CN103301178A - Fatigue syndrome prevention and treatment oral drug - Google Patents
Fatigue syndrome prevention and treatment oral drug Download PDFInfo
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Abstract
The invention discloses a fatigue syndrome prevention and treatment oral drug. The drug is an oral drug which is prepared from raw materials such as 4.5-21 parts by mass of longspur epimedium and 0.5-2 parts by mass of ginseng through utilizing a conventional preparation method. The drug is tested through a loading nekton model, and pole climbing pharmacodynamical contract experiments and acute toxicity tests prove that the drug can obviously prolong Kunming mouse loading swimming and pole climbing tests and show that the drug has an obvious anti-fatigue function, and the acute toxicity tests show that the drug does not have toxity to mice.
Description
Technical field
The invention belongs to the medicinal preparation technical field of the product that contains raw material or itself and not clear structure, be specifically related to derive from the material of plant.
Background technology
Fatigue syndrome is that the loading of health has surpassed the regeneration amount of health, for a long time in the past, will cause the health body injury owing to long-term a large amount of working and learning task and spiritual mental pressure.Its clinical manifestation is mainly reflected in the fatigue performance of the systemic-functions such as body cranial nerve, cardiovascular, digestion endocrine, skeletal muscle, such as dizziness, headache, insomnia, forgetful, low grade fever, muscle, arthralgia and multiple neuropsychic symptom, its basic feature for for a long time extremely tired, can not alleviate after having a rest, physico-chemical examination do not have organic disease; Its cause of disease is still not clear.
Chinese medicine thinks that fatigue syndrome is, syndrome of deficiency of kidney-QI and syndrome of deficiency of spleen qi are lost by the kidney qi element, and sexual life, eating and drinking without temperance or excessive thinking cause.
The mechanism of fatigue syndrome is the multifactor synthesis result that causes immunity, digestion, nerve, cardiovascular and cerebrovascular vessel, the chronic migration of urinary system, gradual infringement, and at present Western medicine mainly adopts symptomatic treatment such as electrolyte, little element, aminoacid, fat milk, tranquilizer, hormones of giving birth to.Uncertain therapeutic efficacy is cut and is easily caused drug dependence.Research in recent years shows, the more effective and safety of Chinese medicine, natural medicinal component multiformity effect many target position property treatment and conditioning fatigue syndrome obtains researcher's attention with this.2003～2009 years Chinese medicine, natural drug single and compound recipe have a lot of resisting fatigue reports, but exist prescription excessive, and the defectives such as proportioning and effective ingredient collection process cause curative effect uneven, and taking dose is excessive, makes the poor shortcoming of patient compliance.Along with social development and progress, people strengthen the progress that will promote this research subject to health perception.
Summary of the invention
Technical problem to be solved by this invention is to overcome the shortcoming of said medicine, and a kind for the treatment of that has no side effect evident in efficacy and prevention fatigue syndrome oral drugs are provided.
It is with the raw material of Chinese medicine of the following proportion by weight medicinal preparation for oral administration made of formulation method routinely to solve the problems of the technologies described above the technical scheme that adopts:
4.5～21 parts of Herba Epimedii
0.5～2 part of Radix Ginseng
The best raw material of Chinese medicine proportion by weight of preparation medicine of the present invention is:
10 parts of Herba Epimedii
1 part of Radix Ginseng
The medicinal preparation for oral administration that above-mentioned each component is made according to a conventional method is said capsule or tablet or granule or oral liquid on the galenic pharmacy.
The preparation method of medicine capsule of the present invention is as follows:
1, Herba Epimedii adds the water extraction 3 times of 10 times of amounts, and each is 1 hour, filter, merging filtrate filters, and concentrating under reduced pressure is that relative density is 1.05(30 ℃) extractum add ethanol to 60% precipitation 24 hours, filter, 60～70 ℃ of Recycled ethanols of supernatant, concentrated relative density is 1.05(30 ℃) extractum.
2, Radix Ginseng is pulverized and to be coarse powder, adds the water of 8 times of amounts, and 4 ℃ of storage cabinet mercerations 2 times are to filter in 24 hours at every turn.Medicinal residues add 10 times of water extraction 2 times, are 1 hour at every turn, filter, merging filtrate, decompression (0.07～-0.08Mpa, 60 ℃) to be concentrated into relative density be 1.05(30 ℃) extractum, adding ethanol to determining alcohol is 75%, left standstill 24 hours, filter, taking precipitate is with 3 times of water dissolutioies, filter, get supernatant and extractum and merge.
4, with above-mentioned steps 1～2 gained extractum, supernatant, simmer down to extractum, vacuum drying was pulverized 80 mesh sieves.
5, add dextrin by the conventional preparation technology of capsule, mix homogeneously is crossed 14 mesh sieves, granulate, and oven dry, granulate, encapsulated, and get final product.Every heavy 0.28g, every contains raw material of Chinese medicine 2.75g.
The preparation method of medicinal tablet of the present invention is as follows:
The used raw material of Chinese medicine of the raw material of Chinese medicine that medicinal tablet of the present invention is used and quality proportioning and medicine capsule of the present invention is identical, the extraction process step of raw material of Chinese medicine is identical with the extraction process step of capsule preparation method thereof raw material of Chinese medicine of the present invention, and used adjuvant and other processing step are undertaken by the conventional preparation technology of tablet.Every heavy 0.5g, every contains crude drug 5.5g.
The preparation technology of medicine oral liquid of the present invention is as follows:
The raw material of Chinese medicine that medicine oral liquid of the present invention is used and weight proportion and medicine capsule of the present invention are identical, the extraction process step of raw material of Chinese medicine is identical with the extraction process step of capsule preparation method thereof raw material of Chinese medicine of the present invention, and used adjuvant and other processing step carry out according to the conventional preparation technology of oral liquid.Every bottle of 10mL, every bottle contains raw material of Chinese medicine 11g.
The preparation technology of medicinal granule of the present invention is as follows:
The used raw material of Chinese medicine of the raw material of Chinese medicine that medicinal granule of the present invention is used and quality proportioning and medicine capsule of the present invention is identical, the extraction process step of raw material of Chinese medicine is identical with the extraction process step of capsule preparation method thereof raw material of Chinese medicine of the present invention, and used adjuvant and other processing step are undertaken by the conventional preparation technology of granule.Every bag heavy 5g, every bag contains raw material of Chinese medicine 11g.
The present invention is through the swimming with a load attached to the body animal model, pharmacodynamics contrast experiment and the acute toxicity testing of pole-climbing show, medicine of the present invention has significant prolongation to kunming mice swimming with a load attached to the body and pole-jump test, shows that this medicine has remarkable antifatigue effect, and acute toxicity testing shows mice nontoxic.
The specific embodiment
The present invention is described in more detail below in conjunction with embodiment, but the invention is not restricted to these embodiment.
Embodiment 1
As an example of 1000 of production medicine capsule products of the present invention example used raw material of Chinese medicine and adjuvant and proportioning thereof as:
Herba Epimedii 2500g
Radix Ginseng 250g
Dextrin adds to 280g
Its preparation method is as follows:
1, get Herba Epimedii 2500g, add the water extraction 3 times of 10 times of amounts, the time is each 1 hour, filters, and merging filtrate, concentrating under reduced pressure are that relative density is 1.05(30 ℃) extractum add most 60% extractum of ethanol.
2, get Radix Ginseng 250g and pulverize and to be coarse powder, add the water of 8 times of amounts, 4 ℃ of mercerations 24 hours 2 times filter.Medicinal residues add 10 times of water extraction 2 times, are 1 hour at every turn, filter, merging filtrate, decompression (0.07～-0.08Mpa, 60 ℃) to be concentrated into relative density be 1.05(30 ℃) extractum, adding ethanol to determining alcohol is 75%, left standstill 24 hours, filter, taking precipitate is with 3 times of water dissolutioies, filter, get supernatant and extractum and merge.
3, with above-mentioned steps 1～2 gained extractum, supernatant; Stirring and evenly mixing, simmer down to extractum vacuum drying was pulverized 80 mesh sieves.
4, add dextrin by the conventional preparation technology of capsule, mix homogeneously is crossed 14 mesh sieves, granulate, and oven dry, granulate in 1000 hard capsule cases of packing into, and get final product.Every heavy 0.28g, every contains raw material of Chinese medicine 2.75g.
As an example of 1000 of production medicinal tablet products of the present invention example used raw material of Chinese medicine and adjuvant and proportioning thereof as:
Herba Epimedii 5000g
Radix Ginseng 500g
Starch adds to 500g
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.5g, every contains raw material of Chinese medicine 5.5g.
As an example of production granule product of the present invention 1000g example used raw material of Chinese medicine and adjuvant and quality proportioning thereof as:
Herba Epimedii 2000g
Radix Ginseng 200g
Sucrose 400g
Dextrin adds to 1000g.
Its preparation technology is undertaken by the preparation technology of granule of the present invention.Every bag heavy 5g, every bag contains raw material of Chinese medicine 11g.
As an example of production oral liquid product of the present invention 1000mL example used raw material of Chinese medicine and adjuvant and quality proportioning thereof as:
Herba Epimedii 1000g
Radix Ginseng 100g
Sucrose 400g
Distilled water adds to 1000mL.
Its preparation technology is undertaken by the preparation technology of oral liquid of the present invention.Every bottle of 10mL, every bottle contains raw material of Chinese medicine 11g.
In the proportioning of the present embodiment, the mass parts of each component of raw material of Chinese medicine is:
10 parts of Herba Epimedii
1 part of Radix Ginseng
Embodiment 2
As an example of 1000 of production medicine capsule products of the present invention example used raw material of Chinese medicine and adjuvant and proportioning thereof as:
Herba Epimedii 2686g
Radix Ginseng 64g
Dextrin adds to 280g
Its preparation method is identical with the preparation technology of embodiment 1 capsule.Every heavy 0.28g, every contains raw material of Chinese medicine 2.75g.
As an example of 1000 of production medicinal tablet products of the present invention example used raw material of Chinese medicine and adjuvant and proportioning thereof as:
Herba Epimedii 5372g
Radix Ginseng 128g
Starch adds to 500g
Its preparation method is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.5g, every contains raw material of Chinese medicine 5.5g.
As an example of production granule product of the present invention 1000g example used raw material of Chinese medicine and adjuvant and quality proportioning thereof as:
Herba Epimedii 2149g
Radix Ginseng 51g
Sucrose 400g
Dextrin adds to 1000g.
Its preparation method is undertaken by the preparation technology of granule of the present invention.Every bag heavy 5g, every bag contains raw material of Chinese medicine 11g.
As an example of production oral liquid product of the present invention 1000mL example used raw material of Chinese medicine and adjuvant and quality proportioning thereof as:
Herba Epimedii 1074g
Radix Ginseng 26g
Sucrose 400g
Distilled water adds to 1000mL.
Its preparation method is undertaken by the preparation technology of oral liquid of the present invention.Every bottle of 10mL, every bottle contains raw material of Chinese medicine 11g.
In the proportioning of the present embodiment, the mass parts of each component of raw material of Chinese medicine is:
21 parts of Herba Epimedii
0.5 part of Radix Ginseng
Embodiment 3
As an example of 1000 of production medicine capsule products of the present invention example used raw material of Chinese medicine and adjuvant and proportioning thereof as:
Herba Epimedii 1904g
Radix Ginseng 846g
Dextrin adds to 280g
Its preparation method is identical with the preparation technology of embodiment 1 capsule.Every heavy 0.28g, every contains raw material of Chinese medicine 2.75g.
As an example of 1000 of production medicinal tablet products of the present invention example used raw material of Chinese medicine and adjuvant and proportioning thereof as:
Herba Epimedii 3808g
Radix Ginseng 1692g
Starch adds to 400g
Its preparation method is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.4g, every contains raw material of Chinese medicine 5.5g.
As an example of production granule product of the present invention 1000g example used raw material of Chinese medicine and adjuvant and quality proportioning thereof as:
Herba Epimedii 1523g
Radix Ginseng 677g
Sucrose 400g
Dextrin adds to 1000g.
Its preparation method is undertaken by the preparation technology of granule of the present invention.Every bag heavy 5g, every bag contains raw material of Chinese medicine 11g.
As an example of production oral liquid product of the present invention 1000mL example used raw material of Chinese medicine and adjuvant and quality proportioning thereof as:
Herba Epimedii 762g
Radix Ginseng 338g
Sucrose 400g
Distilled water adds to 1000ml
Its preparation method is undertaken by the preparation technology of oral liquid of the present invention.Every bottle of 10mL, every bottle contains raw material of Chinese medicine 11g.
In the proportioning of the present embodiment, the mass parts of each component of raw material of Chinese medicine is:
4.5 parts of Herba Epimedii
2 parts of Radix Ginsengs
Embodiment 4
As an example of 1000 of production medicine capsule products of the present invention example used raw material of Chinese medicine and adjuvant and proportioning thereof as:
Herba Epimedii 2475g
Radix Ginseng 275g
Dextrin adds to 280g
Its preparation method is identical with the preparation technology of embodiment 1 capsule.Every heavy 0.28g, every contains raw material of Chinese medicine 2.75g.
As an example of 1000 of production medicinal tablet products of the present invention example used raw material of Chinese medicine and adjuvant and proportioning thereof as:
Herba Epimedii 4950g
Radix Ginseng 550g
Starch adds to 500g
Its preparation method is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.5g, every contains raw material of Chinese medicine 5.5g.
As an example of production granule product of the present invention 1000g example used raw material of Chinese medicine and adjuvant and quality proportioning thereof as:
Herba Epimedii 1980g
Radix Ginseng 220g
Sucrose 400g
Dextrin adds to 1000g.
Its preparation method is undertaken by the preparation technology of granule of the present invention.Every bag heavy 5g, every bag contains raw material of Chinese medicine 11g.
As an example of production oral liquid product of the present invention 1000mL example used raw material of Chinese medicine and adjuvant and quality proportioning thereof as:
Herba Epimedii 990g
Radix Ginseng 110g
Sucrose 400g
Distilled water adds to 1000mL.
Its preparation method is undertaken by the preparation technology of oral liquid of the present invention.Every bottle of 10mL, every bottle contains raw material of Chinese medicine 11g.
In the proportioning of the present embodiment, the mass parts of each component of raw material of Chinese medicine is:
4.5 parts of Herba Epimedii
0.5 part of Radix Ginseng
Embodiment 5
As an example of 1000 of production medicine capsule products of the present invention example used raw material of Chinese medicine and adjuvant and proportioning thereof as:
Herba Epimedii 2511g
Radix Ginseng 239g
Dextrin adds to 280g
Its preparation method is identical with the preparation technology of embodiment 1 capsule.Every heavy 0.28g, every contains raw material of Chinese medicine 2.75g.
As an example of 1000 of production medicinal tablet products of the present invention example used raw material of Chinese medicine and adjuvant and proportioning thereof as:
Herba Epimedii 5022g
Radix Ginseng 478g
Starch adds to 500g
Its preparation method is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.5g, every contains raw material of Chinese medicine 5.5g.
As an example of production granule product of the present invention 1000g example used raw material of Chinese medicine and adjuvant and quality proportioning thereof as:
Herba Epimedii 2009g
Radix Ginseng 191g
Sucrose 400g
Dextrin adds to 1000g.
Its preparation method is undertaken by the preparation technology of granule of the present invention.Every bag heavy 5g, every bag contains raw material of Chinese medicine 11g.
As an example of production oral liquid product of the present invention 1000mL example used raw material of Chinese medicine and adjuvant and quality proportioning thereof as:
Herba Epimedii 1004g
Radix Ginseng 96g
Sucrose 400g
Distilled water adds to 1000mL.
Its preparation method is undertaken by the preparation technology of oral liquid of the present invention.Every bottle of 10mL, every bottle contains raw material of Chinese medicine 11g.
In the proportioning of the present embodiment, the mass parts of each component of raw material of Chinese medicine is:
21 parts of Herba Epimedii
2 parts of Radix Ginsengs
In order to verify medicine of the present invention to kunming mice resisting fatigue effect, the applicant adopts the powder of the medicine of the present invention of the embodiment of the invention 1 proportioning preparation to carry out pharmacodynamics test, and various test situation are as follows:
Test apparatus: micropipettor, model are QUYEQI, are produced by Qingyun Aeronautical Instruments ﹠ Meters Co., Beijing.
Tested medicine powder of the present invention is provided by Pharmacy department of No.1 Hospital Affiliated to No.4 Military Medical Univ. of PLA, and lot number is XJ120601; Positive control drug is the aspartic acid magnesium sheet, batch number: T17308A, and the production date: 2011/07, valid until: 2016/06 company of manufacturer: Huangary girui Gyogyszergyar; Be the metabolism that electrolyte replenisher can promote ammonia and carbon dioxide, replenish the material that generates glycogen, have anti-fatigue effect; Prepare with pure water before the administration.
Experimental animal: two monthly age male mouse of kunming, body weight 18～22g is provided by The Fourth Military Medical University experimental animal center, the quality certification number is SCXK(army) 2002-005.Raising condition: divide at random cage, 10 in every cage.Raise in, 24 ± 2 ° of C of room temperature, humidity 40-60%, control is round the clock automatically.Feed free drinking water with the full nutrition pellet that The Fourth Military Medical University experimental animal center provides.In 1 week of breeding observing before on-test, training on trial swimming every day 1 time, each 30 minutes, select for 5 times healthy suitable mices to be used for test totally.Training on trial pole-climbing every day 1 time, each 10 minutes, select for 5 times healthy suitable mices to be used for test totally.
Dosage and grouping: experimental animal is divided into saline control group, positive controls, test group: large, medium and small metering group.
Be subjected to the test product medication: gavage, capacity: mice 10ml/kg body weight.
Positive drug: by 1 times of clinical dosage every day (70kg), conversion mice dosage is: 0.36g/kg.
The dosage of drug test group mice of the present invention is: dosage group, 0.075g/kg small dose group among the heavy dose of group of 0.3g/kg, the 0.15g/kg.
1, Loaned swimming test
To each group mouse gavaging relative medicine, once-a-day, gavage continuously 2 days with micropipettor, three days mouse gavagings of the mat woven of fine bamboo strips carried out Loaned swimming test after 1 hour, the sheet lead of mouse tail heavy burden 6%, put into diameter 60cm, depth of water 40cm in the cylinder that water temperature 28 scholars 1 ℃, catches up with mice with thin rod frequently, record stopwatch meter record mice swimming time, mice sank to emerging 15 seconds and the swimming time more than 30 minutes stops writing time, surpassed 30 minutes meters 30 minutes, and number of seconds is converted to minute divided by 60.Pull out and dry eye moisture content and get eyeball blood, put to death and get paper and blot rear liver leaflet tissue 100mg.
Date processing: test data at first adopts difference between one-way ANOVA variance analysis population mean, and then multiple comparisons adopts Post-Hoc-Tests LSD check between mean; All statistical procedures adopt the SPSS statistical software to carry out statistical procedures.Result of the test sees Table 1, table 2.
Table 1 the present invention and saline group, aspartic acid magnesium sheet are to the mice burden swimming result
* expression is compared * P＜0.05 with the saline group; * P＜0.01* represents to compare * P＜0.05 with positive group; *＜0.01
Conclusion (of pressure testing): large, medium and small and positive group of dosage group all has the mice burden swimming time of prolongation than the saline group among the present invention, heavy dose of group and positive group quite, in, there is prolongation mice burden swimming time of highly significant in group.In showing, group's dosage has the Endurance of significantly improving and antifatigue effect.
2, pole-jump test
Method: organize the mouse gavaging relative medicine to each with micropipettor, once-a-day, gavage continuously 2 days, three days mouse gavagings of the mat woven of fine bamboo strips are after 1 hour, carry out pole-jump test, mice is put in the upper end fixing-stable, and the diameter of the unsettled 40cm in lower end is 0.6cm, on the high 120cm glass column, until the promptly rear timing of mice, treat that mice falls within on the cushion, stop timing, Jiang mice is put on the glass column repeatedly, catch glass column only to mice is unable, be accumulated as the mice pole-climbing time, namely get eyeball blood, execution is got paper and is only blotted rear liver leaflet tissue 100mg/.
Table 2 the present invention and saline group, positive drug group mice pole-climbing result
* expression is compared * P＜0.05 with the saline group; * P＜0.01* represents to compare * P＜0.05 with positive group; *＜0.01
Conclusion (of pressure testing): large, medium and small and positive group of dosage group all has the mice pole-climbing time of prolongation than the saline group among the present invention, heavy dose of group is organized quite with positive, in, group obviously prolongs the dosage group mice pole-climbing time, in showing, group's dosage has the Endurance of significantly improving and antifatigue effect.
3. the swimming with a load attached to the body side of removing test:
Method: with dosage group among the present invention and middle dosage group Herba Epimedii, Radix Ginseng is pressed preparation method:
(1) Herba Epimedii adds the water extraction 3 times of 10 times of amounts, 1,1,1 hour successively, filter, merging filtrate filters, and concentrating under reduced pressure is that relative density is 1.05(30 ℃) extractum add ethanol to 60% precipitation 24 hours, filter, 60～70 ℃ of Recycled ethanols of supernatant, simmer down to extractum is for subsequent use.
(2) Radix Ginseng is pulverized and to be coarse powder, adds the water of 8 times of amounts, and 4 ℃ of storage cabinet mercerations 2 times are to filter in 24 hours at every turn.Medicinal residues add 10 times of water extraction 2 times, are 1 hour at every turn, filter, merging filtrate, decompression (0.07～-0.08Mpa, 60 ℃) to be concentrated into relative density be 1.05(30 ℃) extractum, adding ethanol to determining alcohol is 75%, left standstill 24 hours, filter, taking precipitate is with 3 times of water dissolutioies, filter, getting supernatant concentration is that extractum is for subsequent use.
(3) Herba Epimedii and Ginseng Quality is more for subsequent use than making extractum by the 10:1 proportioning.
(4) test dosage: the dosage of test group mice is for all conversion contains crude drug amount Herba Epimedii group 1.34g/kg, Radix Ginseng group 0.133g/kg, compound recipe (medicine of the present invention) is organized 1.47g/kg.
(5) test method is identical with Loaned swimming test.
Table 3 saline group, compound recipe group and Herba Epimedii, Radix Ginseng group are to the mice burden swimming result
* expression is compared * P＜0.05 with the saline group; * P＜0.01* represents to compare * P＜0.05 with the compound recipe group; *＜0.01
Conclusion (of pressure testing): medicine group of the present invention all has the significant prolongation mice burden swimming time than saline group and Herba Epimedii group, Radix Ginseng group, shows Herba Epimedii and Radix Ginseng be significantly increased under rational composition of prescription Endurance and antifatigue effect.
3, biochemistry detects index:
Method: serum urea nitrogen, blood lactic acid, hepatic glycogen all build up Science and Technology Ltd.'s test kit description by Nanjing and measure, serum urea nitrogen lot number: 20120618 specification 50T/48 samples, blood lactic acid lot number: 20120723 specification 50T/48 samples, hepatic glycogen lot number: 20120720 specification 50T/48 samples, checkout equipment Ep0ch-267827, instrument: constant water bath box, homogenizer, micropipettor.Normal group is not joined swimming and pole-jump test, only directly gets blood regulating liver-QI leaflet tissue 100mg/.
Table 4 is respectively organized blood lactic acid, blood urea nitrogen and hepatic glycogen testing result relatively
Compare with the saline group: * P＜0.05, * * P＜0.01; Compare with positive group: * P＜0.05, * * P＜0.01
The result divides folding: after using this medicine preparation, on little, middle dosage level, heavy burden swimming and pole-climbing endurance obviously improve, and this group high dose group does not increase and the endurance increase with dosage, show that this anti-fatigue Chinese medicine preparation under rational dosage, has significant antifatigue effect.After taking the animal movement of this agent, hepatic glycogen rise level increases and the urea nitrogen levels ascensional range reduces, and illustrates that this Chinese medicine preparation has significantly generation, the development of delay fatigue.This preparation has that dose is little, the cycle is short, improves rapidly characteristics of resisting fatigue, fatigue alleviating.
3, acute toxicity test
Test method: get 80 of Kunming kind white mice, 20 of trial tests, 60 of formal tests, every group of 20 male and female half and half, gastric infusion.
Trial test: powder of the present invention is added distilled water on a small quantity grope water-soluble situation, it is the 0.4g/ml suspension that heated and stirred is prepared into Cmax.Reference is grace (Horn) family name method suddenly, gets 20 of mices, and male and female half and half are divided into 4 groups at random, every group 5, gavage gives the powder 0.1ml/10g of the present invention of various dose, 0.2ml/10g, 0.3ml/10g respectively, 0.4ml/10g Continuous Observation 72 hours has no the overt toxicity reaction.The prompting gastric infusion is difficult to measure its LD50.
Maximum medicine-feeding test: get 60 of mices, male and female half and half are divided into 3 groups at random, and 20 every group, gavage gives this product powder to be prepared into Cmax be the 0.4g/ml suspension respectively, Continuous Observation 14 days.The administration volume is pressed 0.2ml/10g at every turn, 0.3ml/10g, 0.4ml/10g administration, twice totally administration in a day, Cmax 0.4g/ml, research on maximum utilized quantity be equivalent to be grown up 799 times of quantity.Observe immediately the animal activity situation after the observation index administration and comprise (breathing of mice, autonomic activities and behavioral activity, eye inspection indication, salivation, perpendicular hair, muscular tension, feces, urine etc.) and death condition.Observe These parameters every day, record 1,3,5,7,14 day body weight and change and death condition.
Result of the test: behind the powder gastric infusion of the present invention, mice is without obvious toxic reaction, breathes normally, and autonomic activities and behavioral activity have no eyeball secretions, exophthalmos phenomenon without change, and feces, urine are without unusually.Viewing duration, experimental animal are ingested normally, and body weight increases, and ordinary circumstance is good.Off-test is put to death animal and is carried out anatomic observation, and the internal organs such as the heart, liver, spleen, lung, kidney, testis, uterus have no obvious pathological change.This test records maximum dosage-feeding of the present invention and is equivalent to clinical people (70kg) and intends 799 times of consumption 0.02g/kg.
Function of the present invention cures mainly: Yishen Jianpi, and resisting fatigue, antioxidation, appetite strengthening improves the mental status.Be mainly used in prevention and treatment fatigue syndrome.
The specification of medicine of the present invention: every heavy 0.28g of medicine capsule of the present invention, every contains raw material of Chinese medicine 2.75g; Every heavy 0.5g of medicinal tablet of the present invention, every contains crude drug 5.5g; Every bag heavy 5g of medicinal granule of the present invention, every bag contains raw material of Chinese medicine 11g; Every bottle of 10mL of medicine oral liquid of the present invention, every bottle contains raw material of Chinese medicine 11g.
The usage of medicine of the present invention and consumption: oral medicine capsule of the present invention, 1 time 2,2 times on the 1st; Oral medicinal tablet of the present invention, 1 time 1,2 times on the 1st; Oral medicinal granule of the present invention, boiled water is taken after mixing it with water, 1 time 1 bag, 1 time on the 1st; Oral medicine oral liquid of the present invention, 1 time 1 bottle, 1 time on the 1st.
Banking system: normal temperature drying is preserved.
Effect duration: 2 years.
Claims (2)
1. the oral drugs of a prevention and treatment fatigue syndrome is characterized in that it is by the raw material of Chinese medicine of the following proportion by weight medicinal preparation for oral administration of formulation method preparation routinely:
4.5～21 parts of Herba Epimedii
0.5～2 part of Radix Ginseng.
Prevention according to claim 1 and the treatment fatigue syndrome oral drugs, it is characterized in that the proportion by weight of raw material of Chinese medicine is:
10 parts of Herba Epimedii
1 part of Radix Ginseng.
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Cited By (4)
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| CN106912926A (en) * | 2017-05-11 | 2017-07-04 | 全恒太 | A kind of composition health food and its preparation technology containing pseudo-ginseng, ginseng and Shorthorned Epimedium P.E |
| CN106963868A (en) * | 2016-11-09 | 2017-07-21 | 江苏金氏丹科技有限公司 | A kind of strengthen immunity Chinese medicine composition |
| CN107875216A (en) * | 2017-11-20 | 2018-04-06 | 中国农业科学院特产研究所 | It is a kind of that there is composition for alleviating physical fatigue effect and preparation method thereof |
| CN112656870A (en) * | 2021-01-20 | 2021-04-16 | 森隆药业有限公司 | Anti-fatigue traditional Chinese medicine composition and preparation method and application thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106963868A (en) * | 2016-11-09 | 2017-07-21 | 江苏金氏丹科技有限公司 | A kind of strengthen immunity Chinese medicine composition |
| CN106912926A (en) * | 2017-05-11 | 2017-07-04 | 全恒太 | A kind of composition health food and its preparation technology containing pseudo-ginseng, ginseng and Shorthorned Epimedium P.E |
| CN107875216A (en) * | 2017-11-20 | 2018-04-06 | 中国农业科学院特产研究所 | It is a kind of that there is composition for alleviating physical fatigue effect and preparation method thereof |
| CN112656870A (en) * | 2021-01-20 | 2021-04-16 | 森隆药业有限公司 | Anti-fatigue traditional Chinese medicine composition and preparation method and application thereof |
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| CN103301178B (en) | 2016-12-28 |
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