CN108042766A - 一种补肾通络养脑膏及其制备方法 - Google Patents
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Abstract
本发明公开了一种补肾通络养脑膏及其制备方法,其特征在于由原料药制备而成:熟地、山药、山茱萸、茯苓、丹皮、泽泻、枸杞子、菟丝子、灵芝、女贞子、旱莲草、桑椹子、桑螵蛸、益智仁、生黄芪、玉竹、百合、桃仁、红花、赤芍、川芎、柴胡、炒枳壳、怀牛膝、桔梗、节菖蒲、制远志、苍术、白术、莲子、焦山楂、神曲、炒谷芽、炒麦芽、陈皮、郁金、威灵仙、当归、制半夏、路路通、丹参、砂仁、西洋参、海龙、海马、龟板胶、鳖甲胶、三七、川贝、糖类、黄酒。用于肾虚精亏,气血不足,痰瘀阻络所致的头晕耳鸣,失眠多梦,健忘嗜卧,腰酸腿软,遗精早泄,不孕不育,高血压,中风后遗症,老年痴呆,帕金森氏病,震颤麻痹,多发硬化等,也可用于中年早衰或年老体弱等。
Description
技术领域
本发明涉及中药领域,具体涉及治疗肾虚精亏,气血不足,痰瘀阻络所致疾病的药物及其膏方制备方法。
背景技术
老年病的防治是老年保健的重要措施之一,《灵枢·天年篇》:“五十岁肝气始衰……,六十心气始衰……,七十岁脾气衰……,八十岁肺气虚……,九十岁肾气焦,四脏经脉空虚。”可见人体自五十岁后,五脏的功能减退,人体内阴阳逐渐失去平衡,多脏器虚损是老年人的生理特征,而体质减弱、机体功能减退、抗病能力低下等是其证候特征。现有治疗方案中多以补虚为主,忽视了老年人真气逐渐耗竭,五脏日益虚弱,气机滞塞升降失序导致痰瘀阻络灯因虚致实、虚实夹杂一系列复杂的病理变化。除此之外,老年人精血俱耗,脏腑日衰,致病则缠绵难愈而多枝蔓。攻补兼施和合理剂型,是现有老年病肾虚精亏,气血不足,痰瘀阻络所致疾病,尤其是脑部疾病的要素。
发明内容
本发明的技术任务是针对以上现有技术的不足,提供一种疗效肯定且副作用小的治疗肾虚精亏,气血不足,痰瘀阻络所致疾病的药物,该药物通过滋肾益髓,补气活血,化痰通络改善患者体质,使临床症状消失,且能预防疾病复发。
本发明解决其技术问题的技术方案是:一种补肾通络养脑膏,其特征在于该组合物由如下重量配比的原料药制成:西洋参8-10份、熟地25-30份、砂仁5-6份、山药20-22份、山茱萸8-10份、茯苓12-15份、丹皮12-15份、泽泻8-10份、枸杞子15-16份、菟丝子16-18份、灵芝8-10份、女贞子20-22份、旱莲草16-18份、桑椹子15-16份、桑螵蛸8-9份、益智仁8-10份、生黄芪20-22份、玉竹15-16份、百合15-16份、桃仁6-9份、红花6-9份、赤芍6-9份、川芎6-9份、柴胡6-9份、炒枳壳6-9份、怀牛膝20-22份、桔梗6-9份、节菖蒲12-15份、制远志6-9份、苍术6-9份、白术6-9份、莲子6-9份、焦山楂12-15份、神曲12-15份、炒谷芽15-16份、炒麦芽15-16份、陈皮8-10份、郁金12-15份、威灵仙16-18份、当归12-15份、制半夏6-9份、路路通8-10份、丹参20-22份、龟板胶20-22份、鳖甲胶20-22份、海龙1-2份、海马1-2份、三七粉4-5份、川贝粉3-5份、糖类30-60份、黄酒40-60份。
上述糖类为白文冰20~40份,饴糖10~22份。
上述糖类为糖醇类糖类。具体可以为木糖醇、山梨糖醇或麦芽糖醇。
上述的补肾通络养脑膏的制备方法,由以下步骤组成:
(1)清膏的制备:将熟地、山药、山茱萸、茯苓、丹皮、泽泻、枸杞子、菟丝子、灵芝、女贞子、旱莲草、桑椹子、桑螵蛸、益智仁、生黄芪、玉竹、百合、桃仁、红花、赤芍、川芎、柴胡、炒枳壳、怀牛膝、桔梗、节菖蒲、制远志、苍术、白术、莲子、焦山楂、神曲、炒谷芽、炒麦芽、陈皮、郁金、威灵仙、当归、制半夏、路路通、丹参,加水至水面高出药面5~10cm浸泡,冬季浸泡6-8小时,夏季2-3小时;然后加水煎煮2~3次,每次2~3h,砂仁浸泡后后入煎煮,合并煎液过滤,静置澄清8~12h,药液过100目药筛,90~110℃加热浓缩,并保持搅拌,得浓缩至相对密度为1.20~1.35的清膏;
(2)细料的制备:将西洋参、海龙、海马单独浸泡煎煮3次,合并煎液并浓缩;
(3)糖类的炼制:取糖类溶化,得炼糖备用;
(4)烊化胶的制备:取龟板胶、鳖甲胶粉碎成打成细粉,加入黄酒中浸泡2h后烊化,得烊化胶备用;
(5)药粉的制备:取三七、川贝,粉碎,过100目筛备用;
(6)收膏:将步骤2中所得的细料浓缩液、步骤3所得炼糖、步骤4所得的烊化胶倒入步骤1所得的清膏中,搅拌,75~100℃加热收膏,直至浓缩至相对密度1.35-1.40时停止加热,混入步骤5所得的药粉搅拌均匀、放置洁净通风区域;
(7)分装与凉膏:把熬好的膏剂分装;放置阴凉处过夜凉透,密封,即成。
优化方案中,步骤(3)糖类的炼制为:取白文冰、饴糖混合加水溶化,110℃~130℃加热,不断搅拌至开始显金黄色,泡发亮光及微有青烟发生,停止加热,得炼糖备用。
优化方案中,步骤(3)糖类的炼制为:取糖醇类糖类,用步骤(1)所得清膏溶化,得炼糖备用。
优化方案中,还包括蜂蜜的炼制:取蜂蜜,110℃~120℃加热,出现浅黄色有光泽的翻腾的均匀细气泡时停止加热,得炼蜜备用;并在收膏步骤中将所得炼蜜倒入步骤1所得的清膏中搅拌,75~100℃加热收膏。
其中所述的:
西洋参,为五加科植物西洋参Panax quinquefolium L.的干燥根。性味甘、微苦,凉。归经归心、肺、肾经。功能主治补气养阴,清热生津。
熟地,为玄参科植物地黄Rehmannia glutinosa Libosch.的块根经加工炮制而成。味甘;性温。归肝、肾经。功可补血滋润;益精填髓。
砂仁,为姜科植物阳春砂或缩砂的成熟果实或种子。性味辛,温。归脾、胃、肾经。功可化湿开胃,温脾止泻,理气安胎。
山药,为薯蓣科植物薯蓣Dioscorea opposita Thunb.的干燥根茎。性味甘,平。归脾、肺、肾经。功可补脾养胃,生津益肺,补肾涩精。
山茱萸,为山茱萸科植物山茱萸Cornus officinalis Sieb.et Zucc.的干燥成熟果肉。性味酸、涩,微温。归经归肝、肾经。功能主治补益肝肾,涩精固脱。
茯苓,为多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的干燥菌核。性味甘、淡,平。归心、肺、脾、肾经。功可利水渗湿,健脾宁心。
丹皮,为毛茛科植物牡丹Paeonia suffruticosa Andr.的干燥根皮。性味苦、辛,微寒。归心、肝、肾经。功可清热凉血,活血化瘀。
泽泻,为泽泻科植物泽泻Alisma orientalis(Sam.)Juzep.的干燥块茎。性味甘,寒。归肾、膀胱经。功可利小便,清湿热。
枸杞子,为茄科植物宁夏枸杞Lycium barbarum L.的干燥成熟果实。性味甘,平。归经归肝、肾经。功能主治滋补肝肾,益精明目。
菟丝子,为旋花科植物菟丝子Cuscuta chinensis Lam.的干燥成熟种子。性味甘,温。归肝、肾、脾经。功可滋补肝肾,固精缩尿,安胎,明目,止泻。
灵芝,为多孔菌科真菌赤芝Ganoderma lucidum(Leyss.ex Fr.)Karst.或紫芝Ganoderma sinense Zhao,Xu et Zhang干燥子实体。性味甘,平。归心、肺、肝、肾经。功可补气安神,止咳平喘。
女贞子,为木犀科植物女贞Ligustrum lucidum Ait.的干燥成熟果实。性味甘、苦,凉。归经归肝、肾经。功能主治滋补肝肾,明目乌发。
旱莲草,为菊科植物鳢肠Eclipta prostrata L.的干燥地上部分。性味甘、酸,寒。归经归肾、肝经。功能主治滋补肝肾,凉血止血。
桑椹子,为桑科植物桑Morus alba L.的果穗。性味甘;酸;性寒。归经肝;肾经。功能主治滋阴养血;生津;润肠。
桑螵蛸,为螳螂科昆虫大刀螂Tenodera sinensis Saussure、小刀螂Statiliamaculata(Thunberg)或巨斧螳螂Hierodula patellifera(Serville)的干燥卵鞘。性味甘、咸,平。归经归肝、肾经。功能主治益肾固精,缩尿,止浊。
益智仁,为姜科植物益智Alpinia oxyphylla Miq.的果实。性味味辛;性温。归经脾;肾经。功能主治温脾止泻摄涎;暖肾缩尿固精。
生黄芪,为豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao或膜荚黄芪Astragalus membranaceus(Fisch.)Bge.的干燥根。性味甘,温。归肺、脾经。功可补气固表,利尿托毒,排脓,敛疮生肌。
玉竹,为百合科植物玉竹Polygonatumodoratum(Mill.)Druce的干燥根茎。性味甘,微寒。归经归肺、胃经。功能主治养阴润燥,生津止渴。
百合,为百合科植物卷丹Lilium lancifoliumThunb.、百合Lilium browniiF.E.Brown var.viridulum Baker或细叶百合Lilium pumilum DC.的干燥肉质鳞叶。性味甘,寒。归经归心、肺经。功能主治养阴润肺,清心安神。
桃仁,为蔷薇科植物桃Prunus persica(L.)Batsch或山桃Prunus davidiana(Carr.)Franch.的干燥成熟种子。性味苦、甘,平。归经归心、肝、大肠经。功能主治活血祛瘀,润肠通便。
红花,为菊科植物红花Carthamus tinctorius L.的干燥花。性味辛,温。归经归心、肝经。功能主治活血通经,散瘀止痛。
赤芍,为毛茛科植物芍药Paeonia lactiflora Pall.或川赤芍Paeonia veitchiiLynch的干燥根。性味苦,微寒。归肝经。功可清热凉血,散瘀止痛。
川芎,为伞形科植物川芎Ligusticum chuanxiong Hort.(或Ligusticumwallichii Franch.)的干燥根茎。性味辛,温。归肝、胆、心包经。功可活血行气,祛风止痛。
柴胡,为伞形科植物柴胡Bupleurum chinense DC.或狭叶柴胡Bupleurumscorzonerifolium Willd.的干燥根。性味苦,微寒。归肝、胆经。功可和解表里,疏肝,升阳。
炒枳壳,为芸香科植物酸橙Citrus aurantium L.及其栽培变种的干燥未成熟果实。性味苦、辛、酸,温。归脾、胃经。功可理气宽中,行滞消胀。
怀牛膝,为苋科植物牛膝Achyranthes bidentata Blume.的干燥根。性味苦、酸,平。归经归肝、肾经。功能主治补肝肾,强筋骨,逐瘀通经,引血下行。
桔梗,为桔梗科植物桔梗Platycodon grandiflorum(Jacq.)A.DC.的干燥根。性味苦、辛,平。归肺经。功可宣肺,利咽,祛痰,排脓。
节菖蒲,为天南星科植物石菖蒲Acorus tatarinowii Schott的干燥根茎。性味辛、苦,温。归经归心、胃经。功能主治化湿开胃,开窍豁痰,醒神益智。
制远志,为远志科植物远志Polygala tenuifolia Willd.或卵叶远志Polygalasibirica L.的干燥根。性味苦、辛、温。归经归心、肾、肺经。功能主治安神益智,祛痰,消肿。
苍术,为菊科植物茅苍术Atractylodes lancea(Thunb.)DC.或北苍术Atractylodes chinensis(DC.)Koidz.的干燥根茎。性味辛、苦,温。归经归脾、胃、肝经。功能主治燥湿健脾,祛风散寒,明目。
白术,为菊科植物白术Atractylodes macrocephala Koidz.的干燥根茎。性味苦、甘,温。归脾、胃经。功可健脾益气,燥湿利水,止汗,安胎。
莲子,为睡莲科植物莲Nelumbo nucifera Gaertn.的干燥成熟种子除去莲心。性味甘、涩,平。归脾、肾、心经。功可补脾止泻,涩精,养心安神。
焦山楂,为蔷薇科植物山里红Crataegus pinnatifida Bge.var.major N.E.Br.或山楂Crataegus pinnatifida Bge.的干燥成熟果实,照清炒法炒至焦褐色。性味酸、甘、微温。归脾、胃、肝经。功可消食健胃,行气散瘀。
神曲,为辣蓼、青蒿、杏仁等药加入面粉或麸皮混和后,经发酵而成的曲剂,照清炒法炒至焦褐色。性味甘辛,温。入脾、胃经。功可健脾和胃,消食调中。
炒谷芽,为禾本科植物粟Setaria italica(L.)Beauv.的成熟果实经发芽干燥,照清炒法炒至焦褐色。性味甘,温。归脾、胃经。功可消食和中,健脾开胃。
炒麦芽,为禾本科植物大麦Hordeum vulgare L.的成熟果实经发芽干燥,照清炒法炒至焦褐色,放凉,筛去灰屑。性味甘,平。归脾、胃经。功可行气消食,健脾开胃,退乳消胀。
陈皮,为芸香科植物橘Citrus reticulata Blanco及其栽培变种的干燥成熟果皮。性味苦、辛,温。归肺、脾经。功可理气健脾,燥湿化痰。
郁金,为姜科植物温郁金Curcuma wenyujin Y.H.Chen et C.Ling、姜黄Curcumalonga L.、广西莪术Curcuma kwangsiensis S.G.Lee et C.F.Liang或蓬莪术Curcumaphaeocaulis Val.的干燥块根。性味辛、苦,寒。归肝、心、肺经。功可行气化瘀,清心解郁,利胆退黄。
威灵仙,为毛茛科植物威灵仙Clematis chinensis Osbeck、棉团铁线莲(山蓼)Clematis hexapetala Pall.或东北铁线莲(黑薇)Clematis manshurica Rupr.的干燥根及根茎。性味辛、咸,温。归经归膀胱经。功能主治祛风除湿,通络止痛。
当归,为伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根。性味甘、辛,温。归肝、心、脾经。功可补血活血,调经止痛,润肠通便。
制半夏,为天南星科植物半夏Pinellia ternata(Thunb.)Breit.的干燥块茎。性味辛,温;有毒。归经归脾、胃、肺经。功能主治燥湿化痰,降逆止呕,消痞散结。
路路通,为金缕梅科植物枫香树Liquidambar formosana Hance的干燥成熟果序。性味苦,平。归经归肝、肾经。功能主治祛风活络,利水通经。
丹参,为唇形科植物丹参Salvia miltiorrhiza Bunge.的干燥根及根茎。性味苦,微寒。归心、肝经。功可祛瘀止痛,活血通经,清心除烦。
龟板胶,为龟科动物乌龟的甲壳熬煮成的固体胶块。性偏平和,味甘而咸,功可滋阴,补血,止血。
鳖甲胶,为爬行纲龟鳖目鳖科中华鳖Amyda sinensis(Wiegmann),以背甲熬制成的膏入药。性味味咸;性微寒。归经肺;肝;肾经。功能主治滋阴退热;软坚散结。
海龙,为海龙科动物刁海龙Solenognathus hardwickii(Gray)、拟海龙Syngnathoides biaculeatus(Bloch)或尖海龙Syngnathus acus Linnaeus的干燥体。性味甘,温。归经归肝、肾经。功能主治温肾壮阳,散结消肿。
海马,为海龙科动物线纹海马Hippocampus kelloggi Jordan et Snyder、刺海马Hippocampus histrix Kaup、大海马Hippocampus kuda Bleeker、三斑海马Hippocampustrimaculatus Leach或小海马(海蛆)Hippocampus japonicus Kaup的干燥体。性味甘,温。归经归肝、肾经。功能主治温肾壮阳,散结消肿。
三七粉,为五加科植物三七Panax notoginseng(Burk.)F.H.Chen的干燥根粉碎后的粉末。性味甘、微苦,温。归经归肝、胃经。功能主治散瘀止血,消肿定痛。
川贝粉,为百合科植物川贝母Fritillaria cirrhosa D.Don、暗紫贝母Fritillaria unibracteata Hsiao et K.C.Hsia、甘肃贝母Fritillaria przewalskiiMaxim.或梭砂贝母Fritillaria delavayi Franch.的干燥鳞茎粉碎后的粉末。性味苦、甘,微寒。归经归肺、心经。功能主治清热润肺,化痰止咳。
白文冰为白沙糖煎炼而成的冰块状结晶。味甘,性平。入脾、肺二经。功可补中益气,和胃润肺。
饴糖为米、大麦、小麦、粟或玉蜀黍等粮食经发酵糖化制成的糖类食品。性味甘;温。归脾、胃、肺经。功可缓中、补虚、生津、润燥。
蜂蜜为蜜蜂科昆虫中华蜜蜂Apis cerana Fabricius或意大利蜂APis melliferaLinnaeus所酿的蜜。性味甘,平。归肺、脾、大肠经。功可补中,润燥,止痛,解毒。
黄酒为以大米、黍米为原料,酒精含量为14%~20%的低度酿造酒。
木糖醇(C5H12O5),又名戊五醇,,是一种五碳糖醇。木糖醇是木糖代谢的中间产物,外形为结晶性白色粉末,有吸湿性,无毒无异味,有甜味,极易溶于水,微溶于乙醇和甲醇。广泛存在于果品、蔬菜、谷类、蘑菇之类食物和木材、稻草、玉米芯等植物中。木糖醇可用作甜味剂、营养剂和药剂在化工、食品、医药等工业中广泛应用。
木糖醇、山梨糖醇和麦芽糖醇属于糖醇类糖类,热值较低,且作为一种功能性甜味剂,能参与人体代谢,进入血液后,糖醇可通过非胰岛素机制进入果糖代谢途径,实验证明它不会引起血糖升高,所以可以作为糖味成份用于合并糖尿病病人使用。
组方原理:既往中医治疗老年脑部疾病,重心多在于扶正,治疗方案中多以补虚为主,忽视了老年人真气逐渐耗竭,五脏日益虚弱,气机滞塞升降失序导致痰瘀阻络灯因虚致实、虚实夹杂一系列复杂的病理变化。除此之外,老年人精血俱耗,脏腑日衰,致病则缠绵难愈而多枝蔓。攻补兼施和合理剂型,是现有老年病肾虚精亏,气血不足,痰瘀阻络所致疾病,尤其是脑部疾病的要素。
所谓补,主要有以下方面:
①滋肾益髓:取淮山药、莲子肉健脾益肾,菟丝子、山茱萸、枸杞子、女贞子、旱莲草滋补肝肾,……培补肾阳,熟地、桑葚子、阿胶、龟板胶滋补肾阴;桑螵蛸、益智仁益肾固精;
②培补中焦:“厥阴不治,求之阳明”,“调其中气,使之和平”,调理中焦脾胃,以补后天之源,故方中取广陈皮理气健脾,黄芪、炒白术、西洋参健脾益气,茯苓健脾化湿,砂仁化湿开胃,焦谷芽、焦麦芽、焦山楂、焦神曲健胃消食,灵芝补气安神,饴糖、蜂蜜、白文冰缓中补虚;
③养阴活血:桑椹子、龟板胶滋阴养血,玉竹、百合养阴润燥,鳖甲胶滋阴退热;
④温肾壮阳:取少量的海龙、海马“阳中求阴”。
所谓攻,主要有以下方面:
①活血化瘀:老年病患者均有不同程度的微循环障碍,在脑病患者中尤其普遍存在,活血化瘀中药复方能改善血液循环及血管通透性,保护脑细胞,改善机体免疫功能,还可以促进结缔组织代谢,减轻结缔组织的水肿和纤维化,故方中取丹皮、丹参、桃仁清热凉血,三七粉活血化瘀,赤芍清热凉血,郁金行气化瘀,当归补血活血,川芎、红花活血通经,牛膝补肝肾逐瘀通经,黄酒活血;
②化痰通络:苍术、白术、陈皮、制半夏燥湿健脾,泽泻清利湿热,桔梗宣开气机,节菖蒲、远志开窍豁痰,威灵仙、路路通除湿通络,川贝粉润肺化痰;
③调达气机:气机壅滞,清阳不升,浊阴不降,湿浊互结,壅滞中焦,土壅木郁,升降反作治当升清降浊,调达气机,故方中取郁金、柴胡行气解郁,白芍柔肝止痛,枳壳行滞消胀。
具体实施方式
以下结合实际情况,对本发明的具体实施方式作详细说明。
实施例1,原料药重量配比:西洋参100g、熟地300g、砂仁50g、山药200g、山茱萸100g、茯苓120g、丹皮120g、泽泻100g、枸杞子150g、菟丝子180g、灵芝100g、女贞子200g、旱莲草180g、桑椹子150g、桑螵蛸90g、益智仁100g、生黄芪200g、玉竹150g、百合150g、桃仁60g、红花60g、赤芍90g、川芎90g、柴胡60g、炒枳壳60g、怀牛膝200g、桔梗60g、节菖蒲120g、制远志60g、苍术90g、白术90g、莲子50g、焦山楂120g、神曲120g、炒谷芽150g、炒麦芽150g、陈皮100g、郁金120g、威灵仙180g、当归120g、制半夏60g、路路通100g、丹参200g、龟板胶200g、鳖甲胶200g、海龙20g、海马20g、三七粉45g、川贝粉30g、白文冰300g、饴糖200g、黄酒400ml。
实施例2,原料药重量配比:西洋参80g、熟地300g、砂仁50g、山药200g、山茱萸80g、茯苓150g、丹皮150g、泽泻80g、枸杞子150g、菟丝子180g、灵芝80g、女贞子200g、旱莲草180g、桑椹子150g、桑螵蛸90g、益智仁80g、生黄芪200g、玉竹150g、百合150g、桃仁60g、红花90g、赤芍60g、川芎90g、柴胡60g、炒枳壳90g、怀牛膝200g、桔梗90g、节菖蒲150g、制远志60g、苍术60g、白术90g、莲子60g、焦山楂150g、神曲150g、炒谷芽150g、炒麦芽150g、陈皮80g、郁金150g、威灵仙180g、当归150g、制半夏90g、路路通80g、丹参200g、龟板胶200g、鳖甲胶200g、海龙10g、海马20g、三七粉50g、川贝粉30g、白文冰400g、饴糖100g、黄酒500ml。
实施例3,原料药重量配比:西洋参100g、熟地250g、砂仁50g、山药220g、山茱萸100g、茯苓120g、丹皮120g、泽泻100g、枸杞子150g、菟丝子180g、灵芝100g、女贞子220g、旱莲草180g、桑椹子150g、桑螵蛸80g、益智仁100g、生黄芪220g、玉竹150g、百合150g、桃仁90g、红花60g、赤芍90g、川芎60g、柴胡90g、炒枳壳60g、怀牛膝220g、桔梗60g、节菖蒲120g、制远志90g、苍术90g、白术60g、莲子90g、焦山楂120g、神曲120g、炒谷芽150g、炒麦芽150g、陈皮100g、郁金120g、威灵仙180g、当归120g、制半夏60g、路路通100g、丹参220g、龟板胶220g、鳖甲胶220g、海龙20g、海马10g、三七粉40g、川贝粉50g、白文冰250g、饴糖220g、黄酒400ml。
实施例4,原料药重量配比:西洋参100g、熟地300g、砂仁60g、山药200g、山茱萸100g、茯苓100g、丹皮100g、泽泻100g、枸杞子160g、菟丝子160g、灵芝100g、女贞子200g、旱莲草160g、桑椹子160g、桑螵蛸90g、益智仁100g、生黄芪200g、玉竹160g、百合160g、桃仁60g、红花60g、赤芍90g、川芎90g、柴胡60g、炒枳壳60g、怀牛膝200g、桔梗60g、节菖蒲100g、制远志60g、苍术90g、白术90g、莲子60g、焦山楂100g、神曲100g、炒谷芽160g、炒麦芽160g、陈皮100g、郁金100g、威灵仙160g、当归100g、制半夏60g、路路通100g、丹参200g、龟板胶200g、鳖甲胶200g、海龙20g、海马20g、三七粉45g、川贝粉30g、白文冰200g、饴糖200g、黄酒600ml。
实施例1~4的中药膏方的制作经过备料、浸泡、煎煮、浓缩、收膏、存放等几道工序,具体按照下列方法制备而成:
(1)清膏的制备:将熟地、山药、山茱萸、茯苓、丹皮、泽泻、枸杞子、菟丝子、灵芝、女贞子、旱莲草、桑椹子、桑螵蛸、益智仁、生黄芪、玉竹、百合、桃仁、红花、赤芍、川芎、柴胡、炒枳壳、怀牛膝、桔梗、节菖蒲、制远志、苍术、白术、莲子、焦山楂、神曲、炒谷芽、炒麦芽、陈皮、郁金、威灵仙、当归、制半夏、路路通、丹参,加水至水面高出药面5~10cm浸泡,冬季浸泡6-8小时,夏季2-3小时;用药铲翻动药材,浸泡至厚片无白心即可;然后加水煎煮2~3次,每次2~3h,砂仁浸泡后后入煎煮,合并煎液过滤,静置澄清8~12h,药液过100目药筛,90~110℃加热浓缩,并保持搅拌,得浓缩至相对密度为1.20~1.35的清膏;
(2)细料的制备:将西洋参、海龙、海马单独浸泡煎煮3次,合并煎液并浓缩;
(3)糖类的炼制:取糖类溶化,得炼糖备用;
(4)烊化胶的制备:取龟板胶、鳖甲胶粉碎成打成细粉,加入黄酒中浸泡2h后烊化,得烊化胶备用;
(5)药粉的制备:取三七、川贝,粉碎,过100目筛备用;
(6)收膏:将步骤2中所得的细料浓缩液、步骤3所得炼糖、步骤4所得的烊化胶倒入步骤1所得的清膏中,搅拌,75~100℃加热收膏,直至浓缩成夏季挂线,冬季挂旗的状态(相对密度约1.35-1.40)时停止加热,混入步骤5所得的药粉搅拌均匀、放置洁净通风区域;
(7)分装与凉膏:把熬好的膏剂装入灭菌后的瓷罐中或用膏方包装机打包,贴好标签;放置阴凉处过夜凉透,密封,即成。
优化方案中,步骤(3)糖类的炼制为:取白文冰、饴糖混合加水溶化,110℃~130℃加热,不断搅拌至开始显金黄色,泡发亮光及微有青烟发生,停止加热,得炼糖备用。
优化方案中,步骤(3)糖类的炼制为:取糖醇类糖类,用步骤(1)所得清膏溶化,得炼糖备用。
优化方案中,还包括蜂蜜的炼制:取蜂蜜,110℃~120℃加热,出现浅黄色有光泽的翻腾的均匀细气泡时停止加热,得炼蜜备用;并在收膏步骤中将所得炼蜜倒入步骤1所得的清膏中搅拌,75~100℃加热收膏。
上述药物的有效组合,互相协调,滋肾益髓,补气活血,化痰通络,有效达到治疗中老年病症所致的头晕耳鸣,失眠多梦,健忘嗜卧,腰酸腿软,遗精早泄之目的,且副作用较少。上述结果为临床资料充分证明,有关资料如下。
1对象与方法。
1.1对象。
1.1.1病例选择:2015年10月~2017年1月老年病门诊辩证为“肾虚精亏,气血不足,痰瘀阻络”的患者204例,其中年龄为56~85(69.7±6.1)岁;男性108例,女性96例。其中症状包括:头晕耳鸣,失眠多梦,健忘嗜卧,腰酸腿软,遗精早泄。证候评定标准依从:《中医内科病证诊断疗效标准》(ZY/T001.1-94)。
1.1.2分组:随机分为三组,其中对照组102例,膏方组102例,散剂灌肠组102例。两组患者在性别、年龄、病情分布上比较,差异无统计学意义(P>0.05),具有可比性。
1.2方法。
1.2.1治疗方法:对照组服用五子衍宗丸,膏方组服用本发明实施例1中所得药物。以两个月为一个疗程。
1.2.2观察指标:观察三组患者治疗前后症状、体征和实验室指标,填写《中药新药临床疗效评价量表》。
1.2.3疗效判定标准:根据《中药新药疗效评定标准》,痊愈:临床症状、体征消失,实验室指标恢复正常;显效:临床症状、体征基本好转,实验室指标明显改善;有效:临床症状、体征减轻,实验室指标有所改善;无效:临床症状、体征和实验室指标无变化。
1.2.4统计学分析:SPSS 18.0进行统计学分析。计量资料用t检验,计数资料用χ2检验。
2结果。
2.1两组临床综合疗效比较:
组别 | 例数 | 治愈 | 显效 | 有效 | 无效 | 总有效率 | 治愈率 | 愈显率 |
对照组 | 102 | 23 | 33 | 37 | 9 | 91.18% | 22.55% | 54.90% |
膏方组 | 102 | 36 | 38 | 26 | 2 | 98.04% | 35.29% | 72.55% |
治疗2个月后,膏方组治愈率和总有效率对照组比较,具有显著性统计学差异(χ2=4.02,P<0.05;χ2=4.71,P<0.05);膏方组愈显率和对照组比较,具有极其显著性统计学差异(χ2=6.87,P<0.01)。
2.2三组患者药物相关不良反应发生率比较:三组患者均未出现明显药物相关不良反应,治疗前后血尿常规、肝肾功能无明显变化。
3.结论。
本研究结果显示,使用本发明口服可以明显改善肾虚精亏,气血不足,痰瘀阻络中老年患者症状和体征,并具有不良反应较轻、安全性较高的优点。
Claims (8)
1.一种补肾通络养脑膏,其特征在于该组合物由如下重量配比的原料药制成:西洋参8-10份、熟地25-30份、砂仁5-6份、山药20-22份、山茱萸8-10份、茯苓12-15份、丹皮12-15份、泽泻8-10份、枸杞子15-16份、菟丝子16-18份、灵芝8-10份、女贞子20-22份、旱莲草16-18份、桑椹子15-16份、桑螵蛸8-9份、益智仁8-10份、生黄芪20-22份、玉竹15-16份、百合15-16份、桃仁6-9份、红花6-9份、赤芍6-9份、川芎6-9份、柴胡6-9份、炒枳壳6-9份、怀牛膝20-22份、桔梗6-9份、节菖蒲12-15份、制远志6-9份、苍术6-9份、白术6-9份、莲子6-9份、焦山楂12-15份、神曲12-15份、炒谷芽15-16份、炒麦芽15-16份、陈皮8-10份、郁金12-15份、威灵仙16-18份、当归12-15份、制半夏6-9份、路路通8-10份、丹参20-22份、龟板胶20-22份、鳖甲胶20-22份、海龙1-2份、海马1-2份、三七粉4-5份、川贝粉3-5份、糖类30-60份、黄酒40-60份。
2.根据权利要求1所述的一种补肾通络养脑膏,其特征在于:所述糖类为白文冰20~40份,饴糖10~22份。
3.根据权利要求1所述的一种补肾通络养脑膏,其特征在于:所述糖类为糖醇类糖类。
4.根据权利要求3所述的一种补肾通络养脑膏,其特征在于:所述糖类为木糖醇、山梨糖醇或麦芽糖醇。
5.一种制备权利要求1所述的补肾通络养脑膏的制备方法,由以下步骤组成:
(1)清膏的制备:将熟地、山药、山茱萸、茯苓、丹皮、泽泻、枸杞子、菟丝子、灵芝、女贞子、旱莲草、桑椹子、桑螵蛸、益智仁、生黄芪、玉竹、百合、桃仁、红花、赤芍、川芎、柴胡、炒枳壳、怀牛膝、桔梗、节菖蒲、制远志、苍术、白术、莲子、焦山楂、神曲、炒谷芽、炒麦芽、陈皮、郁金、威灵仙、当归、制半夏、路路通、丹参,加水至水面高出药面5~10cm浸泡,冬季浸泡6-8小时,夏季2-3小时;然后加水煎煮2~3次,每次2~3h,砂仁浸泡后后入煎煮,合并煎液过滤,静置澄清8~12h,药液过100目药筛,90~110℃加热浓缩,并保持搅拌,得浓缩至相对密度为1.20~1.35的清膏;
(2)细料的制备:将西洋参、海龙、海马单独浸泡煎煮3次,合并煎液并浓缩;
(3)糖类的炼制:取糖类溶化,得炼糖备用;
(4)烊化胶的制备:取龟板胶、鳖甲胶粉碎成打成细粉,加入黄酒中浸泡2h后烊化,得烊化胶备用;
(5)药粉的制备:取三七、川贝,粉碎,过100目筛备用;
(6)收膏:将步骤2中所得的细料浓缩液、步骤3所得炼糖、步骤4所得的烊化胶倒入步骤1所得的清膏中,搅拌,75~100℃加热收膏,直至浓缩至相对密度1.35-1.40时停止加热,混入步骤5所得的药粉搅拌均匀、放置洁净通风区域;
(7)分装与凉膏:把熬好的膏剂分装;放置阴凉处过夜凉透,密封,即成。
6.根据权利要求5所述的一种补肾通络养脑膏的制备方法,其特征在于:步骤(3)糖类的炼制为:取白文冰、饴糖混合加水溶化,110℃~130℃加热,不断搅拌至开始显金黄色,泡发亮光及微有青烟发生,停止加热,得炼糖备用。
7.根据权利要求4所述的一种补肾通络养脑膏的制备方法,其特征在于:步骤(3)糖类的炼制为:取糖醇类糖类,用步骤(1)所得清膏溶化,得炼糖备用。
8.根据权利要求4所述的任意一种补肾通络养脑膏的制备方法,其特征在于:还包括蜂蜜的炼制:取蜂蜜,110℃~120℃加热,出现浅黄色有光泽的翻腾的均匀细气泡时停止加热,得炼蜜备用;并在收膏步骤中将所得炼蜜倒入步骤1所得的清膏中搅拌,75~100℃加热收膏。
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