CN104491738A - 一种治疗失眠的中药及其制备方法 - Google Patents
一种治疗失眠的中药及其制备方法 Download PDFInfo
- Publication number
- CN104491738A CN104491738A CN201410844654.2A CN201410844654A CN104491738A CN 104491738 A CN104491738 A CN 104491738A CN 201410844654 A CN201410844654 A CN 201410844654A CN 104491738 A CN104491738 A CN 104491738A
- Authority
- CN
- China
- Prior art keywords
- parts
- radix
- chinese medicine
- insomnia
- rhizoma
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/65—Amphibians, e.g. toads, frogs, salamanders or newts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/285—Aucklandia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/57—Magnoliaceae (Magnolia family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/62—Nymphaeaceae (Water-lily family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/69—Polygalaceae (Milkwort family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
- A61K36/725—Ziziphus, e.g. jujube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/79—Schisandraceae (Schisandra family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/804—Rehmannia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/808—Scrophularia (figwort)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K36/815—Lycium (desert-thorn)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/84—Valerianaceae (Valerian family), e.g. valerian
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8967—Lilium, e.g. tiger lily or Easter lily
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了一种治疗失眠的中药及其制备方法,涉及中药技术领域,该中药的原料有:当归、生地、远志、玄参、哈蟆油、红蚂蚁、五味子、杞子、莲子心、白术、百合、酸枣仁、榆叶、橘皮、缬草、木香、黄莲花、藏红花、郁金、甘草等20种中药材。该中药对失眠有良好的治疗效果,并且其制备工艺简单、制剂稳定、易于推广应用。
Description
技术领域
本发明属于中药领域,具体涉及一种治疗失眠的中药及其制备方法。
技术背景
失眠是由于情志、饮食内伤,或病后及年迈,禀赋不足,心虚胆怯等病因,引起心神失养或心神不安,从而导致经常不能获得正常睡眠为特征的一类病症。主要表现为睡眠时间、深度的不足以及不能消除疲劳、恢复体力与精力,轻者入睡困难,或寐而不酣,时寐时醒,或醒后不能再寐,重则彻夜不寐。失眠是临床常见病症之一,虽不属于危重疾病,但妨碍人们正常生活、工作、学习和健康,并能加重或诱发心悸、胸痹、眩晕、头痛、中风病等病症。顽固性的失眠,给病人带来长期的痛苦,甚至形成对安眠药物的依赖,而长期服用安眠药物又可引起医源性疾病。
现在的治疗失眠的医学手段包括:心理催眠疗法、心理仪器疗法、物理治疗和中医的药(热)熨疗法、食物疗法及药物治疗,但在疗效和治疗质量上,不尽如人意,因此,寻找一种疗效好、无副作用、操作简便的治疗失眠的药物已十分迫切。
发明内容
本发明所要解决的技术问题在于,提供一种能够安全、有效的治疗失眠的中药组合物。
发明人依据多年的中医临床经验和现代人的患病特点,认为失眠的基本病机是:肝郁化火、痰热内绕、瘀扰心神、阴虚火旺、心脾两虚、心胆气虚。为了解决上述问题,发明人提供了一种治疗失眠的中药组合物,由如下重量份的中药材制备而成:当归10-15份、生地15-18份、远志15-18份、玄参9-13份、哈蟆油8-12份、红蚂蚁3-5份、五味子10-15份、杞子10-15份、莲子心10-15份、白术10-15份、百合8-12份、酸枣仁15-18份、榆叶8-12份、橘皮10-15份、缬草8-12份、木香8-12份、黄莲花10-15份、藏红花5-8份、郁金8-12份、甘草10-15份。
在临床实践摸索过程中,发现如下2个配比效果最好,分别为:
配比1:当归13份、生地16份、远志17份、玄参12份、哈蟆油10份、红蚂蚁4份、五味子12份、杞子12份、莲子心13份、白术13份、百合10份、酸枣仁16份、榆叶10份、橘皮14份、缬草10份、木香10份、黄莲花13份、藏红花6份、郁金10份、甘草14份。
配比2:当归12份、生地16份、远志17份、玄参9份、哈蟆油12份、红蚂蚁4份、五味子12份、杞子12份、莲子心14份、白术13份、百合10份、酸枣仁17份、榆叶8份、橘皮14份、缬草11份、木香11份、黄莲花14份、藏红花7份、郁金11份、甘草11份。
发明人为解决上述技术问题,还发明了将本发明中药组方制成方便易用的中药成品制剂的制备工艺,该工艺为以下步骤:
(1)按本发明中药配比称取各味中药材;
(2)取当归、生地、远志、玄参、五味子、杞子、莲子心、白术、百合、酸枣仁、榆叶、橘皮、缬草、木香、黄莲花、藏红花、郁金、甘草放入容器中,第一次加8-11倍量蒸馏水浸泡5-10小时,回流煎煮2-4小时,过滤;第二次加初始药材重量5-8倍量蒸馏水回流煎煮1-3小时,过滤;合并两次滤液,将滤液浓缩成干浸膏,烘干,粉碎,过120目筛,得细粉a,备用;
(3)取红蚂蚁,烘干,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、b混合均匀,加入哈蟆油拌匀吸干,加入辅料制成临床需要的中药剂型,如片剂、丸剂、颗粒剂、胶囊剂、散剂、糖浆剂等。
本发明所用中药材的来源、特点、性味归经及功效:
当归:补血药;补血、活血、调经止痛、润燥滑肠,主治血虚诸证;月经不调;经闭;痛经;症瘕结聚;崩漏;虚寒腹痛;痿痹;肌肤麻木;肠燥便难;赤痢后重;痈疽疮疡;跌扑损伤。选伞形科植物当归的干燥根。
生地:本品为玄参科植物地黄的新鲜或干燥块根。味甘,性寒;归心、肝、肾经;清热凉血,养阴,生津。
远志:味苦、辛、性温;归心、肾、肺经;安神益智,祛痰,消肿。本品为远志科植物远志或卵叶远志的干燥根。
玄参:凉血滋阴,泻火解毒。主治:温热病热和营血、身热、烦渴、舌绛、发斑、骨蒸劳嗽、虚烦不寤、津伤便秘、目涩昏花、咽喉喉肿痛、瘰疬痰核、痈疽疮毒。选玄参科植物玄参的干燥根。
蛤蟆油:补肾益精,养阴润肺。用于阴虚体弱,神疲乏力,心悸失眠,盗汗不止,痨嗽咳血。选蛙科动物中国林蛙雌蛙的输卵管,经采制干燥而得。
红蚂蚁具有明显的抗炎、平喘、镇静、护肝、镇痛作用。对类风湿性关节炎、风湿症、坐骨神经疼、恶性肿瘤、慢性肝炎、肺结核、神经官能症、缺铁性贫血等均有较好疗效。
五味子:味酸、甘,性温;归肺,心、肾经;收敛固涩,益气生津,补肾宁心。选木兰科植物五味子或华中五味子的干燥成熟果实。
杞子: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。选茄科植物宁夏枸杞的果实。
莲子心:清心醒脾,补脾止泻,养心安神明目、补中养神,健脾补胃,止泻固精,益肾涩精止带。滋补元气。主治:心烦失眠,脾虚久泻,大便溏泄,久痢,腰疼,男子遗精,妇人赤白带下。还可预防早产、流产、孕妇腰酸,具有防癌抗癌的营养保健功能。选睡莲科植物莲的成熟种子中的幼叶及胚根。
白术:补脾,益胃,燥湿,和中,安胎。治脾胃气弱,不思饮食,倦怠少气,虚胀,泄泻,痰饮,水肿,黄疸,湿痹,小便不利,头晕,自汗,胎气不安。选菊科植物白术的干燥根茎。
百合:养阴润肺,清心安神。用于阴虚久咳,痰中带血,虚烦惊悸,失眠多梦,精神恍惚。选百合科植物卷丹、百合或细叶百合的干燥肉质鳞叶。
酸枣仁:味甘、酸,性平;归肝、胆、心经;补肝,宁心,敛汗,生津。选鼠李科植物酸枣的干燥成熟种子。
榆叶:清热利尿;安神;祛痰止咳。主水肿;小便不利;石淋;尿浊;失眠;暑热困闷;痰多咳嗽;酒(查皮)鼻。选榆科植物榆树的叶。
橘皮:理气,调中,燥湿,化痰。治胸腹胀满,不思饮食,呕吐哕逆,咳嗽痰多。亦解鱼、蟹毒。选芸香科植物福橘或朱橘等多种橘类的果皮。
缬草:安神,理气,止痛。用于神经衰弱,失眠,癔病,癫痫,胃腹胀痛,腰腿痛,跌打损伤。选败酱科缬草属植物缬草及黑水缬草的根状茎及根入药。
木香:味辛、苦,性温;归脾、胃、大肠、三焦、胆经;行气止痛,健脾消食。选菊科植物木香的干燥根。
黄莲花:镇静;降压。主高血压;头痛;失眠。选报春花科植物黄连花的带根全草。
藏红花:活血化瘀,散郁开结。治忧思郁结,胸膈痞闷,吐血,伤寒发狂,惊怖恍惚,妇女经闭,产后瘀血腹痛,跌扑肿痛。选鸢尾科植物番红花花柱的上部及柱头。
郁金:味辛、苦,性寒;归肝、心、肺经;行气化瘀,清心解郁,利胆退黄。选姜科植物温郁金、姜黄、广西莪术或蓬莪术的干燥块根。
甘草:味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。选豆科植物甘草、胀果甘草或光果甘草的干燥根。
本发明中药组合物为天然纯中药制剂,各组分相互协调,共同作用,可以补心益脾、安神宁心,从而对失眠有良好的治疗效果;本发明中药组合物的制备工艺简单易操作,无不良反应,副作用小,患者用药安全,显著提高了患者的生活质量。
具体实施方式
实施例1
(1)称取各味中药材:当归13份、生地16份、远志17份、玄参12份、哈蟆油10份、红蚂蚁4份、五味子12份、杞子12份、莲子心13份、白术13份、百合10份、酸枣仁16份、榆叶10份、橘皮14份、缬草10份、木香10份、黄莲花13份、藏红花6份、郁金10份、甘草14份;
(2)取上述当归、生地、远志、玄参、五味子、杞子、莲子心、白术、百合、酸枣仁、榆叶、橘皮、缬草、木香、黄莲花、藏红花、郁金、甘草放入容器中,第一次加10倍量蒸馏水浸泡8小时,回流煎煮3小时,过滤;第二次加初始药材重量6倍量蒸馏水回流煎煮2小时,过滤;合并两次滤液,将滤液浓缩成干浸膏,烘干,粉碎,过120目筛,得细粉a,备用;
(3)取上述红蚂蚁,烘干,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、b混合均匀,加入哈蟆油拌匀吸干,加入辅料制成临床颗粒剂,折合生药含量约为0.24g生药/g颗粒。
实施例2
(1)称取各味中药材:当归12份、生地16份、远志17份、玄参9份、哈蟆油12份、红蚂蚁4份、五味子12份、杞子12份、莲子心14份、白术13份、百合10份、酸枣仁17份、榆叶8份、橘皮14份、缬草11份、木香11份、黄莲花14份、藏红花7份、郁金11份、甘草11份;
(2)取上述当归、生地、远志、玄参、五味子、杞子、莲子心、白术、百合、酸枣仁、榆叶、橘皮、缬草、木香、黄莲花、藏红花、郁金、甘草放入容器中,第一次加9倍量蒸馏水浸泡6小时,回流煎煮4小时,过滤;第二次加初始药材重量7倍量蒸馏水回流煎煮1.5小时,过滤;合并两次滤液,将滤液浓缩成干浸膏,烘干,粉碎,过120目筛,得细粉a,备用;
(3)取上述红蚂蚁,烘干,研磨,过120目筛,得细粉b,备用;
(4)、将细粉a、b混合均匀,加入哈蟆油拌匀吸干,加入辅料制成临床颗粒剂,折合生药含量约为0.24g生药/g颗粒。
实施例3
(1)称取各味中药材:当归10份、生地15份、远志15份、玄参9份、哈蟆油8份、红蚂蚁3份、五味子10份、杞子10份、莲子心10份、白术10份、百合8份、酸枣仁15份、榆叶8份、橘皮10份、缬草8份、木香8份、黄莲花10份、藏红花5份、郁金8份、甘草10份;
(2)取上述当归、生地、远志、玄参、五味子、杞子、莲子心、白术、百合、酸枣仁、榆叶、橘皮、缬草、木香、黄莲花、藏红花、郁金、甘草放入容器中,第一次加11倍量蒸馏水浸泡8小时,回流煎煮4小时,过滤;第二次加初始药材重量8倍量蒸馏水回流煎煮2小时,过滤;合并两次滤液,将滤液浓缩成干浸膏,烘干,粉碎,过120目筛,得细粉a,备用;
(3)取上述红蚂蚁,烘干,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、b混合均匀,加入哈蟆油拌匀吸干,加入辅料制成临床颗粒剂,折合生药含量约为0.24g生药/g颗粒。
实施例4
(1)称取各味中药材:当归15份、生地18份、远志18份、玄参13份、哈蟆油12份、红蚂蚁5份、五味子15份、杞子15份、莲子心15份、白术15份、百合12份、酸枣仁18份、榆叶12份、橘皮15份、缬草12份、木香12份、黄莲花15份、藏红花8份、郁金12份、甘草15份;
(2)取上述当归、生地、远志、玄参、五味子、杞子、莲子心、白术、百合、酸枣仁、榆叶、橘皮、缬草、木香、黄莲花、藏红花、郁金、甘草放入容器中,第一次加8倍量蒸馏水浸泡5小时,回流煎煮2小时,过滤;第二次加初始药材重量5倍量蒸馏水回流煎煮3小时,过滤;合并两次滤液,将滤液浓缩成干浸膏,烘干,粉碎,过120目筛,得细粉a,备用;
(3)取上述红蚂蚁,烘干,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、b混合均匀,加入哈蟆油拌匀吸干,加入辅料制成临床颗粒剂,折合生药含量约为0.24g生药/g颗粒。
实施例5本发明中药颗粒剂的动物毒性试验
(1)试验药品:本发明实施例1-4所制得中药颗粒剂,用纯化水按1:1调制成溶液。试验所用动物:普通级NIH小鼠,体重21g±5g,雌雄各半,雌性小鼠均无孕;SD大鼠,初始体重215g±7g,雌雄各半,雌性大鼠均无孕。
(2)急性毒性试验
应用小鼠进行急性毒性实验表明:小鼠灌胃调制好的中药溶液,在759.6g生药/kg剂量下,给药后小鼠出现轻微活动减少,1小时左右恢复正常,给药后连续观察7天,无一小鼠死亡,且全身状况、饮食、摄水、小便和体重增长均正常。实验结果表明:小鼠灌胃本发明的中药颗粒剂的最大给药量为759.6g生药/kg/d(LD50>759.6g生药/kg)。本发明的中药制剂每日临床用药总量为0.12g生药/kg/d;按体重计,小鼠灌胃本发明中药制剂的耐受量为临床病人的6330倍。提示该药急性毒性极低,临床用药安全。
(3)长期毒性试验
选用SD大鼠,给予三种剂量的本发明中药颗粒剂:21.6g生药/kg、7.2g生药/kg、2.4g生药/kg(单位体重给药量按临床用药量的20倍计算,临床用药量依据《中华人民共和国药典》2010 年版一部)。每天灌胃一次,连续90天,末次给药后24小时各组活杀1/2动物(雌雄各半),其余1/2动物继续观察2周后活杀。试验期间观察动物的外观、一般行为、摄食量、体重变化;给药后90天和停药2周进行血液学(RBC、HB、网织红细胞、PLT、CT、WBC及分类)和血液生化(AST、ALT、ALP、Glu、BUN、Crea、TP、T.BIL、ALB、CHOL)、尿液生化、脏器系数、病理组织学等指标检查。
试验结果表明:本发明的中药制剂在高、中、低剂量组动物一般状态良好,外观体征、行为活动、进食量和体重增长均无异常变化;三个剂量组及对照组血液学检查、血液生化学、尿液生化检查均在正常范围,组间无显著差异;各组主要脏器组织病理学检查未见明显异常。上述指标停药2周后也未见改变。本试验用药剂量分别为临床用药剂量的180、60、20倍,根据试验结果:本发明中药制剂在高、中、低三个剂量(21.6g生药/kg、7.2g生药/kg、2.4g生药/kg)连续90天给药对大鼠无明显影响,无明确的毒性靶器官和敏感指标,恢复期观察也未见延迟性毒性反应,提示本发明的中药制剂临床应用的剂量安全性很高。
实施例6、临床效果试验
1、受试者资料
受试者均来自某市中医院2012年6月至2014年2月收治的失眠患者,从中遴选出适合试验的患者123例,其中男52例,年龄17-69岁,女71例,年龄16-72岁。根据患病轻重、年龄、性别将受试者均分成3个组,分别编号为对照组、实验1组、实验2组,每组41人。
2、试验方法
(1)对照组服用艾司唑仑片(山东省平原制药厂,国药准字H37023047),每日3次,每次1mg。
(2)实验1组、实验2组分别服用本发明实施例1、2所制得的中药颗粒,每日2次,每次15g(折合生药为3.6g)。
(3)2周为一个疗程,连续治疗3个疗程。治疗过程中痊愈者可随时脱离治疗,同时记录患者的身体状况、不良反应等情况。对治愈者在6个月后跟踪回访,记录复发者。
3、评价标准
(1)治愈:失眠症状完全消失,醒后头脑清爽,气色好;
(2)显效:失眠症状有所缓解,气色变好,仍需继续治疗;
(3)无效:失眠症状没有任何改善,头脑昏沉,气色差;
(4)不良反应:服药后出现腹痛、头晕、恶心、呕吐等不适。
4、试验结果统计分析
试验全部结束后,对试验记录数据进行统计分析,见表1。
表1 试验结果统计分析表
5、试验结论
从试验结果可以看出,服用本发明中药制剂的患者没有出现不良反应;平均治愈率(73.15%)是对照组的1.9倍,平均总有效率(95.95%)比对照组高22.75%。因此,从这些数据可以看出,本发明中药制剂特别是实施例1、实施例2制备的制剂具有十分显著的技术优势,获得了出人意料的技术成果。
Claims (5)
1.一种治疗失眠的中药,其特征在于由如下重量份的中药材制备而成:当归10-15份、生地15-18份、远志15-18份、玄参9-13份、哈蟆油8-12份、红蚂蚁3-5份、五味子10-15份、杞子10-15份、莲子心10-15份、白术10-15份、百合8-12份、酸枣仁15-18份、榆叶8-12份、橘皮10-15份、缬草8-12份、木香8-12份、黄莲花10-15份、藏红花5-8份、郁金8-12份、甘草10-15份。
2.根据权利要求1所述治疗失眠的中药,其特征在于由如下重量份的中药材制备而成:当归13份、生地16份、远志17份、玄参12份、哈蟆油10份、红蚂蚁4份、五味子12份、杞子12份、莲子心13份、白术13份、百合10份、酸枣仁16份、榆叶10份、橘皮14份、缬草10份、木香10份、黄莲花13份、藏红花6份、郁金10份、甘草14份。
3.根据权利要求1所述治疗失眠的中药,其特征在于由如下重量份的中药材制备而成:当归12份、生地16份、远志17份、玄参9份、哈蟆油12份、红蚂蚁4份、五味子12份、杞子12份、莲子心14份、白术13份、百合10份、酸枣仁17份、榆叶8份、橘皮14份、缬草11份、木香11份、黄莲花14份、藏红花7份、郁金11份、甘草11份。
4.一种如权利要求1-3任一所述治疗失眠的中药的制备方法,其特征在于包括以下步骤:
(1)按本发明中药配比称取各味中药材;
(2)取当归、生地、远志、玄参、五味子、杞子、莲子心、白术、百合、酸枣仁、榆叶、橘皮、缬草、木香、黄莲花、藏红花、郁金、甘草放入容器中,第一次加8-11倍量蒸馏水浸泡5-10小时,回流煎煮2-4小时,过滤;第二次加初始药材重量5-8倍量蒸馏水回流煎煮1-3小时,过滤;合并两次滤液,将滤液浓缩成干浸膏,烘干,粉碎,过120目筛,得细粉a,备用;
(3)取红蚂蚁,烘干,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、b混合均匀,加入哈蟆油拌匀吸干,加入辅料制成临床需要的中药剂型,如片剂、丸剂、颗粒剂、胶囊剂、散剂、糖浆剂等。
5.权利要求1-3任一所述治疗失眠的中药在制备治疗失眠药物中的应用。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410844654.2A CN104491738A (zh) | 2014-12-31 | 2014-12-31 | 一种治疗失眠的中药及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410844654.2A CN104491738A (zh) | 2014-12-31 | 2014-12-31 | 一种治疗失眠的中药及其制备方法 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN104491738A true CN104491738A (zh) | 2015-04-08 |
Family
ID=52933252
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201410844654.2A Withdrawn CN104491738A (zh) | 2014-12-31 | 2014-12-31 | 一种治疗失眠的中药及其制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN104491738A (zh) |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102861228A (zh) * | 2012-10-24 | 2013-01-09 | 田胜硕 | 一种治疗失眠的中药组合物 |
-
2014
- 2014-12-31 CN CN201410844654.2A patent/CN104491738A/zh not_active Withdrawn
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102861228A (zh) * | 2012-10-24 | 2013-01-09 | 田胜硕 | 一种治疗失眠的中药组合物 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN103690919A (zh) | 用于治疗仔猪缺铁性贫血的药物及其制备方法 | |
CN104491801A (zh) | 一种治疗急慢性胃炎的中药制剂及其制备方法 | |
CN103041256B (zh) | 一种治疗小儿反复呼吸道感染的中药制剂 | |
CN103585479A (zh) | 用于治疗缺铁性贫血的补血丸和补血胶囊 | |
CN103041257B (zh) | 治疗小儿发热高烧呼吸道感染的中药制剂 | |
CN104491236A (zh) | 一种治疗原发性高血压的中药制剂及其制备方法 | |
CN103977281A (zh) | 一种治疗女性内分泌失调的中药组合物及其制备方法 | |
CN103877486A (zh) | 用于促升放化疗后白细胞数量的药物及其制备方法 | |
CN103520668B (zh) | 一种治疗心气不足证型胸痹心痛的中药 | |
CN103041255B (zh) | 治疗小儿咽喉肿痛呼吸道感染的中药制剂 | |
CN102743579B (zh) | 一种益气补血中药丸及其制备工艺 | |
CN104887950A (zh) | 一种治疗乳痈的中药组合物 | |
CN104826076A (zh) | 一种治疗妊娠咳嗽的中药制剂及其制备方法 | |
CN104547859A (zh) | 一种中药制剂用于制备治疗慢性气管炎药物中的用途 | |
CN106620475B (zh) | 一种防治糖尿病认知障碍的中药组合物及制备方法 | |
CN104306847A (zh) | 一种六味补气胶囊及其制备工艺 | |
CN104623615A (zh) | 一种治疗哮喘的药物 | |
CN104435962A (zh) | 用于治疗仔猪消化不良性下痢的药物组合物及其制备方法 | |
CN104645080A (zh) | 一种治疗眩晕的中药制剂及其制备方法 | |
CN116139236B (zh) | 一种治疗肝郁型失眠症的中药组合物及其应用 | |
CN103705857B (zh) | 用于预防放射性口腔粘膜反应的中药组合物 | |
CN104491738A (zh) | 一种治疗失眠的中药及其制备方法 | |
CN103041258B (zh) | 治疗小儿呼吸道感染伴纳差不食的中药制剂 | |
CN106668762A (zh) | 一种具有祛黄褐斑、疮毒和痤疮的中药制剂 | |
CN104826080A (zh) | 一种治疗心绞痛的中药制剂 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
CB03 | Change of inventor or designer information | ||
CB03 | Change of inventor or designer information |
Inventor after: Zhang Xiuju Inventor after: Qiao Hongbo Inventor before: Cui Hefang |
|
WW01 | Invention patent application withdrawn after publication | ||
WW01 | Invention patent application withdrawn after publication |
Application publication date: 20150408 |