CN1600349A - Capsule prepared from cicada for soothing the nerves at night - Google Patents
Capsule prepared from cicada for soothing the nerves at night Download PDFInfo
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Abstract
A Chinese medicine in the form of capsule for treating insomnia is prepared from 10 Chinese-medicinal materials including ciccada slough, batryticated silkworm, earthworm, white peony root, etc.
Description
Technical field
The present invention relates to a kind of capsule prepared from cicada for soothing the nerves at night and preparation method thereof.
Background technology
Insomnia be a kind of lasting long duration sleep matter and/or measure situation unsatisfactory, often show as be difficult to fall asleep, can not fall asleep, keep dyskoimesis, too early or intermittence wake up and cause and do not have enough sleep.Insomnia is a kind of modal sleep disordered, and it brings misery on the huge body ﹠ mind to the patient.Along with the development of society, the quickening of rhythm of life, insomnia's incidence rate is on the rise, according to statistics, has 30% adult to suffer from insomnia approximately.
At present, the insomnia method of treatment mostly is and adopts the treatment of Western medicine tranquilizer both at home and abroad.The Western medicine tranquilizer can only negatively be controlled or force patient to sleep, and can not improve sleep quality, and along with the prolongation of the course of disease, dosage will constantly increase.The Western medicine tranquilizer also has very big toxic and side effects to people's systems such as nerve.The existing Chinese patent medicine that is used for the treatment of the type of phlegm-heat attacking internally insomnia, its therapeutic effect is poor.
Summary of the invention
Technical problem to be solved by this invention is to overcome the deficiencies in the prior art, and a kind of Chinese patent medicine--capsule prepared from cicada for soothing the nerves at night and preparation method thereof that is used for the treatment of type of phlegm-heat attacking internally insomnia is provided, and this capsule good effect, toxic action are little.
The technical solution adopted in the present invention is: a kind of capsule prepared from cicada for soothing the nerves at night, its content mainly are to be made by following bulk drugs,
267 parts of 500 parts of Bombyx Batryticatus of 267 portions of Periostracum Cicadaes of Concretio Silicea Bambusae
333 parts of 833 parts of Rhizoma Pinelliae Preparatum of 667 parts of Ramulus Uncariae Cum Uncis of Pheretima
500 parts of 500 parts of Semen Ziziphi Spinosaes of 833 portions of Radix Paeoniae Albas of Caulis Polygoni Multiflori
400 parts of Radix Polygalaes
Its preparation method comprises the following steps:
(1) get the Concretio Silicea Bambusae of 1/3 amount of described weight proportion, 80 ℃ dry 4 hours down, be ground into fine powder, standby;
(2) Caulis Polygoni Multiflori of getting described weight proportion adds 8 times of amount 70% alcohol reflux 2 hours, filters, and medicinal residues add 6 times of amount 70% alcohol reflux 1.5 hours again, merge reflux extracting liquid, filter filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.30～1.35 (70 ℃), standby;
(3) Bombyx Batryticatus of getting described weight proportion adds 10 times of water gagings and decocts and extracted 1.5 hours, filters, and medicinal residues add 8 times of water gagings again and decoct and extracted 1 hour, collecting decoction filters, and filtrate is concentrated into the clear paste of relative density 1.10～1.15 (70 ℃), put cold, add ethanol and make and contain alcohol amount and reach 70%, stir evenly, left standstill 24 hours, filter, filtrate recycling ethanol is concentrated into the thick paste of relative density 1.30～1.35 (70 ℃), and is standby;
(4) getting the Periostracum Cicadae, Pheretima, Rhizoma Pinelliae Preparatum, the Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Polygalae of described weight proportion and 2/3 amount Concretio Silicea Bambusae adds 10 times, 8 times water gagings respectively and decocts and extract secondaries, 2 hours for the first time, 1 hour for the second time, the Ramulus Uncariae Cum Uncis medical material that when extracting for the second time, adds described weight proportion, collecting decoction, filter, filtrate is concentrated into the clear paste of relative density 1.10～1.15 (70 ℃), puts coldly, adds ethanol and makes and contain alcohol amount and reach 70%, stir evenly, left standstill 24 hours, and filtered filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.30～1.35 (70 ℃), standby;
(5) merge the thick paste that described step (2), (3), (4) make, add the Concretio Silicea Bambusae fine powder that described step (1) makes, mixing, 80 ℃ dry down, be ground into fine powder, sieve, add appropriate amount of starch, mixing is distributed into capsule.
The invention has the beneficial effects as follows: the content of capsule prepared from cicada for soothing the nerves at night of the present invention mainly is to be made as crude drug by Concretio Silicea Bambusae, Periostracum Cicadae, Bombyx Batryticatus, Pheretima, Ramulus Uncariae Cum Uncis, Rhizoma Pinelliae Preparatum, Caulis Polygoni Multiflori, the Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Polygalae, it has the function of removing heat-phlegm, tranquillizing and allaying excitement, effective to Insomnia therapy, toxic action is little, is particularly suitable for treating type of phlegm-heat attacking internally insomnia.
Below further set forth the beneficial effect of capsule prepared from cicada for soothing the nerves at night of the present invention by testing example:
Test example one, capsule prepared from cicada for soothing the nerves at night Pharmacodynamic test of active extract
Summary:, observed capsule prepared from cicada for soothing the nerves at night and given animal and irritate the effect that occurs significantly analgesic, antiinflammatory, antibacterial, calm, hypnosis, convulsion, raising animal body immunologic function behind the stomach by animal experiment study.Each dosed administration group of capsule prepared from cicada for soothing the nerves at night all can make fever in rabbit body temperature reduce; Mice ear degree and rat paw edema degree alleviate, and bacteriostasis is arranged; Mice autonomic activities (scale of notation and walk about time and act forelimb method) reduces; The mice dropping asleep latency shortens, and prolong the length of one's sleep; The sleep number of animals increases, and improves the sleep percentage rate; Antagonism central stimulants-strychnine causes the mice convulsion effect; Mice carbon Cl is improved, make the weightening finish of young mice immune organ, the mice delayed hypersensitivity is strengthened, serum hemolysin is generated increase.Above result shows that capsule prepared from cicada for soothing the nerves at night has good preventive and therapeutic effect to the type of phlegm-heat attacking internally insomnia, so this medicine can provide clinic trial, further observes the curative effect of this medicine.
Purpose: analgesic, antibacterial, the antiinflammatory of observing that capsule prepared from cicada for soothing the nerves at night gives to be produced behind the animal gastric infusion, calmness, hypnosis, convulsion, and, treat the type of phlegm-heat attacking internally insomnia for tcm clinical practice is on probation experimental basis is provided the effect that the mice body's immunity influences.
1 experiment material
1.1 medicine: be subjected to the reagent capsule prepared from cicada for soothing the nerves at night, function: removing heat-phlegm, tranquillizing and allaying excitement; Cure mainly the type of phlegm-heat attacking internally insomnia.This medicine is provided by Xingguang Pharmaceutical Mfg. Co., Ltd., Zhuhai, lot number 20020329, the oral capsule dosage form, content is brown ceramic powder, every dress 0.4g, symphysis medicine 5.10g, every 1g capsule 's content symphysis medicine 12.75g, Coming-of-Age Day is (every day 2 times, each 5 with dosage, becoming body weight for humans to press 60kg calculates) 0.067g/kg, symphysis medicine 0.854g/kg.Be mixed with the suspension of variable concentrations during experiment with distilled water, put preserve in the refrigerator standby; Positive control drug---SHUMIAN JIAONANG provides [the accurate word of traditional Chinese medicines (1999) z-33 number] by the grand greatly pharmaceutical Co. Ltd in Guizhou, lot number 20010103, the oral capsule dosage form, content is brown ceramic powder, loading amount is the 0.4g/ grain, Coming-of-Age Day is 0.04g/kg with dosage, is mixed with suspension with distilled water during experiment and puts refrigerator and preserve standby; Pentobarbital is imported and exported sales department by Shanghai medicine and is provided, and lot number 20010908 is mixed with 4.5% and 3% pentobarbital sodium water solution with normal saline during experiment; The strychnine nitrate injection is provided by Shanghai Hefeng Pharmaceutical Co., Ltd., lot number 010901, and the ampoule dosage form, the 2mg/ milliliter is mixed with 0.015% strychnine solution with normal saline during experiment; India ink is provided by the daily jointing material in the Changjiang river factory, and lot number 98112 is mixed with 50% india ink aqueous solution with normal saline during experiment; 2,4 dinitrochlorobenzene (DNCB) are provided by Chinese Shanghai reagent one factory, lot number 981201.
1.2 animal: Kunming mouse, body weight 20～22g; The wistar rat, body weight 210 ~ 230g; Rabbit, body weight 2.5 ± 1.0kg; Cavia porcellus, body weight 300 ± 50g; Above animal ♀ ♂ dual-purpose provides by the Guiyang Medical College Experimental Animal Center, cleaning level, the quality certification numbers 200200018; Cock, commercially available (health).
1.3 key instrument: TMP-1 upper utensil type electronic balance (providing), 721 type spectrophotometers (the 3rd analytical tool factory provides by Shanghai), LD5-2A centrifuge (providing) by Beijing Medical Centrifugal Machine Factory by balance factory of Hunan Instrument General Factory.
2 experimental techniques and result
2.1 capsule prepared from cicada for soothing the nerves at night is to pyrogenicity rabbit refrigeration function
Get 30 of rabbit, weigh respectively, numbering; Under 20 ℃ of conditions of room temperature, survey normal body temperature, select body temperature to use for experiment 38 ~ 39 ℃ rabbit, be divided into five groups at random, every group 6, to every tame rabbit ear vein injection typhoid fever of each group, paratyphoid fever, second triple vaccine 0.5ml/kg body weight, rabbit body temperature raises and causes high thermal model rabbit behind the 5h by only; Press medicine shown in the table 1, dosage gastric infusion, 1h behind medicine, 3h, 5h, 7h measure each rabbit body temperature.The results are shown in Table 1.
Tangible refrigeration function just appears in capsule prepared from cicada for soothing the nerves at night 1h behind gastric infusion as seen from Table 1, and can continue 7h, with fever model rabbit comparing difference remarkable (P＜0.05～P＜0.01), and SHUMIAN JIAONANG group and blank group do not have refrigeration function to the hyperpyrexia rabbit.
Table 1 capsule prepared from cicada for soothing the nerves at night is to high thermal model rabbit refrigeration function (℃ x ± s n=6)
Group dosage is analgesic body temperature after the adstante febre pyrogenicity just often
(g/kg) body temperature body temperature 1h 3h 5h 7h
Blank group-38.3 ± 0.3 39.4 ± 0.4 39.9 ± 0.3 40.1 ± 0.3 39.7 ± 0.20 39.5 ± 0.3
Heavy dose of group 0.670 38.7 ± 0.3 39.3 ± 0.2 39.0 ± 0.18
*38.7 ± 0.27
*38.8 ± 0.13
*38.9 ± 0.2
*
Middle dosage group 0.335 38.9 ± 0.2 39.4 ± 0.4 39.2 ± 0.4
*38.9 ± 0.25
*39.1 ± 0.15
*38.9 ± 0.2
*
Small dose group 0.170 38.8 ± 0.2 39.4 ± 0.3 39.5 ± 0.3
*39.0 ± 0.3
*39.0 ± 0.20
*38.9 ± 0.2
*
SHUMIAN JIAONANG group 0.20 38.7 ± 0.2 39.3 ± 0.4 40.0 ± 0.3 40.0 ± 0.3 39.8 ± 0.30 39.2 ± 0.3
Annotate: relatively * P＜0.05 * * P＜0.01 of body temperature generates heat before body temperature and the medicine behind the medicine
2.2 capsule prepared from cicada for soothing the nerves at night bacteriostasis
2.2.1 experimental strain: staphylococcus aureus, Staphylococcus albus, Staphylococcus citreus, beta hemolytic streptococcus, escherichia coli, Bacillus typhi, Fu Shi dysentery bacterium, bacillus subtilis, bacillus pyocyaneus, lot number 20020601 is provided by microorganism teaching and research room of Guiyang College of Traditional Chinese Medicine.
2.2.2 culture medium: broth medium, ordinary nutrient agar, the blood agar plate (unit of providing: microorganism teaching and research room of Guiyang College of Traditional Chinese Medicine)
2.2.3 anticipate antibacterial and medicine: after routine cultivation 24h increased bacterium respectively with above-mentioned bacterial strains, transferred species was cultivated 6h respectively again, did dilution in 1: 1000 then and promptly used; To be mixed with the concentration that every 1ml contains 1g for reagent thing (capsule prepared from cicada for soothing the nerves at night content).
2.2.4 adopt the test of antimicrobial spectrum primary dcreening operation; The antibacterial strength qualitative test; The antibacterial strength quantitative test.
2.2.5 result
1. antimicrobial spectrum: experimental bacteria such as staphylococcus aureus, Staphylococcus albus, Staphylococcus citreus, beta hemolytic streptococcus, escherichia coli, Bacillus typhi, Fu Shi dysentery bacterium, bacillus subtilis, bacillus pyocyaneus are all had certain antibacterial action for reagent thing capsule prepared from cicada for soothing the nerves at night.
2. the antibacterial strength qualitative results sees Table 2
Table 2 capsule prepared from cicada for soothing the nerves at night antibacterial strength qualitative results
The big ileotyphus Fu Shi dysentery of golden yellow Portugal's white Portugal's lemon yellow Portugal hemolytic hay green pus
Strain
Grape coccus grape coccus grape coccus streptococcus bacillus bacillus Shigella bacillus bacillus
Inhibition zone is straight
2.0 1.9 1.7 1.9 1.4 1.3 1.1 1.2 1.3
Directly (cm)
3. the antibacterial strength quantitative test the results are shown in Table 3
Table 3 capsule prepared from cicada for soothing the nerves at night antibacterial strength quantitative result
Golden yellow
The beta hemolysis Fu Shi of the lemon yellow Portugal of white grapes dysentery bar
The dense Portugal of medicine escherichia coli Bacillus typhi bacillus subtilis bacillus pyocyaneus
Reagent coccus grape coccus property streptococcus bacterium
% grape coccus
Number
MIC MBC MIC MBC MIC MBC MIC MBC MIC MBC MIC MBC MIC MBC MIC MBC MIC MBC
- - - - - - - - - - - - - - - - - -
1 50.0
2 25.0 - - - - - - - - - + - - - - - + - +
3 12.50 - - - - - + - - - + - + - + - + - +
4 6.25 - - - + + + - - + + + + + + + + + +
5 3.13 - + - + + + - + + + + + + + + + + +
6 1.56 - + + + + + - + + + + + + + + + + +
7 0.78 + + + + + + + + + + + + + + + + + +
8 0.39 + + + + + + + + + + + + + + + + + +
Annotate: minimal inhibitory concentration (MIC), minimal bactericidal concentration (MBC), (-) expression has inhibitory action; (+) expression unrestraint effect.
2.2.6 conclusion: capsule prepared from cicada for soothing the nerves at night is to staphylococcus aureus, Staphylococcus albus, Staphylococcus citreus, beta hemolytic streptococcus, escherichia coli, Bacillus typhi, the Fu Shi dysentery bacterium, bacillus subtilis, experimental bacteria such as bacillus pyocyaneus all have certain antibacterial action, wherein to staphylococcus aureus, Staphylococcus albus, Staphylococcus citreus, the beta hemolytic streptococcus antibacterial action is stronger, to escherichia coli, Bacillus typhi, the Fu Shi dysentery bacterium, bacillus subtilis, the bacillus pyocyaneus antibacterial action a little less than, above antibacterial action and said preparation removing heat-phlegm function match.
2.3 capsule prepared from cicada for soothing the nerves at night antiinflammatory action
2.3.1 the capsule prepared from cicada for soothing the nerves at night xylol causes the bullate influence of mouse ear
Get 50 of Kunming mouses, ♀ ♂ half and half, body weight 20 ± 2g is divided into five groups at random, and 10 every group, press the described medicine of table 4, dosage gastric infusion respectively, once a day, continuous 5 days; Behind the last medicine 1 hour, be applied to dimethylbenzene 0.03ml and respectively organize two sides before and after every mouse right ear, clip ears during 15min, with the diameter two auricles about the card punch of 8mm takes off in same position, weigh respectively (mg), (auris dextra heavily deducts poor that left ear weighs, mg) to calculate every Mus ear swelling degree, organize a t check, swelling degree diversity between comparable group.The results are shown in Table 4.
By acute inflammation due to visible each the dosage xylol of capsule prepared from cicada for soothing the nerves at night of table 4 antagonism is in various degree arranged all, promptly show the reduce phlegm mechanism of function of capsule prepared from cicada for soothing the nerves at night.The inflammation that the SHUMIAN JIAONANG xylol brings out does not have the antagonism effect.
Table 4 capsule prepared from cicada for soothing the nerves at night xylol cause mice ear influence (x ± s, n=10)
Dosage body weight ear swelling degree inhibitory rate of intumesce
Group
(g/kg) (g) (mg) (％)
Blank group-21.0 ± 0.85 6.0 ± 1.21-
Heavy dose of group 1.34 21.1 ± 0.88 3.7 ± 1.16
* *38
Middle dosage group 0.67 20.8 ± 0.86 4.0 ± 1.20
*33
Small dose group 0.34 20.9 ± 0.94 4.4 ± 0.70
*27
SHUMIAN JIAONANG group 0.40 20.5 ± 0.76 6.1 ± 1.11-
Annotate: each administration group and blank group be * P＜0.05 * * P＜0.01 * * * P＜0.001 relatively
2.4 capsule prepared from cicada for soothing the nerves at night is to the mice sedation
2.4.1 influence (activity scale of notation) to the mice autonomic activities
Get 50 of ♀ mices, be divided into 5 groups at random, that is: the blank group---give distilled water 0.2ml/10g body weight and irritate stomach; The large, medium and small dosage group of capsule prepared from cicada for soothing the nerves at night---dosage is respectively 1.34g, 0.67g, 0.34g/kg (symphysis medicine 17.1g, 8.5g, 4.3g/kg), respectively, be mixed with 6.7%, 3.4%, 1.7% capsule prepared from cicada for soothing the nerves at night content suspension with distilled water during experiment and irritate stomach by the 0.2ml/10g body weight for 20 times, 10 times, 5 times of Coming-of-Age Day usefulness dosage 0.067g/kg (symphysis medicine 0.85g/kg); Positive drug control group---SHUMIAN JIAONANG group with the SHUMIAN JIAONANG content, is mixed with 2.0% suspension with distilled water and irritates stomach by the 0.2ml/10g body weight.In 8 o'clock～11 o'clock morning 20 ℃ ± 1 ℃ of room temperature experimentize, each organizes mice respectively by 20min behind the body weight gastric infusion, mice is placed in the mice activity inventory instrument, earlier behind the adaptation 5min, write down each Mus spontaneous activity number of times in the 5min again, calculate and respectively organize spontaneous activity in mice inhibition percentage rate (%).The results are shown in Table 5.
By visible each the dosage group of capsule prepared from cicada for soothing the nerves at night of table 5 spontaneous activity in mice all there is the obvious suppression effect, compares significant difference with the blank group; And can improve the spontaneous activity suppression ratio, more excellent than SHUMIAN JIAONANG effect.
Table 5 capsule prepared from cicada for soothing the nerves at night is to the influence of spontaneous activity in mice---activity scale of notation (x ± s n=10)
Spontaneous activity number of times suppression ratio in the dosage 5min
Group
(g/kg) (inferior) (%)
Blank group-11778 ± 3179-
Heavy dose of group 1.34 8017 ± 957
* *32
Middle dosage group 0.67 8419 ± 1059
*29
Small dose group 0.34 8367 ± 1814
*29
SHUMIAN JIAONANG group 0.40 10149 ± 2,300 14
Annotate: compare * * P＜0.01 * * *＜0.001 with the blank group
2.4.2 the influence that capsule prepared from cicada for soothing the nerves at night is walked about the time and lifted two forelimbs mice
Get 50 of ♂ mices, body weight 18～22g, random packet is with above-mentioned experimental project 2.4.1; After mice is placed on experimental box endoadaptation 5min respectively with each group, measures the time of walking about in each Mus 5min and forelimb and upwards praise number of times, as mice autonomic activities during each Mus normal condition before the administration.The same time of next day is pressed medicine shown in the table 6, dosage administration respectively; After with above-mentioned same procedure mice being put into experimental box endoadaptation 5min during 15min after the administration, measure the autonomic activities in each Mus 5min, between the gained result organizes and the comparison that changes of the forward and backward mice autonomic activities of administration, the results are shown in Table 6.
By table 6 as seen, respectively organize walk about time and forelimb of mice before the administration and upwards praise the number of times no significant difference, administration group and blank group are relatively after the administration, walk about time and forelimb upwards praised the number of times significant difference, administration group mice autonomic activities obviously reduces, after each administration group administration with administration before walk about time and forelimb of mice upwards praise number of times and obviously reduce, more excellent than the effect of positive control drug SHUMIAN JIAONANG.
Above result shows that capsule prepared from cicada for soothing the nerves at night has tangible sedation to the mice autonomic activities.
Table 6 capsule prepared from cicada for soothing the nerves at night is to mice autonomic activities inhibitory action (x ± s n=10)
After the preceding administration of administration
Dosage
Group
(g/kg)
(s) forelimb of walking about the time is upwards praised number of times (s) forelimb of walking about the time and is upwards praised number of times
Blank group-106.0 ± 9.75 24.8 ± 4.37 108.9 ± 11.32 24.1 ± 5.20
Heavy dose of group 1.34 109.3 ± 13.91 26.1 ± 5.38 41.4 ± 12.12
* * Δ Δ Δ15.2 ± 1.80
* * Δ Δ Δ
Middle dosage group 0.67 113.4 ± 17.96 26.2 ± 5.73 51.2 ± 10.1
* * Δ Δ Δ17.7 ± 2.58
* Δ Δ Δ
Small dose group 0.34 108.9 ± 15.63 24.7 ± 6.78 50.3 ± 10.1
* * Δ Δ Δ17.3 ± 2.91
* Δ Δ
SHUMIAN JIAONANG 0.40 113.8 ± 13.25 22.3 ± 5.59 56.3 ± 9.42
* * Δ Δ Δ17.2 ± 4.10
* △
Annotate: compare * * P＜0.01 * * * P＜0.001 with the blank group;
Compare before the medicine with behind the medicine
ΔP＜0.05
The Δ ΔP＜0.01
Δ Δ ΔP＜0.001.
2.4.3 capsule prepared from cicada for soothing the nerves at night causes the influence of mice sleep to pentobarbital sodium hypnosis amount
Get 100 of mices, the same experimental project 2.4.1 of random packet, 20 every group, ♀ ♂ half and half; Press medicine shown in the table 7, dosage gastric infusion, once a day, continuous three days; 30min and 60min take out half and half 10 mices of ♀ ♂ respectively behind the last medicine, with 4.5% pentobarbital sodium (45mg/kg) 0.1ml/10g body weight lumbar injection (ip), observe and write down the time of mice righting reflex loss and the time that the mice righting reflex recovers immediately, this time is respectively this mice dropping asleep latency (length of one's sleep occurring) and sleep time.The results are shown in Table 7.
By table 7 as seen: capsule prepared from cicada for soothing the nerves at night has collaborative pentobarbital sodium central inhibitory action, shows as two medicines and share the shortening of mice dropping asleep latency, and prolong the length of one's sleep, compares significant difference (P＜0.01, P＜0.001) with the blank group.Approximate with the SHUMIAN JIAONANG syngignoscism.
Table 7 capsule prepared from cicada for soothing the nerves at night is to the influence (x ± s n=10) of pentobarbital sodium syngignoscism
60min behind the 30min medicine after the administration
Dosage
Group
(g/kg) dropping asleep latency sleep time dropping asleep latency sleep time
(min) (min) (min) (min)
Blank group-8.60 ± 2.26 17.88 ± 2.8 9.60 ± 3.13 17.1 ± 4.51
Heavy dose of group 1.34 4.89 ± 1.79
* *88.56 ± 33.23
* *5.70 ± 1.89
*38.3 ± 12.11
* *
Middle dosage group 0.67 4.78 ± 1.10
* *56.00 ± 15.30
* *6.10 ± 1.66
*38.1 ± 13.91
* *
Small dose group 0.34 4.17 ± 1.85
* *34.75 ± 15.90
* *6.20 ± 1.99
*27.1 ± 6.77
*
SHUMIAN JIAONANG group 0.40 4.90 ± 1.85
* *48.40 ± 19.10
* *6.40 ± 2.07
*30.6 ± 7.37
* *
Annotate: each administration group and blank group are relatively
*P＜0.01
* *P＜0.001
2.4.4 capsule prepared from cicada for soothing the nerves at night is got 120 of mices to the imitative document of the influence of mice subliminal hypnosis dosage pentobarbital sodium effect, ♀ ♂ half and half, body weight 20～22g, random packet is with above-mentioned experimental project 2.4.1, after giving respectively to organize mice 30min and 60min by medicine shown in the table 8, dosage, by mice difference ip 3% a pentobarbital sodium solution 30mg/kg, observe and also write down the animal number of elements of respectively organizing mice righting reflex loss (promptly sleeping), calculate its sleep percentage rate.The results are shown in Table 8.By table 8 as seen, each group of capsule prepared from cicada for soothing the nerves at night and SHUMIAN JIAONANG group sleep number of animals obviously increase, and the sleep percentage rate obviously raises.As seen after the capsule prepared from cicada for soothing the nerves at night administration behind 30min and the medicine 60min syngignoscism all strong, the amount of being is imitated positive correlation, shows that capsule prepared from cicada for soothing the nerves at night and pentobarbital sodium share central inhibitory action is obviously strengthened.
Table 8 capsule prepared from cicada for soothing the nerves at night is to the synergistic influence of subliminal hypnosis dosage pentobarbital sodium (x ± s n=12)
60min behind the 30min medicine behind the medicine
Dosage
Group
(g/kg) the sleeping percentage rate of the sleeping number of animals of the sleeping percentage rate of sleeping number of animals
(only) (%) (only) (%)
Blank group-1 800
Heavy dose of group 1.34 7
*58 8
*66
Middle dosage group 0.67 4 33 7
*58
Small dose group 0.34 3 25 5 42
SHUMIAN JIAONANG group 0.40 3 25 5 42
Annotate: x
2Check is compared * P＜0.05 with the blank group
2.4.5 capsule prepared from cicada for soothing the nerves at night antagonism strychnine causes the mice convulsion effect
Get 50 of mices, be divided into 5 groups at random, 10 every group, ♀ ♂ half and half presses medicine shown in the table 9, dosage gastric infusion respectively, once a day, and continuous 3 days; 30min behind the last medicine, with 0.015% strychnine nitrate solution 0.1ml/10g body weight lumbar injection, the immediate record strychnine causes frightened incubation period (s) and mice mouse diing time (s), observing convulsions is index with excited, restless, perpendicular tail to clonism death, and its result learns by statistics to handle and organizes a t check.The results are shown in Table 9.
By table 9 as seen, the large, medium and small dosage of capsule prepared from cicada for soothing the nerves at night causes convulsions to strychnine all tangible antagonism, makes to cause obviously to prolong frightened incubation period, and the death time obviously prolongs.
Table 9 capsule prepared from cicada for soothing the nerves at night causes the influence that frightened dosage strychnine causes convulsions to mice
Group dosage number of animals convulsions animal death time incubation period
(g/kg) (only) (s) (s)
Blank group-10 173.4 ± 32.53 146.6 ± 17.48
Heavy dose of group 1.34 10 237.3 ± 52.92
*172.6 ± 16.65
*
Middle dosage group 0.67 10 225.7 ± 32.51
*178.9 ± 19.20
*
Small dose group 0.34 10 214.0 ± 28.69
*168.7 ± 12.73
* △
SHUMIAN JIAONANG group 0.40 10 188.8 ± 14.16 161. 0 ± 15.36
Annotate: compare * * P＜0.01 with the blank group
2.5 capsule prepared from cicada for soothing the nerves at night is to effect of immunologic function
2.5.1 to mice carbon Cl---the phagocytotic influence of reticuloendothelial cell
Get 50 of Kunming mouses, random packet, every group 10, ♀ ♂ half and half presses medicine shown in the table 10, dosed administration, once a day, continuous 8 days, 1h behind the last medicine was with 50% india ink 0.1ml/10g body weight tail vein injection, 2min, 12min get blood 0.02ml from eye socket respectively in the injection back, add to fill 0.1%Na
2CO
3Solution 2ml in vitro leaves standstill that (λ=680nm), read optical density calculates phagocytic index (K value) with 721 type spectrophotometer colorimetrics behind the 10min.Put to death mice after getting blood, get liver, spleen is weighed, calculation correction phagocytic index (α value).The results are shown in Table 10.
By table 10 as seen: except that capsule prepared from cicada for soothing the nerves at night small dose group K value, all the other respectively organize the K value, the α value all has tangible increase, compare significant difference (P＜0.05～P＜0.001) with the blank group.The dosage group is close with the SHUMIAN JIAONANG effect in the capsule prepared from cicada for soothing the nerves at night, shows that capsule prepared from cicada for soothing the nerves at night has the effect of the mice of raising non-specific immunity.
Table 10 capsule prepared from cicada for soothing the nerves at night is to the influence (x ± s n=10) of mice reticuloendothelial system phagocytic effect
Dosage
Group K value α value
(g/kg)
Blank group-0.0305 ± 0.0182 5.359 ± 1.216
Heavy dose of group 1.34 0.0575 ± 0.0336
*6.567 ± 1.056
*
Middle dosage group 0.67 0.0536 ± 0.0169
*6.600 ± 0.654
*
Small dose group 0.34 0.0436 ± 0.0138 6.717 ± 1.217
*
SHUMIAN JIAONANG group 0.40 0.0550 ± 0.0181
*6.922 ± 1.060
*
Annotate: compare *＜0.05 * * P＜0.01 with the blank group
2.5.2 capsule prepared from cicada for soothing the nerves at night is to the influence of young mice immune organ weight
Get 50 of young mices, body weight 14 ~ 16g is divided into 5 groups at random, and 10 every group, ♀ ♂ half and half presses medicine shown in the table 11 and dosage gastric infusion, once a day, and continuous 13 days; Each group mice was taken off cervical vertebra in the 14th day and put to death, cut open and get spleen and thymus is weighed respectively, and calculate spleen and thymus organ index.The results are shown in Table 11.
By table 11 as seen, except that the capsule prepared from cicada for soothing the nerves at night small dose group, all administration groups all have the trend of increase to mouse spleen, thymic weight and index, not statistically significant (P＞0.05), but can show that also capsule prepared from cicada for soothing the nerves at night has the function that can improve the mice nonspecific immunity to a certain degree.
Table 11 capsule prepared from cicada for soothing the nerves at night is to young mice immune organ weight and index influence (x ± s n=10)
Group dosage organ weights (g) organ index (g/10g body weight)
(g/kg) spleen thymus body weight spleen thymus
Blank group-0.106 ± 0.035 0.069 ± 0.030 22.14 ± 6.12 0.048 ± 0.0122 0.0305 ± 0.0092
Heavy dose of group 1.34 0.101 ± 0.028 0.079 ± 0.047 20.02 ± 2.66 0.0514 ± 0.0164 0.0340 ± 0.0139
Middle dosage group 0.67 0.107 ± 0.016 0.075 ± 0.022 19.83 ± 0.81 0.0548 ± 0.0112 0.0377 ± 0.0098
Small dose group 0.34 0.096 ± 0.024 0.063 ± 0.022 18.31 ± 4.73 0.0536 ± 0.0121 0.0339 ± 0.0056
SHUMIAN JIAONANG 0.40 0.096 ± 0.024 0.071 ± 0.038 18.90 ± 2.80 0.0517 ± 0.0155 0.0360 ± 0.0148
Annotate: each administration group and blank group compare P all＞0.05
2.5.3 capsule prepared from cicada for soothing the nerves at night is to the influence of mice delayed hypersensitivity (DTH)
Get 50 of Kunming mouses, random packet is with above-mentioned experimental project 2.5.1; Press medicine shown in the table 12, dosage gastric infusion, once a day, continuous 8 days; With 0.02ml/ back of 2.5%DNCB acetone solution subcutaneous injection sensitization, 1h only was coated with mouse right ear (attack) with 1%DNCB acetone solution 0.02ml/ behind the 8th day medicine in the 3rd day and the 5th day.Put to death mice and cut ears next day, is the auricle at the same position of two ears about the card punch of 8mm takes off with diameter, weighs respectively, calculates poor (the swelling degree) of two auricle weight.The results are shown in Table 12.
As seen from the table, big or middle dosage of capsule prepared from cicada for soothing the nerves at night and positive drug SHUMIAN JIAONANG all can make the mice ear degree obviously increase, and show that above two kinds of medicines all can obviously improve the mice specific immune function.
Table 12 capsule prepared from cicada for soothing the nerves at night is to the influence (x ± s n=10) of mice delayed hypersensitivity
Dosage ear swelling degree
Group
(g/kg) (mg)
Blank group-3.25 ± 1.41
Heavy dose of group 1.34 5.44 ± 2.13
*
Middle dosage group 0.67 5.15 ± 2.76
*
Small dose group 0.34 3.97 ± 1.72
SHUMIAN JIAONANG group 0.40 5.04 ± 1.24
*
Annotate: compare * P＜0.05 * * P＜0.01 with the blank group
2.5.4 capsule prepared from cicada for soothing the nerves at night is to the influence of mice serum hemolysin content
Get 50 of Kunming mouses, random packet is pressed medicine shown in the table 13, dosage gastric infusion, once a day, and continuous 9 times.Immunity is carried out with 5% chicken red blood cell (CRBC) 0.2ml/ lumbar injection of suspension (ip) in the 2nd day of administration, 1h behind the 9th day medicine, pluck eyeball and get blood and leave standstill 30min, get serum 10 μ 1, add normal saline (NS) 1ml, add 5%CRBC suspension and each 0.5ml of 10% complement again, mixing after putting 37 ℃ constant water bath box and hatching 30min, moves into refrigerator cooling 5min again, measure optical density (OD) value with spectrophotometer, observe hemolysin and generate situation.Other establishes not increase serum blank pipe supernatant work accent " 0 " benchmark, as the index of judging serum hemolysin, respectively organizes difference with optical density (OD) reading.The results are shown in Table 13.
Recording optical density value by visible each the dosage group of capsule prepared from cicada for soothing the nerves at night of table 13 all obviously increases, compare with the blank group, and P＜0.001 ~ P＜0.05, and the amount of being is imitated positive correlation.Positive drug SHUMIAN JIAONANG and small dose group are approximate, show that the administration group all can make the mice serum hemolysin generate and increase, and promptly the antibody generation increases; Illustrate that capsule prepared from cicada for soothing the nerves at night can improve mice humoral immunity of organism function, promptly improves mice body specific immune function.
Table 13 capsule prepared from cicada for soothing the nerves at night generates influence (x ± s n=10) to the mice hemolysin
Group dosage hemolysin
(g/kg)
Blank group-0.0812 ± 0.014
Heavy dose of group 1.34 0.1272 ± 0.026
* *
Middle dosage group 0.67 0.1151 ± 0.026
*
Small dose group 0.34 0.1115 ± 0.028
*
SHUMIAN JIAONANG group 0.40 0.1186 ± 0.036
*
Annotate: administration group and blank group be * P＜0.05 * * P＜0.01 * * * P＜0.001 relatively
3 conclusions
The result shows through the main pharmacodynamics zoopery, that capsule prepared from cicada for soothing the nerves at night has is significantly analgesic, suppress antibacterial, antiinflammatory is reduced phlegm, the effect of calmness, hypnosis, convulsion and raising immune function of mice, matches with clinical Chinese traditional treatment type of phlegm-heat attacking internally insomnia mechanism.Said preparation has refrigeration function to the hyperpyrexia rabbit, and various bacteria is had antagonism; Xylol induced mice ear swells the obvious suppression effect; The mice autonomic activities there is the obvious suppression effect, pentobarbital sodium hypnosis amount and subliminal hypnosis dosage syngignoscism are all had synergism; Mice RE phagocytic function is strengthened, the immune organ weightening finish, the delayed quick reaction that becomes improves, and the mice serum hemolysin is generated to be increased.
Above result shows that said preparation has the effect of heat clearing away, antiinflammatory, calmness, hypnosis, convulsion and human body immunity improving function; Therefore, capsule prepared from cicada for soothing the nerves at night has the pharmacological basis of good curing type of phlegm-heat attacking internally insomnia, and clinic trial can be provided.
Test example two, capsule prepared from cicada for soothing the nerves at night acute toxicity test
Summary: observe oral administration route, measure the test of capsule prepared from cicada for soothing the nerves at night maximum dosage-feeding.The result shows: the oral capsule prepared from cicada for soothing the nerves at night content of mice aqueous suspension, and maximum dosage-feeding is 28g/kg, symphysis medicine 357g/kg is equivalent to 418 times of adult's dosages every day.So, can think that clinical to draft adult oral administration dosage 0.067g/kg (symphysis medicine 0.854g/kg) be safe, so this product can provide clinic trial.
Purpose: after observing capsule prepared from cicada for soothing the nerves at night short-term orally give animal, toxic reaction that is produced and death condition, or maximum dosage, or calculate clinical adult's consumption safety multiple, the safety of this medicine of overall merit.
1 experiment material
1.1 medicine is provided by Guangdong Xingguang Pharmaceutical Mfg. Co., Ltd., Zhuhai by reagent thing capsule prepared from cicada for soothing the nerves at night, lot number: 20020329, the oral capsule dosage form, every 1g capsule 's content symphysis medicine 12.75g, drafting clinical Coming-of-Age Day is every day 2 times with dosage, each 5, and the 0.4g/ grain, this dosage is calculated as 0.067g/kg, symphysis medicine 0.854g/kg by kg body weight (becoming body weight for humans by 60kg).During experiment with distilled water be mixed with capsule prepared from cicada for soothing the nerves at night content suspension put in the refrigerator preserve standby.
1.2 the animal Kunming mouse, body weight 20 ± 2g, ♀ ♂ half and half is provided by the Guiyang Medical College Experimental Animal Center, the quality certification number: 0200015.Give raising conforming in 3 days earlier, experimentized in the 4th day.
2 experimental techniques
2.1 prerun experiment
Get 6 of mices, with capsule prepared from cicada for soothing the nerves at night content suspension Cmax 0.35g/ml (symphysis medicine 4.4625g/ml), maximum volume 0.4ml/10g body weight, give mice and once irritate stomach, this dosage 14g/kg (symphysis medicine 178.5g/kg) is equivalent to 209 times of adult's dosage every day 0.067g/kg (symphysis medicine 0.854g/kg); Observed 7 days, and do not cause dead mouse.Because of not measuring the median lethal dose(LD 50) (LD of medicine
50), so carry out the formal experiment of this product maximum dosage-feeding.
2.2 formal experiment
20 of Kunming mouses, ♀ ♂ half and half, fasting be can't help water 12 hours, gave mice 0.35g/ml capsule prepared from cicada for soothing the nerves at night content suspension 0.4ml/10g body weight, and in one day 2 times, dose amounts to 28g/kg, symphysis medicine 357g/kg.This dosage is equivalent to 418 times of adult's dosage every day 0.067g/kg (symphysis medicine 0.854g/kg) according to the weight.Conventional raising mice is 7 days after the administration, observes the mice performance day by day.
3 experimental results
After the mice administration in 7 days, remove after the administration mice and transient activity occurs and reduce, do not like bite, ingest outside, do not see that the toxic reaction and the phenomena of mortality appear in mice.This result shows that giving mice in 1 day irritates stomach capsule prepared from cicada for soothing the nerves at night suspension Cmax (0.35g/ml), heap(ed) capacity (0.4ml/10g body weight) 2 times, its dosage amounts to 28g/kg, symphysis medicine 357g/kg, be equivalent to be grown up 418 times of dosage 0.067g/kg every day (symphysis medicine 0.854g/kg), and unlikely animal dead.According to the literature: " it is then safer more than 100 times to it is generally acknowledged that according to the weight the mice maximum tolerated dose is equivalent to people's consumption, and clinic trial can be provided ".
Can think that according to above-mentioned experimental result the capsule prepared from cicada for soothing the nerves at night oral administration is very little to the acute toxicity of animal, clinically draft the adult to take said preparation 0.067g/kg (symphysis medicine 0.854g/kg) body weight every day be safe, clinic trial can be provided.
4 conclusion
Be subjected to drug level and volumetrical restriction, 1 gastric infusion of mice can not surveyed LD
50, measure through maximum dosage-feeding, give the mouse stomach administration 2 times in 1 day, maximum dosage-feeding is equivalent to 418 times of the clinical application amount, so can think that the acute toxicity of this product is low, oral safety.
Test example three, the test of capsule prepared from cicada for soothing the nerves at night long term toxicity test
Summary: continuous 8 weeks of rat irritate stomach (po) and give capsule prepared from cicada for soothing the nerves at night content 3.35g, 2.01g, 1.005g/kg, symphysis medicine 42.71g, 25.63g, 12.81g/kg body weight---three dosage group dosage are respectively 50 times, 30 times, 15 times that intend with clinical Coming-of-Age Day dosage 0.067g/kg (symphysis medicine 0.854g/kg) body weight (becoming body weight for humans by 60kg), and 2 weeks of drug withdrawal.Remove and respectively organize rat body weight, ingest day by day increase outside, do not observe and respectively organize obviously ANOMALOUS VARIATIONS such as rat behavior, activity, fur, defecation, do not observe and respectively organize rat blood cytology, the significant change of blood biochemical index (liver function, renal function), do not observe and respectively organize the rat major organs: the heart, liver, spleen, lung, kidney, adrenal gland, thymus coefficient ANOMALOUS VARIATIONS, above-mentioned internal organs pathological tissue inspection simultaneously shows no obvious abnormalities.
1 purpose
Observe heavy dose, long period, give rat continuously and repeat to irritate 8 weeks of stomach capsule prepared from cicada for soothing the nerves at night, to the toxigenicity reaction of rat institute, the order of severity and the symptom of appearance at first; Observe target organ and the recovery and the development of toxic reaction, determine nontoxic amounts of reactants, provide foundation for drafting the human safe dose.
2 experiment materials
2.1 the medicine capsule prepared from cicada for soothing the nerves at night is an oral capsule, every dress 0.4g, and symphysis medicine 5.1g, every 1g capsule 's content symphysis medicine 12.75g is provided lot number: 20020329 by Xingguang Pharmaceutical Mfg. Co., Ltd., Zhuhai.The capsule prepared from cicada for soothing the nerves at night content is a brown ceramic powder, is mixed with the variable concentrations suspension with distilled water during experiment, and refrigerator is preserved standby.
2.2 80 of animal wistar rats, ♀ ♂ half and half, body weight 100 ~ 120g is provided by the Guiyang Medical College Experimental Animal Center, the quality certification number: 0200015.
2.3 key instrument: SC-970 Automatic Blood Cell Analyzer, Switzerland Bei Ken company; The 7170A of Hitachi automatic clinical chemistry analyzer, U.S. Kodak.
2.4 experimental data statistics: represent with X ± S, organize a t check.
3 experimental techniques
3.1 the other group support of all every cage unisexuality of rat before and after the experiment condition administration, every cage with 5 rats of sex, are raised with full-valence pellet feed and are fed, and freely drink water 20 ~ 25 ℃ of room temperatures, humidity 55% ~ 65%.Observe 7 days general situations of rat before the administration earlier, no abnormal variation begins administration again and tests.
3.2 grouping and dosage
Get 80 of wistar rats, be divided into 4 groups at random, 20 every group, ♀ ♂ half and half is respectively as high, medium and low 3 kinds of dosage groups of capsule prepared from cicada for soothing the nerves at night and blank group (matched group).Administration group dosage is respectively 3.35g, 2.01g, 1.005g/kg (symphysis medicine 42.71g, 25.63g, 12.81g/kg), respectively for drafting 50 times, 30 times, 15 times with dosage 0.067g/kg (symphysis medicine 0.854g/kg) body weight of clinical Coming-of-Age Day.Before the experiment capsule prepared from cicada for soothing the nerves at night content is mixed with 33.5%, 20.1%, 10.05% capsule prepared from cicada for soothing the nerves at night suspension with distilled water, place preserve in the refrigerator standby.The administration volume is the 10ml/kg body weight.
3.3 route of administration and method
Because capsule prepared from cicada for soothing the nerves at night clinical application approach is an oral administration, so respectively organize equal gastric infusion, every day, at 8 o'clock in the morning, animal was irritated stomach once on an empty stomach, continuous 8 weeks; Claim the weight of animals weekly once, increase according to the weight of animals and change the adjustment dosage.
3.4 the test period
Testing total cycle was 10 weeks, and preceding 8 weeks are administration time, and 2 weeks of back are drug withdrawal recovery time; Animal has non-toxic reaction during at first observing 8 weeks of administration, gets the half sacrifice of animal for every group, measures every index, after all the other half animal drug withdrawals raised for 2 weeks, detects every index with above-mentioned method.
4 inspection items
4.1 overview food-intake, body weight, mode of appearance sign, behavioral activity, stool character etc.; Find that the poisoning animal isolates primary part observation immediately; Find dead or dying animal, postmortem at once.
4.2 8 weeks of test item successive administration, behind the last medicine 24 hours, after claiming rat body weight, every treated animal half ♀ ♂ half and half, femoral vein gets that blood tests that blood cell is learned, blood biochemical is learned after the index sacrifice of animal, cut open immediately and get each Mus major organs heart, liver, spleen, lung, kidney, adrenal gland, thymus, weigh respectively, calculate the acropetal coefficient; Drawing materials in same position is soaked in 10% formalin and fixes again, and carries out paraffin embedding, section, HE dyeing; Put observation by light microscope and compare at first comparison check high dose group and control animals tissue slice, the variation of observation organ tissue morphology with matched group.
Hematological examination index: erythrocyte (RBC) counting, erythrocyte volume (HCT), mean corpuscular volume (MCV), hemoglobin (Hgb), hemoglobin average magnitude (MCH), platelet (PLT), leukocyte (WBC) counting, lymphocyte (LY), granulocyte (GR), mononuclear cell (MO).
Blood biochemical is learned (liver, renal function) and is checked index: blood urea nitrogen (BUN), creatinine (Crea), ALT (ALT), aspartic acid aminotransferase (AST), total protein (TP), albumin (ALB), alkali phosphatase (AKP) content.
4.3 every day index observing time all laboratory animals of complete observation general situation, the animal activity behavior, the stool character, outward appearance sign, feedstuff consumption at night; Weigh weekly once; Behind administration 8 all last medicines 24 hours, and 2 weeks of drug withdrawal recover the end of term, respectively carry out once comprehensive inspection of every index.
5 experimental results
5.1 capsule prepared from cicada for soothing the nerves at night to the influence of rat ordinary circumstance and feed in 8 weeks of successive administration and 2 weeks of drug withdrawal, each administration group and matched group are compared, observe animal activity, behavior, diet, stool, hair luster etc., the two treated animal situations of observing are similar, show no obvious abnormalities variation.Interior at one time rat food ration male mouse has increase slightly than female Mus, but no significant difference.The results are shown in Table 1-1, table 1-2.
5.2 capsule prepared from cicada for soothing the nerves at night sees Table 2-1, table 2-2 to the experimental result that influences of rat body weight.
In show as seen, body weight and the matched group comparison of the high, medium and low three kinds of dosage of capsule prepared from cicada for soothing the nerves at night after, its difference not statistically significant (P＞0.05) to rat successive administration different time; But the female Mus body weight gain of male Mus weight ratio is slightly high.Be that experimental result shows in big capsule prepared from cicada for soothing the nerves at night dosage, the medication longer course of treatment (8 week) and 2 weeks of drug withdrawal rat growthing development (body weight gain) avirulence influenced.
5.3 influencing experimental result to the rat blood cytology, capsule prepared from cicada for soothing the nerves at night sees Table 3-1, table 3-2.
As seen from the table, the high, medium and low 3 kinds of dosage of capsule prepared from cicada for soothing the nerves at night are to 8 weeks of rat successive administration and 2 weeks of drug withdrawal, and the routine blood test of rat be there is no appreciable impact; The numerical value of numerical value such as each administration treated animal RBC, Hgb, PCT, WBC and matched group is approaching; Compare with matched group, learn by statistics and handle P＞0.05; Therefore, can think that capsule prepared from cicada for soothing the nerves at night is heavy dose of, long period (8 week) administration, and 2 weeks of drug withdrawal, the hemopoietic function of rat there is not significant toxic effect.
5.4 capsule prepared from cicada for soothing the nerves at night sees Table 4-1, table 4-2 to the experimental result that influences of rat blood biochemical (liver function, kidney merit).
As seen from the table, the high, medium and low 3 kinds of dosage of capsule prepared from cicada for soothing the nerves at night are to 8 weeks of rat successive administration and 2 weeks of drug withdrawal, and the every biochemical indicator numerical value of liver function of rat and renal function is compared with the matched group respective value respectively, does not see notable difference, P＞0.05; So show more heavy dose of 8 weeks of continuous use of capsule prepared from cicada for soothing the nerves at night and 2 weeks of drug withdrawal rats'liver function, renal function all do not had remarkable toxic action.
5.5 capsule prepared from cicada for soothing the nerves at night sees Table 5-1, table 5-2 to the experimental result that influences of rat major organs coefficient.
As seen from the table, the high, medium and low 3 kinds of dosage of capsule prepared from cicada for soothing the nerves at night are to 8 weeks of rat successive administration and 2 weeks of drug withdrawal, and the rat vitals: the numerical value and the matched group of the heart, liver, spleen, lung, kidney, adrenal gland, thymic weight coefficient are all close; Learn by statistics and handle, every index value of each administration group and matched group compare, and there are no significant for its difference, and P all＞0.05.Show capsule prepared from cicada for soothing the nerves at night heavy dose of long-term (8 week) filling stomach and 2 weeks of drug withdrawal, rat organ's weight coefficient is not had obvious influence.
5.6 capsule prepared from cicada for soothing the nerves at night was 8 weeks to the influence of rat important organ histopathology form to the capsule prepared from cicada for soothing the nerves at night successive administration, and two batches of 2 weeks of drug withdrawal, got rat extremely and separate to cut the heart, liver, spleen, lung, kidney, adrenal gland, the thymus of respectively organizing rat; Draw materials in same area, fix with 10% formalin.High dose group and blank group Rats Organs and Tissues Aliquoting are carried out tissue slice, carry out pathological examination.
The result: through two treated animal organ specimens are surveyed sample, various organ structures are normal substantially, and cell dyeing is even, do not have obviously to change.Because appearring in the checked organ of high dose group animal, the pathogenic reason of medicine do not change, so centering dosage group and low dose group are carried out the organ-tissue section.
During table 1-1 long-term 8 weeks of successive administration of capsule prepared from cicada for soothing the nerves at night and 2 weeks of drug withdrawal to the influence of the per day food-intake of ♀ rat (x ± s)
Dosage group low dose group in the cycle blank group high dose group
1 77.07±08.10 75.29±09.98 75.64±08.64 77.21±08.59
2 107.86±10.80 108.86±11.89 105.86±08.82 103.50±08.36
3 135.71±10.90 139.71±15.00 126.33±13.84 126.36±13.48
4 189.93±22.11 185.79±24.72 187.79±16.78 186.14±25.74
5 231.71±15.25 231.36±20.53 222.36±16.35 226.93±20.42
6 279.36±17.36 275.43±18.90 271.64±19.00 281.57±15.20
7 336.64±23.56 344.86±29.45 340.64±37.62 345.07±36.54
8 368.14±38.57 420.50±51.18 397.29±42.94 387.50±39.23
9 226.22±6.48 217.07±10.44 222.29±5.28 216.57±5.05
10 237.07±04.92 335.15±5.19 234.65±7.57 237.86±6.17
Annotate: each administration group and matched group compare, P＞0.05; 1～8 week was administration phase food-intake, g/10/day, and n=10;
9～10 weeks were the withdrawal time food-intake, g/5/day, and n=5.
During table 1-2 long-term 8 weeks of successive administration of capsule prepared from cicada for soothing the nerves at night and 2 weeks of drug withdrawal to the influence of the per day food-intake of ♂ rat (x ± s)
Dosage group low dose group in the cycle matched group high dose group
1 77.57±04.48 80.14±06.25 78.00±07.30 80.79±06.82
2 120.00±16.60 110.43±10.31 112.79±13.28 111.14±16.11
3 146.07±16.03 141.57±15.34 138.43±12.95 132.92±12.09
4 190.57±27.91 189.14±27.08 196.79±24.18 191.43±20.68
5 242.14±14.87 240.64±20.41 235.86±15.11 241.29±19.87
6 292.86±18.56 287.43±16.97 284.00±19.09 288.14±19.90
7 365.29±37.90 361.29±33.39 353.21±31.51 367.71±35.66
8 417.93±27.38 424.79±37.96 414.29±49.26 369.79±39.90
9 223.57±9.19 221.72±8.32 225.15±5.70 223.36±04.82
10 241.22±5.68 239.50±7.87 239.15±04.38 243.57±13.45
Annotate: each administration group and matched group compare, P＞0.05; 1～8 week was administration phase food-intake, g/10/day, and n=10;
9～10 weeks were the withdrawal time food-intake, g/5/day, and n=5.
During table 2-1 long-term 8 weeks of successive administration of capsule prepared from cicada for soothing the nerves at night and 2 weeks of drug withdrawal to the influence of ♀ rat body weight (g) (x ± s)
Dosage group low dose group in the cycle blank group high dose group
1 119.30±7.40 118.30±06.68 120.60±08.11 120.40±08.63
2 133.70±10.01 131.1±07.17 134.00±06.50 130.70±05.77
3 151.10±08.76 151.8±07.44 151.70±07.29 149.20±6.70
4 160.00±17.66 169.2±21.70 164.1±22.46 165.00±19.80
5 182.70±18.03 182.2±15.08 183.8±17.06 187.10±23.88
6 198.70±17.31 200.50±22.86 198.50±15.11 207.00±09.10
7 229.10±22.03 220.00±22.85 217.40±24.71 210.50±12.91
8 256.50±18.04 254.4±22.07 243.90±17.69 240.50±14.32
9 264.80±06.42 272.00±21.97 269.80±11.30 269.00±15.59
10 270.70±12.94 277.00±20.80 275.80±20.51 277.40±23.56
Annotate: each administration group and matched group compare, and P＞0.05,1～8 weeks are administration phase, n=10;
9～10 weeks were withdrawal time, n=5.
During table 2-2 long-term 8 weeks of successive administration of capsule prepared from cicada for soothing the nerves at night and 2 weeks of drug withdrawal to ♂ rat body weight (g) influence (x ± s)
Dosage group small dose group in the heavy dose of group of cycle matched group
1 121.00±09.30 118.10±13.95 121.80±14.94 123.40±12.04
2 138.70±07.89 138.80±13.34 138.50±10.30 141.70±11.27
3 157.70±09.32 160.40±09.47 160.60±09.43 161.20±10.73
4 168..30±20.33 166.00±20.61 167.00±22.36 167.80±21.26
5 184.40±20.44 183.30±14.02 184.90±20.28 195.70±06.86
6 202.40±21.40 22.00±31.18 205.50±21.66 210.00±26.14
7 217.00±25.30 223.10±30.83 227.00±20.03 225.10±22.41
8 252.70±23.90 253.40±24.73 255.70±17.53 254.10±17.37
9 280.60±12.52 279.00±19.85 282.80±21.75 274.20±19.58
10 286.00±21.91 281.00±21.62 289.00±20.43 282.00±19.24
Annotate: each administration group and matched group compare, and P＞0.05,1～8 weeks are administration phase, n=10;
9～10 weeks were withdrawal time, n=5.
Table 3-1 long-term 8 weeks of successive administration of capsule prepared from cicada for soothing the nerves at night are to the influence (X ± S n=10) of rat blood cytology index
Group dosage RBC HCT MCV Hgb MCH PLT WBC WDC%
g/kg (×10
12/L) (％) (fl) (g/L) (pg) (×10
9/L) (×10
9/L) LY MO GR
Matched group-7.04 ± 0.61 39.92 ± 5.78 55.80 ± 4.10 135.60 ± 10.86 19.00 ± 0.82 495.20 ± 253.44 5.63 ± 1.10 67.60 ± 9.52 3.70 ± 0.95 28.70 ± 9.12
Cicadae pacifies 3.35 7.62 ± 0.45 41.71 ± 2.58 54.90 ± 2.85 142.00 ± 9.04 18.80 ± 0.92 561.70 ± 244.30 5.48 ± 1.67 70.20 ± 14.00 3.80 ± 0.75 26.00 ± 13.86 night
Refreshing capsule
2.01 7.18±0.33 39.73±2.68 55.00±2.36 138.60±7.60 18.8±0.79 616.60±116.47 5.60±1.69 74.50±3.78 3.90±0.88 22.50±4.55
1.01 6.87±0.47 38.04±2.93 55.60±2.12 128.00±6.39 18.80±0.42 506.80±127.88 5.17±1.31 69.10±4.61 3.40±0.84 24.50±3.98
Annotate: each administration treated animal blood cell learn every index value respectively with matched group corresponding index numeric ratio than P＞0.05
Long-term 8 back 2 weeks of drug withdrawal in week of successive administration of table 3-2 capsule prepared from cicada for soothing the nerves at night are to the influence (X ± S n=10) of rat blood cytology index
Group dosage RBC HCT MCV Hgb MCH PLT WBC WDC%
g/kg (×10
12/L) (％) (fl) (g/L) (pg) (×10
9/L) (×10
9/L) LY MO GR
Matched group-7.13 ± 0.42 38.25 ± 3.17 53.50 ± 1.96 136.20 ± 7.80 19.1 ± 0.88 496.0 ± 166.98 4.08 ± 1.68 86.2 ± 3.33 2.7 ± 0.82 11.3 ± 2.87
Cicadae pacifies 3.35 7.24 ± 0.52 39.89 ± 4.53 54.80 ± 2.49 131.3 ± 6.04 18.2 ± 0.92 444.8 ± 117.66 5.30 ± 1.91 85.1 ± 3.81 3.0 ± 0.82 12.1 ± 3.48 night
Refreshing capsule
2.01 7.09±0.69 38.73±4.17 54.60±2.32 131.4±11.40 18.6±0.84 426.4±134.68 4.85±2.56 86.3±2.56 3.4±0.97 10.3±4.67
1.01 6.84±0.60 37.84±4.88 54.70±2.68 128.8±8.90 19.0±0.94 498.4±157.68 5.33±1.59 85.9±1.59 3.3±0.82 10.8±5.07
Annotate: each administration treated animal blood cell learn every index value respectively with matched group corresponding index numeric ratio than P＞0.05
Table 4-1 long-term 8 weeks of successive administration of capsule prepared from cicada for soothing the nerves at night to rat blood biochemical indicator influence (x ± s, n=10)
Group dosage BUN Crea ALT AST TP ALB AKP
g/kg mmol/L μmol/L u/L u/L g/L g/L u/L
Matched group-7.68 ± 3.87 31.2 ± 14.9 71.0 ± 17.13 336.1 ± 89.63 73.67 ± 9.84 33.80 ± 3.01 301.2 ± 13.60
Cicadae pacifies 3.35 8.04 ± 1.06 28.5 ± 3.89 71.5 ± 11.77 296.9 ± 61.51 77.91 ± 4.20 35.07 ± 1.50 350.2 ± 11.05 night
Refreshing capsule
2.01 8.05±0.90 28.0±2.49 60.2±26.90 322.9±80.39 76.11±4.12 33.86±2.09 348.6±99.88
1.01 7.81±1.11 26.9±4.51 68.7±15.41 301.6±74.21 75.15±3.87 32.83±3.04 362.2±96.17
Annotate: each administration treated animal blood parameters numerical value respectively with blank group corresponding index numeric ratio than P＞0.05
2 weeks of drug withdrawal in table 4-2 long-term 8 weeks of successive administration of capsule prepared from cicada for soothing the nerves at night to rat blood biochemical indicator influence (x ± s, n=10)
Group dosage BUN Crea ALT AST TP ALB AKP
g/kg mmol/L μmol/L u/L u/L g/L G/L u/L
Matched group-7.03 ± 1.98 60.20 ± 10.14 50.5 ± 15.20 221.3 ± 50.20 67.68 ± 6.60 34.20 ± 3.00 309.0 ± 83.3
Cicadae pacifies 3.35 8.28 ± 0.69 65.43 ± 10.50 53.7 ± 14.98 186.6 ± 33.48 74.27 ± 5.90 36.74 ± 3.98 280.6 ± 50.0 night
Refreshing capsule
2.01 8.16±1.21 65.52±6.37 50.5±10.41 180.7±38.58 75.18±4.43 36.36±3.51 293.4±66.2
1.01 7.56±0.94 59.23±8.50 56.0±11.96 188.7±25.90 75.24±6.43 38.24±5.30 243.8±48.9
Annotate: each administration treated animal blood parameters numerical value respectively with blank group corresponding index numeric ratio than P＞0.05
The table 5-1 long-term 8 weeks of successive administration of capsule prepared from cicada for soothing the nerves at night to the exponential influence of rat main organs (g/100g body weight) (s ± x, n=10)
Group dosage conscience spleen lung kidney adrenal gland thymus
g/kg
Matched group-0.33 ± 0.05 3.22 ± 0.66 0.30 ± 0.02 0.81 ± 0.09 0.70 ± 0.10 0.024 ± 0.005 0.018 ± 0.003
Cicadae pacifies 3.35 0.32 ± 0.05 3.33 ± 0.27 0.31 ± 0.03 0.87 ± 0.12 0.67 ± 0.10 0.024 ± 0.004 0.017 ± 0.003 night
Refreshing capsule
2.01 0.34±0.04 3.36±0.32 0.32±0.07 0.87±0.06 0.63±0.10 0.025±0.007 0.017±0.004
1.01 0.33±0.04 3.32±0.09 0.29±0.03 0.79±0.05 0.70±0.06 0.025±0.005 0.018±0.002
Annotate: each administration treated animal main organs coefficient index value respectively with blank group corresponding index numeric ratio, P＞0.05.
Long-term 8 back 2 weeks of drug withdrawal in week of successive administration of table 5-2 capsule prepared from cicada for soothing the nerves at night to the exponential influence of rat main organs (g/100g body weight) (s ± x, n=10)
Group dosage conscience spleen lung kidney adrenal gland thymus
g/kg
Matched group-0.33 ± 0.026 3.58 ± 0.69 0.29 ± 0.085 0.981 ± 0.165 0.646 ± 0.068 0.022 ± 0.004 0.0174 ± 0.002
Cicadae pacifies 3.35 0.34 ± 0.032 3.27 ± 0.43 0.306 ± 0.091 0.842 ± 0.104 0.691 ± 0.01 10.022 ± 0.005 0.0181 ± 0.004 night
Refreshing capsule
2.01 0.35±0.038 3.09±0.21 0.285±0.067 0.968±0.274 0.671±0.066 0.023±0.007 0.0151±0.004
1.01 0.34±0.050 3.04±0.42 0.29±0.051 0.795±0.141 0.635±0.011 0.027±0.008 0.0168±0.005
Annotate: each administration treated animal main organs coefficient index value respectively with blank group corresponding index numeric ratio, P＞0.05.
6 conclusion
The result shows through the rat long term toxicity test,---be respectively 50 times, 30 times, 15 times that draft clinical Coming-of-Age Day consumption 0.067g/kg (symphysis medicine 0.854g/kg) body weight---once a day with capsule prepared from cicada for soothing the nerves at night content 3.35g, 2.01g, three kinds of dosage of 1.005g/kg body weight (the symphysis medicine is 42.71g, 25.63g, 12.81g/kg body weight), continuous 8 weeks to rat oral gavage administration and drug withdrawal after 2 weeks, with the matched group of irritating the stomach distilled water relatively; Various dosed administrations are to the general state (mode of appearance, activity, stool shape etc.) of rat, growth promoter (body weight gain), hemopoietic function (hematological examination), liver, renal function (blood biochemical), the vitals weight coefficient all finds no tangible toxic action; Prove that through pathological examination high dose group and matched group comparative observation to the rat heart, liver, spleen, lung, kidney, adrenal gland, thymic tissue, all find no tangible toxic damages and change.
So the toxicity of can think heavy dose of, taking capsule prepared from cicada for soothing the nerves at night the longer course of treatment is lower, take safelyr, clinic trial can be provided.
The specific embodiment
Embodiment:
Capsule prepared from cicada for soothing the nerves at night of the present invention, its content mainly are to be made by the following raw materials in weight medicine:
Concretio Silicea Bambusae 267g Periostracum Cicadae 500g Bombyx Batryticatus 267g
Pheretima 667g Ramulus Uncariae Cum Uncis 833g Rhizoma Pinelliae Preparatum 333g
Caulis Polygoni Multiflori 833g Radix Paeoniae Alba 500g Semen Ziziphi Spinosae 500g
Radix Polygalae 400g
Above crude drug is made 1000 of capsules.
Its preparation method comprises the following steps:
(1) get the Concretio Silicea Bambusae of 1/3 amount of described weight, 80 ℃ dry 4 hours down, be ground into fine powder, standby;
(2) Caulis Polygoni Multiflori of getting described weight adds 8 times of amount 70% alcohol reflux 2 hours, filters, and medicinal residues add 6 times of amount 70% alcohol reflux 1.5 hours again, merge reflux extracting liquid, filter filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.30～1.35 (70 ℃), standby;
(3) Bombyx Batryticatus of getting described weight adds 10 times of water gagings and decocts and extracted 1.5 hours, filters, and medicinal residues add 8 times of water gagings again and decoct and extracted 1 hour, collecting decoction filters, and filtrate is concentrated into the clear paste of relative density 1.10～1.15 (70 ℃), put cold, add ethanol and make and contain alcohol amount and reach 70%, stir evenly, left standstill 24 hours, filter, filtrate recycling ethanol is concentrated into the thick paste of relative density 1.30～1.35 (70 ℃), and is standby;
(4) getting the Periostracum Cicadae, Pheretima, Rhizoma Pinelliae Preparatum, the Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Polygalae of described weight and 2/3 amount Concretio Silicea Bambusae adds 10 times, 8 times water gagings respectively and decocts and extract secondaries, 2 hours for the first time, 1 hour for the second time, the Ramulus Uncariae Cum Uncis medical material that when extracting for the second time, adds described weight, collecting decoction, filter, filtrate is concentrated into the clear paste of relative density 1.10～1.15 (70 ℃), puts coldly, adds ethanol and makes and contain alcohol amount and reach 70%, stir evenly, left standstill 24 hours, and filtered filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.30～1.35 (70 ℃), standby;
(5) merge the thick paste that described step (2), (3), (4) make, add the Concretio Silicea Bambusae fine powder that described step (1) makes, mixing, 80 ℃ dry down, be ground into fine powder, sieve, add appropriate amount of starch, mixing is distributed into 1000 of capsules.
Claims (2)
1. a capsule prepared from cicada for soothing the nerves at night is characterized in that, its content mainly is former by following weight portion
The material medicine is made:
267 parts of 500 parts of Bombyx Batryticatus of 267 portions of Periostracum Cicadaes of Concretio Silicea Bambusae
333 parts of 833 parts of Rhizoma Pinelliae Preparatum of 667 parts of Ramulus Uncariae Cum Uncis of Pheretima
500 parts of 500 parts of Semen Ziziphi Spinosaes of 833 portions of Radix Paeoniae Albas of Caulis Polygoni Multiflori
400 parts of Radix Polygalaes
2. the preparation method of the described capsule prepared from cicada for soothing the nerves at night of claim 1 is characterized in that, it comprises the following steps:
(1) get the Concretio Silicea Bambusae of 1/3 amount of described weight proportion, 80 ℃ dry 4 hours down, be ground into fine powder, standby;
(2) Caulis Polygoni Multiflori of getting described weight proportion adds 8 times of amount 70% alcohol reflux 2 hours, filters, and medicinal residues add 6 times of amount 70% alcohol reflux 1.5 hours again, merge reflux extracting liquid, filter filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.30～1.35 (70 ℃), standby;
(3) Bombyx Batryticatus of getting described weight proportion adds 10 times of water gagings and decocts and extracted 1.5 hours, filters, and medicinal residues add 8 times of water gagings again and decoct and extracted 1 hour, collecting decoction filters, and filtrate is concentrated into the clear paste of relative density 1.10～1.15 (70 ℃), put cold, add ethanol and make and contain alcohol amount and reach 70%, stir evenly, left standstill 24 hours, filter, filtrate recycling ethanol is concentrated into the thick paste of relative density 1.30～1.35 (70 ℃), and is standby;
(4) getting the Periostracum Cicadae, Pheretima, Rhizoma Pinelliae Preparatum, the Radix Paeoniae Alba, Semen Ziziphi Spinosae, Radix Polygalae of described weight proportion and 2/3 amount Concretio Silicea Bambusae adds 10 times, 8 times water gagings respectively and decocts and extract secondaries, 2 hours for the first time, 1 hour for the second time, the Ramulus Uncariae Cum Uncis medical material that when extracting for the second time, adds described weight proportion, collecting decoction, filter, filtrate is concentrated into the clear paste of relative density 1.10～1.15 (70 ℃), puts coldly, adds ethanol and makes and contain alcohol amount and reach 70%, stir evenly, left standstill 24 hours, and filtered filtrate recycling ethanol, be concentrated into the thick paste of relative density 1.30～1.35 (70 ℃), standby;
(5) merge the thick paste that described step (2), (3), (4) make, add the Concretio Silicea Bambusae fine powder that described step (1) makes, mixing, 80 ℃ dry down, be ground into fine powder, sieve, add appropriate amount of starch, mixing is distributed into capsule.
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