CN1493319A - Medicine composition for treating neurasthenia - Google Patents
Medicine composition for treating neurasthenia Download PDFInfo
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Abstract
A Chinese medicine for treating neurasthenia, insommia, amnesia, dizziness, etc is prepared from 9 Chinese-medicinal materials including wild jujube, mulberry fruit, ganoderma, haw, etc. Its advantages are high curative effect, quickly taking its effect and low by-effect.
Description
The present invention relates to the Chinese herbal medicine is the pharmaceutical composition of raw material, specifically is used for the treatment of neurasthenic pharmaceutical composition.
The neurasthenia is a common clinical.Its clinical manifestation is insomnia, forgetful, fidgety, dreaminess, dizziness, nervous, spiritlessness and weakness, soreness of the waist and knees etc.Modern medicine thinks that its pathogenic factor is influenced each other, interacted by multiple factor and causes normal brain activity nerve " excited with suppress " process obstacle.In treatment, modern medicine advocates to adopt psychotherapy on the one hand, adopts chemotherapy on the one hand.Chemicals has only the symptomatic treatment effect for the neurasthenia, and at present with the most use is antianxiety drug (as tranquilizer).Antianxiety drug has the mood of improving patient neurasthenia, makes effects such as muscular flaccidity and tranquilizing soporific.Therefore, effective to patient's psychology, physiological signs.But antianxiety drug has only short-term to use effect is preferably just arranged, and takes not only weak curative effect for a long time, also causes drug dependence easily.And its stadium delay of neurasthenia, the chemicals symptomatic treatment of short-term can't tackle the problem at its root.Chinese medicine thinks, diseases such as insomnia, forgetful, dizzy, spiritlessness and weakness, soreness of the waist and knees appear in neurastheniac, surely belong to " being insomnia " disease category.It is often can not obtain a kind of disease that ortho sleep is a feature.Be insomnia with the passing of time visceral dysfunction.It is concentrated and is reflected on the heart, liver, spleen, lung, all dirty functional disorders of kidney.So the five internal organs are become estranged, the vital essence blood deficiency is its main etiology and pathogenesis, and is wherein close with heart kidney relation especially.Clinically, though the neurasthenia has the branch of deficiency and excess, see so that deficient syndrome more.The neurasthenia is normally with reinforce insufficiency and reduce excessiveness in the Chinese medicine treatment, regulating YIN and YANG, the calm principle that is of calming the nerves.Be used for the treatment of neurasthenic Chinese patent medicine at present clinically Cinnabaris repose ball, nourishing blood to tranquillize the mind sheet, ZAOREN ANSHEN YE or the like are arranged.These medicines all have certain curative effect to the neurasthenia.But also have some problems, slow as some drug effect, Time of Administration is long, curative effect instability or the like.
Purpose of the present invention just provides the neurasthenic pharmaceutical composition of treatment of a kind of rapid-action, good effect, few side effects.
Chinese medicine is thought, the heart being a vital viscus like a king of the body, main gods.Therefore, human-body viscera function and the activity of spiritual feelings will are all commanded by the heart.So deficiency of heart-blood, the heart is become homeless foster, and refreshing nothing is given up, and insomnia, dreaminess, dizziness, all diseases of spiritlessness and weakness then occur.On the other hand, people's ergasia is also inseparable with the function of kidney.The kidney being the origin of congenital constitution, main store essential substances, and main bone is given birth to marrow, brain being the marrow sea, kidney essense is full, and then brain must be supported, and just can give full play to the physiological function of its " house of intelligence ".Otherwise deficiency of kidney-essence then brain lose to be supported, and diseases such as spiritlessness and weakness, forgetful, dizzy, tinnitus, soreness of the waist and knees therefore can occur.
The realization of the object of the invention is based on tcm theory, and dialectical prescription based on tonify deficiency, nourishes painstaking effort, fills up kidney essense, regulates the five internal organs, and its mind is complied with to some extent, and brain must be filled, coordination between the heart and kidney, thus play good effect.
Pharmaceutical composition of the present invention selects for use the following weight proportion raw material to make, Ziziphi Spinosae 6-36 part, Fructus Mori 6-36 part, Ganoderma 2-12 part, Bulbus Lilii 1-6 part, Fructus Crataegi 2-12 part, Poria 1-6 part, Pericarpium Citri Reticulatae 1-6 part, Flos Chrysanthemi 2-12 part, Folium Nelumbinis 1-6 part.
The preferred weight proportioning of pharmaceutical composition of the present invention is Ziziphi Spinosae 30-36 part, Fructus Mori 30-36 part, Ganoderma 10-12 part, Bulbus Lilii 5-6 part, Fructus Crataegi 10-12 part, Poria 5-6 part, Pericarpium Citri Reticulatae 5-6 part, Flos Chrysanthemi 10-12 part, Folium Nelumbinis 5-6 part.
Ziziphi Spinosae in the medicine of the present invention is a monarch drug, focuses on the moon that nourishes heart, tranquilizing mind.Select for use full Fructus Jujubae to be used as medicine, be intended to wide medicine source, mechanical-power-producing; Fructus Mori tonifying liver kidney yin essence is aided with the Bulbus Lilii lung moistening and flourish hundred arteries and veins; Ganoderma replenishing QI and blood, tranquilizing mind, and can assist Ziziphi Spinosae, make the cloudy blood of the heart fill Sheng, refreshing from being able to peacefulness; The Bulbus Lilii yin nourishing, clear away heart-fire, calm the nerves, have restoring normal coordination between the heart and kidney and reach the merit of mind tranquilizing and the heart calming; Three medicines are ministerial drug altogether.Fructus Crataegi focuses on strengthening the spleen to promote digestion and helps the back God's willization as a means of the change source, makes the nutrient blood abundance, and the mind must be supported.Also can borrow the power of its blood stasis dispelling simultaneously, eliminate because of deficiency of heart-blood the blood stasis that the heart is become homeless and supported and cause.Poria, Pericarpium Citri Reticulatae two medicines and Fructus Crataegi make the QI and blood abundance and nourishing the heart to keep a sound mind with helping transporting and transforming function of the spleen and stomach altogether, and Poria also can help Ziziphi Spinosae, Ganoderma to strengthen the merit of mind tranquilizing and the heart calming simultaneously.Flos Chrysanthemi both can help Fructus Mori to grow and fill out kidney essense, can help the clear part of the body cavity above the diaphragm housing the heart and lungs pathogenic heat of Bulbus Lilii again.Fructus Crataegi, Poria, Pericarpium Citri Reticulatae, Flos Chrysanthemi are adjuvant drug altogether.The Folium Nelumbinis bitter and puckery flavor draws on all dirty clearing heat in QI system and flourishly in brain brain must be filled, spirited must supporting, and it is a messenger drug.
All medicines share, can tranquilizing by nourishing the hearts, and kidney-tonifying and brain tonic, again can spleen benefiting and stimulating the appetite invigorating blood circulation clears away heart-fire, and has the adjusting function of five internal organs.Medicine invigorating middle warmer of the present invention has logical, and tonify without causing stagnation is logical and just do not hinder, and heart kidney must be supported, the five internal organs fill Sheng, the QI and blood smoothness, and brain god must fill, insomnia, forgetful, dizzy, spiritlessness and weakness, oneself removes all diseases such as soreness of the waist and knees.
The present invention is to physical weakness, and the refreshing nothing of blood deficiency is supported, insomnia, cardiopalmus, and all diseases of spiritlessness and weakness, it is flourish that the damage of essence brain loses taste, and dizzy, dizzy, forgetful all diseases all have obvious curative effects.
Medicine of the present invention can be prepared into oral liquid, and its concrete preparation method is:
Weight proportion by among the present invention takes by weighing each drug component, mixes coarse crushing, decocts with water secondary, and 1-2 hour for the first time, 1-2 hour for the second time, filter, collecting decoction, concentrating under reduced pressure become relative density 1.2-1.25 (60 ℃ of heat are surveyed) clear paste.Add 95% ethanol, the limit edged stirs, to determining alcohol be 70-80%, left standstill below 4 ℃ 24 hours.Filter decompression recycling ethanol.Adding water to relative density is 1.05-1.10, stirs well, and leaves standstill embedding, sterilization.
Pharmaceutical composition of the present invention can also be prepared into oral formulations such as tablet, capsule, drop pill.
Pharmaceutical composition of the present invention has raise immunity, improves mental work efficient, improves the learning and memory effect and obviously strengthens anoxia enduring and antifatigue effect.
Medicine of the present invention can be used for nourishing blood to tranquillize the mind, kidney-tonifying and brain tonic.Be applicable to diseases such as insomnia due to the neurasthenia, forgetful, dizzy, spiritlessness and weakness, soreness of the waist and knees.
When the present invention is used for the treatment of the neurasthenia, have rapid-action, good effect, the advantage that side effect is little.
Beneficial effect of the present invention has obtained proof by following clinical trial.
Clinical trial is adopted at random, and counter point is divided into test group 100 examples at random in 2: 1 ratios, matched group 50 examples.
Diagnostic criteria:
The Western medicine diagnose standard is published with reference to Science Press, p738 neurasthenia diagnostic criteria among the Bei Zhengping chief editor " 3200 internal disease diagnostic criterias ".
" the clinical research guideline of new Chinese medicine Cure for insomnia " p186 that tcm diagnosis standard reference Ministry of Health of the People's Republic of China develops and publishes.
" the clinical research guideline of new Chinese medicine Cure for insomnia " p186 type of deficiency of both the heart and kidney that differential diagnosis in tcm is developed and published with reference to Ministry of Health of the People's Republic of China.
" the clinical research guideline of new Chinese medicine Cure for insomnia " p187 that insomnia weight grade scale Ministry of Health of the People's Republic of China develops and publishes.
Clinical symptoms, the sign standard of keeping the score:
1, insomnia
0 fen length of one's sleep normal or nighttime sleep 〉=6 hour.
Sleep in 1 fen is awakened often or is slept and unstable, and it is too early to wake up morning, but does not influence work.
Do not have enough sleep in 2 minutes 4 hours, and influenced work.
Lay awake all night in 3 minutes, difficulty is adhered to work.
2, forgetful
There was not this symptom in 0 minute
1 fen few appearance
Sometimes occurred in 2 minutes
Often occurred in 3 minutes
3, dizzy
There was not this symptom in 0 minute
Conscious dizziness in 1 fen does not have self and scenery rotates, and does not influence work.
Conscious dizziness in 2 fens has self and scenery to rotate, and influences work by chance.
Conscious dizziness in 3 fens, and have self and scenery to rotate, influence work.
4, spiritlessness and weakness
There was not this symptom in 0 minute
1 fen few appearance
Sometimes occurred in 2 minutes
Often occurred in 3 minutes
5, soreness of the waist and knees
There was not this symptom in 0 minute
Take place when dry weight was lived in 1 minute
Take place during work in 2 fens
3 fens gentle activities or do not have work and the time have
6, picture of the tongue
Picture of the tongue was normal in 0 minute
The light red tongue tongue was white in 1 minute
7, pulse condition
Pulse condition was normal in 0 minute
1 minute heavy carefully unable
Test case standard
Include standard in
Allly meet the diagnosis of the neurasthenic diagnosis and the traditional Chinese medical science, dialectical standard person, can include the test case in.
Get rid of and the rejecting standard
1, every systemic disease and external environmental interference factor causer.
2, gestation or women breast-feeding their children are to this medicine allergy sufferers below 18 one full year of life or the over-65s person age.
3, merge to have the inclination, serious primary disease persons such as lung, liver, kidney and hemopoietic system, the psychotic.
4, all standards of including in that do not meet, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment and safety judgement person.
Dosage regimen
Test group: medicine of the present invention (promptly day power oral liquid is provided by Yiling Pharmaceutical Co., Ltd, Shijiazhuang, and lot number is 20000606), a 20ml, 3 times on the one.
Matched group: ZAOREN ANSHEN YE (produced by Tongrentang Pharmaceutical Factory, Beijing, Main Ingredients and Appearance is Semen Ziziphi Spinosae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, and lot number is 9260030), oral, a 20ml, 3 times on the one.
The course of treatment: be 2 weeks a course of treatment.
Carry out comprehensive review after finishing the course of treatment, and the measurement data of result of the test, enumeration data, ranked data adopt t check, X respectively
2Statistical procedures is carried out in check and Ridit check.
Curative effect judging standard (formulating) with reference to " the clinical research guideline of new Chinese medicine Cure for insomnia "
Cure in the recent period: recover the length of one's sleep normal or nighttime sleep more than 6 hours, sleep is dull, the back of waking up is hale and hearty, or total mark reduces more than 90%.
Produce effects: sleep is clearly better, and increases the length of one's sleep more than 3 hours, and Depth of sleep increases, or total mark reduces 70-89%.
Progressive: sx, the length of one's sleep, more preceding increase less than was 3 hours, or total mark reduces 30-69%.
Invalid: insomnia nothing in treatment back is obviously improved or is not increased the weight of the person on the contrary, or total mark reduces below 30%.
Wake up before sleep awakening degree, the treatment before the length of one's sleep, treatment between sex, age, the course of disease, insomnia degree, the treatment eve comparison of projects such as tcm symptom score situation before the back mental status, the treatment, the preceding Syndrome in TCM marquis total mark of treatment of test group and matched group is checked through t, does not all have significant difference.So test group and matched group have comparability.
Result of the test
Two groups of comparisons: see Table 1 to neurasthenia's curative effect
Table 1 liang group is to the comparison of neurasthenia's curative effect
Group example number is cured the invalid total effective rate of produce effects progress (%) obvious effective rate (%) in the recent period
Test group 100 53 12 29 6 94.00 65.00
Matched group 50 14 4 22 10 80.00 36.00
Through Ridit check, R
Examination=0.5, R
Right=0.3382, u=3.30, there is significant difference P＜0.01, and test group is better than matched group to the curative effect of neurastheniac.
Nighttime sleep time situation of change relatively before and after two groups of treatments: see Table 2
Nighttime sleep time situation of change compares (x ± s hour) before and after the table 2 liang group treatment
Treatment back difference t P before the treatment of group example number
Test group 100 3.53 ± 1.25 5.54 ± 1.34-2.01 ± 1.07
Matched group 50 3.86 ± 0.97 5.39 ± 1.16-1.53 ± 1.03 2.62＜0.01
Two groups of patients are after treatment, and all there is obvious prolongation the nighttime sleep time, through t check, t
Examination=10.97, t
Right=7.15, P all＜0.01 has significant difference; Before and after two groups of patient treatments differences relatively, t=2.62, there is significant difference P＜0.01, illustrates that test group improves the patient and act on the length of one's sleep and be better than matched group.
The tcm symptom situation of change relatively before and after two groups of treatments: see Table 3
Tcm symptom score situation of change compares (x ± s branch) before and after table 3 treatment
Difference contrast between contrast groups before and after treating in the difference group of back before the treatment of group example number
T check t check
Lose test group 100 1.79 ± 0.61 0.55 ± 0.70 1.24 ± 0.59 13.35
* *
Dormancy matched group 50 1.66 ± 0.56 0.74 ± 0.59 0.92 ± 0.65 8.00
* *3.03
###
Strong test group 100 2.07 ± 0.75 0.94 ± 0.79 1.13 ± 0.71 10.37
* *
Forget matched group 50 1.90 ± 0.97 1.16 ± 0.88 0.74 ± 0.66 4.00
* *3.25
###
Dizzy test group 100 1.40 ± 0.78 0.47 ± 0.66 0.93 ± 0.73 9.10
* *
Dizzy matched group 50 1.16 ± 0.72 0.60 ± 0.74 0.56 ± 0.65 3.84
* *3.03
###
Mental fatigue test group 100 2.24 ± 0.83 0.92 ± 0.72 1.32 ± 0.76 12.01
* *
Weak matched group 50 2.08 ± 0.85 1.04 ± 0.89 1.04 ± 0.69 5.98
* *2.19
###
Waist knee joint test group 100 1.66 ± 0.90 0.66 ± 0.76 1.00 ± 0.74 8.49
* *
Aching and limp matched group 50 1.44 ± 0.91 0.78 ± 0.71 0.66 ± 0.79 4.04
* *2.59
###
Tongue test group 100 0.73 ± 0.39 0.31 ± 0.46 0.42 ± 0.49 6.96
* *
Resemble matched group 50 0.72 ± 0.39 0.24 ± 0.43 0.48 ± 0.47 5.85
* *0.72
#
Arteries and veins test group 100 0.70 ± 0.35 0.30 ± 0.45 0.40 ± 0.48 7.19
* *
Resemble matched group 50 0.74 ± 0.35 0.54 ± 0.49 0.20 ± 0.41 2.35
* *2.52
###
Annotate: contrast before and after in the group
*P＞0.05
*P＜0.05
* *P＜0.01.
Difference contrast #P＞0.05 ##P＜0.05 ###P＜0.01 between group.
Test group patient is after treatment, and the score of each tcm symptom all obviously descends, before and after the treatment contrast through the t check, P all＜0.01, there were significant differences; Treat back difference contrast for two groups, test group is to forgetful, dizzy, spiritlessness and weakness, and the improvement of pulse condition obviously is better than matched group, learns by statistics and handles, and there is significant difference P＜0.05 or P＜0.01.
Tcm syndrome total mark situation of change relatively before and after two groups of treatments: see Table 4
The tcm syndrome total mark changes (x ± s branch) before and after table 4 treatment
Treatment back difference t P before the treatment of group example number
Test group 100 10.62 ± 2.97 4.12 ± 3.35 6.50 ± 2.89
Matched group 50 9.70 ± 3.03 5.10 ± 2.86 4.60 ± 2.61 3.92＜0.01
Behind two groups of patient treatments, the tcm syndrome total mark all obviously descends, through t test, t
Examination=14.52, t
Right=7.81, P all＜0.01 has significant difference; Two groups of treatment back difference contrasts, t=3.92, P＜0.01, significant difference illustrates that test group is better than matched group to the reduction of tcm syndrome total mark.
Two groups of insomnia onset times, extinction time be relatively: see Table 5
Table 5 liang group insomnia onset time, extinction time be (x ± s days) relatively
The effective routine number onset time t P of the group routine number extinction time t P that disappears
Test group 94 6.84 ± 2.10 51 10.41 ± 3.03
Matched group 39 7.78 ± 2.73 2.15＜0.05 14 11.11 ± 2.79 0.93＞0.05
The onset time contrast of two groups of patient's insomnias, t=2.15, there is significant difference P＜0.05, illustrates that test group is short than matched group to the onset time of patient's insomnia; The extinction time contrast, t=0.93, P＞0.05, there was no significant difference illustrates that two medicines are similar to the extinction time of patient's insomnia.
Medicine of the present invention has obtained confirmation to the beneficial effect that improves memory, anti-hypoxia, resisting fatigue and raising survival ability by following animal experiment.
Scopolamine is caused the test of mouse memory acquired disturbance
Test material:
Medicine: medicine of the present invention (10ml/ props up, the 1.1g crude drug/ml), Yiling Pharmaceutical Co., Ltd, Shijiazhuang, lot number 20000502; Scopolamine hydrobromide (0.3mg/ props up), Shanghai Hefeng Pharmaceutical Co., Ltd., lot number 990101.
Animal: Kunming mouse, body weight 18-20g, male and female half and half.Provided by Hebei province's Experimental Animal Center, the quality certification number is the moving word the 04056th of doctor.
Instrument: mice electric shock diving tower device
Test method:
50 mices are divided into 5 groups at random, be respectively the normal control group, model control group, medicine small dose group of the present invention (dosage group in 8.5g crude drug/kg), the medicine of the present invention (17.0g crude drug/kg), the heavy dose of group of medicine of the present invention (the 34.0g crude drug/kg), every group 10, male and female half and half are raised under similarity condition.Administration group gastric infusion every day once, capacity is the 0.2ml/10g body weight, normal control group, model control group such as give every day at the capacity normal saline, continuous 12 days.Except that the normal control group, all the other respectively organize mice all after in the end two days administration 20-30 minute, and lumbar injection scopolamine 4mg/kg, last begin training for scopolamine after 30 minutes.During training, mice is put into reflective box, adapt to 3 minutes earlier, then energising.When animal was subjected to shocking by electricity, normal reaction was the rebound diving tower to hide electric shock, and the mice biped the copper grid for getting an electric shock, and is considered as wrong reaction.Trained 5 minutes and write down wrong reaction number of times in the mice 5 minutes.Test after 24 hours, write down 5 minutes wrong reaction number of times, promptly remember wrong reaction number of times in 5 minutes phases.Adopt the t check respectively to organize difference condition.
Result of the test sees Table 6
Table 6 medicine of the present invention causes the influence (x ± s) of mouse memory acquired disturbance to the industrial occupancy hyoscyamine
The animal training phase
The dosage memory phase
The group number
(errors number in 5 minutes errors number of g crude drug/kg) 5 minutes
(only)
The normal control group---10 1.8 ± 0.79
※ ※1.4 ± 0.52
※
Model control group---10 3.8 ± 1.03 2.3 ± 0.95
Medicine group 8.5 10 2.2 ± 0.92 of the present invention
※ ※1.5 ± 0.53
※
17.0 10 2.5±0.97
※※ 1.4±0.70
※
34.0 10 2.5±1.08
※※ 1.4±0.52
※
Annotate: compare with model control group:
※P＜0.05;
※ ※P＜0.01.
From the result as seen, the obviously normal matched group many (P＜0.01) of model control group mice errors number in 5 minutes training periods illustrates after mice is given scopolamine to cause memory acquisition disturbance.Medicine of the present invention (the group mice of 8.5g crude drug/kg, 17.0g crude drug/kg, 34.0g crude drug/kg) in training period in 5 minutes errors number obviously than model control group few (P＜0.01).In the memory phase, the obviously normal matched group many (P＜0.05) of 5 minutes errors number of model control group mice, (8.5g crude drug/kg, 17.0g crude drug/kg, 34.0g crude drug/kg) are organized in the mice 5 minutes errors number obviously than model control group few (P＜0.05) to medicine of the present invention.
This shows that medicine of the present invention can obviously improve scopolamine and cause the mouse memory acquired disturbance.
Influence to ethanol induced mice memory represents obstacle.
Test material:
Medicine: medicine of the present invention (10ml/ props up, the 1.1g crude drug/ml), Yiling Pharmaceutical Co., Ltd, Shijiazhuang, lot number 20000502; Dehydrated alcohol (analyzing alcohol) Beijing Chemical Plant, lot number 991180.
Animal: Kunming mouse, body weight 18-20g, male and female half and half are provided by Hebei province's Experimental Animal Center, and the quality certification number is the moving word the 04056th of doctor.
Instrument: mice electric shock diving tower device
Test method:
50 mices are divided into 5 groups at random, be respectively the normal control group, model control group, medicine small dose group of the present invention (dosage group in 8.5g crude drug/kg), the medicine of the present invention (17.0g crude drug/kg), the heavy dose of group of medicine of the present invention (the 34.0g crude drug/kg), every group 10, male and female half and half are raised under similarity condition.Administration group gastric infusion every day once, capacity is the 0.2ml/10g body weight, normal control group, model control group such as give every day at the capacity normal saline, continuous 12 days.Began training in 1 hour in the last administration.During training, mice is put into reflective box, adapt to 3 minutes earlier, then energising.When animal was subjected to shocking by electricity, normal reaction was the rebound diving tower to hide electric shock, and the mice biped the copper grid for getting an electric shock, and is considered as wrong reaction.Trained 5 minutes and write down errors number in the mice 5 minutes.Test after 24 hours, in preceding 30 minutes of test, model group and each administration group mouse stomach 40% ethanol 0.1ml/10g body weight, capacity normal saline such as normal control group mouse stomach.After 30 minutes, test mouse wrong reaction times in 5 minutes.Adopt the t check respectively to organize difference condition.
Result of the test: see Table 7
Table 7 medicine of the present invention causes the influence (x ± s) of memory represents obstacle to 40% ethanol
Errors number in the dosage number of animals 5 minutes
Group
((only) testing period training period of g crude drug/kg)
The normal control group---10 1.4 ± 0.52 1.2 ± 0.42
※ ※
Model control group---10 1.6 ± 0.52 3.3 ± 0.82
Medicine group 8.5 10 1.7 of the present invention ± 0.48 2.4 ± 1.07
※
17.0 10 1.4±0.70 2.3±0.95
※
34.0 10 1.5±0.53 2.2±1.03
※
Annotate: compare with model control group:
※P＜0.05;
※ ※P＜0.01.
From the result as seen, training period is respectively organized in 5 minutes errors number does not have significant change (P＞0.05).The obviously normal control group mice of wrong reaction number of times increases (P＜0.01) in the testing period model control group mice 5 minutes, the memory represents obstacle occurs after mouse stomach 40% ethanol is described.(errors number in the group mice of 8.5g crude drug/kg, 17.0g crude drug/kg, 34.0g crude drug/kg) 5 minutes all obviously reduces (P＜0.05) than the model control group mice to medicine of the present invention.
This shows that (8.5g crude drug/kg, 17.0g crude drug/kg, 34.0g crude drug/kg) all can obviously reduce by 5 minutes wrong reaction number of times improve the memory represents obstacle that ethanol causes to medicine of the present invention.
Medicine of the present invention is to the protective effect of chmice acute cerebral anoxia
Test material:
Medicine: medicine of the present invention (10ml/ props up, the 1.1g crude drug/ml), Yiling Pharmaceutical Co., Ltd, Shijiazhuang, lot number 20000502;
Animal: Kunming mouse, body weight 18-20g, male and female half and half are provided by Hebei province's Experimental Animal Center, and the quality certification number is the moving word the 04056th of doctor;
Test method:
40 mices are divided into 4 groups at random, every group 10, be respectively normal control group, medicine small dose group of the present invention ((17.0g crude drug/kg), the heavy dose of group of medicine of the present invention (the 34.0g crude drug/kg) of dosage group in 8.5g crude drug/kg), the medicine of the present invention, administration group gastric infusion every day, capacity is the 0.2ml/10g body weight, the normal control group waits the capacity normal saline, once a day, successive administration 12 days, 40 minutes time broken ends after the last administration, write down the duration of dehiscing that breaks end, adopt the t check respectively to organize difference condition.
Result of the test:
The results are shown in Table 8
Table 8 medicine of the present invention is to chmice acute cerebral anoxia protective effect (x ± sD)
The dosage number of animals is dehisced the time
Group
(g crude drug/kg) (only) (S)
The normal control group---10 21.2 ± 2.15
Medicine 8.5 10 24.8 ± 2.66 of the present invention
※ ※
17.0 10 25.6±2.72
※※
34.0 10 25.9±2.68
※※
Annotate: compare with the normal control group:
※P＜0.05;
※ ※P＜0.01.
From the result as seen, medicine of the present invention (8.5g crude drug/kg, 17.0g crude drug/kg, 34.0g crude drug/kg) organize the duration of dehiscing after mice breaks end obviously than normal matched group prolongation (P＜0.01).
This result of the test shows, medicine of the present invention (dehisce the time after all can prolonging the mice broken end, and the chmice acute cerebral anoxia is had the certain protection effect by 8.5g crude drug/kg, 17.0g crude drug/kg, 34.0g crude drug/kg).
Influence to yang deficiency mouse anti-reflecting fatigue ability
Test material:
Medicine: medicine of the present invention (10ml/ props up, the 1.1g crude drug/ml), Yiling Pharmaceutical Co., Ltd, Shijiazhuang, lot number 20000502; Hydrocortisone injection, people pharmaceutical factory of Tianjin aminoacid company, lot number 20000307.
Animal: Kunming mouse, body weight 18-20g, male, provide by Hebei province's Experimental Animal Center, the quality certification number is the moving word the 04056th of doctor;
Test method:
50 mices are divided into 5 groups at random, every group 10, be respectively the normal control group, the model of yang asthenia group, medicine small dose group of the present invention (the 8.5g crude drug/kg), dosage group in the medicine of the present invention (the 17.0g crude drug/kg), the heavy dose of group of medicine of the present invention (the 34.0g crude drug/kg), each organizes gastric infusion every day (water) once, and capacity is the 0.2ml/10g body weight, successive administration 7 days, the hydrocortisone of intramuscular injection simultaneously 0.75mg/ is (except the normal control group) only, after the last administration 1 hour, carry out swimming test, during test, respectively mice is born a heavy burden 5%, drop in the water, the time that the record mice begins to swim and sinks under water, adopt the t check respectively to organize difference condition.
Result of the test:
The result sees table 9 for details
Table 9 medicine of the present invention is to the influence of yang deficiency mice swimming time (x ± s)
Dosage number of animals swimming time
Group
(g crude drug/kg) (only) (min)
The normal control group---10 7.76 ± 1.32
※ ※
The model of yang asthenia group---10 4.42 ± 0.94
Medicine 8.5 10 5.53 ± 1.05 of the present invention
※
17.0 10 5.92±1.12
※※
34.0 10 6.22±0.98
※※
Compare with the model of yang asthenia group
※P＜0.05;
※ ※P＜0.01
From the result as seen, the obviously normal matched group of model of yang asthenia group mice swimming time short (P＜0.01), medicine of the present invention (8.5g crude drug/kg, 17.0g crude drug/kg, 34.0g crude drug/kg) organize the mice swimming time all obviously than long (P＜0.05 of model of yang asthenia group mice; P＜0.01).
This shows that (8.5g crude drug/kg, 17.0g crude drug/kg, 34.0g crude drug/kg) all can obviously prolong yang deficiency mice swimming time have certain antifatigue effect to medicine of the present invention.
Influence to yang deficiency mice low temperature survival ability
Test material
Medicine: medicine of the present invention (10ml/ props up, the 1.1g crude drug/ml), Yiling Pharmaceutical Co., Ltd, Shijiazhuang, lot number 20000502; Hydrocortisone injection, people pharmaceutical factory of Tianjin aminoacid company, lot number 20000307.
2, animal: Kunming mouse, body weight 18-20g, male, provide by Hebei province's Experimental Animal Center, the quality certification number is the moving word the 04056th of doctor;
Test method:
100 mices are divided into 5 groups at random, every group 20, be respectively the normal control group, the model of yang asthenia group, medicine small dose group of the present invention (the 8.5g crude drug/kg), dosage group in the medicine of the present invention (the 17.0g crude drug/kg), the heavy dose of group of medicine of the present invention (the 34.0g crude drug/kg), each organizes gastric infusion every day (water) once, and capacity is the 0.2ml/10g body weight, successive administration 7 days, the hydrocortisone of intramuscular injection simultaneously 0.75mg/ is (except the normal control group) only, after the last administration 1 hour, carry out the low temperature survival test, during test, mice is put into the refrigerator of temperature-14 ℃, 2.5 take out mice after hour, the surviving animals number respectively organized in record, adopts the X2 check respectively to organize difference condition.
Result of the test:
The result sees table 10 for details
Table 10 medicine of the present invention is to the influence of yang deficiency mice low temperature survival ability (x ± s)
Dosage number of animals surviving animals number
Group
((only) (only) of g crude drug/kg)
The normal control group---20 15
*
The model of yang asthenia group---20 2
Medicine 8.5 20 11 of the present invention
*
17.0 20 10
*
34.0 20 11
**
Compare with the model of yang asthenia group
※P＜0.05;
※ ※P＜0.01
From the result as seen, model of yang asthenia group mice tolerance to cold obviously descends, the obviously normal matched group few (P＜0.01) of surviving animals number, medicine of the present invention (8.5g crude drug/kg, 17.0g crude drug/kg, 34.0g crude drug/kg) organize the surviving animals number obviously than model of yang asthenia group many (P＜0.05 or P＜0.01).
This shows, (8.5g crude drug/kg, 17.0g crude drug/kg, 34.0g crude drug/kg) all can obviously improve yang deficiency mice low temperature survival ability to medicine of the present invention.
The present invention does not find any toxic reaction through animal and clinical trial.
Embodiment 1
Semen Ziziphi Spinosae 300g, Fructus Mori 300g, Flos Chrysanthemi 100g, Poria 50g, Fructus Crataegi 100g, Bulbus Lilii 50g, Pericarpium Citri Reticulatae 50g, Folium Nelumbinis 50g, Ganoderma 100g.
More than nine flavors, mix coarse crushing.Add 9 times of amounts of water, soaked 1 hour, heating decocts secondary, and 1.5 hours for the first time, 1 hour for the second time, filter, collecting decoction, concentrating under reduced pressure become relative density 1.2-1.25 (60 ℃ of heat are surveyed) clear paste.Add 95% ethanol, the limit edged stirs, and to determining alcohol 70-80%, leaves standstill below 4 ℃ 24 hours.Filter, decompression recycling ethanol is to there not being the alcohol flavor.Add sodium benzoate 0.1%, regulate pH value, add water to 1000ml, stir well, leave standstill, filter to prescribed limit, embedding, sterilization is promptly.
Embodiment 2-5, its preparation method are with embodiment 1, and just the consumption proportion of each component is different, but all can reach effect of the present invention.
Claims (2)
1, the neurasthenic pharmaceutical composition of a kind of treatment is characterized in that it is made Ziziphi Spinosae 6-36 part, Fructus Mori 6-36 part by the following weight proportion raw material, Ganoderma 2-12 part, Bulbus Lilii 1-6 part, Fructus Crataegi 2-12 part, Poria 1-6 part, Pericarpium Citri Reticulatae 1-6 part, Flos Chrysanthemi 2-12 part, Folium Nelumbinis 1-6 part.
2, the neurasthenic pharmaceutical composition of treatment according to claim 1, the weight proportion that it is characterized in that its said raw material is Ziziphi Spinosae 30-36 part, Fructus Mori 30-36 part, Ganoderma 10-12 part, Bulbus Lilii 5-6 part, Fructus Crataegi 10-12 part, Poria 5-6 part, Pericarpium Citri Reticulatae 5-6 part, Flos Chrysanthemi 10-12 part, Folium Nelumbinis 5-6 part.
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