CN101559168B - Pharmaceutical composition for invigorating Qi, tonifying blood and nourishing liver and kidney as well as preparation method and application thereof - Google Patents
Pharmaceutical composition for invigorating Qi, tonifying blood and nourishing liver and kidney as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a pharmaceutical composition for invigorating Qi, tonifying blood and nourishing the liver and kidney. The pharmaceutical composition is prepared by the following pharmaceuticalmaterials according to the parts by weight: 35-65 of prepared fleece flower root, 15-27 of astragalus root, 15-27 of sealwort, 10-20 of epimedium, 10-20 of medlar and 7-14 of salvia miltiorrhiza. The invention also provides a preparation method and an application of the pharmaceutical composition. Raw materials of the pharmaceutical composition are all derived from the pharmaceuticals with the sa me function and have no defect of hurting a body for long-time use; all pharmaceuticals have mild properties and no dryness or cold and cool and are suitable for subhealth persons to take as a health product for a long time; and the pharmaceutical match pays attention to the flat supplement of Qi, blood, body fluid and essence and the flat regulation of the heat, liver, spleen, lung and kidney, takes account of the outside and inside and can completely improve the physical function of the body.
Description
Technical field
The invention provides a kind of QI replenishing and blood tonifying, the pharmaceutical composition of nourishing the liver and kidney belongs to drug world.
Technical field
Application number: 01100117.8, denomination of invention: nano Huolisu medicine for restoring vitality and preparation method thereof the invention discloses a kind of nano Huolisu medicine for restoring vitality; It is to be raw material with nanometer Radix Polygoni Multiflori Preparata, nanometer Herba Epimedii, nanometer Rhizoma Polygonati, nanometer Fructus Lycii, nano astragalus, nano red sage, and new pharmaceutical preparation is processed in preparation in proportion; Its fineness of the particles reaches the 1200-1500 order; Particle diameter is 0.1-200nm, and wherein most particle diameters are less than 100nm, and has new rerum natura.Adopt steps such as microwave extracting, concentrating under reduced pressure, supersonic jet technology spray drying to process.This drug bioavailability is high, and therapeutic effect is remarkable.Wherein, the consumption of described nanoscale Chinese medicine is actual to be the Chinese crude drug extract, and in fact said nanometer formulation fail on industry, to implement, and can't obtain.
The Chinese traditional patent formulation preparation; The 17th 1998, vigor Soviet Union oral liquid wherein discloses Radix Polygoni Multiflori Preparata, Herba Epimedii, Rhizoma Polygonati (system), Fructus Lycii, the Radix Astragali, Radix Salviae Miltiorrhizae; Though disclose prescription, method for making, the function of product and cure mainly, and the weight proportion of Six-element medicine in the unexposed prescription.Because the Chinese patent medicine prescription, the consumption proportion of raw material has determined the drug effect that Chinese patent medicine is final.
Summary of the invention
Technical scheme of the present invention has provided a kind of QI replenishing and blood tonifying, the pharmaceutical composition of nourishing the liver and kidney, and another technical scheme of the present invention has provided this preparation of drug combination method and purposes.
The invention provides a kind of QI replenishing and blood tonifying, the pharmaceutical composition of nourishing the liver and kidney, it is prepared from following raw materials by weight proportions:
Radix Polygoni Multiflori Preparata 35-65 part, Radix Astragali 15-27 part, Rhizoma Polygonati 15-27 part,
Herba Epimedii 10-20 part, Fructus Lycii 10-20 part, Radix Salviae Miltiorrhizae 7-14 part.
Further preferably, it is prepared from following raw materials by weight proportions:
50 parts of Radix Polygoni Multiflori Preparatas, 22 parts of the Radixs Astragali, 22 parts of Rhizoma Polygonatis,
15 parts of Herba Epimedii, 15 parts of Fructus Lycii, 11 parts of Radix Salviae Miltiorrhizaes.
Wherein, the dosage form of pharmaceutical composition of the present invention is oral liquid, tablet, capsule, pill, granule or drop pill.
The present invention also provides this preparation of drug combination method, comprises the steps:
A, take by weighing materials of weight proportions:
Radix Polygoni Multiflori Preparata 35-65 part, Radix Astragali 15-27 part, Rhizoma Polygonati 15-27 part,
Herba Epimedii 10-20 part, Fructus Lycii 10-20 part, Radix Salviae Miltiorrhizae 7-14 part;
B, get Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, Fructus Lycii decocte with water, concentrate, add the ethanol precipitate with ethanol, the repeated hydrogenation sodium oxide is regulated pH value to 8.0, filters, and filtrating transfers to pH to 7.0, and is subsequent use;
C, get Herba Epimedii, Rhizoma Polygonati decocte with water, collecting decoction filters, and leaves standstill, and gets supernatant concentration, adds the ethanol precipitate with ethanol, and the repeated hydrogenation sodium oxide is regulated pH value to 8.0, filters, and filtrating transfers to pH to 7.0, and is subsequent use;
D, get Radix Astragali decocte with water, filter, concentrate;
E, get the combining medicine of b, c, d preparation.
In addition, comprise also after step e that add acceptable accessories or complementary composition and be prepared into preparation pharmaceutically commonly used, described preparation is oral liquid, tablet, capsule (comprising soft capsule), pill, granule, drop pill.
Wherein, adopt ethanol precipitation twice among the step b, the ethanol alcohol precipitation concentration is respectively: 70% ethanol, 80% ethanol.
Wherein, adopt ethanol precipitation twice among the step c, the ethanol alcohol precipitation concentration is respectively: 65% ethanol, 80% ethanol.
The present invention also provides this pharmaceutical composition to have QI replenishing and blood tonifying in preparation, the effect in the medicine of nourishing the liver and kidney.
Wherein, said be medicine be used to treat that old, lethargy, insomnia forgetfulness, dim eyesight are deaf, medicine that alopecia or early whitening of hair belong to insufficiency of vital energy and blood, caused by liver and kidney deficiency person.
Described medicine is the medicine of slow down aging.Described medicine is the medicine of resisting fatigue or enhancing human body immunity function, improving memory.
Pharmaceutical composition of the present invention is based on traditional ancient Chinese medicine good recipe, and through for many years clinical verification, meets Chinese medical theory, determined curative effect.Medicine material compatibility of the present invention has QI replenishing and blood tonifying, the function of nourishing the liver and kidney.Be used to get old and weak, lethargy, insomnia forgetfulness, dim eyesight is deaf, and alopecia or early whitening of hair belong to insufficiency of vital energy and blood, caused by liver and kidney deficiency person.Radix Polygoni Multiflori with invigorating the liver and kidney, benefiting essence-blood, black beard and hair, bone and muscle strengthening is monarch; With the Radix Astragali of invigorating QI to consolidate the body surface resistance, benefiting QI and nourishing blood be good at invigorating the spleen to benefit the lung, beneficial essence to fill out the Rhizoma Polygonati of marrow be minister; Assistant is played QI replenishing and blood tonifying, the effect of nourishing the liver and kidney altogether with the Fructus Lycii and the Herba Epimedii of kind invigorating the liver and kidney.It is wonderful that function is enriched blood and is invigorated blood circulation at the using corrigent Radix Salviae Miltiorrhizae simply, tranquilizing by nourishing the heart, and the effect of the five tastes before both having increased, the five tastes are too grown greasy and are had side effects real good recipe for flat tonifying five ZANG-organs before preventing again.It has stronger resisting fatigue the modern pharmacology proof, and antioxidation is removed free radical, increases the effect of immunity.
Make a general survey of medicine material proportioning of the present invention, characteristics have three:
A, whole flavour of a drug are the thing that the medicine food is used together entirely, and " clothes can be made light of one's life by commiting suicide not old for a long time " of Li Shizhen (1518-1593 A.D.) meaning do not have of a specified duration with the trouble of being harmful to the health;
B, all flavour of a drug character is gentle, and neither warm-dryness syndrome is also not cold and cool, is fit to the subhealth state personnel and takes for a long time as health product;
Gas, blood, Tianjin, smart flat the benefit are particular about in c, flavour of a drug collocation, and the exterior and the interior taken into account simultaneously in conscience spleen lung kidney the five internal organs Heibei provincial opera, can improve the physical function of human body comprehensively.
The specific embodiment
The preparation of embodiment 1 medicine oral liquid of the present invention
[prescription] Radix Polygoni Multiflori Preparata 1000g, Radix Astragali 440g, Rhizoma Polygonati (system) 440g, Herba Epimedii 300g, Fructus Lycii 300g, Radix Salviae Miltiorrhizae 220g process 1000ml
[method for making] above Six-element, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Fructus Lycii decocte with water three times, collecting decoction filters, and filtrating is concentrated into syrupy shape; Put coldly, add ethanol and make and contain alcohol amount and reach 70%, place, filter, filtrating adds ethanol again to be made and contains the alcohol amount and reach 80%; Place, filter, regulate pH value to 8.0, place with 10% sodium hydroxide solution; Filter, filtrating is regulated pH value to 7.0 with 10% hydrochloric acid solution, reclaims ethanol, and medicinal liquid is subsequent use; Herba Epimedii, Rhizoma Polygonati decocte with water secondary, collecting decoction filters, and leaves standstill, and gets supernatant concentration to an amount of; Put coldly, add ethanol and reach 65% to containing alcohol amount, leave standstill, filter, filtrating adds ethanol to be made and contains the alcohol amount and reach 80%; Leave standstill, filter, filtrating is regulated pH value to 8.0 with 10% sodium hydroxide solution, leaves standstill; Filter, filtrating is regulated pH value to 7.0 with 10% hydrochloric acid solution, reclaims ethanol, and medicinal liquid is subsequent use; Radix Astragali decocte with water three times, collecting decoction filters, and filtrating is concentrated into about 95ml, and medicinal liquid is subsequent use.Subsequent use medicinal liquid stirs more than the merging, and cold preservation is placed, and filters, and adds water to 1000ml, adds an amount of Sugarless type sweeting agent, filters, and filtrating is regulated pH value to 7.0～7.5 with 10% sodium hydroxide solution, promptly gets.
[usage and consumption] is oral, a 10ml, and 1 time on the one, the preceding clothes of sleeping, serveing on three months is a course of treatment.
[specification] every dress 10ml
[storage] sealing.
Drug quality control method of the present invention
[assay] measured according to HPLC (appendix VID).Chromatographic condition and system suitability test use octadecylsilane chemically bonded silica to be filler; With methanol-0.2% phosphoric acid solution (57: 43) is mobile phase; The detection wavelength is 271nm; Column temperature is 40 ℃; Number of theoretical plate calculates by the icariine peak should be not less than 2500.
The preparation precision of reference substance solution takes by weighing the about 10mg of icariine reference substance, puts in the 100ml measuring bottle, with dissolve with methanol and be diluted to scale, shakes up, and promptly gets (containing icariine 100 μ g among every 1ml).The preparation precision of need testing solution is measured these article 1.0ml, is added in the polyamide column [get polyamides 5g (75～180nm), wet method dress post (post footpath 20mm) is cleaned subsequent use]; Water 100ml eluting discards eluent, reuse ethanol 150ml eluting; Eluent is in 50 ℃ of following evaporated under reduced pressure, and residue is used dissolve with methanol, puts in the 25ml measuring bottle; Add methanol to scale, shake up, promptly get.
Algoscopy precision is respectively measured reference substance solution and each 10 μ l of need testing solution, injects chromatograph of liquid, measures, and promptly gets.
The every 1ml of these article contains icariine (C33H40O15) must not be less than 0.5mg.
The preparation tablets of embodiment 2 medicines of the present invention
Radix Polygoni Multiflori Preparata 1000g, Radix Astragali 440g, Rhizoma Polygonati (system) 440g, Herba Epimedii 300g, Fructus Lycii 300g, Radix Salviae Miltiorrhizae 220g
Above Six-element, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Fructus Lycii decocte with water three times, collecting decoction filters, and filtrating is concentrated into syrupy shape; Put coldly, add ethanol and make and contain alcohol amount and reach 70%, place, filter; Filtrating adds ethanol again to be made and contains alcohol amount and reach 80%, places, and filters, and regulates pH value to 8.0 with sodium hydroxide solution; Place, filter, filtrating is regulated pH value to 7.0 with 10% hydrochloric acid solution, and it is subsequent use to reclaim ethanol liquid; Herba Epimedii, Rhizoma Polygonati decocte with water secondary, collecting decoction filters, and leaves standstill; Get supernatant concentration to an amount of, put coldly, add ethanol and reach 65%, leave standstill to containing the alcohol amount; Filter, filtrating adds ethanol to be made and contains the alcohol amount and reach 80%, leaves standstill, and filters; Filtrating is regulated pH value to 8.0 with 10% sodium hydroxide, leaves standstill, and filters, and medicinal liquid is subsequent use; Radix Astragali decocte with water three times, collecting decoction filters, and filtrating is concentrated into about 95ml, and medicinal liquid is subsequent use.Subsequent use medicinal liquid stirs placement more than the merging, filters, and filtrating is concentrated into the thick paste that relative density is 1.35～1.40 (80 ℃); Add an amount of Icing Sugar, dextrin, mixing is processed granule, drying; Compacting is (coating) in flakes, or above-mentioned thick paste adopts microwave vacuum drying, the adding appropriate amount of auxiliary materials; Compacting is (coating) in flakes, processes 100 doses altogether, promptly gets.
Capsule (the comprising soft capsule) preparation of embodiment 3 medicines of the present invention
Radix Polygoni Multiflori Preparata 700g, Radix Astragali 300g, Rhizoma Polygonati (system) 300g, Herba Epimedii 200g, Fructus Lycii 200g, Radix Salviae Miltiorrhizae 140g;
Above Six-element, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Fructus Lycii decocte with water three times, collecting decoction filters, and filtrating is concentrated into syrupy shape; Put coldly, add ethanol and make and contain alcohol amount and reach 70%, place, filter; Filtrating adds ethanol again to be made and contains alcohol amount and reach 80%, places, and filters, and regulates pH value to 8.0 with sodium hydroxide solution; Place, filter, filtrating is regulated pH value to 7.0 with 10% hydrochloric acid solution, and it is subsequent use to reclaim ethanol liquid; Herba Epimedii, Rhizoma Polygonati decocte with water secondary, collecting decoction filters, and leaves standstill; Get supernatant concentration to an amount of, put coldly, add ethanol and reach 65%, leave standstill to containing the alcohol amount; Filter, filtrating adds ethanol to be made and contains the alcohol amount and reach 80%, leaves standstill, and filters; Filtrating is regulated pH value to 8.0 with 10% sodium hydroxide, leaves standstill, and filters, and medicinal liquid is subsequent use; Radix Astragali decocte with water three times, collecting decoction filters, and filtrating is concentrated into about 95ml, and medicinal liquid is subsequent use.Subsequent use medicinal liquid stirs placement more than the merging, filters, and filtrating is concentrated into the thick paste that relative density is 1.35～1.40 (80 ℃), adds an amount of starch; Mixing, cold drying is ground into fine powder, sieves; Mixing incapsulates, or above-mentioned thick paste adopts microwave vacuum drying, the adding appropriate amount of auxiliary materials; Mixing incapsulates, and processes 100 doses altogether, promptly gets.
The pill preparation of embodiment 4 medicines of the present invention
Radix Polygoni Multiflori Preparata 1300g, Radix Astragali 540g, Rhizoma Polygonati (system) 540g, Herba Epimedii 400g, Fructus Lycii 400g, Radix Salviae Miltiorrhizae 280g;
Above Six-element, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Fructus Lycii decocte with water three times, collecting decoction filters, and filtrating is concentrated into syrupy shape; Put coldly, add ethanol and make and contain alcohol amount and reach 70%, place, filter; Filtrating adds ethanol again to be made and contains alcohol amount and reach 80%, places, and filters, and regulates pH value to 8.0 with sodium hydroxide solution; Place, filter, filtrating is regulated pH value to 7.0 with 10% hydrochloric acid solution, and it is subsequent use to reclaim ethanol liquid; Herba Epimedii, Rhizoma Polygonati decocte with water secondary, collecting decoction filters, and leaves standstill; Get supernatant concentration to an amount of, put coldly, add ethanol and reach 65%, leave standstill to containing the alcohol amount; Filter, filtrating adds ethanol to be made and contains the alcohol amount and reach 80%, leaves standstill, and filters; Filtrating is regulated pH value to 8.0 with 10% sodium hydroxide, leaves standstill, and filters, and medicinal liquid is subsequent use; Radix Astragali decocte with water three times, collecting decoction filters, and filtrating is concentrated into about 95ml, and medicinal liquid is subsequent use.Subsequent use medicinal liquid stirs placement more than the merging, filters, and filtrating is concentrated into the thick paste that relative density is 1.35～1.40 (80 ℃); Add an amount of starch, mixing, cold drying is ground into fine powder; Sieve, mixing is processed the watered pill with water pill, or adds an amount of refined honey and process honeyed pill; Drying is processed 100 doses altogether, promptly gets.
The granule preparation of embodiment 5 medicines of the present invention
Radix Polygoni Multiflori Preparata 700g, Radix Astragali 540g, Rhizoma Polygonati (system) 300g, Herba Epimedii 400g, Fructus Lycii 200g, Radix Salviae Miltiorrhizae 280g
Above Six-element, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Fructus Lycii decocte with water three times, collecting decoction filters, and filtrating is concentrated into syrupy shape; Put coldly, add ethanol and make and contain alcohol amount and reach 70%, place, filter; Filtrating adds ethanol again to be made and contains alcohol amount and reach 80%, places, and filters, and regulates pH value to 8.0 with sodium hydroxide solution; Place, filter, filtrating is regulated pH value to 7.0 with 10% hydrochloric acid solution, and it is subsequent use to reclaim ethanol liquid; Herba Epimedii, Rhizoma Polygonati decocte with water secondary, collecting decoction filters, and leaves standstill; Get supernatant concentration to an amount of, put coldly, add ethanol and reach 65%, leave standstill to containing the alcohol amount; Filter, filtrating adds ethanol to be made and contains the alcohol amount and reach 80%, leaves standstill, and filters; Filtrating is regulated pH value to 8.0 with 10% sodium hydroxide, leaves standstill, and filters, and medicinal liquid is subsequent use; Radix Astragali decocte with water three times, collecting decoction filters, and filtrating is concentrated into about 95ml, and medicinal liquid is subsequent use.Subsequent use medicinal liquid stirs placement more than the merging, filters, and filtrating is concentrated into the thick paste that relative density is 1.35～1.40 (80 ℃); Add an amount of Icing Sugar, dextrin, mixing is processed granule, or above-mentioned thick paste adopts microwave vacuum drying; Add appropriate amount of auxiliary materials, mixing is processed granule; Drying is processed 100 doses altogether, promptly gets.
The drop pill preparation of embodiment 6 medicines of the present invention
Radix Polygoni Multiflori Preparata 1000g, Radix Astragali 440g, Rhizoma Polygonati (system) 440g, Herba Epimedii 300g, Fructus Lycii 300g, Radix Salviae Miltiorrhizae 220g;
Above Six-element, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Fructus Lycii decocte with water three times, collecting decoction filters, and filtrating is concentrated into syrupy shape; Put coldly, add ethanol and make and contain alcohol amount and reach 70%, place, filter; Filtrating adds ethanol again to be made and contains alcohol amount and reach 80%, places, and filters, and regulates pH value to 8.0 with sodium hydroxide solution; Place, filter, filtrating is regulated pH value to 7.0 with 10% hydrochloric acid solution, and it is subsequent use to reclaim ethanol liquid; Herba Epimedii, Rhizoma Polygonati decocte with water secondary, collecting decoction filters, and leaves standstill; Get supernatant concentration to an amount of, put coldly, add ethanol and reach 65%, leave standstill to containing the alcohol amount; Filter, filtrating adds ethanol to be made and contains the alcohol amount and reach 80%, leaves standstill, and filters; Filtrating is regulated pH value to 8.0 with 10% sodium hydroxide, leaves standstill, and filters, and medicinal liquid is subsequent use; Radix Astragali decocte with water three times, collecting decoction filters, and filtrating is concentrated into about 95ml, and medicinal liquid is subsequent use.Subsequent use medicinal liquid stirs placement more than the merging, filters; Filtrating is concentrated into the thick paste that relative density is 1.20～1.25 (80 ℃); Medicine thick paste+substrate → suspendible or fusion → drip make → cool off → wash ball → drying → select ball → quality inspection → packing, process 100 doses altogether, and promptly get.
Embodiment 7 medicine of the present invention and application numbers: 01100117.8 medicine contrast
Above-mentioned contrast can be known, contrasts from raw material, dosage, technology, industrialization etc. are many-sided, and is all different with medicine of the present invention, and according to the disclosed technology contents of contrast patent, according to realizing.
Below prove beneficial effect of the present invention through pharmacodynamics test.
Test Example 1 medicine oral liquid function in delaying senility of the present invention
1. medicine oral liquid of the present invention is to the influence of lipofuscin content in the Aged Mice cerebral tissue
Get 48 of BALB/C mices, male and female half and half were raised after 10 months, were divided into old Mus high dose and low dosage administration group and old Mus matched group at random, 16 every group (each 8 of male and female).Other gets 2 monthly age mices (16, each 8 of male and female) of the same race and makes young Mus matched group.Because administration time is grown (4 week); So employing is admixed normal diet with the dense thick paste of medicine and is made block cookies; The standard of quantitative 5g pastille feedstuff is freely ingested by mice by the every 20g body weight of mice every day; Every day, dosage was 10.8g crude drug/kg and 5.4g crude drug/kg (people's consumption 20 times and 10 times), took medicine continuously for 4 weeks.Old Mus matched group and young Mus matched group be feeding normal diet only then, does not add medicine.After 4 weeks the disconnected simultaneously in batches neck of four treated animals is put to death, cut open immediately get cerebral tissue and weigh after, press Sohal method survey lipofuscin content.The result sees table 1.
Table 1 medicine of the present invention is to the influence of Aged Mice cerebral tissue lipofuscin content
Annotate: make comparisons with young Mus matched group (1),
*P＜0.01.
(2) make comparisons △ P＜0.05 with old Mus matched group.
Visible by table 1, young Mus matched group and old Mus group compare, and the content of three groups of old murine brain lipofuscins all obviously increases, and tool significant difference (P＜0.01) conforms to other bibliographical informations.The lipofuscin deposition is the change that the most often occurs in the old and feeble neuron, also observes the atrophy or the swelling distortion of some organelle sometimes.Tend to generally think that the volume lipofuscin is piled up and to have been reduced the space that the slurry inner cell organ occupies, disturb the passage of oxygen and nutrient substance disperse to organelle and can cause damage neuron.Contain high dose and the low dosage old Mus in 4 weeks of medicine oral liquid feedstuff of the present invention and ingest, though the content of its cerebral tissue lipofuscin apparently higher than young Mus matched group, but be starkly lower than old Mus matched group (P＜0.05).Show that medicine of the present invention has lipofuscin formation and sedimentary effect in the remarkable inhibition cerebral tissue.
2. medicine oral liquid of the present invention is to the active influence of old Mus blood superoxide dismutase (SOD)
Get 64 of BALB/C mices, the monthly age of half and half, four group of mice of male and female, grouping, dosage, medication, administration time all are same as the 1st brain lipofuscin determination experiment in the test ().Drug delivery regimen finishes back 24 hours, takes out eyeball of mouse and gets blood, uses heparin anti-coagulating, presses Massayasu Minami method and surveys SOD activity in the whole blood.The result sees table 2.
Table 2 medicine oral liquid of the present invention is to the active influence of Aged Mice blood SOD
Annotate: make comparisons with young Mus matched group (1),
*P＜0.01.
(2) make comparisons △ △ P＜0.01 with old Mus matched group.
Visible by table 2, the SOD activity all significantly reduces (P＜0.01) than young control in three groups of old Mus blood, and the active reduction of SOD in the old body blood is described.And old Mus ingests high dose medicine oral liquid of the present invention after 4 weeks, in the blood SOD activity the more old Mus matched group of feeding medicine obvious rising is arranged.The active rising of SOD can effectively reduce cylinder super-oxidation lipid and form, thereby plays function in delaying senility.
Test Example 2 medicine oral liquids of the present invention are to the influence of neurotransmitter content in the old murine brain
Get 40 of BALB/C mices, male and female half and half.The monthly age of four groups of mices, grouping, dosage (high dose), medication, administration time etc. all are same as the 1st brain lipofuscin determination experiment in the test ().Drug delivery regimen finishes, and strips cerebral tissue immediately behind the disconnected neck, also puts into liquid nitrogen immediately after brain is weighed and cools off.Fluorimetry by the improvement of the biochemical teaching and research room of Suzhou Medical College is carried out 5-hydroxy tryptamine (5-HT), norepinephrine (NA) and dopamine (DA) assay.The result sees table 3.
Table 3 medicine oral liquid of the present invention is to the influence (
μ g/g cerebral tissue) of mouse brain neurotransmitter content
Annotate: compare with young Mus matched group (1),
*P＜0.01
(2) compare △ P＜0.05, △ △ P＜0.01 with old Mus matched group
Visible from table 3; NA and DA all are starkly lower than young Mus matched group (P all＜0.01) in the old Mus matched group brain; And the ingest medicine oral liquid of the present invention of high dose and low dosage of old Mus makes NA and DA that rebound significantly (P all＜0.01) is all arranged after 4 weeks, makes it the level near young Mus matched group.5-HT content obviously increases (P all＜0.01) in the old Mus brain, but medicine of the present invention does not have obvious change effect to 5-HT in the brain.
Through detection, prove that medicine of the present invention has therapeutical effect to dysmnesia to 5-hydroxy tryptamine (5-HT), norepinephrine (NA) and dopamine neurotransmitteies such as (DA).
The antifatigue effect of Test Example 3 medicine oral liquids of the present invention
The application mice climbs glass rod ability test method and carries out.Get 48 of Kunming mouses, male and female half and half, arranging in pairs or groups at random by mice sex and body weight is divided into 4 groups.Respectively as medicine oral liquid high dose group of the present invention (10.8g crude drug/kg, people's consumption 20 times), low dosage (5.4g crude drug/kg, people's consumption 10 times), WUJIJING KOUFUYE (8ml/kg, people's consumption 20 times) and blank group (equal-volume distilled water).Every day, gastric infusion was 1 time, continuous 7 days.Respectively each group mice was afraid of the glass rod ability test in 24 hours before the administration and after the last administration.Specific practice is: mice is placed on axial long 150cm, and the broken of diameter 0.7cm caught up with, and lets mice creep up and down freely or on bar, stop to creep broken catching up with, and makes muscular strength be in the static(al) tense situation.After after a while, drop down from glass rod because mice limb muscle fatigue is unable.With mice from being placed on the glass rod to the time that drops down---" pole-climbing time " is as the tired index of mice.Experimental result is seen table 4.
The antifatigue effect of table 4 medicine oral liquid of the present invention (mice climbs the glass rod test)
Annotate: compare before and after the administration in (1) group,
*P＜0.05.
(2) compare △ P＜0.05 with the blank group.
Visible from table 4, medicine oral liquid high dose of the present invention and low dosage had the obvious anti-fatigue effect to after the mouse stomach administration in continuous 7 days, were that mice climbs the glass rod time and obviously prolongs.
Test Example 4 medicine oral liquids of the present invention are to the influence of body's immunity
The grouping of Kunming mouse, dosage, administration sky number average are tested with the mouse anti-reflecting fatigue effect.1 as a child after the last administration; From (the E.Merck import packing of mouse tail vein injection 0.5% Congo red; Shanghai chemical reagent packing factory) solution 0.1ml/10g body weight; Respectively the disconnected neck of mice is got blood centrifuging and taking supernatant 0.1ml after 15 minutes, after the adding distil water 5ml dilution, be worth in 520nm wavelength colorimetric determination optical density (OD) with BeckMan700 type automatic clinical chemistry analyzer.Experimental result is seen table 5.
Table 5 medicine oral liquid of the present invention is to the influence of mouse monokaryon macrophage phagocytic function
Visible from table 5, two kinds of dosage of medicine oral liquid of the present invention to the mouse stomach administration after, the ability of mouse monokaryon macrophage phagocytic Congo red is obviously strengthened, but shows its enhancing human body immunity function.
Above-mentioned evidence, medicine of the present invention have effects such as slow down aging, treatment dysmnesia, resisting fatigue, raising immunologic function, are to be used for treatment to get old and weak; Lethargy; Insomnia forgetfulness, dim eyesight is deaf, and alopecia or early whitening of hair belong to insufficiency of vital energy and blood, caused by liver and kidney deficiency person's ideal medicament.
Claims (4)
1. the application of pharmaceutical composition in preparation human body immunity improving function medicament is characterized in that said pharmaceutical composition is prepared from following raw materials by weight proportions:
50 parts of Radix Polygoni Multiflori Preparatas, 22 parts of the Radixs Astragali, 22 parts of Rhizoma Polygonatis,
15 parts of Herba Epimedii, 15 parts of Fructus Lycii, 11 parts of Radix Salviae Miltiorrhizaes.
2. application as claimed in claim 1 is characterized in that preparing the application that improves in the mononuclear-macrophage phagocytic function medicine.
3. according to claim 1 or claim 2 application, it is characterized in that: the dosage form of said drug regimen is oral liquid, tablet, capsule, pill or granule.
4. the content assaying method of the drug composition oral liquid of a QI replenishing and blood tonifying, nourishing the liver and kidney is characterized in that this method is:
Chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filler; With 57: 43 methanol-0.2% phosphoric acid solution is mobile phase; The detection wavelength is 271nm; Column temperature is 40 ℃; Number of theoretical plate calculates by the icariine peak should be not less than 2500;
The preparation of reference substance solution: precision takes by weighing the about 10mg of icariine reference substance, puts in the 100ml measuring bottle, with dissolve with methanol and be diluted to scale, shakes up, and promptly gets the reference substance solution that contains icariine 100 μ g among every 1ml;
The preparation of need testing solution: precision is measured said oral liquid 1.0ml, gets 75～180nm polyamide 5g and is added on polyamide column, wet method dress post, post footpath 20mm; Clean subsequent use] in, water 100ml eluting discards eluent, reuse ethanol 150ml eluting; Eluent is in 50 ℃ of following evaporated under reduced pressure, and residue is used dissolve with methanol, puts in the 25ml measuring bottle; Add methanol to scale, shake up, promptly get;
Algoscopy: precision is measured reference substance solution and each 10 μ l of need testing solution respectively, injects chromatograph of liquid, according to high effective liquid chromatography for measuring, promptly gets;
Wherein, the crude drug of drug composition oral liquid consists of: Radix Polygoni Multiflori Preparata 1000g, Radix Astragali 440g, Rhizoma Polygonati (processed) 440g, Herba Epimedii 300g, Fructus Lycii 300g, Radix Salviae Miltiorrhizae 220g, process 1000ml;
Said drug composition oral liquid is prepared from as follows: above Six-element, and Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Fructus Lycii decocte with water three times, collecting decoction filters, and filtrating is concentrated into syrupy shape; Put coldly, add ethanol and make and contain alcohol amount and reach 70%, place, filter, filtrating adds ethanol again to be made and contains the alcohol amount and reach 80%; Place, filter, regulate pH value to 8.0, place with 10% sodium hydroxide solution; Filter, filtrating is regulated pH value to 7.0 with 10% hydrochloric acid solution, reclaims ethanol, and medicinal liquid is subsequent use; Herba Epimedii, Rhizoma Polygonati decocte with water secondary, collecting decoction filters, and leaves standstill, and gets supernatant concentration to an amount of; Put coldly, add ethanol and reach 65% to containing alcohol amount, leave standstill, filter, filtrating adds ethanol to be made and contains the alcohol amount and reach 80%; Leave standstill, filter, filtrating is regulated pH value to 8.0 with 10% sodium hydroxide solution, leaves standstill; Filter, filtrating is regulated pH value to 7.0 with 10% hydrochloric acid solution, reclaims ethanol, and medicinal liquid is subsequent use; Radix Astragali decocte with water three times, collecting decoction filters, and filtrating is concentrated into about 95ml, and medicinal liquid is subsequent use.Subsequent use medicinal liquid stirs more than the merging, and cold preservation is placed, and filters, and adds water to 1000ml, adds an amount of Sugarless type sweeting agent, filters, and filtrating is regulated pH value to 7.0～7.5 with 10% sodium hydroxide solution, promptly gets.
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| CN104324225A (en) * | 2014-11-13 | 2015-02-04 | 滨州市知识产权维权援助中心 | Traditional Chinese medicine composition for reinvigorating body resistance and reinforcing kidney and application method thereof |
| CN108295160A (en) * | 2018-04-20 | 2018-07-20 | 陈婷 | A kind of Traditional Chinese medicine foot bath side and preparation method thereof for improving immunity |
| CN111375010A (en) * | 2020-03-19 | 2020-07-07 | 兰州大学第一医院 | A Chinese medicinal composition with effects of strengthening body resistance, consolidating constitution, nourishing liver, invigorating kidney, and enhancing immunity |
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Address after: 635000 Dazhou City, Sichuan Province Jian min Lu, Tongchuan District No. 96 Co-patentee after: Chengdu Thai Health Technology Group Limited by Share Ltd Patentee after: Chengdu Diao Group Tianfu Medicine Co., Ltd. Address before: 635000 Dazhou City, Sichuan Province Jian min Lu, Tongchuan District No. 96 Co-patentee before: Chengdu Huanshen Group Co., Ltd. Patentee before: Chengdu Diao Group Tianfu Medicine Co., Ltd. |
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Address after: 635000 Dazhou City, Sichuan Province Jian min Lu, Tongchuan District No. 96 Co-patentee after: Chengdu Huashen Technology Group Co., Ltd Patentee after: CHENGDU DIAO GROUP TIANFU PHARMACEUTICAL Co.,Ltd. Address before: 635000 Dazhou City, Sichuan Province Jian min Lu, Tongchuan District No. 96 Co-patentee before: Chengdu Taihe Health Technology Group Co.,Ltd. Patentee before: CHENGDU DIAO GROUP TIANFU PHARMACEUTICAL Co.,Ltd. |
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Application publication date: 20091021 Assignee: Pharmaceutical factory of Chengdu Huashen Technology Group Co.,Ltd. Assignor: Chengdu Huashen Technology Group Co.,Ltd. Contract record no.: X2021510000021 Denomination of invention: The invention relates to a pharmaceutical composition for supplementing qi and blood and nourishing liver and kidney, and a preparation method and application thereof Granted publication date: 20121121 License type: Common License Record date: 20210714 |