CN105395680B - It is a kind of to treat neurasthenic Chinese medicine composition and its preparation method and application - Google Patents

It is a kind of to treat neurasthenic Chinese medicine composition and its preparation method and application Download PDF

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CN105395680B
CN105395680B CN201511010189.3A CN201511010189A CN105395680B CN 105395680 B CN105395680 B CN 105395680B CN 201511010189 A CN201511010189 A CN 201511010189A CN 105395680 B CN105395680 B CN 105395680B
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parts
chinese medicine
medicine composition
bombyx batryticatus
valerian
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CN105395680A (en
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余洋
刘可
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Yu Yang
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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
    • A61K36/10Bryophyta
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/63Arthropods
    • 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)
    • 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)
    • A61K36/26Aristolochiaceae (Birthwort family), e.g. heartleaf
    • A61K36/264Aristolochia (Dutchman's pipe)
    • 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)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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)
    • A61K36/57Magnoliaceae (Magnolia family)
    • 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)
    • A61K36/72Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
    • A61K36/725Ziziphus, e.g. jujube
    • 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)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • 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)
    • A61K36/79Schisandraceae (Schisandra family)
    • 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)
    • A61K36/84Valerianaceae (Valerian family), e.g. valerian
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • 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

Abstract

Neurasthenic Chinese medicine composition is treated the invention discloses a kind of, is made of the raw material below according to parts by weight: 22-28 parts of rose rhodobryum herb, 10-15 parts of semen ziziphi spinosae, 5-9 parts of bombyx batryticatus, 3-6 parts of valerian, 5-9 parts of Hedge Prinsepia Nut, 9-14 parts of field pennycress, 11-17 parts, 4-8 parts of herba aristolochiae of label grass of Schisandra chinensis 8-12 Fen, pig.The present invention also provides the preparation method of the Chinese medicine composition and purposes.Chinese medicine composition prepared by the present invention is significant in efficacy to neurastheniac, control difficulty in relapse after healing, and it has no toxic side effect, cure rate is up to 72.7%, for total effective rate up to 95.5%, prescription is simple, herba aristolochiae and Hedge Prinsepia Nut and other drugs compatibility, and using the preparation method of the traditional chinese medicine composition of the invention, be conducive to enhance drug effect.

Description

It is a kind of to treat neurasthenic Chinese medicine composition and its preparation method and application
Technical field
The present invention relates to the field of Chinese medicines, specifically a kind of neurasthenic Chinese medicine composition for the treatment of and preparation method thereof and use On the way.
Background technique
Neurasthenia refers to due to being chronically under nervous and pressure, the easily excited and mental easily tired phenomenon of spirit occurs, Be often accompanied by mood worry, irritability, sleep disturbance, muscle tone pain etc., these symptoms cannot be attributed to brain, physical disease and
Other mental diseases.Weight when light when symptom fluctuates, the course of disease mostly delay related with psychosocial factor.
Most scholars think that mental element is to cause neurasthenic main cause at present.It is all to cause the lasting nervous heart Some factors of feelings and long-term intrapsychic conflict keep nervous activity process strong and persistently in tension, are more than nerve Neurasthenia can occur for the tolerance limit of system tension.Such as over fatigue and cannot to rest be that excited process is excessively tight ?;Dissatisfied to present situation is then overstrain of inhibitory process;Often change living environment and inadaptable, central nervous system The activity of system plays a leading role in body Activities.And corticocerebral nerve cell have quite high tolerance, one As in the case of be not easy to cause neurasthenia or failure.After nervous mental labour, although producing fatigue, pause It can restore after having a rest or sleeping, still, the nervous activity of strong tense situation, once surmount tenability limit, it is possible to it produces Raw neurasthenia.
The quickening of today's society work and life rhythm, causes the pressure of people increasing, so that with nerve Weak people is also more and more, this disease can not only largely effect on the mood of people, also will affect working efficiency.It mostly uses at present Mode based on psychotherapy, supplemented by drug therapy, but therapeutic effect is often not satisfactory, incubation period is longer, and at present Our people can't acceptable learning treatment completely mode, and drug therapy relies primarily on stabilization agent, hypnotic sedative dose etc., but These drugs existing defects in terms of safety and dependence, side effect is bigger, additive, drug resistance easy to form, therefore not Preferably take for long periods of time.
Summary of the invention
Neurasthenic Chinese medicine composition and preparation method thereof is treated the purpose of the present invention is to provide a kind of, on solving State the problem of proposing in background technique.
To achieve the above object, the invention provides the following technical scheme:
It is a kind of to treat neurasthenic Chinese medicine composition, it is made of the raw material below according to parts by weight: rose rhodobryum herb 22-28 Part, 10-15 parts of semen ziziphi spinosae, 5-9 parts of bombyx batryticatus, 3-6 parts of valerian, 5-9 parts of Hedge Prinsepia Nut, 9-14 parts of field pennycress, Schisandra chinensis 8-12 Fen, pig label It is 11-17 parts careless, 4-8 parts of herba aristolochiae.
As a further solution of the present invention: being made of the raw material below according to parts by weight: 23-27 parts of rose rhodobryum herb, wild jujube 11-14 parts of benevolence, 6-8 parts of bombyx batryticatus, 4-5 parts of valerian, 6-8 parts of Hedge Prinsepia Nut, 10-13 parts of field pennycress, Schisandra chinensis 9-11 Fen, pig label grass 12- 16 parts, 5-7 parts of herba aristolochiae.
As further scheme of the invention: being made of the raw material below according to parts by weight: 25 parts of rose rhodobryum herb, semen ziziphi spinosae 13 parts, 7 parts of bombyx batryticatus, 5 parts of valerian, 7 parts of Hedge Prinsepia Nut, 12 parts of field pennycress, 14 parts, 6 parts of herba aristolochiae of grass of 10 Fen, pig label of Schisandra chinensis.
The preparation method of the neurasthenic Chinese medicine composition for the treatment of, steps are as follows:
1) rose rhodobryum herb, semen ziziphi spinosae, Hedge Prinsepia Nut, pig label grass are weighed, is cleaned, drying after grinding, is put into container, and 10-12 is added The edible alcohol of amount, heating and refluxing extraction 3-4h obtain an extracting solution and a residue, an extracting solution are collected, by one again The 6-8 times of edible alcohol measured is added in secondary residue again, and heating and refluxing extraction 1-2h obtains secondary raffinate and secondary residual, receives Collect secondary raffinate, an extracting solution and secondary raffinate are merged, filtering obtains reflux extracting liquid, spare;
2) valerian, field pennycress, Schisandra chinensis and herba aristolochiae are weighed, is cleaned, drying after grinding, is put into container, and 8-12 is added The edible alcohol of amount again, ultrasonic wave extraction 40-60 minutes, filtering obtained ultrasonic extract, spare;
3) bombyx batryticatus is weighed, stir-frying crushes as smalls to yellowish, spare;
4) reflux extracting liquid and ultrasonic extract are mixed, is concentrated under reduced pressure at 60 DEG C -70 DEG C, obtain dried cream powder;
5) dried cream powder is uniformly mixed with bombyx batryticatus smalls, capsule is made to get neurasthenic Chinese medicine composition is treated.
Above-mentioned Chinese medicine composition is used to prepare the neurasthenic drug for the treatment of.
Compared with prior art, the beneficial effects of the present invention are: Chinese medicine composition prepared by the present invention suffers from neurasthenia Person is significant in efficacy, controls difficulty in relapse after healing, and have no toxic side effect, and cure rate is up to 72.7%, and total effective rate is up to 95.5%.The present invention The Chinese medicine composition prescription of preparation is simple, herba aristolochiae and Hedge Prinsepia Nut and other drugs compatibility, and using the traditional chinese medicine composition of the invention Preparation method is conducive to enhance drug effect.
Specific embodiment
Technical solution of the present invention is described in more detail With reference to embodiment.
Embodiment 1
It is a kind of to treat neurasthenic Chinese medicine composition, it is made of the raw material below according to parts by weight: 28 parts of rose rhodobryum herb, acid 15 parts of jujube kernel, 9 parts of bombyx batryticatus, 6 parts of valerian, 9 parts of Hedge Prinsepia Nut, 14 parts of field pennycress, 17 parts, 8 parts of herba aristolochiae of grass of 12 Fen, pig label of Schisandra chinensis.
The preparation method of the neurasthenic Chinese medicine composition for the treatment of described in the present embodiment, steps are as follows:
1) rose rhodobryum herb, semen ziziphi spinosae, Hedge Prinsepia Nut, pig label grass are weighed, is cleaned, drying after grinding, is put into container, is added 12 times The edible alcohol of amount, heating and refluxing extraction 4h obtain an extracting solution and a residue, collect an extracting solution, will be primary residual The edible alcohol of 8 times of amounts is added in slag again, and heating and refluxing extraction 2h obtains secondary raffinate and secondary residual, collects secondary mention Liquid is taken, an extracting solution and secondary raffinate are merged, filtering obtains reflux extracting liquid, spare;
2) valerian, field pennycress, Schisandra chinensis and herba aristolochiae are weighed, is cleaned, drying after grinding, is put into container, is added 12 times The edible alcohol of amount, ultrasonic wave extraction 60 minutes, filtering obtained ultrasonic extract, spare;
3) bombyx batryticatus is weighed, stir-frying crushes as smalls to yellowish, spare;
4) reflux extracting liquid and ultrasonic extract are mixed, is concentrated under reduced pressure at 70 DEG C, obtain dried cream powder;
5) dried cream powder is uniformly mixed with bombyx batryticatus smalls, capsule is made to get neurasthenic Chinese medicine composition is treated.
Embodiment 2
It is a kind of to treat neurasthenic Chinese medicine composition, it is made of the raw material below according to parts by weight: 22 parts of rose rhodobryum herb, acid 10 parts of jujube kernel, 5 parts of bombyx batryticatus, 3 parts of valerian, 5 parts of Hedge Prinsepia Nut, 9 parts of field pennycress, 11 parts, 4 parts of herba aristolochiae of grass of 8 Fen, pig label of Schisandra chinensis.
The preparation method of the neurasthenic Chinese medicine composition for the treatment of described in the present embodiment, steps are as follows:
1) rose rhodobryum herb, semen ziziphi spinosae, Hedge Prinsepia Nut, pig label grass are weighed, is cleaned, drying after grinding, is put into container, is added 10 times The edible alcohol of amount, heating and refluxing extraction 4h obtain an extracting solution and a residue, collect an extracting solution, will be primary residual The edible alcohol of 7 times of amounts is added in slag again, and heating and refluxing extraction 2h obtains secondary raffinate and secondary residual, collects secondary mention Liquid is taken, an extracting solution and secondary raffinate are merged, filtering obtains reflux extracting liquid, spare;
2) valerian, field pennycress, Schisandra chinensis and herba aristolochiae are weighed, is cleaned, drying after grinding, is put into container, is added 11 times The edible alcohol of amount, ultrasonic wave extraction 50 minutes, filtering obtained ultrasonic extract, spare;
3) bombyx batryticatus is weighed, stir-frying crushes as smalls to yellowish, spare;
4) reflux extracting liquid and ultrasonic extract are mixed, is concentrated under reduced pressure at 65 DEG C, obtain dried cream powder;
5) dried cream powder is uniformly mixed with bombyx batryticatus smalls, capsule is made to get neurasthenic Chinese medicine composition is treated.
Embodiment 3
It is a kind of to treat neurasthenic Chinese medicine composition, it is made of the raw material below according to parts by weight: 25 parts of rose rhodobryum herb, acid 13 parts of jujube kernel, 7 parts of bombyx batryticatus, 5 parts of valerian, 7 parts of Hedge Prinsepia Nut, 12 parts of field pennycress, 14 parts, 6 parts of herba aristolochiae of grass of 10 Fen, pig label of Schisandra chinensis.
The preparation method of the neurasthenic Chinese medicine composition for the treatment of described in the present embodiment, steps are as follows:
1) rose rhodobryum herb, semen ziziphi spinosae, Hedge Prinsepia Nut, pig label grass are weighed, is cleaned, drying after grinding, is put into container, is added 11 times The edible alcohol of amount, heating and refluxing extraction 3.5h obtain an extracting solution and a residue, collect an extracting solution, will be primary The edible alcohol of 7 times of amounts is added in residue again, and heating and refluxing extraction 1.5h obtains secondary raffinate and secondary residual, collects two Secondary extracting solution merges an extracting solution and secondary raffinate, filtering, obtains reflux extracting liquid, spare;
2) valerian, field pennycress, Schisandra chinensis and herba aristolochiae are weighed, is cleaned, drying after grinding, is put into container, is added 10 times The edible alcohol of amount, ultrasonic wave extraction 50 minutes, filtering obtained ultrasonic extract, spare;
3) bombyx batryticatus is weighed, stir-frying crushes as smalls to yellowish, spare;
4) reflux extracting liquid and ultrasonic extract are mixed, is concentrated under reduced pressure at 65 DEG C, obtain dried cream powder;
5) dried cream powder is uniformly mixed with bombyx batryticatus smalls, capsule is made to get neurasthenic Chinese medicine composition is treated.
Embodiment 4
It is a kind of to treat neurasthenic Chinese medicine composition, it is made of the raw material below according to parts by weight: 23 parts of rose rhodobryum herb, acid 14 parts of jujube kernel, 8 parts of bombyx batryticatus, 5 parts of valerian, 6 parts of Hedge Prinsepia Nut, 14 parts of field pennycress, 13 parts, 7 parts of herba aristolochiae of grass of 12 Fen, pig label of Schisandra chinensis.
The preparation method of the neurasthenic Chinese medicine composition for the treatment of described in the present embodiment, steps are as follows:
1) rose rhodobryum herb, semen ziziphi spinosae, Hedge Prinsepia Nut, pig label grass are weighed, is cleaned, drying after grinding, is put into container, is added 10 times The edible alcohol of amount, heating and refluxing extraction 3h obtain an extracting solution and a residue, collect an extracting solution, will be primary residual The edible alcohol of 6 times of amounts is added in slag again, and heating and refluxing extraction 1h obtains secondary raffinate and secondary residual, collects secondary mention Liquid is taken, an extracting solution and secondary raffinate are merged, filtering obtains reflux extracting liquid, spare;
2) valerian, field pennycress, Schisandra chinensis and herba aristolochiae are weighed, is cleaned, drying after grinding, is put into container, is added 8 times The edible alcohol of amount, ultrasonic wave extraction 40 minutes, filtering obtained ultrasonic extract, spare;
3) bombyx batryticatus is weighed, stir-frying crushes as smalls to yellowish, spare;
4) reflux extracting liquid and ultrasonic extract are mixed, is concentrated under reduced pressure at 60 DEG C, obtain dried cream powder;
5) dried cream powder is uniformly mixed with bombyx batryticatus smalls, capsule is made to get neurasthenic Chinese medicine composition is treated.
Embodiment 5
It is a kind of to treat neurasthenic Chinese medicine composition, it is made of the raw material below according to parts by weight: 24 parts of rose rhodobryum herb, acid 15 parts of jujube kernel, 6 parts of bombyx batryticatus, 6 parts of valerian, 9 parts of Hedge Prinsepia Nut, 12 parts of field pennycress, 12 parts, 7 parts of herba aristolochiae of grass of 11 Fen, pig label of Schisandra chinensis.
The preparation method of the neurasthenic Chinese medicine composition for the treatment of described in the present embodiment, steps are as follows:
1) rose rhodobryum herb, semen ziziphi spinosae, Hedge Prinsepia Nut, pig label grass are weighed, is cleaned, drying after grinding, is put into container, is added 12 times The edible alcohol of amount, heating and refluxing extraction 3h obtain an extracting solution and a residue, collect an extracting solution, will be primary residual The edible alcohol of 7 times of amounts is added in slag again, and heating and refluxing extraction 2h obtains secondary raffinate and secondary residual, collects secondary mention Liquid is taken, an extracting solution and secondary raffinate are merged, filtering obtains reflux extracting liquid, spare;
2) valerian, field pennycress, Schisandra chinensis and herba aristolochiae are weighed, is cleaned, drying after grinding, is put into container, is added 9 times The edible alcohol of amount, ultrasonic wave extraction 60 minutes, filtering obtained ultrasonic extract, spare;
3) bombyx batryticatus is weighed, stir-frying crushes as smalls to yellowish, spare;
4) reflux extracting liquid and ultrasonic extract are mixed, is concentrated under reduced pressure at 63 DEG C, obtain dried cream powder;
5) dried cream powder is uniformly mixed with bombyx batryticatus smalls, capsule is made to get neurasthenic Chinese medicine composition is treated.
Comparative example 1
25 parts of rose rhodobryum herb, 13 parts of semen ziziphi spinosae, 7 parts of bombyx batryticatus, 5 parts of valerian, 7 parts of Hedge Prinsepia Nut, field pennycress 12 are weighed according to parts by weight Part, 14 parts of grass of 10 Fen, pig label of Schisandra chinensis.Decoct patent medicine soup.
Comparative example 2
25 parts of rose rhodobryum herb, 13 parts of semen ziziphi spinosae, 7 parts of bombyx batryticatus, 5 parts of valerian, 12 parts of field pennycress, Schisandra chinensis are weighed according to parts by weight 10 14 parts, 6 parts of herba aristolochiae of grass of Fen, pig label.Decoct patent medicine soup.
Drug test
One, acute toxicity testing:
Mouse 50 are randomly selected, half male and half female, weight 16-25g carries out acute toxicity test.
Mouse is randomly divided into two groups, i.e. control group and administration group, fasting 12 hours before testing, by the embodiment of the present invention 3 The capsule of preparation is dissolved in water, and (concentration is 5.36g crude drug/ml, maximum concentration) carries out stomach-filling to administration group mouse, and stomach-filling is held Product is 5ml/kg (i.e. unit dosage form is 26.8 crude drugs/kg), and control group gives same amount of normal saline, is administered 2 times within one day, gives It medicine interval time 6 hours, is observed continuously after administration 14 days, and records the toxic reaction and death toll of mouse.
The results showed that compared with the control group, administration group mouse has no notable difference, and experiment is observed continuously 14 days, small Mouse body condition, diet, drinking water and weight gain is normal.The Mouse oral stomach-filling crude drug of tablet, that is, LD50 > 26.8 of the invention/ Kg, daily maximum dosage-feeding are 53.6 crude drugs/kg/ days.Chinese medicine clinical dosage of the invention is 5.8g crude drug/day/people, adult For weight in terms of 60KG, average dosage is 0.097g crude drug/kg/ days.By batheroom scale: mouse (average weight is in terms of 21g) mouth The dosis tolerata for taking stomach-filling Chinese medicine of the invention is 552 times of quantity.Therefore middle acute toxicity of the invention is extremely low, clinical Drug safety.
Two, long term toxicity test:
Mouse 50 are randomly selected, half male and half female, weight 18-26g carries out long term toxicity test.
Mouse is randomly divided into two groups, i.e. control group and administration group, and administration group uses the capsule solution of the embodiment of the present invention 3 Stomach-filling is carried out, 26.8g crude drug/kg (1.Oml/100g weight, 2 times a day), control group gives same amount of normal saline, continuous use 15 weeks, and be discontinued 3 weeks.
The result shows that: administration group is compared with the control group without significant changes, the hair of Chinese medicine composition of the invention to mouse The indexs such as hair, behavior, stool and urine, weight, organ weights, blood picture, hepatic and renal function, blood glucose, blood lipid all have no significant effect, internal organs meat After eye is without finding that abnormal variation and histological indications show medication 15 weeks and be discontinued 3 weeks, Organs of Mice is without obvious Change.Illustrate the traditional chinese medicine composition of the invention to small toxicity after mouse long-term administration, also without abnormal reaction after drug withdrawal, therefore the medicine Object is safe and non-toxic.
Three, clinical test
1, choose make a definite diagnosis neurastheniac 132, the age at 20-56 years old, the course of disease between-four years 3 months, 132 neurastheniacs are randomly divided into three groups, respectively two groups, every group 44 for the treatment of group, one group of control and control.
Two groups for the treatment of group, one group of control and control, the age of this three groups of cases, the course of disease, degrees of symptoms are almost the same, No significant difference is comparable.
2, diagnostic criteria
It is formulated according to diagnostic criteria neurasthenic in " neurology ".
(1) debilitating symptoms: such as metal fatigue, mental retardation, attention is difficult to concentrate, memory difficulty, and work or study are not It can lasting, efficiency reduction.
(2) Agitation: work or study brain can cause mental excitation;Recall and association increases, loses control of;It can It is sensitive to acousto-optic;But it and does not appear as speech movement and increases.
(3) emotional symptoms: easily worried, Yi Ji, also can express work, learning efficiency decline or it is deficient in energy and anxious, Worries, but it is droning without the unknown mental state of extensive anxiety or reason.
(4) tonicity pain: such as tension headache, tonic muscle pain.
(5) sleep disturbance: such as difficulty falling asleep, dreaminess, Yi Xing, wake up after do not recover from fatigue.
When at least having three in above five, diagnosable is neurasthenia.
Exclusion criteria: merge personality disorder person;Less than 3 months persons of the course of disease;Physical disease or brain structural disease become;In drug Poison;Post-traumatic brain syndrome;The comprehensive card of fatigue;Adapt to reaction;The mental patients such as schizophrenia, depression and other nerves Symptom obstacle;Person caused by physiological barrier caused by psychological factor or external environment;It is tight to merge severe cardiac, liver, kidney and hemopoietic system Weight primary disease;Gestation or breast feeding women.
3, medicament selection
The Chinese medicinal composition capsules obtained of the embodiment of the present invention 3 are taken by treatment group, take orally, three times a day, two every time, 20-day courses.
It compares one group and takes medicine soup, one dose per day obtained by comparative example 1 and be taken in two divided doses, 20-day courses.
It compares two groups and takes medicine soup, one dose per day obtained by comparative example 2 and be taken in two divided doses, 20-day courses.
4, curative effect determinate standard
Cure: body and mental symptom disappearance or substantially reduced, sleeping time restores normal or Nighttime sleep is in 6h More than, work, learning efficiency restore normal.
Effective: body and mental symptom improve, and sleep improves, and sleeping time obviously mentions in 4-6h, work, learning efficiency Height can be engaged in general mental and physical exertion.
Invalid: body and mental symptom are unchanged or aggravate, and sleeping time less than 4h or without improvement, can not be engaged in general Mental and physical exertion.
5, treatment results
Two groups for the treatment of group, one group of control and control carry out the treatment of two courses for the treatment of.Treatment results are as follows
Treatment group: totally 44, healing 32, effective 10, invalid 2, cure rate 72.7%, total effective rate 95.5%.
Compare one group: totally 44, healing 26, effective 12, invalid 6, cure rate 59.1%, total effective rate 86.4%.
Compare two groups: totally 44, healing 24, effective 13, invalid 7, cure rate 54.5%, total effective rate 84.1%.
As can be seen that Chinese medicine composition prepared by the present invention is significant in efficacy to neurastheniac from treatment results, and It has no toxic side effect, cure rate is up to 72.7%, and total effective rate is up to 95.5%.
In addition, the therapeutic effect for the treatment of group, better than two groups of one group of control and control, treatment group uses 3 institute of the embodiment of the present invention The Chinese medicinal composition capsules of acquisition, one group of drug taken of control compared with Example 3, are free of herba aristolochiae, and using conventional Decoction, two groups of drugs taken of control compared with Example 3, are free of Hedge Prinsepia Nut, and using conventional decoction.Due to treatment group Therapeutic effect better than two groups of one group of control and control, therefore, it can be seen that herba aristolochiae and Hedge Prinsepia Nut and other drugs compatibility, and adopt With the preparation method of the traditional chinese medicine composition of the invention, be conducive to enhance drug effect.
6, typical case
Case 1, Mr. Wang, male, 36 years old, there are the diseases such as dizziness, failure of memory in long campaigns mental labour before half a year Shape, easily worried once in a while with headache, work decline, poor sleeping quality does not recover from fatigue after waking up, is diagnosed as neurasthenia.Take this hair Capsule prepared by bright embodiment 3, after a course for the treatment of, symptom is mitigated, and is continued taking the two courses, and is fully recovered, after half a year with It visits without recurrence.
Case 2, Zhang, female, 42 years old, due to operating pressure cause greatly it is absent minded, and often occur insomnia and dreamful sleep, The symptoms such as Yi Xing, have seriously affected working efficiency.Once hypnotic is taken, symptom is alleviated, and recurs immediately once being discontinued.It makes a definite diagnosis For neurasthenia.Take capsule prepared by the embodiment of the present invention 3, after two courses for the treatment of, symptom is substantially reduced, continues to take two The course for the treatment of, recovery from illness, follow-up is without recurrence after half a year.
Case 3, Sui, male, 46 years old, the private entrepreneur, for the fatigue of hurrying back and forth for a long time that works, appearance in nearest five months was dizzy Dim eyesight, nocturnal insomnia, daytime is listless, and attention can not be concentrated, loss of appetite, and with tension headache.It is diagnosed as mind Through weak.Take capsule prepared by the embodiment of the present invention 3, after a course for the treatment of, symptom is mitigated, and continues to take three treatments Journey, recovery from illness, follow-up is without recurrence after half a year.
Better embodiment of the invention is explained in detail above, but the present invention is not limited to above-mentioned embodiment party Formula within the knowledge of one of ordinary skill in the art can also be without departing from the purpose of the present invention Various changes can be made.

Claims (4)

1. a kind of treat neurasthenic Chinese medicine composition, which is characterized in that be made of the raw material below according to parts by weight: Hui Xin 22-28 parts careless, 10-15 parts of semen ziziphi spinosae, 5-9 parts of bombyx batryticatus, 3-6 parts of valerian, 5-9 parts of Hedge Prinsepia Nut, 9-14 parts of field pennycress, Schisandra chinensis 8-12 11-17 parts, 4-8 parts of herba aristolochiae of Fen, pig label grass;
The preparation method of the neurasthenic Chinese medicine composition for the treatment of, steps are as follows:
1) rose rhodobryum herb, semen ziziphi spinosae, Hedge Prinsepia Nut, pig label grass are weighed, is cleaned, drying after grinding, is put into container, is added 10-12 times and is measured Edible alcohol, heating and refluxing extraction 3-4h obtains an extracting solution and a residue, collects an extracting solution, will be primary residual The 6-8 times of edible alcohol measured is added in slag again, and heating and refluxing extraction 1-2h obtains secondary raffinate and secondary residual, collects two Secondary extracting solution merges an extracting solution and secondary raffinate, filtering, obtains reflux extracting liquid, spare;
2) valerian, field pennycress, Schisandra chinensis and herba aristolochiae are weighed, is cleaned, drying after grinding, is put into container, is added 8-12 times and is measured Edible alcohol, ultrasonic wave extraction 40-60 minutes, filtering, obtain ultrasonic extract, it is spare;
3) bombyx batryticatus is weighed, stir-frying crushes as smalls to yellowish, spare;
4) reflux extracting liquid and ultrasonic extract are mixed, is concentrated under reduced pressure at 60 DEG C -70 DEG C, obtain dried cream powder;
5) dried cream powder is uniformly mixed with bombyx batryticatus smalls, capsule is made to get neurasthenic Chinese medicine composition is treated.
2. the neurasthenic Chinese medicine composition for the treatment of according to claim 1, which is characterized in that by below according to parts by weight Raw material composition: 23-27 parts of rose rhodobryum herb, 11-14 parts of semen ziziphi spinosae, 6-8 parts of bombyx batryticatus, 4-5 parts of valerian, 6-8 parts of Hedge Prinsepia Nut, field pennycress 10-13 parts, 12-16 parts, 5-7 parts of herba aristolochiae of label grass of Schisandra chinensis 9-11 Fen, pig.
3. the neurasthenic Chinese medicine composition for the treatment of according to claim 2, which is characterized in that by below according to parts by weight Raw material composition: 25 parts of rose rhodobryum herb, 13 parts of semen ziziphi spinosae, 7 parts of bombyx batryticatus, 5 parts of valerian, 7 parts of Hedge Prinsepia Nut, 12 parts of field pennycress, Schisandra chinensis 10 14 parts, 6 parts of herba aristolochiae of grass of Fen, pig label.
4. purposes of the Chinese medicine composition a method according to any one of claims 1-3 in preparation treatment neurasthenia drug.
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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1903250A (en) * 2005-07-29 2007-01-31 天津天士力现代中药研究开发有限公司 Method for extraction and separation of red rooted salvia
CN103536854A (en) * 2013-10-26 2014-01-29 王永妍 Traditional Chinese medicine composition capable of effectively treating neurasthenia, and preparation method thereof
CN104383272A (en) * 2014-12-11 2015-03-04 谭清平 Traditional Chinese medicine preparation used for treating diabetes
CN104771524A (en) * 2015-04-22 2015-07-15 秦文官 Traditional Chinese medicine composition for treating neurasthenia and preparation method of traditional Chinese medicine composition

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1903250A (en) * 2005-07-29 2007-01-31 天津天士力现代中药研究开发有限公司 Method for extraction and separation of red rooted salvia
CN103536854A (en) * 2013-10-26 2014-01-29 王永妍 Traditional Chinese medicine composition capable of effectively treating neurasthenia, and preparation method thereof
CN104383272A (en) * 2014-12-11 2015-03-04 谭清平 Traditional Chinese medicine preparation used for treating diabetes
CN104771524A (en) * 2015-04-22 2015-07-15 秦文官 Traditional Chinese medicine composition for treating neurasthenia and preparation method of traditional Chinese medicine composition

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