CN108283662A - It is a kind of to treat neurasthenic cassia tree bark oil dripping pill and preparation method thereof - Google Patents
It is a kind of to treat neurasthenic cassia tree bark oil dripping pill and preparation method thereof Download PDFInfo
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- 239000011159 matrix material Substances 0.000 claims abstract description 46
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- 230000002936 tranquilizing effect Effects 0.000 claims abstract description 15
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- Health & Medical Sciences (AREA)
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Abstract
Neurasthenic cassia tree bark oil dripping pill and preparation method thereof is treated the invention discloses a kind of, is formed through dripping by 2 parts of cinnamon oils and 7~25 parts of matrix.Cassia tree bark oil dripping pill has the advantages that drugloading rate is big, dose is small, bioavilability is high, action is rapid.It is verified by experiments, cassia tree bark oil dripping pill has the function of tranquilizing the mind hypnosis, antidepression, antifatigue, can be used for treating neurasthenia.
Description
Technical field
The invention belongs to the field of Chinese medicines, are related to a kind of for treating neurasthenic Chinese medicine preparation and preparation method thereof.
Background technology
Neurasthenia is due to being chronically under nervous and pressure, the easily excited and mental easily tired phenomenon of spirit occur, often
With symptoms such as emotional handicap, sleep disturbance, neurasthenia in traditional Chinese medicine category lily disease, be insomnia, melancholia, the emotional disorders model such as manic
Farmland.Its interpretation of the cause, onset and process of an illness cold and heat and asthenia and sthenia is mixed, changeful.Modern medicine there is no specific drug to treat.According to《Synopsis Golden Chamber lily fox is puzzled
YIN YANG toxin syndrome abnormal pulse is demonstrate,proved and is controlled》, after neurasthenia arises from typhoid fever serious disease, waste heat does not solve, or feelings will is unsuccessful usually, and meets extraneous essence
Caused by god's stimulation.Neurasthenia be modern society common disease and frequently-occurring disease, be mainly seen in 15 years old~59 years old crowd, at present its
Incidence steeply rises, and in global range, is once had reached 4.5 hundred million at present by neurasthenic uncomfortable crowd's quantity in life
People.Therefore, numerous medical personals' focus of attention is had become for neurasthenic treatment.In clinical treatment, chemical drugs
Have the characteristics that effect is rapid, curative for effect to neurasthenia, but its side effect is larger.Therefore, Chinese medicine treatment neurasthenia obtains
More concerns have been arrived, and have had its apparent advantage.It controls nerve for example, Lan Fusen etc. reports coptis Chinese cassia tree radix scrophulariae honey soup and declines
Weak efficacious prescriptions (bee magazine, 2006 (08):34).But the compound complicated component of Chinese medicine, the active ingredient to play a crucial role are difficult to
It determines, needs to set about carrying out experimental study from single medicinal material, neurasthenic active ingredient is treated in extraction, promotes Chinese medicine treatment god
Through weak effect and drug development.
Cinnamon oil (also known as cassia oil), record in《Chinese Pharmacopoeia》It 2015 editions one, with mends fire supporing yang, ignites and returns
Source, eliminating cold to stop pain, invigorate blood circulation and other effects.The volatilization of bark, branch, leaf through distillation gained of cinnamon oil system canella Chinese cassia tree
Oil.The main component of cinnamon oil is cinnaldehydrum, accounts for about 70%~85%.Having not yet to see related cinnamon oil has treatment nerve
The report of weak effect.
TCM Dripping Pills are that specific support is added in the extract of Chinese medicine, solid by fusion method or solvent-fusion method etc.
Body dispersion technology, which is first made, makes the solid dispersion of drug in a highly dispersed state, is then added dropwise to immiscible with pharmaceutical carrier
In liquid coolant, through pill made of rapid cooling meat.Pill has stable quality, uniformity, content accurate, molten
Go out the volatilization that fast, efficiently quick-acting, bioavilability is high, can reduce drug, increase medicine stability, reduction toxic side effect, be convenient for
It carries, storage, the unique distinction in the dosage forms such as convenient to take.Since the biological utilisation of insoluble drug can be improved in drops
Degree, sublingual administration can work in 3 minutes, solve the problems such as Chinese medicine action is slow, quality control is unstable, thus curative effect ratio
Conventional dosage forms are good.Chinese patent " cinnamon oil is in the application for preparing the drug for the treatment of arrhythmia cordis and prepared drug "
(CN102949446A) matrix formulations, drug and the matrix ratios and preparation process for disclosing cassia tree bark oil dripping pill show to improve medicine
Proportional difference between object carrier can improve dripping pill drugloading rate and specification.But it does not disclose cinnamon oil (dripping pill) and can be used for
Treat neurasthenia.
Invention content
Neurasthenic cassia tree bark oil dripping pill and preparation method thereof is treated the purpose of the present invention is to provide a kind of.
In order to achieve the above objectives, present invention employs following technical schemes:
The present invention is studied from the target spot of effect, different ions channel, the gene in channel and protein expression level, is passed through
Pharmacological experiment study shows that cinnamon oil has the function of tranquilizing the mind hypnosis, antidepression and antifatigue, to reach treatment neurasthenia
The effect of.According to this result of study, the neurasthenic single medicinal material for the treatment of, i.e. cassia tree bark oil dripping pill have been developed.
Above-mentioned cassia tree bark oil dripping pill is prepared by the raw material of following weight proportion:7~25 parts of 2 parts of cinnamon oil and matrix,
The matrix includes two or more pharmaceutical carrier, and one of which pharmaceutical carrier is 6~22 parts, remaining pharmaceutical carrier summation is 1
~3 parts.
Preferably, the matrix is made of two kinds of pharmaceutical carriers, and pharmaceutical carrier is selected from polyethylene glycol 400, polyethylene glycol
4000, two kinds in Macrogol 6000, polyethylene glycol 10000, stearic acid, stearic acid polyoxyl 40 ester.
The preferred dripping pill includes 2 parts of cinnamon oils by weight, and matrix is 10~13 parts of Macrogol 6000s and 1~2
Part stearic acid.
The preparation method of the cassia tree bark oil dripping pill, includes the following steps:
1) above-mentioned matrix is melted in 65~100 DEG C of water-baths or oil bath, cinnamon oil is added into the matrix after melting,
Then same direction stirs 10~30min, until being uniformly mixed, obtains liquid;
2) liquid is put into the dripping tank of pill dripping machine, according to the condition of dripping pill dripping, pill dripping machine parameters is set, respectively
Parameter request is:70~100 DEG C of chassis temperature, 70~100 DEG C of oil bath temperature, 70~100 DEG C of fluid temperature, dripping temperature 70~
100 DEG C and 0.01~0.03Mpa of dripping pressure;
3) dripping:It waits for that each arrange parameter of pill dripping machine reaches requirement and stabilization, liquid is instilled into coolant liquid, wherein coolant liquid
1~12 DEG C of temperature, 12~20/min of dripping pill dripping speed, 20~50 DEG C of nozzle temperature, 5~20cm of dripping distance;It waits instilling
The liquid of coolant liquid shrinks molding, takes out, and dries coolant liquid;Then successively through whole grain, drying, coating to get 100~300mg/
Grain cassia tree bark oil dripping pill.
Dripping pill coating constituents:Hydroxypropyl methyl cellulose, polyethylene glycol, PVP K30, lemon yellow color lake, titanium dioxide,
Talcum powder, except lemon yellow color lake is food-grade, other is pharmaceutical grade.It is coated purpose:Appearance looks elegant increases cassia tree bark oil dripping pill
Stability.
Preferably, the coolant liquid is selected from dimethicone 100, dimethicone 150, dimethicone 300, dimethyl
It is one or more in silicone oil 350, dimethicone 400, atoleine.
Beneficial effects of the present invention are embodied in:
Cassia tree bark oil dripping pill of the present invention forms prescription by single medicinal material bulk pharmaceutical chemicals, is that cinnamon oil is added to certain base
Matter, and control dripping procedure parameter and be made, principle active component is clear, and drugloading rate is high, rapid-action, is easy to carry out quality control
System and stability study.It is confirmed by pharmacological evaluation, cinnamon oil has the function of tranquilizing the mind hypnosis, antidepression and antifatigue, has
The effect for the treatment of neurasthenia.The present invention has a wide range of applications valence in neurasthenia treating and related drugs research and development, preparation
Value.
Cassia tree bark oil dripping pill provided by the invention is prepared using substance dispersion theory, has the quick-acting efficient spies of injection
Sign, while also there is oral preparation to use characteristic easy to carry, it is suitble to people small to the three of modern medicines preparation, triple effect, five
Convenient primary demand has broad prospects and huge market, meets the requirement of modern traditional Chinese medicine preparation.
Specific implementation mode
The present invention is described in further detail with reference to embodiments, described to be explanation of the invention rather than limit
It is fixed.
(1) cassia tree bark oil dripping pill preparation process
1, Chinese cassia tree oil extract
According to 6.5% recovery rate of document highest, the method used is dry cassia bark microwave radiation technology-Water distillation extractor.Chinese cassia tree
Oil by《Chinese Pharmacopoeia》2015 editions one is recorded (page 402), is bulk pharmaceutical chemicals.
2, cassia tree bark oil dripping pill preparation method
Example 1
(1) preparation recipe:2 parts of cinnamon oils are taken, (bulk pharmaceutical chemicals and the weight ratio of matrix 2 are mixed with 9 parts of matrix:9), wherein
Matrix is Macrogol 4000 and stearic acid polyoxyl 40 ester by weight 8:1 mixes.
(2) matrix is melted in 100 DEG C of oil baths, cinnamon oil is then added, ceaselessly stirred according to same direction, until mixed
It closes uniform.
(3) liquid stirred evenly is put into the dripping tank of pill dripping machine, according to the condition of dripping pill dripping, is controlled each
Parameter stirs in dripping tank, until each Con trolling index of pill dripping machine reaches requirement, i.e. 100 DEG C of chassis temperature, oil
100 DEG C of bath temperature, 100 DEG C of fluid temperature, 100 DEG C of dripping temperature, start dripping after parameter stability.
(4) dripping pill is prepared on the dripping pill preparing instrument (i.e. pill dripping machine) equipped with closed storage tank, and control dripping pressure is
0.01Mpa。
(5) select dimethicone 400 for coolant liquid, control coolant temperature is 11 DEG C, and the speed of dripping pill dripping is 18
Grain/min, nozzle temperature 45 C, dripping distance 13cm carry out dripping, and type to be shrunk to takes out, and dry coolant liquid, and whole grain is done
It is dry, coating.
Example 2
(1) preparation recipe:2 parts of cinnamon oils are taken, (bulk pharmaceutical chemicals and the weight ratio of matrix 2 are mixed with 11 parts of matrix:11),
Mesostroma is poly- second dimerization 6000 and stearic acid by weight 10:1 mixes.
(2) matrix is melted in 80 DEG C of water-baths, cinnamon oil is then added, ceaselessly stirred according to same direction, until mixed
It closes uniform.
(3) liquid stirred evenly is put into the dripping tank of pill dripping machine, according to the condition of dripping pill dripping, is controlled each
Parameter stirs in dripping tank, until each Con trolling index of pill dripping machine reaches requirement, i.e. 80 DEG C of chassis temperature, oil
80 DEG C of bath temperature, 80 DEG C of fluid temperature, 80 DEG C of dripping temperature, start dripping after parameter stability.
(4) dripping pill is prepared on the dripping pill preparing instrument (i.e. pill dripping machine) equipped with closed storage tank, and control dripping pressure is
0.02Mpa。
(5) select dimethicone 350 for coolant liquid, control coolant temperature is 10 DEG C, and the speed of dripping pill dripping is 12
Grain/min, 30 DEG C of nozzle temperature, dripping distance 8cm carry out dripping, and type to be shrunk to takes out, and dry coolant liquid, and whole grain is dry,
Coating.
Example 3
(1) preparation recipe:2 parts of cinnamon oils are taken, (bulk pharmaceutical chemicals and the weight ratio of matrix 2 are mixed with 13 parts of matrix:13),
Mesostroma is Macrogol 4000.
(2) matrix is melted in 70 DEG C of water-baths, cinnamon oil is then added, ceaselessly stirred according to same direction, until mixed
It closes uniform.
(3) liquid stirred evenly is put into the dripping tank of pill dripping machine, according to the condition of dripping pill dripping, is controlled each
Parameter stirs in dripping tank, until each Con trolling index of pill dripping machine reaches requirement, i.e. chassis temperature 70 C, oil
70 DEG C of bath temperature, 70 DEG C of fluid temperature, dripping temperature 70 C start dripping after parameter stability.
(4) dripping pill is prepared on the dripping pill preparing instrument (i.e. pill dripping machine) equipped with closed storage tank, and control dripping pressure is
0.03Mpa。
(5) select dimethicone 150 for coolant liquid, control coolant temperature is 8 DEG C, and the speed of dripping pill dripping is 18
Grain/min, 40 DEG C of nozzle temperature, dripping distance 12cm carry out dripping, and type to be shrunk to takes out, and dry coolant liquid, and whole grain is done
It is dry, coating.
Example 4
(1) preparation recipe:2 parts of cinnamon oils are taken, (bulk pharmaceutical chemicals and the weight ratio of matrix 2 are mixed with 17 parts of matrix:17),
Mesostroma is Macrogol 6000.
(2) matrix is melted in 75 DEG C of water-baths, cinnamon oil is then added, ceaselessly stirred according to same direction, until mixed
It closes uniform.
(3) liquid stirred evenly is put into the dripping tank of pill dripping machine, according to the condition of dripping pill dripping, is controlled each
Parameter stirs in dripping tank, until each Con trolling index of pill dripping machine reaches requirement, i.e. 75 DEG C of chassis temperature, oil
75 DEG C of bath temperature, 75 DEG C of fluid temperature, 75 DEG C of dripping temperature, start dripping after parameter stability.
(4) dripping pill is prepared on the dripping pill preparing instrument (i.e. pill dripping machine) equipped with closed storage tank, and control dripping pressure is
0.02Mpa。
(5) select dimethicone 100 for coolant liquid, control coolant temperature is 8 DEG C, and the speed of dripping pill dripping is 15
Grain/min, 35 DEG C of nozzle temperature, dripping distance 14cm carry out dripping, and type to be shrunk to takes out, coolant liquid dried, whole grain, does
It is dry, coating.
Example 5
(1) preparation recipe:2 parts of cinnamon oils are taken, (bulk pharmaceutical chemicals and the weight ratio of matrix 2 are mixed with 15 parts of matrix:15),
Mesostroma is Macrogol 6000 and stearic acid by weight 13:2 mix.
(2) matrix is melted in 80 DEG C of water-baths, cinnamon oil is then added, ceaselessly stirred according to same direction, until mixed
It closes uniform.
(3) liquid stirred evenly is put into the dripping tank of pill dripping machine, according to the condition of dripping pill dripping, is controlled each
Parameter stirs in dripping tank, until each Con trolling index of pill dripping machine reaches requirement, i.e. 80 DEG C of chassis temperature, oil
80 DEG C of bath temperature, 80 DEG C of fluid temperature, 80 DEG C of dripping temperature, start dripping after parameter stability.
(4) dripping pill is prepared on the dripping pill preparing instrument (i.e. pill dripping machine) equipped with closed storage tank, and control dripping pressure is
0.03Mpa。
(5) select dimethicone 300 for coolant liquid, cooling temperature is 9 DEG C, and the speed of dripping pill dripping is 10/min,
40 DEG C of nozzle temperature, dripping distance 10cm carry out dripping, and type to be shrunk to takes out, and dry coolant liquid, whole grain is dry, coating.
Example 6
(1) preparation recipe:2 parts of cinnamon oils are taken, (bulk pharmaceutical chemicals and the weight ratio of matrix 2 are mixed with 21 parts of matrix:21),
Mesostroma is stearic acid polyoxyl 40 ester.
(2) matrix is melted in 85 DEG C of water-baths, cinnamon oil is then added, ceaselessly stirred according to same direction, until mixed
It closes uniform.
(3) liquid stirred evenly is put into the dripping tank of pill dripping machine, according to the condition of dripping pill dripping, is controlled each
Parameter stirs in dripping tank, until each Con trolling index of pill dripping machine reaches requirement, i.e. 85 DEG C of chassis temperature, oil
85 DEG C of bath temperature, 85 DEG C of fluid temperature, 85 DEG C of dripping temperature, start dripping after parameter stability.
(4) dripping pill is prepared on the dripping pill preparing instrument (i.e. pill dripping machine) equipped with closed storage tank, and control dripping pressure is
0.01Mpa。
(5) select dimethicone 400 for coolant liquid, control coolant temperature is 5 DEG C, and the speed of dripping pill dripping is 16
Grain/min, 35 DEG C of nozzle temperature, dripping distance 17cm carry out dripping, and type to be shrunk to takes out, and dry coolant liquid, and whole grain is done
It is dry, coating.
Example 7
(1) preparation recipe:2 parts of cinnamon oils are taken, (bulk pharmaceutical chemicals and the weight ratio of matrix 2 are mixed with 19 parts of matrix:19),
Mesostroma is Macrogol 4000 and polyethylene glycol 400 by weight 18:1 mixes.
(2) matrix is melted in 90 DEG C of water-baths, cinnamon oil is then added, ceaselessly stirred according to same direction, until mixed
It closes uniform.
(3) liquid stirred evenly is put into the dripping tank of pill dripping machine, according to the condition of dripping pill dripping, is controlled each
Parameter stirs in dripping tank, until each Con trolling index of pill dripping machine reaches requirement, i.e. 90 DEG C of chassis temperature, oil
90 DEG C of bath temperature, 90 DEG C of fluid temperature, 90 DEG C of dripping temperature, start dripping after parameter stability.
(4) dripping pill is prepared on the dripping pill preparing instrument (i.e. pill dripping machine) equipped with closed storage tank, and control dripping pressure is
0.02Mpa。
(5) select dimethicone 150 for coolant liquid, control coolant temperature is 6 DEG C, and the speed of dripping pill dripping is 13
Grain/min, 40 DEG C of nozzle temperature, dripping distance 9cm carry out dripping, and type to be shrunk to takes out, and dry coolant liquid, and whole grain is dry,
Coating.
Example 8
(1) preparation recipe:2 parts of cinnamon oils are taken, (bulk pharmaceutical chemicals and the weight ratio of matrix 2 are mixed with 25 parts of matrix:25),
Mesostroma is polyethylene glycol 10000 and stearic acid polyoxyl 40 ester by weight 22:3 mix.
(2) matrix is melted in 95 DEG C of oil baths, cinnamon oil is then added, ceaselessly stirred according to same direction, until mixed
It closes uniform.
(3) liquid stirred evenly is put into the dripping tank of pill dripping machine, according to the condition of dripping pill dripping, is controlled each
Parameter stirs in dripping tank, until each Con trolling index of pill dripping machine reaches requirement, i.e. 95 DEG C of chassis temperature, oil
95 DEG C of bath temperature, 95 DEG C of fluid temperature, 95 DEG C of dripping temperature, start dripping after parameter stability.
(4) dripping pill is prepared on the dripping pill preparing instrument (i.e. pill dripping machine) equipped with closed storage tank, and control dripping pressure is
0.03Mpa。
(5) select dimethicone 300 for coolant liquid, control coolant temperature is 7 DEG C, and the speed of dripping pill dripping is 17
Grain/min, 40 DEG C of nozzle temperature, dripping distance 16cm carry out dripping, and type to be shrunk to takes out, and dry coolant liquid, and whole grain is done
It is dry, coating.
(2) Pharmacodynamics of cassia tree bark oil dripping pill act on experimental study
1 experiment material
1.1 experimental animal
KM mouse, 18~22g of weight, male.Barrier system is raised, 20~25 DEG C of temperature, humidity 40%~70%.Raising
It is tested after a period of time.
1.2 test reagent
Electronic balance, stopwatch, yellow Jackets, barbital sodium
1.3 tested medicine
Cassia tree bark oil dripping pill;Seven leaf tranquilizing dripping pills, Yunnan Jinqi Pharmaceutical Co., Ltd., lot number:20160203;Chinese cassia tree.
2 experimental methods
2.1 extend the experiment of yellow Jackets inducing mouse sleeping time
Mouse is divided into blank control group, cassia tree bark oil dripping pill low dose group (0.6g/kg), equivalent Chinese cassia tree low dose group
(9.2g/kg), cassia tree bark oil dripping pill middle dose group (1.2g/kg), equivalent Chinese cassia tree middle dose group (18.4g/kg), cassia tree bark oil dripping pill are high
Dosage group (2.4g/kg), equivalent Chinese cassia tree high dose group (36.8g/kg) and positive controls (seven leaf god quieting drip pill 0.72g/kg),
Every group 10 (equivalent refers to giving the Chinese cassia tree of corresponding amount, similarly hereinafter by Chinese cassia tree oil content in corresponding dosage dripping pill).Cinnamon oil
Dripping pill each group adds distilled water to be configured to 20% suspension, each gavage amount 1mL by 2.0mL/100g weight, Chinese cassia tree each group with Chinese cassia tree
(middle dosage and high dose group are using medication for multiple daily) oral continuous gavage relative medicine 30d, blank control group give
Same volume distilled water, 1 time/d.15min after the last administration prepares yellow Jackets and carries out abdominal cavity note to each group by 50mg/kg
It penetrates (10mL/kg), record is from mouse righting reflex loss to the awakening time.
2.2 yellow Jackets sub-threshold dose hypnosis are tested
Experimental animal grouping, administering mode are the same as 2.1.Oral continuous gavage relative medicine 30d, blank control group are distilled
Water.Yellow Jackets are injected intraperitoneally to every group of animal by 10mL/kg by 15min after the last administration, using 39mg/kg as
Hypnotic dose under maximum threshold is more than that 1 minute sleep number of animals are recorded to righting reflex loss in 30min.
2.3 barbital sodium Sleep latencies are tested
Experimental animal grouping, administering mode are the same as 2.1.Oral continuous gavage relative medicine 30d, blank control group are distilled
Water.15min after the last administration prepares barbital sodium and (10mL/kg), observation index is injected intraperitoneally to each group by 405mg/kg
For righting reflex loss, statistics each group Sleep latency (from this period for being administered into righting reflex loss).
2.4 Tail suspension test
Experimental animal grouping, administering mode are the same as 2.1.Successive administration 15d, blank control group give distilled water.It is given in last
30min will be fixed on a horizontal waddy at mouse tail 2cm after medicine, make mouse at overhang, and head is about from desktop
5cm, suspension both sides separate animal sight with plate, observe and record the dead time of administration group and blank control group in 4min.
2.5 mouse swimming test
Experimental animal grouping, administering mode are the same as 2.1.Successive administration 15d, blank control group give distilled water.It is given in last
30min after medicine, animal is put into water vat, is adjusted water temperature to 23~25 DEG C, per one, cylinder, is set and observe 6min in water, record small
Add up the dead time in 4min after mouse.
2.6 mouse swimming power exhausts experiment
Experimental animal grouping, administering mode are the same as 2.1.Successive administration 15d, blank control group give distilled water.Last dose
Preceding fasting 8h.1h and 2h, the hydrophobic clay that upper every piece of 1.5g is pasted in mouse back are (about small after the last administration before last dose
Mouse weight 5%), it is carried out at the same time experiment with 5 large-scale tanks (length, width and height 80cm × 80cm × 30cm).Water temperature and environment temperature are equal
Control is at 30 DEG C or so, depth of water 25cm.The stimulation mouse that constantly churns the surface does not stop to move about, and mouse is recorded from water is entered to tired with stopwatch
Swimming time when labour exhausts observes that mouse strokes are obviously lacked of proper care, cannot adhere to again that it is non-rising that mouse head enters water 5s
When, judge that its swimming exercise is exhausted to power, is picked up from water rapidly.
3 experimental results
3.1 extend the experiment of yellow Jackets inducing mouse sleeping time
The result shows that cassia tree bark oil dripping pill low dose group, cassia tree bark oil dripping pill middle dose group compared with blank control group, equal energy
Extend the sleeping time of yellow Jackets inducing mouse, there are significant difference (P≤0.05).Cassia tree bark oil dripping pill high dose group with
The sleeping time that positive controls (seven leaf tranquilizing dripping pills) can extend yellow Jackets inducing mouse, there are significant difference (P≤
0.01).Chinese cassia tree each group is to extending the sleeping time of yellow Jackets inducing mouse without remarkable effect (P >=0.05).It is shown in Table 1.
Influence (X ± S) of the table 1. to extension yellow Jackets inducing mouse sleeping time
Note:Compared with blank control group, P≤0.01 * P≤0.05, * *
Dosage hypnosis is tested under 3.2 yellow Jackets threshold values
The result shows that cassia tree bark oil dripping pill middle dose group, positive controls (seven leaf tranquilizing dripping pills) are compared with blank control group,
Dosage under yellow Jackets threshold value, each group number of animals of falling asleep obviously increase, and there are significant difference (P≤0.05);Chinese cassia tree oil droplet
Ball high dose group has significant difference (P≤0.01) compared with blank control group.Chinese cassia tree each group falls asleep number of animals without notable increasing
Add (P >=0.05).It is shown in Table 2.
Table 2. is to dosage mouse syngignoscism under yellow Jackets threshold value
3.3 barbital sodium Sleep latencies are tested
The result shows that cassia tree bark oil dripping pill low dose group, cassia tree bark oil dripping pill middle dose group be compared with blank control group, in a bar ratio
There is significant difference (P≤0.05) on the appropriate sodium Sleep latency time;Cassia tree bark oil dripping pill high dose group, positive controls (seven
Leaf tranquilizing dripping pill) compared with blank control group, on the barbital sodium Sleep latency time have significant difference (P≤
0.01).Chinese cassia tree each group compared with blank control group, be not significantly different on the barbital sodium Sleep latency time (P >=
0.05).It is shown in Table 3.
Influence (X ± S) of the table 3. to the barbital sodium Sleep latency time
Note:Compared with blank control group, P≤0.01 * P≤0.05, * *
3.4 Tail suspension test
The result shows that cassia tree bark oil dripping pill middle dose group, positive controls (seven leaf tranquilizing dripping pills) are compared with blank control group,
Its outstanding tail dead time significantly reduces, and has significant difference (P≤0.05), cassia tree bark oil dripping pill high dose group and blank control group
Compare, the outstanding tail dead time significantly reduces, and has significant difference (P≤0.01).Cassia tree bark oil dripping pill high dose group and the positive are right
Compare according to group (seven leaf tranquilizing dripping pills), hangs the reduction of tail dead time, there is significant difference (P≤0.05).Chinese cassia tree each group and sky
White control group compares, and the mouse tail suspension dead time, there was no significant difference (P >=0.05).It is shown in Table 4.
Influence (X ± S) of the table 4. to the mouse tail suspension dead time
Note:Compared with blank control group, P≤0.01 * P≤0.05, * *;
Compared with positive controls, △≤0.01 △ P≤0.05, △
3.5 mouse swimming test
The result shows that (seven leaves, which are calmed the nerves, to drip for cassia tree bark oil dripping pill middle dose group, cassia tree bark oil dripping pill high dose group, positive controls
Ball) compared with blank control group, non-swimming time significantly reduces, and has significant difference (P≤0.05).Cassia tree bark oil dripping pill
High dose group compared with positive controls (seven leaf tranquilizing dripping pills), non-swimming time reduce, have significant difference (P≤
0.05).Chinese cassia tree each group is compared with blank group, and there was no significant difference for mouse non-swimming time (P >=0.05).It is shown in Table 5.
Influence (X ± S) of the table 5. to mouse non-swimming time
Note:Compared with blank control group, P≤0.01 * P≤0.05, * *;
Compared with positive controls, △≤0.01 △ P≤0.05, △
3.6 cassia tree bark oil dripping pills exhaust mouse swimming power the influence of experiment
The middle and high dosage group of cassia tree bark oil dripping pill can increase the swimming time of mouse compared with blank control group;Chinese cassia tree oil droplet
Ball high dose group can significantly increase the swimming time of mouse, that is, enhance the fatigue resistance (P of mouse compared with blank control group
≤ 0.01), and middle dose group and positive controls (seven leaf tranquilizing dripping pills) effect in terms of the swimming time for increasing mouse are not so good as
High dose group is apparent (P≤0.05).Cassia tree bark oil dripping pill high dose with group be administered after compared with before administration, the swimming time of mouse
Increase (P≤0.05), and compared with positive controls, it may have significant difference (P≤0.05).Chinese cassia tree each group and blank control
Group, the administration of Chinese cassia tree each group are front and back relatively, and all there was no significant difference for mouse swimming time (P >=0.05).It is shown in Table 6.
Influence (X ± S) of the table 6. to the mice burden swimming time
Note:Compared with blank control group, P≤0.01 * P≤0.05, * *;Compared with before gavage, △ P≤0.05, △ △ P≤
0.01;
Compared with positive controls, ▲ P≤0.05, ▲ ▲ P≤0.01
The present invention has chosen most important three big disease of neurasthenia by analyzing neurasthenia associated clinical symptoms
Shape, i.e.,:Insomnia, depression, fatigue, and carried out cassia tree bark oil dripping pill tranquilizing the mind accordingly and promoted dormancy, antidepression, antifatigue related classical animal
Experiment.The result shows that (with 1~table of upper table 6 for 5 result of example), there is cassia tree bark oil dripping pill (cinnamon oil) certain tranquilizing the mind to promote to sleep,
Antidepression, antifatigue effect, and apparent dose-effect relationship is showed, antidepression and antifatigue effect are better than positive control drug
Object (seven leaf tranquilizing dripping pills).Other examples also have similar results, but are better than in effect using the dripping pill of composite parts matrix
Using the dripping pill of single component matrix.
(Macrogol 6000 is with stearic acid by weight 13 for the matrix disclosed using example 5:2 mixing) make dripping pill, warp
Above-mentioned pharmacological evaluation verification, effect are better than according to dripping pill made by following matrix:Polyethylene glycol 400 and stearic acid are by weight
13:2 mixing, Macrogol 4000 and stearic acid are by weight 13:2 mixing, polyethylene glycol 10000 and stearic acid are by weight
13:2 mixing, stearic acid polyoxyl 40 ester and stearic acid are by weight 13:2 mixing.Accordingly, it is determined that Macrogol 6000 is preferred
Matrix components.
The effect of by comparing example 2 and 5 respective dripping pill of example, showing, which suitably reduces Macrogol 6000 ratio, not only may be used
To obtain the dripping pill that drugloading rate is big, specification is big, and have effects that more preferably.
Clinic takes (one time 1~10, three times per day) effect and shows cassia tree bark oil dripping pill in treatment neurasthenia correlation disease
There is apparent effect on shape.
Cassia tree bark oil dripping pill provided by the invention is prescription list one first, is that cinnamon oil bulk pharmaceutical chemicals compare with matrix according to certain
The big specification dropping pill formulation of big drugloading rate prepared by example;Next has selected composite interstitial substance, increases the drugloading rate and drug of matrix
Dispersibility, improve dripping pill leaches the time limit;Third, controlling the pressure (0.01-0.03Mpa) of dripping when preparing dripping pill, determine
The specification of dripping pill coordinates to use the increase, it can be achieved that drugloading rate with other process conditions, the increase of specification, roundness and at
The raising of product rate.
In short, the cassia tree bark oil dripping pill prepared by the present invention:First, the drugloading rate of cinnamon oil is big, specification is big, smell faint scent, life
Object availability is high, it is rapid, quality controllable to work;Second is that alleviating the related indication effect of neurasthenia obviously, clinically it is applicable in
In treatment neurasthenia.
Claims (10)
1. a kind of cassia tree bark oil dripping pill, it is characterised in that:The dripping pill is described by weight including 2 parts of bulk pharmaceutical chemicals and 7~25 parts of matrix
Bulk pharmaceutical chemicals are selected from cinnamon oil, and the matrix includes two or more pharmaceutical carrier, and one of which pharmaceutical carrier is 6~22 parts.
2. a kind of cassia tree bark oil dripping pill according to claim 1, it is characterised in that:The matrix is made of two kinds of pharmaceutical carriers,
Pharmaceutical carrier is selected from polyethylene glycol 400, Macrogol 4000, Macrogol 6000, polyethylene glycol 10000, stearic acid, stearic acid
Two kinds in poly- 40 ester of hydrocarbon oxygen.
3. a kind of cassia tree bark oil dripping pill according to claim 1, it is characterised in that:The dripping pill includes 2 portions of Chinese cassia trees by weight
Oil, 10~13 parts of Macrogol 6000s and 1~2 part of stearic acid.
4. a kind of method preparing cassia tree bark oil dripping pill as claimed in claim 1,2 or 3, it is characterised in that:Include the following steps:
1) matrix is melted in 65~100 DEG C of water-baths or oil bath, matrix is uniformly mixed with cinnamon oil then, obtains liquid;
2) liquid is put into pill dripping machine, pill dripping machine parameter is set;
3) after each arrange parameter of pill dripping machine reaches requirement and stablizes, liquid is instilled into coolant liquid, wherein coolant temperature 1
~12 DEG C, dripping pill dripping speed is 12~20/min, and nozzle temperature is 20~50 DEG C, and dripping distance is 5~20cm;It waits instilling
The liquid of coolant liquid dries coolant liquid after shrinking molding;Then successively through whole grain, drying to get cassia tree bark oil dripping pill.
5. according to the method described in claim 4, it is characterized in that:The coolant liquid is selected from dimethicone 100, dimethyl-silicon
It is one or more in oil 150, dimethicone 300, dimethicone 350, dimethicone 400, atoleine.
6. according to the method described in claim 4, it is characterized in that:The pill dripping machine parameter is set as:Chassis temperature be 70~
100 DEG C, oil bath temperature be 70~100 DEG C, fluid temperature is 70~100 DEG C, dripping temperature is 70~100 DEG C and dripping pressure is
0.01~0.03Mpa.
7. a kind of cassia tree bark oil dripping pill is being prepared for treating the application in neurasthenic drug.
8. application according to claim 7, it is characterised in that:The cassia tree bark oil dripping pill promotees dormancy for tranquilizing the mind, antidepression, resists
Fatigue.
9. a kind of cinnamon oil is being prepared for treating the application in neurasthenic drug.
10. a kind of cinnamon oil is being prepared for the application in promoting dormancy, antidepression, antifatigue drug of calming the nerves.
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Application publication date: 20180717 |