CN108938988A - It is a kind of for treating the morning-night compound medicine of senile insomnia - Google Patents

It is a kind of for treating the morning-night compound medicine of senile insomnia Download PDF

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CN108938988A
CN108938988A CN201811173803.1A CN201811173803A CN108938988A CN 108938988 A CN108938988 A CN 108938988A CN 201811173803 A CN201811173803 A CN 201811173803A CN 108938988 A CN108938988 A CN 108938988A
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parts
night
insomnia
daytime
morning
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CN108938988B (en
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黄俊山
张松涛
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Fujian College of traditional Chinese Medicine
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Fujian Academy Of Traditional Chinese Medicine (fujian Province Herbal Medicine Development Service Center)
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    • 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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
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    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • 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
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    • A61K36/076—Poria
    • 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
    • A61K36/13—Coniferophyta (gymnosperms)
    • A61K36/14—Cupressaceae (Cypress family), e.g. juniper or cypress
    • 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)
    • A61K36/34—Campanulaceae (Bellflower family)
    • A61K36/344—Codonopsis
    • A—HUMAN NECESSITIES
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    • 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
    • A61K36/488—Pueraria (kudzu)
    • A—HUMAN NECESSITIES
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    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537—Salvia (sage)
    • 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)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/884—Alismataceae (Water-plantain 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
    • A61K36/8888—Pinellia
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    • 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)
    • A61K36/9062—Alpinia, e.g. red ginger or galangal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives

Abstract

The invention discloses a kind of for treating the morning-night compound medicine of senile insomnia, it includes daytime side and night side, and medicinal material used in daytime side is by weight are as follows: 10 parts of ramulus cinnamomi, 10 parts of pueraria lobata, 15 parts of umbellate pore furgus, 15 parts of rhizoma alismatis, 10 parts of rhizoma pinellinae praeparata, 15 parts of Radix Salviae Miltiorrhizae, 15 parts of Radix Codonopsis, 15 parts of intelligence development；Medicinal material used in night side is by weight are as follows: 30 parts of mother-of-pearl, 10 parts of magnetite, 20 parts of keel, 15 parts of semen ziziphi spinosae, 15 parts of fushen, 15 parts of the seed of Oriental arborvitae, 15 parts of Radix Curcumae, 20 parts of lily.The compound medicine bases oneself upon the latent square medication of physilogical characteristics of the old's " qi and blood declines; its muscle is withered; air flue is puckery; QI of five ZANG-organs is mutually won, deficiency of nutrient QI with inner disturbance of defensive QI " with harmonizing yingfen and weifen, combines the more simulataneous insufficiencies and excessives of insomnia of the old people, it controls and reality is rushed down with qi-restoratives, daytime inspires enthusiasm, night tranquilizing and allaying excitement, to treat the insomnia of the elderly's biorhythm disorder.

Description

It is a kind of for treating the morning-night compound medicine of senile insomnia
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of for treating the morning-night compound medicine of senile insomnia.
Background technique
" Ling Shu Miraculous Pivot or Divine Axis seeks hygienic meeting " is said: " qi and blood of the old declines, and muscle is withered, and air flue is puckery, mutual disturbances among ZANG-QI, ying-qi Declining, it is weary in gas to defend less, therefore brightlessness in the daytime, night do not close the eyes ".The elderly due to worn with age, decline by viscera function day, and battalion defends in-fighting, causes Battalion defends that circulation is not in tune, and night, which defends gas, then to weaken the function that supports of ying-qi, battalion defends with ying-qi circulation in yin channel or internal organ It is unable to the culvert of wife's the five internal organs and holds back its manner, manner is floating more, then occurs being unable to ortho, i.e. " night does not close the eyes "；Gas is defended from morning for battalion Yin seeks asthenic yin, defends in gas and cut down, between battalion of stopping over, patient often show as tired mind, crack between the teeth sleep, be slow in reacting, failure of memory etc. Phenomenon, i.e. " brightlessness in the daytime "." brightlessness in the daytime night does not close the eyes ", therefore need the gas of sending up the lucid yang daytime, it is put forth energy with adding to the fun；Checking exuberance of yang is then needed at night Calm the nerves, reduces excitability.
Summary of the invention
The present invention for the elderly " brightlessness in the daytime night does not close the eyes " (i.e. daytime sleepiness doze off not spiritual, nocturnal insomnia) illness, There is provided a kind of for treating the morning-night compound medicine of senile insomnia, basing oneself upon the old, " qi and blood declines, and muscle is withered, and air flue is puckery, the five internal organs Gas phase it is rich, deficiency of nutrient QI with inner disturbance of defensive QI " the latent square medication of physilogical characteristics with harmonizing yingfen and weifen, how empty combine senile insomnia It is mingled in fact, controls and reality is rushed down with qi-restoratives, to treat the insomnia of the elderly's biorhythm disorder.
To achieve the above object, the present invention adopts the following technical scheme:
It is a kind of for treating the morning-night compound medicine of senile insomnia comprising daytime side and night side, medicinal material used in daytime side is by weight It is calculated as: 10 parts of ramulus cinnamomi, 10 parts of pueraria lobata, 15 parts of umbellate pore furgus, 15 parts of rhizoma alismatis, 10 parts of rhizoma pinellinae praeparata, 15 parts of Radix Salviae Miltiorrhizae, 15 parts of Radix Codonopsis, intelligence development 15 Part；Medicinal material used in night side is by weight are as follows: 30 parts of mother-of-pearl, 10 parts of magnetite, 20 parts of keel, 15 parts of semen ziziphi spinosae, 15 parts of fushen, 15 parts of the seed of Oriental arborvitae, 15 parts of Radix Curcumae, 20 parts of lily.
On the basis of with ramulus cinnamomi, pueraria lobata uplifting yang qi, basing oneself upon the old, " qi and blood declines, and muscle is withered, gas for daytime side in the present invention Road is puckery " physilogical characteristics, filled blood with Radix Codonopsis, with umbellate pore furgus, rhizoma alismatis, rhizoma pinellinae praeparata, Radix Salviae Miltiorrhizae dampness removing invigorate blood circulation air passage, sought with drawing to defend out Patient is set to reach " daytime essence " state；And the application of umbellate pore furgus, rhizoma alismatis, rhizoma pinellinae praeparata, Radix Salviae Miltiorrhizae, fructus alpiniae oxyphyllae, while modern Chinese medicine should have been closed The pathological characteristic that research phlegm-blood stasis knot is senile insomnia is learned, is the research achievement for causing the elderly's sleep disturbance most common reason. Night side draws to defend with mother-of-pearl, magnetite, keel checking exuberance of yang to join the army, semen ziziphi spinosae, fushen, seed of Oriental arborvitae nourishing heart blood, Radix Curcumae, the ventilation of lily relieve stagnation Road, full side draw defend join the army on the basis of, base oneself upon the physilogical characteristics of " The heart controls mental activities, and Shen Anze sleeps ", widely apply sedative, with Patient is set to enter " night closes the eyes " state；The application of lily, Radix Curcumae combines feelings will often and is the experience of risk factor of having a sleepless night, with better Treat senile insomnia.Two sides base oneself upon the old, and " qi and blood declines, and muscle is withered, and air flue is puckery, and QI of five ZANG-organs is mutually won, and ying-qi declines less and defends Cut down in gas " the latent square medication of physilogical characteristics with harmonizing yingfen and weifen, combine the more simulataneous insufficiencies and excessives of senile insomnia, control and reality is rushed down with qi-restoratives, To treat the insomnia of the elderly's biorhythm disorder.
Specific embodiment
In order to make content of the present invention easily facilitate understanding, With reference to embodiment to of the present invention Technical solution is described further, but the present invention is not limited only to this.
1 research case
It is medical in Second People's Hospital of Fujian Province's insomnia special outpatient clinic to choose in July, 2016 in December, 2017, and meets old age The insomnia case of the insomnia of " brightlessness in the daytime, night do not close the eyes " type and complete data.
2 diagnostic criteria
2.1 doctor trained in Western medicine insomnia diagnostic criteria
Insomnia diagnostic criteria is non-referring to " Chinese Spirit Obstacles classification with diagnostic criteria the 3rd edition " (CCMD-3) formulated for 2001 Organic sleep disturbance diagnostic criteria: be it is a kind of with have a sleepless night based on sleep quality be unsatisfied with situation, other symptoms secondary to Insomnia, including have difficulty in going to sleep, sleep not depth, Yi Xing, dreaminess, early awakening, wake up after be not easy to sleep again, wake up sense of discomfort, tired or daytime afterwards It is sleepy.Insomnia can cause patient anxiety, depression or the feared state of mind, and cerebration efficiency is caused to decline, and interfere social function.
The elderly's age divides: 65 years old or more.
[symptom standard]
(1) it with insomnia for main symptom, including has difficulty in going to sleep, sleep not depth, dreaminess, early awakening, or is not easy after waking up after sleeping, waking up again Sense of discomfort, tired or daytime sleepiness etc.；
(2) there is the dominant idea of insomnia and extremely concern insomnia result.
[serious standard] causes apparent worried or social function impaired sleep quantity, the discontented of quality.
[course of disease standard] at least occurs 3 times weekly, and at least 1 month.
[exclusion criteria] excludes insomnia secondary caused by physical disease or phrenoblabia symptom.
2.2 tcm diagnosis standard
The insomnia diagnostic criteria for meeting " the clinical test guideline of new Chinese medicine treatment insomnia " (meets doctor trained in Western medicine insomnia to examine Disconnected standard)；
(1) age >=65 year old；
(2) have lassitude on daytime, sleepy drowsy, amnesia, absent minded, spiritlessness and weakness, it is depressed in one or It is multinomial；
(3) associate generation, which tells patient often, consciously automatic sleepy behavior；
(4) doctor judges: patient medical history, symptom meet tcm diagnosis standard of being insomnia, and daytime, mobility normally (can determine whether to suffer from Person's lying bed time increases or has consciously automatic sleepy behavior).
Above-mentioned (1) be desirable criterion, (2), (3), (4) meet one or more it is i.e. diagnosable.
3 drugs and instructions of taking
Daytime side's (breakfast half an hour after is taken): ramulus cinnamomi 10g, pueraria lobata 10g, umbellate pore furgus 15g, rhizoma alismatis 15g, rhizoma pinellinae praeparata 10g, Radix Salviae Miltiorrhizae 15g, Radix Codonopsis 15g, intelligence development 15g.
Night side's (dinner half an hour after is taken): mother-of-pearl 30g, magnetite 10g, keel 20g, semen ziziphi spinosae 15g, fushen 15g, cypress Sub- benevolence 15g, Radix Curcumae 15g, lily 20g.
It is taken on time after the above drug is added water to cook.7 days as a course for the treatment of.
4 are included in standard
(1) age >=65 year old meet " brightlessness in the daytime, night do not close the eyes " insomnia diagnostic criteria, Pittsburgh Sleep Quality Index scale score >=7 points；
(2) daytime side, night side's treatment (4 courses for the treatment of, totally 28 days) and the complete person of case-data are only taken；
(3) Western medicine, patent medicine and the decoction person for the treatment of insomnia are not taken in medical the last week；
5 exclusion criterias
(1) the last week interior use of going to a doctor influences sleep drug person；
(2) it has a sleepless night because organic disease causes or have nypnapagogic organic disease, as hyperthyroidism, heart failure, bronchus are roared Breathe heavily acute attack, Uremic, acute cerebrovascular disease etc.；
(3) have an impact the mental disease of sleep, such as anxiety disorder, depression, through Analysisof Self-rating Anxiety Scale (SAS), depression self-rating scale (SDS) more than score 70 is divided；
(4) there is severe cognitive dysfunction.
6 reject standard
(1) having an impact the drug person of effect other than this compound medicine to sleep is voluntarily taken during treating；(2) occur during treating Serious adverse events person, such as to this compound medicine or ingredient allergy.
7 the standard of curative effect evaluation
Referring in 2002 " new Chinese medicine guideline of clinical investigations (tentative) ", " clinical research of new Chinese medicine treatment insomnia refers to Lead principle " and the newest promulgation of WHO insomnia clinical efficacy judgment criteria evaluation formulate:
Total effective: recovery from illness: sleeping time recovery is normal or Nighttime sleep increases to 6h or more, sleeps deep, spiritual after awake Plentifully, 75% or more Sleep efficiency；
Effective: sleep is clearly better, and sleeping time increases 3h or more, and Depth of sleep increases, 65% or more Sleep efficiency；
Effective: symptom mitigates, and sleeping time increases earlier above less than 3h, 55% or more Sleep efficiency.
Invalid: insomnia is not improved or aggravates instead after treatment.
8 statistical results
According to be included in, exclude, rejecting standard, altogether collect 159 complete cases, be divided into two groups according to the standard of curative effect evaluation, wherein Total effectively group 117, accounts for 73.58%, and invalid group 42 accounts for 26.42%.General information, night are slept respectively based on curative effect grouping Dormancy related symptoms, cardinal symptom, the factor of the aspect of minor symptom four carry out statistical analysis, then by statistically significant Dan Yin Element carries out logistic regression analysis.
8.1 general information single factor analysis
Age, PSQI score, the course of disease, body mass index are first used as measurement data to carry out in general informationtExamine orZIt examines, as a result Prompt it is not statistically significant (P> 0.05).See Table 1 for details, table 2.
1 general information of tabletInspection result
2 general information of tableZInspection result
Each single factor test carries out Chi-square Test in general information, and as a result prompt: daily routines content, severity of insomnia have statistics Meaning (P< 0.05).See Table 3 for details.
3 general information of tableInspection result
8.2 nighttime sleep related symptoms single factor analysis
Nighttime sleep related symptoms carry out Chi-square Test respectively, belong in symptom ordered succession data and there are three and three with Upper entry, Chi-square Test is carried out after each entry is successively merged again.As a result prompt: time for falling asleep is using half an hour as boundary, i.e., It is statistically significant (P < 0.05) that whether there is or not difficulty falling asleeps.See Table 4 for details, table 5, table 6, table 7.
4 time for falling asleep of tableInspection result
5 night of table easily wakes upInspection result
6 daydream situation of tableInspection result
7 early awakening situation of tableInspection result
8.3 cardinal symptom single factor analysis
Cardinal symptom single factor test statistic analysis result prompts sleepy drowsy, lassitude, depressed and spiritlessness and weakness to have statistics Meaning (P< 0.05).See Table 8 for details.
8 cardinal symptom of tableInspection result
8.4 minor symptom single factor analysis
According to tcm symptom scale Frequency statistics as a result, therefrom to select highest 18 minor symptoms of the frequency of occurrences (nervous, vexed Irritability, palpitaition, uncomfortable in chest, timid easily frightened, dizzy alliteration, headache, tinnitus, dry, worry too much, interest reduction, lustreless complexion, bitter taste, Soreness and weakness of waist and knees, bodily pain are received less, enuresis nocturna frequency, stool situation (partially dry, normal, partially dilute)) single factor test statistics is carried out, statistical result is aobvious Show: enuresis nocturna frequency it is statistically significant (P< 0.05).See Table 9 for details.
9 minor symptom of tableInspection result
8.5 logistic regression analysis situations
The multifactor binary logistic of " morning-night therapy " treatment " brightlessness in the daytime, night do not close the eyes " type senile insomnia Different therapeutical effect is returned Analysis: total effectively group and invalid group are set as dependent variable, wherein invalid group is denoted as 0, total effectively group is denoted as 1.It will be through single factor test point Analyse the obtained factor to affect the treatment: daily routines content, severity of insomnia, difficulty falling asleep, sleepy drowsy, lassitude, Depressed, spiritlessness and weakness, enuresis nocturna frequency are set as covariant, are carried out digitlization transformation, wherein daily routines content: normal note It is 0, reduction is denoted as 1；Severity of insomnia is denoted as 0,1,2 from light to heavy, remaining symptom is denoted as 1 without being denoted as 0.As a result it prompts Logistic regression model have statistical significance (=31.432,P=0.000), logistic Regression Analysis Result shows day Normal activity description, sleepy drowsy, enuresis nocturna frequency have statistical significance (P< 0.05), see Table 10 for details.
10 logistic regression analysis result of table
9 conclusions
By the statistical that 159 " morning-night " methods are treated with the complete case-data of " brightlessness in the daytime, night do not close the eyes " type insomnia of the old people Analysis, is concluded that
1, " morning-night " method can effectively improve the sleep of " brightlessness in the daytime, night do not close the eyes " type insomnia the elderly.
2, the suitable elderly population of " morning-night " method: daily routines content is few, sleepy drowsy, enuresis nocturna frequency.
The foregoing is merely presently preferred embodiments of the present invention, all equivalent changes done according to scope of the present invention patent with Modification, is all covered by the present invention.

Claims (1)

1. a kind of for treating the morning-night compound medicine of senile insomnia, including daytime side and night side, it is characterised in that: the medication of institute of daytime side Material is by weight are as follows: 10 parts of ramulus cinnamomi, 10 parts of pueraria lobata, 15 parts of umbellate pore furgus, 15 parts of rhizoma alismatis, 10 parts of rhizoma pinellinae praeparata, 15 parts of Radix Salviae Miltiorrhizae, Radix Codonopsis 15 Part, 15 parts of intelligence development；
Medicinal material used in night side is by weight are as follows: 30 parts of mother-of-pearl, 10 parts of magnetite, 20 parts of keel, 15 parts of semen ziziphi spinosae, fushen 15 Part, 15 parts of the seed of Oriental arborvitae, 15 parts of Radix Curcumae, 20 parts of lily.
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Address after: 350003 No. 54, 282 Gulou District, Fujian, Fuzhou

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