CN1709340B - Medicinal composition for nourishing heart-disney, invigorating brain and tranquilizing mind, and its preparing method and use - Google Patents
Medicinal composition for nourishing heart-disney, invigorating brain and tranquilizing mind, and its preparing method and use Download PDFInfo
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- CN1709340B CN1709340B CN 200510021085 CN200510021085A CN1709340B CN 1709340 B CN1709340 B CN 1709340B CN 200510021085 CN200510021085 CN 200510021085 CN 200510021085 A CN200510021085 A CN 200510021085A CN 1709340 B CN1709340 B CN 1709340B
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Abstract
The present invention provides a Chinese medicine composition with the functions of tonifying and nourishing heart and kidney and tonifying brain and tranquilizing mind. Said Chinese medicine preparation is made up by using 8 Chinese medicinal materials of flowery knotweed root, acorus root, psoralea seed, schisandra berry, spiny jujube kernel, ligustrum fruit and others as raw material. Said invention also provides its preparation process and application.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that is used for nourishing heart-disney, invigorating brain and relieving mental uneasiness, particularly, is to be the pharmaceutical composition of feedstock production with the Chinese crude drug.
Background technology
In the market be used for the treatment of neurasthenic medicine based on Western medicine, be primarily aimed at treatment of sleep disorders as Benzodiazepines, barbiturates, but headache, drowsiness, dizzy, xerostomia can occur after taking, side effect such as memory difficulty; Chinese medicine such as mentality are strong, brain-invigorating and kidney-tonifying pill is primarily aimed at and improves memory function, improves cerebral circulation, and sleep disorder is not had therapeutical effect.These medicines all can not be taken into account treatment sleep simultaneously and improve brain function, and the Chinese medicine medication is based on Chinese medical theory, the kind of medication and consumption difference, dialectical difference, at indication also inequality.
Summary of the invention
The present invention relates to a kind of pharmaceutical composition that is used for nourishing heart-disney, invigorating brain and relieving mental uneasiness, the present invention also provides this preparation of drug combination method and purposes.
The invention provides a kind of pharmaceutical composition that is used for nourishing heart-disney, invigorating brain and relieving mental uneasiness, it is to contain by the following weight proportion raw material to be prepared from medicament:
2～10 parts of Radix Polygoni Multiflori Preparatas, 1～8 part of Rhizoma Acori Graminei, 1～10 part of Fructus Psoraleae, 1～8 part of Fructus Schisandrae Chinensis, 1～8 part of Semen Ziziphi Spinosae, 1～10 part of Fructus Ligustri Lucidi, 1～8 part of bee pollen, 1～8 part of Radix Salviae Miltiorrhizae.
Further, it is to be prepared from medicament by the following weight proportion raw material:
2～10 parts of Radix Polygoni Multiflori Preparatas, 1～8 part of Rhizoma Acori Graminei, 1～10 part of Fructus Psoraleae, 1～8 part of Fructus Schisandrae Chinensis, 1～8 part of Semen Ziziphi Spinosae, 1～10 part of Fructus Ligustri Lucidi, 1～8 part of bee pollen, 1～8 part of Radix Salviae Miltiorrhizae.
Wherein, Semen Ziziphi Spinosae, Fructus Ligustri Lucidi can adopt the product of giving birth to, and also can adopt processed product, as parched medicinal material.
Further, it is the medicament that is prepared from by the following weight proportion raw material:
5.33 parts of Radix Polygoni Multiflori Preparatas, 1.33 parts of Rhizoma Acori Graminei, 2 parts of Fructus Psoraleaes, 2.66 parts of Fructus Schisandrae Chinensis, 4 parts of Semen Ziziphi Spinosaes, 2 parts of Fructus Ligustri Lucidi, 2.66 parts of pollen, 2.66 parts of Radix Salviae Miltiorrhizaes.
Described pharmaceutical composition is by the water extract of Radix Polygoni Multiflori Preparata, Rhizoma Acori Graminei, Fructus Psoraleae, Fructus Schisandrae Chinensis, Semen Ziziphi Spinosae, Fructus Ligustri Lucidi and Radix Salviae Miltiorrhizae or ethanol extraction, be mixed into active component with the bee pollen ethanol extraction, add that acceptable accessories or complementary composition are prepared from medicament.
Wherein, described medicament is: granule, tablet, capsule, pill, mixture, syrup.
Every in described tablet contains emodin C
15H
10O
5, must not be less than 25ug; Contain emodin C in every of the capsule
15H
10O
5, must not be less than 25ug; Contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside (C
20H
22O
9) must not be less than 1.5mg.Granule contains emodin C for every bag
15H
10O
5, must not be less than 25ug; Contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside (C
20H
22O
9) must not be less than 1.5mg.The every 10ml of oral liquid contains emodin C
15H
10O
5, must not be less than 25ug; Contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside (C
20H
22O
9) must not be less than 1.5mg.The every ball of pill contains emodin C
15H
10O
5, must not be less than 25ug; Contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside (C
20H
22O
9) must not be less than 1.5mg.
The present invention also provides this preparation of drug combination method, and it comprises the steps:
A, take by weighing each materials of weight proportions medicine: 2～10 parts of Radix Polygoni Multiflori Preparatas, 1～8 part of Rhizoma Acori Graminei, 1～10 part of Fructus Psoraleae, 1～8 part of Fructus Schisandrae Chinensis, 1～8 part of Semen Ziziphi Spinosae, 1～10 part of Fructus Ligustri Lucidi, 1～8 part of bee pollen, 1～8 part of Radix Salviae Miltiorrhizae;
B, pollen is added 75%～95% ethanol extraction, reclaims ethanol, ethanol extraction;
C, all the other seven flavor medicines add water or add 75%～95% ethanol extraction, get water extract or ethanol extraction;
D, the water extract or the ethanol extraction of the pollen extract of b step gained, c step gained mixed, add the medicament that acceptable accessories or complementary composition are prepared from.
The present invention also provides the purposes of this pharmaceutical composition in the neurasthenic medicine of preparation treatment.
Wherein, described medicine is the medicine of tranquillizing and allaying excitement.
The present invention also provides the purposes of this pharmaceutical composition in the medicine of preparation nourishing the brain and improving intelligence.
The medicine of the present invention kidney that nourishes heart promotes coordination between the heart and kidney, kidney tonifying marrow facilitating, and QI invigorating and blood producing, and active dissipating blood stasis, expectorant falls in sharp key, and effect is remarkable.Medicine material of the present invention compatibility under Chinese medical theory instructs uses, and Radix Polygoni Multiflori Preparata is gone into liver, kidney channel, and enrich and benefit essence and blood nourishes marrow, and brain being the marrow sea, but the also invigorating brain and relieving mental uneasiness of using; The Semen Ziziphi Spinosae sweet in the mouth is gone into the heart, Liver Channel, the moon that can nourish heart, and the blood of the beneficial heart, liver and calming the nerves, two medicines share, and are longer than invigorating heart and kidney, and nourishing blood to tranquillize the mind is monarch drug altogether.The hot temperature of Rhizoma Acori Graminei, fragrant odour is longer than the mind tranquilizing and the heart calming of having one's ideas straightened out, and has the merit of the removing dampness of eliminating the phlegm concurrently, and the key of using in the side that can make is clearly opened, and turbidization of expectorant with controlling diseases such as dizzy, drowsiness, forgetful, insomnia, dreaminess due to the phlegm-damp, has the effect of nourishing the brain and improving intelligence; The sweet temperature of Fructus Schisandrae Chinensis, GUIXIN, kidney channel, energy mind tranquilizing and the heart calming; Radix Salviae Miltiorrhizae GUIXIN, Liver Channel, function blood-cooling and spirit-quieting, and arrogate to oneself blood circulation promoting and blood stasis dispelling is more suitable for giddy, dizziness etc. due to the resistance of the brain arteries and veins stasis of blood; Three medicine compatibilities are longer than mind tranquilizing and the heart calming, to strengthen the merit that monarch drug is calmed the nerves, are ministerial drug altogether.Bee pollen energy nourishing heart-disney, modern study are found its energy defying age, resisting fatigue; Fructus Ligustri Lucidi is returned liver, kidney channel, the moon of energy invigorating the liver and kidney; Fructus Psoraleae is warm in nature, is good at reinforcing the kidney and supporting YANG, more than three medicines be all adjuvant drug, to help the merit of monarch, ministerial drug nourishing heart-disney.Above-mentioned all medicines share, can tonification the cloudy blood of the heart, liver, replenishing kidney-essence again can restoring normal coordination between the heart and kidney, makes coordinating water and firely, is longer than the modern because giddy that the neurasthenia causes of treatment, dizziness, insomnia, Chinese medical discrimination such as forgetful belongs to heart-liver blood deficiency, the disarmony between the heart and kidney person.Be applicable to that brain function decline syndrome due to the aging is (as the neurasthenia, climacteric syndrome, dizziness during cerebral arteriosclerosis, headache, insomnia, hypomnesis etc.), can improve the brain metabolism, reduce gathering of aging metabolite, cerebral function improvement, and can adjust other visceral motility, health invigorating, anti-senility.
Medicine of the present invention is taken into account the nourishing blood to tranquillize the mind brain-strengthening, except that fundamentally improving the sleep quality situation, can also improve the brain metabolism, reduces gathering of aging metabolite, cerebral function improvement, and can adjust other visceral motility, health invigorating, anti-senility.Take that the precipitation of the lipofuscin in the cerebral tissue obviously reduces after this product, SOD is active to raise.Lipofuscin and neuronal function are negative correlativing relation, can reduce the interior lipofuscin of cerebellum Pu Schwann Cells gathers, this is to safeguarding that neuronic physiological function is useful, can substantially improve the giddy that causes by the neurasthenia, dizziness, forgetful disease such as grade, drug effect is obvious, and steady quality, controllability is strong, provides a kind of new medicinal selection for clinical.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
The preparation of embodiment 1 medicinal tablet of the present invention
Radix Polygoni Multiflori Preparata 533g, Rhizoma Acori Graminei 133g, Fructus Psoraleae 200g, Fructus Schisandrae Chinensis 266g, Semen Ziziphi Spinosae 400g, Fructus Ligustri Lucidi 200g, bee pollen 266g, Radix Salviae Miltiorrhizae 266g.
Technology: above eight flavors, bee pollen sprays sterilization 1-2 hour, freezing 48 hours with 75% ethanol, behind the warm water thermosol, colloid mill breaking cellular wall, the pollen breast alcohol reflux behind the breaking cellular wall, the filtrate standing over night, decompression recycling ethanol, continuing to be concentrated into relative density is 1.3 thick pastes (70-80 ℃); Seven flavors such as Radix Polygoni Multiflori Preparata decoct with water three times, add 8 times of amounts of water for the first time, decoct 1 hour, add 6 times of amounts of water for the second time, for the third time respectively, all decocted 0.5 hour, filter, collecting decoction, it is 1.08-1.10 (heat survey) that filtrate is concentrated into relative density, puts coldly, adds ethanol and makes and contain the alcohol amount and reach 60%, placement is spent the night, filter, decompression filtrate recycling ethanol continues to be concentrated into the clear paste that relative density is 1.25 (50 ℃), add pollen cream, starch 35g, dextrin 15g while hot, stir, make granule, drying, add magnesium stearate 2.8g again, be pressed into 1000, coating, promptly.
The preparation of embodiment 2 medicine capsules of the present invention
Radix Polygoni Multiflori Preparata 500g, Rhizoma Acori Graminei 400g, Fructus Psoraleae 500g, Fructus Schisandrae Chinensis 400g, Semen Ziziphi Spinosae (stir-fry) 400g, Fructus Ligustri Lucidi (stir-fry) 500g, bee pollen 400g, Radix Salviae Miltiorrhizae 400g.
Technology: above eight flavors, bee pollen sprays sterilization 1-2 hour, freezing 48 hours with 75% ethanol, behind the warm water thermosol, colloid mill breaking cellular wall, the pollen breast alcohol reflux behind the breaking cellular wall, the filtrate standing over night, decompression recycling ethanol, continuing to be concentrated into relative density is 1.3 thick pastes (70-80 ℃); Seven flavors such as Radix Polygoni Multiflori Preparata decoct with water three times, add for the first time 8 times of amounts of water, decocted 1 hour, and added 6 times of amounts of water for the second time, for the third time respectively, all decocted 0.5 hour, filter, it is 1.08-1.10 (heat is surveyed) that collecting decoction, filtrate are concentrated into relative density, puts cold, adding ethanol makes and contains alcohol amount and reach 60%, placement is spent the night, and filters decompression filtrate recycling ethanol, continue to be concentrated into the clear paste that relative density is 1.25 (50 ℃), add pollen cream, starch 35g, dextrin 15g while hot, stir, make granule, drying, encapsulated.
The preparation of embodiment 3 medicinal granules of the present invention
Radix Polygoni Multiflori Preparata 500g, Rhizoma Acori Graminei 250g, Fructus Psoraleae 250g, Fructus Schisandrae Chinensis 250g, Semen Ziziphi Spinosae (stir-fry) 250g, Fructus Ligustri Lucidi 250g, bee pollen 250g, Radix Salviae Miltiorrhizae 250g.
Technology: above eight flavors, bee pollen sprays sterilization 1-2 hour, freezing 48 hours with 75% ethanol, behind the warm water thermosol, colloid mill breaking cellular wall, the pollen breast alcohol reflux behind the breaking cellular wall, the filtrate standing over night, decompression recycling ethanol, continuing to be concentrated into relative density is 1.3 thick pastes (70-80 ℃); Seven flavors such as Radix Polygoni Multiflori Preparata decoct with water three times, add for the first time 8 times of amounts of water, decocted 1 hour, and added 6 times of amounts of water for the second time, for the third time respectively, all decocted 0.5 hour, filter, it is 1-08-1.10 (heat is surveyed) that collecting decoction, filtrate are concentrated into relative density, puts cold, adding ethanol makes and contains alcohol amount and reach 60%, placement is spent the night, and filters decompression filtrate recycling ethanol, continue to be concentrated into the clear paste that relative density is 1.25 (50 ℃), add pollen cream, starch 35g, dextrin 15g while hot, stir, make granule, drying, promptly.
The preparation of embodiment 4 bolus of drug of the present invention
Radix Polygoni Multiflori Preparata 533g, Rhizoma Acori Graminei 53.3g, Fructus Psoraleae 53.3g, Fructus Schisandrae Chinensis 53.3g, Semen Ziziphi Spinosae 53.3g, Fructus Ligustri Lucidi 53.3g, bee pollen 53.3g, Radix Salviae Miltiorrhizae 53.3g.
Technology: above eight flavors, bee pollen sprays sterilization 1-2 hour, freezing 48 hours with 75% ethanol, behind the warm water thermosol, colloid mill breaking cellular wall, the pollen breast alcohol reflux behind the breaking cellular wall, the filtrate standing over night, decompression recycling ethanol, continuing to be concentrated into relative density is 1.3 thick pastes (70-80 ℃); Seven flavors such as Radix Polygoni Multiflori Preparata decoct with water three times, add 8 times of amounts of water for the first time, decoct 1 hour, add 6 times of amounts of water for the second time, for the third time respectively, all decocted 0.5 hour, and filtered, collecting decoction, it is 1.08-1.10 (heat is surveyed) that filtrate is concentrated into relative density, put coldly, add ethanol and make and contain alcohol amount and reach 60%, placement is spent the night, and filters, decompression filtrate recycling ethanol continues to be concentrated into the clear paste that relative density is 1.25 (50 ℃), adds pollen cream while hot, mixing, oven dry adds refined honey, pill, drying, polishing, promptly.
The preparation of embodiment 5 drug mixtures of the present invention
Radix Polygoni Multiflori Preparata 533g, Rhizoma Acori Graminei 133g, Fructus Psoraleae 200g, Fructus Schisandrae Chinensis 266g, Semen Ziziphi Spinosae 400g, Fructus Ligustri Lucidi 200g, bee pollen 266g, Radix Salviae Miltiorrhizae 266g.
Technology: above eight flavors, bee pollen sprays sterilization 1-2 hour, freezing 48 hours with 75% ethanol, behind the warm water thermosol, colloid mill breaking cellular wall, the pollen breast alcohol reflux behind the breaking cellular wall, the filtrate standing over night, decompression recycling ethanol, continuing to be concentrated into relative density is 1.3 thick pastes (70-80 ℃); Seven flavors such as Radix Polygoni Multiflori Preparata decoct with water three times, add 8 times of amounts of water for the first time, decoct 1 hour, add 6 times of amounts of water for the second time, for the third time respectively, all decocted 0.5 hour, filter, it is 1.08-1.10 (heat is surveyed) that collecting decoction, filtrate are concentrated into relative density, puts cold, add ethanol and make and contain alcohol amount and reach 60%, placement is spent the night, and filters, decompression filtrate recycling ethanol, it is an amount of to add pollen cream, sodium benzoate 3g and correctives while hot, adds water to 1000ml, filter, embedding, promptly.
The preparation of embodiment 6 medical syrup agent of the present invention
Radix Polygoni Multiflori Preparata 533g, Rhizoma Acori Graminei 133g, Fructus Psoraleae 200g, Fructus Schisandrae Chinensis 266g, Semen Ziziphi Spinosae 400g, Fructus Ligustri Lucidi 200g, bee pollen 266g, Radix Salviae Miltiorrhizae 266g, Radix Polygalae 100g, Caulis Polygoni Multiflori 120g.
Technology: above eight flavors, bee pollen sprays sterilization 1-2 hour, freezing 48 hours with 75% ethanol, behind the warm water thermosol, colloid mill breaking cellular wall, the pollen breast alcohol reflux behind the breaking cellular wall, the filtrate standing over night, decompression recycling ethanol, continuing to be concentrated into relative density is 1.3 thick pastes (70-80 ℃); Seven flavors such as Radix Polygoni Multiflori Preparata decoct with water three times, add 8 times of amounts of water for the first time, decoct 1 hour, add 6 times of amounts of water for the second time, for the third time respectively, all decocted 0.5 hour, filter, it is 1.08-1.10 (heat is surveyed) that collecting decoction, filtrate are concentrated into relative density, puts cold, add ethanol and make and contain alcohol amount and reach 60%, placement is spent the night, and filters, decompression filtrate recycling ethanol, it is an amount of to add pollen cream, 650g sucrose, sodium benzoate 3g and correctives while hot, adds water to 1000ml, filter, embedding, promptly.
The method of quality control of embodiment 7 medicines of the present invention
10 in the tablet of embodiment 1 preparation is got in [discriminating] (1), removes film-coat, adds ethanol 30ml, supersound process 30 minutes, filter, filtrate evaporate to dryness, residue add water 20ml makes dissolving, and the 20ml that adds diethyl ether extracts 2 times, divide and get ether layer, volatilize, residue adds chloroform 1ml makes dissolving, as need testing solution.Other gets emodin, physcione reference substance, adds methanol respectively and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 6 μ l of above-mentioned three kinds of solution, putting respectively on same silica gel g thin-layer plate, is developing solvent with the upper solution of toluene-ethyl acetate-formic acid (volume ratio 15: 2: 1), launches, take out, dry, put under the uviol lamp (365nm) and inspect, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put ammonia in steaming smoked after, inspect under the daylight, mottle becomes redness.
(2) get 10 in the tablet of embodiment 1 preparation, remove film-coat, porphyrize adds ethanol 30ml, and reflux 30 minutes is taken out, and filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution.Other gets psoralen, and the isopsoralen reference substance adds ethyl acetate respectively and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 5 μ l of above-mentioned three kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with normal hexane-ethyl acetate (stopping long-pending than 4: 1) is developing solvent, launch, take out, dry, spray is put under the uviol lamp 365 (nm) and is inspected with 10% sodium hydroxide alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
(3) get 10 in the tablet of embodiment 1 preparation, remove film-coat, porphyrize adds ethanol 30ml, and reflux 30 minutes is taken out, and filters, and filtrate evaporate to dryness, residue add dehydrated alcohol-chloroform (volume ratio 3: 2) mixed liquor 1ml makes dissolving, as need testing solution.Other evens up pier fruit acid reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer spectrometry (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with cyclohexane extraction-acetone-ethyl acetate (volume ratio 5: 2: 1) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(4) get 10 in the tablet of embodiment 1 preparation, remove film-coat, porphyrize adds chloroform 20ml, and reflux 30 minutes filters, and filtrate evaporate to dryness, residue add chloroform 1ml makes dissolving, as need testing solution.Other gets Fructus Schisandrae Chinensis control medicinal material 1g, shines medical material solution in pairs with legal system.Get the deoxyschizandrin reference substance again, chlorination is copied into the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 2 μ l of control medicinal material solution and reference substance solution, need testing solution 4 μ l put in same silica gel G F
254On the lamellae, be developing solvent, launch, take out, dry, put under the ultra-violet lamp (254nm) and inspect with the upper solution of petroleum ether (30～60 ℃)-Ethyl formate-formic acid (volume ratio 15: 5: 1).In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the speckle of same color.
Other should meet every regulation relevant under the tablet item (" appendix ID of Chinese pharmacopoeia version in 2000) [inspection].
[n-butanol extract] gets 10 in the tablet of embodiment 1 preparation, removes film-coat, accurate claim fixed, porphyrize is got the about 1g of powder, and accurate the title decides, put in the apparatus,Soxhlet's, the 150ml that adds diethyl ether refluxed 2 hours, take out, volatilize ether, filtration paper cylinder is continued to place apparatus,Soxhlet's, add methanol 40ml, merceration spends the night, and it is an amount of to add methanol again, put in the water-bath and to reflux 4 hours, extracting solution reclaims methanol and is concentrated into driedly, and residue adds water 20ml, slight fever makes dissolving, extracts 5 times with water saturated n-butyl alcohol jolting, each 20ml, merge n-butanol extracting liquid, put in the evaporating dish that is dried to constant weight, behind the water bath method, in 105 ℃ of dryings 3 hours, move in the exsiccator, cooled off 30 minutes, weight decided in accurate rapidly title, calculate, promptly.
Every of this product contains n-butanol extract must not be less than 20mg.
40 in the tablet of embodiment 1 preparation is got in [assay] (1), removes film-coat, accurate claim fixed, porphyrize is got powder 2g, and accurate the title decides, put in the conical flask, the accurate methanol 50ml that adds claims to decide weight, reflux 1 hour is put coldly, claims to decide weight again, supply the weight that subtracts mistake with methanol, shake up, filter, precision is measured subsequent filtrate 25ml, puts in the evaporating dish evaporate to dryness, residue adds water 20ml makes dissolving, adds hydrochloric acid 2ml, reflux 1 hour, put coldly, move in the separatory funnel, and pour in the separatory funnel in the lump with the minimum of chloroform washing container, with chloroform extraction 3 times, each 20ml, combined chloroform liquid, by the funnel of anhydrous sodium sulfate is housed, filter washs with minimum of chloroform, and washing liquid is incorporated in the filtrate, put evaporate to dryness in the water-bath, residue adds dissolve with methanol and is transferred in the 2ml measuring bottle, adds methanol to scale, shake up, as need testing solution; Precision takes by weighing the emodin reference substance, adds methanol and makes the solution that every 1ml contains 0.10mg, in contrast product solution; According to a thin layer chromatography " appendix VI of Chinese pharmacopoeia version in 2000 B test, draw need testing solution 5 μ l and 6 μ l, reference substance solution 1 μ l and 3 μ l, the cross point is on same silica gel g thin-layer plate respectively, with normal hexane-ethyl acetate-formic acid (6: 2: 0.1) is developing solvent, launch, take out, dry, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side, the photograph thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2000 B thin layer chromatography scanning) scan wavelength X
S=440nm, λ
R=700nm measures test sample trap integrated value and reference substance trap integrated value, calculates, promptly.
Every of this product contains emodin (C
15H
10O
5), must not be less than 25 μ g.
(2) assay of Radix Polygoni Multiflori Preparata
The lucifuge operation is measured according to high performance liquid chromatography (appendix VI D).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water (25: 75) is a mobile phase; The detection wavelength is 320nm.Number of theoretical plate by 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside peak calculates and should be not less than 2000.
The preparation precision of reference substance solution takes by weighing 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside reference substance is an amount of, and add Diluted Alcohol and make the solution that every 1ml contains 0.05mg, promptly.
20 of this product are got in the preparation of need testing solution, remove film-coat, and accurate the title decides, porphyrize (crossing sieve No. three), precision takes by weighing in right amount (being equivalent to 1 weight approximately), puts in the conical flask, the accurate Diluted Alcohol 50ml that adds claims to decide weight, reflux 30 minutes, put cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with Diluted Alcohol, supernatant filters with microporous filter membrane (0.45 μ m), promptly.
Accurate respectively reference substance solution and each the 5 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Every of this product contains 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside (C
20H
22O
9) must not be less than 1.5mg.
The content that can measure other agent that uses the same method limits: contain emodin C in every of the capsule
15H
10O
5, must not be less than 25ug; Contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside (C
20H
22O
9) must not be less than 1.5mg.Granule contains emodin C for every bag
15H
10O
5, must not be less than 25ug; Contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside (C
20H
22O
9) must not be less than 1.5mg.The every 10ml of oral liquid contains emodin C
15H
10O
5, must not be less than 25ug; Contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside (C
20H
22O
9) must not be less than 1.5mg.The every ball of pill contains emodin C
15H
10O
5, must not be less than 25ug; Contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside (C
20H
22O
9) must not be less than 1.5mg.
Below prove beneficial effect of the present invention by pharmacodynamics test.
The 1 medicine nourishing the brain and improving intelligence test of the present invention of test example
1 experiment material
1.1 medicine
1. be subjected to the reagent thing: medicinal tablet of the present invention, by embodiment 1 preparation.Every contains crude drug in whole 2.3 grams.Three dosage groups 2.875,5.75,11.5g crude drug in whole/Kg body weight (be equivalent to respectively clinical dosage every day 5,10,20 times) are established in test.Compound method: 50 of medicinal tablets of the present invention, adding distil water 100ml, mixing promptly get 115% medicinal liquid and use for heavy dose of group, be diluted in proportion 57.5% and 28.75% medicinal liquid in dosage group and small dose group use.
2. positive control medicine: hydergine by Sandoz Pharma Ltd., Tianjin Hua Jin pharmaceutical factory Joint Production, cures mainly the sings and symptoms of degenerating with old relevant spirit, the function behind the treating acute and chronic cerebrovascular, the symptom of the hypophrenia.Oral dose is 6mg/60kg, and dosage is 2.0mg/kg (is equivalent to clinical day clothes dosage 20 times) during test.Collocation method: get 20 of hydergine, be mixed with 100ml hydergine medicinal liquid with distilled water and use.
1.2 animal
Kunming mouse, male and female half and half, body weight 20 ± 2g; The SD rat, male and female half and half, body weight 180 ± 20g.Provided by Chengdu University of Traditional Chinese Medicine Animal Experimental Study center, the quarantine back is standby.
2 experimental techniques
2.1 influence to mouse memory acquired disturbance model
Get 60 of Kunming mouses, be divided into dosage group (N=10), medicinal tablet low dose group of the present invention (N=10) in blank group (N=10), memory acquisition disturbance model group (N=10), positive controls (N=10), medicinal tablet high dose group of the present invention (N=10), the medicinal tablet of the present invention at random.Except that the blank group, all the other each groups are irritated stomach distilled water, hydergine medicinal liquid, 115% medicinal tablet medicinal liquid of the present invention, 57.5% medicinal tablet medicinal liquid of the present invention, 28.75% medicinal tablet medicinal liquid 10ml/kg.d of the present invention respectively
-1, continuous 15d.Behind the last administration 1h, lumbar injection scopolamine 5mg/kg, behind the 30min mice being put into the electricity irritation of 12 * 12 * 18cm tests on the valve rubber of reflective box, pass to the 50v alternating current immediately, animal jumps to experiment reflective box bottom from valve rubber, be subjected to electricity irritation, meeting rebound valve rubber is to hide noxious stimulation.So carry out step down test training 5min.The test mice jumps off the incubation period of valve rubber and the errors number in the 5min for the 1st time behind the 24h.Test data with " the Chinese medicine encyclopedia. medicostatistics " statistical package PEMS data base carries out statistical disposition.
2.2 rat is remembered the influence of consolidating the obstacle model
Get 60 of SD rats, be divided into blank group (N=10) at random, remember and consolidate dosage group (N=10), medicinal tablet low dose group of the present invention (N=10) in obstacle model group (N=10), positive controls (N=10), medicinal tablet high dose group of the present invention (N=10), the medicinal tablet of the present invention.Except that the blank group, all the other each groups are irritated stomach distilled water, hydergine medicinal liquid, 115% medicinal tablet medicinal liquid of the present invention, 57.5% medicinal tablet medicinal liquid of the present invention, 28.75% medicinal tablet medicinal liquid 8ml/kg.d of the present invention respectively
-1, continuous 30d.Behind the last administration 1h, rat is put into the arm top of non-place of safety, MG-2 labyrinth, pass to the alternating current of 100v then, after rat is shocked by electricity, will run away in a great rush, drop into the place of safety at last, this is training 1 time, 10 times so repeatedly.Train when finishing, immediately subcutaneous injection sodium nitrite 120mg/kg.Measure rat behind the 24h and enter the incubation period of place of safety from non-place of safety the 1st time, and the errors number that enters non-place of safety.
2.3 mouse memory reproduces the disappearance model
Get 60 of Kunming mouses, be divided into dosage group (N=10), medicinal tablet low dose group of the present invention (N=10) in blank group (N=10), memory represents disappearance model group (N=10), positive controls (N=10), medicinal tablet high dose group of the present invention (N=10), the medicinal tablet of the present invention at random.Except that the blank group, all the other each groups are irritated stomach distilled water, hydergine medicinal liquid, 115% medicinal tablet medicinal liquid of the present invention, 57.5% medicinal tablet medicinal liquid of the present invention, 28.75% medicinal tablet medicinal liquid 10ml/kg.d of the present invention respectively
-1, continuous 15d.Behind the last administration 1h, mice is carried out diving tower training 5min as preceding method.Behind the 24h, before preceding method mensuration incubation period and errors number 30min, give the medical ethanol 10ml/kg of mouse stomach 30%.
3 experimental results
3.1 medicine of the present invention is to the influence of mouse memory acquired disturbance model
Shorten the incubation period that memory acquisition disturbance model group animal gets shocked for the 1st time, and the errors number that gets shocked increases, and compares with the blank group, and difference has significance or utmost point significance.After medicinal tablet medicinal liquid treatment of the present invention, the prolongation of latency that high dose group and middle dosage group get shocked for the 1st time, the errors number that gets shocked reduces, and compares with model group, and difference has significance or utmost point significance.The results are shown in Table 1
Table 1 medicinal tablet of the present invention is to the influence of the acquired obstacle model of mouse memory (X ± SD)
Annotate: compare * P＜0.05, * * P＜0.01 with the blank group.
Compare △ P＜0.05, △ △ P＜0.01 with model group
3.2 the influence that medicinal tablet of the present invention is consolidated the obstacle model to the rat memory
The 1st prolongation of latency from non-place of safety to the place of safety of model group animal consolidated in memory, and errors number increases, and compares with the blank group, and difference has significance or utmost point significance.After medicinal tablet medicinal liquid treatment of the present invention, high dose group shortening incubation period, errors number reduces, and compares with model group, and difference has significance or utmost point significance.The results are shown in Table 2:
Table 2 medicinal tablet of the present invention is consolidated the influence (X ± SD) of obstacle model to rat memory
Annotate: compare * P＜0.05, * * P＜0.01 with the blank group.
Compare △ P＜0.05, △ △ P＜0.01 with model group
3.3 medicine of the present invention reproduces the influence of disappearance model to mouse memory
Shorten the incubation period that memory represents disappearance model group animal gets shocked, and errors number increases, and compares with the blank group, and difference has utmost point significance.After medicine medicinal liquid treatment of the present invention, high dose group, the prolongation of latency of middle dosage group, the high dose group errors number reduces, and compares with model group, and difference has significance or utmost point significance.The results are shown in Table 3
Table 3 medicinal tablet of the present invention is to the influence of rat memory represents disappearance model (X ± SD)
Annotate: compare * * P＜0.01 with the blank group;
Compare △ P＜0.01, △ △ P＜0.01 with model group
The 2 medicine tranquillizing and allaying excitement tests of the present invention of test example
1 experiment material
1.1 medicine
1. be subjected to the reagent thing: medicinal tablet of the present invention, by embodiment 1 preparation.Every contains crude drug in whole 2.3 grams.Three dosage groups 2.875,5.75,11.5g crude drug in whole/Kg body weight (be equivalent to respectively clinical dosage every day 5,10,20 times) are established in test.Compound method: 50 of medicinal tablets of the present invention, adding distil water 100ml, mixing promptly get 115% medicinal liquid and use for heavy dose of group, be diluted in proportion 57.5% and 28.75% medicinal liquid in dosage group and small dose group use.
2. positive control drug: estazolam, produce by the Yellow River, Shanghai Leah pharmaceutical Co. Ltd.Be mixed with 10% concentration (every ml contains estazolam 0.1mg) with distilled water standby.
1.2 animal
Kunming mouse, male and female half and half, body weight 20 ± 2g is provided by Chengdu University of Traditional Chinese Medicine Animal Experimental Study center, and the quarantine back is standby.
2 experimental techniques
2.1 influence to the mice autonomic activities
Get 50 of Kunming mouses, be divided into dosage group (N=10), medicinal tablet low dose group of the present invention (N=10) in negative control group (N=10), positive controls (N=10), medicinal tablet high dose group of the present invention (N=10), the medicinal tablet of the present invention at random.Irritate stomach distilled water, 10% estazolam medicinal liquid, 115% medicinal tablet medicinal liquid of the present invention, 57.5% medicinal tablet medicinal liquid of the present invention, 28.75% medicinal tablet medicinal liquid 10ml/kg of the present invention respectively by group.Behind the administration 1h, trace the movable analyzer of formula toy with the CB3201 numeral and measure the mice autonomic activities number of times in 5 minutes between 5 o'clock to 11 o'clock in the afternoon.Test data with " the Chinese medicine encyclopedia. medicostatistics " statistical package PEMS data base carries out statistical disposition.
2.2 influence to the sleep of mice pentobarbital sodium
Get 50 of Kunming mouses, be divided into dosage group (N=10), medicinal tablet low dose group of the present invention (N=10) in negative control group (N=10), positive controls (N=10), medicinal tablet high dose group of the present invention (N=10), the medicinal tablet of the present invention at random.Irritate stomach distilled water, 10% estazolam medicinal liquid, 115% medicinal tablet medicinal liquid of the present invention, 57.5% medicinal tablet medicinal liquid of the present invention, 28.75% medicinal tablet medicinal liquid 10ml/kg of the present invention respectively by group.Behind the administration 1h, lumbar injection pentobarbital sodium 40mg/kg, the incubation period and the length of one's sleep (being the time of righting reflex loss) of sleep appear in each treated animal of observed and recorded.Test data with " the Chinese medicine encyclopedia. medicostatistics " statistical package PEMS data base carries out statistical disposition.
2.3 influence to mice pentobarbital sodium subliminal hypnosis
Get 50 of Kunming mouses, be divided into dosage group (N=10), medicinal tablet low dose group of the present invention (N=10) in negative control group (N=10), positive controls (N=10), medicinal tablet high dose group of the present invention (N=10), the medicinal tablet of the present invention at random.Irritate stomach distilled water, 10% estazolam medicinal liquid, 115% medicinal tablet medicinal liquid of the present invention, 57.5% medicinal tablet medicinal liquid of the present invention, 28.75% medicinal tablet medicinal liquid 10ml/kg of the present invention respectively by group.Behind the administration 1h, lumbar injection pentobarbital sodium 30mg/kg, the animal number of elements that each treated animal righting reflex loss 1min of observed and recorded is above.Test data with " the Chinese medicine encyclopedia. medicostatistics " statistical package PEMS data base carries out statistical disposition.
3 experimental results
3.1 medicine of the present invention is to the influence of mice autonomic activities
Estazolam positive controls, medicine high dose group independent activity of animals animal number of times of the present invention obviously reduce, and compare with negative control group, and difference has significance or utmost point significance, the results are shown in Table 4.
Table 4 medicinal tablet of the present invention is to the influence of mice autonomic activities (X ± SD)
Annotate: compare with negative control group: * P＜0.05, * * P＜0.01.
3.2 medicine of the present invention is to the influence of mice pentobarbital sodium sleep
Shorten the incubation period of estazolam positive control treated animal righting reflex loss, and prolong the length of one's sleep; Medicinal tablet height of the present invention, middle dosage treated animal obviously prolong the length of one's sleep; Compare with negative control group, difference has utmost point significance.The results are shown in Table 5
The influence that table 5 medicinal tablet of the present invention is slept to the mice pentobarbital sodium (X ± SD)
Annotate: compare with negative control group: * * P＜0.01.
3.3 medicine of the present invention is to the influence of mice pentobarbital sodium subliminal hypnosis
The estazolam positive controls, medicine high dose group animal righting reflex loss of the present invention, the animal number of elements that occurs sleeping obviously increase, and compare with negative control group, and difference has significance or utmost point significance.The results are shown in Table 6
Table 6 medicinal tablet of the present invention is to the influence of mice pentobarbital sodium subliminal hypnosis
Annotate: compare with negative control group: * P＜0.05, * * P＜0.01.
(3) conclusion (of pressure testing)
Medicine of the present invention can obviously improve mouse memory acquired disturbance model, rat is remembered the memory ability of consolidating obstacle animal model, mouse memory reproduction obstacle animal model; Obviously prolong the mice step down test and wrong incubation period occurs, reduce mice and wrong number of times occurs; Obviously shorten the incubation period of rat Y maze test, reduce rat and wrong number of times occurs; Obviously reduce the autonomic activities of mice, prolong the hypnosis time of pentobarbital sodium, collaborative pentobarbital sodium subliminal hypnosis effect.
The 3 medicine acute toxicity tests of the present invention of test example
(1) experiment material
1. medicine
Medicinal tablet of the present invention is subjected to the reagent thing, and every contains crude drug in whole 2.3g.Being mixed with every ml with distilled water, to contain crude drug in whole 2.35g standby.
2. animal
Kunming mouse, male and female half and half, body weight 20 ± 2g is provided by Chengdu University of Traditional Chinese Medicine Animal Experimental Study center, and the quarantine back is standby.
(2) experimental technique
Through prerun, medicinal tablet medicine liquid irrigation stomach of the present invention can not be measured LD
50So, the maximum tolerated dose of mensuration medicinal tablet of the present invention.
Get 20 of Kunming mouses, male and female half and half, fasting 12hr, can't help water, the Cmax (every ml contains crude drug in whole 2.35g) that can accept with animal and the dosage of maximum volume 0.4ml/10g.B.W are irritated stomach, observe 7d continuously, the record animal has non-toxic reaction and experiment front and back body weight change, is maximum tolerated dose (MTD) not produce dead dosage.
(3) experimental result
After Kunming mouse is irritated stomach medicine medicinal liquid of the present invention 160g/kg, grow healthy, fleshiness, dense and glossy by hair, be close to its body, bright and flexible, the N/R secretions of eyes, the crissum cleaning, it is normal to ingest, the extremity stalwartness, spontaneous activity is normal, and body weight increases gradually.Do not see animal dead and toxicity in the 7d.Experiment concluding time naked eyes become celestial and do not see obvious pathological change.Body weight change sees table 7 for details.
Table 7 medicinal tablet medicinal liquid of the present invention MTD body weight change (X ± SD)
(4) conclusion
Kunming mouse 24h irritates stomach medicinal tablet medicinal liquid of the present invention 40ml/kg * 3 times (being equivalent to 282 crude drug in whole/kg body weight), dead and unusual toxic reaction does not appear in animal, 34.5g compares with clinical day clothes of people dosage, and the animal daily intaking amount is equivalent to 490 times of the clinical consumption per day of people.
Results suggest: medicinal tablet of the present invention, oral, 3 times on the 1st, each 5, no acute toxicity.
Claims (4)
1. pharmaceutical composition that is used for nourishing heart-disney, invigorating brain and relieving mental uneasiness, it is characterized in that: it is the medicament that is prepared from by the following weight proportion raw material:
5.33 parts of Radix Polygoni Multiflori Preparatas, 1.33 parts of Rhizoma Acori Graminei, 2 parts of Fructus Psoraleaes, 2.66 parts of Fructus Schisandrae Chinensis, 4 parts of Semen Ziziphi Spinosaes, 2 parts of Fructus Ligustri Lucidi, 2.66 parts of bee pollen, 2.66 parts of Radix Salviae Miltiorrhizaes;
Wherein, described medicament is tablet, capsule, granule, oral liquid or pill; Every in described tablet contains emodin, must not be less than 25ug; Every contains 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside must not be less than 1.5mg; Contain emodin in every of the capsule, must not be less than 25ug, contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside must not be less than 1.5mg; Granule contains emodin for every bag, must not be less than 25ug; Contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside must not be less than 1.5mg; The every 10ml of oral liquid contains emodin, must not be less than 25ug, contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside must not be less than 1.5mg; The every ball of pill contains emodin, must not be less than 25ug, contain 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside must not be less than 1.5mg.
2. the pharmaceutical composition that is used for nourishing heart-disney, invigorating brain and relieving mental uneasiness according to claim 1, it is characterized in that: it is by the water extract of Radix Polygoni Multiflori Preparata, Rhizoma Acori Graminei, Fructus Psoraleae, Fructus Schisandrae Chinensis, Semen Ziziphi Spinosae, Fructus Ligustri Lucidi and Radix Salviae Miltiorrhizae or ethanol extraction, be mixed into active component with the bee pollen ethanol extraction, add the medicament that acceptable accessories is prepared from.
3. the purposes of the described pharmaceutical composition of claim 1 in the medicine of preparation treatment tranquillizing and allaying excitement.
The described pharmaceutical composition of claim 1 the preparation nourishing the brain and improving intelligence medicine in purposes.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1080535A (en) * | 1992-06-29 | 1994-01-12 | 赵奕成 | Intelligent brain health care bag |
| CN1093921A (en) * | 1993-11-22 | 1994-10-26 | 四川内江制药五厂 | The natural component Peroral solid dosage form medicine that is used for nervous system disease |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1080535A (en) * | 1992-06-29 | 1994-01-12 | 赵奕成 | Intelligent brain health care bag |
| CN1093921A (en) * | 1993-11-22 | 1994-10-26 | 四川内江制药五厂 | The natural component Peroral solid dosage form medicine that is used for nervous system disease |
Non-Patent Citations (2)
| Title |
|---|
| 廖海民等.何首乌的生物学及化学成分研究进展.中草药36 2.2005,36(2),311-314. * |
| 梁前等.黑豆汁制首乌的质量控制研究.现代中药研究与实践18 6.2004,18(6),48-49. * |
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