CN104491310B - Anti-Fatigue Composition and its preparation method and application - Google Patents
Anti-Fatigue Composition and its preparation method and application Download PDFInfo
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- CN104491310B CN104491310B CN201410789238.7A CN201410789238A CN104491310B CN 104491310 B CN104491310 B CN 104491310B CN 201410789238 A CN201410789238 A CN 201410789238A CN 104491310 B CN104491310 B CN 104491310B
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- 210000004243 sweat Anatomy 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 150000003505 terpenes Chemical class 0.000 description 1
- 235000007586 terpenes Nutrition 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000035922 thirst Effects 0.000 description 1
- 230000001256 tonic effect Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 210000003932 urinary bladder Anatomy 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Classifications
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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)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/254—Acanthopanax or Eleutherococcus
-
- 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
- A61K36/06—Fungi, e.g. yeasts
- A61K36/062—Ascomycota
- A61K36/066—Clavicipitaceae
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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)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
- A61K36/638—Ligustrum, e.g. Chinese privet
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/738—Rosa (rose)
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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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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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 or decoction
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- 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
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Abstract
The invention discloses a kind of anti-Fatigue Composition and its preparation method and application, belong to pharmaceutical technology field.The active ingredient of said composition is prepared from by the raw material of following parts by weight：10.0 20.0 parts of wilsonii, 8.0 18.0 parts of Cordyceps militaris, 5.0 23.0 parts of Chinese yam, 3.0 10.0 parts of the fruit of Cherokee rose, 3.0 10.0 parts of the fruit of glossy privet.Wilsonii, Cordyceps militaris, Chinese yam, the fruit of Cherokee rose, the fruit of glossy privet are engaged by the anti-Fatigue Composition, with Cordyceps militaris kidney-nourishing tonifying lung, mend marrow, the congenital gas of main benefit, is monarch drug in a prescription；Replenished qi to invigorate the spleen, tonified the kidney to relieve mental strain with wilsonii, the main gas for mending the day after tomorrow, is ministerial drug；With Chinese yam supplementing qi and nourishing yin, the fruit of glossy privet tonifies the liver and kidney, and is altogether adjutant；With fruit of Cherokee rose reinforcing the kidney and controlling nocturnal emission, mediation property of medicine is to make medicine.This several raw material cooperates, and synergy, work plays antifatigue effect.
Description
Technical field
The present invention relates to pharmaceutical technology field, more particularly to a kind of anti-Fatigue Composition and its preparation method and application.
Background technology
With the quickening of social life rhythm, modern is chronically under the big environment of work strain, competitive pressure, is caused
Emotional instability, is easy to produce fatigue, is absorbed in sub-health state.
Fatigue is divided into two kinds of physiologic fatigability and pathological fatigue.Wherein：Physiologic fatigability can be by normally resting
It is eased, and pathological fatigue then can not effectively be alleviated by rest, severely impact daily live and work, be
The very big hidden danger of human health, it is necessary to give and treat by methods such as medicine or psychotherapies.
If tired cannot alleviate for a long time, chronic fatigue syndrome will be developed into, serious even results in sudden death,
Its typical case's sudden death symptom is " overworking death ".Epidemiology survey is shown：Fatigue is mainly in a middle-aged person of middle higher education degree
Group, it is especially in the majority with women, and have the trend towards Young Patients developmenting spread, have become the master of 21 century threat human health
Want one of hidden danger.
At present, clinically belong to the chemical drugs of central nervous excitation agent mostly for antifatigue medicine, with additive and
Dependence, significantly limit its clinical practice.Therefore, exploitation has anti-fatigue effect and the pure natural health-care having no toxic side effect
Food has particularly important realistic meaning and social effect.
The content of the invention
Based on this, it is an object of the invention to the defect for overcoming prior art, there is provided a kind of anti-Fatigue Composition, the combination
Thing has good antifatigue effect, and is made up of entirely natural component, with without additive and dependence, Small side effects it is excellent
Point.
To achieve the above object, the present invention takes following technical scheme：
A kind of anti-Fatigue Composition, the active ingredient of the composition is prepared from by the raw material of following parts by weight：
10.0-20.0 parts of wilsonii, 8.0-18.0 parts of Cordyceps militaris, 5.0-23.0 parts of Chinese yam, 3.0-10.0 parts of the fruit of Cherokee rose, female
Loyal sub- 3.0-10.0 parts.
The anti-Fatigue Composition of the present invention, using traditional Chinese medical theory as guidance, it is believed that the appearance of fatigue phenomenon, the mistake with the five internal organs
Tune has close relationship, and such as weakness of limbs is how relevant with taste, and waist soreness is how relevant with kidney, and short wind is more to be had with lungs
Close, insobriety is how relevant with heart, endurance is not how relevant with liver.The whole vital movement of people, relies in " vigour ", member entirely
Gas natural endowment is nourished in the day after tomorrow (taste) in congenital (kidney), is the source of body energy, and the combination of vigour and different organs is produced
Different functions, therefore, vigour weakness can cause each function holddown at a low ebb of people, and this is also the root that fatigue is produced
This reason.Therefore, help the five internal organs are not only wanted in the treatment for fatigue, can not ignore the supplement to " gas ".
On the basis of the studies above, wilsonii, Cordyceps militaris, Chinese yam, the fruit of Cherokee rose, the fruit of glossy privet are engaged in the present invention, with
Kidney-nourishing tonifying lung, strengthening the spleen and replenishing qi is therapy, and compatibility of drugs is carried out according to the principles of formulating prescriptions of monarch.Cordyceps militaris kidney-nourishing is mended in side
Lung, mends marrow, and the congenital gas of main benefit is monarch drug in a prescription；Wilsonii replenishes qi to invigorate the spleen, and tonifies the kidney to relieve mental strain, and the main gas for mending the day after tomorrow is ministerial drug；Chinese yam
Supplementing qi and nourishing yin, the fruit of glossy privet tonifies the liver and kidney as adjutant；Fruit of Cherokee rose reinforcing the kidney and controlling nocturnal emission, mediation property of medicine is to make medicine.This several raw material phase interworking
Close, synergy, work plays antifatigue effect.
Fang Zhong：Cordyceps militaris (belongs to Hypocreales, Clavicipitaceae, Cordyceps, also known as northern Chinese caterpillar Fungus), sweet, mild-natured, returns
Kidney, lung channel.With kidney-nourishing tonifying lung, marrow, effect of hemostasis and phlegm are mended.For impotence and seminal emission, chronic cough and dyspnea of deficiency type, overstrain cough phlegm blood.Pupa
The main component of cordyceps sinensis includes ucleosides, polysaccharide, sugar alcohol and sterols material.Modern pharmacology research shows that Cordyceps militaris can
Promote cellular immunity and suppress humoral immunity, and promote marrow hemopoietic stem cells (CFU-3), CFU-E (CFU-E BFU-
E) and marrow fibroblast colony forming unit (CFU-E) propagation, while also Andrin-like action.We are using Cordyceps militaris as monarch
Medicine, it is intended to play its kidney-nourishing tonifying lung, mends the effect of marrow, and nourshing kidney essence is to mend the congenital foundation, and beneficial lung qi is with up to the work(of a surname's drop.
Wilsonii (belongs to Umbellales, Araliaceae, Acanthopanax), and pungent, slight bitter is warm-natured, returns spleen, kidney, the heart channel of Hang-Shaoyin.With QI invigorating
Invigorating the spleen, the effect of tonifying the kidney to relieve mental strain.It is physically weak weak for the insufficiency of both the spleen and the kindey, poor appetite, soreness of waist and knee joint, insomnia and dreamful sleep.Modern medicine
Research shows that the main component of wilsonii --- eleutheroside has similar effect to ginseng, can stimulate mind ＆ body
Vigor, increase endurance, agility and learning ability extend rat load swimming time, and mouse rope climbing experiment and movable energy
The result of amount demonstrates the antifatigue effect of eleutheroside.We play its nourishing replenished qi to invigorate the spleen using wilsonii as ministerial drug
While the gas effect of the day after tomorrow, with body recovery function after the improved effect patient motion tonified the kidney to relieve mental strain.
Chinese yam (being Dioscoreaceae plant Chinese yam Dioscorea opposita Thunb. dry rhizome), it is sweet, it is mild-natured,
Returns spleen, lung, kidney channel.With supplementing qi and nourishing yin, help spleen and lung, the effect of invigorating the kidney and stopping nocturnal emission.For spleen eating less, diarrhea with loose stool, the deficiency syndrome of the lung
Cough and asthma, frequent micturition of passing out semen, the deficiency of Yin is quenched one's thirst.Modern pharmacy research shows, Chinese yam contain a variety of mucins, amylase, saponin(e, polysaccharide and
Dietary fiber, it is aid digestion with reducing blood lipid, strengthen the effect of immunologic function.
The fruit of glossy privet (being Oleaceae plants glossy privet Ligustrum lucidum Ait. dry mature fruit), sweet, hardship,
It is cool in nature.Return liver and kidney channel.With tonifying the liver and kidney, improving eyesight, effect of clearind deficient heat.For having a dizzy spell, poliosis, blurring of vision,
Fever due to yin deficiency.The main composition of the fruit of glossy privet is the materials, wherein oleanolic acid and glossy privet such as terpene, glycosides, organic acid and polysaccharide
Sub- polysaccharide is the main component that the fruit of glossy privet adjusts body's immunity.
Using Chinese yam and the fruit of glossy privet as adjutant in the present invention, it is intended to helped while aiding in all gas of building up one's health by taking tonic of the monarch and his subjects to act on Chinese yam
The tonifying liver heat-clearing of yin-nourishing controlling nocturnal emission with astringent drugs and the fruit of glossy privet, reaches reinforcing both QI and YIN, the purpose of controlling nocturnal emission with astringent drugs soothing the liver.
The fruit of Cherokee rose (belongs to Rosales, the rose family, Rosa), sweet, slightly sour, puckery, mild-natured, returns kidney, bladder, large intestine channel.
With reinforcing the kidney and controlling nocturnal emission, effect of reducing urination and antidiarrheal.For involuntary emission, the enuresis, frequent urination, insufficiency of the spleen rush down dysentery, the deficiency syndrome of the lung is breathed with cough, and spontaneous perspiration is stolen
Under sweat, uterine bleeding band.Using the fruit of Cherokee rose as medicine is made in side, while the effect of its reinforcing the kidney and controlling nocturnal emission is played, the spy of its mild in medicine property sum is utilized
The more than point mediation property of medicine of all medicines.
Aforementioned pharmaceutical compositions take into account the gas of congenital gas and the day after tomorrow using fatigue-relieving as target, and based on tonifying Qi, with
And the main organs such as kidney,spleen,liver, lung, with compatibility rationally, the characteristics of scientific formula, also with kidney-nourishing tonifying lung, strengthening the spleen and replenishing qi it
Effect.
In one of the embodiments, the active ingredient of the composition is prepared from by the raw material of following parts by weight：Thorn
13-17 parts of slender acanthopanax, 10-14 parts of Cordyceps militaris, 6-10 parts of Chinese yam, 2-5 parts of the fruit of Cherokee rose, 4-7 parts of the fruit of glossy privet.
The invention also discloses a kind of preparation method of above-mentioned anti-Fatigue Composition, comprise the following steps：By weight
Wilsonii, Cordyceps militaris, Chinese yam, the fruit of Cherokee rose and the fruit of glossy privet are weighed, crushed after being dried, mixing is produced.
The invention also discloses a kind of preparation method of above-mentioned anti-Fatigue Composition, comprise the following steps：By weight
Wilsonii and the fruit of glossy privet are weighed, the ethanol that 10~20ml concentration expressed in percentage by volumes are 35-65%, 60-80 DEG C are added according to 1g raw materials
Lower to extract 1-3 times, 1~2h, dries to obtain dry extract one every time；Cordyceps militaris, Chinese yam and the fruit of Cherokee rose are separately weighed by weight, according to 1g
Raw material is added at 10~20ml water, 70-90 DEG C and extracted 1-3 times, and 1~2h, dries to obtain dry extract two every time；By above-mentioned dry extract
One and dry extract two it is well mixed, produce.
The invention also discloses a kind of antifatigue preparation, including as the above-mentioned anti-Fatigue Composition of active component,
And pharmaceutically acceptable carrier.The anti-Fatigue Composition can be prepared according to the conventional production process of pharmaceutical field, for example
Active component is mixed with one or more carriers, be then made into required formulation.
In one of the embodiments, the formulation of the antifatigue preparation is oral disintegrating tablet, including following component：
The oral disintegrating tablet that anti-Fatigue Composition is constructed to be disintegrated rapidly in the oral cavity, part active ingredient can be through sublingual mucosa
Absorb, reach the purpose of rapid-onset；Remainder is dispersed into trickle particle before intestines and stomach are reached, therefore in stomach
Enteron aisle large area is distributed, and absorbs point and increases, bioavilability is high.
In one of the embodiments, the filler be microcrystalline cellulose, lactose starch, lactose, pre-paying starch and
At least one of mannitol；The disintegrant is low substituent hydroxypropyl methylcellulose, PVPP, friendship
Join at least one of sodium carboxymethyl starch and Ac-Di-Sol；The effervescent agent be sodium acid carbonate and tartaric acid,
Sodium acid carbonate and at least one set in citric acid, sodium acid carbonate and fumaric acid, sodium acid carbonate and vitamin C；The flavouring is
At least one of menthol, peppermint oil dementholized, lemon extract, honey element and Aspartame；The lubricant is magnesium stearate, ten
At least one of dialkyl group magnesium sulfate and talcum powder；The glidant is at least one of superfine silica gel powder, talcum powder.
The key for preparing oral disintegrating tablet is to select suitable auxiliary material, to ensure the good fluidity of particle, compressibility during tabletting
By force, after compacting disintegration of tablet speed is fast, additionally to ensure that obtained tablet is in good taste.
After the present invention is index screening with solubility property, tablet hardness, wetting time, water absorption etc., preferred microcrystalline cellulose
At least one of element, lactose starch, lactose, pre-paying starch and mannitol are used as filler.
After the present invention is using water-swelling property and rate of water absorption as index screening, preferably low substituent hydroxypropyl fiber
Plain (L-HPC), PVPP (PVPP), crosslinked carboxymethyl fecula sodium (CCMS-Na) and cross-linked carboxymethyl fiber
At least one of plain sodium (CMC-Na) is used as disintegrant.
The present invention by volunteer's taste test, sheltering after its micro bitter taste, preferably menthol, peppermint oil dementholized,
At least one of lemon extract, honey element and Aspartame are used as flavouring.
The invention also discloses a kind of preparation method of above-mentioned oral disintegrating tablet, comprise the following steps：Weigh by weight anti-
Tired composition, filler, disintegrant, effervescent agent, flavouring, lubricant and glidant, respectively cross 60-80 mesh sieves, in 40 DEG C-
60 DEG C of drying, then by anti-Fatigue Composition respectively with filler, disintegrant, effervescent agent and flavouring are mixed with equivalent method of progressively increasing
Uniformly, lubricant and glidant are added, is well mixed, direct powder compression is produced.
The invention also discloses a kind of preparation method of above-mentioned oral disintegrating tablet, comprise the following steps：Weigh by weight anti-
Tired composition, filler, disintegrant, effervescent agent, flavouring, lubricant and glidant, respectively cross 60-80 mesh sieves, in 40 DEG C-
60 DEG C of drying, then by anti-Fatigue Composition respectively with filler, disintegrant, effervescent agent and flavouring are mixed with equivalent method of progressively increasing
Uniformly, polyvinylpyrrolidone (PVP) ethanol solution, wet granulation, by obtained wet granular at 30 DEG C~50 DEG C are added
Drying, whole grain adds lubricant and glidant, is well mixed, and compacting is produced.
Compared with prior art, the invention has the advantages that：
The anti-Fatigue Composition of the present invention, by wilsonii, Cordyceps militaris, Chinese yam, the fruit of Cherokee rose, the fruit of glossy privet is engaged, with pupa worm
Careless kidney-nourishing tonifying lung, mends marrow, the congenital gas of main benefit, is monarch drug in a prescription；Replenished qi to invigorate the spleen, tonified the kidney to relieve mental strain with wilsonii, the main gas for mending the day after tomorrow,
For ministerial drug；With Chinese yam supplementing qi and nourishing yin, the fruit of glossy privet tonifies the liver and kidney, and is altogether adjutant；With fruit of Cherokee rose reinforcing the kidney and controlling nocturnal emission, mediation property of medicine is to make
Medicine.This several raw material cooperates, and synergy, work plays antifatigue effect.
Also,, can be by the trip of mouse with extraordinary antifatigue effect after each raw material is coordinated with specific ratio
Time lengthening of swimming is to 3.4 times, and serum urea nitrogen content reduces by 18.3%, and hepatic glycogen content improves 2.3 times, and can be by mouse
Lactic acid rise multiple reduction by 20.5% after motion, with extraordinary effect.
The antifatigue oral disintegrating tablet of the present invention, extra water delivery service is not needed when taking, saliva is only relied in oral cavity i.e.
Can rapidly it be disintegrated in 1 minute, the dissolution rate of active ingredient is more than 75% in oral disintegrating tablet in 25 minutes.Mucous membrane of mouth is not pierced
Swash property, in good taste, no feeling of grittiness is particularly suitable for high intensity brain worker and taken.
The oral disintegrating tablet of the present invention is formulated reasonable, mature preparation process, suitable for industrial-scale production.
Embodiment
Describe the present invention in detail below in conjunction with specific embodiment, but any limitation is not caused to the present invention.
Embodiment 1
A kind of anti-Fatigue Composition, the active ingredient of the composition is prepared from by the raw material of following parts by weight：
Wilsonii 15g, Cordyceps militaris 12g, Chinese yam 8g, fruit of Cherokee rose 3g, fruit of glossy privet 5g.
The above-mentioned specific preparation method of anti-Fatigue Composition is as follows：
Wilsonii and the fruit of glossy privet are weighed by recipe quantity, the amount for adding 10ml solvents according to 1g raw materials adds concentration expressed in percentage by volume
For 50% ethanol (i.e. 200ml), extracted 3 times at 70 DEG C, each 2h dries to obtain dry extract one；Separately pupa worm is weighed by recipe quantity
Grass, Chinese yam and the fruit of Cherokee rose, the amount for adding 10ml solvents according to 1g raw materials add extraction 3 times at water (i.e. 230ml), 80 DEG C, every time
1h, dries to obtain dry extract；Above-mentioned 2 kinds of dry extracts are well mixed and produce anti-Fatigue Composition A.
Embodiment 2
A kind of anti-Fatigue Composition, the active ingredient of the composition is prepared from by the raw material of following parts by weight：
Wilsonii 10g, Cordyceps militaris 18g, Chinese yam 5g, fruit of Cherokee rose 10g, fruit of glossy privet 3g.
The above-mentioned specific preparation method of anti-Fatigue Composition is as follows：
Wilsonii, Cordyceps militaris, Chinese yam, the fruit of Cherokee rose and the fruit of glossy privet are weighed by recipe quantity, crushed after being dried, mixing is produced anti-
Tired composition B.
Embodiment 3
A kind of anti-Fatigue Composition, the active ingredient of the composition is prepared from by the raw material of following parts by weight：
Wilsonii 20g, Cordyceps militaris 8g, Chinese yam 23g, fruit of Cherokee rose 3g, fruit of glossy privet 10g.
The above-mentioned specific preparation method of anti-Fatigue Composition prepares antifatigue group with reference to the preparation method in embodiment 1
Compound C.
Embodiment 4
A kind of antifatigue oral disintegrating tablet, prescription is as follows：
The oral disintegrating tablet preparation method of the present embodiment is as follows：
Precision weighs the anti-Fatigue Composition A of recipe quantity, microcrystalline cellulose, lactose starch, sodium acid carbonate, tartaric acid, friendship
Join polyvinylpyrrolidone, low substituent hydroxypropyl methylcellulose, superfine silica gel powder, lemon extract, honey element and magnesium stearate,
Cross 80 mesh sieves, in 45 DEG C drying, using equivalent progressively increase method be well mixed.
Above-mentioned direct powder compression is taken, oral disintegrating tablet X is made, average piece weighs about 250mg.
Embodiment 5
A kind of antifatigue oral disintegrating tablet, prescription is as follows：
The oral disintegrating tablet preparation method of the present embodiment is as follows：
Precision weighs the anti-Fatigue Composition B of recipe quantity, and mannitol, lactose starch, sodium acid carbonate, vitamin C, crosslinking are poly-
Vinylpyrrolidone, superfine silica gel powder, lemon extract, Aspartame and magnesium stearate, cross 60 mesh sieves, are dried in 60 DEG C, using etc.
Method of progressively increasing is measured to be well mixed.
Above-mentioned direct powder compression is taken, oral disintegrating tablet Y is made, average piece weighs about 400mg.
Embodiment 6
A kind of antifatigue oral disintegrating tablet, prescription is as follows：
The oral disintegrating tablet preparation method of the present embodiment is as follows：
Precision weighs the anti-Fatigue Composition C of recipe quantity, mannitol, microcrystalline cellulose, pregelatinized starch, sodium acid carbonate,
Fumaric acid, PVPP, Aspartame, in 40 DEG C of drying, cross 80 mesh sieves, and method mixing is progressively increased using equivalent
It is even.Pelletized with 2.0% PVP ethanols, 40 DEG C are dried, and lemon extract is sprayed into after whole grain, add magnesium stearate, tabletting is made
Oral disintegrating tablet Z, average piece weighs about 500mg.
Comparative example 1
This comparative example prepares a kind of composition, and the anti-Fatigue Composition with embodiment 1 is essentially identical, and difference is,
The composition of this comparative example is prepared from by the raw material of following parts by weight：
Wilsonii 15g, Chinese yam 8g, fruit of Cherokee rose 3g, fruit of glossy privet 5g.
Composition D is prepared with reference to the method for embodiment 1.
Comparative example 2
This comparative example prepares a kind of composition, and the anti-Fatigue Composition with embodiment 1 is essentially identical, and difference is,
The composition of this comparative example is prepared from by the raw material of following parts by weight：
Cordyceps militaris 12g, Chinese yam 8g, fruit of Cherokee rose 3g, fruit of glossy privet 5g.
Composition E is prepared with reference to the method for embodiment 1.
Comparative example 3
This comparative example prepares a kind of composition, and the anti-Fatigue Composition with embodiment 1 is essentially identical, and difference is,
The composition of this comparative example is prepared from by the raw material of following parts by weight：
Cordyceps militaris 15g, wilsonii 12g.
Composition F is prepared with reference to the method for embodiment 1.
Comparative example 4
This comparative example prepares a kind of composition, and the composition with embodiment 1 is essentially identical, and difference is, this contrast
The composition of example is prepared from by the raw material of following parts by weight：
Wilsonii 15g, saline cistanche 12g, Chinese yam 8g, fruit of Cherokee rose 3g, fruit of glossy privet 5g.
Composition G is prepared with reference to the method for embodiment 1.
Comparative example 5
This comparative example prepares a kind of composition, and the composition with embodiment 1 is essentially identical, and difference is, this contrast
The composition of example is prepared from by the raw material of following parts by weight：
Wilsonii 5g, Cordyceps militaris 5g, Chinese yam 25g, fruit of Cherokee rose 15g, fruit of glossy privet 15g.
Composition H is prepared with reference to the method for embodiment 1.
Experimental example 1
The above-mentioned composition A-H prepared is subjected to experimental verification, its effect is investigated.
1. experimental drug：Positive drug is Shengwujian Oral Liquid (source：Apollo Group Co., Ltd, 021D1), embodiment
Composition D-G prepared by composition A-C prepared by 1-3, comparative example 1-5.
2. experimental animal：The male BALB/C mice (2011-0004) provided from Jilin University's Experimental Animal Center, clearly
Clean animal, 18~22g of body weight is grouped at random by body weight.
3. experiment packet：Administration group is scaled to mouse dose,equivalent as administration using 9 multiple doses equivalent to human body recommended amounts
Dosage, i.e. 2.69mg/10g body weight, positive controls dosage be 0.03ml/10g, blank control group normal diet, continuously
Equivalent feeding tested material 30 days, determines indices.
4. laboratory apparatus：Swimming trunk, galvanized wire, electronic balance, ELIASA, ultraviolet-uisible spectrophotometer, centrifuge, homogenate
Device.
5. experimental method：
5.1 swimming test
After last gives mouse tested material 30 minutes, the galvanized wire of mouse weight 3% is born in mouse tail root, and it is 30 to be put into water temperature
DEG C, in depth of water 35cm swimming trunk.Water temperature is adjusted to 30 DEG C before water under per a collection of mouse.6 mouse are at most put into every time,
Record time for being exhausted to power from swim with stopwatch, the time for mouse swimming time.
5.2 serum urea nitrogen determinations
After last gives mouse tested material 30 minutes, mouse is put in the water went swimming 90 minutes of 30 DEG C of temperature, eyeball is plucked
Blood is taken, takes serum to determine its value.
5.3 hepatic glycogen are determined
After last gives mouse tested material 30 minutes, put to death immediately.Liver is taken to be blotted after being rinsed through physiological saline with filter paper,
It is accurate to weigh liver 200mg, 4mL 5% trichloroacetic acid (TCA) is added, often pipe is homogenized 1 minute, and homogenate is poured into centrifugation
Pipe, 3000 revs/min are centrifuged 15 minutes, and supernatant is transferred in another test tube.Add 4mL TCA again in precipitation, be homogenized 1 point
Clock, is centrifuged 15 minutes again, takes supernatant, and is merged with the supernatant of first time centrifugation, is fully mixed.1mL supernatants are taken to put
Enter in 10mL centrifuge tubes, often pipe adds 95% ethanol 4mL, fully mix and do not leave interface between two kinds of liquid.With clean plug
Son beyond the Great Wall, is stood overnight vertically at room temperature.After precipitation is complete, test tube is centrifuged 15 minutes in 3000 revs/min.Carefully outwell supernatant
Liquid simultaneously makes test tube handstand place 10 minutes.Glycogen is dissolved with 2mL distilled water, the glycogen of tube wall is washed down when adding water, is allowed to complete
Dissolving.
Test tube blank：2mL distilled water is inhaled to clean centrifuge tube.
Standard pipe：By 0.5mL glucose standards (glucose containing 100mg/dL) and 1.5mL distilled water be put into it is same from
Heart pipe.
Determine：10mL anthrone reagents are exerted oneself to add each pipe, liquid stream is directly entered pipe center, it is ensured that be sufficiently mixed.
Injecting anthrone reagent from pipe, pipe is put into cold water, reached after cold water temperature, boiling water bath is dipped in 15 minutes,
Then cold bath is moved on to, room temperature is cooled to.Liquid in pipe is moved into cuvette, 620nm wavelength is determined after being returned to zero with reagent blank
The absorbance of sample cell and standard pipe.Hepatic glycogen content (being represented with mg/g livers) is converted into according to liver weight.
5.4 blood lactase acids are determined
After last gives mouse tested material 30 minutes, 30 DEG C of water temperature, depth of water 35cm swimming trunk went swimming 10 minutes are put into
After take out, adopt the μ L of tail blood 20 at once, add in the test tube for filling 40 μ L hemolytic agents and mix, with bio-sensing analysis-e/or determining blood breast
Acid number.Blood lactase acid level when being determined before swimming and being rested 20 minutes after swimming using same method.
6. experimental result：Experimental data is subjected to statistical analysis.
Experimental result is as follows：
1) swimming test：As a result see following table.
Table 1：The mice burden swimming time experimental result ()
In from the above, it will be seen that 1-3 of embodiment of the present invention composition A-C, the swimming time of mouse is equal
It is longer than blank group, illustrates that said composition has antifatigue effect.And composition A can extend to the swimming time of mouse
3.4 times, with extraordinary effect.
Though comparative example 1-5 composition D-H mouse swimming time is better than blank group, it is not so good as A-C groups, illustrates comparative example
1-5 composition D-H also has antifatigue effect, but its effect is not so good as A-C groups.
Though the mouse swimming time of positive group is better than composition D-H groups, suitable with composition C groups, it is not so good as composition A, B
Group, illustrates its effect preferably, but still not as composition A, B.
2) serum urea nitrogen determination：As a result see following table.
Table 2：Mice serum urea nitrogen content experimental result ()
In from the above, it will be seen that 1-3 of embodiment of the present invention composition A-C, the serum urea nitrogen of mouse
Content is below blank group, illustrates that said composition has antifatigue effect.And composition A can be by the serum urea nitrogen of mouse
Content reduction by 18.3%, with extraordinary effect.
Though comparative example 1-5 composition D-H mice serum urea nitrogen content is less than blank group, it is not so good as A-C groups, explanation
Comparative example 1-5 composition D-H also has antifatigue effect, but its effect is not so good as A-C groups.
Though the mice serum urea nitrogen content of positive group is less than composition D-H groups, suitable with composition C groups, but still compares group
Compound A, B group is high, illustrates its effect preferably, but still not as composition A, B group.
3) hepatic glycogen is determined：As a result see following table.
Table 3：Mouse hepatic glycogen content experimental result ()
In from the above, it will be seen that 1-3 of embodiment of the present invention composition A-C, the hepatic glycogen content of mouse
Blank group is above, illustrates that said composition has antifatigue effect.And composition A can improve the hepatic glycogen content of mouse
2.3 times, with extraordinary effect.
Though comparative example 1-5 composition D-H mouse hepatic glycogen content is higher than blank group, it is not so good as A-C groups, illustrates contrast
Example 1-5 composition D-H also has antifatigue effect, but its effect is not so good as A-C groups.
Though the mouse hepatic glycogen content of positive group is higher than composition D-H groups, but still lower than composition A-C groups, illustrate that its is imitated
Fruit preferably, but still is not so good as composition A-C groups.
4) blood lactase acid is determined：As a result see following table.
Table 4：Each group swim 10 minutes on mouse blood lactase acid value influence experimental result ()
In from the above, it will be seen that lactic acid liter after 1-3 of embodiment of the present invention composition A-C, mouse movement
High magnification numbe is respectively less than blank group, illustrates that said composition has antifatigue effect.And composition B can raise the lactic acid of mouse
Multiple reduction by 20.5%, with extraordinary effect.
Though comparative example 1-5 composition D-H lactic acid rise multiple is less than blank group, it is not so good as A-C groups, illustrates comparative example
1-5 composition D-H also has antifatigue effect, but its effect is not so good as A-C groups.
Though the mouse lactic acid rise multiple of positive group is less than composition D-H groups, suitable with composition C groups, but still compares combination
Thing A, B group is high, illustrates its effect preferably, but still not as composition A, B group.
4. conclusion
It is administered orally the composition of mouse embodiment 1-3 preparations 30 days, mouse swimming time, significantly drop can be obviously prolonged
Serum urea nitrogen after low mouse movement, significantly improves the speed that blood lactase acid is removed after mouse movement, and significantly improve mouse glycogen
Former content.According to《Function of health food assessment process and the method for inspection》Regulation, health products of the invention have antifatigue
Effect.
Also, the generation of present invention energy fatigue-relieving and the elimination that can be accelerated fatigue, improve it can be seen from experimental result
The situation of body, it is possible to decrease blood lactase acid is removed in serum urea nitrogen and acceleration, increases hepatic glycogen content, and effect is significantly, is anti-
The ideal product of fatigue.
Experimental example 2
The above-mentioned oral disintegrating tablet X-Z prepared is subjected to experimental verification, its effect is investigated.
1st, ifs vitro disintegration timing
It is container to take 5mL test tubes, and it is medium to add 2mL distilled water, and test tube is placed in into the water-bath reclaimed water that temperature is 37 DEG C
Bath, by embodiment 3-6 prepare to oral disintegrating tablet be put into pipe and start timing, until tablet is disintegrated into the time of particle completely
For disintegration time, whole process static measurement.Every group of measure 10, concrete outcome is as shown in the table, and when calculating average disintegration
Between.
Table 5：The ifs vitro disintegration time
In from the above, it will be seen that the ifs vitro disintegration time is 50.74 ± 5.50s, 49.10 ± 5.92s,
46.63 ± 4.39s, was disintegrated rapidly in 1 minute, with disintegration effect it is good the characteristics of.
2nd, intraoral disintegration timing
From 6 healthy volunteers, oral disnitegration tablet X-Z made from Example 4-6 is put into volunteer mouthful, that is, opened
Begin to record the time that oral disintegrating tablet is disintegrated completely in the oral cavity.Every group of measure 10, concrete outcome is as shown in the table, and calculates average
The Orally disintegrating time.
Calculate Mean disintegration time.As a result such as table 6, the intra-oral disintegration time is 50.22 ± 3.11s.
Table 6：The Orally disintegrating time
In from the above, it will be seen that disintegration time be 51.46 ± 4.32s, 50.20 ± 5.18s, 47.16 ±
4.06s, was disintegrated rapidly in 1 minute, with disintegration effect it is good the characteristics of.Also, volunteer reflects the oral disintegrating tablet to oral cavity
Mucous membrane does not have excitant, in good taste, no feeling of grittiness.
Embodiment described above only expresses the several embodiments of the present invention, and it describes more specific and detailed, but simultaneously
Therefore the limitation to the scope of the claims of the present invention can not be interpreted as.It should be pointed out that for one of ordinary skill in the art
For, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to the guarantor of the present invention
Protect scope.Therefore, the protection domain of patent of the present invention should be determined by the appended claims.
Claims (8)
1. a kind of anti-Fatigue Composition, it is characterised in that the active ingredient of the composition is prepared by the raw material of following parts by weight
Form：
13-17 parts of wilsonii, 10-14 parts of Cordyceps militaris, 6-10 parts of Chinese yam, 2-5 parts of the fruit of Cherokee rose, 4-7 parts of the fruit of glossy privet.
2. the preparation method of the anti-Fatigue Composition described in claim 1, it is characterised in that comprise the following steps：By weight
Wilsonii, Cordyceps militaris, Chinese yam, the fruit of Cherokee rose and the fruit of glossy privet are weighed, crushed after being dried, mixing is produced.
3. the preparation method of the anti-Fatigue Composition described in claim 1, it is characterised in that comprise the following steps：By weight
Wilsonii and the fruit of glossy privet are weighed, the ethanol that 10~20ml concentration expressed in percentage by volumes are 35-65%, 60-80 DEG C are added according to 1g raw materials
Extract 1-3 times, 1~2h, dries to obtain dry extract one every time；Separately Cordyceps militaris, Chinese yam and the fruit of Cherokee rose are weighed by weight, it is former according to 1g
Material adds 10~20ml water, and 70-90 DEG C is extracted 1-3 times, and 1~2h, dries to obtain dry extract two every time；By the above-mentioned He of dry extract one
Dry extract two is well mixed, and is produced.
4. a kind of antifatigue preparation, it is characterised in that including the antifatigue combination described in the claim 1 as active component
Thing, and pharmaceutically acceptable carrier.
5. antifatigue preparation according to claim 4, it is characterised in that the formulation of the preparation is oral disintegrating tablet, including
Following component：
6. antifatigue preparation according to claim 5, it is characterised in that the filler is microcrystalline cellulose, lactose
At least one of starch, lactose, pre-paying starch and mannitol；The disintegrant is low substituent hydroxypropyl fiber
At least one of element, PVPP, crosslinked carboxymethyl fecula sodium and Ac-Di-Sol；The bubble
Agent is risen in sodium acid carbonate and tartaric acid, sodium acid carbonate and citric acid, sodium acid carbonate and fumaric acid, sodium acid carbonate and vitamin C
At least one set；The flavouring is at least one of menthol, peppermint oil dementholized, lemon extract, honey element and Aspartame；
The lubricant is at least one of magnesium stearate, Stepanol MG and talcum powder；The glidant be superfine silica gel powder,
At least one of talcum powder.
7. the preparation method of the oral disintegrating tablet described in a kind of any one of claim 5-6, it is characterised in that comprise the following steps：Press
Parts by weight weigh anti-Fatigue Composition, filler, disintegrant, effervescent agent, flavouring, lubricant and glidant, and 60-80 is crossed respectively
Mesh sieve, in 40 DEG C of -60 DEG C of drying, then by anti-Fatigue Composition respectively with filler, disintegrant, effervescent agent and flavouring with etc.
Measure method of progressively increasing to be well mixed, add lubricant and glidant, be well mixed, direct powder compression is produced.
8. the preparation method of the oral disintegrating tablet described in a kind of any one of claim 5-6, it is characterised in that comprise the following steps：Press
Parts by weight weigh anti-Fatigue Composition, filler, disintegrant, effervescent agent, flavouring, lubricant and glidant, and 60-80 is crossed respectively
Mesh sieve, in 40 DEG C of -60 DEG C of drying, then by anti-Fatigue Composition respectively with filler, disintegrant, effervescent agent and flavouring with etc.
Measure method of progressively increasing to be well mixed, add the ethanol solution of polyvinylpyrrolidone, wet granulation, by obtained wet granular at 30 DEG C
~50 DEG C of drying, whole grain adds lubricant and glidant, is well mixed, and compacting is produced.
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| CN103211222A (en) * | 2013-05-03 | 2013-07-24 | 江南大学 | Composition with effect of relieving physical fatigue |
| CN103271356A (en) * | 2013-06-14 | 2013-09-04 | 海南通宝投资有限公司 | Composition for enhancing immunity and relieving physical fatigue and preparation method of composition |
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| CN103211222A (en) * | 2013-05-03 | 2013-07-24 | 江南大学 | Composition with effect of relieving physical fatigue |
| CN103271356A (en) * | 2013-06-14 | 2013-09-04 | 海南通宝投资有限公司 | Composition for enhancing immunity and relieving physical fatigue and preparation method of composition |
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