CN108743792A - Be conducive to anti-fatigue traditional Chinese mixture to refresh the mind and preparation method thereof - Google Patents
Be conducive to anti-fatigue traditional Chinese mixture to refresh the mind and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/41—Crassulaceae (Stonecrop family)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/58—Reptiles
- A61K35/586—Turtles; Tortoises, e.g. terrapins
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/074—Ganoderma
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/344—Codonopsis
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/57—Magnoliaceae (Magnolia family)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/64—Orobanchaceae (Broom-rape family)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/79—Schisandraceae (Schisandra family)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8968—Ophiopogon (Lilyturf)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
Abstract
The present invention is a kind of anti-fatigue traditional Chinese mixture for being conducive to refresh the mind, and is mainly prepared by the rhodiola root, Radix Codonopsis, ganoderma lucidum, Radix Astragali, Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, Schisandra chinensis, Herba Cistanches, turtle shell, Chinese yam, ginseng and the ginkgo that centainly match.Mixture of the present invention is the non-traditional medicament to adjust human body physiological function or for the purpose of the element that supplements the nutrients, various outdoor sports can be widely used in, and during different occupations needs, physical function can be improved, improve energy, the demand of mixture of the present invention also more increases in pressure exposed population group.Mixture of the present invention meets the market requirement just as the antifatigue herb mixture that refreshes the mind, and has positive effect particularly with coal miner for alleviating Difference of Occupational Stress, to reduce mine safety accidents, improve production efficiency, increase economic benefit.
Description
Technical field
The present invention relates to herb mixture technical field, specifically a kind of anti-fatigue traditional Chinese mixture for being conducive to refresh the mind and
Preparation method.
Background technology
With the development of society, Difference of Occupational Stress gradually causes the extensive concern of the public as a kind of new occupational hazards,
Its prevention and the new demand that control is sanitary work development.Difference of Occupational Stress refer under the conditions of certain occupation, objective demand with
Physiological change and psychology unbalance and occur change between subjective response, and cause corresponding work(due to being unable to meet demand
It can sexual disorder.Its pathogenic factor is the lasting presence in various nervous sources, and nervous source can be professional load, labor style, operation
Conflict etc. is related to many factors such as home environment, social environment, consitution, age and the length of service.
Difference of Occupational Stress is related to the links of mental labour and manual labor, and various professional populations are potential exposed on this kind of
Risk factor, professional nature cause this kind of crowd that cannot alleviate for a long time, this may can lead to adverse consequences.In psychology and essence
Refreshing aspect, easily causes stress reaction and the special sexual tension relevant disease of this two class of group Cardiac disease, generates fatigue, head
Bitterly, helpless, valueless, anxiety and depression.In terms of behavior, nervous mental strain can behave as the change of behavior, such as to the external world
The reaction of stimulation is inaccurate, and ability to work declines, and practitioner is caused nerve impulse behavior occur, aggravate fatigue accumulation.Even
Show the change in terms of physiology, Difference of Occupational Stress is hypertension, the risk factor of ischemic heart disease, can result in coronary heart disease,
It reduces the immune function of body, promote the generation of musculoskeletal pain syndrome.
Especially for coal mining enterprise, underground coal mine work is a special occupation, long-term excessive operating pressure and spy
Different working environment causes Difference of Occupational Stress, and how to reduce the Difference of Occupational Stress degree of coal mine working personnel is that departments of government urgently solves
One of certainly the problem of.Therefore, if it can be that the Chinese medicine that such as coal mine working personnel are refreshed the mind antifatigue closes that can develop a kind of
Agent, to alleviate the Difference of Occupational Stress of staff, reducing mine safety accidents incidence just seems extremely urgent.
Invention content
The purpose of the present invention is to solve above-mentioned problems of the prior art, and provide one kind be conducive to refresh oneself it is awake
Anti-fatigue traditional Chinese mixture of brain and preparation method thereof.
The present invention is achieved through the following technical solutions：
A kind of anti-fatigue traditional Chinese mixture for being conducive to refresh the mind, including each Chinese medicine material of following parts by weight are made：
9-10 parts of rhodiola root, 9-10 parts of Radix Codonopsis, 7-9 parts of ganoderma lucidum, 6-8 parts of Radix Astragali, 5-6 parts of Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis 5-6 part, 3-4 parts of Schisandra chinensis,
3-5 parts of Herba Cistanches, 3-4 parts of turtle shell, 2-3 parts of Chinese yam, 1-2 parts of ginseng, 1-2 parts of ginkgo.
Qing Dynasty Wu Yi is said Lip river：" main patient, key medicine to the ill, therefore the monarch of meaning.Monarch person's taste number is few and heavy, Lai Zhiwei
It is main.Assistant monarch thinks minister, and taste number is slightly more, and component is slightly light, so the monarch's that rectifies does not compel.Ying Chenzhe meanings make, and number can come in and go out, and divide
Amount is lighter, and institute is in case current guide makes.The justice of this then monarch ".In anti-fatigue traditional Chinese mixture of the present invention, monarch drug in a prescription
Be rhodiola root, Radix Codonopsis, be to play the drug of primary treatment for fatigue symptom, in the efficacy of a drug side of residence first of, dosage is compared with conduct
It is maximum when minister, adjutant application, it is indispensable drug.Ministerial drug is ganoderma lucidum, Radix Astragali, Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, and effect has two, when
Auxiliary monarch drug in a prescription reinforces the main disease for the treatment of or main symptom, second is that playing therapeutic effect for simultaneous disease or accompanying symptoms, the efficacy of a drug is less than monarch drug in a prescription.Adjutant is
Schisandra chinensis, Herba Cistanches, turtle shell and Chinese yam, to eliminate or slow down the toxicity of monarch drug in a prescription, ministerial drug or strong, the efficacy of a drug is less than ministerial drug,
Dosage is lighter.It is ginseng, ginkgo to make medicine, and effect has two, first, tying-in, all medicines are to reach lesion in the side of drawing, second is that reconciling, coordinate
All medicine effects, the efficacy of a drug is minimum, and dosage is most light.By " monarch " compound compatibility, optimum organization prescription reaches synergy, subtracts
Poison expands therapeutic domain, adapts to the complicated state of an illness, is finally reached the purpose for treating main disease or main symptom.
The present invention also provides the preparation methods of the above-mentioned anti-fatigue traditional Chinese mixture for being conducive to refresh the mind, including walk as follows
Suddenly：1) each Chinese medicine material prepared in proportion is sequentially placed into Chinese medicine extracting tank, the boiling boiling of 8 times of amounts is added, is boiled by fire
After change and be cooked by slow fire 1h, stand, pour out liquid；2) boiling for adding 3 times of amounts, is cooked by slow fire 0.5h, stands, pours out liquid；3) after
The continuous boiling that 3 times of amounts are added, is cooked by slow fire 0.5h, stands, pours out liquid；4) liquid poured out three times is merged, by 10% ratio
0.1% chitin is added in example, is stood overnight after precipitation, liquid is then centrifuged 10min under conditions of centrifugal force 3000g, quiet
It sets, takes supernatant, water lift concentration, sterilizing, 4 DEG C of preservations.
As a preferred technical solution, in step 4), after liquid concentration, corrigent and preservative is added.
It is liquid gross mass after concentration that corrigent, which uses Aspartame, addition, as a preferred technical solution,
0.5%；It is 0.1% of liquid gross mass after concentrating that preservative, which uses benzoic acid, addition,.
As a preferred technical solution, in step 4), when water lift concentrates, it can be completed after liquid proportion reaches 1.5 dense
Contracting obtains concentrated medicament.
With the transformation of medical model, people increasingly pay attention to effect of the Difference of Occupational Stress in pathogenic process, Difference of Occupational Stress
Long-term existence there are causalities with hypertension.Coal miner is potential exposed on this kind of risk factor, and professional nature leads to this
Class crowd cannot be alleviated for a long time, lead to a series of adverse consequences.Mixture of the present invention is to adjust human body physiological function or to mend
The non-traditional medicament for the purpose of nutrient is filled, can be widely used in various outdoor sports and different occupation needs,
Physical function can be improved, improve energy, the demand of mixture of the present invention also more increases in pressure exposed population group.The present invention closes
Agent meets the market requirement just as the antifatigue herb mixture that refreshes the mind, for alleviating Difference of Occupational Stress particularly with coal mine
Worker has positive effect, to reduce mine safety accidents, improve production efficiency, increase economic benefit.
Specific implementation mode
Technical scheme of the present invention is clearly and completely described below in conjunction with specific embodiment, it is clear that described
Embodiment be only a part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, ability
The every other embodiment that domain those of ordinary skill is obtained without making creative work, belongs to guarantor of the present invention
The range of shield.
Embodiment 1
A kind of anti-fatigue traditional Chinese mixture for being conducive to refresh the mind, including each Chinese medicine material of following parts by weight are made：
10 parts of rhodiola root, 9 parts of Radix Codonopsis, 7 parts of ganoderma lucidum, 7 parts of Radix Astragali, 6 parts of Rhizoma Atractylodis Macrocephalae, 5 parts of Radix Ophiopogonis, 3 parts of Schisandra chinensis, 5 parts of Herba Cistanches, turtle shell 4
Part, 2 parts of Chinese yam, 1 part of ginseng, 2 parts of ginkgo.
The preparation method of above-mentioned herb mixture includes the following steps：
1) each Chinese medicine material prepared in proportion is sequentially placed into Chinese medicine extracting tank, the boiling boiling of 8 times of amounts, big fire is added
Change after boiling and be cooked by slow fire 1h, stands, pour out liquid；2) boiling for adding 3 times of amounts, is cooked by slow fire 0.5h, stands, pours out liquid；
3) boiling for continuously adding 3 times of amounts, is cooked by slow fire 0.5h, stands, pours out liquid；4) liquid poured out three times is merged, by 10%
Ratio 0.1% chitin is added, stand overnight after precipitation, then centrifuge liquid under conditions of centrifugal force 3000g
10min is stood, and takes supernatant, water lift to be concentrated into liquid proportion and reach 1.5, corrigent is added and preservative, corrigent are adopted
With Aspartame, addition is 0.5% of liquid gross mass after concentrating, and it is medicine after concentration that preservative, which uses benzoic acid, addition,
The 0.1% of liquid gross mass, sterilizing, 4 DEG C of preservations.
Embodiment 2
A kind of anti-fatigue traditional Chinese mixture for being conducive to refresh the mind, including each Chinese medicine material of following parts by weight are made：
9 parts of rhodiola root, 10 parts of Radix Codonopsis, 8 parts of ganoderma lucidum, 8 parts of Radix Astragali, 5 parts of Rhizoma Atractylodis Macrocephalae, 6 parts of Radix Ophiopogonis, 4 parts of Schisandra chinensis, 3 parts of Herba Cistanches, turtle shell 3
Part, 3 parts of Chinese yam, 2 parts of ginseng, 2 parts of ginkgo.
The preparation method of above-mentioned herb mixture includes the following steps：
1) each Chinese medicine material prepared in proportion is sequentially placed into Chinese medicine extracting tank, the boiling boiling of 8 times of amounts, big fire is added
Change after boiling and be cooked by slow fire 1h, stands, pour out liquid；2) boiling for adding 3 times of amounts, is cooked by slow fire 0.5h, stands, pours out liquid；
3) boiling for continuously adding 3 times of amounts, is cooked by slow fire 0.5h, stands, pours out liquid；4) liquid poured out three times is merged, by 10%
Ratio 0.1% chitin is added, stand overnight after precipitation, then centrifuge liquid under conditions of centrifugal force 3000g
10min is stood, and takes supernatant, water lift to be concentrated into liquid proportion and reach 1.5, corrigent is added and preservative, corrigent are adopted
With Aspartame, addition is 0.5% of liquid gross mass after concentrating, and it is medicine after concentration that preservative, which uses benzoic acid, addition,
The 0.1% of liquid gross mass, sterilizing, 4 DEG C of preservations.
Embodiment 3
A kind of anti-fatigue traditional Chinese mixture for being conducive to refresh the mind, including each Chinese medicine material of following parts by weight are made：
9 parts of rhodiola root, 10 parts of Radix Codonopsis, 9 parts of ganoderma lucidum, 6 parts of Radix Astragali, 5 parts of Rhizoma Atractylodis Macrocephalae, 6 parts of Radix Ophiopogonis, 3 parts of Schisandra chinensis, 3 parts of Herba Cistanches, turtle shell 4
Part, 3 parts of Chinese yam, 1 part of ginseng, 1 part of ginkgo.
The preparation method of above-mentioned herb mixture includes the following steps：
1) each Chinese medicine material prepared in proportion is sequentially placed into Chinese medicine extracting tank, the boiling boiling of 8 times of amounts, big fire is added
Change after boiling and be cooked by slow fire 1h, stands, pour out liquid；2) boiling for adding 3 times of amounts, is cooked by slow fire 0.5h, stands, pours out liquid；
3) boiling for continuously adding 3 times of amounts, is cooked by slow fire 0.5h, stands, pours out liquid；4) liquid poured out three times is merged, by 10%
Ratio 0.1% chitin is added, stand overnight after precipitation, then centrifuge liquid under conditions of centrifugal force 3000g
10min is stood, and takes supernatant, water lift to be concentrated into liquid proportion and reach 1.5, corrigent is added and preservative, corrigent are adopted
With Aspartame, addition is 0.5% of liquid gross mass after concentrating, and it is medicine after concentration that preservative, which uses benzoic acid, addition,
The 0.1% of liquid gross mass, sterilizing, 4 DEG C of preservations.
Traditional Chinese medicine ingredients are complicated, and general taste is how bitter, puckery, salty, sour, pungent, therefore often corrigent need to be added to cover to a certain extent
With the bad smell for improving preparation, it is convenient for for oral administration.It is that liquid is total that corrigent in mixture of the present invention, which uses Aspartame, addition,
The 0.5% of quality.Screening for corrigent, the specific method is as follows：3 parts of this mixture for not adding corrigent is taken, peace is separately added into
Match honey, Aspartame, honey element 0.5g, obtain 3 parts of samples, stirring to particle is completely dissolved under room temperature, in range estimation solution whether
There is precipitation, judge its clarification situation, and ask 5 volunteer's sensory evaluation mouthfeels, is evaluated by 5-1 points, 5 points are best.
The results show that being separately added into anti-fatigue fluid mixture prepared by acesulfame potassium, Aspartame, the different corrigents of 3 kinds of honey element
Clarify.By the investigation of mouthfeel, the sample mouthfeel containing Aspartame is best, therefore selects Aspartame for the flavoring of this mixture
Agent.The determination of the dosage of corrigent is as follows：3 parts of this mixture for not adding corrigent is taken, 0.3%, 0.5%, 0.7% Ah is separately added into
It is stirred completely under this Ba Tian and room temperature, asks 5 volunteer's sensory evaluation mouthfeels.
| Sample | 0.3% | 0.5% | 0.7% |
| Mouthfeel | It is slightly sour | It is slightly sweet | Cross sweet tea, slightly bitter |
The result shows that：The anti-fatigue fluid mixture mouthfeel that 0.5% Abbas's sweet tea is added is best.Therefore determine that the corrigent of this mixture is
0.5% Aspartame.
Mixture of the present invention is liquid preparation, is preserved for convenience of storage, also needs that certain preservative is added, mixture of the present invention
Preservative uses benzoic acid.Screening for preservative, the specific method is as follows：3 parts of the mixture of the present invention of non-adding preservative agent is taken, point
Not Jia Ru ethylparaben, benzoic acid, sorbic acid mixing, it is stirring while adding, be respectively prepared containing 0.05%, 0.10%, 0.20%
The mixture of ethylparaben, benzoic acid, sorbic acid, tests by microbial limit tests, when bacterial population is more than 100
Microorganism limitation is no longer carried out when a/mL (going mouldy) to check.The results are shown in table below for anti-corrosion effect observation (bacteria colony count, a/
mL)：
The result shows that：The anti-fatigue fluid mixture of 0.10% benzoic acid, which is added, can ensure that 2 years mixture do not go mouldy.Therefore determine this
The preservative of mixture is 0.10% benzoic acid.
One, assay and stability
1, character
Mixture of the present invention is yellowish-brown supernatant liquid, and taste is slightly sweet.
2, thin-layered chromatography Qualitive test
Because the monarch drug in a prescription of mixture of the present invention is rhodiola root and Radix Codonopsis, so being carried out to rhodiola root, Radix Codonopsis using thin-layered chromatography
Qualitive test can reflect mixture content to a certain extent.
Rhodiola root：Rhodioside reference substance is taken, adds methanol that the solution of 1mg/ml is made, as a contrast product solution.Take red scape
Its control medicinal material 2g adds methanol 30mL, is ultrasonically treated 1h, 3500 revs/min of centrifugation 15min, taking supernatant, medicinal material is molten as a contrast
Liquid；The oral solution of rhodiola root will be free of in the prescription of preparation as negative control solution.This product is test solution.According to thin layer color
Spectrometry (Chinese Pharmacopoeia, 1995 editions annex VIB) is tested.Reference substance solution 2 μ L, other each 10 μ L of solution are drawn, respectively point
In on same polyamide film, with isopropanol-methanol-formic acid (9:1:0.5) solution is solvent, and expansion is dried, set ultraviolet
It is inspected under light lamp (254nm).
As a result：The spot and R f value of spot and reference substance solution in control medicinal material solution is corresponding, illustrates have in test sample
The spot of rhodioside ingredient, test solution is corresponding with the control spot and R f value of material solution, illustrates there is red scape in test sample
Its glycosides ingredient, and with aubergine spot that same color is shown on reference substance corresponding position and negative sample liquid is noiseless.
Radix Codonopsis：Radix Codonopsis control medicinal material 2g is taken, methanol 10mL is added, is ultrasonically treated 1h, 3500 revs/min of centrifugation 15min take supernatant
Liquid medicinal material solution as a contrast；The oral solution of Radix Codonopsis will be free of in the prescription of preparation as negative control solution.This product is for examination
Product solution.It is tested according to thin-layered chromatography (Chinese Pharmacopoeia, 2005 editions annex VIB), draws reference substance solution 2 μ L, Qi Tarong
Each 10 μ L of liquid are put respectively on same polyamide film, with isopropanol-methanol-formic acid (9:1:0.5) solution is solvent,
Expansion is dried, and is set and is inspected under ultraviolet lamp (254nm).
As a result：The spot and R f value of spot and reference substance solution in control medicinal material solution is corresponding, illustrates have in test sample
The spot of Radix Codonopsis ingredient, test solution is corresponding with the control spot and R f value of material solution, illustrates there is Radix Codonopsis ingredient in test sample,
And with aubergine spot that same color is shown on reference substance corresponding position and negative sample liquid is noiseless.
3, high performance liquid chromatography quantitative analysis
Rhodiola root, Radix Codonopsis are monarch drug in a prescription in mixture of the present invention, therefore the assay of rhodioside can be used as anti-fatigue traditional Chinese conjunction
One of the quantitative target of agent quality standard.Using high performance liquid chromatography, Determination of Salidroside in finished product is measured, is prepared from 6 parts
Test solution respectively takes 10 μ L, is measured respectively.
*：P<0.05, difference is statistically significant.
Each group rhodioside, Radix Codonopsis content difference are not statistically significant (P > 0.05).Illustrate in this product rhodioside and
Radix Codonopsis stable content, to reflect the quality stability of mixture of the present invention.
4, property measures
1) relative density determination
Three batches of mixture (lot number) of the present invention are taken respectively, according to《Pharmacopoeia of People's Republic of China》The one annex IJ of version in 2015
[relative density] and VII A relative density determinations method of annex (bottle method (2) method) regulation measure its relative density under mixture item.
The specific gravity bottle for taking clean, dry and accurately weighed weight respectively is separately filled with three batches of mixture test sample (temperature of the present invention
Degree should be less than 20 DEG C) after, there is the bottle stopper of pore at insertion center, dries the liquid overflowed from consent with filter paper, sets 20 DEG C of perseverances
In tepidarium, places five minutes, the liquid that bottle stopper top is overflowed is dried with filter paper at any time, waits for that liquid is no longer overflowed by consent,
Specific gravity bottle is taken out from water-bath immediately, will be cleaned outside specific gravity bottle with filter paper, it is accurately weighed, the weight of specific gravity bottle is subtracted,
Up to the weight of test sample.Test sample is inclined, specific gravity bottle is cleaned, the new cold water boiled is filled, same temperature is measured according to upper method
The weight of Shi Shui, be calculated by formula the relative density of test sample to get.
| Lot number | 171114 | 171115 | 171116 |
| Relative density | 1.012 | 1.013 | 1.012 |
*：P<0.05, difference is statistically significant.
The results show that the relative density of mixture test sample of the present invention is not less than 1.01, difference is not statistically significant (P >
0.05).Illustrate that this product relative density is stablized, not time to time change.
2) pH is measured
The mixture test sample of the present invention for taking three batches of different lot numbers respectively, respectively takes 10ml, shines《Pharmacopoeia of People's Republic of China》
One annex of version in 2015, VII GpH value measuring methods are measured.
| Lot number | 171114 | 171115 | 171116 |
| PH value | 7.3 | 7.5 | 7.4 |
*：P<0.05, difference is statistically significant.
The results show that the pH value of mixture test sample of the present invention, between 7-8, difference is not statistically significant (P > 0.05).
Illustrate this product pH stable, not time to time change.
3) microbial limit
According to《Chinese Pharmacopoeia》The method of 2015 editions four general rules 1105, it is inoculation escherichia coli, staphylococcus aureus, withered
In the fresh cultured object of careless bacillus and pseudomonas aeruginosa to pancreas junket soya peptone fluid nutrient medium, 35 DEG C of cultures 18~24 are set
Hour；It is inoculated in the fresh cultured object to Sabouraud dextrose fluid nutrient medium of Candida albicans, sets 25 DEG C and cultivate 2~3 days.It is above-mentioned
Bacteria suspensions of every 1ml containing bacterium number no more than 100cfu is made with 0.9% aseptic sodium chloride solution in culture.Inoculated aspergillus niger it is new
In fresh culture to Sabouraud's dextrose agar slant medium, sets 25 DEG C and cultivate 5~7 days, add 0.9% aseptic sodium chloride solution 3
~5ml, spore is eluted；Spore suspension is sucked out, is filtered with the funnel for being lined with absorbent cotton, removes mycelia, collect spore suspension extremely
It is used as bacterium stoste in another sterile test tube, every 1ml is made containing spore count no more than 100cfu's with 0.9% aseptic sodium chloride solution
Spore suspension.
Above-mentioned 6 kinds of bacterium solutions are seeded on corresponding culture medium (each bacterium solution is inoculated with 2 plates) respectively, escherichia coli,
Staphylococcus aureus, bacillus subtilis and pseudomonas aeruginosa are cultivated 2 days in 35 DEG C；Candida albicans, aspergillus niger are in 25
DEG C culture 3 days.Bacterium colony technical result (taking 2 plate count mean values) see the table below：
Mixture 10ml of the present invention is taken, pH7.0 sterile NaCls-peptone buffer agent to 100mL, mixing is added to be made 1:10
Test liquid.
Test liquid 1ml and the test organisms no more than 100cfu are taken, is set in same plate, same medium is injected, mixing is solidifying
Gu being inverted culture.Every plant of test organisms 2 plates of parallel preparation.The test liquid prepared is taken, replaces bacterium solution with experiment with dilution
Group operation.The test organisms no more than 100cfu is taken, is tested by test group operation.Defined time and temperature are pressed respectively by three groups
Degree culture.Verification result is as follows：
As a result show that in 50%~200% range, it is micro- to show that the method can be used for this herb mixture for the rate of recovery of 5 kinds of bacterium
The counting of biology.
Test liquid 1ml and the escherichia coli no more than 100cfu is taken to be inoculated in 90ml fluid nutrient mediums, mixing, 35 DEG C
Culture 18 hours.As a result escherichia coli grows fine, and shows that the method is suitable for the control bacterium inspection of this product.
According to above-mentioned experimental result, according to《Chinese Pharmacopoeia》Four general rules 1105 of version in 2015 carry out mixture of the present invention micro-
Biological limit test, aerobic bacteria, yeast and mold inspection use Plating；Bacterium escherichia coli inspection is compareed using conventional
Method.According to regulation, per in 1ml anti-fatigue fluid mixtures, aerobic bacteria sum must not cross 100cfu, and yeast and mold sum must not mistake
10cfu, escherichia coli must not detect.As a result as follows：
| Group | Need bacterium total | Yeast and mold sum | Escherichia coli |
| 1 | It is not detected | It is not detected | It is not detected |
| 2 | It is not detected | It is not detected | It is not detected |
| 3 | It is not detected | It is not detected | It is not detected |
| 4 | It is not detected | It is not detected | It is not detected |
*：P<0.05, difference is statistically significant.
The results show that mixture test liquid content of microorganisms of the present invention meets《Chinese Pharmacopoeia》Standard.
5, the stability of drug
1) temperature influences experiment
Mixture of the present invention is randomly divided into 3 groups, every group 10, respectively by three combination agents place temperature be 0 DEG C, 25 DEG C, 50
DEG C constant incubator in, take 2 mixture to be detected for every group at random in 0d, 10d, 20d same time, record face shaping,
The situation of change of clarity, pH value, microbial limit and rhodioside.
Data are analyzed with SPSS23.0 statistical softwares, normal state measurement data mean ± standard deviationIt indicates, uses
T is examined；Enumeration data uses χ2Compare, P<0.05 thinks statistically significant.
*：In group relatively, P<0.05, difference is statistically significant.
It preserves for a long time at normal temperatures, this product character, relative density, pH value, active constituent content and early results do not have
Significant difference (P > 0.05).Mixture of the present invention suitable for room temperature preserve, temperature increase, mixture stability (character, relative density,
PH value, active constituent content) decline with resting period extension.
2) illumination effect is tested
Mixture of the present invention is first randomly divided into 3 groups, the placement illumination of three combination agents is respectively 200W, 100W by every group 10,
20d under the conditions of 0W (being protected from light) takes 2 mixture to be detected for every group at random in 0d, 10d, 20d same time, record face shaping,
The situation of change of clarity, pH value, microbial limit and rhodioside.
Data are analyzed with SPSS23.0 statistical softwares, normal state measurement data mean ± standard deviationIt indicates, using t
It examines；Enumeration data uses χ2Compare, P<0.05 thinks statistically significant.
*：In group relatively, P<0.05, difference is statistically significant.
It preserves for a long time under low lighting conditions, this product character, relative density, pH value, active constituent content and initially knot
Fruit does not have significant difference (P > 0.05).The result shows that mixture of the present invention is preferably kept in dark place, illumination enhancing increases, and mixture is stablized
Property (character, relative density, pH value, active constituent content) with the resting period extend decline.
3) accelerated test
It is 40 ± 2 DEG C that mixture of the present invention, which is first placed on temperature, and the constant temperature and humidity that relative humidity is 70% ± 10% is stablized
It is observed in case.It took 2 mixture to be detected at random at 0,1,2,3,6,9,12,15,18,21,24,27,30 month respectively, remembers
Shape, the situation of change of relative density, pH value and rhodioside are recorded,
Data are analyzed with SPSS23.0 statistical softwares, normal state measurement data mean ± standard deviationIt indicates, uses
T is examined；Enumeration data uses χ2Compare, P<0.05 thinks statistically significant.
*：P<0.05, difference is statistically significant.
Be 40 ± 2 DEG C in temperature, under the conditions of relative humidity is 70% ± 10% the short period preserve, it is this product character, opposite
Density, pH value, active constituent content and early results do not have significant difference, but a time lengthening, this product stability indicator with most
First result difference has statistical significance (P<0.05).
See whether meet examination criteria when measuring the microbial limit of oral solution, the final correlation according to accelerated test is wanted
The shelf-life of oral solution can be set to 2 years by summation feature.
Two, safety
1, acute toxicity testing --- median lethal dose
1) animal packet and processing
80 (20 ± 2) g males of health are tested and are randomly divided into eight dosage groups with mouse, according to 1：1.5 etc. compare grade
Number sets 1.0,1.5,2.25,3.375,5.063,7.594,11.391ml/kg seven dosage groups and a blank control
Group.
2) test method
8h stops feeding feed stuff before gavage, but can be calculated by its weight with normal water, the dosage of each mouse
It obtains, is returned daily to mouse perfusion one with metal gastric perfusion needle.The mouse of control group is without gavage, but normal feeding.Each group
It is observed continuously 7 days after mouse administration, carefully the state of mind of mouse, dietary amount and amount of drinking water, activity condition, and the dead of mouse
Die number to record, if there is poisoning symptom also to record, dissect all mouse at the end of experiment, visually observe the subcutaneous, heart,
Liver, spleen, lung, kidney and gastro-intestinal tract organs.
Data are analyzed with SPSS23.0 statistical softwares, normal state measurement data mean ± standard deviationIt indicates, uses
T is examined；Enumeration data uses χ2Compare, P<0.05 thinks statistically significant.
3) result
*：P<0.05, difference is statistically significant.
By 7 days be observed continuously, the mouse for gavaging drug all survived, mental status, diet and drink between eight groups of mouse
Water, activity condition are without significant difference (P > 0.05), when off-test, dissect mouse, visually observe the subcutaneous, heart, liver, spleen,
Lung, kidney and gastro-intestinal tract organs are showed no obvious abnormalities.
2, acute toxicity testing --- maximum dosage-feeding method
1) animal packet and processing
20 (20 ± 2) g males experiment of health is randomly divided into maximum dose group and control group with mouse, maximum dose with
40.0ml/kg/d gavage anti-fatigue traditional Chinese mixture, Normal group is with isometric physiological saline gavage, successive administration 7 days.
2) test method
It is interior for 24 hours to be administered 3 times by maximum administration concentration, maximum administered volume anti-fatigue traditional Chinese mixture gavage after fasting 8h,
Control group gives same volume physiological saline.Successive administration 7 days observes the state of mind, dietary amount and amount of drinking water, the activity feelings of mouse
Condition observes the organs such as the subcutaneous, heart, liver, spleen, lung, kidney and gastrointestinal tract after execution.
Data are analyzed with SPSS23.0 statistical softwares, normal state measurement data mean ± standard deviationIt indicates, uses
T is examined；Enumeration data uses χ2Compare, P<0.05 thinks statistically significant.
3) result
| Group | Number of mice (n) | Dosage (ml/kg/d) | Death toll (only) | The death rate (%) |
| Experimental group | 10 | 40.0 | 0 | 0 |
| Control group | 10 | 0.0 | 0 | 0 |
*：P<0.05, difference is statistically significant.
After 40.0ml/kg/d anti-fatigue fluid mixture gavages, by observation in 7 days, no dead mouse, the spiritual shape of mouse
State, dietary amount and amount of drinking water, activity condition are normal, dissect mouse, observe the subcutaneous, heart, liver, spleen, lung, kidney and gastrointestinal tract not
See apparent exception.Show that mouse is 40mL/kg/d or more to the maximal tolerance dose of mixture of the present invention.
According to humans and animals (mouse) dose lonvestion, the maximum anti-fatigue fluid mixture amount of drinking is 1L, daily drink to adult daily
It is the dosage that is perfectly safe with dosage.
3, long term toxicity test
1) animal packet and processing
40 (20 ± 2) g males of health are tested and are randomly divided into four dosage groups with mouse：Normal group, height, in,
Low dosage administration group.High, medium and low dosage administration group presses 5.0,2.5,1.25ml/kg/d gavage mixture of the present invention respectively, normal right
According to group with isometric physiological saline gavage, successive administration 9 weeks.
2) test method
8h stops feeding feed stuff before gavage, but can be calculated by its weight with normal water, the dosage of each mouse
It obtains, put to death animal, eye socket takes 10 μ L to carry out blood routine examination, and abdominal aorta blood sampling detaches serum with 3500r/min, 10min
Carry out biochemical indicator detection：Aspartate amino transferase (AST), alanine aminotransferase (ALT), alkaline phosphatase
(ALP), total bilirubin (TBIL), total cholesterol (TC), total triglycerides (TG), total protein (TP), albumin (ALB), highly dense
Spend lipoprotein (HDL), low-density lipoprotein (LDL), urea nitrogen (BUN) kit, creatinine (Cr), creatine kinase (CK), grape
Sugared (Glu).Solution takes liver, the heart, spleen, kidney, brain, thymus gland, adrenal gland, genitals, visually observes its form.
Data are analyzed with SPSS23.0 statistical softwares, normal state measurement data mean ± standard deviationIt indicates, uses
T is examined；Enumeration data uses χ2Compare, P<0.05 thinks statistically significant.
3) result
*：P<0.05, difference is statistically significant.
After mouse is handled 9 weeks by the administration of high, medium and low dosage respectively, body weight increase is compared with Normal group without significant difference
(P > 0.05).Show Mixture on Mice weight of the present invention without obvious effect.
*：P<0.05, difference is statistically significant.
After mouse is handled 9 weeks by the administration of high, medium and low dosage respectively, white blood cell count(WBC) is substantially reduced compared with Normal group
(P<0.05), and red blood cell count(RBC), hemoglobin, platelet count, lymphocyte, monocyte, neutrophil count are equal
Without significant difference (P > 0.05).Show that Mixture on Mice of the present invention has anti-inflammatory effect, and this effect to be formed independent of other
The change divided.
*：P<0.05, difference is statistically significant.
High dose administration handles 9 weeks mice serum total cholesterols (TC) compared with Normal group apparent increase, and higher than just
Ordinary water is flat, significant difference (P<0.05)
Three, pharmacodynamics
1, experimental animal grouping and administering mode method
Male mice 60, weight (20 ± 2) g is taken to be randomly divided into 4 groups by weight：Normal group, high, medium and low dosage
Administration group.High, medium and low dosage administration group respectively press 5.0,2.5,1.25ml/kg/d gavage mixture of the present invention, Normal group with
Isometric physiological saline gavage, successive administration 10 days.
2, reagent
Anti-fatigue traditional Chinese mixture of the present invention；Liver glycogen/Body development kit；Full blood lactic (LD) kit；Lactic dehydrogenase
Enzyme (LDH) kit；Blood urea nitrogen (BUN) kit；Superoxide dismutase (SOD) kit.
3, method
Successive administration 10d, after 30min after the last administration weighs to every mouse, mouse weight 10% is born in rat-tail root
Sheet lead to be placed in water temperature be 25 DEG C, the swimming trunk went swimming 3min of depth of water 25cm, plucking eyeball after 5min takes blood.
0.1ml whole bloods are taken, the processed centrifuge tube of heparin sodium is placed in, the protein precipitant in whole blood LD kits is added,
Stand 10min, 3 500r/min.8min is centrifuged, supernatant is taken to be detected again with whole blood LD kits.
Remaining whole blood is placed in the processed centrifuge tube of heparin sodium, and 3 500r/min centrifuge 8min, detaches serum, with SOD,
LDH detects 3 kinds of biochemical indicators in serum respectively with BUN kits.
The mouse of execution takes liver and hindlimb muscle immediately, is placed in frost physiological saline, rejects connective tissue, use filter paper
It blots, liver glycogen and Body development content is measured with Body development and liver glycogen assay kit.
Data are analyzed with SPSS23.0 statistical softwares, normal state measurement data mean ± standard deviationIt indicates, uses
T is examined；Enumeration data uses χ2Compare, P<0.05 thinks statistically significant.
4, result
*：P<0.05, difference is statistically significant
Mouse respectively by basic, normal, high dosage administration processing 10 days after, lactic acid (LD), urea nitrogen (BUN) calibration in serum
Normal control group is substantially reduced (P<0.05), SOD, lactic dehydrogenase (LDH), muscle glycogen are increased significantly (P compared with control group<
0.05), middle and high dosage administration group hepatic glycogen is increased significantly (P compared with control group<0.05), low dosage administration group hepatic glycogen is more right
According to the not statistically significant (P of group difference>0.05), but still there is raising trend.
The result shows that mixture of the present invention is improved phosphagen system, reduces lactic acid concn, increases glycogen deposit, protection liver kidney
Function, and act on dosage increase and change, low dosage administration i.e. can reach more satisfactory effect.
Four, it summarizes
According to humans and animals (mouse) dose lonvestion, the daily maximum mixture amount of drinking of the present invention of adult is 1L, daily drink
It is the dosage that is perfectly safe with dosage, from economical and effective angle, recommends one bottle of 250ml, the day for human beings amount of drinking of growing up is
500ml.This mixture is suitble to be protected from light room temperature preservation, and the shelf-life is 2 years.
Mixture of the present invention has positive effect in range of doses for improving energy, exercise tolerance, resisting fatigue, because
This reply mixture prescription and the stringent control of production process, can be directed to the diversified demand in market, and exploitation is directed to different crowd
New beverage.
Claims (5)
1. a kind of anti-fatigue traditional Chinese mixture for being conducive to refresh the mind, which is characterized in that each Chinese medicine including following parts by weight
Raw material is made：9-10 parts of rhodiola root, 9-10 parts of Radix Codonopsis, 7-9 parts of ganoderma lucidum, 6-8 parts of Radix Astragali, 5-6 parts of Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis 5-6 part, the five tastes
3-4 parts sub-, 3-5 parts of Herba Cistanches, 3-4 parts of turtle shell, 2-3 parts of Chinese yam, 1-2 parts of ginseng, 1-2 parts of ginkgo.
2. the preparation method as described in claim 1 for being conducive to the anti-fatigue traditional Chinese mixture to refresh the mind, which is characterized in that packet
Include following steps：1）Each Chinese medicine material prepared in proportion is sequentially placed into Chinese medicine extracting tank, the boiling boiling of 8 times of amounts is added,
Change after being boiled by fire and be cooked by slow fire 1h, stands, pour out liquid；2）The boiling for adding 3 times of amounts, is cooked by slow fire 0.5h, stands, pours out medicine
Liquid；3）The boiling for continuously adding 3 times of amounts, is cooked by slow fire 0.5h, stands, pours out liquid；4）The liquid poured out three times is merged, is pressed
0.1% chitin is added in 10% ratio, stands overnight after precipitation, then centrifuges liquid under conditions of centrifugal force 3000g
10min is stood, and takes supernatant, water lift concentration, sterilizing, 4 DEG C of preservations.
3. the preparation method of the anti-fatigue traditional Chinese mixture according to claim 2 for being conducive to refresh the mind, it is characterised in that：
Step 4）In, after liquid concentration, corrigent and preservative is added.
4. the preparation method of the anti-fatigue traditional Chinese mixture according to claim 3 for being conducive to refresh the mind, it is characterised in that：
It is 0.5% of liquid gross mass after concentrating that corrigent, which uses Aspartame, addition,；It is dense that preservative, which uses benzoic acid, addition,
The 0.1% of liquid gross mass after contracting.
5. the preparation method of the anti-fatigue traditional Chinese mixture according to claim 2 for being conducive to refresh the mind, it is characterised in that：
Step 4）In, when water lift concentrates, it can be completed after liquid proportion reaches 1.5 and be concentrated to give concentrated medicament.
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