为胶囊剂。
以上所述的强身壮阳的药物组合物的制备方法,包括以下步骤:
(1)按重量份称取下列组分:水蛭5~20份、淫羊霍80~110、肉丛蓉15~28份、鹿鞭20~30份、鹿茸8~12份、蛤蚧18~28份、蛤蚧雄睾1~3份、人参15~30份、海马15~28份、锁阳12~25份、东革阿里15~28份、牡蛎15~30份、党参20~26份、分心木2~4份、茯苓15~26份、桂圆10~16份、甘草22~36份、蚓激酶12~18份;
(2)鹿茸和人参分别研磨成粉末;
(3)水蛭、鹿鞭、蛤蚧、蛤蚧雄睾、海马,加入上述各组分总重量4~6倍重量浓度为70~80%的乙醇,加热回流提取2~3次,每次2~5小时,分次滤过,合并滤液,浓缩,回收乙醇,得浓缩液A;备用;
(4)淫羊霍、肉丛蓉、锁阳、东革阿里、牡蛎、党参、分心木、茯苓、桂圆和甘草,加入上述各组分总重量6~10倍重量的水,加热提取2~3次,每次1~2小时,分次滤过,合并滤液,加入浓缩液A,浓缩成稠膏,加入鹿茸粉末、人参粉末、蚓激酶及适量淀粉,干燥、粉碎,得干膏粉;
(5)取干膏粉加入淀粉浆、硬脂酸镁和微晶纤维素,混匀,制成颗粒,装入胶囊,即得胶囊剂。
本发明的药物组合物主要由水蛭、淫羊霍、肉丛蓉、鹿鞭、鹿茸、蛤蚧、蛤蚧雄睾、人参、海马、锁阳、东革阿里、牡蛎、党参、分心木、茯苓、桂圆和甘草组成,方中各药的功效为:
水蛭:性味咸苦,平;具有活血、散瘀、清瘀之功效,可用于治疗闭经、跌打损伤等;
淫羊霍:性味辛,甘,温,具有补肾壮阳、强筋壮骨、益气强心、祛风除湿的功效,适用于治疗阳痿、遗精、早泄、性机能衰退、月经不调、更年期综合征、高血压、风湿痛、半身不遂、四肢麻木、膝软无力等症;
肉丛蓉:性味归经甘、咸,温;功能主治补肾阳,益精血,润肠通便;用于阳痿,不孕,腰膝酸软,筋骨无力,肠燥便秘;
鹿鞭:性温,味咸辛,无毒;补肾精,壮肾阳,益精,强腰膝;主治肾虚劳损,腰膝酸痛,耳聋耳鸣,阳痿,遗精,早泄,宫冷不孕,带下清稀;
鹿茸:性温而不燥,具有振奋和提高机体功能,对全身虚弱、久病之后患者,有较好的强身作用;李时珍在《本草纲目》上称鹿茸“善于补肾壮阳、生精益血、补髓健骨”;
蛤蚧:《纲目》记载,补肺气,益精血,定喘止嗽,疗肺痈消渴,助阳道;《本草再新》记载,温中益肾,固精助阳,通淋,行血;
蛤蚧雄睾:即蛤蚧睾丸,具有补肾壮阳,补肺定喘,补血强身,抗老延年之功效;
人参:人参自古誉为“百草之王”,是“滋阴补生,扶正固本”之极品,含多种皂甙和多糖类成分,浸出液可被皮肤缓慢吸收且无不良刺激,能扩张皮肤毛细血管,促进皮肤血液循环,增加皮肤营养;人参的肉质根为著名强壮滋补药,适用于调整血压、恢复心脏功能、神经衰弱及身体虚弱等症,也有祛痰、健胃、利尿、兴奋等功效;
海马:具有强身健体、补肾壮阳、舒筋活络、消炎止痛、镇静安神、止咳平喘等药用功效;
锁阳:能补肾、益精、润燥,主治阳痿遗精、腰膝酸软、肠燥便秘,对瘫痪和改善性机能衰弱有一定的作用;
东革阿里:味苦,性凉,被称为“天然的催情药”,具有清热、截疟、利湿退黄、壮阳之功效;
牡蛎:性味咸,微寒;有收敛、镇静、解毒、镇痛的作用;富含新元素,可提高男性精子的活力;
党参:味甘,具有补中益气、健脾益肺、抗癌、降压、抗缺氧、抗衰老之功效,还可以增强人体免疫力,提高超氧化物歧化酶的活性,增强消除自由基的能力;与人参配伍可以补脾益肺,生津养血;
分心木:固肾涩精;治遗精滑泄,淋病,尿血,遗溺,崩中,带下,泻痢;
茯苓:利水渗湿,健脾,宁心;用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠;
桂圆:补心脾,益气血,健脾胃,养肌肉;思虑伤脾,头昏,失眠,心悸怔忡,虚赢,病后或产后体虚,及由于脾虚所致之下血失血症;
甘草:具有补脾益气、润肺止咳、泻火解毒、缓急止痛、调和诸药等多方面的功效;
蚓激酶:具有溶栓,抗凝及去纤作用;蚓激酶是活性最高的蛋白水解酶,能激活人体各种细胞。
本发明以淫羊霍、肉丛蓉、鹿鞭、鹿茸、蛤蚧、蛤蚧雄睾、海马、锁阳、东革阿里和分心木为补肾气、养精血、壮阳的主药,佐以水蛭活血清瘀,佐以牡蛎提高精子活力,佐以人参、党参、茯苓、桂圆和甘草补脾益气、宁心安神、扶本固正,另还有配以蚓激酶激活细胞活性,本发明通过上述药物的合理配伍,达到强身健体、补肾壮阳、提高人体免疫力的目的。
具体实施方式
以下结合具体实施例对本发明作进一步说明,但本发明的保护范围不限于以下实施例:
一、强身壮阳的药物组合物的制备
实施例1
强身壮阳的药物组合物,主要由以下组分按重量份配比制成:水蛭12份、淫羊霍105、肉丛蓉22份、鹿鞭25份、鹿茸10份、蛤蚧23份、蛤蚧雄睾2份、人参23份、海马23份、锁阳19份、东革阿里23份、牡蛎24份、党参23份、分心木3份、茯苓22份、桂圆13份、甘草31份、蚓激酶15份。
上述药物组合物的制备方法为:
(1)按重量份称取上述组分;
(2)鹿茸和人参分别研磨成粉末;
(3)水蛭、鹿鞭、蛤蚧、蛤蚧雄睾、海马,加入上述各组分总重量4~6倍重量浓度为70~80%的乙醇,加热回流提取2~3次,每次2~5小时,分次滤过,合并滤液,浓缩,回收乙醇,得浓缩液A;备用;
(4)淫羊霍、肉丛蓉、锁阳、东革阿里、牡蛎、党参、分心木、茯苓、桂圆和甘草,加入上述各组分总重量6~10倍重量的水,加热提取2~3次,每次1~2小时,分次滤过,合并滤液,加入浓缩液A,浓缩成稠膏,加入鹿茸粉末、人参粉末、蚓激酶及适量淀粉,干燥、粉碎,得干膏粉;
(5)取干膏粉加入淀粉浆、硬脂酸镁和微晶纤维素,混匀,制成颗粒,装入胶囊,即得胶囊剂。
实施例2
强身壮阳的药物组合物,主要由以下组分按重量份配比制成:水蛭5份、淫羊霍80、肉丛蓉15份、鹿鞭20份、鹿茸8份、蛤蚧18份、蛤蚧雄睾1份、人参15份、海马15份、锁阳12份、东革阿里15份、牡蛎15份、党参20份、分心木2份、茯苓15份、桂圆10份、甘草22份、蚓激酶12份。
上述药物组合物的制备方法为:
(1)按重量份称取上述组分;
(2)鹿茸和人参分别研磨成粉末;
(3)水蛭、鹿鞭、蛤蚧、蛤蚧雄睾、海马,加入上述各组分总重量4~6倍重量浓度为70~80%的乙醇,加热回流提取2~3次,每次2~5小时,分次滤过,合并滤液,浓缩,回收乙醇,得浓缩液A;备用;
(4)淫羊霍、肉丛蓉、锁阳、东革阿里、牡蛎、党参、分心木、茯苓、桂圆和甘草,加入上述各组分总重量6~10倍重量的水,加热提取2~3次,每次1~2小时,分次滤过,合并滤液,加入浓缩液A,浓缩成稠膏,加入鹿茸粉末、人参粉末、蚓激酶及适量淀粉,干燥、粉碎,得干膏粉;
(5)取干膏粉加入淀粉浆、硬脂酸镁和微晶纤维素,混匀,制成颗粒,装入胶囊,即得胶囊剂。
实施例3
强身壮阳的药物组合物,主要由以下组分按重量份配比制成:水蛭20份、淫羊霍110、肉丛蓉28份、鹿鞭30份、鹿茸12份、蛤蚧28份、蛤蚧雄睾3份、人参30份、海马28份、锁阳25份、东革阿里28份、牡蛎30份、党参26份、分心木4份、茯苓26份、桂圆16份、甘草36份、蚓激酶18份。
上述药物组合物的制备方法为:
(1)按重量份称取上述组分;
(2)鹿茸和人参分别研磨成粉末;
(3)水蛭、鹿鞭、蛤蚧、蛤蚧雄睾、海马,加入上述各组分总重量4~6倍重量浓度为70~80%的乙醇,加热回流提取2~3次,每次2~5小时,分次滤过,合并滤液,浓缩,回收乙醇,得浓缩液A;备用;
(4)淫羊霍、肉丛蓉、锁阳、东革阿里、牡蛎、党参、分心木、茯苓、桂圆和甘草,加入上述各组分总重量6~10倍重量的水,加热提取2~3次,每次1~2小时,分次滤过,合并滤液,加入浓缩液A,浓缩成稠膏,加入鹿茸粉末、人参粉末、蚓激酶及适量淀粉,干燥、粉碎,得干膏粉;
(5)取干膏粉加入淀粉浆、硬脂酸镁和微晶纤维素,混匀,制成颗粒,装入胶囊,即得胶囊剂。
二、临床应用
1、病例的选择:
选择阳痿患者,经120例临床观察。
(1)纳入标准:
a.年龄在30-60岁之间的有配偶男性,平均年龄48岁。
b.中医诊断阳痿患者为标准:青壮年男子性交时,由于阴茎不能有效地勃起,而致性交计划的75%以上不能进行,即可诊断为阳痿。
c.无器质性疾病。
c.能配合治疗,按时复诊的患者。
(2)排除标准
a.年龄在30岁以下或60岁以上者。
b.确诊的器质性阳痿患者。
c.合并有心血管、肝、肾和造血系统等严重原发性疾病和精神、精神病患者。
d.过敏体质或对多种药物过敏者。
e.未按规定用药或中断治疗,无法判定疗效或资料不全等影响疗效或安全性判断者。
2、临床试验:
(1)治疗方案:
a.治疗组:将上述制备好的实施例1和实施例4样品,用于临床试验。口服,一次2粒,一日3次。疗程:用药45天。
b.对照组:男宝胶囊(市售)。口服,一次3粒,一日2次。疗程:用药45天。
(2)疗效判定:
a.显效:治疗后阴茎勃起>90,性交机会的50%以上能成功。
b.有效:治疗后阴茎勃起有所改善,性交机会的25%以上能成功。
c.无效:用药前后各项指标均无改善。
(3)试验结果:
用于治疗120例门诊病人。将上述制备好的实施例1、实施例4和男宝胶囊,分别用于病人:治疗组:90例(服用实施例1~3,各30例),对照组:30例。临床试验时,停服其它药物和保健营养品。结果详见下表:
组别 | 显效 | 有效 | 无效 | 有效率 |
实施例1 | 13 | 13 | 4 | 86.7% |
实施例2 | 12 | 13 | 5 | 83.3% |
实施例3 | 12 | 13 | 5 | 83.3% |
对照组 | 12 | 11 | 7 | 76.6% |
结果表明:实施例1效果最优,有效率达86.7%,优于对照组;实施例2和3的有效率达83.3%,也优于对照组。患者经治疗后,普遍反应可改善四肢无力、阳痿早泄的症状。
Claims (5)
1.一种强身壮阳的药物组合物,其特征在于,它主要由以下组分按重量份配比制成:
水蛭5~20份、淫羊霍80~110、肉丛蓉15~28份、鹿鞭20~30份、鹿茸8~12份、蛤蚧18~28份、蛤蚧雄睾1~3份、人参15~30份、海马15~28份、锁阳12~25份、东革阿里15~28份、牡蛎15~30份、党参20~26份、分心木2~4份、茯苓15~26份、桂圆10~16份、甘草22~36份、蚓激酶12~18份。
2.根据权利要求1所述的强身壮阳的药物组合物,其特征在于,它主要由以下组分按重量份配比制成:
水蛭12份、淫羊霍105、肉丛蓉22份、鹿鞭25份、鹿茸10份、蛤蚧23份、蛤蚧雄睾2份、人参23份、海马23份、锁阳19份、东革阿里23份、牡蛎24份、党参23份、分心木3份、茯苓22份、桂圆13份、甘草31份、蚓激酶15份。
3.根据权利要求1或2所述的强身壮阳的药物组合物,其特征在于:
所述药物组合物按药剂学方法加入常规辅料制成临床接受的任意剂型。
4.根据权利要求3所述的强身壮阳的药物组合物,其特征在于:
所述剂型为胶囊剂。
5.根据权利要求1所述的强身壮阳的药物组合物的制备方法,其特征在于包括以下步骤:
(1)按重量份称取下列组分:水蛭5~20份、淫羊霍80~110、肉丛蓉15~28份、鹿鞭20~30份、鹿茸8~12份、蛤蚧18~28份、蛤蚧雄睾1~3份、人参15~30份、海马15~28份、锁阳12~25份、东革阿里15~28份、牡蛎15~30份、党参20~26份、分心木2~4份、茯苓15~26份、桂圆10~16份、甘草22~36份和蚓激酶12~18份;
(2)鹿茸和人参分别研磨成粉末;
(3)水蛭、鹿鞭、蛤蚧、蛤蚧雄睾、海马,加入上述各组分总重量4~6倍重量浓度为70~80%的乙醇,加热回流提取2~3次,每次2~5小时,分次滤过,合并滤液,浓缩,回收乙醇,得浓缩液A;备用;
(4)淫羊霍、肉丛蓉、锁阳、东革阿里、牡蛎、党参、分心木、茯苓、桂圆和甘草,加入上述各组分总重量6~10倍重量的水,加热提取2~3次,每次1~2小时,分次滤过,合并滤液,加入浓缩液A,浓缩成稠膏,加入鹿茸粉末、人参粉末、蚓激酶及适量淀粉,干燥、粉碎,得干膏粉;
(5)取干膏粉加入淀粉浆、硬脂酸镁和微晶纤维素,混匀,制成颗粒,装入胶囊,即得胶囊剂。
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