CN106177172A - A kind of for enhancing immunity, the Chinese medicine preparation and preparation method thereof of alleviating physical fatigue - Google Patents
A kind of for enhancing immunity, the Chinese medicine preparation and preparation method thereof of alleviating physical fatigue Download PDFInfo
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- CN106177172A CN106177172A CN201610649736.0A CN201610649736A CN106177172A CN 106177172 A CN106177172 A CN 106177172A CN 201610649736 A CN201610649736 A CN 201610649736A CN 106177172 A CN106177172 A CN 106177172A
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Abstract
The present invention relates to a kind of for enhancing immunity, the Chinese medicine preparation and preparation method thereof of alleviating physical fatigue, concrete crude drug includes that Radix Ginseng, Radix Angelicae Sinensis, Fructus Lycii, Radix Rhodiolae form, wherein ginseng crude drug's part is used as medicine for former medicated powder, remain and be prepared from the processing step such as Radix Rhodiolae medical material mixed ethanol extraction, in its side, Radix Ginseng consolidates primordial qi strengthening for the monarch drug in side, in order to strengthening the body resistance, resist exopathogen invasion；Be equipped with the Radix Angelicae Sinensis of tonification nutrient blood, the Radix Rhodiolae of benefiting QI for activating blood circulation is the ministerial drug in side altogether, makes internal organs sufficiently be moistened foster simultaneously；Helping the Fructus Lycii with liver and kidney tonifying again so that it is function is not fully exerted, all medicines share, to reach the health-care effect of " strengthening the body resistance, benefiting QI and nourishing blood, liver and kidney tonifying ", thus effective enhancing immunity, alleviating physical fatigue.
Description
Technical field
The present invention relates to the technical field of Chinese traditional compound medicine；Especially a kind of for enhancing immunity, alleviation body
Chinese medicine preparation that power is tired and preparation method thereof.
Background technology
Along with people's work, accelerating to rhythm of life, the health of people is threatened by various factors, under immunity
Fall, fatiguability etc. are its healthy affected main performances.Theory of Chinese medical science thinks that hypoimmunity, fatigue all belong to " deficient syndrome " model
Farmland, deficient mainly due to body vigour, internal organs virtual loss, caused by imbalance between YIN and YANG, the most hepatic and/or renal function is exempted from enhancing
Epidemic disease power, alleviating physical fatigue effect in play vital effect.
Radix Ginseng is the dry root and rhizome of Araliaceae Radix Ginseng.Hardship sweet, micro-, flat.Return spleen, lung, heart channel.Radix Ginseng is China
One of special product valuable ingredient of Chinese medicine, in ancient medicine books, first appeared in Shennong's Herbal, " tonifying five ZANG-organs, peace spirit determine soul, spasmolytic
Throb with fear ... ", it is classified as top grade.Radix Ginseng main chemical compositions has ginsenoside, liposoluble constituent, saccharide, amino acids and peptides, dimension
Raw element class etc. (Qin Yu etc., 1995), can strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, invigorating the spleen to benefit the lung, promotes the production of body fluid, calms the nerves, and is clinically used for body void and is intended to
De-, insufficiency of the spleen lack of appetite, the diseases such as insomnia of palpitating with fear.Modern pharmacological research shows, immune regulation effect is mainly stimulated by Radix Ginseng
The various changes of immunologic hypofunction so that it is tend to normalization, and stop the ill effect caused because of immunologic function degression.Real
Testing research to show, Radix Ginseng extract can be obviously prolonged mouse survival time and lasting, swimming time, thus shows that Radix Ginseng can
It is effectively improved hypoxia-bearing capability and the anti-fatigue ability (Zhang Aimin, 2001) of mice.Wu Chenglin etc. (2003) experimental result shows,
Ginseng polysaccharide's solution can the generation of delay fatigue, keep and improve the stability of organismic internal environment, be effectively improved the fortune of rat
Kinetic force.Ginsenoside can increase the content of myosin adenosinetriphosphataes, tired caused by alleviation chronic constriction (Huanghai Sea English,
2003).Modern pharmacological research shows, ginsenoside Rg1Can by strengthen antioxidase activity, accelerate free radical removing with
And the approach such as the damage alleviating radical pair skeletal muscle is to the recovery (He Hong etc., 2002) etc. of mice physical ability after promoting power to exhaust swimming
Deng.
When the dry root being classified as umbellifer section plant Radix Angelicae Sinensis.Sweet, acrid, warm.Gui Gan, the heart, spleen channel.Replenishing and activating blood, regulating menstruation
Pain relieving, loosening bowel to relieve constipation.For blood deficiency and yellow complexion, dizziness cardio palmus.Main pharmacological components in Radix Angelicae Sinensis is phthalide analog compound, fragrant
Legumin class, flavonoid, the material such as organic acid.Zhao from former grade (1995) Radix Angelicae Sinensis polysaccharide is carried out ion vitro immunization regulation experiment grind
Studying carefully middle discovery, Radix Angelicae Sinensis polysaccharide is obviously promoted proliferation function to mice spleen lymphsystem, the most external resists hydrocortisone
Inhibitory action value-added to mouse chest cell.Experimental study finds, Angelica sinensis Polysaccharides and separation component thereof can improve the least
Mus content of complement C 3 and Function of mononuclear phagocyte, find that Angelica sinensis Polysaccharides can resist prednisolone to cell and humoral immunization simultaneously
The suppression of function, all can make mouse spleen lymphocyte IL-2 secretory function under prednisolone inhibitory state obtain in internal, in vitro tests
To improving, illustrate that Angelica sinensis Polysaccharides has extensive immunomodulatory effect (summer snow goose etc., 2001).Feng Junzhi etc. (2003) research is sent out
Existing, the effect of Radix Angelicae Sinensis enhancing immunity is by exempting from macrophage phagocytic function, T lymphocyte function, cytokine, body fluid
Epidemic disease function, natural killer cell and lymphokine kill cell and the impact of allergy and realize.Experimental study finds,
Angelica sinensis polysaccharide can significantly raise rat blood serum antioxidase (superoxide dismutase SOD, glutathion peroxidase
GSH-PX, cat catalase) activity, Peroxidation Product malonaldehyde (MDA) content can be made to reduce simultaneously, illustrate that Radix Angelicae Sinensis is the most
Sugar can improve rat motor ability (Zheng Huifang etc., 2009) etc..
Fructus Lycii is the dry mature fruit of plant of Solanaceae lycium barbarum.Nature and flavor are sweet flat, return liver, kidney channel.As traditional
Two source materials eaten by medicine, have the effect of " nourishing the liver and kidney, replenishing vital essence to improve eyesight ".Essentials of Matea Medica is recorded: Fructus Lycii profit liver liver heat removing, nourishing kidney benefit
Gas, spermatogenesis is supporing yang, qi-restoratives labor, bone and muscle strengthening, dispelling pathogenic wind for improving eyesight, profit defecation." Treatise on Dietetic Therapy " upper records Fructus Lycii and has that " hard muscle is resistance to
Labor, except wind, tonification muscles and bones, can benefit people, remove asthenia " effect.The chemical composition of Fructus Lycii mainly contains lycium barbarum polysaccharide, Radix Betae
The compositions such as alkali, carotenoid and carotenoid ester, vitamin C, scopoletin, several amino acids and trace element (Qian Yancong etc.,
2000).Pharmacological research finds, lycium barbarum polysaccharide not only can be obviously enhanced body's immunity, but also have immunoregulation effect.
Zhang Fenglan etc. (2004) test discovery, and Fructus Lycii decocting liquid can make ovalbumin antibody and IL-2 growing amount in mice serum obvious
Raise, illustrate that Fructus Lycii has immune rise effect.Experimental study shows, Fructus Lycii crude polysaccharides is to mouse spleen cell proliferation reaction and resists
Body reaction of formation has obvious facilitation, can substantially increase the number of Senescence-Accelerated Mouse spleen antibody-producting cell simultaneously
Mesh, and splenocyte generation IgG antibody level can be raised, prompting Fructus Lycii crude polysaccharides is principal immune active component in Fructus Lycii, promotes
Or improve humoral immune function and be probably it to one of immune Main Function (Qi Chun can wait, 2001).Fructus Lycii extracts
Thing can be obviously prolonged mouse survival time and lasting, swimming time, thus shows that Fructus Lycii can be effectively improved the resistance to of mice
Hypoxia ability and anti-fatigue ability (Xu Chengshui, 2000) etc..
Radix Rhodiolae is the dry root and rhizome of crassulaceae plants Radix Rhodiolae.Property is sweet, bitter, flat, returns lung, heart channel, has
Benefiting QI for activating blood circulation, the function relievingd asthma of promoting blood circulation, for blood stasis due to qi deficiency, obstruction of qi in the chest and cardialgia, apoplectic hemiplegia, asthenia are panted.Radix Rhodiolae main
Composition has rhodioside, Radix Rhodiolae polysaccharide etc.；Shen Hongyi etc. (2003) test discovery, take the body weight of compound rhodiola root rat relatively
Tired group has clear improvement, and swimming time is obviously prolonged, and immune indexes is significantly improved, and illustrates that compound rhodiola root has regulation tired
Labor rat motor ability and the effect of immunologic function.The pharmacological research of Radix Rhodiolae and clinical practice find, injection Radix Rhodiolae carries
After taking thing, when mice pole-jump test and heavy burden pole-jump test, all can dramatically increase the persistent period, improve work efficiency, and show
Its antifatigue effect, research is it is also shown that Radix Rhodiolae can strengthen the mass motion ability of skeletal muscle endurance and rat, tired mobility
Labor demonstrates obvious antagonism advantage (Gong Yun, 2001).Zhang Hongzhi etc. (1996) are studying Radix Rhodiolae to athlete's endurance shadow
Finding in the test rung, the hemoglobin that Radix Rhodiolae can make athlete reduce after moving in a large number raises, and can make total egg simultaneously
White reduce phenomenon be improved significantly, and the activity of creatine phosphokinase is had facilitation, illustrate that Radix Rhodiolae moves to improving
Member's endurance and recovery exercise fatigue have certain effect.
Summary of the invention
It is an object of the invention to provide a kind of for enhancing immunity, alleviating physical fatigue Chinese medicine preparation, in compound recipe system
In agent, many with enhancing immunity, the relevant compound recipe of alleviating physical fatigue have Radix Ginseng, Radix Angelicae Sinensis, Fructus Lycii, Radix Rhodiolae mutual
Compatibility.Fructus Lycii sheds from Holy Benevolent Prescriptions, is made up of Fructus Lycii and Radix Ginseng two herbal medicine, and wherein Fructus Lycii is apt to tonifying liver kidney essense
Blood, cardiopulmonary spleen the moon liquid, also have the kidney invigorating gas effect, and invigorating primordial QI is apt to by Radix Ginseng, has the nourishing YIN effect of promoting the production of body fluid.Two medicine one nourishing YIN one YANG invigorating, one
Replenishing vital essence and blood one invigorating primordial QI, yang blood and qi giving young employees remedial-courses in general knowledge and vocational skills, the vital organs of the human body are the most beneficial.Two medicine compatibilities, make complementation mutually, and QI invigorating training is first, benefit essence hemopoietic.
Modern pharmacological research shows, Fructus Lycii dissipates cellular immunization and the humoral immune function that can improve body, resisting fatigue, is good for
Health, provides comprehensive tonification function (Gao Chunbo etc., 2005) for the person of having a delicate constitution.Qiao Tie etc. (2005) study discovery, Radix Angelicae Sinensis
There is the effect improving Human Hemorheology, and this effect can be strengthened with ginseng compatibility, can preferably in auxiliary formula other
Medical material plays the effect of alleviating physical fatigue.In country's Chinese herbal medicine compilation internal medicine qi-blood-body fluid fascicle, contained many is exempted from enhancing
The medicine that epidemic disease power, function of physical fatigue alleviation are relevant has the mutual compatibility of above medical material.Wherein with Fructus Lycii, Radix Angelicae Sinensis and other
Benefit unit Rhizoma Polygonati syrup, the body-building Changchun granule of different medical material compatibilities, is respectively provided with the merit of kidney-replenishing blood-nourishing, is clinically used for blood of suffering from a deficiency of the kidney
Lose, spiritlessness and weakness person.Calmed the nerves syrup by the different ginseng hygiene pill of medical material compatibility such as Radix Ginseng, Radix Angelicae Sinensis, Fructus Lycii, Radix Triplostegiae Grandiflorae,
Be respectively provided with fill blood, the effect of liver and kidney tonifying, for deficiency of both QI and blood, have a delicate constitution, the treatment of soreness of the waist and knees.Ginseng stilbene Colla Corii Asini capsule by
The medical material compatibility such as Radix Ginseng, Fructus Lycii forms, and has the effect of benefiting vital QI and blood, is clinically used for Qi and blood deficiency, and eipathia asthenia person controls
Treat.With the Shenrongbujiu of the medical material compatibility such as Radix Ginseng, Radix Angelicae Sinensis, there is the merit of benefiting vital QI and blood, for physical weakness, mental weariness
Treatment Deng disease.Examined by State Food and Drug Administration, there is Ke Zang territory, the centre board of enhancing immunity effect
Rhodiola rosea capsules (state food strong word G20050750) and there is the demutation unit board of alleviating physical fatigue effect by hair spore Herba hylotelephii erythrosticti capsule
(state food strong word G20070247) is formed by different medical material compatibilities such as Radix Rhodiolae and Fructus Lycii.
In sum, it is the monarch drug in side that Radix Ginseng consolidates primordial qi strengthening, in order to strengthening the body resistance, resists exopathogen invasion；It is equipped with simultaneously
The Radix Angelicae Sinensis of tonification nutrient blood, benefiting QI for activating blood circulation the Radix Rhodiolae side of being altogether in ministerial drug, make internal organs sufficiently be moistened foster；Help again with
The Fructus Lycii of liver and kidney tonifying so that it is function is not fully exerted, all medicines share, reaching " strengthening the body resistance, benefiting QI and nourishing blood,
Liver and kidney tonifying " health-care effect, thus effective enhancing immunity, alleviating physical fatigue.
Concrete summary of the invention is achieved through the following technical solutions:
A kind of for enhancing immunity, the Chinese medicine preparation of alleviating physical fatigue, including the raw material of Chinese medicine of following weight proportioning:
Radix Ginseng 300-400g, Radix Angelicae Sinensis 300-400g, Fructus Lycii 300-400g, Radix Rhodiolae 200-300g.
Above-mentioned is a kind of for enhancing immunity, the Chinese medicine preparation of alleviating physical fatigue, including in following weight proportioning
Medicine raw material: Radix Ginseng 350g, Radix Angelicae Sinensis 350g, Fructus Lycii 350g, Radix Rhodiolae 250g.
Above-mentioned is a kind of for enhancing immunity, the preparation method of the Chinese medicine preparation of alleviating physical fatigue, including following step
Rapid:
(1), ginseng crude drug is taken in right amount, crushed after being dried, sieve, collect fine powder, after sterilizing, standby.
(2) remainder amount ginseng crude drug mixes with Radix Rhodiolae medical material, with 70% alcohol reflux 2 times, adds 8 times amount every time
70-80% alcohol reflux 2.0 hours, filters merging filtrate, and medicinal residues are standby；Filtrate recycling ethanol to be condensed into clear paste standby
With.
(3) take medicinal residues extracting in water 2 times after Radix Angelicae Sinensis, Fructus Lycii medical material and above-mentioned alcohol extraction, each 2 hours, filter, merge
Filtrate, filtrate reduced in volume is to clear paste, standby.
(4) merging above two clear paste, drying under reduced pressure, pulverize and sieve, the powder that gets dry extract is standby；
(5) above-mentioned dried cream powder is mixed homogeneously with Radix Ginseng fine powder, add pharmaceutically conventional adjuvant or complementary composition system
Standby preparation.
Above-mentioned is a kind of for enhancing immunity, the preparation method of the Chinese medicine preparation of alleviating physical fatigue, specifically include with
Lower step:
(1), take ginseng crude drug 100-120g, 60 DEG C of crushed after being dried, cross 100 mesh sieves, collect fine powder, with 5kGy dosage
After 60Co irradiation sterilization, standby.
(2) another remainder amount ginseng crude drug mix with Radix Rhodiolae medical material, by alcohol reflux 2 times, each addition 8 times amount
75% ethanol, reflux, extract, 2.0 hours, filter merging filtrate, and medicinal residues are standby；Ethanol dense to the closeest is reclaimed under the conditions of 65 DEG C
Degree be 1.20～1.30 clear paste standby.
(3) separately take medicinal residues boiling 2 times after Radix Angelicae Sinensis, Fructus Lycii medical material and above-mentioned alcohol extraction, each 2 hours, filter, close
And filtrate, filtrate-0.060～-0.070Mpa, be evaporated under the conditions of 75 DEG C relative density be 1.20～1.30 clear
Cream, standby.
(4) merge above two clear paste, at-0.075Mpa, drying under reduced pressure under the conditions of 65 DEG C, pulverized 80 mesh sieves, and obtained dry
Cream powder is standby；
(5) being mixed homogeneously with Radix Ginseng fine powder by above-mentioned dried cream powder, with 85% appropriate amount of ethanol soft material, 16 mesh sieves are pelletized, and 55
～60 DEG C be dried, 14 mesh sieve granulate, load capsule, get product.
Above-mentioned (2) step uses 75% alcohol reflux.
Above-mentioned stating adds 10 times amount water every time in (3) step, each decoction 2 hours.
It is an advantage of the current invention that: according to hypoimmunity and the tired mechanism produced, we combine Chinese medical theory, with
And modern pharmacological research, with " strengthening the body resistance, benefiting QI and nourishing blood, liver and kidney tonifying " as the rule for the treatment of, select the gentle Radix Ginseng of character, Radix Angelicae Sinensis,
Fructus Lycii, Radix Rhodiolae are raw material, are equipped with suitable proportioning raw materials and make this product, to reach enhancing immunity, alleviating physical fatigue
Effect.
Specific embodiment
Embodiment one: optimization of process conditions is screened
In order to the portion of techniques parameter of extraction process is more specific, flour extraction, solvent concentration, solvent addition are carried out respectively
The investigation of the technological parameters such as amount, extraction time, extraction time.
1.1, disintegrating process is investigated
Weigh the clean medical material of Radix Ginseng 3 parts, each 100g, in 60 DEG C after drying, be ground into fine powder, cross 100 mesh sieves, weigh, calculate
Flour extraction, the results are shown in Table 1.
Table 1 pulverizing medicinal materials technique investigates result
Result of the test shows, the average flour extraction that Radix Ginseng is pulverized is 97.4%, and flour extraction is more stable, has production feasible
Property.Preparation is used as medicine with enough fine powders, the accuracy fed intake with guarantee.
1.2, ethanol extraction process is investigated
(1) test objective and the determination of performance assessment criteria
By multifactorial orthogonal test, the parameters of preferred alcohol extraction process.With ethanol extraction dry spun and
Total saponin content is as performance assessment criteria, to select optimal technological parameter.
(2) design of orthogonal test
1. the choosing and the selection of orthogonal table of factor and level: affect alcohol extraction because of have concentration of alcohol, ethanol consumption,
Extraction time and extraction time, 3 levels of each factor design on the basis of this 4 factor, factor level table is shown in Table 2, in order to
The most comprehensive and systematic investigation technological parameter, we use orthogonal table L9(34), it is shown in Table 3.
Table 2 alcohol extraction factor level table
2. test method and result: in 1/10 recipe quantity ratio, weighs Radix Ginseng 25g, Radix Rhodiolae 25g, altogether 50g, and parallel 9
Part, it is 1～9 tested number that randomization is compiled.By orthogonal table L9(34In), each tested number requires to test, and filters, and merges filter
Liquid, standby for test (dry spun, total saponin content measures).
A dry spun measures: measure above-mentioned reserve liquid 100ml, puts in the evaporating dish being dried, water bath method, and vacuum is done
After dry, weigh, be calculated as follows dry spun, the results are shown in Table 4.
B total saponin content measures: by " health food inspection and assessment technique specification " (version in 2003) " in health food always
The mensuration of saponin " in method measure
Table 3 alcohol extraction L9(34) orthogonal test calendar and result of the test
Table 4 alcohol extraction dry spun and total saponin content variance analysis
F0.05(2.2)=19.0 F0.01(2.2)=99.0
In table 3, in result of the test and table 4, the results of analysis of variance shows, during with dry spun for inspection target, and A2＞ A3＞
A1,B3＞ B2＞ B1,C3＞ C2＞ C1,D3＞ D2＞ D1, the impact of A, B, C, D each factor is followed successively by D ＞ A ＞ B ＞ C, and D factor affects
The most notable, there is significant difference, A, B, C impact is the least, there was no significant difference, and therefore optimised process group should be A2B3C3D3。
During with total saponin content for inspection target, A2＞ A3＞ A1, B2＞ B1＞ B3, C3＞ C2＞ C1, D2＞ D3＞ D1,A、B、
The impact of C, D each factor is followed successively by A ＞ D ＞ C ＞ B, A and D factor and is respectively provided with significant difference, and wherein the impact of A factor is the most notable, B,
C impact is the least, there was no significant difference, and therefore optimised process group should be A2B2C3D2。
From the interpretation of result of These parameters, the purpose that should consider this technique is intended to extract effectively becoming in medical material
Divide, consider energy-saving and cost-reducing simultaneously and reduce cost, therefore determine that the ethanol extraction part Optimal technique process of this technique is
A2B2C3D2, i.e. with 75% alcohol reflux 2 times, add 8 times amount every time, reflux 2.0 hours.
(3) selection process checking test: in 1/10 recipe quantity ratio, weigh Radix Ginseng 25g, Radix Rhodiolae 25g, altogether 50g, flat
Row 3 parts, with 75% alcohol reflux 2 times, adds 8 times amount, backflow 2.0 hours every time, filters, merging filtrate, (dry for test
Cream yield and total saponin content measure) use.Dry spun and total saponin content assay method are with under ethanol extraction orthogonal investigation item
Method.Checking result of the test is shown in Table 5.
Table 5 ethanol extraction checking result of the test
The result shows, alcohol extraction dry cream average yield is 15.38%, and alcohol extraction total saponins average content is
368.3mg.In the checking result of the test i.e. orthogonal table of item the highest with total saponin content in orthogonal test, the 4th is compared, and total saponins contains
Amount, higher than the 4th, illustrates this technique basic feasible solution.Therefore determine with 75% alcohol reflux 2 times, add 8 times amount, backflow every time
2.0 hour.
1.3, decocting extraction process is investigated
(1) test objective and the determination of performance assessment criteria
Parameters by multifactorial orthogonal test, preferably water extraction process.Dry spun and crude polysaccharides is carried with water
Amount is as performance assessment criteria, to select optimal technological parameter.
(2) design of orthogonal test
1. the choosing and the selection of orthogonal table of factor and level: affect the principal element of water boiling and extraction have decoct number of times,
Amount of water and decocting time, on the basis of this factor, 3 levels of each factor design, factor and level are shown in Table 6.In order to more
The concrete technological parameter investigating water extraction, we select L9(34) orthogonal manner be designed research, L9(34) orthogonal test table
It is shown in Table 8.
Table 6 water carries experimental factor water-glass
2. test method and result: weigh Radix Angelicae Sinensis 35g, Fructus Lycii 35g, Radix Ginseng 25g, Radix Rhodiolae in prescription 1/10 ratio
25g, altogether 120g, parallel 9 parts, it is 1～9 tested number that randomization is compiled.Take Radix Ginseng, Radix Rhodiolae two taste medical material, add 75% second
Alcohol reflux 2 times, adds 8 times amount ethanol every time, refluxes 2 hours, filters, and medicinal residues and Radix Angelicae Sinensis, Fructus Lycii are by orthogonal table L9(34In) each
Tested number requires to test, and filters, merging filtrate, and filtrate concentrates and is settled to certain volume, for test (dry spun, slightly
Determination of polysaccharide) use.
A dry spun measures: measures reserve liquid 100ml, puts and be dried to the evaporating dish of constant weight, water bath method, vacuum
After drying, weigh rapidly, be calculated as follows dry spun, the results are shown in Table 8.
B crude polysaccharides content assaying method (measures with reference to method under one Rhizoma Polygonati Odorati item of China's coastal port.)
Table 7 water carries L9(34) orthogonal table and orthogonal experiments
Table 8 water proposes dry spun and crude polysaccharides amount variance analysis
F0.05(2.2)=19.0 F0.01(2.2)=99.0
From the results of analysis of variance in result of the test in table 7 and table 8, during with dry spun for inspection target, A3>A2>
A1, B3>B2>B1, C3>C2>C1, C factor impact maximum, A, B factor is taken second place.Each factor effect primary and secondary is C > B > A, wherein C factor
Having significant difference, A, B factor there are no significant difference, therefore extraction process by water should be A3B3C3。
During with crude polysaccharides content for inspection target, A3>A2>A1,B3>B2>B1,C2>C3>C1, each factor of A, B, C affects successively
For C > B > A, wherein the impact of C factor tool is the most notable, has significant difference；The impact of A, B factor is less, there was no significant difference, intuitively
Analysis optimised process is A3B3C2。
Inconsistent, in view of this work from having C factor between the interpretation of result of These parameters, dry spun and crude polysaccharides content only
The purpose of skill is intended to the effective ingredient extracting in medical material, the volume reducing preparation, reduces dose, simultaneously from reducing cost,
Save the energy and raising production efficiency is set out, determine that the decocting part Optimal technique process of this technique is A3B3C2, i.e. weigh medicine
Material, boiling 2 times, add 10 times amount water, each decoction 2 hours every time.
(3) selection process checking test: weigh Radix Angelicae Sinensis 35g, Fructus Lycii 35g, Radix Ginseng 25g, red scape in prescription 1/10 ratio
It 25g, altogether 120g, take Radix Ginseng, Radix Rhodiolae two taste medical material, add 75% alcohol reflux 2 times, add 8 times amount second every time by parallel 3 parts
Alcohol, refluxes 2 hours, filters, and medicinal residues and Radix Angelicae Sinensis, Fructus Lycii, according to the process conditions screened, boiling 2 times, add 10 every time
Times amount water, decocts 2 hours, filters, merging filtrate, and filtrate concentrates and is settled to certain volume, (dry spun, the most for testing
Sugar assay) use.Test method extracts method under orthogonal investigation item with reference to decocting, and result of the test is shown in Table 9.
Table 9 decocting extracts checking result of the test
The result shows, it is 20.47% that decocting extracts average dry spun, and crude polysaccharides average content is 1.769g, its
Middle crude polysaccharides content with orthogonal test the highest item that is the 9th basically identical, technique basic feasible solution is described, therefore determines extraction process by water
For boiling 2 times, add 10 times amount water, each decoction 2 hours every time.
Embodiment two pharmaceutical preparation of the present invention specific embodiment
The preparation of 2.1 capsules:
Prescription: Radix Ginseng 350g, Radix Angelicae Sinensis 350g, Fructus Lycii 350g, Radix Rhodiolae 250g
Preparation method: (1) Radix Ginseng, Radix Angelicae Sinensis, Fructus Lycii, Radix Rhodiolae four Chinese medicine material, after the assay was approved for preparation.
(2) take Radix Ginseng 125g, be dried (60 DEG C) and pulverize afterwards, cross 100 mesh sieves, collect fine powder 100g, with 5kGy dosage60After Co irradiation sterilization, standby.
(3) another remainder amount Radix Ginseng (250g) mix with Radix Rhodiolae, by 75% alcohol reflux 2 times, each addition 8 times amount
75% ethanol, reflux, extract, 2.0 hours, filter (medicinal residues are standby), merging filtrate, filtrate recycling ethanol (-0.060～-
0.070MPa, 65 DEG C) and dense to the clear paste that relative density is 1.20～1.30 (60 DEG C of surveys), standby.
(4) after separately taking Radix Angelicae Sinensis, Fructus Lycii and alcohol extraction, medicinal residues add 10 times amount soak by water 2 times, each 2 hours, filter, and merge
Filtrate (medicinal residues discard), filtrate reduced in volume (-0.060～-0.070Mpa, 75 DEG C) is 1.20～1.30 (60 to relative density
DEG C survey) clear paste, standby.
(5) merging above two clear paste, drying under reduced pressure (-0.075Mpa, 65 DEG C), gained dried cream powder is broken into fine powder, crosses 80
Mesh sieve, standby.
(6) being mixed homogeneously with Radix Ginseng fine powder by above-mentioned dried cream powder, with 85% appropriate amount of ethanol soft material, 16 mesh sieves are pelletized, and 55
～60 DEG C be dried, 14 mesh sieve granulate, load No. 0 capsule, polish, pack, check, get product.
The preparation of 2.2 granules:
Prescription: Radix Ginseng 400g, Radix Angelicae Sinensis 300g, Fructus Lycii 400g, Radix Rhodiolae 200g
Preparation method: (1) Radix Ginseng, Radix Angelicae Sinensis, Fructus Lycii, Radix Rhodiolae four Chinese medicine material, after the assay was approved for preparation.
(2) take Radix Ginseng 100g, be dried (60 DEG C) and pulverize afterwards, cross 100 mesh sieves, collect fine powder 100g, with 5kGy dosage60After Co irradiation sterilization, standby.
(3) another remainder amount Radix Ginseng (300g) mix with Radix Rhodiolae, by 70% alcohol reflux 2 times, each addition 8 times amount
70% ethanol, reflux, extract, 2.0 hours, filter (medicinal residues are standby), merging filtrate, filtrate recycling ethanol (-0.060～-
0.070MPa, 65 DEG C) and dense to the clear paste that relative density is 1.20～1.30 (60 DEG C of surveys), standby.
(4) after separately taking Radix Angelicae Sinensis, Fructus Lycii and alcohol extraction, medicinal residues add 10 times amount soak by water 2 times, each 2 hours, filter, and merge
Filtrate (medicinal residues discard), filtrate reduced in volume (-0.060～-0.070Mpa, 75 DEG C) is 1.20～1.30 (60 to relative density
DEG C survey) clear paste, standby.
(5) merging above two clear paste, drying under reduced pressure (-0.075Mpa, 65 DEG C), gained dried cream powder is broken into fine powder, crosses 80
Mesh sieve, standby.
(6) being mixed homogeneously with Radix Ginseng fine powder by above-mentioned dried cream powder, with 85% appropriate amount of ethanol soft material, 16 mesh sieves are pelletized, and 55
～60 DEG C be dried, 14 mesh sieve granulate, pack and i.e. obtain granule finished product.
The preparation of 2.3 tablets:
Prescription: Radix Ginseng 300g, Radix Angelicae Sinensis 400g, Fructus Lycii 300g, Radix Rhodiolae 300g
Preparation method: (1) Radix Ginseng, Radix Angelicae Sinensis, Fructus Lycii, Radix Rhodiolae four Chinese medicine material, after the assay was approved for preparation.
(2) take Radix Ginseng 150g, be dried (60 DEG C) and pulverize afterwards, cross 100 mesh sieves, collect fine powder 100g, with 5kGy dosage60After Co irradiation sterilization, standby.
(3) another remainder amount Radix Ginseng (250g) mix with Radix Rhodiolae, by 70% alcohol reflux 2 times, each addition 8 times amount
Ethanol, reflux, extract, 2.0 hours, filter (medicinal residues are standby), merging filtrate, filtrate recycling ethanol (-0.060～-0.070MPa,
65 DEG C) and dense to the clear paste that relative density is 1.20～1.30 (60 DEG C of surveys), standby.
(4) after separately taking Radix Angelicae Sinensis, Fructus Lycii and alcohol extraction, medicinal residues add 10 times amount soak by water 2 times, each 2 hours, filter, and merge
Filtrate (medicinal residues discard), filtrate reduced in volume (-0.060～-0.070Mpa, 75 DEG C) is 1.20～1.30 (60 to relative density
DEG C survey) clear paste, standby.
(5) merging above two clear paste, drying under reduced pressure (-0.075Mpa, 65 DEG C), gained dried cream powder is broken into fine powder, crosses 80
Mesh sieve, standby.
(6) being mixed homogeneously with Radix Ginseng fine powder by above-mentioned dried cream powder, with 85% appropriate amount of ethanol soft material, 16 mesh sieves are pelletized, and 55
～60 DEG C be dried, 14 mesh sieve granulate, tabletting i.e. obtains tablet finished product.
Embodiment three enhancing immunity of the present invention drug efficacy study
3.1 instruments and material
Instrument: dual-beam ultraviolet spectrophotometer: UV-2100, Beijing Rayleigh Analytical Instrument Co., Ltd；Electronic balance:
AE200, prunus mume (sieb.) sieb.et zucc. torr instrument Shanghai company；Centrifuge etc..
Medicine of the present invention: the capsule preparations of the present embodiment 1；Prednisone acetate tablets: Guangdong Huanan Pharmaceutical Co., Ltd.
Animal: SPF level Kun Ming mice, male and female dual-purpose, body weight 18～22g, Guangxi Medical University's Experimental Animal Center
There is provided.Animal productiong credit number: osmanthus SCXK2009-0002, animal use credit number: osmanthus SCXK2009-0004.
The impact on hypoimmunity mice immune organ quality of 3.2 medicines of the present invention
Method: take mice 50, is randomly divided into 5 groups: blank group, model group, high, medium and low dosage group (20,10,5g/kg/
D), in addition to blank group, other organizes mice gavage 40mg/kg/d in morning prednisolone acetate, blank group isometric(al) water, afternoon is high, in,
Low dose group mouse stomach relative medicine, blank group and model group gavage isometric(al) water, continuous 12d.After last gastric infusion 1h,
Put to death mice, blot residual blood with filter paper, claim weight, take spleen and thymus, claim quality with electronic balance, calculate spleen and thymus
Index (I): I spleen=m spleen/m body；I thymus=m thymus/m body.
3.2.1 result
Comparing with blank group, model group mouse spleen index, thymus index all significantly reduce (P < 0.01), show that acetic acid sprinkles
Buddhist nun pine causes immunodeficiency models success.Basic, normal, high dosage group all improves hypoimmunity mice index and spleen index, compares with model group
Difference has significant (P < 0.01).Basic, normal, high dosage group all improves hypoimmunity mice thymus index, with model group ratio
Relatively difference has significant (P < 0.05), is shown in Table 10.
Table 10 medicine of the present invention is on hypoimmunity mice index and spleen index, the impact (X ± s, n=10) of thymus index
Note: compare with blank group, 1. P < 0.01: compare with model group, 2. P < 0.05,3. P < 0.01.
The impact on hypoimmunity mice mononuclear-macrophage phagocytic function of 3.3 medicines of the present invention
3.3.1 method
Take mice 50, be randomly divided into 5 groups: blank group, model group, high, medium and low dosage group (20,10,5g/kg/d),
Last is administered after 1h, tail vein injection Beijing burnt black ink juice (10ml/kg) 2min and 12min afterwards, with glass capillary from
Mouse orbit rear vein beard takes blood 2～3, draws 20uL and is dissolved in 3ml0.1% sodium carbonate liquor, shakes up, in spectrophotometer
Survey absorbance (A) at 675nm, calculate and clean up index (IK).
(IK) (absorbance when D2, D12 are respectively 2min, 12min, t12, t2 divide=(logD2-logD12)/(t12-t2)
Wei time 12min, 2min).
3.3.2 result
Hypoimmunity mice is cleaned up the impact (n=10) of index by table 11 medicine of the present invention
Note: compare with blank group, 1. P < 0.01；Compare with model group, 2. P < 0.05.
As shown in Table 11, basic, normal, high dosage group is significantly increased model group clearance in mice index (P < 0.05).Ik value is more
Greatly, phagocyte identification poisonous substance or paracytic ability are the strongest.
3.4 medicines of the present invention cause mice serum antibody (hemolysin) to chicken red blood cell and form impact
3.4.1 method
Take Mus 60, be randomly divided into 6 groups: blank group, model group, prednisolone acetate group (dosage is 40mg/kg/d), low,
Middle and high dosage group (5,10,20g/kg/d).In addition to blank group, each group Mus elder generation lumbar injection chicken red blood cell suspension and physiology salt
Water presses the 0.2mL immunoreation of (100:5) diluent, every d gavage 1 time, continuous 12d.1h after last administration, wins eyeball and takes blood,
Centrifugation serum, takes 30uL serum normal saline dilution 100 times, takes dilute serum 1mL, measures chicken by hemolysin test method
Erythrocyte antibody (EA) (hemolysin), surveys trap A value at spectrophotometer wavelength 540nm, to be not added with serum solution supernatant work
For blank reference solution.
3.4.2 result
Mice is after chicken red blood cell immunity, and serum antibody (hemolysin) increases, i.e. model group serum A value is significantly higher than blank
Group (P < 0.01), compares with model group, and basic, normal, high dosage group all increases serum hemolysis cellulose content.It is shown in Table 12.
The impact that chicken red blood cell induced mice serum hemolysin is formed by table 12 medicine of the present invention
Note: compare with blank group, 1. P < 0.01；Compare with model group, 2. P < 0.05,3. P < 0.01.
3.5 brief summary
A lot of diseases are had a major impact by body's immunity state.Medicine of the present invention is understood low in immunity by above-mentioned experiment
Time lower, add mouse thymus and index and spleen index；Cleaning up index also to dramatically increase, Function of mononuclear phagocyte is remarkably reinforced, and increases
Strong body non-specific immunity；Increase serum hemolysis cellulose content, enhancing body specific immune function, alleviate muscle power tired
Labor.Medicine of the present invention has good raising immunity, alleviating physical fatigue effect, and compared to the drug effect of single Chinese medicine, this
The drug effect of invention medicine is obviously enhanced.
Embodiment four resisting fatigue drug efficacy study
4.1. experimental technique
4.2 take body weight 22～26g male mice in kunming 50 to the impact of Normal male mice swimming time, divide at random
Becoming 5 groups, often group 10,3 groups of dosage of medicine of the present invention are respectively 2.2g/kg every day, and 4.3g/kg, 8.6g/kg (are equivalent to adult
Dosage 5,10,20 times)；Body-strengthening granules electuary group, dosage 4.3g/kg every day；Matched group, gives isopyknic normal saline.Even
Continuous administration 15d, weighs before the most secondary administration and fasting 12h, is administered half an hour after, ties up rat-tail root with animal own body weight
The lead of 10%, puts into the thermostatic water bath went swimming that depth of water 20cm, water temperature are 25 DEG C, no longer rises to extremely being sunken to underwater 6s
Dying index, record swimming time, statistical analysis uses q inspection.
4.3 take Kunming mouse 50 to the impact of adult mice normal pressure resistant anoxia effect, male and female half and half, body weight 22～
26g, group technology, dosage and administration time are with 2.1, and after being administered 30min last 1 time, mice is the most single puts into
In the wide mouthed bottle of 250ml, inside add appropriate sodica calx and add a cover, sealing bottleneck, observed and recorded death time of animal, system with vaseline
Meter is analyzed and is used q inspection.
4.4. result
The test of mice swimming time shows, pharmaceutical preparation of the present invention can extend adult male mice swimming time significantly
(P ＜ 0.01), points out this medicine to have antifatigue effect, and in a certain amount effect relationship.The test of mice normal pressure resistant anoxia shows, this
Invention pharmaceutical preparation can make the time of adult mice anoxia enduring be obviously prolonged (P ＜ 0.01), the results are shown in Table 13.
Table 13 pharmaceutical preparation of the present invention is on mice swimming and the impact of hypoxia endurance time
Note compares △ △ P ＜ 0.01 with matched group；※ P ＜ 0.01 is compared with pharmaceutical preparation group of the present invention
4.5. conclusion
Pharmaceutical preparation low dose group of the present invention compares with body-strengthening granules, mice swimming time and the basic phase of hypoxia endurance time
With, and middle dosage group and the mice swimming time of high dose group and hypoxia endurance time are through being significantly improved than ZHENQI FUZHENG KELI,
Illustrate that medicine resisting fatigue effect of the present invention is better than body-strengthening granules.
Meanwhile, inventor's granule in also using medicine of the present invention, tablet have carried out drug efficacy study, and it all can
Reach, increase mouse thymus and index and spleen index；Cleaning up index also to dramatically increase, Function of mononuclear phagocyte is remarkably reinforced, and strengthens
Body non-specific immunity；Increase serum hemolysis cellulose content, enhancing body specific immune function, alleviating physical fatigue；
Wherein with capsule prescription proportioning be optimal.
Claims (6)
1. for enhancing immunity, a Chinese medicine preparation for alleviating physical fatigue, including the raw material of Chinese medicine of following weight proportioning: people
Ginseng 300-400g, Radix Angelicae Sinensis 300-400g, Fructus Lycii 300-400g, Radix Rhodiolae 200-300g.
The most according to claim 1 a kind of for enhancing immunity, the Chinese medicine preparation of alleviating physical fatigue, its feature exists
In: include the raw material of Chinese medicine of following weight proportioning: Radix Ginseng 350g, Radix Angelicae Sinensis 350g, Fructus Lycii 350g, Radix Rhodiolae 250g.
3., for enhancing immunity, a preparation method for the Chinese medicine preparation of alleviating physical fatigue, comprise the steps: (1), take
Ginseng crude drug is appropriate, and crushed after being dried is sieved, collected fine powder, after sterilizing, standby.
(2) remainder amount ginseng crude drug mixes with Radix Rhodiolae medical material, with alcohol reflux 2 times, adds 8 times amount 70-80% every time
Alcohol reflux 2.0 hours, filters merging filtrate, and medicinal residues are standby；Filtrate recycling ethanol to be condensed into clear paste standby.
(3) take medicinal residues extracting in water 2 times after Radix Angelicae Sinensis, Fructus Lycii medical material and above-mentioned alcohol extraction, each 2 hours, filter, merge filter
Liquid, filtrate reduced in volume is to clear paste, standby.
(4) merging above two clear paste, drying under reduced pressure, pulverize and sieve, the powder that gets dry extract is standby；
(5) above-mentioned dried cream powder is mixed homogeneously with Radix Ginseng fine powder, add pharmaceutically conventional adjuvant or the preparation of complementary composition and
The preparation become.
The most according to claim 3 a kind of for enhancing immunity and the preparation side of the Chinese medicine preparation of alleviating physical fatigue
Method, comprises the following steps:
(1), take ginseng crude drug 100-120g, 60 DEG C of crushed after being dried, cross 100 mesh sieves, collect fine powder, with the 60Co of 5kGy dosage
After irradiation sterilization, standby.
(2) another remainder amount ginseng crude drug mix with Radix Rhodiolae medical material, by alcohol reflux 2 times, each addition 8 times amount 75% second
Alcohol, reflux, extract, 2.0 hours, filter merging filtrate, and medicinal residues are standby；Reclaim ethanol under the conditions of 65 DEG C and dense to relative density be
The clear paste of 1.20～1.30 is standby.
(3) separately take medicinal residues boiling 2 times after Radix Angelicae Sinensis, Fructus Lycii medical material and above-mentioned alcohol extraction, each 2 hours, filter, merge filter
Liquid, filtrate ,-0.060～-0.070Mpa, is evaporated to the clear paste that relative density is 1.20～1.30 under the conditions of 75 DEG C, standby
With.
(4) merging above two clear paste, at-0.075Mpa, drying under reduced pressure under the conditions of 65 DEG C, pulverized 80 mesh sieves, get dry extract powder
Standby；
(5) above-mentioned dried cream powder is mixed homogeneously with Radix Ginseng fine powder, with 85% appropriate amount of ethanol soft material, 16 mesh sieves granulations, 55～60
DEG C be dried, 14 mesh sieve granulate, load capsule, get product.
5. a kind of for enhancing immunity, the preparation side of the Chinese medicine preparation of alleviating physical fatigue according to described in claim 3 or 4
Method, it is characterised in that: described (2) step uses 75% alcohol reflux.
6. a kind of for enhancing immunity, the preparation side of the Chinese medicine preparation of alleviating physical fatigue according to described in claim 3 or 4
Method, it is characterised in that: described (3) step adds 10 times amount water, each decoction 2 hours every time.
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