CN105853573A - Pharmaceutical composition for improving female climacteric insomnia and preparing method and application thereof - Google Patents
Pharmaceutical composition for improving female climacteric insomnia and preparing method and application thereof Download PDFInfo
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- CN105853573A CN105853573A CN201610235985.5A CN201610235985A CN105853573A CN 105853573 A CN105853573 A CN 105853573A CN 201610235985 A CN201610235985 A CN 201610235985A CN 105853573 A CN105853573 A CN 105853573A
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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)
- A61K36/80—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)
- A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
-
- 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)
- A61K36/40—Cornaceae (Dogwood 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- 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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- 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
- 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 or 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
Landscapes
- 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 relates to a pharmaceutical composition for improving female climacteric insomnia and a preparing method and application thereof. The pharmaceutical composition comprises, by weight, 1-9 parts of prepared rehmannia roots, 1-9 parts of radix achyranthis bidentatae, 1-9 parts of dogwood, 1-6 parts of spina date seeds, 1-6 parts of silktree albizzia bark and 1-6 parts of moutan bark. The disease cause of female climacteric insomnia is analyzed according to the theory of traditional Chinese medicine, prepared rehmannia roots, radix achyranthis bidentatae, dogwood, spina date seeds, silktree albizzia bark and moutan bark are selected as raw materials, the ratio of all the raw materials is further optimized and selected, all the raw materials in the pharmaceutical composition are in coordination with each other and jointly act according to the compatibility relationship, the pharmaceutical composition has the effects of nourishing the liver and the kidney, quieting the heart and calming the nerves, and the effect of improving female climacteric insomnia is played accordingly; the pharmaceutical composition only comprises the six raw materials, the composition is simple, and cost is low.
Description
Technical field
The invention belongs to medicine or field of health care products, be specifically related to a kind of pharmaceutical composition improving Menopause insomnia and preparation method thereof and purposes.
Background technology
Climacteric refer to women from there being the fecundity transition stage to apogeny, between the 45-55 year typically betiding women.In this stage, there is change in menstrual cycle characteristics in women, such as polymenorrhea, Hypomenorrhea, irregular menses and amenorrhoea etc..Simultaneously, there is the light or heavy syndrome based on vegetative nerve functional disturbance because of changing of Function of Ovary in climacteric women, prominent performance be paramenia, whole body warm, blush perspiration, fidgety, irritability, have a headache, have a sleepless night, uncomfortable in chest, palpitaition, depression, waist joint pain.Insomnia is one of puzzlement chronic disease of highlighting the most of climacteric women.
In recent years, due to aging population, rhythm of life is accelerated, social pressures strengthen, and the illness rate of Menopause insomnia has the trend of rising.The normal work of Menopause insomnia not only impact, living and studying, and the multiple diseases such as cardiovascular and cerebrovascular disease, hypertension, breast cancer, diabetes may be further resulted in.
Chinese patent literature CN104689042A discloses a kind of Chinese medicine treating Menopause insomnia, and its bulk drug consists of: 140-200 gram of Poria cocos, root bark of Chinese wolf-berry 140-200 gram, RADIX POLYGONI MULTIFLORI PREPARATA 105-150 gram, cortex albiziae 140-200 gram, Polygonum multiflower knotweed 140-200 gram, bighead atractylodes rhizome 105-150 gram, Radix Angelicae Sinensis 140-200 gram, root of herbaceous peony 140-200 gram, lily 140-200 gram, cape jasmine 70-100 gram, yncaria stem with hooks 70-100 gram.But, above-mentioned composition exists and forms the shortcomings such as complicated, relatively costly, thus limits its application.
Therefore, study that novel result for the treatment of is good, toxic and side effect is little, it is simple to form, the lower-cost pharmaceutical composition improving Menopause insomnia significant.
Summary of the invention
Therefore, the present invention provides that a kind of result for the treatment of is good, toxic and side effect is little, it is simple to form, the lower-cost pharmaceutical composition improving Menopause insomnia, and then provides its preparation method and purposes.
For solving above-mentioned technical problem, the present invention is achieved through the following technical solutions:
The present invention provides a kind of pharmaceutical composition improving Menopause insomnia, and the raw material of described pharmaceutical composition consists of:
Prepared rhizome of rehmannia 1~9 weight portion, the root of bidentate achyranthes 1~9 weight portion, Fructus Corni 1~9 weight portion, spina date seed 1~6 weight portion, cortex albiziae 1-6 weight portion, moutan bark 1-6 weight portion.
Preferably, the above-mentioned pharmaceutical composition improving Menopause insomnia of the present invention, the raw material of described pharmaceutical composition consists of:
Prepared rhizome of rehmannia 3~6 weight portion, the root of bidentate achyranthes 3~6 weight portion, Fructus Corni 3~6 weight portion, spina date seed 2~5 weight portion, cortex albiziae 1~3 weight portion, moutan bark 1~3 weight portion.
It is further preferred that the above-mentioned pharmaceutical composition improving Menopause insomnia of the present invention, the raw material of described pharmaceutical composition consists of:
Prepared rhizome of rehmannia 4 weight portion, the root of bidentate achyranthes 3 weight portion, Fructus Corni 3 weight portion, spina date seed 3 weight portion, cortex albiziae 2 weight portion, moutan bark 2 weight portion;Or
Prepared rhizome of rehmannia 4 weight portion, the root of bidentate achyranthes 4 weight portion, Fructus Corni 4 weight portion, spina date seed 3 weight portion, cortex albiziae 2 weight portion, moutan bark 2 weight portion;Or
Prepared rhizome of rehmannia 3 weight portion, the root of bidentate achyranthes 6 weight portion, Fructus Corni 3 weight portion, spina date seed 5 weight portion, cortex albiziae 1 weight portion, moutan bark 3 weight portion;Or
Prepared rhizome of rehmannia 6 weight portion, the root of bidentate achyranthes 3 weight portion, Fructus Corni 6 weight portion, spina date seed 2 weight portion, cortex albiziae 3 weight portion, moutan bark 1 weight portion.
The present invention also provides for the preparation method of the above-mentioned pharmaceutical composition improving Menopause insomnia, comprises the following steps:
Taking the prepared rhizome of rehmannia of selected weight portion, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and moutan bark, heating and refluxing extraction at least 1 time respectively, the water every time adding 2~12 weight times amount extracts at least 0.5h, merge extract, filtering, concentrating the filtrate to 80 DEG C of relative densities is 1.10-1.30, to obtain final product.
It is further preferred that the preparation method of the above-mentioned pharmaceutical composition improving Menopause insomnia of the present invention, comprise the following steps:
Taking the prepared rhizome of rehmannia of selected weight portion, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and moutan bark, heating and refluxing extraction 1~3 times respectively, the water every time adding 5~9 weight times amount extracts 0.5~3h, merge extract, filtering, concentrating the filtrate to 80 DEG C of relative densities is 1.10-1.30, to obtain final product.
It is further preferred that the preparation method of the above-mentioned pharmaceutical composition improving Menopause insomnia of the present invention, comprise the following steps:
Take the prepared rhizome of rehmannia of selected weight portion, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and moutan bark respectively, heating and refluxing extraction 2 times, the water adding 8 weight times amount for 1st time extracts 2h, the water adding 6 weight times amount for 2nd time extracts 2h, merge extract, filtering, concentrating the filtrate to 80 DEG C of relative densities is 1.15-1.25, to obtain final product.
The present invention also provides for including the preparation of the above-mentioned pharmaceutical composition improving Menopause insomnia or includes the preparation of pharmaceutical composition that above-mentioned preparation method prepares,
Described pharmaceutical composition adds customary adjuvant, according to common process, makes the most acceptable tablet, capsule, powder, mixture, pill, granule, oral liquid, syrup, paste, electuary, vina, injection or beverage.
The application in preparation improves the medicine of Menopause insomnia or health products of the present invention also provides for aforementioned pharmaceutical compositions, above-mentioned preparation method prepares pharmaceutical composition or the preparation of aforementioned pharmaceutical compositions.
Described customary adjuvant is: filler, disintegrant, lubricant, suspending agent, adhesive, sweetener, flavouring, preservative, matrix etc..Filler includes: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose etc.;Disintegrant includes: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, PVPP, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose are received;Lubricant includes: magnesium stearate, lauryl sodium sulfate, talcum powder, silica etc.;Suspending agent includes: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methyl cellulose etc.;Adhesive includes, starch slurry, polyvinylpyrrolidone, hydroxypropyl methyl cellulose etc.;Sweetener includes: saccharin sodium, aspartame, sucrose, honey element, enoxolone etc.;Flavouring includes: sweetener and various essence;Preservative includes: parabens, benzoic acid, Sodium Benzoate, sorbic acid and its esters, benzalkonium bromide, fixed, the eucalyptus oil of acetic acid chloroethene etc.;Matrix includes: PEG6000, PEG4000, insect wax etc..
For traditional Chinese medical science angle, menopausal syndrome is to cause a disease to suffer from a deficiency of the kidney as this;Kidney storing essence, grows again the source of reproduction for growth in humans, for the root of vital movement, referred to as the congenital foundation.As "Nei Jing" is sayed: " woman seventy-seven, and kidney qi declines, the menopause, and taichong channel declines few, menostasia, shape is bad and s.m.p also." hyperactivity of heart-liver fire is the mark of pathology;Heart governing blood and vessels and house mind, liver controlling conveyance and dispersion and hide soul, the climacteric deficiency of the kidney yin, the not good fire of water, internal heat is the most prosperous, causes warming the diseases such as perspiration, insomnia and dreamful sleep.
[prepared rhizome of rehmannia] is warm in nature, and taste is sweet, returns Liver Channel, kidney channel, has enriching yin of enriching blood, benefit essence fills out effect of marrow.
[root of bidentate achyranthes] property is put down, bitter, sweet, sour, returns Liver Channel, kidney channel, have stimulate the menstrual flow by the stasis of blood, filling liver kidney, strengthening the bones and muscles, effect of inducing diuresis for treating strangurtia.
[Fructus Corni] slightly warm in nature, taste is sour, puckery, returns Liver Channel, kidney channel, has tonifying the liver and kidney, restrains admittedly de-effect.
[spina date seed] property is put down, and taste is sweet, sour, thoughts of returning home warp, Liver Channel, gallbladder channel, the spleen channel, has effect of antitoxic heart-soothing and sedative, nourishing the liver, arrest sweating.
[cortex albiziae] property is put down, and taste is sweet, thoughts of returning home warp, Liver Channel, has effect of resolving stagnation for tranquilization, activating blood circulation and reducing swelling.
[moutan bark] is cool in nature, be slightly cold, and taste is pungent, bitter, thoughts of returning home warp, Liver Channel, kidney channel, lung channel, have clearing heat and cooling blood, activate blood circulation and disperse blood clots, effect of reducing the asthenic fever.
Technical scheme has the advantage that
(1) the Menopause insomnia cause of disease is analyzed by the present invention according to theory of traditional Chinese medical science, selecting prepared rhizome of rehmannia, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and moutan bark is raw material, one-step optimization of going forward side by side selects the proportioning of each raw material, in this pharmaceutical composition, each raw material cooperates according to compatibility relationship, jointly acts on, there is nourishing liver and kidney, effect of antitoxic heart-soothing and sedative, thus play the effect improving Menopause insomnia;
(2) composition of the present invention, only includes six kinds of raw materials, and composition is simple, cost is relatively low.
Detailed description of the invention
Embodiment
1
The raw material of the pharmaceutical composition that the present embodiment improves Menopause insomnia consists of: prepared rhizome of rehmannia 4g, root of bidentate achyranthes 3g, Fructus Corni 3g, spina date seed 3g, cortex albiziae 2g, moutan bark 2g;
The preparation method of this pharmaceutical composition, comprise the following steps: take the prepared rhizome of rehmannia of selected weight, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and moutan bark respectively, heating and refluxing extraction 2 times, the water adding 8 weight times amount for 1st time extracts 2h, the water adding 6 weight times amount for 2nd time extracts 2h, merges extract, filters, concentrating the filtrate to 80 DEG C of relative densities is 1.15-1.25, to obtain final product.
The present embodiment improves the pharmaceutical composition of Menopause insomnia, adds customary adjuvant, according to common process, makes granule.
Embodiment
2
The raw material of the pharmaceutical composition that the present embodiment improves Menopause insomnia consists of: prepared rhizome of rehmannia 4g, root of bidentate achyranthes 4g, Fructus Corni 4g, spina date seed 3g, cortex albiziae 2g, moutan bark 2g;
The preparation method of this pharmaceutical composition, comprise the following steps: take the prepared rhizome of rehmannia of selected weight, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and moutan bark respectively, heating and refluxing extraction 2 times, the water adding 8 weight times amount for 1st time extracts 2h, the water adding 6 weight times amount for 2nd time extracts 2h, merges extract, filters, concentrating the filtrate to 80 DEG C of relative densities is 1.15-1.25, to obtain final product.
The present embodiment improves the pharmaceutical composition of Menopause insomnia, adds customary adjuvant, according to common process, makes tablet.
Embodiment
3
The raw material of the pharmaceutical composition that the present embodiment improves Menopause insomnia consists of: prepared rhizome of rehmannia 3g, root of bidentate achyranthes 6g, Fructus Corni 3g, spina date seed 5g, cortex albiziae 1g, moutan bark 3g;
The preparation method of this pharmaceutical composition, comprise the following steps: take the prepared rhizome of rehmannia of selected weight, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and moutan bark respectively, heating and refluxing extraction 2 times, the water adding 8 weight times amount for 1st time extracts 2h, the water adding 6 weight times amount for 2nd time extracts 2h, merges extract, filters, concentrating the filtrate to 80 DEG C of relative densities is 1.15-1.25, to obtain final product.
The present embodiment improves the pharmaceutical composition of Menopause insomnia, adds customary adjuvant, according to common process, makes capsule.
Embodiment
4
The raw material of the pharmaceutical composition that the present embodiment improves Menopause insomnia consists of: prepared rhizome of rehmannia 6g, root of bidentate achyranthes 3g, Fructus Corni 6g, spina date seed 2g, cortex albiziae 3g, moutan bark 1g;
The preparation method of this pharmaceutical composition, comprise the following steps: take the prepared rhizome of rehmannia of selected weight, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and moutan bark respectively, heating and refluxing extraction 2 times, the water adding 8 weight times amount for 1st time extracts 2h, the water adding 6 weight times amount for 2nd time extracts 2h, merges extract, filters, concentrating the filtrate to 80 DEG C of relative densities is 1.15-1.25, to obtain final product.
The present embodiment improves the pharmaceutical composition of Menopause insomnia, adds customary adjuvant, according to common process, makes oral liquid.
Experimental examplePharmaceutical composition of the present invention improves the research of Menopause insomnia effect
1, experimental design
1.1 laboratory apparatus and reagent
BS110S electronic balance, Beijing Sai Duolisi balance Co., Ltd;
NIH mouse, SPF level, body weight 14~16g;
Diazepam injection, commercially available product.
1.2 experiment packets
Take 150 healthy NIH female mices, be randomly divided into 5 groups, it may be assumed that dosage group, experimental group high dose group and positive controls in blank group, experimental group low dose group, experimental group, often 30 mouse of group.
1.3 medication
Blank group: distilled water 70mg/kg bw;
Experimental group low dose group: the pharmaceutical composition 335mg/kg bw of embodiment 1 preparation;
Dosage group in experimental group: the pharmaceutical composition 670mg/kg bw of embodiment 1 preparation;
Experimental group high dose group: the pharmaceutical composition 2010mg/kg bw of embodiment 1 preparation;
Positive controls: diazepam injection 70mg/kg bw.
2, experimental technique
2.1 direct sleep experiments
In experimental group low dose group, experimental group, dosage group and experimental group high dose group are respectively according to above-mentioned dosage gastric infusion 30 days, are given daily 1 time;Positive controls is according to above-mentioned dosage gastric infusion 1 time at the end of experiment, and blank group is according to above-mentioned dosage gavage distilled water.After last is administered, observe whether each group of mouse sleep phenomenon occurs.
Sleep, with righting reflex loss as index, when mouse is placed in dorsal position, can right body position immediately.As more than 30-60s can not the person of righting, i.e. think righting reflex loss, enter sleep.Righting reflex recovers to be animal awakening, and righting reflex loss is the animal sleep time to recovering during this period of time.Dosage group and the sleep number of animals of experimental group high dose group and the length of one's sleep in record blank group, experimental group low dose group, experimental group, respectively group sleep number of animals and the difference of the length of one's sleep.
2.2 extend the yellow Jackets experiment length of one's sleep
(1) preliminary experiment
Grope the threshold dose of amobarbital, it may be assumed that select 100% mouse to fall asleep (righting reflex loss reaches more than 60s) but do not make the length of one's sleep long 0.3% the suitable dose (30~60mg/kg) of yellow Jackets.
(2) formally test
In experimental group low dose group, experimental group, dosage group and experimental group high dose group are respectively according to above-mentioned dosage gastric infusion 30 days, are given daily 1 time;Positive controls is according to above-mentioned dosage gastric infusion 1 time at the end of experiment, and blank group is according to above-mentioned dosage gavage distilled water.Last is administered after 40min (occur before peak effect 10~15min), the dosage 49.5mg/kg (groping to determine that the threshold dose groping amobarbital is carried out according to preliminary experiment) of each treated animal abdominal cavity yellow Jackets, the time for falling asleep of immediate record animal and wakeing up the time, the difference between respectively group extends the length of one's sleep.
2.3 yellow Jackets sub-threshold dose hypnosis experiments
(1) preliminary experiment
Grope the threshold dose of amobarbital, that is: select 80~90% mouse righting reflex do not disappear 0.3% the maximum threshold dose (with 20 mouse, 0.3% yellow Jackets 0.09-0.12mL/10g finds out the maximum dose that 80-90% mouse righting reflex does not disappears) of yellow Jackets.
(2) formally test
In experimental group low dose group, experimental group, dosage group and experimental group high dose group are respectively according to above-mentioned dosage gastric infusion 30 days, are given daily 1 time;Positive controls is according to above-mentioned dosage gastric infusion 1 time at the end of experiment, and blank group is according to above-mentioned dosage gavage distilled water.Last is administered after 40min (occur before peak effect 10~15min), each treated animal abdominal cavity yellow Jackets 37.5mg/kg, in immediate record 30min, animal righting reflex loss reaches the number of animals of more than 1min, and record the time for falling asleep of animal, the time for falling asleep of wake up time and sleep percentage (%), relatively each treated animal, wake up time and the difference of sleep percentage (%).
2.4 barbital sodium Sleep latency experiments
(1) preliminary experiment
Grope the threshold dose of barbital sodium, it may be assumed that select 100% mouse to fall asleep (righting reflex loss reaches more than 1min) but do not make the suitable dose (200~300mg/kg) of the long barbital sodium length of one's sleep.
(2) formally test
In experimental group low dose group, experimental group, dosage group and experimental group high dose group are respectively according to above-mentioned dosage gastric infusion 30 days, are given daily 1 time;Positive controls is according to above-mentioned dosage gastric infusion 1 time at the end of experiment, and blank group is according to above-mentioned dosage gavage distilled water.Last is administered after 40min (occur before peak effect 10~15min), the dosage of each treated animal abdominal cavity 0.2% barbital sodium is 300mg/kg (0.2ml/20g), with righting reflex loss as index, observe the impact on barbital sodium Sleep latency, the more each group of difference on the impact of barbital sodium Sleep latency.
3, experimental result
The experimental result of 3.1 direct sleep experiments
Directly the experimental result of sleep experiments is as shown in table 1.
The experimental result (x ± s, n=30) of the direct sleep experiments of table 1 mouse
Group | Sleep number of animals (only) |
Blank group | 0 |
Experimental group low dose group | 0 |
Dosage group in experimental group | 0 |
Experimental group high dose group | 0 |
Positive controls | 0 |
As shown in Table 1, after last is administered, each group mouse does not all fall asleep, and in experimental group low dose group, experimental group, the state of mind of dosage group, experimental group high dose group and positive controls mouse is the most normal.This shows, mouse is acted on by the pharmaceutical composition of embodiment 1 preparation without direct sleep.
3.2 experimental results extending the yellow Jackets experiment length of one's sleep
The experimental result extending the yellow Jackets experiment length of one's sleep is as shown in table 2.
Table 2 extend experiment yellow Jackets lengths of one's sleep experimental result (N=13)
Group | The length of one's sleep (min) |
Blank group | 10.80±2.74 |
Experimental group low dose group | 13.90±3.16* |
Dosage group in experimental group | 16.20±3.74** |
Experimental group high dose group | 18.40±4.62*** |
Positive controls | 29.80±6.14*** |
Note: compared with blank group, * P < 0.05, * * P < 0.01, * * * P < 0.001
As shown in Table 2, in experimental group low dose group, experimental group, dosage group, experimental group high dose group all can extend the length of one's sleep of yellow Jackets mouse to some extent, have preferably synergy with yellow Jackets;Compared with blank group, in experimental group low dose group, experimental group, dosage group, experimental group high dose group are respectively provided with significant difference (P < 0.05, P < 0.01, P < 0.001) to the prolongation of the length of one's sleep of yellow Jackets mouse.This shows, extends in the yellow Jackets experiment length of one's sleep, and the pharmaceutical composition of embodiment 1 preparation can extend the length of one's sleep.
The experimental result of 3.3 yellow Jackets sub-threshold dose hypnosis experiments
The experimental result of yellow Jackets sub-threshold dose hypnosis experiment is as shown in table 3.
The experimental result (x ± s, n=30) of table 3 yellow Jackets sub-threshold dose hypnosis experiment
Group | Sleep number of animals (only) |
Blank group | 4 |
Experimental group low dose group | 12* |
Dosage group in experimental group | 15** |
Experimental group high dose group | 18*** |
Positive controls | 23*** |
Note: compared with blank group, * P < 0.05, * * P < 0.01, * * * P < 0.001
As shown in Table 3, in experimental group low dose group, experimental group, dosage group, experimental group high dose group all can increase sleep number of animals in various degree;Compared with blank group, in experimental group low dose group, experimental group, dosage group, experimental group high dose group are respectively provided with significant difference (P < 0.05, P < 0.01, P < 0.001) to the increase of sleep number of animals.This shows, in yellow Jackets sub-threshold dose hypnosis experiment, the pharmaceutical composition of embodiment 1 preparation can improve incidence of falling asleep.
The experimental result of 3.4 barbital sodium Sleep latency experiments
The experimental result of barbital sodium Sleep latency experiment is as shown in table 4.
Table 4 barbital sodium Sleep latency experiment experimental result (N=13)
Group | Sleep latency (min) |
Blank group | 28.70±5.95 |
Experimental group low dose group | 22.40±5.62* |
Dosage group in experimental group | 20.90±5.42** |
Experimental group high dose group | 19.13±4.66*** |
Positive controls | 14.20±3.40*** |
Note: compared with blank group, * P < 0.05, * * P < 0.01, * * * P < 0.001
As shown in Table 4, in experimental group low dose group, experimental group, dosage group, the Sleep latency of experimental group high dose group mouse the most substantially shorten, and have certain synergy with barbital sodium;Compared with blank group, in experimental group low dose group, experimental group, dosage group, experimental group high dose group are respectively provided with significant difference (P < 0.05, P < 0.01, P < 0.001) to the shortening of Sleep latency.This shows, in the experiment of barbital sodium Sleep latency, the pharmaceutical composition of embodiment 1 preparation can shorten Sleep latency.
4, experiment conclusion
The pharmaceutical composition of embodiment 1 preparation can extend the length of one's sleep of yellow Jackets mouse significantly, significantly improves the incidence of falling asleep of yellow Jackets mouse, the notable Sleep latency shortening barbital sodium mouse.This shows, pharmaceutical composition of the present invention has the effect improving sleep.
To sum up, the Menopause insomnia cause of disease is analyzed by the present invention according to theory of traditional Chinese medical science, selecting prepared rhizome of rehmannia, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and moutan bark is raw material, one-step optimization of going forward side by side selects the proportioning of each raw material, each raw material in this pharmaceutical composition is made to cooperate according to compatibility relationship, jointly act on, there is nourishing liver and kidney, effect of antitoxic heart-soothing and sedative, thus play the effect improving Menopause insomnia;Composition of the present invention, only includes six kinds of raw materials, and composition is simple, cost is relatively low.
Obviously, above-described embodiment is only for clearly demonstrating example, and not restriction to embodiment.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here without also cannot all of embodiment be given exhaustive.And the obvious change thus extended out or variation still in the protection domain of the invention among.
Claims (8)
1. a pharmaceutical composition, it is characterised in that the raw material of described pharmaceutical composition consists of:
Prepared rhizome of rehmannia 1~9 weight portion, the root of bidentate achyranthes 1~9 weight portion, Fructus Corni 1~9 weight portion, spina date seed
1~6 weight portions, cortex albiziae 1-6 weight portion, moutan bark 1-6 weight portion.
Pharmaceutical composition the most according to claim 1, it is characterised in that described drug regimen
The raw material of thing consists of:
Prepared rhizome of rehmannia 3~6 weight portion, the root of bidentate achyranthes 3~6 weight portion, Fructus Corni 3~6 weight portion, spina date seed
2~5 weight portions, cortex albiziae 1~3 weight portion, moutan bark 1~3 weight portion.
Pharmaceutical composition the most according to claim 2, it is characterised in that described drug regimen
The raw material of thing consists of:
Prepared rhizome of rehmannia 4 weight portion, the root of bidentate achyranthes 3 weight portion, Fructus Corni 3 weight portion, spina date seed 3 weight portion,
Cortex albiziae 2 weight portion, moutan bark 2 weight portion;Or
Prepared rhizome of rehmannia 4 weight portion, the root of bidentate achyranthes 4 weight portion, Fructus Corni 4 weight portion, spina date seed 3 weight portion,
Cortex albiziae 2 weight portion, moutan bark 2 weight portion;Or
Prepared rhizome of rehmannia 3 weight portion, the root of bidentate achyranthes 6 weight portion, Fructus Corni 3 weight portion, spina date seed 5 weight portion,
Cortex albiziae 1 weight portion, moutan bark 3 weight portion;Or
Prepared rhizome of rehmannia 6 weight portion, the root of bidentate achyranthes 3 weight portion, Fructus Corni 6 weight portion, spina date seed 2 weight portion,
Cortex albiziae 3 weight portion, moutan bark 1 weight portion.
4. a preparation method for the pharmaceutical composition described in any one of claim 1-3, its feature exists
In, comprise the following steps:
Take the prepared rhizome of rehmannia of selected weight portion, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and tree peony respectively
Skin, heating and refluxing extraction at least 1 time, the water every time adding 2~12 weight times amount extracts at least 0.5h,
Merging extract, filter, concentrating the filtrate to 80 DEG C of relative densities is 1.10-1.30, to obtain final product.
The preparation method of pharmaceutical composition the most according to claim 4, it is characterised in that bag
Include following steps:
Take the prepared rhizome of rehmannia of selected weight portion, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and tree peony respectively
Skin, heating and refluxing extraction 1~3 times, the water every time adding 5~9 weight times amount extracts 0.5~3h, merges
Extract, filters, and concentrating the filtrate to 80 DEG C of relative densities is 1.10-1.30, to obtain final product.
The preparation method of pharmaceutical composition the most according to claim 5, it is characterised in that bag
Include following steps:
Take the prepared rhizome of rehmannia of selected weight portion, the root of bidentate achyranthes, Fructus Corni, spina date seed, cortex albiziae and tree peony respectively
Skin, heating and refluxing extraction 2 times, the water adding 8 weight times amount for the 1st time extracts 2h, adds for the 2nd time
The water of 6 weight times amount extracts 2h, merges extract, filters, concentrates the filtrate to 80 DEG C of relative densities
For 1.15-1.25, to obtain final product.
7. include the preparation of the pharmaceutical composition described in any one of claim 1-3 or include right
The preparation of the pharmaceutical composition that requirement preparation method described in any one of 4-6 prepares, its feature exists
In,
Described pharmaceutical composition adds customary adjuvant, according to common process, makes the most acceptable
Tablet, capsule, powder, mixture, pill, granule, oral liquid, syrup, paste, punching
Agent, vina, injection or beverage.
8. described in pharmaceutical composition described in any one of claim 1-3, any one of claim 4-6
The pharmaceutical composition for preparing of preparation method or claim 7 described in the system of pharmaceutical composition
Agent application in preparing the medicine or health products improving Menopause insomnia.
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Cited By (2)
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CN106309809A (en) * | 2016-09-23 | 2017-01-11 | 广州中医药大学第附属医院 | Granule with efficacy of clearing away heart-fire and tranquillizing and preparation method of granule |
CN112057542A (en) * | 2020-08-24 | 2020-12-11 | 河北平安健康集团股份有限公司 | A Chinese medicinal composition for treating insomnia, anxiety, depression and climacteric syndrome, and its preparation method |
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Cited By (2)
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CN106309809A (en) * | 2016-09-23 | 2017-01-11 | 广州中医药大学第附属医院 | Granule with efficacy of clearing away heart-fire and tranquillizing and preparation method of granule |
CN112057542A (en) * | 2020-08-24 | 2020-12-11 | 河北平安健康集团股份有限公司 | A Chinese medicinal composition for treating insomnia, anxiety, depression and climacteric syndrome, and its preparation method |
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