CN104398601A - Medicine composition for treating insomnia and preparation method for medicine composition - Google Patents

Medicine composition for treating insomnia and preparation method for medicine composition Download PDF

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Publication number
CN104398601A
CN104398601A CN201410685210.9A CN201410685210A CN104398601A CN 104398601 A CN104398601 A CN 104398601A CN 201410685210 A CN201410685210 A CN 201410685210A CN 104398601 A CN104398601 A CN 104398601A
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extract
reflux
preparation
herba calthae
ether
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CN201410685210.9A
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CN104398601B (en
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马慧
张寿涛
林绪涛
张贞美
赵洁
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Secret Biography (Beijing) Technology Co., Ltd.
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Binzhou Medical University Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/35Extraction with lipophilic solvents, e.g. Hexane or petrol ether
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

The invention discloses a medicine composition for treating insomnia and a preparation method for the medicine composition. The medicine composition is prepared from a ligularia fischeri extract and pharmaceutically available auxiliary materials, wherein the ligularia fischeri extract is ether extract of ligularia fischeri. The preparation method comprises the following steps: performing reflux extraction on ligularia fischeri by using petroleum ether, filtering, discarding the filtrate, and performing reflux extraction on the obtained filter residue by using ether to obtain the medicine composition. By adopting the medicine composition, not only is the fall-asleep time shortened, that is, the sleep induction period is shortened, but also the sleep time is prolonged, and the sleep depth is increased.

Description

Pharmaceutical composition of a kind of Cure for insomnia and preparation method thereof
Technical field
The invention belongs to active components of plants extractive technique field, in particular to a kind of pharmaceutical composition and preparation method thereof of Cure for insomnia.
Background technology
Insomnia is one of clinical modal symptom; starting and maintaining generation obstacle of sleep; sleep quality can not meet Human Physiology needs, thus affects normal activity on daytime, occurs a kind of sleep disorder syndrome of the symptoms such as fatigue, aprosexia, bradykinesia.Modern life rhythm is more and more faster, and many people have the immense pressure from various aspects, and ortho sleep be can not be guaranteed, and have groups of people cannot fall asleep because pressure is huge.Frequent insomnia causes that absent minded, understandability declines, the learning efficiency reduces, hypomnesis, thus affect the duty of people, long-time insomnia also can reduce the immunity of body, cause endocrine disturbance, easily bring out and increase the weight of gastrointestinal disease, infectious disease, cardiovascular and cerebrovascular disease etc.For alleviating these pressure, insomniac often relies on hypnotic drug to fall asleep, the Benzodiazepines sedative hypnotic such as diazepam, but these medicines also bring a lot of side effect, as additive, drug resistance, chronic toxicity while help is fallen asleep.And continuous application easily produces giddy, the untoward reaction such as drowsiness, weak.There are some researches show that many Chinese herbal medicine have good sedative-hypnotic effect, and untoward reaction is less, without additive, therefore, from natural plants, finds new sedative hypnotic drug seem and be even more important.
Herba Calthae is the herb of cohosh kincup, belongs to perennial herb, high 40 ~ 60 centimetres; Rhizome is sturdy, crawls.Stem purple, hollow, normal branch; Basal leaf oval or heart, diameter 5 ~ 12 centimetres, edge tool rough sawn tooth, base portion is deeply heart-shaped, and two sides is without hair; Long 6 ~ 15 centimetres of petiole, purple green; Stem leaf and basal leaf similar shape, tool stipule, the leaf tool handle of bottom, upper leaf stockless.Uniparous cyme is born in stem or branch top, brightly yellowish color, diameter 1.6 ~ 3.2 centimetres; Sepal 5, petal-shaped, ovum shape is oval, is about 1 ~ 1.8 centimetre; Without petal; Stamen is most, and flower pesticide is yellow; Carpel number is piece from life; Follicle radish fruit oblong, be about 1 centimetre, tip becomes hook-shaped, green.Seed is most, kidney shape oblong, and there is longitudinal grin on surface, and brown is glossy; 4 ~ May of florescence; Really 6 ~ July of phase.At present, there is no effect that bibliographical information Herba Calthae extract has tranquilizing soporific.
Summary of the invention
The object of the present invention is to provide a kind of tranquilizing soporific Be very effective, untoward reaction is less, without addicted pharmaceutical composition and its preparation method and application.
In order to realize object of the present invention, inventor, by lot of experiments research also persistent exploration, finally obtains following technical scheme:
A pharmaceutical composition for Cure for insomnia, by Herba Calthae extract and pharmaceutically can adjuvant be prepared from, described Herba Calthae extract is the ether extract of Herba Calthae.It should be noted that, according to the common process of formulation art, such as direct powder compression, wet granule compression tablet method etc., those skilled in the art is easy to adjuvant available on gained Herba Calthae extract and pharmaceutics is prepared into conventional oral formulations, as granule, tablet, capsule, pill, oral liquid etc.Wherein, available on pharmaceutics adjuvant comprises filler, disintegrating agent, binding agent, correctives, lubricant.
Present invention also offers the preparation method of described Herba Calthae extract, the method comprises the steps: to take Herba Calthae medical material, load in reflux, extract, device, add petroleum ether, to put under 70-80 DEG C of water bath with thermostatic control environment reflux, extract, 1-5 time, each 0.5-2.5h, filter, filtrate discards after reclaiming petroleum ether, and filtering residue is after volatilization removing petroleum ether, load in reflux, extract, device, add ether, to put under 38-45 DEG C of water bath with thermostatic control environment reflux, extract, 1-5 time, each 0.5-2.5h, filter, after concentrating filter liquor drying, obtain Herba Calthae ether extract.When the present invention prepares Herba Calthae ether extract, selected medical material is the herb before cohosh kincup blooms.
Preferably, the preparation method of Herba Calthae extract as above, wherein petroleum ether add volume be the 5-15 of quality of medicinal material doubly (L/kg), more preferably 7-8 is doubly (L/kg).
Preferably, the preparation method of Herba Calthae extract as above, wherein ether add volume be the 6-12 of quality of medicinal material doubly (L/kg), more preferably 7-8 is doubly (L/kg).
Preferably, the preparation method of Herba Calthae extract as above, wherein soaks 5-60min by medical material, more preferably 30-40min before each reflux, extract.
Preferably, the preparation method of Herba Calthae extract as above, the number of times that wherein petroleum ether or aether backflow are extracted is 2-4 time, and extraction time successively decreases successively.
In several embodiments on ground preferred for this invention, the preparation method of Herba Calthae extract as above, the number of times that wherein petroleum ether or aether backflow are extracted is 3 times, and the 1st reflux, extract, is l.0-1.5h, 2nd reflux, extract, 0.7-1.0h, the 3rd reflux, extract, 0.4-0.6h.
The present invention adopts organic solvent to screen Herba Calthae sedative-hypnotic effect position, shown by a large amount of animal experiment, Herba Calthae ether extract prepared by the present invention prolonged sleep time to mice is the longest, other solvent extractable matter effects are more weak, may not contain the relatively rare pass of amount of effective ingredient or contained effective ingredient by extract part therewith.Therefore, another object of the present invention is to provide a kind of pharmaceutical applications, that is: above-mentioned Herba Calthae extract is for the preparation of the application in the medicine of tranquilizing soporific or health product.
Advantage of the present invention is the Be very effective of tranquilizing soporific, can not only shorten time for falling asleep, namely shortens the sleep derivation phase, and can extend the length of one's sleep, and deepen Depth of sleep.In addition, medicine of the present invention, without obvious toxic-side effects, can not cause drug dependence through life-time service, and raw material sources are extensive simultaneously, and preparation technology is simple, and without the need to main equipment, production cost is low.
Detailed description of the invention
Be below preparation embodiment and the effect test example of Herba Calthae of the present invention each live part extract dry extract, technical scheme of the present invention and technique effect are described further and are explained.When the present invention prepares Herba Calthae ether extract, selected medical material is the herb before cohosh kincup blooms.
Embodiment 1: the preparation of Herba Calthae ether extract
Accurately take dry Herba Calthae medical material 0.5kg, chopping, load in 6L round-bottomed flask, petroleum ether is added with the solid-liquid ratio of 1:8 (kg:L), after soaking 30min, to put in 75 DEG C of thermostat water baths reflux, extract, 3 times, 1st reflux, extract, lh, 2nd reflux, extract, 45min, 3rd reflux, extract, 30min, filter, filtrate discards after reclaiming petroleum ether, filtering residue is after volatilization removing petroleum ether, load in 6L round-bottomed flask, ether is added with the solid-liquid ratio of 1:8 (kg:L), after soaking 30min, to put in 40 DEG C of thermostat water baths reflux, extract, 3 times, 1st reflux, extract, 1h, 2nd reflux, extract, 45min, 3rd reflux, extract, 30min, filter, merge 3 extracting solution, filtrate is decompression and solvent recovery on a rotary evaporator, concentrated solution obtains dark brown dry extract after volatilizing solvent, be weighed as 27.53g, yield is 5.51%.
Embodiment 2: the preparation of Herba Calthae ether extract
Accurately take dry Herba Calthae medical material 1.0kg, chopping, load in 10L round-bottomed flask, petroleum ether is added with the solid-liquid ratio of 1:7 (kg:L), after soaking 45min, to put in 75 DEG C of thermostat water baths reflux, extract, 3 times, 1st reflux, extract, l.5h, 2nd reflux, extract, 1h, 3rd reflux, extract, 30min, filter, filtrate discards after reclaiming petroleum ether, filtering residue is after volatilization removing petroleum ether, load in 6L round-bottomed flask, ether is added by the solid-liquid ratio of 1:7 (kg:L), after soaking 45min, to put in 40 DEG C of thermostat water baths reflux, extract, 3 times, 1st reflux, extract, 1.5h, 2nd reflux, extract, 1h, 3rd reflux, extract, 30min, filter, merge 3 extracting solution, filtrate is decompression and solvent recovery on a rotary evaporator, concentrated solution obtains dark brown dry extract after volatilizing solvent, be weighed as 53.70g, yield is 5.37%.
Comparative example 1: the preparation of Herba Calthae ethanol extraction
Accurately take dry Herba Calthae medical material 0.5kg, chopping, load in 6L round-bottomed flask, petroleum ether is added with the solid-liquid ratio of 1:8 (kg:L), after soaking 30min, to put in 75 DEG C of thermostat water baths reflux, extract, 3 times, 1st reflux, extract, lh, 2nd reflux, extract, 45min, 3rd reflux, extract, 30min, filter, filtrate discards after reclaiming petroleum ether, filtering residue is after volatilization removing petroleum ether, load in 6L round-bottomed flask, ethanol is added by the solid-liquid ratio of 1:8 (kg:L), after soaking 30min, to put in 90 DEG C of thermostat water baths reflux, extract, 3 times, 1st reflux, extract, 1h, 2nd reflux, extract, 45min, 3rd reflux, extract, 30min, filter, merge 3 extracting solution, filtrate is decompression and solvent recovery on a rotary evaporator, concentrated solution obtains dark brown dry extract after volatilizing solvent, be weighed as 60.18g, yield is 12.04%.
Comparative example 2: the preparation of Herba Calthae ethyl acetate extract
Accurately take dry Herba Calthae medical material 0.5kg, chopping, load in 6L round-bottomed flask, petroleum ether is added with the solid-liquid ratio of 1:8 (kg:L), after soaking 30min, to put in 75 DEG C of thermostat water baths reflux, extract, 3 times, 1st reflux, extract, lh, 2nd reflux, extract, 45min, 3rd reflux, extract, 30min, filter, filtrate discards after reclaiming petroleum ether, filtering residue is after volatilization removing petroleum ether, load in 6L round-bottomed flask, ethyl acetate is added with the solid-liquid ratio of 1:8 (kg:L), after soaking 30min, to put in 85 DEG C of thermostat water baths reflux, extract, 3 times, 1st reflux, extract, 1h, 2nd reflux, extract, 45min, 3rd reflux, extract, 30min, filter, merge 3 extracting solution, filtrate is decompression and solvent recovery on a rotary evaporator, concentrated solution obtains dark brown dry extract after volatilizing solvent, be weighed as 31.44g, yield is 6.29%.
Embodiment 3 Herba Calthae extract is to the experimental study of Sedative And Hypnotic Effect
Cleaning grade Kunming mouse 50, male and female half and half, body weight (20 ± 2) g.Be divided into blank group, positive controls, ether extract group, ethanol extraction group, ethyl acetate extract group at random, often organize 10 animals, male and female half and half.Ether extract group gives Herba Calthae ether extract 40.0mg/kg prepared by the embodiment of the present invention 1, ethanol extraction group gives above-mentioned comparative example 1 the Herba Calthae ethanol extraction 40.0mg/kg of preparation, ethyl acetate extract group gives above-mentioned comparative example 2 the Herba Calthae ethyl acetate extract 40.0mg/kg of preparation, positive controls gives diazepam 2mg/kg, and blank group gives isopyknic normal saline; Each group of equal gastric infusion, every day 1 time, continuous 3 days, gavage volume 15ml/kg.Stand number of times and the movable number of times of 5min put into case with mice autonomic activities instrument record mice after second day administration 60min after.After last administration 60min, each group of mice equal lumbar injection pentobarbital sodium 50mg/kg, sleep is index with righting reflex loss, more than 30s person is kept with the downward posture of animal back, be judged as righting reflex loss, record injection pentobarbital sodium after to mice sleeping duration as dropping asleep latency, and observed and recorded righting reflex loss to awakening time as the prolonged sleep time.
Can be found out by the result of the test of table 1, except ether extraction beyond the region of objective existence, the solvent extractable matter of other Herba Calthaes almost without impact, improves the frequency of mice autonomic activities on normal mouse autonomic activities even to a certain extent, in addition, in the prolonged sleep time, ether extract, ethanol extraction and ethyl acetate extract group more obviously extend with blank group, but only have ether extract group the most remarkable on the impact of prolonged sleep time, compare with blank group and there is pole significant difference (P<0.01), compare with positive controls and there is significant difference (P<0.05), ether extract group shortens dropping asleep latency simultaneously, with blank group or positive controls, more all there is significant difference (P<0.05).
Table 1 is respectively organized mice autonomic activities and is compared the length of one's sleep
Compare with blank group, p < 0.05, ★ ★p < 0.01; Compare with positive controls, p < 0.05, ▼ ▼p < 0.01.

Claims (8)

1. a pharmaceutical composition for Cure for insomnia, by Herba Calthae extract and pharmaceutically can adjuvant be prepared from, it is characterized in that, described Herba Calthae extract is the ether extract of Herba Calthae.
2. the preparation method of Herba Calthae extract according to claim 1, it is characterized in that, the method comprises the steps: to take Herba Calthae medical material, load in reflux, extract, device, add petroleum ether, to put under 70-80 DEG C of water bath with thermostatic control environment reflux, extract, 1-5 time, each 0.5-2.5h, filter, filtrate discards after reclaiming petroleum ether, filtering residue is after volatilization removing petroleum ether, load in reflux, extract, device, add ether, to put under 38-45 DEG C of water bath with thermostatic control environment reflux, extract, 1-5 time, each 0.5-2.5h, filter, Herba Calthae ether extract is obtained after concentrating filter liquor drying.
3. the preparation method of Herba Calthae extract according to claim 2, is characterized in that, petroleum ether add volume be the 5-15 of quality of medicinal material doubly.
4. the preparation method of Herba Calthae extract according to claim 2, is characterized in that, ether add volume be the 6-12 of quality of medicinal material doubly.
5. the preparation method of Herba Calthae extract according to claim 2, is characterized in that, before each reflux, extract, medical material is soaked 5-60min.
6. the preparation method of Herba Calthae extract according to claim 2, is characterized in that, the number of times that petroleum ether or aether backflow are extracted is 2-4 time, and extraction time successively decreases successively.
7. the preparation method of Herba Calthae extract according to claim 6, is characterized in that, the number of times that petroleum ether or aether backflow are extracted is 3 times, the 1st reflux, extract, l.0-1.5h, the 2nd reflux, extract, 0.7-1.0h, the 3rd reflux, extract, 0.4-0.6h.
8. Herba Calthae extract according to claim 1 is for the preparation of the application in the medicine of tranquilizing soporific or health product.
CN201410685210.9A 2014-11-25 2014-11-25 A kind of pharmaceutical composition treating insomnia and preparation method thereof Active CN104398601B (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102397503A (en) * 2011-10-09 2012-04-04 邓华伦 Chinese herbal medicine for treating insomnia

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102397503A (en) * 2011-10-09 2012-04-04 邓华伦 Chinese herbal medicine for treating insomnia

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
云南省药物研究所编著: "《云南天然药物图鉴》", 31 May 2004, article "马鞍叶", pages: 73 *
李经纬等主编: "《中医大辞典》", 31 May 1995, article "夜合叶根", pages: 970 *
郜红利等: "土家苗药夜关门对小鼠实验性失眠的疗效观察与机制初探", 《中成药》, vol. 36, no. 2, 28 February 2014 (2014-02-28), pages 383 - 385 *

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Inventor after: Zhang Shoutao

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Inventor after: Lin Xutao

Inventor after: Sun Huili

Inventor after: Shang Yimei

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Address after: 100016 Beijing Chaoyang District Jiuxianqiao East Road, No. 9 Courtyard, Building 3, 301, 30

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Address before: 256603 No. 661 No. 2 Huanghe Road, Bincheng District, Binzhou City, Shandong Province

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