CN104398986A - 一种安神补脑的淫羊藿口服液及其制备方法 - Google Patents
一种安神补脑的淫羊藿口服液及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种安神补脑的淫羊藿口服液，其所述口服液的原料药的重量份数为：淫羊藿10～50份，墨旱莲10～20份，五味子10～20份，茯苓10～20份，制首乌10～20份，女贞子10～20份，白芍10～20份，石菖蒲10～20份，柏子仁10～20份，桑葚10～20份，珍珠母10～20份，远志10～20份，合欢皮10～20份，麦冬10～20份，酸枣仁10～20份，夜交藤10～20份，黄连10～20份，玉竹10～20份，丹皮10～20份，郁金10～20份。本发明生精补髓，益气养血，强脑安神。用于肾精不足、气血两亏所致的头晕、乏力、健忘、失眠；神经衰弱症。本发明以淫羊藿为主料，加上一些健脑安神、活血化瘀，补气活血、疏肝解郁、平肝潜阳、滋阴补肾、清热解毒、清热泻火的天然中药，能调节人体的新陈代谢机能，本发明配伍科学，纯中药制剂，没有任何毒副作用，并且见效快，口感好，可以长期使用。
Description
技术领域
本发明涉及含有来源于植物、动物或矿物原料药的医用配制品，特别涉及一种安神补脑的淫羊藿口服液及其制备方法。
背景技术
社会的进步使得脑力劳动者成为社会的主力。脑力劳动者是亚健康的高危人群，求职、升职、住房、加薪、病患、孩子教育，方方面面生活的琐事让现代人心力交瘁；据一项调查显示，近90％的脑力劳动者处于不同程度的亚健康状态。这是因为，大脑是人体最为精密的“仪器”，脑力劳动者长期承受单一姿势的静力性劳动，使肌肉处于持续紧张的状态，易致气血凝滞，脑供血不足，从而诱发各种疾病。
求职、升职、住房、加薪、病患、孩子教育，方方面面生活的琐事让现代人心力交瘁，感觉身体入不敷出。再加上现代都市上班族普遍使用电脑办公，烟酒无度，夜生活不节制，熬夜，这些都直接伤害了肝肾。久视以及辐射，为电脑一族的眼睛健康埋下了隐患。这类人需要在注意用眼卫生的同时护肝养血。现代人们的生活饮食过于精细，运动量减少，或暴饮暴食，或劳倦过度，使得人体代谢机能逐渐衰退，导致脏腑功能失调，容易产生睡眠问题。想睡个好觉可能成了很多白领、用脑一族的奢望。
社会环境污染严重，生活压力大，在城市生活压力使很多人都睡不好觉；再加上现代都市上班族普遍使用电脑办公久视，烟酒无度，夜生活不节制、熬夜等伤害肝肾的行为，双眼受到血的给养才能视物，而过度用眼，会使肝血亏虚，使双目得不到营养的供给，从而出现眼干涩、看东西模糊、夜盲等。另外，长期久坐用眼，除双目供血不足外，颈椎、腰椎也会产生劳损，总得不到缓解，也会对肝脏造成损害。
由于经济的日益发达，现代人生活水平的不断提升，致使人们过多的热爱享受，不注意自己的生活方式、行为习惯、饮食嗜好，从而引起的疾病。快节奏的社会生活，激烈竞争的工作压力，对现代人的身心健康造成了严重的威胁，加上长期的饮食不合理，即：精粮完全取代粗粮，大量的三高(高热、高蛋白、高脂肪)、三多(防腐剂多、增味剂多、激素多)食物的摄入和食物中残留的农药、化肥在体内的存积，再加上空气、水源污染和运动量偏小，肥胖和 糖尿病就成了都市一族的富贵病。工作辛苦，持久的情绪紧张、忧虑、工作和学习上的困难，长期繁重的脑力劳动，如伴有不良情绪，更让人觉得疲惫不堪。
淫羊藿，性辛苦，味温，归肝肾经。全草供药用。主治阳萎早泄，腰酸腿痛，四肢麻木，半身不遂，神经衰弱，健忘，耳鸣，目眩等症。淫羊藿是中国常用中药。主要治疗补肾壮阳，祛风除湿。治阳痿不举，偏风不遂，小便淋沥，筋骨挛急，咳嗽，病后青盲，虚火牙痛，半身不遂，腰膝无力，风湿痹痛，四肢不仁。《本经》载其：主阴痿绝伤，茎中痛。利小便，益气力，强志。《别录》载其：坚筋骨。消瘰疬、赤痈；下部有疮，洗，出虫。《日华子本草》载其：治一切冷风劳气，补腰膝，强心力，丈夫绝阳不起，女子绝阴无子，筋骨挛急，四肢不任，老人昏耄，中年健忘。《医学入门》载其：补肾虚，助阳。治偏风手足不遂，四肢皮肤不仁。
主要含黄酮类化合物、木脂素、生物碱、挥发油等.淫羊藿等植物中含有蜡醇(Ceryl alcohol)、卅一烷(Hentriacontane)、植物甾醇(Phytosterol)、棕榈酸(Palmitic acid)、硬脂酸(Stearic acid)、油酸(Oleic acid)、亚油酸(Linoleic acid)、亚麻酸(Linolenic acid)、银杏醇(Bilobanol)、木兰碱(Magnoflorin)、葡萄糖(Glucose)、果糖(Fructose)、维生素E等.淫羊藿的叶和茎中含淫羊藿甙(Icariin)、淫羊藿次甙(Icariside)、去氧甲基淫羊藿甙(des-O-Methylicariin)、β-去水淫羊藿素(β-anhy-Droicaritin)、淫羊藿糖甙(Epimedoside)A、B、C、D、E.此外，箭叶淫羊藿尚含异槲皮素(Iso-quercetin)、淫羊藿-3-O-α-鼠李糖甙(Icaritin--3-O-α-rhamnoside)、金丝桃甙(Hyperin)；箭叶淫羊藿甙(Sagittatoside)A、B、C；箭叶淫羊藿素(Sagittatin)A、B等.
现在市面上各种养肝护肝、安神补脑的保健品、药品泛滥，但大多数徒有其表，大张旗鼓的虚假宣传，很可能没有任何保健功能，但造成人身体的巨大伤害，因此，寻找健康有效的保肝护肝、安神补脑的保健品具有很现实的重要意义。中药保肝护肝、安神补脑具有无毒、能被生物体完全吸收的优点，是我们研究的主要方向。中药存在着双向调节作用,当中药浓度过高时,可能引起某种拮抗作用,而使药效受影响；低剂量时，可能药物浓度过低,致药效不显。而对于中医来说，不论是从所依据的中医机理、剂型还是药物的配方成分各个方面都没有较大的突破，服用起来口感不佳，药物清苦，服用很不方便，不能满足各种患者的需求，也不能满足现代高节奏的都市生活。
发明内容
本发明所要解决的技术问题在于，现在市场上各种养肝护肝、安神补脑的保健品、药品泛滥，但大多数徒有其表，大张旗鼓的虚假宣传，很可能没有任何保健功能，但造成人身体的巨大伤害，因此，寻找健康有效的保肝护肝、安神补脑的保健品具有很现实的重要意义。中药保肝护肝、安神补脑具有无毒、能被生物体完全吸收的优点，是我们研究的主要方向。但中药存在着双向调节作用,当中药浓度过高时,可能引起某种拮抗作用,而使药效受影响；低剂量时,可能药物浓度过低,致药效不显。淫羊藿，性辛苦，味温，归肝肾经。全草供药用。主治阳萎早泄，腰酸腿痛，四肢麻木，半身不遂，神经衰弱，健忘，耳鸣，目眩等症。淫羊藿是中国常用中药。主要治疗补肾壮阳，祛风除湿。治阳痿不举，偏风不遂，小便淋沥，筋骨挛急，咳嗽，病后青盲，虚火牙痛，半身不遂，腰膝无力，风湿痹痛，四肢不仁。本发明是由淫羊藿、远志、制首乌、赤芍等药物制成的口服液，具有健脑安神，生精补髓，清肝明目益气养血的功效，用于神经衰弱、失眠、健忘、头晕等症。
为解决上述技术问题，本发明提供一种安神补脑的淫羊藿口服液，其所述口服液包括以下重量份数的原料药：淫羊藿10～50份，墨旱莲10～20份，五味子10～20份，茯苓10～20份，制首乌10～20份，女贞子10～20份，白芍10～20份，石菖蒲10～20份，柏子仁10～20份，桑葚10～20份，珍珠母10～20份，远志10～20份，合欢皮10～20份，麦冬10～20份，酸枣仁10～20份，夜交藤10～20份，黄连10～20份，玉竹10～20份，丹皮10～20份，郁金10～20份。
所述安神补脑的淫羊藿口服液，其所述口服液可以包括以下重量份数的原料药：淫羊藿10～30份，墨旱莲10～15份，五味子10～15份，茯苓10～15份，制首乌10～15份，女贞子10～15份，白芍10～15份，石菖蒲10～15份，柏子仁10～15份，桑葚10～15份，珍珠母10～15份，远志10～20份，合欢皮10～20份，麦冬10～20份，酸枣仁10～20份，夜交藤10～20份，黄连10～20份，玉竹10～20份，丹皮10～20份，郁金10～20份。
所述一种安神补脑的淫羊藿口服液，其所述口服液还可以包括以下重量份数的原料药：淫羊藿10～40份，墨旱莲10～20份，五味子10～20份，茯苓10～20份，制首乌10～20份，女贞子10～20份，白芍10～20份，石菖蒲10～20份，柏子仁10～20份，桑葚10～20份，珍珠母10～20份，远志10～15份，合欢皮10～15份，麦冬10～15份，酸枣仁10～15份，夜交藤10～15份，黄连10～15份，玉竹10～15份，丹皮10～15份，郁金10～15份。
为解决上述技术问题，本发明还提供一种安神补脑的淫羊藿口服液的制备方法，其所述口服液的制备步骤包括：
a、淫羊藿的制备；为组分1
b、其余原料药热提取2次，为组分2
c、将上述两种组分合并，浓缩成糊状加蜂蜜或糊精调和后罐装。
所述步骤a中，可以将淫羊藿放入占其质量10倍量的乙醇中，加热回流提取2次，每次1-2小时，去上清液，合并提取液，100-110目滤过，再经截流分子量为6000-10000的超滤柱超滤，超滤液减压浓缩相对密度为80℃时1.36的浸膏，加热浓缩至膏状，静置备用；再将上述乙醇提取过的药渣加占其质量10倍量的水加热回流提取2次，去上清液，合并提取液，100-110目滤过，再经截流分子量为6000-10000的超滤柱超滤，超滤液减压浓缩相对密度为80℃时1.36的浸膏，加热浓缩至膏状，静置备用；将上述两种提取浸膏合并，回收乙醇后减压放入浓缩器中浓缩，减压得浸膏。
所述步骤b中，可以取其余原料药泡入水中，浸泡2小时以上，分别加原料药药总重量的8倍量、6倍量的水提取2次，提取时间为2小时、1小时；合并2次提取液，提取液通过管式离心，得离心液，离心液过D 101大孔树脂进行吸附，先用水洗除杂，然后用70％的乙醇进行洗脱，收集洗脱液，减压浓缩，成浸膏。
所述步骤c中，可以将上述两种提取浸膏置入双效真空浓缩器中，浓缩至90℃时相对密度为1.50的糊状，置0～5℃低温冷藏24小时；将冷藏液加0.3％的助滤剂硅藻土，过滤，滤液再置入双效真空浓缩器中，浓缩至每1ml含0.1g生药量，然后加蜂蜜或糊精调和装瓶。
为解决上述技术问题，本发明再提供一种安神补脑的淫羊藿口服液的制备方法，所述口服液的制备方法包括：
a、将所有原料药放入乙醇浸泡，热提取2次，为组分1；
b、再将上述步骤提取的药渣加水提取2次，为组分2；
c、最后将组分1与组分2合并，搅拌均匀后浓缩，放入蜂蜜调和，紫外线杀毒装瓶。
所述步骤a中，可以将所有原料药泡入占其质量10倍量的乙醇中1-5小时，加热提取2次，每次1-2小时，去上清液，合并提取液，100-110目滤过，再经截流分子量为6000-10000的超滤柱超滤，超滤液减压浓缩相对密度为80℃时1.36的浸膏待用，为组分1
所述步骤b中，可以将提取过的药渣加10倍量水，然后放入提取罐加热煮沸1小时，过滤，滤液备用；滤渣加水，第二次加热，煮沸45分钟，过滤，滤液备用；滤渣再加水，第三次加热煮沸半小时，过滤；将三次滤液合在一起，用纱布过滤，残渣中加入50-60％乙醇，60℃-70℃继续浸提2h，每10min搅拌一次，纱布过滤，合并浸提液，浓缩成糊状，成为组分2。
所述步骤c中,可以将两种组分合并，回收乙醇后减压放入浓缩 器中浓缩时，浓缩至90℃时相对密度为1.50的浓缩液，置0～5℃低温冷藏24小时；将冷藏液加0.3％的助滤剂硅藻土，过滤，滤液再置入双效真空浓缩器中，浓缩至每1ml含0.1g生药量，搅拌均匀后浓缩，放入蜂蜜调和，紫外线杀毒装瓶。
本发明有益技术效果在于：本发明生精补髓，益气养血，强脑安神。用于肾精不足、气血两亏所致的头晕、乏力、健忘、失眠；神经衰弱症。本发明以淫羊藿为主料，加上一些健脑安神、活血化瘀，补气活血、疏肝解郁、平肝潜阳、滋阴补肾、清热解毒、清热泻火的天然中药，能调节人体的新陈代谢机能，本发明配伍科学，纯中药制剂，没有任何毒副作用，并且见效快，口感好，可以长期使用。
具体实施方式
脑力劳动者是亚健康的高危人群，据一项调查显示，近90％的脑力劳动者处于不同程度的亚健康状态。这是因为，大脑是人体最为精密的“仪器”，脑力劳动者长期承受单一姿势的静力性劳动，使肌肉处于持续紧张的状态，易致气血凝滞，脑供血不足，从而诱发各种疾病。
求职、升职、住房、加薪、病患、孩子教育，方方面面生活的琐事让现代人心力交瘁，感觉身体入不敷出。再加上现代都市上班族普遍使用电脑办公，烟酒无度，夜生活不节制，熬夜，这些都直接伤害了肝肾。久视以及辐射，为电脑一族的眼睛健康埋下了隐患。这类人需要在注意用眼卫生的同时护肝养血。现代人们的生活饮食过于精细，运动量减少，或暴饮暴食，或劳倦过度，使得人体代谢机能逐渐衰退，导致脏腑功能失调，容易产生睡眠问题。想睡个好觉可能成了很多白领、用脑一族的奢望。
淫羊藿，性辛苦，味温，归肝肾经。全草供药用。主治阳萎早泄，腰酸腿痛，四肢麻木，半身不遂，神经衰弱，健忘，耳鸣，目眩等症。淫羊藿是中国常用中药。主要治疗补肾壮阳，祛风除湿。治阳痿不举，偏风不遂，小便淋沥，筋骨挛急，咳嗽，病后青盲，虚火牙痛，半身不遂，腰膝无力，风湿痹痛，四肢不仁。《本经》载其：主阴痿绝伤，茎中痛。利小便，益气力，强志。《别录》载其：坚筋骨。消瘰疬、赤痈；下部有疮，洗，出虫。《日华子本草》载其：治一切冷风劳气，补腰膝，强心力，丈夫绝阳不起，女子绝阴无子，筋骨挛急，四肢不任，老人昏耄，中年健忘。《医学入门》载其：补肾虚，助阳。治偏风手足不遂，四肢皮肤不仁。
主要含黄酮类化合物、木脂素、生物碱、挥发油等.淫羊藿等植物中含有蜡醇(Ceryl alcohol)、卅一烷(Hentriacontane)、植物甾醇(Phytosterol)、棕榈酸(Palmitic acid)、硬脂酸(Stearic acid)、 油酸(Oleic acid)、亚油酸(Linoleic acid)、亚麻酸(Linolenic acid)、银杏醇(Bilobanol)、木兰碱(Magnoflorin)、葡萄糖(Glucose)、果糖(Fructose)、维生素E等.淫羊藿的叶和茎中含淫羊藿甙(Icariin)、淫羊藿次甙(Icariside)、去氧甲基淫羊藿甙(des-O-Methylicariin)、β-去水淫羊藿素(β-anhy-Droicaritin)、淫羊藿糖甙(Epimedoside)A、B、C、D、E.此外，箭叶淫羊藿尚含异槲皮素(Iso-quercetin)、淫羊藿-3-O-α-鼠李糖甙(Icaritin--3-O-α-rhamnoside)、金丝桃甙(Hyperin)；箭叶淫羊藿甙(Sagittatoside)A、B、C；箭叶淫羊藿素(Sagittatin)A、B等.
石菖蒲化湿开胃，开窍豁痰，醒神益智。用于脘痞不饥，噤口下痢，神昏癫痫，健忘耳聋。理气，活血，散风，去湿。治癫痫，痰厥，热病神昏，健忘，气闭耳聋，心胸烦闷，胃痛，腹痛，风寒湿痹，痈疽肿毒，跌打损伤。
合欢皮性味甘、平。有解郁、和血、宁心、消痈肿之功。有治心神不安、忧郁、失眠、肺痈、痈肿、瘰疠、筋骨折伤之效。合欢皮为豆科植物合欢的树皮，合欢皮别名合昏皮、夜台皮、合欢木皮，合欢皮有安神解郁、活血消痈的功效，合欢皮有治疗心神不安、忧郁、不眠、内外痈疡、跌打损伤的作用，胃炎患者慎服合欢皮，风热自汗、外感不眠者禁服合欢皮。《本经》：主安五脏，和心志，令人欢乐无忧。《本草拾遗》：杀虫。
郁金本品为姜科植物温郁金Curcumawenyujin Y.H.Chen et C.Ling、姜黄Curcuma longaL.的干燥块根。前两者分别习称“温郁金”和“黄丝郁金”，其余按性状不同习称“桂郁金”或“绿丝郁金”。冬季茎叶枯萎后采挖，除去泥沙及细根，蒸或煮至透心，干燥。性味与归经：辛、苦，寒。归肝、心、肺经。功能主治：活血止痛，行气解郁，清心凉血，利胆退黄。用于经闭痛经,胸腹胀痛、刺痛，热病神昏，癫痫发狂，黄疸尿赤。
白芍性凉，味苦酸，微寒，具有补血柔肝、平肝止痛。敛阴收汗等功效，适用于阴虚发热、月经不调、胸腹胁肋疼痛、四肢挛急，泻痢腹痛、自汗盗汗、崩漏、带下等症。芍药甙有抗菌、解热、抗炎、增加冠状动脉流量、改善心肌营养血流、扩张血管、对抗急性心肌缺血、抑制血小板聚集、镇静、镇痛、解痉、抗溃疡、调节血糖的作用。白芍煎剂能抑制痢疾杆菌、肺炎链球菌、大肠杆菌、伤寒杆菌、溶血性链球菌、绿脓杆菌等。血虚阴虚、胸腹胁肋疼痛、肝区痛、胆囊炎、胆结石疼痛、泻痢腹痛、妇女行经腹痛、自汗易汗盗汗、腓肠肌痉挛、四肢拘挛疼痛、不安腿综合症等病症患者适宜食用。
玉竹含有合欢甙，鞣质，解郁安神，理气开胃，活络止痛，用于心神不安、忧郁失眠。治郁结胸闷，失眠，健忘，风火眼，能安 五脏，和心志，悦颜色，有较好的强身、镇静、安神、美容的作用，也是治疗神经衰弱的佳品。也具有清热解暑，养颜祛斑解酒等功效。《本草经》说：“玉竹能安五脏，和心志，悦颜色。”尤其对孕妇，有较好的强身、镇静、安神、美容的作用，也是治疗神经衰弱的佳品。
黄连清热燥湿，泻火解毒。用于湿热痞满，呕吐吞酸，泻痢，黄疸，高热神昏，心火亢盛，心烦不寐，血热吐衄，目赤，牙痛，消渴，痈肿疔疮；外治湿疹，湿疮，耳道流脓。酒黄连善清上焦火热。用于目赤，口疮。姜黄连清胃和胃止呕。用于寒热互结，湿热中阻，痞满呕吐。萸黄连舒肝和胃止呕。用于肝胃不和，呕吐吞酸。
女贞子，味甘苦、性凉，归肝肾经，具有滋补肝肾、益阴养血之功。现代医学研究证明，女贞子内含熊果酸、甘露醇、葡萄糖、脂肪油等，有强心、利尿和保肝作用，能使因化疗引起的白细胞下降数量升高，并对金黄色葡萄球菌、大肠杆菌有抑制作用。女贞子中含有齐墩果酸女贞子酸、女贞苷、熊果酸、硬脂酸、油酸、甘露醇、白桦脂醇、磷脂以及糖类如女贞子多糖、阿拉伯糖、葡萄糖等，还含有15种氨基酸，11种微量元素及挥发油等。研究认为女贞子有降血糖及降血脂并有抗动脉粥样硬化作用，还有抗菌、抗病毒作用，女贞子煎剂对金黄色葡萄球菌、福氏痢疾杆菌、伤寒杆菌、绿脓杆菌和大肠杆菌均有抑制作用。
远志(Radix Polygalae)为常用中药，最早记载于《神农本草经》，列为上品，并被视为养命要药，来源于远志科植物远志Polygala tenuifoliaWilld.和卵叶远志P.sibiricaL.的干燥根。性温，味苦、辛，具有安神益智、祛痰、消肿的功能，用于心肾不交引起的失眠多梦、健忘惊悸，神志恍惚，咳痰不爽，疮疡肿毒，乳房肿痛。《神农本草经》：主咳逆伤中，补不足，除邪气，利九窍，益智慧，耳目聪明，不忘，强志倍力。
夜交藤，拉丁名：药材Caulis Polygoni Multiflori原植物何首乌Polygonum multiflorumThunb.功效：养心，安神，通络，祛风，主治：治失眠症，劳伤，多汗，血虚身痛，痈疽，瘰疬，风疮疥癣。性味归经：甘微苦，平。药物配伍：配酸枣仁，滋心阴，宁心神；配生地，养血补阴；配天门冬、麦冬，清虚火、养心阴；配羌活、独活，祛风胜湿、舒利关节。用于虚烦失眠。夜交藤具有养血安神作用，以用于阴虚血少所致的失眠为主，常与合欢皮相须配合，也可与枣仁、柏子仁、远志等同用。
珍珠母是贝类珍珠层的粉末，具有平肝潜阳；安神定惊；清肝明目的功效。咸、寒。归肝、心经。平肝潜阳；安神定惊；清肝明目考证。功用主治平肝，潜阳，定惊，止血。治头眩，耳鸣，心悸，失眠，癫狂， 惊痫，吐血，衄血，妇女血崩。《中国医学大辞典》：滋肝阴，清肝火。治癫狂惊痫，头眩，耳鸣，心跳，胸腹膜胀，妇女血热，血崩，小儿惊搐发痉。《饮片新参》：平肝潜阳，安神魂，定惊痫，消热痞、眼翳。
酸枣仁中国最早的一部药书《神农本草经》中记载：“补中益肝，坚筋骨，助阴气，皆酸枣仁之功也。”明代李时珍《本草纲目》中记载，枣仁“熟用疗胆虚不得眠，烦渴虚汗之症；生用疗胆热好眠，皆足厥阴少阳药也。功效养肝，宁心，安神，敛汗。治虚烦不眠，惊悸怔忡，烦渴，虚汗。《本经》：主心腹寒热，邪结气聚，四肢酸疼，湿痹。《别录》：主烦心不得眠，脐上下痛，血转久泄，虚汗烦渴，补中，益肝气，坚筋骨，助阴气，令人肥健。《药性论》：主筋骨风，炒末作汤服之。《本草拾遗》：睡多生使，不得睡炒熟。王好古：治胆虚不眠，寒也，炒服；治胆实多睡，热也，生用。《本草汇言》：敛气安神，荣筋养髓，和胃运脾。《本草再新》：平肝理气，润肺养阴，温中利湿，敛气止汗，益志定呵，聪耳明目。药理作用：.镇静、催眠作用：酸枣仁煎剂给大白鼠口服或腹腔注射均表现镇静及嗜眠，无论白天或黑夜，酸枣仁均能表现上述作用。小白鼠口服时的镇静指数为1.95，与巴比妥类药物表现协同作用，酸枣仁被连续使用6天后，动物睡眠会变浅，持续时间缩短，即产生耐受性，但停药1周后可消失。
五味子：五味子以根茎入药。具有补气养阴，健脾，润肺，益肾功能。用于治疗脾胃虚弱，体倦乏力，口干食少，肺虚燥咳，精血不足，内热消渴等症。对于糖尿病很有疗效。五味子具有降血压，降血糖，降血脂，防止动脉粥样硬化，延缓衰老和抗菌等作用，五味子多糖具有免疫激活作用。用于阴虚肺燥，干咳少痰，及肺肾阴虚的劳嗽久咳等。用于脾胃虚弱。既补脾阴，又益脾气，用于肾虚精亏得头晕，腰膝酸软，须发早白及消渴等。五味子壮筋骨，壮骨髓，变白发；适宜用于肺阴不足所致的咳嗽痰少，干咳无痰，咳血等症。
茯苓味甘、淡、性平，入药具有利水渗湿、益脾和胃、宁心安神之功用。现代医学研究：茯苓能增强机体免疫功能，茯苓多糖有明显的抗肿瘤及保肝脏作用。茯苓性味甘淡平，入心、肺、脾经。具有渗湿利水，健脾和胃，宁心安神的功效。可治小便不利，水肿胀满，痰饮咳逆，呕逆，恶阻，泄泻，遗精，淋浊，惊悸，健忘等症。茯苓之利水，是通过健运脾肺功能而达到的，与其它直接利水的中药不同。用于脾虚泄泻，带下茯苓既能健脾，又能渗湿，对于脾虚运化失常所致泄泻、带下，应用茯苓有标本兼顾之效，常与党参、白术、山药等配伍。有可用为补肺脾，治气虚之辅佐药。
中药何首乌有生首乌与制首乌之分，直接切片入药为生首乌， 用黑豆煮汁拌蒸后晒干入药为制首乌。二者的功用有所不同：生首乌功能解毒、消痈、润肠通便，常用于治疗瘰疬疮痈、风疹瘙痒、肠燥便秘；制首乌功能补肝肾、益精血、乌须发、强筋骨，用于血虚萎黄、眩晕耳鸣、须发早白、腰膝酸软、肢体麻木、崩漏带下、久疟体虚等。本发明所采用的制首乌是补肾益肾的佳品。
旱莲草味甘酸，性凉，入肝肾二经，无毒。主治：滋补肝肾、凉血止血，可治各种吐血，肠出血等症。捣汁涂眉发，能促进毛发生长，内服有乌发、黑发功效。《唐本草》说，墨旱莲“主血痢，针灸疮发，洪血不可止者敬之”。《日华子本草》中也说，墨旱莲可以“排脓，止血，通小肠，敷一切疮并蚕瘑”。《滇南本草》载，墨旱莲“固齿，乌发，洗九种痔疮”。
丹皮性寒，味苦；凉；微寒。归心；肝；肾；肺经。清热凉血；活血散瘀。温热病热入血分；发斑；吐衄；热病后期热伏阴分发热；阴虚骨蒸潮热；血滞经闭；痛经；痈肿疮毒；跌扑伤痛；风湿热痹。给小鼠分别灌胃牡牡丹皮，牡丹皮酚、芍药甙、氧化芍药甙、苯甲酰芍药甙，均能促进静脉注射的碳粒在血中的廓清速度，即使单核巨噬细胞系统功能处于低下状态也有促进作用，显微镜检查见肝中枯氏细胞及脾中巨噬细胞吞噬力增强。芍药甙、氧化芍药甙在体外亦能增强小鼠腹腔巨噬细胞对乳液的吞噬功能。牡丹皮液给小鼠腹腔注射能使其脾脏溶血后斑数增加。用牡丹皮酚给小鼠腹腔注射每大25mg/kg，连用6天，能使脾重明显增加，且可对抗考的松、环磷酰胺所致胸腺重量的减轻。由上可见牡牡丹皮对体液及细胞免疫均有增强作用。《本草经疏》：牡丹皮，其味苦而微辛，其气寒而无毒，辛以散结聚，苦寒除血热，入血分，凉血热之要药也。寒热者，阴虚血热之候也。中风瘛疭、痉、惊痫，皆阴虚内热，营血不足之故。热去则血凉，凉则新血生、阴气复，阴气复则火不炎而无因热生风之证矣，故悉主之。
本发明具体实施方式：
具体实施例1
将淫羊藿放在乙醇中浸泡，提取，药渣用水提取，作为组分1；
其他原料药的提取，备置，作为组分2；
将组分1和组分2合并，浓缩后加糊精或蜂蜜调和，紫外线杀菌后装瓶。
具体实施例2
将淫羊藿5000g放入占其质量10倍量的乙醇中，加热回流提取2次，每次1-2小时，去上清液，合并提取液，100-110目滤过，再经截流分子量为6000-10000的超滤柱超滤，超滤液减压浓缩相对密度为80℃时1.36的浸膏，加热浓缩至膏状，静置备用；再将上述乙醇提取 过的药渣加占其质量10倍量的水加热回流提取2次，去上清液，合并提取液，100-110目滤过，再经截流分子量为6000-10000的超滤柱超滤，超滤液减压浓缩相对密度为80℃时1.36的浸膏，加热浓缩至膏状，静置备用；将上述两种提取浸膏合并，回收乙醇后减压放入浓缩器中浓缩，减压得浸膏成为组分1。
将其余原料药墨旱莲1500g，五味子1500g，茯苓1500g，制首乌1500g，女贞子1500g，白芍1500g，石菖蒲1500g，柏子仁1500g，桑葚1500g，珍珠母1500g，远志1500g，合欢皮1500g，麦冬1500g，酸枣仁1500g，夜交藤1500g，黄连1500g，玉竹1500g，丹皮1500g，郁金1500g，加10倍量水，然后放入提取罐加热煮沸1小时，过滤，滤液备用；滤渣加水，第二次加热，煮沸45分钟，过滤，滤液备用；滤渣再加水，第三次加热煮沸半小时，过滤；将三次滤液合在一起，用纱布过滤，残渣中加入50-60％乙醇，60℃-70℃继续浸提2h，每10min搅拌一次，纱布过滤，合并浸提液，浓缩成糊状，成为组分2。
将上述两种提取浸膏置入双效真空浓缩器中，浓缩至90℃时相对密度为1.50的糊状，置0～5℃低温冷藏24小时；将冷藏液加0.3％的助滤剂硅藻土，过滤，滤液再置入双效真空浓缩器中，浓缩至每1ml含0.1g生药量，然后加蜂蜜或糊精调和装瓶。
具体实施例3
将淫羊藿4000g浸泡水中2-5小时，分别加占其质量的8倍量、6倍量的水提取2次，提取时间为2小时、1小时；合并2次提取液，提取液通过管式离心，得离心液，离心液过D 101大孔树脂进行吸附，先用水洗除杂，然后用70％的乙醇进行洗脱，收集洗脱液，减压浓缩，成浸膏，备用；将上述提取过的淫羊藿的药渣加乙醇，分别加占其质量的10倍量、8倍量的乙醇温浸2次，温浸时间为2小时、1.5小时，温度为85℃，合并2次温浸液；温浸液减压浓缩至密度为60℃时1.25浸膏，将浸膏加入其4倍量的乙酸乙酯萃取二次，萃取液回收完乙酸乙酯，成浸膏，备用。将上述两种提取组分合并，减压浓缩相对密度为80℃时1.35的滤液，回收乙醇，将上述两种提取液置入双效真空浓缩器中，浓缩至90℃时相对密度为1.60的浓缩液，置0～5℃低温冷藏24小时；将冷藏液加0.3％的助滤剂硅藻土，过滤，滤液再置入双效真空浓缩器中，浓缩至每1ml含0.1g生药量，成为组分1。将其余原料药墨旱莲1200g，五味子1100g，茯苓1100g，制首乌1100g，女贞子1200g，白芍1100g，石菖蒲1200g，柏子仁1100g，桑葚1100g，珍珠母1200g，远志1200g，合欢皮1100g，麦冬1100g，酸枣仁1100g，夜交藤1100g，黄连1100g，玉竹1100g，丹皮1100g，郁金1100g，加10倍量水，然后放入提取罐加热煮沸1小时，过滤，滤液备用；滤渣加水，第二次加热，煮沸45分钟，过滤，滤液备用；滤渣再加水， 第三次加热煮沸半小时，过滤；将三次滤液合在一起，用纱布过滤，残渣中加入50-60％乙醇，60℃-70℃继续浸提2h，每10min搅拌一次，纱布过滤，合并浸提液，浓缩成糊状，成为组分2。将组分1和组分2合并，然后放入减压浓缩罐内，回收乙醇，浓缩至90℃时相对密度为1.50的浸膏，浓缩至每1ml含0.1g生药量，然后加蜂蜜或糊精调和装瓶。
具体实施例4
取淫羊藿4500g，墨旱莲1200g，五味子1300g，茯苓1300g，制首乌1200g，女贞子1200g，白芍1300g，石菖蒲1200g，柏子仁1200g，桑葚1200g，珍珠母1200g，远志1200g，合欢皮1300g，麦冬1200g，酸枣仁1200g，夜交藤1200g，黄连1200g，玉竹1200g，丹皮1200g，郁金1200g，将所有原料药放入10倍量乙醇中浸泡24小时以上，加热回流提取2次，每次1～2小时，将2次提取液合并静置；再将上述乙醇提取过的组份原料药药材的药渣加10倍量水加热回流提取2次，每次1～2小时，将2次提取液合并静置；将上述两种提取液合并，回收乙醇后减压放入浓缩器中浓缩时，浓缩至90℃时相对密度为1.50的浓缩液，置0～5℃低温冷藏24小时；将冷藏液加0.3％的助滤剂硅藻土，过滤，滤液再置入双效真空浓缩器中，浓缩至每1ml含0.1g生药量；然后加糊精调和，紫外线杀菌消毒后包装。
药理学毒性试验
一、皮肤刺激实验
1、实验方法
将豚鼠背部脊柱两侧将脱毛剂均匀涂上，使去毛范围约20平方厘米。洗净脱毛剂归笼观察24小时，每组豚鼠分别涂本发明(丸剂)4、8和12g，分别含生药92mg、184mg和368mg，另一组涂溶媒0.8ml每日二次，连续一周，实验结束后，将豚鼠处死，心，肝，肾及脱毛皮肤做病理检验。
2、结果
上述三组用药豚鼠躯干脱毛区，未见局部皮肤有水肿、充血、红斑、出血点及溃疡。用药组豚鼠毛发色泽、摄食、四肢活动等对照组无明显差异，病理组织学检查，给药组心、肝、肾及脱毛皮与对照字比较也无明显差异。
结果提示，本发明无局部刺激作用，也未见全身毒性表现。表明本发明制剂使用安全。
二、动物急性毒性试验研究：
本发明经预试验，不能测出LD 50，故测定最大给药量。采用直肠给药途径，测得小鼠的一日最大给药量为62.7g/kg(以药粉计)，约为拟临床人用量的1567.5倍(人以60kg计)，大鼠的一日最大给药量 62.7g/kg(以药粉计)，约为拟临床人用量的1567.5倍。实验动物均连续观察一周，其外观体征、精神状态、饮食、饮水、粪便等均未见明显异常。实验结束时，动物均健康存活，体重增加。
三、动物长期毒性试验研究：
一、试验材料及方法
(一)受试药物：本发明实施例所制的口服液。
(二)实验动物，健康大鼠Wistar，体重100-130g，140只雌雄各半，按性别及体重随机分组，四组，每组35只。1、2、3组服用受试药物，剂量分别为9.6/kg/d，6.4/kg/d，3.2/kg/d。4组对照给相应体积量的蒸馏水、大鼠均灌胃肠给药，每组一次连用6个月，处死一半，余下1/2停药观察12天全部死亡。
二、测试指标
(一)一般状况包括体重、饮食、情绪、活动能量。
(二)血象检查：红细胞计数、白细胞计数、血小板计数、血象等，血红蛋白定量计数。
(三)生化检查、血清蛋白定量、胆固醇、血糖定量。
(四)病理组织检查：实验结果后取半数动物称重，断头处死，取血，同时解剖心、肝、肾、肺、脑、脾、胃肠、膀胱、肾上腺做病理组织检查。
三、试验结果：经大鼠长期毒性试验表明，用本发明大剂量灌肠六个月，对大鼠的生长、体重增加、对脑、肝、肾功能均无毒副作用。对大鼠的各组织器官、循环系统未发现损害改变，用药组与对照组比较无明显差异。说明本发明药物具有温补肾阳、益气、补血、增强新陈代谢等药效，无毒性。
临床试验：
本发明是由远志、制首乌、淫羊藿、赤芍等药物制成的保健口服液，具有健脑安神，生精补髓，清肝明目益气养血的功效，用于神经衰弱、失眠、健忘、头晕等症。本文观察了本发明对未成年小鼠学习记忆能力及脑内单胺类神经递质5一HT，DA，NA，5一HIAA含量的影响。
1试验材料
1.1药物本发明保健保健口服液，由本院药剂科按实施例2的方法制备；阳性对照药，安神补脑液，国药准字Z22022453，生产企业：吉林敖东延边药业股份有限公司。
1.2动物昆明种小鼠11～15g，雌雄各半，购自长春生物制品研究所，许可证号：SCXK.2002.0001。
1.3仪器Y.型水迷宫；ES.180电子分析天平，沈阳龙腾公司生产；RF.540型荧光分光光度计，日本岛津公司生产。
1.4试剂5.羟色胺硫酸肌酐，中国医药公司上海化学试剂采购供应站，批号：65-02.28，瑞士进口分装，纯度99％；5.羟吲哚乙酸，Sigma产品，批号：60k1083，纯度98％～100％；重酒石酸钾去甲肾上腺素，上海禾丰制药有限公司出品，批号：0205037，2mg/mL；盐酸多巴胺，由上海禾丰制药有限公司出品，批号：0204011，20mg/2mL；其它试剂均为国产分析纯。
2方法与结果
对未成年小鼠学习记忆能力的影响(水迷宫法)取小鼠80只，随机分为：空白对照组，安神补脑液液13mL/kg给药组，本发明组10.0，5.0，2.5mL/kg 3个剂量给药组。每天给药1次，连续给药15d，于初次给药的第11d开始将小鼠置于水迷宫中进行训练。实验采用Y.型水迷路装置。该装置分长臂端和两分枝短臂端。左侧短臂端装有平台，作为小鼠栖身之处，平台上方有灯光照明。三个枝臂端留有一个10cm的开口，中间部分用黑色有机玻璃盖上，作为暗道。水深10cm，水温(30±2)℃，共训练5d，每只动物每天训练10次，训练时将小鼠的尾部朝向迷宫的双叉端轻轻地放入水中，以其在15S内直接达到有光源的平台为正确反应，否则视为错误，记录每只动物每天发生错误的次数，并计算5d平均成绩。实验数据以-X±S表示，组间比较用样本2.1均数t检验方法，结果见表1。
表1 本发明对未成年小鼠学习记忆能力的影响(x±s，n＝16)
注：与空白对照组比*P<0.05，**P<0.01，***P<0.001，以下各表均同。
由表1结果可见，本发明10.0mL/kg剂量组，于训练的第3d开始便能明显地减少小鼠的错误次数，且随着给药时间的延长，错误次数逐渐减少，说明其可增强小鼠学习记忆能力。
2.2对未成年小鼠脑内单胺类递质含量的影响
取小鼠80只，同上分组给药，连续给药15d，末次给药后1h将动物处死，迅速取脑组织，立即放入液氮灌内冷冻，分批取出匀浆，按荧光分光光度法测定小鼠脑组织中5-HT，DA，NA，5-HIAA的含量，实验数据以x±s表示，组间比较用样本均数t检验方法，结果见表2。
表2 本发明对未成年小鼠脑内单胺类递质含量的影响(x±s，n＝16)
由表2结果可见，本发明能明显地增加小鼠大脑组织中5-HT，DA，NA含量。
2.3对未成年小鼠胸腺、脾、肾上腺指数的影响取小鼠80只，同2.1分组给药，末次给药后1h将动物处死，取胸腺、脾、肾上腺称重计算脏器指数，实验数据以x±s表示，组间比较用样本均数t检验方法，结果见表3。
表3 本发明对未成年小鼠相关脏器指数的影响(x±s，n＝16)
由表3结果可见，本发明能明显地增加肾上腺指数。
3讨论
学习记忆是脑的高级功能之一，是衡量动物智力发育的重要指 标，学习记忆是通过神经系统一系列生理生化过程实现的。单胺类神经递质对注意力，记忆力和反应能力有着重要的调节作用，它包括NA，DA，5-HT，5-HIAA等，突触中NA，DA，5-HT含量丰富，它不仅与突触传递有关，而且与突触成熟有关。NA，DA，5-HT，5-HIAA的减少，必然影响脑内神经递质的平衡，导致智力损伤而减退。实验结果表明，安神补脑液能增强未成年小鼠的学习记忆能力，同时还表明其可提高动物脑内NA，DA，5-HT的含量，安神补脑液在I缶床上已应用多年，作用明显，疗效确切，但对其用于治疗健忘的作用机制从未进行深入的研究，本文从对未成年动物脑内单胺类神经递质方面的影响结果提示，本发明可能通过激活脑代谢，增加大脑皮质中多种神经介质的数量，从而达到增强记忆的功能。实验结果还显示本发明可增加未成年小鼠肾上腺重量，给药组与对照组有明显差异，这也可能与其方中含有制首乌、淫羊藿等补肾药有关。
淫羊藿，性辛苦，味温，归肝肾经。全草供药用。主治阳萎早泄，腰酸腿痛，四肢麻木，半身不遂，神经衰弱，健忘，耳鸣，目眩等症。淫羊藿是中国常用中药。主要治疗补肾壮阳，祛风除湿。治阳痿不举，偏风不遂，小便淋沥，筋骨挛急，咳嗽，病后青盲，虚火牙痛，半身不遂，腰膝无力，风湿痹痛，四肢不仁。《本经》载其：主阴痿绝伤，茎中痛。利小便，益气力，强志。《别录》载其：坚筋骨。消瘰疬、赤痈；下部有疮，洗，出虫。《日华子本草》载其：治一切冷风劳气，补腰膝，强心力，丈夫绝阳不起，女子绝阴无子，筋骨挛急，四肢不任，老人昏耄，中年健忘。《医学入门》载其：补肾虚，助阳。治偏风手足不遂，四肢皮肤不仁。本发明生精补髓，益气养血，强脑安神。用于肾精不足、气血两亏所致的头晕、乏力、健忘、失眠；神经衰弱症完全。
本发明是绿色健康环保的保健品。加上一些健脑安神、活血化瘀，补气活血、疏肝解郁、平肝潜阳、滋阴补肾、清热解毒、清热泻火的天然中药，生精补髓，益气养血,强脑安神，调节人体的新陈代谢机能，本发明配伍科学，纯中药制剂，没有任何毒副作用，并且见效快，口感好，可以长期使用。
Claims (10)
1.一种安神补脑的淫羊藿口服液，其特征在于，所述口服液包括以下重量份数的原料药：淫羊藿10～50份，墨旱莲10～20份，五味子10～20份，茯苓10～20份，制首乌10～20份，女贞子10～20份，白芍10～20份，石菖蒲10～20份，柏子仁10～20份，桑葚10～20份，珍珠母10～20份，远志10～20份，合欢皮10～20份，麦冬10～20份，酸枣仁10～20份，夜交藤10～20份，黄连10～20份，玉竹10～20份，丹皮10～20份，郁金10～20份。
2.根据权利要求1所述安神补脑的淫羊藿口服液，其特征在于，所述口服液包括以下重量份数的原料药：淫羊藿10～30份，墨旱莲10～15份，五味子10～15份，茯苓10～15份，制首乌10～15份，女贞子10～15份，白芍10～15份，石菖蒲10～15份，柏子仁10～15份，桑葚10～15份，珍珠母10～15份，远志10～20份，合欢皮10～20份，麦冬10～20份，酸枣仁10～20份，夜交藤10～20份，黄连10～20份，玉竹10～20份，丹皮10～20份，郁金10～20份。
3.根据权利要求1所述一种安神补脑的淫羊藿口服液，其特征在于，所述口服液包括以下重量份数的原料药：淫羊藿10～40份，墨旱莲10～20份，五味子10～20份，茯苓10～20份，制首乌10～20份，女贞子10～20份，白芍10～20份，石菖蒲10～20份，柏子仁10～20份，桑葚10～20份，珍珠母10～20份，远志10～15份，合欢皮10～15份，麦冬10～15份，酸枣仁10～15份，夜交藤10～15份，黄连10～15份，玉竹10～15份，丹皮10～15份，郁金10～15份。
4.一种如权利要求1～3中任一项所述安神补脑的淫羊藿口服液的制备方法，其特征在于，所述口服液的制备步骤包括：
a、淫羊藿的制备；为组分1
b、其余原料药热提取2次，为组分2
c、将上述两种组分合并，浓缩成糊状加蜂蜜或糊精调和后罐装。
5.根据权利要求4所述安神补脑的淫羊藿口服液的制备方法，其特征在于，所述步骤a中，将淫羊藿放入占其质量10倍量的乙醇中，加热回流提取2次，每次1-2小时，去上清液，合并提取液，100-110目滤过，再经截流分子量为6000-10000的超滤柱超滤，超滤液减压浓缩相对密度为80℃时1.36的浸膏，加热浓缩至膏状，静置备用；再将上述乙醇提取过的药渣加占其质量10倍量的水加热回流提取2次，去上清液，合并提取液，100-110目滤过，再经截流分子量为6000-10000的超滤柱超滤，超滤液减压浓缩相对密度为80℃时1.36的浸膏，加热浓缩至膏状，静置备用；将上述两种提取浸膏合并，回收乙醇后减压放入浓缩器中浓缩减压得浸膏。
6.根据权利要求4所述安神补脑的淫羊藿口服液的制备方法，其特征在于，所述步骤b中，取其余原料药泡入水中，浸泡2小时以上，分别加原料药药总重量的8倍量、6倍量的水提取2次，提取时间为2小时、1小时；合并2次提取液，提取液通过管式离心，得离心液，离心液过D101大孔树脂进行吸附，先用水洗除杂，然后用70％的乙醇进行洗脱，收集洗脱液，减压浓缩，成浸膏。
7.根据权利要求4所述安神补脑的淫羊藿口服液的制备方法，其特征在于，所述步骤c中，将上述两种提取浸膏置入双效真空浓缩器中，浓缩至90℃时相对密度为1.50的糊状，置0～5℃低温冷藏24小时；将冷藏液加0.3％的助滤剂硅藻土，过滤，滤液再置入双效真空浓缩器中，浓缩至每1ml含0.1g生药量，然后加蜂蜜或糊精调和装瓶。
8.一种如权利要求1～3中任一项所述安神补脑的淫羊藿口服液的制备方法，其特征在于，所述口服液的制备方法包括：
a、将所有原料药放入乙醇浸泡，热提取2次，为组分1；
b、再将上述步骤提取的药渣加水提取2次，为组分2；
c、最后将组分1与组分2合并，搅拌均匀后浓缩，放入蜂蜜调和，紫外线杀毒装瓶。
9.根据权利要求8所述安神补脑的淫羊藿口服液的制备方法，其特征在于，所述步骤a中，将所有原料药泡入占其质量10倍量的乙醇中1-5小时，加热提取2次，每次1-2小时，去上清液，合并提取液，100-110目滤过，再经截流分子量为6000-10000的超滤柱超滤，超滤液减压浓缩相对密度为80℃时1.36的浸膏待用，为组分1
所述步骤b中，将提取过的药渣加10倍量水，然后放入提取罐加热煮沸1小时，过滤，滤液备用；滤渣加水，第二次加热，煮沸45分钟，过滤，滤液备用；滤渣再加水，第三次加热煮沸半小时，过滤；将三次滤液合在一起，用纱布过滤，残渣中加入50-60％乙醇，60℃-70℃继续浸提2h，每10min搅拌一次，纱布过滤，合并浸提液，浓缩成糊状，成为组分2。
10.根据权利要求8所述安神补脑的淫羊藿口服液的制备方法，其特征在于，所述步骤c中,将两种组分合并，回收乙醇后减压放入浓缩器中浓缩时，浓缩至90℃时相对密度为1.50的浓缩液，置0～5℃低温冷藏24小时；将冷藏液加0.3％的助滤剂硅藻土，过滤，滤液再置入双效真空浓缩器中，浓缩至每1ml含0.1g生药量，搅拌均匀后浓缩，放入蜂蜜调和，紫外线杀毒装瓶。
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