CN100369613C - Composition for treating and improving chronic fatigue syndrome and its preparing method - Google Patents
Composition for treating and improving chronic fatigue syndrome and its preparing method Download PDFInfo
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Abstract
The present invention discloses a composition for treating and relieving chronic fatigue syndrome and a preparation method thereof. The composition is composed of 40% to 60% of rhodiola roots, 15% to 35% of astragalus roots and 15% to 35% of Chinese angelica according to the weight percentage, wherein the weight sum of raw materials is 100%; the raw materials are taken according to the weight percentage, carry out coating layer removal by collision, and are respectively pulverized into superfine powder; auxiliary materials are added in the superfine powder of the raw materials and is mixed, and the composition of the present invention is obtained. The composition of the present invention has the antiaging effect, and has the functions of improving immunity, strengthening bodies, preventing fatigue and preventing hypoxia, and can effectively treating and relieving a subhealthy state caused by the deficiency of both yin and yang and the deficiency of both qi and blood. The present invention also discloses a novel application method of the composition in the fields of medical preparation and health food.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of compositions for the treatment of and improving chronic fatigue syndrome, the preparation method that the invention still further relates to said composition with and application in preparation medicine and health food.
Background technology
Arrival along with development in Hi-Tech and information age, people's rhythm of life is accelerated, dog-eat-dog, pressure day by day increases, work over loading, in the highlands because of adverse circumstances factor affecting such as high altitude anoxias, the persistence, the repeated relapsing that take place are a series of symptoms of primary symptom with fatigue, spread all over the world as " infectious disease ", become a kind of " the modern civilization disease in the fashionable world ", even the title of " overworking death " is arranged.In April, 1987, the Center for Disease Control passes through expert testimony, with one group with lastingly chronic or repeatedly the outbreak mental fatigue and physical fatigue be the syndrome of principal character, definite designation is chronic fatigue syndrome (CFS), and has formulated corresponding diagnostic criteria and made a definite diagnosis condition.The WHO of World Health Organization (WHO) was called sub-health state with the state between disease and the health in 1999, and from the numeral of WHO and domestic report, the sub-health state person accounts for the 60%-70% of total population.
The clinical manifestation of subhealth state belongs to the traditional Chinese medical science, and " deficient " category, symptom such as have melancholia concurrently, be insomnia are meant the disturbance state of allomeric function on the whole, but material injury do not take place as yet.Mainly be by multiple reason cause with dirtyly bow, QI and blood, negative and positive are not enough is the general name of the multiple chronic weak symptom of main pathogenesis, are the light diseases in " deficient ", just said chronic fatigue syndrome.Subhealth state belongs to the body function sexually transmitted disease (STD) and becomes, and is due to the energy and blood of human body imbalance between YIN and YANG.Sub-health population often has the discomfort of body and psychology, is in this state for a long time, will influence its endocrine function, causes imbalance between YIN and YANG, deficiency of qi and blood, makes health enter low ebb.
So far, still do not have the specially good effect Western medicine, moxibustion commonly used, cupping method, digital acupoint pressure, medicated tea method, medicated wine method, medicine are desired non-drug therapies such as method, food therapy, amusement, motion, psychology regulation and control.
Summary of the invention
The object of the present invention is to provide a kind of compositions for the treatment of and improving chronic fatigue syndrome, treat effectively and improve " subhealth state " state that causes because of imbalance of YIN and YANG, deficiency of both QI and blood.
Another object of the present invention is to provide the preparation method of above-mentioned composition.
The present invention also aims to provide the application of above-mentioned composition in pharmacy and health food.
The technical solution adopted in the present invention is, a kind of compositions for the treatment of and improving chronic fatigue syndrome, and it consists of by weight percentage: Radix Rhodiolae 40%～60%, the Radix Astragali 15%～35%, Radix Angelicae Sinensis 15%～35%, each raw material weight sum is 100%.
Another technical scheme of the present invention is that the preparation method of above-mentioned composition may further comprise the steps: get Radix Rhodiolae 40%～60%, the Radix Astragali 15%～35%, Radix Angelicae Sinensis 15%～35% by weight percentage, hit skin, pulverize separately becomes superfine powder, adds adjuvant and mixes, promptly.
The characteristics of this technical scheme of the present invention also are: adjuvant is a dispersant.
The technical solution adopted in the present invention also comprises,
Above-mentioned composition is in the medicine of preparation enhancing immunity and the application in the health food.
The application of above-mentioned composition in preparation antifatigue medicine and health food.
Above-mentioned composition is in the preparation treatment and improve the medicine of myocardial ischemia and the application in the health food.
Above-mentioned composition is in the preparation treatment and improve the medicine of chronic fatigue syndrome and the application in the health food.
The traditional Chinese medical science is because its whole sight and determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, and the multiformity of Chinese medicine also adapts to multifarious characteristics, and Chinese medicine is being regulated the body equilibrium between yin and yang, improved and have incomparable unique effect aspect the sub-health state.The present invention is according to Traditional Chinese medical theory, utilize modern technologies to combine with Traditional Chinese medical theory, adopt modernized extractive techniques such as micronizing, the compositions that develops has defying age, enhancing immunity is kept fit, resisting fatigue, the effect of anti-hypoxia is effectively treated and is improved " subhealth state " state that deficiency of both YIN and YANG, deficiency of both QI and blood cause.
The specific embodiment
The present invention is described in detail below in conjunction with the specific embodiment.
Treatment of the present invention and improve the compositions of chronic fatigue syndrome, it consists of by weight percentage: Radix Rhodiolae 40%～60%, the Radix Astragali 15%～35%, Radix Angelicae Sinensis 15%～35%, each raw material weight sum is 100%.
Wherein, Radix Rhodiolae is a monarch drug, the Radix Astragali, when being classified as ministerial drug.Radix Rhodiolae can " the YANG invigorating tonifying YIN removes cold tonifying YANG for strengthening by means of tonics, strengthening the body resistance ", has anti-hypoxia, cold resistance, resisting fatigue but also has the body aging of delaying, prevents effect such as infirmities of age; Radix Angelicae Sinensis " sweet in the mouth is arduous, and inrigorating qi and promoting blood circulation is moisturized laxation " the beneficial marrow of prolonging life, improving healthy complexion, big tonification, qi and blood invigorating, tranquilizing mind, strengthening the spleen and stomach have the strong merit of tonify deficiency; Radix Astragali replenishing vital essence and invigorating vital QI.Above-mentioned all flavor ministerial drugs share, and both the void of QI invigorating was enriched blood again and lost, and the prosperous blood of gas is given birth to, and nourishing YIN for tranquillization is with the merit of principal drug assistance.This reasonable recipe, the pathogenesis that hits has negative and positive and transfers benefiting qi and nourishing blood, invigorating brain and relieving mental uneasiness, add smart merit of mending marrow, and reach defying age, enhancing immunity, keep fit, resisting fatigue, the effect of anti-hypoxia can be improved tired, the symptom such as have a dizzy spell of the tired body of forgetful insomnia, body that deficiency of both YIN and YANG, deficiency of both QI and blood cause rapidly.Confirm that according to differential diagnosis in tcm theory and pharmacodynamic experiment this prescription proportioning is the most reasonable.
The preparation method of the present composition may further comprise the steps: get Radix Rhodiolae 40%～60%, the Radix Astragali 15%～35%, Radix Angelicae Sinensis 15%～35% by weight percentage, hit skin, pulverize separately becomes particle diameter less than 100 microns superfine powder, adds adjuvant and mixes, promptly.
The active component of the present composition can also add various conventional adjuvant required when preparing different dosage form, be prepared into any peroral dosage form commonly used as disintegrating agent, lubricant, binding agent etc. with the method for Chinese medicinal of routine, as pill, powder, tablet, oral liquid etc.
Embodiment 1
Get Radix Rhodiolae 40%, the Radix Astragali 35%, Radix Angelicae Sinensis 25% by weight percentage, hit skin, pulverize separately becomes superfine powder, adds appropriate amount of starch and mixes, and makes capsule.
Embodiment 2
Get Radix Rhodiolae 60%, the Radix Astragali 25%, Radix Angelicae Sinensis 15% by weight percentage, hit skin, pulverize separately becomes superfine powder, adds proper honey and mixes, and makes pill.
Embodiment 3
Get Radix Rhodiolae 50%, the Radix Astragali 15%, Radix Angelicae Sinensis 35% by weight percentage, hit skin, pulverize separately becomes superfine powder, adds appropriate amount of starch and mixes, and makes powder.
Embodiment 4
Get Radix Rhodiolae 50%, the Radix Astragali 25%, Radix Angelicae Sinensis 25% by weight percentage, hit skin, pulverize separately becomes superfine powder, adds appropriate amount of starch and mixes, and makes tablet.
The present invention is to provide a kind of compositions for the treatment of and improving chronic fatigue syndrome, for proving its safety, the capsule that uses method for preparing to obtain has carried out toxicity test, and result of the test is as follows:
Acute toxicity test
Material capsule of the present invention, every is equivalent to crude drug in whole 1g, grinds to form suspension with distilled water and carries out oral administration gavage with preceding.
60 of experimental animal Kunming kind healthy mices, body weight (21.0 ± 3.0) g, male and female half and half.Available from Lanzhou biological products assay institute animal center.Supply examination behind the normal 3d of raising.
Test method is selected 20 of Kunming mouses at random, and body weight 18.0～21.5g is divided into 2 groups by sex, every group each 10.Fasting 16h can't help water.With capsular maximum suspendible degree (0.33kg/L), maximum dosage-feeding (0.8ml/20g) gives mice an oral administration gavage, and dosage is 13.3g/kg.Mice poisoning symptom after the observation administration, and observe feed, behavioral activity and body weight gain situation 7d continuously.
Result treatment (1) adopts the Bliss method to calculate the LD 50 and 95% fiducial limit of logical sheet.
(2) calculate the maximum tolerance of mice multiple with following formula:
The capsule suspension of the maximum tolerated dose of mouse stomach administration as a result, the maximum suspendible degree of oral administration gavage of mice, maximum administration volume, dosage is 13.3g/kg, does not occur dead.No abnormality seens such as hair, general behavior, activity, breathing, heart rate are observed in 7d, there was no significant difference (P＞005) between normal, female, male two groups of situations such as mice behavioral activity, feed drinking-water and body weight gain.
Conclusion (of pressure testing)
According to the acute toxicity test method of medicine,, can not find and once irritate stomach and cause dead mouse dosage, so can't measure LD because of being subjected to drug level and volume restrictions
50Use the maximum tolerance determination method, calculate this product maximum tolerated dose and be equivalent to 900 times of clinical consumption, show that this drug toxicity is very little, clinical practice is safe and reliable.
Long term toxicity test
The healthy Wistar rat of animal subject, body weight 70～90g, ♀ ♂ half and half.Purchase Lanzhou Institute of Biological Products's animal center.Standby behind the raising 1w after buying.
80 of the suitable rats of body weight are selected in experiment grouping, and ♀ ♂ half and half is divided into 4 groups (matched group and 3 dosage groups) at random, each 10 of every group of ♀ ♂.Test dose is arranged: with reference to the clinical application amount, high dose is 50 times of clinical application amount, i.e. 5g/kg.Middle dosage is 30 times of clinical application amount, i.e. 3g/kg.Low dosage is 10 times of clinical application amount, i.e. 1g/kg.The normal control group is irritated the equivalent distilled water.
Route of administration and cycle gastric infusion, 1 time/d, continuous 12w.During this period, observed and recorded animal general state every day (mental status, diet, mobility, growth etc.), and survey body weight weekly 1 time, 24h after the administration the last time, matched group, high dose group are got the half animal, and all the other respectively organize all animals, measure every index.Residue matched group, high dose group half animal, the every index of check behind the drug withdrawal 2w.
Observation index
General index is observed every day such as reaction behind the animals administer, the mental status, diet, mobility, hair color etc.
Reach before the body weight administration and survey body weight weekly 1 time, after experiment finished, each treated animal was weighed respectively.
Electrocardioscopy is adopted standard I I to lead and is write down the animal electrocardiogram.
The hematological examination abdominal aortic blood is measured numeration of leukocyte, classification, red blood cell count(RBC), hemoglobinometry, platelet count.
Liver function and renal function are measured abdominal aortic blood, measure aspartic acid aminotransferase (AST enzyme coupling connection method), ALT (ALT enzyme coupling method) and blood urea nitrogen (BUN urase Na Shi reagent explicit representation) and creatinine (Cr alkaline picric acid method).
Pathological examination is dissected animal observation internal organs and is had or not intoxicating phenomenon, gets each main organs and does specimen observation and pathomorphology inspection substantially.
Administration cross-reference group and each administration group compare as a result, every equal zero differences such as animal appetite, defecation, mobility.
Influence to body weight
Experimental session, matched group and administration treated animal body weight all have increase in various degree, the results are shown in Table 1.
The influence of table 1 pair rat body weight (g, x ± s)
| Group | Before the administration | 4w | 8w | 12w |
| Dosage group low dose group in the matched group high dose group | 849±114 864±147 792±132 864±125 | 1709±153 1674±149 1592±161 1664±136 | 2650±192 2691±183 2625±174 2781±194 | 3049±204 3182±165 2948±186 3166±172 |
By table 1 as seen, the increase of each treated animal body weight and normal control group compare there was no significant difference (P＞005).
Influence to peripheral leukocyte of rat and classification
As shown in table 2, each dosage of this medicine is to rat leukocyte and leukocyte differential count there are no significant difference (P＞005).
Table 2 pair rat leukocyte and classification influence (x ± s)
| Group | Leukocyte count (10 9/L) | Classification | |
| Lymph % | Neutral % | ||
| Dosage group low dose group in the matched group high dose group | 1202±182 1126±129 1082±120 1258±104 | 3013±387 2952±550 2858±502 3006±693 | 6990±387 7054±550 7157±502 7003±683 |
To rat periphery erythrocyte sum, hematochrome and hematoblastic influence
By table 3 as seen, each administration group and matched group relatively, erythrocyte sum, hematochrome, platelet there are no significant difference (P＞005).
Table 3 pair rat periphery erythrocyte sum, hematochrome, hematoblastic influence (x ± s)
| Group | RBC number (10 12/L) | Hematochrome (g/L) | Platelet (10 9/L) |
| Dosage group low dose group in the matched group high dose group | 875±045 882±049 913±028 875±032 | 1465±67 1445±75 1515±88 1455±47 | 2835±254 2781±559 2708±544 2917±5153 |
Influence to rats'liver, renal function
By table 4 as seen, each dosage of this medicine is to rats'liver, renal function there are no significant difference (P＞005).
The influence of table 4 pair rats'liver, renal function (x ± s)
| Group | AST (u/L) | ALT (u/L) | BUN (mmol/L) | Cr (umol/L) |
| Low agent group of agent group in the matched group high dose group | 3351±662 3268±606 3234±654 3357±371 | 865±253 829±361 745±290 856±572 | 323±026 329±040 372±034 378±042 | 6542±796 6099±826 5569±803 6276±726 |
Influence to organ index
Dissect animal, it is all no abnormal that Rats Organs and Tissues is respectively organized in perusal, cores, liver, spleen, lung, kidney weigh respectively, calculates organ index, the results are shown in Table 5.
The influence of table 5 pair each organ index of rat (x ± s)
| Group | The heart | Liver | Spleen | Lung | Stomach |
| Dosage group in the matched group high dose group | 033±003 034±002 034±003 | 351±051 376±029 354±042 | 014±004 015±003 014±005 | 085±002 078±005 075±005 | 077±004 076±002 076±003 |
| Low dose group | 034±004 | 294±044 | 017±004 | 048±008 | 078±004 |
By table 5 as seen, each administration group and matched group relatively, each organ index value there are no significant difference (P＞005), and all in range of normal value.
To heart rate, Electrocardiographic influence
Each administration group and matched group relatively, heart rate, standard I I lead all no abnormal changes such as sign electrocardiogram QRS wave group, PR interval, ST section and T ripple.
Pathologic finding
Internal organs such as each the administration group and the control animals heart, liver, lung, spleen, kidney, intestinal, adrenal gland reach under the mirror observation substantially all not to be had pathology and changes, and the result is as follows:
Heart: each administration group and control animals heart tissue structure are clear, and degeneration, necrosis and fracture are not seen in cardiac muscle fiber, do not see inflammatory cell infiltration in the matter.
Liver: it is clearly visible that each organizes lobules of liver, and hepatic cords is radial arrangement around central vein, sinus hepaticus as seen, hepatocyte does not see swelling, degeneration and necrosis.Between in the matter portal area be normal configuration.
Kidney: each organizes skin medullary substance boundary clear, and the cortex internal glomerulus is not seen swelling and transudate, does not see the glomerule fibrosis, and the renal tubules,convoluted epithelium is complete, the interior no cast of tube chamber.
Lung: it is obvious that each organizes the pulmonary lobule structure, and tiny bronchus portion each layer of film is clear, and superficial epithelium is complete, does not see ulcer and necrosis, the broadening of alveolar wall part, vasodilation, hyperemia.
Spleen: it is complete that each organizes the spleen tunicle, red white pulp boundary clear.
Stomach and intestine and small intestine: it is complete that each organizes gastrointestinal mucosal, body of gland as seen, the down visible normal lymph follicle of mucosa.
The adrenal gland: as seen each organize adrenal gland's skin medullary substance, and three-decker is clear in the cortex.
Ovary: each treated animal tunicle is complete, and a matter nodositas has well-developed normal follicles at different levels in the fine and close fibrous tissue.
Testis: visible convoluted seminiferous tubule is round or oval type in the compact and complete peplos, and spermatocytes at different levels physically well develop.
The result as seen, matched group and each each organs and tissues of administration treated animal there is no drug intoxication sexually transmitted disease (STD) reason morphological change.Matched group, the drug withdrawal of sheet high dose group half animal are put to death after observing 2w, more than every index all in normal range, the pathological observation no abnormality seen.
Conclusion (of pressure testing)
Adopt high, medium and low 3 dosage through 90d gastric infusion every day, long term toxicity test is observed, during the administration, the activity of each treated animal, hair color, ingest, feces and body weight gain and blank group comparison there was no significant difference.Conventional hematology, blood parameters, electrocardiogram and the heart rate detection of each administration treated animal are all normal, compare there was no significant difference with the blank group.Behind each treated animal administration 90d and the drug withdrawal 2w behind the residue sacrifice of animal, internal organs such as its heart, liver, lung, spleen, kidney, intestinal, adrenal gland are reached mirror under to observe substantially be the normal structure structure, do not see the change of drug intoxication sexually transmitted disease (STD) reason form.This medicine acute toxicity test of doing in early stage shows that its cumulative maximum dosage is equivalent to 900 times of clinical consumption.Therefore, can think to have higher-security, drug withdrawal 2w does not see the after effect that is caused by cumulative toxicity.
The invention still further relates in the medicine and health food of preparation enhancing immunity, in preparation antifatigue medicine and health food, in the medicine and health food of preparation treatment myocardial ischemia, in the preparation treatment and improve the medicine of chronic fatigue syndrome and the application in the health food, in order to understand essence of the present invention better, pharmacodynamics test and the result who carries out with the capsule of the present composition illustrates its new purposes in pharmacy and field of health care food below.
Pharmacodynamics test
1, to the influence of mouse immune power
The laboratory animal Kunming mouse, ♀ ♂ dual-purpose, body weight 18g～24g is provided by institute of Biological Products Animal Experimental Study center, Lanzhou.
Of the present invention day astragalus capsules of medicine; ZHENQI FUZHENG JIAONANG.Sodica calx, lot number: 910815A R, Shanghai the May 4th chemicals factory produces.
The experiment of mice reticuloendothelial cell phagocytic function
Get 50 of healthy mices, ♀ ♂ dual-purpose, body weight 18g～24g is divided into normal saline blank group at random, the known medicine matched group of ZHENQI FUZHENG JIAONANG and day 3 dosage groups of astragalus capsules (4g/kg, 8g/kg, 16g/kg).Every group of 10 mices.Each is organized continuous ig and gave different pharmaceutical 7.The 7th day behind last administration 1h every mouse tail vein injection normal saline be diluted to 5 times india ink 0.1mL/10g.Behind injection 2min and the 10min, the eye socket venous plexus is got blood 20 μ L respectively, puts into the test tube of 0.1% sodium carbonate 2mL solution, shakes up, and with reagent blank pipe zeroising, surveys the OD value at 680nm wavelength place, calculates and cleans up index k value (k=1/8O D2/O D10) [1].It astragalus capsules increases with dosage and obviously strengthens mice reticuloendothelial cell phagocytic function, improves the effect of body nonspecific immunity.The results are shown in Table 6.
The influence (n=10) of table 6 pair mice reticuloendothelial cell phagocytic function
| Group | Dosage (g/kg) | Clean up index k value (x ± s) * 10 -3 |
| Normal saline sky astragalus capsules ZHENQI FUZHENG JIAONANG | Deng capacity 4.0 8.0 16.0 6.0 | 9.2±5.5 10.7±9.9 17.9±10.5 1) 19.5±11.4 1) 20.8±10.9 2) |
Compare 1 with matched group) P＜0.05; 2) P＜0.01.
Mice serum hemolysin assay
Get 50 of healthy mices, grouping and dosage are the same.Ig gave different pharmaceutical 12 continuously respectively.In the time of the 7th day, every mice difference lumbar injection 20% sheep red blood cell (SRBC) 0.2mL carries out once immunity in administration.Behind last administration 1h, the extraction eyeball is got blood, and is centrifugal.Serum is got dilute serum 1mL and is mixed with 20%SRBC 0.5mL and complement (guinea pig serum of normal saline dilution in 1: 10) 0.5mL with 50 times of normal saline dilutions, is incubated 10min in 37 ℃ of waters bath with thermostatic control.The ice bath cessation reaction, centrifugal 10min.Get supernatant 3mL and add Dou Shi reagent (high-potassium ferricyanide 0.2g adds distilled water to 1000mL for sodium bicarbonate 1.0g, potassium cyanide 0.05g).Fully shake up, place 10min, with 722 type spectrophotometer colorimetrics, wavelength 540nm.With increase serum not is blank, surveys the OD value.Calculate half hemolysis value HC50=sample OD value/SRBC HD50 OD value * extension rate at last.As a result, increase with sky astragalus capsules dosage, serum hemolysin content improves, and strengthens humoral immune function.The results are shown in Table 7.
The influence of table 7 pair mice serum hemolysin content (n=10, x ± s)
| Group | Dosage (g/kg) | HC 50 |
| Normal saline sky astragalus capsules ZHENQI FUZHENG JIAONANG | Deng capacity 4.0 8.0 16.0 6.0 | 41.5±35.0 48.9±34.2 56.3±39.8 78.1±31.9 1) 104.9±11.4 2) |
Compare 1 with matched group) P＜0.05; 2) P＜0.01.
Experimental result shows that a day astragalus capsules obviously increases carbon clearance exponential sum serum hemolysin content.Has the effect that improves body non-specific immunity and specific immune function.But Radix Astragali replenishing and restoring lung-QI in the side, the modern pharmacological research astragalus polysaccharides can increase immunologic function.But full side human body immunity improving power on replenishing vital essence and invigorating vital QI, activating blood circulation to dissipate blood stasis basis.
2, antifatigue effect
Sample soft capsule of the present invention, content are brown fraction.It is everyone 2.1g (0.35g/ grain, 2/time, 3 times/d) every day that human body is recommended consumption.Prepare each dose concentration with distilled water.
Experimental animal is provided by Lanzhou institute of Biological Products Experimental Animal Center, 240 of healthy Kunming kind secondary male mices, body weight 18～22g.18～20 ℃ of animal housing's temperature, humidity 40%～50%.Feedstuff, bedding and padding provide by General Hospital of Lanzhou Military Command's Experimental Animal Center.
Instrument and reagent swimming case, Roberval's balance, electronic balance, sheet lead, 752C ultraviolet-uisible spectrophotometer, A G II automatic clinical chemistry analyzer, 10ml tool plug test tube, constant water bath box, test kit (biological reagent company produces blood urea nitrogen by giving birth in Beijing, blood lactic acid and hepatic glycogen be Nanjing and build up bio-engineering research and produced), centrifuge, oscillator, operating theater instruments, micro sample adding appliance, suction pipe, graduated centrifuge tube etc.
Dosage design is divided into 1.050,0.525 and 0.263g/kg3 dosage group, and its dosage is equivalent to 30,15,7.5 times of human body recommendation consumption respectively, and other establishes 1 solvent (distilled water) matched group.
Test method adopts " the health food function assessment assessment process and the method for inspection " (Ministry of Public Health) (6) middle method to test, and after mice is bought back, swims every day 1 time, each 5min, 3d continuously earlier in advance.Select the grouping of weighing of 160 of correct set mices then.3 dosage groups and 1 solvent control group are all established in swimming with a load attached to the body, serum urea nitrogen, liver glycogen, 4 tests of blood lactic acid, every group of 10 mices.Tried thing 1 time by above-mentioned dosage per os every day, the solvent control group waits the capacity distilled water, continuous 30d, and the assay method of every index is as follows:
Swimming with a load attached to the body test last is tried 30min behind the thing, makes mice (the 5% body weight sheet lead) swimming test that bears a heavy burden, 25 ℃ of water temperatures, and depth of water 50cm, the mice swimming time respectively organized in record, calculates and respectively organize average swimming time, and the result carries out variance analysis.
Serum urea nitrogen determination last is tried 30min behind the thing, not swimming with a load attached to the body of mice 90min, and 30 ℃ of water temperatures, depth of water 50cm pulls out and dries, and pulls out the eyeball blood sampling, carries out the serum urea nitrogen determination by the test kit requirement, and the result carries out variance analysis.
Hepatic glycogen is measured last and is tried 30min behind the thing, and mice is not swum, and puts to death, and dissects and gets liver, accurately takes by weighing the 100mg liver, carries out hepatic glycogen content mensuration by test kit requirements, and the result carries out variance analysis.
Full blood lactic is measured last and is tried 30min behind the thing, and mice is not swimming with a load attached to the body 20min in 30 ℃ of water, depth of water 50cm.Before swimming, after the swimming, reach swimming back rest 30min immediately, endocanthion blood sampling respectively, mensuration full blood lactic content.With blood lactic acid rising amplitude and elimination amplitude is that index is carried out variance analysis.
The result
Mice swimming with a load attached to the body timing result by table 8 as seen, the average swimming time of each dosage group mice all obviously prolongs than solvent control group swimming time, and dose-effect relationship is arranged, through variance analysis, high dose group and solvent control group are relatively, difference has highly significant (P＜0.01), in, low dose group and solvent control group relatively, difference all has significance (P＜0.05).
Table 8 mice swimming with a load attached to the body result of the test (x ± s)
| Dosage (g/kg) | Number of animals (only) | Swimming time (min) |
| Solvent control 1.050 0.525 0.263 | 10 10 10 10 | 25.05±13.20 61.15±29.62 51.85±24.83 46.00±21.85 |
Annotate: P＜0.05.
Tired mice serum determination of urea nitrogen result by table 9 as seen, each dosage group mice serum urea nitrogen content obviously reduces than the solvent control group, through variance analysis height, middle dosage group and solvent control group relatively, difference all has highly significant (P＜0.01), low dose group and solvent control group compare, and difference has significance (P＜0.05).
The influence of table 9 pair mice serum urea nitrogen content (x ± s)
| Dosage (g/kg) | Number of animals (only) | Blood urea nitrogen (mmol/L) |
| 1.050 0.525 0.263 solvent control | 10 10 10 10 | 10.216±0.903 10.763±1.156 11.024±1.111 12.281±1.109 |
Annotate: P＜001
The Mouse Liver glycogen is measured by visible each the dosage group Mouse Liver glycogen content of table 10 and is obviously raise than solvent control group, compares through each dosage group of variance analysis and solvent control group, and highly significant (P＜0.01) is all arranged.
The influence of table 10 pair Mouse Liver glycogen content (x ± s)
| Dosage (g/ μ g) | Number of animals (only) | Liver glycogen (mg/100g liver) |
| 1.050 0.525 0.263 solvent control | 10 10 10 10 | 3046.46±722.20 2763.81±578.55 2348.42±557.22 1482.67±425.65 |
Annotate: P＜0.01.
Tired mice blood lactic acid is measured through variance analysis, and each organizes mice blood lactic acid rising amplitude, there are no significant for blood lactic acid elimination amplitude differences, and the F value is respectively 0.2375 and 0.1451, and the P value all＞0.05.
Each each phase body weight of dosage group mice and weightening finish are compared with the solvent control group in 4 experiments, and there are no significant for difference (P＞005).
Conclusion sky astragalus capsules can obviously prolong the mice swimming time in 0.263～1.050g/kg dosage range, reduce tired Mus serum urea nitrogen content and improve hepatic glycogen content, and promptly 1. positive result is tested in the mice swimming with a load attached to the body; 2. the positive result of mice serum determination of urea nitrogen; 3. the Mouse Liver glycogen is determined as positive findings; 4. mice blood lactic acid is determined as negative findings.According to antifatigue effect criterion as a result in the Ministry of Public Health " the health food function assessment assessment process and the method for inspection ", think that this product has antifatigue effect.The Radix Astragali for " one of Chinese medicine that Chinese pharmacopoeia version in 2005 is recorded, also for Ministry of Public Health defend the method prison send out announce in (2002) No. 51 files can be used for one of article of health food.Radix Astragali master contains astragaloside and astragalus polysaccharides etc., experiment showed, that the Radix Astragali is that main Chinese herbal medicine complexing agent antifatigue effect is obvious.Illustrate that astragaloside and astragalus polysaccharides have played certain effect in anti-fatigue effect.
3, oxygen lack resistant function
Instrument: RM6200C four leads physiograph (Chengdu Instruement Factory's production).
Medicine: of the present invention day astragalus capsules, Main Ingredients and Appearance is Radix Rhodiolae, the Radix Astragali, Radix Angelicae Sinensis; ZHENQI FUZHENG JIAONANG, Main Ingredients and Appearance are the Radix Astragali, Fructus Ligustri Lucidi.
Animal: Kunming mouse is provided by institute of Biological Products zoopery center, Lanzhou.
Influence experiment to anoxia in mice endurance
Get 50 of healthy Kunming mouses, body weight 20～24g.Be divided into matched group at random, day astragalus capsules high dose group, low dose group; ZHENQI FUZHENG JIAONANG high dose group, low dose group.Every group 10, male and female half and half, sub-cage rearing.With the conversion of people's conventional therapy dosage is the dosage of mice.The conversion formula is: tested animal is tried out the body surface area ratio of the body surface area ratio/known animal of dosage=known animals administer amount * tested animal.High dose is the twice of low dosage administration.It astragalus capsules high and low dose group respectively by 10, the 5ml/kg administration; The ZHENQI FUZHENG JIAONANG high and low dose respectively by 375, the 1875mg/kg administration, administering mode is for irritating stomach (ig); Control group administered physiological saline, 1 time/d, continuous 13d.1h after the last administration, it is the 150ml port grinding bottle that mice is placed volume respectively, in put the 15g sodica calx, its time-to-live of airtight observation.
To the anoxybiotic protective effect experiment of mouse cardiac muscle
Get 70 of healthy Kunming mouses, body weight 18～22g is divided into 7 groups at random, is respectively a day astragalus capsules high dose, middle dosage, low dose group, ZHENQI FUZHENG JIAONANG high dose, middle dosage, low dose group and matched group, and each organizes male and female half and half, sub-cage rearing.With the conversion of people's conventional therapy dosage is the middle dosage of mice, and high dose is 2 times of middle dosed administration amount, and low dosage is 1/2 of a middle dosed administration amount.Therefore day high, medium and low dosage group of astragalus capsules respectively by 25,10,5, the mg/kg administration, the high, medium and low dosage group of ZHENQI FUZHENG JIAONANG respectively by 375,187.5, the 93.75mg/kg administration, administering mode is for irritating stomach; Control group administered physiological saline.Medication: 1 time/d, continuous 6d.1h is with urethane 12g/kg intraperitoneal injection of anesthesia after the last administration, and back fixation is separated trachea, with the bulldog clamp folder pipe of holding one's breath, observes electrocardio with electrocardiogram equipment, and writes down the little mousetrap with stopwatch and hold one's breath time of Guan Houzhi electrocardio disappearance.
The result
It astragalus capsules, ZHENQI FUZHENG JIAONANG the results are shown in Table 11 to the influence of anoxia in mice endurance.Table 11 shows that day astragalus capsules and high and low each the dosage group of ZHENQI FUZHENG JIAONANG all can improve mice normobaric hypoxia endurance, and mean survival time is all than matched group significant prolongation (P＜0.05 or＜0.01); The effect of high dosage of it astragalus capsules and ZHENQI FUZHENG JIAONANG all is better than low dosage (P＜0.05), and day astragalus capsules high dose group and ZHENQI FUZHENG JIAONANG high dose group, day astragalus capsules low dose group and the anti-normobaric hypoxia effect of ZHENQI FUZHENG JIAONANG low dose group have significant difference (P＜0.01).
The influence of table 11 pair mice normobaric hypoxia (x ± SD)
| Group | Mus number (only) | Mean survival time (min) |
| Astragalus capsules high dose group sky, matched group sky astragalus capsules low dose group ZHENQI FUZHENG JIAONANG high dose group ZHENQI FUZHENG JIAONANG low dose group | 10 10 10 10 10 | 19.39±2.17 28.79±3.10 ① 24.34±3.53 ② 27.40±2.53 ① 24.94±2.05 ② |
Annotate: compare with matched group, 1. P＜0.01; 2. P＜0.05
It astragalus capsules, ZHENQI FUZHENG JIAONANG see Table 12 to mouse cardiac muscle hypoxia protection effect experimental result.Table 12 prompting, day astragalus capsules and high, medium and low each the dosage group of ZHENQI FUZHENG JIAONANG all can prolong mice electrocardio extinction time, compare effect significantly (P＜0.05 or＜0.01) with matched group, and between two kinds of each dosage groups of medicine significant difference (P＜0.05) are arranged.
The anoxybiotic influence of table 12 pair mouse cardiac muscle (x ± SD)
| Group | Mus number (only) | Mean survival time (min) |
| Dosage group ZHENQI FUZHENG JIAONANG low dose group in the dosage group sky astragalus capsules low dose group ZHENQI FUZHENG JIAONANG high dose group ZHENQI FUZHENG JIAONANG in astragalus capsules high dose group sky, the matched group sky astragalus capsules | 10 10 10 10 10 10 10 | 6.55±0.83 7.70 ① 7.56±0.81 ① 7.24±0.50 ① 7.75±0.52 ② 7.48±0.63 ① 7.29±0.37 ① |
Annotate: compare with matched group, 1. P＜0.01; 2. P＜0.05.
Conclusion
This experimental result shows that day astragalus capsules and ZHENQI FUZHENG JIAONANG can significantly improve the protective capability of animal normobaric hypoxia endurance and myocardial ischemia.
From above result, can draw and the invention has the advantages that:
1) develops a kind of new treatment and improve the composition of chronic fatigue syndrome, and opened up a new application aspect pharmacy and the health food.
2) composition safety non-toxic of the present invention, pharmacological action is strong, and is evident in efficacy.
3) preparation technology of the present invention is simple, can make multiple formulation.
4) composition of the present invention can be used for disposing treatment and improves in the medicine and health food of chronic fatigue syndrome, also can be used for disposing strengthening immunity, antifatigue, treatment and improving in the medicine and health food of myocardial ischemia.
Claims (7)
1. compositions for the treatment of and improving chronic fatigue syndrome, it consists of by weight percentage: Radix Rhodiolae 40%～60%, the Radix Astragali 15%～35%, Radix Angelicae Sinensis 15%～35%, each raw material weight sum is 100%.
2. according to the described preparation of compositions method of claim 1, it is characterized in that, may further comprise the steps: get Radix Rhodiolae 40%～60%, the Radix Astragali 15%～35%, Radix Angelicae Sinensis 15%～35% by weight percentage, hit skin, pulverize separately becomes superfine powder, adds adjuvant and mixes, promptly.
3. according to the described preparation of compositions method of claim 2, it is characterized in that described adjuvant is a dispersant.
According to the described compositions of claim 1 in preparation medicine of enhancing immunity and the application in the health food.
5. according to the application of the described compositions of claim 1 in preparation antifatigue medicine and health food.
6. preparing treatment and improving the medicine of myocardial ischemia and the application in the health food according to the described compositions of claim 1.
7. preparing treatment and improving the medicine of chronic fatigue syndrome and the application in the health food according to the described compositions of claim 1.
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| CN101248880B (en) * | 2008-03-25 | 2012-06-27 | 香港科技大学 | Fatigue resistant sport drink and method of preparing the same |
| CN101991037B (en) * | 2010-11-11 | 2012-10-10 | 扬州斯大锅炉有限公司 | Angelica-aronia melanocarpa pill and manufacturing method thereof |
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| CN102552379A (en) * | 2012-01-06 | 2012-07-11 | 韩健宝 | Veterinary drug composition capable of enhancing immunity and preparation method of veterinary drug composition |
| CN102526457B (en) * | 2012-01-18 | 2013-12-18 | 甘肃奇正实业集团有限公司 | Rhodiola composition and preparation method and application thereof |
| CN104027381A (en) * | 2014-06-20 | 2014-09-10 | 苏州法莫生物技术有限公司 | Compound Chinese angelica powder preparation |
| CN105477180A (en) * | 2015-12-09 | 2016-04-13 | 兰州大学 | Traditional Chinese medicine composition for treating chronic fatigue syndrome |
| CN106728564B (en) * | 2016-12-05 | 2020-01-07 | 广州睿森生物科技有限公司 | Refreshing composition and preparation thereof |
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| 现代中医药方剂在抗运动性疲劳中的应用. 高顺生.中国临床康复，第12期. 2005 * |
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