CN101797290A - Medicament for treating spleen deficiency and preparation method thereof - Google Patents
Medicament for treating spleen deficiency and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medicinal composition consisting of traditional Chinese medicines for treating spleen deficiency and a preparation method thereof. The medicament consists of the following components in part by weight: 35 to 45 grams of mix-fried raidx astragali, 12 to 20 grams of pilose asiabell root, 8 to 14 grams of Chinese date and 8 to 15 grams of yellow wine. The medicament of the invention can weigh mix-fried raidx astragali, pilose asiabell root, Chinese date and yellow wine according to the components in part by weight and decocts raidx astragali, pilose asiabell root and Chinese date by water. After being added with yellow wine, the water decoction can be drunk. The medicament also can be prepared into granules to be take.
Description
Technical field
The present invention relates to a kind of medicinal mixture of forming by Chinese medicine that is used for the treatment of spleen deficiency and preparation method thereof.
Background technology
Motherland's medical science is thought: The spleen and stomach provide the material basis of the acquired, source of generating QI and blood, and deficiency of spleen-QI and stomach-QI is received with strong fortune weakly, and then diet reduces; Endogenous damp formation is so big loose stool is thin; Spleen governing muscles, deficiency of spleen-QI and stomach-QI, limb muscle do not have institute to be possessed, so limbs fatigue; Insufficiency of generating and transforming QI and blood, insufficiency of blood are not flourish in face, and the meeting color withers white; Spleen is the mother of lung, taste one void, lung qi is earlier exhausted, thus see breathe hard, faint low voice; Pale tongue with white fur, deficient and weak pulse are all resembling of the deficiency of vital energy.Said as " hospital examines ": " husband's complexion is withered white, then prestige and know its deficiency of vital energy; Speech is slight, then news and know its deficiency of vital energy; Myasthenia of limbs, then ask and know its deficiency of vital energy; Arteries and veins comes weak, then cut and know its deficiency of vital energy." spleen deficiency is commonly encountered diseases, taste function deficiency, the ascending, descending, exiting and entering functional imbalance, thus occur based on the one group of insufficiency of the spleen disease.Show as digestive system function and go down, the parasympathetic nervous system function is high partially, and immunologic function and metaboilic level are on the low side etc.Control the gas that should strengthen the spleen and stomach, to answer the merit that its fortuneization is received.
Insufficiency of the spleen paathogenic factor mainly contains due to damp, troubled thoughts, diet work and rest, flavor have a liking for etc. partially, with the quickening pace of modern life, work and study pressure is increasing, showing as digestive system function goes down, the parasympathetic nervous system function is high partially, the syndrome of spleen-deficiency sickness rate that immunologic function and metaboilic level are on the low side etc. is just presenting increase trend year by year, and people's routine work studying and living quality has been caused serious negative effect.The spleen being the foundation of acquired constitution, source of generating QI and blood.Transfer spleen reinforcing soil to be principle of treatment, proper with it, the Zhuo that produces effects.
Take all factors into consideration, though the angle difference that each doctor's opinion is controlled, but all be to be core with deep parsing etiology and pathogenesis characteristics, with transferring the internal organs meridians is purport, disease institute is directly gone in comprehensive medication, by improving the foundation again that cardinal symptom promotes total balance of the body, wherein contained method of treatment is various, medication is flexible, but mainly based on build middle QI invigorating, help fortune, promote the production of body fluid, enrich blood, lift sunken, take the photograph liquid, the row water.Spleen state placed in the middle, main in gas, strong fortune, catch build in gas one method, with food with change, spleen reinforcing nourishing YIN and spermatogenesis, ascending spleen-QI is adjusted the operation of water liquid; Transporting and transforming nutrients from foodstuff, essence and blood body fluid the source of vital function, the flourish whole body of supporting.There are the beautiful two dirt medicated porridge of decoction of four noble drugs, BUZHONG YIQI TANG, five tastes Yigong San powder with marveous Effect, spleen-strengthening bolus, ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae ball, erdong gao, Rhizoma Polygonati Odorati cream, pearl produce effects side, support living soup, incomparable Rhizoma Dioscoreae ball, SHIHUYEGUANG WAN, decoction of four noble drugs add the Radix Polygoni Multiflori or Rhizoma Polygonati, low dose of GUIPI TANG, GUIPI TANG, taste are warded off drink, incomparably Rhizoma Dioscoreae ball, WULING SAN, WUPI YIN, tonifying the spleen drink etc.
Chinese invention patent 95108291.4 disclosed a kind of nourishing healthy soft sweets and preparation method thereof belong to health food.This soft sweet is mainly by the food or the medicine of (1) kernel 10-50% food and medicament dual-purpose; (2) Radix Codonopsis, the Radix Astragali, Rhizoma Dioscoreae, Fructus Jujubae, one or more 1-30% wherein; (3) Radix Polygoni Multiflori, Rhizoma Polygonati, Fructus Lycii, the Radix Rehmanniae, one or more 0-20% wherein; (4) Fructus Crataegi, Poria, one or more 0-10% wherein; (5) Auricularia, Tremella, agar, alginic acid, pectin, one or several 1-10% wherein; (6) Mel, xylitol, wherein one or more surpluses are formed.This health care soft sweet is based on QI invigorating, YIN nourishing, tonifying speen and tonifying kidney, and especially suitable physical weakness, the middle-aged and elderly people that cardio and vascular function is not good enough eat.
Chinese invention patent 94119239.3 disclosed a kind of Hanjingbaoyuan beverages add decocting system by the Radix Astragali, Radix Codonopsis, Fructus Jujubae and Radix Glycyrrhizae and form, and it is used for the convection potential treatment, are suitable for treating the symptom of the deficiency of vital energy, blood deficiency or QI and blood deficiency.As: tumour patient is owing to the discomfort that chemicotherapy causes is candidate; Children physique weakness, and the gynecological patient that shows as the deficiency of vital energy, blood deficiency, qi-blood deficiency syndrome.Be a kind of all-ages treatment and health promoting beverage.Be made into spissated oral liquid, can be secular, take easily, and also cheap.Clinical research shows that the symptomatic treatment effect is excellent.
Summary of the invention
The invention provides a kind of medicine that is used for the treatment of spleen deficiency.
Medicine of the present invention is formed with weight portion:
Radix Astragali Preparata 35～45g, Radix Codonopsis 12～20g, Fructus Jujubae 8～14g, yellow wine 8～15g.
Medicine of the present invention can take by weighing Radix Astragali Preparata, Radix Codonopsis, Fructus Jujubae and yellow wine by above-mentioned component and weight portion, and the Radix Astragali, Radix Codonopsis, Fructus Jujubae are through decocting, and it is promptly drinkable that decocting liquid adds yellow wine.
The present invention also can be prepared into granule as follows and take:
A. earlier the Radix Astragali that cleans is soaked into the back section, reuse is equivalent to the Flos Sophorae Mel processed with honey of astragalus weight 25% to be handled, and again will the Radix Astragali after processed with honey is handled uses the water extraction 3 times of 12 times, 10 times and 8 times respectively, and the water extract is merged, get the clear liquid concentrate drying through post precipitation and handle, obtain exsiccant astragalus membranaceus powder;
B. Radix Codonopsis and the Fructus Jujubae that cleans cleaned, Fructus Jujubae removes nuclear, dried then;
C. take by weighing astragalus membranaceus powder, Radix Codonopsis and Fructus Jujubae in proportion, mix homogeneously after abundant pulverization process adds yellow wine again and granulates, and obtains tablet or ball or the grain or the electuary of solid dosage forms.
In above step c, also can in medicine, add an amount of sugar, essence, to adjust its taste.
Because historical reasons, theory of Chinese medical science part concept obfuscation, lack of standardization to its intension arrangement, analyze, standardizes, Standardization Research, should be the important goal of modern Chinese medicine basic research development.The syndrome of spleen-deficiency notion is not clear and definite as yet so far.Once mentioned " deficiency of spleen-QI " in " interior warp ", symptom then relates to digestive system and some non-digestive diseases in the modern medicine.And disease, disease, card three's difference is not fully aware of, and its speech deficiency of spleen-QI is a kind of notion of disease seemingly.Back physicians from a family for generations family has proposed notions such as deficiency of spleen-YIN, deficiency of spleen-YANG again in succession.Modern many scholars think that syndrome of spleen-deficiency should be a upperseat concept, comprises syndrome of deficiency of spleen qi, syndrome of deficiency of spleen yin, syndrome of deficiency of spleen yang etc.But usually self-existent middle Qi collapse syndrome and dysfunction of the spleen in transportation etc. seldom are mentioned in clinical, also have some simultaneously and are called as compound syndrome of levying as stagnation of liver-QI with deficiency of the spleen etc.Relation between this type of syndrome and syndrome of spleen-deficiency, syndrome of deficiency of spleen qi, syndrome of deficiency of spleen yin, the syndrome of deficiency of spleen yang is worth further research.
The spleen feebleness diagnosis standard that propose the seventies in last century first comprises 6 primary symptoms and some time diseases, with 3 above primary symptoms or 2 primary symptoms add 2 with last time disease diagnose.When whole nation combination of Chinese and Western medicine deficiency syndrome and senile disease research committee formulate the dialectical reference standard of deficiency syndrome in nineteen eighty-two, stipulated the standard of syndrome of deficiency of spleen qi, and clear and definite syndrome of deficiency of spleen qi is made of the some symptom and signs of foundation during diagnosis insufficiency of the spleen and the deficiency of vital energy.This standard has added 2 lab index of xylose excretion rate and ptyalin stress test when revision in 1986, makes that the spleen feebleness diagnosis standard further objectifies, standardization.Be widely used at present and representative achievement in research is spleen feebleness diagnosis and a criterion of therapeutical effect in Ministry of Public Health in 1993 promulgation " new Chinese medicine guideline ".
Syndrome of spleen-deficiency is single factors both, also polynary factor interaction result.The multiple performance that the present invention shows the animal spleen deficiency by the multiple animal sign that demonstrates fully syndrome of spleen-deficiency in the animal modeling, and show that by relevant test medicine of the present invention is to the spleen deficiency better therapeutic effect.
Among the present invention:
The Radix Astragali is gone into lung, spleen channel, tonifying Qi and lifting yang, and hemostasis by invigorating QI, the QI invigorating row stagnates, blood stasis removing eliminating stagnation, benefiting QI for strengthening the superficies, QI invigorating tonifying YIN, inducing diuresis to remove edema, warming the interior cold expelling, pus expelling by strengthening vital QI granulation promoting, strong body constitution, life lengthening.Process usefulness: invigorating the spleen and replenishing QI.Control the internal injury overstrain, diarrhea due to hypofunction of the spleen, proctoptosis, deficiency of vital energy blood prostration, metrorrhagia and leukorrhagia, and the card of all weakness of QI blood deficiency.Radix Astragali main chemical compositions has: choline (Choline), glucuronic acid, phlegmatic temperament, sucrose, several aminoacid, bitter principle, betanin (Betaine), folic acid, 2 ', 4 '-dihydroxy-5,-dimethoxy isoflavan (2 ', 4 '-Dihydroxy-5,6-dimethoxyisoflavane) and kumatakenin (Kumatakenin).Modern pharmacology studies show that to have anti-aging effects, and the effect of enhance immunity is arranged.Radix Astragali effective ingredient is dissolved in water, and itself contains higher fiber again, and feeding intake to take after mixing it with water with powder influences mouthfeel, so water extraction is with low cost.
Radix Codonopsis is returned spleen, lung meridian, power energy spleen reinforcing nourishing the stomach, and the lung moistening and production of body fluid promoting, gas in the tendon fortune, very mutually not far away with Radix Ginseng.Its valuable person, spleen invigorating fortune and not dry is grown stomach-Yin and wet, and lung moistening and do not violate is cold and coolly nourished blood and is not grown greasyly partially, inspires clear sun, gas in the vibration, and do not have dry fraud just.And the strength than the Liao Dynasty's ginseng is thick and heavy, and few relatively cloudy gentle, the abnormal smells from the patient magnificence of Korean Ginseng, and littlely dislike in fiery and forthright person, particularly must neutralize just, suitable the five internal organs are handed over and supported by it, and do not have past should not be also.Modern pharmacology studies show that Radix Codonopsis has not same-action to central nervous system, spontaneous activity, digestive system, immune system, cardiovascular system, has effects such as oxygen lack resistant function, acute myocardial ischemia, microcirculation disturbance, ulcer simultaneously.Radix Codonopsis flavor itself is sweet, and fibre-bearing is less, feeds intake good mouthfeel with powder.
Fructus Jujubae is returned spleen, stomach warp, invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.Be used for insufficiency of the spleen lack of appetite, weak loose stool, woman hysteria.Fruit contains alkaloid: N-demethyl nuciferine (N-nornuciferine), stepharine (stephar-ine), asimilobine (asmilobine).Contain the triterpenic acid compounds again: maslinic acid (maslinic acid) promptly is Crataegolic acid (cratagolicacid), 3-O-trans right-coumaric acyl maslinic acid (3-O-trans-p-coumaroyl-maslinic acid), Betulonic acid (betulonic acid), the 3-O-cis is to coumaric acyl maslinic acid (3-O-cis-p-coumaroyl-maslinic acid), betulic acid (betulinic acid), oleanolic acid (oleanoic acid), 3-O-is trans to coumaric acyl alphitolic acid (3-O-trans-p-coumaroyl alphi-tolic acid), alphitolic acid (alphitolic acid), the 3-O-cis is right-coumaric acyl alphitolic acid (3-O-cis-P-coumaroylal-phitolic acid).Also contain soap formula compounds: Fructus Jujubae soap formula (zizyphus saponin) I, II, III and jujuboside (jujuboside) B etc.Modern pharmacology studies show that Fructus Jujubae has effects such as antitumor, I allergic reaction type.Fructus Jujubae flavor itself is sweet, and fibre-bearing is less, feeds intake with powder, also can make mouthfeel better.
Description of drawings
Fig. 1 is a medication preparation flow process of the present invention.Fig. 2 is a medicine of the present invention to the influence of model of spleen deficiency mice body weight due to the reserpine.Fig. 3 is a medicine of the present invention to the influence of mice with spleen deficiency spleen coefficient due to the reserpine.Fig. 4 is a Radix Astragali Radix Codonopsis granule to the influence of model of spleen deficiency mice body weight due to the Radix Et Rhizoma Rhei.Fig. 5 is a Radix Astragali Radix Codonopsis granule to the influence of mice with spleen deficiency spleen coefficient due to the Radix Et Rhizoma Rhei.Among Fig. 2 to Fig. 5: # and normal group compare, P＜0.05; # ※ and model group compare, P＜0.05.Fig. 6 is medicine acute toxicity testing nephropathy reason of the present invention section, and kidney is normal as seen from the figure, and epithelial cell does not have degeneration, NIP.Fig. 7 is internal organs pathological sections such as medicine acute toxicity testing liver of the present invention, and hepatocyte does not have degeneration as seen from the figure, no inflammatory cell infiltration.Fig. 8 is medicine long term toxicity test nephropathy reason of the present invention section, and as seen from the figure, kidney is normal, and epithelial cell does not have degeneration, NIP.Fig. 9 medicine long term toxicity test of the present invention hepatopathy reason section (10 *), hepatocyte does not have degeneration as seen from the figure, no inflammatory cell infiltration.
The specific embodiment
Studies show that syndrome of spleen-deficiency is relevant with multisystem.The syndrome of spleen-deficiency patient is at digestive system, has that gastrointestinal motility and digestive juice secretion are unusual, neuro humor is regulated disorder and nutrient metabolism obstacle; Aspect immune system, common non-specific immunity is unusual, and cellular immune function reduces, regulates disorder, and humoral immunization is unusual, and visible lysozyme activity reduces, and phagocytic activity of leukocytes descends, lymphopenia and active reduction, atrophy of immune organ; The trace element aspect, insufficiency of the spleen can directly the influence in the bodies such as sodium, potassium, copper, ferrum, calcium absorbs, distributes, drains, and micronutrient levels changes with syndrome of spleen-deficiency simultaneously certain internal relation; The blood circulation aspect, visible blood flow is slowed down, and whole blood viscosity and plasma viscosity increase, and erythrocyte sedimentation rate is accelerated, and platelet aggregation increases; The neuroendocrine aspect, one's own judgment autonomic nervous dysfunction, some organs and body of gland such as hypothalamus, hypophysis, thyroid, gonad, adrenal gland etc. synthesize, secrete and regulate and control unusually; The insufficiency of the spleen enzyme that also can influence changes, as superoxide dismutase (SOD), Na
+K
+-ATP enzyme, Ca
2+Mg
2+-ATP enzyme, ptyalin etc. are along with insufficiency of the spleen degree difference has different the variation.Syndrome of spleen-deficiency and cell biological mode structure and changes of function, the transmission of cell information and gene expression also have certain dependency
[17～25]
In the syndrome of spleen-deficiency research, specifically detected more or less a hundred index, but do not found that has a specific diagnosis index, the index that changes when insufficiency of the spleen is weak specific index.In fact, the whole guiding theory of seeing in the self-examination theory of Chinese medical science, syndrome of spleen-deficiency is not found specific index, and all influential at many system aspects, the whole thought of seeing of the traditional Chinese medical science embodies just, and the same with pathomechanism with the physiological function of spleen in the Basic Theories of Chinese Medicine have a multiformity.We can say that syndrome of spleen-deficiency is multisystem in the modern medicine, many-side, multi-functional, many sick results who plants common influence under different physiology, pathology environment
One, the preparation of medicine
The Radix Astragali, Radix Codonopsis, Fructus Jujubae are provided by the honest pharmaceutcal corporation, Ltd in the west of Gansu Province, Gansu, and yellow wine is provided by Gansu Wushanchi Yellow Wine Co., Ltd..
Preceding medical material is cleaned, then:
A. earlier the Radix Astragali that cleans is soaked into the back section, reuse is equivalent to the Flos Sophorae Mel processed with honey of astragalus weight 25% to be handled, and again will the Radix Astragali after processed with honey is handled uses the water extraction 3 times of 12 times, 10 times and 8 times respectively, and the water extract is merged, get the clear liquid concentrate drying through post precipitation and handle, obtain exsiccant astragalus membranaceus powder;
B. Radix Codonopsis and the Fructus Jujubae that cleans cleaned, Fructus Jujubae removes nuclear, dried then;
C. take by weighing astragalus membranaceus powder, Radix Codonopsis and Fructus Jujubae in proportion, mix homogeneously after abundant pulverization process adds yellow wine again and granulates, and obtains the granule of solid dosage forms.
Its concrete preparation process is referring to accompanying drawing 1.
In above step c, also can in medicine, add an amount of sugar, essence, to adjust its taste.
The every g of drug particles that obtains after as above handling is equivalent to crude drug 1.75g.
Two, pharmacological evaluation
Test medication and test method
The test medication is for pressing the granule of preceding method preparation.Pharmaceutical factory, China Tian Bao, BUZHONG YIQI WAN (lot number 090118) Shuande product.
Test method is to get it filled that composition granule grinds and adding distil water is made into 3% suspension respectively for the mouse stomach administration.
Laboratory animal
Kunming mouse, body weight (20 ± 2) g, female, male half and half, provide by Lanzhou University's Experimental Animal Center, standby after qualified through quarantining.
2.1 medicine of the present invention is to the research of experimental " syndrome of spleen-deficiency " mice therapeutical effect
" syndrome of spleen-deficiency " mice is set up the spleen deficiency model to adopt reserpine and Radix Et Rhizoma Rhei respectively in the test.
2.1.1. reserpine modeling test
120 of mices, male and female half and half are divided 12 groups: each 2 groups of model group, normal group, positive drug group [BUZHONG YIQI WAN 6g/kg.d)], medicine low dose group of the present invention [1.03g/ (kg.d)], middle dosage group [3.10g/ (kg.d)] and high dose group [9.29g/ (kg.d)] at random.Wherein model group and positive drug group all cause Mice with Spleen with reserpine and set up model.
Get respectively in the test model group, normal group, positive drug group, medicine of the present invention low, in and each 1 group of high dose group, mice the 1st all adaptabilities are raised, the 2nd week is except that normal group, all the other respectively organize mice afternoon every day all by 0.3mg/kg (volume only is about 0.2mL/) lumbar injection reserpine, 9d makes the Mice with Spleen model continuously.Except that normal group and model group, all the other are respectively organized mice and irritate stomach medicine of the present invention or BUZHONG YIQI WAN suspension by 0.1mL/10g morning every day.Normal group and model group give the equal-volume distilled water.Successive administration 10d weighs 1 every day.Observe outward appearance sign of mice and the insufficiency of the spleen symptom that may occur.11d put into mice in-20 ℃ of refrigerators 3 hours, observed the animal dead number, and dissected and respectively organize mice, got spleen and weighed, and calculated the spleen coefficient.Relatively mortality rate adopts X 2 test, relatively spleen coefficients by using t check.
Medicine of the present invention influences the result referring to accompanying drawing 2 to model of spleen deficiency mice body weight due to the reserpine, to the influence of mice with spleen deficiency spleen coefficient due to the reserpine referring to accompanying drawing 3.
In the modeling process, mice occur diarrhoea, inappetence, gastrointestinal peristalsis hyperfunction, lose weight etc., simultaneously with the performance of other autonomic nervous dysfunctions,, fear of cold low, blink etc., even dead as body temperature.Medicine of the present invention can increase body weight (see figure 2), the spleen coefficient (see figure 3) of mice to the above-mentioned symptom effect that all has clear improvement.Test shows that also medicine of the present invention also can reduce the model of spleen deficiency mortality of mice that is caused by reserpine under the cryogenic conditions.
2.1.2 Radix Et Rhizoma Rhei modeling test
120 of mices, male and female half and half are divided 12 groups: each 2 groups of model group, normal group, positive drug group [BUZHONG YIQI WAN 6g/kg.d)], medicine low dose group of the present invention [1.03g/ (kg.d)], middle dosage group [3.10g/ (kg.d)] and high dose group [9.29g/ (kg.d)] at random.Wherein model group and positive drug group all cause Mice with Spleen with Radix Et Rhizoma Rhei and set up model.
Medicine of the present invention to the influence of Radix Et Rhizoma Rhei induced mice model of spleen deficiency get respectively model group, normal group, positive drug group, medicine of the present invention low, in and each 1 group of high dose group, mice the 1st all adaptabilities are raised, the 2nd week is except that normal group, all the other are respectively organized mice and all only gavage Radix Et Rhizoma Rhei decocting liquid by 0.4mL/ afternoon every day, 9d causes the Mice with Spleen model continuously.Except that normal group and model group, all the other are respectively organized mice and irritate stomach medicine of the present invention or BUZHONG YIQI WAN suspension by 0.1mL/10g morning every day.Normal group and model group give the equal-volume distilled water.Successive administration 10d, weigh once every day.Observe the insufficiency of the spleen symptom of mice outward appearance sign and appearance.11d puts into mice-20 ℃ of refrigerator 3h, the dead animal counting, and dissect and respectively organize mice, get spleen and weigh, calculate the spleen coefficient.The spleen coefficient ratio adopts the t check, and mortality rate relatively adopts X 2 test.
Behind the mouse stomach Radix Et Rhizoma Rhei, occur that stool is shapeless, inappetence, gastrointestinal peristalsis are hyperfunction etc.Medicine of the present invention also has the improvement effect to above-mentioned symptom, can increase mice with spleen deficiency body weight (see figure 4), spleen coefficient (see figure 5).Test shows that also medicine of the present invention also can reduce the model of spleen deficiency mortality of mice that is caused by Radix Et Rhizoma Rhei under the cryogenic conditions.
2.2 medicine of the present invention is to the influence of confirmed fatigue mouse immune regulatory function
This test is inquired into medicine of the present invention to insufficiency of the spleen mechanisms of therapeutic action of levying from the angle of interleukin II (IL-2)-interferon-natural killer cell immunomodulating net.
2.2.1 modeling method
The laboratory animal room temperature is raised, the 1st all acclimatization trainings, and the 2nd week began except that normal group, respectively organizes mice and carry out swimming instruction in the stationary water of diameter 65cm, depth of water 70cm, and water temperature keeps 15 ± 2 ℃, training every day.Training time: begin to be 10min the 1st week, increase 10min later on day by day, keep this training burden to experiment when adding to 50min and finish.Electricity irritation when every day, mice was taken food simultaneously.
2.2.2 intervening measure
48 of mices, be divided into 6 groups at random, every group 8, be respectively: normal group, model control group, BUZHONG YIQI WAN positive controls [6g/ (kg.d)], medicine low dose group of the present invention [1.03g/ (kg.d)], middle dosage group [3.10g/ (kg.d)] and 3 administration groups of high dose group [9.29g/ (kg.d)].According to above dosage BUZHONG YIQI WAN and medicine of the present invention are mixed with suspension respectively.Irritate the each 0.4mL of stomach amount, 2 times/d; Normal group and model group are irritated stomach normal saline, continuous 3 weeks.
2.2.3 splenocyte suspension preparation
After the laboratory animal drug withdrawal, fasting 8h plucks eyeball and gets blood, and dislocation is put to death, and aseptic condition takes out spleen down, pushes 200 order stainless steel meshs gently with rubber closure, and preparation cell suspension filters, and collects filtrate in test tube, and the centrifugal 5min of 1500r/min abandons supernatant.Every pipe adds the Tris-NH of pH 7.2
4Cl solution 3mL lysed erythrocyte, centrifugal, Hanks liquid is washed 2 times.Adjust cell concentration to 1 * 10 with RPMI-1640 complete nutrition liquid
11/ L cell suspension, standby.
2.2.4 the mensuration of natural killer cell activity
Splenocyte suspension is added respectively in 96 well culture plates, and every hole 100 μ L establish 3 multiple holes for every group, with L
929As target cell, detect natural killer cell activity
[2], represent its activity with target cell dissolving percentage rate.
2.2.5 IL-2 determination of activity
Splenocyte suspension adds in 96 well culture plates, and every hole 100 μ L establish 3 multiple holes, add 10mg/L ConA 100 μ L again, 50mL/L CO for every group
2, cultivate 24h under 37 ℃ of conditions, collect supernatant, promptly get the IL-2 testing sample.Relying on the strain ctll cell with IL-2 is to detect cell, adjusts cell concentration to 1 * 10
10/ L is inoculated in 96 well culture plates, and every hole 100 μ L add 100 μ L IL-2 sample to be measured, 37 ℃, 50mL/LCO again
2Cultivate 24h, detect the A value with the microplate reader mtt assay.
2.2.6 interferon activity is measured
Splenocyte is added in 96 well culture plates, and every hole 100 μ L add 10mg/L ConA 100 μ L, 37 ℃, 50mL/LCO again
2Cultivate 48h, centrifugal, collect supernatant, measure interferon activity with micro-cytopathic-effect inhibition assay
[4], and calculate its activity with Reed Muench method.
Medicine of the present invention sees Table 1 to the influence of confirmed fatigue model mice IL-2-interferon-natural killer cell immunomodulating net.
Table 1 is respectively organized mouse interleukin 2, interferon and natural killer cell activity and is changed
Compare with normal group
P＜0.01, P＜0.05; Compare * P＜0.05, ▲ P＜0.01 with model group; Compare with positive controls ◆ P＜0.05,
P＞0.05; Compare with low dose group
＞P0.05.
Chinese medicine thinks that spleen deficiency is a kind of disease that relates to many internal organs, multisystem functional disorder.The spleen being the foundation of acquired constitution, source of generating QI and blood.Transfer spleen reinforcing soil to be principle of treatment, proper with it, the Zhuo that produces effects.Ancients have all diseases not heal, and seek saying that spleen promptly heals, it serves to show that the method for controlling spleen can not despise in the effect of motherland's medical science.Syndrome of spleen-deficiency and patient's physical strength, vigour prosperity and decline are relevant with pathogenic pathogen.Many, the work and rests unsuccessful with feelings will of its morbidity, exopathogen are relevant.Experiment and clinical research show that all chronic stress can cause body behavior change, multiple functional disorder.That can not expect stress stress easilier produce harmful effect to body than expected in various chronic stresses.
Based on above understanding and according to document, this experiment is selected for use and is forced cold water swimming as stressor, and different time modeling every day changes the modeling persistent period simultaneously, reduce body to stress tolerance.In addition, the feed mice use electricity irritation, makes the animal model due to the many stressors that comprise physical demands (swimming), electricity irritation and direct stimulation (pressure cold water swim due to emotional distress), thermal stimulus (cold) as far as possible.Both simulated the relevant insufficiency of the spleen symptom of the traditional Chinese medical science, immunity is reduced.And interferon, IL-2, natural killer cell all have active immunoregulation effect.Experimental result shows that model control group and normal group comparing difference are remarkable, and the model of spleen deficiency animal immune is regulated level than the obvious reduction of intact animal, and the modeling success is described.After Drug therapy of the present invention, low interferon, IL-2, the natural killer cell activity of model of spleen deficiency animal all obviously raises, and middle and high dosage group is almost near normal level, aspect raising IL-2, natural killer cell activity, medicine high dose group of the present invention effect and BUZHONG YIQI WAN group are suitable substantially, and aspect the raising interferon activity, the effect of medicine high and low dose group of the present invention is all remarkable than BUZHONG YIQI WAN.
In sum, medicine of the present invention has immunostimulant and immunoregulation effect, can improve the low IL-2 of body, interferon, natural killer cell immunomodulating net level, may be its performance invigorating the spleen and replenishing QI effect, one of mechanism of treatment spleen deficiency.
2.3 medicine of the present invention is to the influence of mice fatigue resistance
Be equipped with the tired discussion of mice medicine antifatigue effect of the present invention with the swimming legal system.
32 of mices, be divided into 5 groups at random, every group 8, adaptability raised for 1 week, and the 2nd week was respectively: normal group, BUZHONG YIQI WAN positive controls [6g/ (kg.d)], medicine low dose group of the present invention [1.03g/ (kg.d)], middle dosage group [3.10g/ (kg.d)] and 3 administration groups of high dose group [9.29g/ (kg.d)].Medicine of the present invention is mixed with the suspension of respective concentration respectively according to above dosage.Irritate the each 0.2mL of stomach amount, 2 times/d; Normal group is irritated the stomach normal saline.Herewith operate continuous 1w.Behind the administration 8d, each treated animal root of the tail portion bears a heavy burden and is 8% of body weight, throws the dark 30cm of people, temperature and is in 21 ± 2 ℃ the water, and the time that stops to struggle to sinking under water with the mice entry is index, respectively organizes difference.
Medicine of the present invention sees Table 2 to the endurance influence of tired model mice.
Table 2 medicine of the present invention is to the result that influences of mice swimming time
Compare * P＜0.01 with normal group.
The result shows that the swimming time of the high, medium and low dosage group of medicine of the present invention all obviously prolongs, and with normal group the significance meaning is arranged more all.Point out medicine of the present invention can improve the mice fatigue resistance.
2.4 medicine of the present invention is to mouse small intestine propulsion functions and large intestine moisture content influence
Inquire into the therapeutical effect of the transporting and transforming nutrients from foodstuff of medicine of the present invention from the angle of small intestine movement of mice propulsion functions and large intestine moisture.
Test the preparation of used prepared Chinese ink: active carbon, Arabic gelatin, east, Chongqing examination chemical industry company limited is produced.Accurately take by weighing Radix Acaciae senegalis 100g, add water 800mL, boil to solution transparently, take by weighing activated carbon (powdery) 50g, add to and boil in the above-mentioned solution 3 times, treat to add the water standardize solution to 1000mL after the solution cold.
32 of mices, the male and female dual-purpose is divided into 4 groups at random, every group 8, the 1st all adaptabilities are raised, after the 2nd week, medicine low dosage of the present invention [1.03g/ (kg.d)], middle dosage [3.10g/ (kg.d)] and 3 administration groups of high dose [9.29g/ (kg.d)], blank group normal saline is irritated stomach.Medicine of the present invention is mixed with the suspension oral gavage of respective concentration respectively according to dosage.Irritate the each 0.4mL of stomach amount, 2 times/d, continuous 1w.After water 12h is can't help in the equal fasting of laboratory animal in the 8th day, 2% prepared Chinese ink distilled water is irritated stomach, the cervical vertebra dislocation is put to death behind the 15min, open the abdominal cavity, separate mesentery, take out from pylorus intestinal tube to ileocecus, do not having gently small intestinal to be pulled into straight line under the situation of tractive, measuring pylorus to the distance of ileocecus is the small intestinal total length, and measuring and advancing the distance in forward position from pylorus to prepared Chinese ink is the prepared Chinese ink advance distance, and with formula: " prepared Chinese ink propelling rate=prepared Chinese ink advances length/small intestinal total length * 100% " calculates propelling rate; After calculating prepared Chinese ink propelling rate, calculate moisture,, claim weight in wet base there not being accurate clip mice large intestine (5cm place, rectum top) 5cm under the tractive situation; Put into 60 ℃ of dry 5h of baking oven then, again behind 105 ℃ of dry 20h to constant weight, claim its dry weight, with formula " moisture %=(weight in wet base-dry weight)/weight in wet base * 100% ".Each group is organized relatively with blank, t check between the work group.
Medicine of the present invention sees Table 6 to mouse small intestine propulsion functions and large intestine moisture content influence.
Table 6 medicine of the present invention is to mouse small intestine propulsion functions and large intestine moisture content influence
With value comparison ▲ P＜0.05 before the modeling; Compare * P＞0.05 with the blank group.
The result as seen, medicine height of the present invention, middle dosage group compare with the blank group respectively, intestinal propulsion rate and large intestine moisture all are higher than the blank group, wherein the intestinal propulsion rate of high dose group and large intestine moisture content difference have the significance meaning, the merit of pointing out medicine of the present invention to have invigorating the spleen and replenishing QI, transporting and transforming nutrients from foodstuff can significantly increase small intestine movement of mice propelling rate and large intestine moisture.
2.5 the safety evaluatio of medicine of the present invention
2.5.1 maximum dosage-feeding test
Dividing 40 mices at random is 2 groups, male and female half and half, water 12h is can't help in fasting before the experiment, by the maximum volume that can gavage (0.4mL/10g, 1.56g/mL), the administration group is given the drug suspension 1mL of the present invention of every mouse gavaging Cmax at every turn, and within 1 day, connect to 5 times, each 4.8h at interval, a day accumulated dose is 390.0g/ (kg.d), is equivalent to 125.9 times (the clinical application amount is 0.258g/kg) of people's consumption; The blank group gavages with the volume normal saline.The laboratory animal normal diet was observed 7 days continuously then, did not see that the animal generation is dead, and animal activity slightly reduces after the perfusion, does not have other unusual biological property, recovers normally in the general 1h.Weighed in the 7th day, and put to death mice then, dissect, the unusual of macroscopic liver, the heart, spleen, lung, kidney, stomach, intestinal do not arranged, the 7th day body weight of blank group mice is 24.86 ± 1.9g, and the 7th day body weight of administration group is 23.3 ± 3.7g.
Table 1 medicine maximum dosage-feeding of the present invention measurement result
2.5.2 long term toxicity test
Get 60 of mices, male and female half and half are divided into 3 groups at random: matched group, medicine low dosage of the present invention [3.10g/ (kg.d)] and 2 administration groups of high dose [9.27g/ (kg.d)].According to above dosage BUZHONG YIQI WAN (6g/kg) and medicine of the present invention are mixed with suspension respectively.Irritate the each 0.4mL of stomach amount, 2 times/d; Matched group is irritated the stomach normal saline, continuously 10w.Measure indexs such as mice body weight, darling renal function, electrocardiogram, the administration group compares with matched group respectively, shows no obvious abnormalities.
2.5.3 tissue slice preparation method
Get internal organs 10% formalins such as liver, kidney of acute toxicity and long term toxicity test animal and fix, the decalcification of 48h mixed acid, circulating water flushing in 10 days, the dehydration of 4h ethanol gradient, paraffin embedding, section is with tissues observed form under the HE dyeing mirror.
Internal organs pathological sections such as acute toxicity testing kidney, liver are seen Fig. 8.
Above day accumulated dose is 390.0g/ (kg.d), this dosage be scaled human dosage be equivalent to 125.9 times of clinical the highest consumption doubly more than, can think that this product clinical practice safety is than higher.
Internal organs pathological sections such as long term toxicity test kidney, liver are seen Fig. 9
Internal organs (Fig. 1-2) such as pathological examination liver, kidney, administration group compare with matched group respectively, there is no toxic and change.Above results suggest safety of medicine of the present invention is nontoxic, can be used for clinical.
Acute toxicity and long term toxicity test show: all do not see the overt toxicity reaction, point out safety of medicine of the present invention nontoxic, clinical use is more safe and reliable.
Claims (2)
1. medicine for the treatment of spleen deficiency is characterized in that medicine is formed with weight portion and is:
Radix Astragali Preparata 35～45g, Radix Codonopsis 12～20g, Fructus Jujubae 8～14g, yellow wine 8～15g.
2. the preparation method of the medicine of the described treatment spleen deficiency of claim 1 is characterized in that:
A. earlier the Radix Astragali that cleans is soaked into the back section, reuse is equivalent to the Flos Sophorae Mel processed with honey of astragalus weight 25% to be handled, and again will the Radix Astragali after processed with honey is handled uses the water extraction 3 times of 12 times, 10 times and 8 times respectively, and the water extract is merged, get the clear liquid concentrate drying through post precipitation and handle, obtain exsiccant astragalus membranaceus powder;
B. Radix Codonopsis and the Fructus Jujubae that cleans cleaned, Fructus Jujubae removes nuclear, dried then;
C. take by weighing astragalus membranaceus powder, Radix Codonopsis and Fructus Jujubae in proportion, mix homogeneously after abundant pulverization process adds yellow wine again and granulates, and obtains the granule of solid dosage forms.
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| CN111149969A (en) * | 2020-01-13 | 2020-05-15 | 山西大学 | Preparation method of anti-fatigue solid beverage |
| CN116785344A (en) * | 2021-07-13 | 2023-09-22 | 山西中医药大学 | Astragalus mongholicus strengthening tea with immunity regulating function and preparation method thereof |
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| CN101205517A (en) * | 2007-12-08 | 2008-06-25 | 吴煌发 | Body-tonifying heath life-beneficial wine |
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| CN101205517A (en) * | 2007-12-08 | 2008-06-25 | 吴煌发 | Body-tonifying heath life-beneficial wine |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111149969A (en) * | 2020-01-13 | 2020-05-15 | 山西大学 | Preparation method of anti-fatigue solid beverage |
| CN116785344A (en) * | 2021-07-13 | 2023-09-22 | 山西中医药大学 | Astragalus mongholicus strengthening tea with immunity regulating function and preparation method thereof |
| CN116850223A (en) * | 2021-07-13 | 2023-10-10 | 山西中医药大学 | Astragalus mongholicus strengthening tea with immunity regulating function and preparation method thereof |
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Application publication date: 20100811 |