CN107569612A - A kind of medicine for improving sleep and preparation method thereof - Google Patents
A kind of medicine for improving sleep and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of medicine for improving sleep and preparation method thereof, the medicine is mainly made up of sealwort, rhizoma Gastrodiae, polygala, radix pseudostellariae, ganoderma lucidum and Poria cocos.The medicine has the effect of shortening Sleep latency and extending sleep period, while can extend and faint from fear incubation period and reduce the convulsions death rate, has no side effect safely, can be long-term use of.
Description
Technical field
Medicine slept the present invention relates to a kind of improvement and preparation method thereof, belong to the field of medicine technology.
Technical background
Insomnia is due to feelings will, diet internal injury, or after being ill and old, insufficiency of natural endowment, the cause of disease such as have a guilty consicence, causes the mind
Lose and support or confused and worried, be common face so as to cause can not often to obtain the sleep disordered disease that ortho is characterized
Bed symptom.It is mainly shown as the deficiency of the length of one's sleep and depth and is unable to dispelling fatigue, regain one's strength and energy, the lighter enters
Sleep difficulty, or sleep but not soundly, sometimes sleeping and sometimes waking, or can not be slept again after waking up is heavy then be insomnia all night.The incidence of disease is very high, U.S.'s epidemic disease
Investigation to be learned to show, its incidence of disease is 36% and 49% 1991 and nineteen ninety-five, and in the situation increased year by year, wherein having respectively
9% and 12% patient's chronicity is had a sleepless night, especially common in the elderly and women.As modern life rhythm is accelerated, people's psychology
Pressure increases, and aging population and spectrum of disease change, and China adult sleep-disorder incidence is 38.2%, the elderly's insomnia
The incidence of disease steeply rises.Sleep-disorder belongs to common non-organic illness, more with headache, it is dizzy, dizzy, have difficulty in going to sleep, shallow sleep
Dormancy, Yi Xing, early awakening, dreaminess, wake up after be not easy to fall asleep, wake up after the malaise symptoms such as tired sleepy, night sweat.It is characterized in recurrent exerbation,
It is difficult to effect a radical cure, using tiredness and asthenic feeling as cardinal symptom.Extended sleep obstacle can make patient anxiety, depression, fear, memory
Decline, poor appetite, quality of life is influenceed, hinder the study and work and health of people.And aggravate or induce the diseases such as cardiovascular and cerebrovascular
Disease, intractable aypnia, bring long-term pain, it has also become a public health problem.
Today's society, insomniac especially senile insomnia patient numbers are in significantly to increase trend.The just serious shadow of insomnia
Ring life and the physical and mental health of the elderly.Western medicine species currently used for treatment insomnia is more, but it is low security to be all present, easily
The side effect such as habituation and dependence.
The content of the invention：
It is an object of the present invention to provide a kind of medicine for improving sleep and preparation method thereof.The medicine has QI invigorating
Enrich blood, the effect of invigorating the spleen calming heart, can extend and faint from fear incubation period and reduce the convulsions death rate, available for insomnia forgetfulness, dreaming often and waking easily,
Have a dizzy spell, spiritlessness and weakness, the few China of face yellow, pale tongue with thin fur, arteries and veins is thin and delicate, improves sleep, has no side effect safely, can take for a long time
With.
The present invention is realized using following technical scheme：A kind of medicine for improving sleep, is calculated, mainly by sealwort by weight
1-10 parts, rhizoma Gastrodiae 1-6 parts, polygala 1-10 parts, radix pseudostellariae 1-6 parts, ganoderma lucidum 1-6 parts and Poria cocos 1-6 parts are made.
In the medicine of foregoing improvement sleep, calculate by weight, mainly by sealwort 4-6 parts, rhizoma Gastrodiae 2-4 parts, polygala 4-6
Part, radix pseudostellariae 2-4 parts, ganoderma lucidum 2-4 parts and Poria cocos 2-4 parts are made.
In the medicine of foregoing improvement sleep, calculate by weight, mainly by 5 parts of sealwort, 3 parts of rhizoma Gastrodiae, 5 parts of polygala, too
3 parts of 3 parts of son ginseng, 3 parts of ganoderma lucidum and Poria cocos are made.
A kind of preparation method of the medicine of foregoing improvement sleep, takes said medicine, can add auxiliary material, can also be not added with auxiliary
Material, is made pharmaceutical preparation.
The preparation method of the medicine of foregoing improvement sleep, the pharmaceutical preparation is oral formulations.
The preparation method of the medicine of foregoing improvement sleep, the external preparation is granule, tablet dose or capsule.
The preparation method of the medicine of foregoing improvement sleep, the granule are prepared：Above medicine is taken, adds 9-11 times
The water of amount, decoct 2-4 times, decoct every time 1-2 hours, decoction liquor merges, and filtration, filtrate decompression is concentrated into relative density under normal temperature
It is 1 by the mass ratio of clear cream and auxiliary material for 1.30-1.35 clear cream:1.5-2.5 adds auxiliary material, mixes, particle is made, and dries,
Produce.
The preparation method of the medicine of foregoing improvement sleep, the tablet are prepared：Above medicine is taken, adds 9-11 times to measure
Water, decoct 2-4 time, decoct every time 1-2 hours, decoction liquor merges, and filters, filtrate decompression is concentrated into relative density under normal temperature and is
1.30-1.35 clear cream, it is 1 by the mass ratio of clear cream and auxiliary material:1.5-2.5 adds auxiliary material, mixes, tabletting, dries, produces.
The preparation method of the medicine of foregoing improvement sleep, the capsule are prepared：Above medicine is taken, adds 9-11 times
The water of amount, decoct 2-4 times, decoct every time 1-2 hours, decoction liquor merges, and filtration, filtrate decompression is concentrated into relative density under normal temperature
It is 1 by the mass ratio of clear cream and auxiliary material for 1.30-1.35 clear cream:1.5-2.5 adds auxiliary material, mixes, particle is made, and dries,
Load capsule, produce.
In the preparation method of the medicine of foregoing improvement sleep, the auxiliary material is starch and dextrin, mixes, produces；It is described
The weight of starch and dextrin ratio is 1:1.
Medicine of the present invention is mainly made up of sealwort, rhizoma Gastrodiae, polygala, radix pseudostellariae, ganoderma lucidum and Poria cocos, wherein, sealwort (scientific name：
Polygonatum sibiricum), medicinal plant, there is tonifying spleen, the effect of moistening lung and production of body fluid.Rhizoma Gastrodiae (scientific name：Gastrodia
Elata Bl.), it is orchid family Gastrodia herbaceos perennial.Nature and flavor：It is sweet, put down.Channel tropism：Enter Liver Channel.Effect：Ceases wind, arresting convulsion.
Control dizziness pupil, head wind headache, extremity numbness, hemiplegia, aphasia, pediatric epilepsy scared moves wind.Polygala (scientific name：
Polygala tenuifolia Willd), there is tranquilize the mind and promote the intelligence, eliminating the phlegm, the function of detumescence, for mistake caused by breakdown of the normal physiological coordination between the heart and the kidney
Dormancy dreaminess, forgetful palpitation with fear, wandering, expectoration is not well, sore swollen toxin, mastosis.Nature and flavor：It is bitter, pungent, warm.The channel tropism thoughts of returning home,
Kidney, lung channel.Radix pseudostellariae, Chinese medicine name.For pinkwort caryophyllaceous ginseng Pseudostellaria heterophylla (Miq.) Pax
Ex Pax et Hoffm. dried root.With replenishing qi to invigorate the spleen, it is promoting production of body fluid and nourishing the lung the effect of.It is tired to be usually used in insufficiency of the spleen body, appetite is not
Shake, eak after being ill, deficiency of both vital energy and Yin, spontaneous sweat and frequent thirstiness, dryness of the lung dry cough.Ganoderma lucidum is also known as the precious (scientific name of Lin Zhongling, fine jade：Ganoderma
Lucidum Karst) be On Polyporaceae ganoderma lucidum fructification.With invigorating qi for tranquilization, the relieving cough and asthma, work(promoted longevity
Effect.For dizziness egersis, palpitation, neurasthenia, consumptive disease cough and asthma.Poria cocos, Chinese medicine name.For On Polyporaceae Poria cocos
Poria cocos (Schw.) Wolf dry sclerotia.Nature and flavor：It is sweet, light, it is mild-natured.Channel tropism：The thoughts of returning home, lung, spleen, kidney channel.Effect：
Clearing damp and promoting diuresis, invigorating the spleen, calming heart.Cure mainly：For oedema oliguria, phlegm retention anti-dazzle nervous, spleen eating less, loose stool diarrhea is confused and worried, palpitation with fear
Insomnia.
We's disease of curing the disease is by the insufficiency of heart and spleen, insufficiency of vital energy and blood, it is impossible to support the mind, cause it is confused and worried, and give birth to insomnia,
Dreaminess, it is not easy to fall asleep after waking up.In side sealwort it is sweet it is mild-natured enter spleen kidney channel, both tonifying spleen kidney qis, and beneficial spleen kidney yin, have qi-supplementing, blood-engendering,
The work(of production of sperm benefit blood；Polygala tepor of working hard enters heart kidney channel, property is kind lead off it is sensible, can happily gas and antitoxic heart-soothing and sedative, and can lead to kidney
Gas and strong will is not forgotten, restoring normal coordination between heart and kidney, stabilize mind, two medicines are shared, mended without stagnant, sensible mind, are altogether monarch drug in a prescription.Poria cocos, crown prince
Join the sweet power put down into the spleen channel, help sealwort QI invigorating tonifying spleen, fill taste gas, then qi and blood biochemistry is active；Poria cocos, ganoderma lucidum it is sweet it is mild-natured enter
The heart channel of Hang-Shaoyin, the work(of polygala restoring normal coordination between heart and kidney, coordination between the heart and kidney are helped, mind must pacify, and be altogether ministerial drug.Rhizoma Gastrodiae is sweet cold in nature, calms down liver wind, to control
Wind formation from blood deficiency, endogenous deficient wind, the effect of vertigo, with for adjutant.All medicine compatibilities, blood-enrich, the work(of invigorating the spleen calming heart are played altogether.
Invention is further described with reference to embodiment, but is not intended as the foundation limited the present invention.
The Study on extraction of experimental example 1
The measure of 1.1 medicinal materials
1.1.1 rhizoma Gastrodiae
This product is the dry tuber of orchid rhizoma Gastrodiae (Gastrodia elata Bl.).Unlimited low temperature drying after steaming thoroughly.
Rhizoma Gastrodiae is beaten after powder crosses No. three sieves (50 mesh), accurately weighed 2.0360g, according to《Chinese Pharmacopoeia》2010 editions " rhizoma Gastrodiaes "
Content assaying method measure gastrodin content is 0.27% under, is met《Chinese Pharmacopoeia》Assay under 2010 editions " rhizoma Gastrodiae " items
(this product is calculated regulation by dry product, must not be less than 0.20%) containing Gastrodin.
1.1.2 Poria cocos
This product is On Polyporaceae Poria cocos Poria cocos (Schw.) Wolf dry sclerotia.The Fu of cutting after peeling
Siberian cocklebur, it is not of uniform size in a cube bulk.
Poria cocos is beaten into powder and crosses No. 2 sieves (24 mesh), according to《Chinese Pharmacopoeia》Require to carry out extract under 2015 editions " Poria cocos " items
Measure, determined according to the hot dipping under ethanol soluble extractives determination method (A of annex Ⅹ) item, make solvent with Diluted Alcohol.It the results are shown in Table 1.
The Poria cocos determination of extractives of table 1
Conclusion：This product extract content average value is 2.57%, is met《Chinese Pharmacopoeia》Leached under 2015 editions " Poria cocos " items
Thing regulation (must not be less than 2.5%).
The Processing methods of 1.2 medicinal materials
The processing of Rhizoma Gastrodiae：Take a certain amount of rhizoma Gastrodiae, put slightly steeped in clear water steam 40 in the rearmounted steamers of about 10min~
60min, section, shave, 40 DEG C of drying in baking oven are taken out after steaming to the saturating heart.
The investigation of 1.3 medicinal material water absorption rates
Got it filled material 12g by 1/2 recipe quantity, 3 parts, respectively plus 10 times of amount water (120mL) immersions, per observing 1 time every other hour
Saturating mood condition, soaks the heart in as a result 48 hours, filters out non-imbibition, water absorption rate when calculating 48 hours, tries to achieve water absorption rate, the results are shown in Table
2。
The water absorption rate of table 2. is investigated
Note：1. gross weight is medicinal material and beaker weight sum.
2. water absorption rate %=[(medicinal material weight in wet base-medicinal material dry weight)/medicinal material dry weight] 100%
As a result show, medicinal material soaks the heart after 48h, calculates to obtain water absorption rate, and mean water absorption rate is 163.36%.
1.4 extraction schemes are preferred
Traditional extraction process by water typically boils, therefore Extracting temperature is not carried out preferred.Selection decocts number (A), decocted
Time (B), amount of water (C) are investigated, and each factor is defined as three levels, by L9(34) orthogonal arrage arrangement experiment.Every part takes one
Individual recipe quantity about 22g altogether, is decocted.Because polysaccharide is principle active component, Gastrodin composition is again representative, therefore with
Gastrodin content, total sugar content and dry extract content carry out comprehensive grading as index, respectively weight 0.4,0.4 and 0.2, through comprehensive
After closing evaluation, directly perceived and variance analysis is carried out, screens optimum extraction process.Factor level table is shown in Table 3.
The extraction process by water factor of table 3. and level
1.5 indexs and assay method
1.5.1 gastrodin content determines
Instrument and reagent high performance liquid chromatograph (LC-2010CHT, Japanese Shimadzu), Gastrodin (lot number：110807-
200205, Nat'l Pharmaceutical ＆ Biological Products Control Institute), acetonitrile (chromatographically pure), phosphoric acid, heartily pure water.
Chromatographic condition C18Post；Mobile phase is the phosphate aqueous solution of acetonitrile -0.05% (3:97)；30 DEG C of column temperature；Detection wavelength
220nm；Flow velocity 1.0mL/min；Sample size 10uL.
It is prepared by reference substance solution：Precision weighs Gastrodin reference substance 0.00052g and put in 10ml volumetric flasks, adds flowing to mix
Solution is diluted to scale, shakes up, and it is 0.052mg/mL reference substance solutions to obtain concentration.
It is prepared by need testing solution：By L9(3)4Orthogonal arrage arrangement extracts 9 parts of test liquids, and the wherein extract solution of scheme 1~4 is dense
A certain amount of rearmounted 200mL volumetric flasks are reduced to, adds water constant volume, shakes up；The extract solution of scheme 5~9, which is concentrated into a certain amount of rearmounted 500mL, to be held
Measuring bottle, add water constant volume, shake up.Respectively draw 9 scheme extract solutions filtered through miillpore filter, put high liquid bottle both test sample it is molten
Liquid.
Determination method：It is accurate respectively to draw reference substance solution and each 10uL of need testing solution, it is high by above-mentioned chromatographic condition, injection
Effect liquid phase chromatogram instrument, measure, is calculated as follows mass fraction w%.
Note：C pairs：Gastrodin reference substance concentration, i.e. 0.052mg/mL；
A is supplied：The peak area detected for test sample；
V：1~4V=200mL of scheme；5~9V=500mL of scheme；
m：Dry medicinal material gross weight (g).
1.5.2 total sugar content determines
It is prepared by reference substance solution：Precision weighs DEXTROSE ANHYDROUS 0.00330g and puts 10mL volumetric flasks, adds distilled water dissolving dilute
Release to scale, shake up and both obtained, it is 0.33mg/mL reference substance solutions to obtain concentration.
0.2% Anthrone Sulphuric acid solution allocation weighs anthrone 0.2047g, and with concentrated sulfuric acid dissolution and constant volume is to 100mL, faces use
When configure.The reference substance solution 1mL that solution allocation is drawn the extract solution 1mL after 9 scheme constant volumes and configured respectively puts 10mL
Dry in tool plug test tube, then accurate 1mL distilled water of drawing is added in dry tool plug test tube, is shaken up, it is standby；Precision is drawn 2mL and steamed
Distilled water is dried in tool plug test tube to 10mL and is used as blank solution, standby.
11 tool plug test tubes, which are put, by more than adds 0.2% Anthrone Sulphuric acid solution to 10mL scales in ice-water bath, mix, treat
It places into after cooling down and 10min is heated in boiling water bath, is put into after cooling down 10min in ice-water bath and takes out afterwards, standby.
Detection compares school zero with blank solution, and absorbance is determined at 582nm wavelength.It is calculated as follows mass fraction
W%.
Note：C pairs：DEXTROSE ANHYDROUS reference substance concentration, i.e. 0.33mg/mL；
A is supplied：The absorbance that test sample detects；
V：The program tests the volume of last constant volume, i.e. 1~scheme of scheme 4：V=200mL, 5~scheme of scheme 9：V=
500mL；
A pairs：The absorbance that DEXTROSE ANHYDROUS reference substance detects after being configured；
m：Dry medicinal material gross weight (g).
1.5.3 the measure of dry extract
The accurate extract solution 10mL drawn after constant volume respectively, puts and dries into the evaporating dish of constant weight, and water-bath volatilizes, in
After 105 DEG C of dryings 3 hours, cooled down 0.5 hour in dislocation drier, rapid accurately weighed weight, record, dry leaching is calculated as follows
Cream yield.
The extraction process by water condition L of table 49(34) orthogonal test calendar and result
Note：
Comprehensive grading=dry extract yield scoring+gastrodin content scoring+total sugar content scoring；
The results of analysis of variance of table 5
* significant factor P is represented<0.01；
Interpretation of result：The extreme difference size of each factor in comparison sheet 4, it is known that the influence order of each factor is A>B>C, that is, decoct
Number>Decocting time>Amount of water, optimal extraction process by water are A3B2C3, that is, decoct 3 times, decoct 1.5 hours every time, add 10 times every time
Water.
It was found from the variance analysis of table 5：Decocting number has pole significant difference (P<0.01), illustrate this factor to this prescription medicine
Recovery rate influences maximum；Decocting time and amount of water influence smaller without significant difference, its extraction on this prescription medicine.Therefore in life
Decoction number is must assure that in production.
The checking of 1.6 water extraction optimum process conditions
For process rationality selected by determining, the optimum process scheme of three parts of prescription medicine water extraction orthogonal experiments is taken to repeat
Experiment 3 times.By A3B2C3Method is tested, and constant volume obtains in 500ml, measure Gastrodin yield, total reducing sugar after each extract solution concentration
Rate, dry extract yield.
The extraction process of table 6 is verified
The result shows, the technique gastrodin content, total starches, each index of total solid substance with the orthogonal extraction preferably gone out
Technique is suitable, illustrates that the process conditions that orthogonal test preferentially goes out are more stable, relatively feasible.Therefore determine that extraction process is：Decoct 3
It is secondary, decoct 1.5 hours every time, each 10 times of amount of water.
2 concentration technologies are studied
Conventional drying process has normal pressure concentration in production, be concentrated under reduced pressure concentrates with microwave.In view of contain in this extract
There are a large amount of polysaccharide, be not suitable for being concentrated with microwave.Normal pressure concentrates, such as conditions permit, it is also possible to which be concentrated under reduced pressure (low temperature, to having
It is few to imitate component damage, improves thickening efficiency.) relative density is concentrated into as 1.30~1.35.
The Study on Forming of experimental example 2
1 instrument and reagent
1.1 instrument
Vacuum drying chamber (DZF-6210 Shanghai Qi Xin scientific instrument Co., Ltd)；Drying box (202-4 Shanghai City experiment instrument
Device head factory) constant temperature and humidity incubator (LRH-150S Guangdong medical apparatus and instruments factory)；(AE/240 Shanghai plum Teller instrument has electronic balance
Limit company).
1.2 reagents and reagent
Soluble starch (20130422 Tianjin Jinnan District salt water buy industrial park), dextrin (20130507 Chengdu sections
Imperial chemical reagent) medicinal material (buying in the big pharmacy of GuiyangTongJitang) such as rhizoma Gastrodiae, polygala, sealwort.
2. extraction process route
Glycoside, polysaccharide constituents are mainly contained in we, there is higher water solubility, from the point of view of the medicine formed from side,
The active ingredient of full side is mainly water soluble ingredient, and in view of medication custom among the people, feature, and industrial feasibility and
Cost, we preferably use water extraction for extraction process (specially：Above medicine is taken, adds the 9-11 times of water measured, decocts 2-4 times, often
Secondary decoction 1-2 hours, decoction liquor merge, filtration, and filtrate is dense, and to be concentrated under reduced pressure into relative density under normal temperature be the clear of 1.30-1.35
Cream).
3. the research of moulding process
The decoction of 3.1 medicinal materials
Weigh 15 times of recipe quantity medicinal materials to be decocted, decoct 3 times, add 10 times of amount water every time, decoct 1.5h, merge and decoct
Liquid, is divided into two parts, and a part of decocting liquid concentration makes pellet for clear cream (relative density is about 1.30~1.35)；Another part concentrates
Moisture is placed in reduced vacuum drying box to after doing and dried, standby to play powder pelleting.
3.2 auxiliary materials it is preferred
3.2.1 clear cream makes pellet
Take 3 parts of clear creams each 27.60g, 15.01g, 18.15g；28.09g, 15.02g, 18.13g are respectively respectively clear in proportion
Cream：Auxiliary material=1：1、1：2 and 1：3 add auxiliary material (starch and dextrin) 27.60g, 30.03g, 54.45g；28.11g、30.05g、
54.42g, two auxiliary materials are 1：1 mixing.Shaping situation is shown in Table 7.
The clear cream of table 7 pelleting situation table
It is clear cream by form situation Preliminary Determination auxiliary material proportion：Auxiliary material=1：2 and clear cream：Auxiliary material=1：3 shaped granules
Granularity qualification rate, heap density, mobility and hygroscopicity.
3.2.1.1 clear cream：Auxiliary material=1：2
Granularity disqualification rate determines：It is parallel to do two groups of experiments, obtained particle 55.38g is respectively taken, is placed in medicine sieve and sieves,
Record can not be sieved by No. 1 and can the results are shown in Table 8. by the granular mass of No. 5 sieves
The granularity disqualification rate measurement result of table 8
From table results, less than 15 ﹪, granularity disqualification rate meets 2010 editions States Pharmacopoeia specifications.
Heap density measurement：The drying test tube of 3 10ml tool scales is taken, weighs 5.01g, 5.03g, 5.01g particle respectively
It is put into test tube, test tube is highly fallen on plank by 5cm, after being repeated 5 times vibration, determines its volume, as a result such as table 9.
Heap density=mass/volume
The clear cream of table 9：Auxiliary material=1：2 granule heap density measurement data
Fluidity determining (measure at angle of repose)：Using fixed funnel method, 3 funnels are connected and are fixed on horizontal positioned
Graph paper on 1cm height at, carefully medicinal powder is poured into the funnel on most until formed on graph paper along hopper walls
Untill grain cone tips touch bell mouth, the diameter (2R) of conical base is measured by graph paper, repeated measurement 5 times, is calculated
Go out angle of repose (tg α=H/R), the results are shown in Table 10.
The clear cream of table 10：Auxiliary material=1：2 granule angle of repose determination datas
Hygroscopicity determines：The glass desicator that bottom is filled to sodium chloride supersaturated solution is put into 25 DEG C of constant incubator
Interior, constant temperature 24 hours, now the relative humidity in drier is 75%.1.0071g, 1.0054g particle is taken to be respectively placed in permanent
In the measuring cup of weight, dry to accurately weighed quality after constant weight 24h, be placed in the glass desicator of sodium chloride supersaturated solution
(weigh the cap opening), preserved in 25 DEG C of constant incubators.Take out and weigh after 48 hours, Moisture percentage is calculated as follows.Knot
Fruit is shown in Table 11.
The clear cream of table 11：Auxiliary material=1：2 granule hydroscopicity determination datas
Melting：Particle 10.06g after the sieving is taken, heats water 200ml, is stirred 5 minutes, the particle all dissolves but molten
Liquid has slight haze, has no any foreign matter.
3.2.1.2 clear cream：Auxiliary material=1：3 granules
Granularity disqualification rate determines：It is parallel to do two groups of experiments, obtained particle 81.98g is respectively taken, is placed in medicine sieve and sieves,
Record can not be sieved by No. 1 and can the results are shown in Table 12. by the granular mass of No. 5 sieves
The granularity disqualification rate measurement result of table 12
From table results, less than 15 ﹪, granularity disqualification rate meets 2010 editions States Pharmacopoeia specifications.
Heap density measurement：The drying test tube of 3 10ml tool scales is taken, weighs 5.03g, 5.03g, 5.03g particle respectively
It is put into test tube, test tube is highly fallen on plank by 5cm, after being repeated 5 times vibration, determines its volume, as a result such as the heap of table 13.
Density=mass/volume
The clear cream of table 13：Auxiliary material=1：3 granule heap density measurement data
Fluidity determining (measure at angle of repose)：Using fixed funnel method, 3 funnels are connected and are fixed on horizontal positioned
Graph paper on 1cm height at, carefully medicinal powder is poured into the funnel on most until formed on graph paper along hopper walls
Untill grain cone tips touch bell mouth, the diameter (2R) of conical base is measured by graph paper, repeated measurement 5 times, is calculated
Go out angle of repose (tg α=H/R), the results are shown in Table 14.
The clear cream of table 14：Auxiliary material=1：3 granule angle of repose determination datas
Hygroscopicity determines：The glass desicator that bottom is filled to sodium chloride supersaturated solution is put into 25 DEG C of constant incubator
Interior, constant temperature 24 hours, now the relative humidity in drier is 75%.1.0190g, 1.0538g particle is taken to be respectively placed in permanent
In the measuring cup of weight, dry to accurately weighed quality after constant weight 24h, be placed in the glass desicator of sodium chloride supersaturated solution
(weigh the cap opening), preserved in 25 DEG C of constant incubators.Take out and weigh after 48 hours, Moisture percentage is calculated as follows.Knot
Fruit is shown in Table 15.
The clear cream of table 15：Auxiliary material=1：3 granule hydroscopicity determination datas
Melting：Particle 10.01g after the sieving is taken, heats water 200ml, is stirred 5 minutes, the particle all dissolves but molten
Liquid has slight haze, has no any foreign matter.
3.2.2 cream powder makes pellet
Take 2 parts of dry cream, dried cream powder each 10.02g, 4.71g；10.13g, 4.68g are separately added into auxiliary material (starch and dextrin)
10.02g、9.42g；10.10g, 9.41g auxiliary material additional proportion are respectively (cream powder：Auxiliary material=1：1 and 1：2), two auxiliary materials are 1：1
Add.Shaping situation is shown in Table 16.
The cream powder of table 16 pelleting situation table
It is cream powder by form situation Preliminary Determination auxiliary material proportion：Auxiliary material=1：Ratio of briquetting, heap density, the stream of 2 shaped granules
Dynamic property and hygroscopicity.
3.2.2.1 cream powder：Auxiliary material=1：2
Granularity disqualification rate determines：It is parallel to do two groups of experiments, respectively take obtained particle 12.70g, be placed in medicine sieve and sieve,
Record can not be sieved by No. 1 and can the results are shown in Table 17. by the granular mass of No. 5 sieves
The granularity disqualification rate measurement result of table 17
From table results, higher than 15 ﹪, granularity disqualification rate meets 2010 editions States Pharmacopoeia specifications.
Heap density measurement：The drying test tube of 3 10ml tool scales is taken, weighs 5.00g, 5.00g, 5.00g particle respectively
It is put into test tube, test tube is highly fallen on plank by 5cm, after being repeated 5 times vibration, determines its volume, as a result such as table 18.
The cream powder of table 18：Auxiliary material=1：2 granule heap density measurement data
Fluidity determining (measure at angle of repose)：Using fixed funnel method, 3 funnels are connected and are fixed on horizontal positioned
Graph paper on 1cm height at, carefully medicinal powder is poured into the funnel on most until formed on graph paper along hopper walls
Untill grain cone tips touch bell mouth, the diameter (2R) of conical base is measured by graph paper, repeated measurement 5 times, is calculated
Go out angle of repose (tg α=H/R), the results are shown in Table 19.
The cream powder of table 19：Auxiliary material=1：2 granule angle of repose determination datas
Hygroscopicity determines：The glass desicator that bottom is filled to sodium chloride supersaturated solution is put into 25 DEG C of constant incubator
Interior, constant temperature 24 hours, now the relative humidity in drier is 75%.1.0050g, 1.0027g particle is taken to be respectively placed in permanent
In the measuring cup of weight, dry to accurately weighed quality after constant weight 24h, be placed in the glass desicator of sodium chloride supersaturated solution
(weigh the cap opening), preserved in 25 DEG C of constant incubators.Take out and weigh after 48 hours, Moisture percentage is calculated as follows.Knot
Fruit is shown in Table 20.
The cream powder of table 20：Auxiliary material=1：2 granule hydroscopicity determination datas
Melting：Particle 10.06g after the sieving is taken, heats water 200ml, is stirred 5 minutes, the particle all dissolves but molten
Liquid is muddy, micro- to have precipitation.
The effect experiment of experimental example 3
1 experiment material
1.1 tested materials and medicine ordinance
Medicine (being prepared by embodiment 1) of the present invention.Zoopery dosage：Mouse dosage is respectively high, medium and low
Dosage, as 6.66g/kg, 3.33g/kg, 1.66g/kg dosage, be respectively equivalent to 20 times of Coming-of-Age Day dosage, 10 times, 5
Times；Be each configured to 8%, 4%, 2% suspension with distilled water, i.e., respectively high, medium and low three dose concentrations, mouse stomach
Administration, 0.2ml/10g body weight, once a day.Positive drug is gastrodia-glossy ganoderma mixture (mental-tranquilization), and the auspicious medicine company in Kweiyang Dechang has
Limit company, dosage 2.08gl/kg, mouse stomach administration, 0.2ml/10g body weight, once a day.
1.2 animals and experimental site
Kunming mouse, male and female dual-purpose, body weight 20 ± 2, Jun You Kweiyang Guiyang College of Traditional Chinese Medicine animal experimental center provide, and close
Lattice card number：SCXK (Chongqing) 2012-0005, feed are complete granular mouse feed, are provided by above-mentioned unit.Experimental site is Kweiyang
College of traditional Chinese medicine's pharmacological toxicology laboratory, well-ventilated, hygiene.The other sub-cage rearing of animal unisexuality, free water feed.
1.3 reagent
Yellow Jackets, nikethamidum.
1.4 statistical procedures
Data represent that carrying out multigroup measurement data using SPSS17.0 statistical analysis softwares and compare two-by-two should with x ± s
Use one-way analysis of variance.
1.5 instrument
ALC-210.3 types electronic balance (upper current chart level instruments and meters Co., Ltd)；ZZ-6 type mouse autonomic activitieses instrument (into
Science and Technology Ltd. of Dou Tai alliances)
2 experimental methods and result
2.1 mouse autonomic activitieses are tested
Take Kunming mouse 60, after adaptability is fed 3 days, be randomly divided into 5 groups, every group 12, be respectively the present invention it is high,
In, low dose group and blank control group and positive controls, blank control group be fed with distilled water daily；High dose of the present invention：
(6.66g/kg)；Middle dosage of the present invention：(3.33g/kg)；Low dosage of the present invention：(1.66g/kg)；Positive controls gastrodia-glossy ganoderma
Mixture, dosage：After 30 days last dose 30min of (2.08gl/kg) continuous gavage, put in autonomic activities tester, record 5min
Interior autonomic activities number.Data carry out statistical analysis, are shown in Table 21.
Influence (n=11, x ± S) of the table 21 to normal mouse autonomic activities
Note：Each group is compared with blank group, * p<0.05
As a result show, for walking about, positive group and high dose group of the present invention contrast blank group are variant, low in the present invention
Dosage group does not have difference；Slave station Rob Roy sees each administration group equal indifference compared with blank group, prompts medicine high dose pair of the present invention
The autonomic activities of mouse influences without conspicuousness.
2.2 above threshold dose of sodium pentobarbitone sleep experiments
Take Kunming mouse 60, after adaptability is fed 3 days, be randomly divided into 5 groups, every group 12, be respectively the present invention it is high,
In, low dose group and blank control group and positive controls, blank control group be fed with distilled water daily；High dose of the present invention：
(6.66g/kg)；Middle dosage of the present invention：(3.33g/kg)；Low dosage of the present invention：(1.66g/kg)；Positive controls gastrodia-glossy ganoderma
Mixture, dosage：(2.08g/kg), successive administration 30 days, intraperitoneal injection yellow Jackets above threshold hypnosis is given after last dose 30min
Dosage (mouse) 50mg/kg, parenteral solution face and matched somebody with somebody with facing, be injected intraperitoneally by 0.2ml/20g injection volumes.(enter 100% animal
Sleep, but do not make the length of one's sleep long intraperitoneal injection dosage) whether observation test medicine extend yellow Jackets and make small white mouse
The time of righting reflex loss.Sleep lies on the back animal back on flat board down using righting reflex loss as index, if animal protects
Hold this more than posture 30s, then it is assumed that righting reflex loss.Dropping asleep latency is observed and recorded (to be injected intraperitoneally to righting reflex loss
Time) and sleep time (righting reflex loss to recover time).Testing result is shown in Table 22.
Table 22 above threshold dosage yellow Jackets experiment (n=11, x ± S)
Note：Each group is compared with blank group, * p<0.05
As a result show, there were significant differences compared with blank group for high dose group in the present invention for Sleep latency, positive
Group and low dose group of the present invention indifference compared with blank group；Each administration group more has conspicuousness with blank group for sleep
Difference, medicine of the present invention is prompted to have the function that to shorten Sleep latency for mouse and extend sleep period.
2.3 sub-threshold dose yellow Jackets sleep experiments
Take Kunming mouse 60, after adaptability is fed 3 days, be randomly divided into 5 groups, every group 12, be respectively the present invention it is high,
In, low dose group and blank control group and positive controls, blank control group be fed with distilled water daily；High dose of the present invention：
(6.66g/kg)；Middle dosage of the present invention：(3.33g/kg)；Low dosage of the present invention：(1.66g/kg)；Positive controls gastrodia-glossy ganoderma
Mixture, dosage：(2.08g/kg) successive administration 30 days, after last dose 30min, each group is injected intraperitoneally penta bar by 35mg/kg
Than appropriate sodium, using more than righting reflex loss 30s as sleep criterion, mouse of the observation tested material to yellow Jackets under threshold
The influence of sleep rate.On the basis of yellow Jackets hypnosis, whether observation test medicine can shorten animal dropping asleep latency,
It is Sleep latency to be fallen asleep from injection yellow Jackets to animal, shadow of the observation tested material to yellow Jackets Sleep latency
Ring.On the basis of yellow Jackets hypnosis, can observation tested material extend the length of one's sleep, with righting reflex loss to recovering this
The section time is the animal sleep time.Observation the results are shown in Table 23.
The yellow Jackets experiment (n=11, x ± S) of the sub-threshold dose of table 23
Note：Each group is compared with blank group, * p<0.05
As a result show, relatively there were significant differences with blank group for each administration group for incubation period, except this for sleep period
Invention low dose group, relatively there were significant differences with blank group for remaining group, prompts medicine of the present invention to be cooperateed with yellow Jackets
Effect, mice sleep incubation period can be shortened and extend the effect of sleep period.
The anticonvulsion experiment of 2.4 mouse
Take Kunming mouse 60, after adaptability is fed 3 days, be randomly divided into 5 groups, every group 12, be respectively the present invention it is high,
In, low dose group and blank control group and positive controls, blank control group be fed with distilled water daily；Height (dosage of the invention：
6.66g/kg)；Middle dosage of the present invention：(3.33g/kg)；Low dosage of the present invention：(1.66g/kg)；Positive controls gastrodia-glossy ganoderma
Mixture, dosage：(2.08g/kg) continuous gavage is after 30 days, after last dose after 1 hour, each group intraperitoneal injection nikethamidum
(there is the mandatory convulsions of whole body for index with mouse), fainted from fear latent in 300mg/kg (0.1ml/10g mouse weight), record mice convulsion number
Volt phase and death toll, statistical analysis is as a result carried out, the results are shown in Table 24.
The anticonvulsion experiment (n=11, x ± S) of the mouse of table 24
Note：Each group is compared with blank group, * p<0.05
As a result show, each administration group more has significant difference with blank group, prompts medicine of the present invention to have mouse
Extend faint from fear incubation period and the reduction convulsions death rate.
2.5 acute toxicity tests (MTD)
2.5.1 median lethal dose determines
Choose healthy Kunming mouse 40, female, male half and half, 18~22g of body weight.It is classified as four groups：Blank group is (male
Property), blank group (female), drug administration group of the present invention (male), drug administration group of the present invention (female), every group 10.
Given the test agent dosage is arranged to 0.8088g/ml, that is, take given the test agent 202.212g add distilled water to 250ml dissolve,
The fasting 16h before experiment, unlimited drinking-water, second day gavage 0.3ml/10g, it is administered once in one day.To observation post administration seven days, knot
Fruit shows that no dead mouse and lesion situation occur.LD50 can not be measured.
2.5.2 maximum tolerance determination
Choose healthy Kunming mouse 40, female, male half and half, 18~22g. of body weight is classified as four groups：Blank group is (male
Property), blank group (female), drug administration group of the present invention (male), drug administration group of the present invention (female), every group 10.
Given the test agent dosage is arranged to 0.8088g/ml, that is, take given the test agent 202.212g add distilled water to 250ml dissolve,
Point 3 gavages in one day, each time interval is 5h, and gavage volume is 0.4ml/10g, intergal dose 970.56g/kg.
To observation post administration seven days, the results showed that, no dead mouse and lesion situation occur.The maximal tolerance times for calculating mouse are 2911
Times.
3 conclusions
To sum up show, medicine of the present invention reduces to the autonomic activities for being unable to mouse positive effect；Extending sleep and contracting
Short Sleep latency has positive effect；And there is certain anticonvulsant action.
Note, above medicine of the present invention refer both to the medicine prepared by embodiment 1.
Compared with prior art, medicine of the present invention has the effect of blood-enrich, invigorating the spleen calming heart, and it is latent to extend convulsions
Volt phase and the reduction convulsions death rate, available for insomnia forgetfulness, dreaming often and waking easily, have a dizzy spell, spiritlessness and weakness, the few China of face yellow, tongue
Light tongue is thin, and arteries and veins is thin and delicate, improves sleep, has no side effect safely, can be long-term use of.
Embodiment：
Embodiment 1.
Formula：Sealwort 5kg, rhizoma Gastrodiae 3kg, polygala 5kg, radix pseudostellariae 3kg, ganoderma lucidum 3kg and Poria cocos 3kg.
Technique：Above medicine is taken, adds the water of 10 times of amounts, is decocted 3 times, is decocted 1.5 hours every time, decoction liquor merges, filtration,
The dense clear cream for being concentrated under reduced pressure into relative density under normal temperature and being 1.30-1.35 of filtrate, is 1 by the mass ratio of clear cream and auxiliary material:2 add
Auxiliary material, mix, particle is made, dry, produce granule；The auxiliary material is that starch and dextrin mix, and is produced；The starch and paste
The weight ratio of essence is 1:1.
Specification：Every bag of 5g.
Usage and dosage：Each 5-10g, it is daily 2-3 times.
Embodiment 2.
Formula：Sealwort 6kg, rhizoma Gastrodiae 4kg, polygala 6kg, radix pseudostellariae 4kg, ganoderma lucidum 4kg and Poria cocos 4kg.
Technique：Above medicine is taken, adds the water of 11 times of amounts, is decocted 4 times, is decocted 2 hours every time, decoction liquor merges, and filters, filter
The dense clear cream for being concentrated under reduced pressure into relative density under normal temperature and being 1.30-1.35 of liquid, is 1 by the mass ratio of clear cream and auxiliary material:2.5 add
Auxiliary material, mix, tabletting, dry, produce tablet；The auxiliary material is that starch and dextrin mix, and is produced；The weight of the starch and dextrin
Amount is than being 1:1.
Specification：0.3g/ pieces.
Usage and dosage：Each 2-3 pieces, it is daily 2-3 times.
Embodiment 3.
Formula：Sealwort 4kg, rhizoma Gastrodiae 2kg, polygala 4kg, radix pseudostellariae 2kg, ganoderma lucidum 2kg and Poria cocos 2kg.
Technique：Above medicine is taken, adds the water of 9 times of amounts, is decocted 2 times, is decocted 1 hour every time, decoction liquor merges, and filters, filter
The dense clear cream for being concentrated under reduced pressure into relative density under normal temperature and being 1.30-1.35 of liquid, is 1 by the mass ratio of clear cream and auxiliary material:1.5 add
Auxiliary material, mix, particle is made, dry, load capsule, produce capsule；The auxiliary material is that starch and dextrin mix, and is produced；Institute
The weight ratio for stating starch and dextrin is 1:1.
Specification：0.3g/ grains；
Usage and dosage：Each 2-3 grains, it is daily 2-3 times.
Claims (10)
- A kind of 1. medicine for improving sleep, it is characterised in that：Calculate by weight, mainly by sealwort 1-10 parts, rhizoma Gastrodiae 1-6 parts, Polygala 1-10 parts, radix pseudostellariae 1-6 parts, ganoderma lucidum 1-6 parts and Poria cocos 1-6 parts are made.
- 2. the medicine as claimed in claim 1 for improving sleep, it is characterised in that：Calculate by weight, mainly by sealwort 4-6 Part, rhizoma Gastrodiae 2-4 parts, polygala 4-6 parts, radix pseudostellariae 2-4 parts, ganoderma lucidum 2-4 parts and Poria cocos 2-4 parts are made.
- 3. the medicine as claimed in claim 2 for improving sleep, it is characterised in that：Calculate by weight, mainly by 5 parts of sealwort, 3 parts of 3 parts of rhizoma Gastrodiae, 5 parts of polygala, 3 parts of radix pseudostellariae, 3 parts of ganoderma lucidum and Poria cocos are made.
- A kind of 4. preparation method of the medicine of improvement sleep as any one of claim 1-3, it is characterised in that：Take Medicine is stated, adds auxiliary material or is not added with auxiliary material, pharmaceutical preparation is made.
- 5. the preparation method of the medicine as claimed in claim 4 for improving sleep, it is characterised in that：The pharmaceutical preparation is oral Preparation.
- 6. the preparation method of the medicine as claimed in claim 5 for improving sleep, it is characterised in that：The external preparation is particle Agent, tablet dose or capsule.
- 7. the preparation method of the medicine as claimed in claim 5 for improving sleep, it is characterised in that：The granule is so made It is standby：Above medicine is taken, adds the 9-11 times of water measured, is decocted 2-4 times, is decocted every time 1-2 hours, decoction liquor merges, and filtration, filtrate subtracts Pressure is concentrated into the clear cream that relative density under normal temperature is 1.30-1.35, is 1 by the mass ratio of clear cream and auxiliary material:1.5-2.5 adds auxiliary Material, mix, particle is made, dry, produce.
- 8. the preparation method of the medicine as claimed in claim 5 for improving sleep, it is characterised in that：The tablet is prepared： Above medicine is taken, adds the 9-11 times of water measured, is decocted 2-4 times, is decocted every time 1-2 hours, decoction liquor merges, filtration, filtrate decompression The clear cream that relative density under normal temperature is 1.30-1.35 is concentrated into, is 1 by the mass ratio of clear cream and auxiliary material:1.5-2.5 adds auxiliary Material, mix, tabletting, dry, produce.
- 9. the preparation method of the medicine as claimed in claim 5 for improving sleep, it is characterised in that：The capsule is so made It is standby：Above medicine is taken, adds the 9-11 times of water measured, is decocted 2-4 times, is decocted every time 1-2 hours, decoction liquor merges, and filtration, filtrate subtracts Pressure is concentrated into the clear cream that relative density under normal temperature is 1.30-1.35, is 1 by the mass ratio of clear cream and auxiliary material:1.5-2.5 adds auxiliary Material, mix, particle is made, dry, load capsule, produce.
- 10. improve the preparation method of the medicine of sleep as claimed in any one of claims 7-9, it is characterised in that：It is described auxiliary Expect for starch and dextrin, mix, produce；The weight ratio of the starch and dextrin is 1:1.
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| CN108853366A (en) * | 2018-09-28 | 2018-11-23 | 南宁常春藤肿瘤研究院 | A kind of drug that can promote and improve sleep quality and its production method |
| CN109303333A (en) * | 2018-09-12 | 2019-02-05 | 珠海霍普金斯医药研究院股份有限公司 | A kind of Halth-care composition improving sleep |
| CN114569675A (en) * | 2022-01-17 | 2022-06-03 | 沈阳爱可生健康咨询管理有限责任公司 | Sleep improving method with sleep quality improving effect |
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