CN101496858B - Chinese medicinal composition for treating insomnia and preparation method thereof - Google Patents
Chinese medicinal composition for treating insomnia and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating insomnia, which is mainly prepared from the following raw material drugs in portion by weight: 5 to 15 portions of dactylicapnos root, 3 to 10 portions of grassleaf sweelflag rhizome, and 1 to 5 portions of Szechuan lovage rhizome. The invention also discloses a method for preparing crude drug powder, active component liquid medicine and dry extract powder of the traditional Chinese medicine composition. The traditional Chinese medicine composition has a simple formulation, and has the efficacies of tranquilizing and allaying excitement, activating blood and promoting Qi. Pharmacodynamics research results show that the traditional Chinese medicine composition applied by lavage can remarkably shorten the sleep latency of mice induced by sodium pentobarbital of threshold dosage, prolong sleep time, strengthen the hypnotic effects of the sodium pentobarbital of the threshold dosage, induce the mice given with the sodium pentobarbital of the sub-threshold dosage, and strengthen the hypnotic effects of the sodium pentobarbital of the sub-threshold dosage.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and preparation method thereof, be specifically related to Chinese medicine composition of a kind of Cure for insomnia and preparation method thereof.
Background technology
Insomnia is meant starting of sleep and keeps the generation obstacle, cause the quality and quantity of sleep can not satisfy individual physiological need, cause patient's daytime to some extent self-induction fail fully to have a rest and regain one's vigor, thereby body tiredness, lethargy, drowsiness, aprosexia, the thinking difficulty, bradykinesia, depressed, impatient.It may be a modal clinical symptoms except that pain, more in women and old people sees more.Insomnia is modal sleep disorder, has very high sickness rate.In the U.S., Australia and some European countries, the prevalence of insomnia is 35.2%.The incidence rate of having a sleepless night in the population of China is 10%-20%.In recent years, along with the continuous aggravation of social competition, the quickening of rhythm of life, the sickness rate of insomnia is the trend of rising, has had a strong impact on daily life, work and physical and mental health.Investigation shows that 40% insomniac is other mental diseases of secondary simultaneously, mainly are depressions, and sickness rate is apparently higher than normal population.The traditional Chinese medical science is then had a sleepless night and is " being insomnia ", how tightly do not hand over, hyperactivity of fire caused by deficiency of YIN and disorder of the stomach etc. influence the mind and cause because of pondering over overstrain, interior sad spleen, the heart, but always relevant with the heart, spleen, Liver and kidney and deficiency of YIN-blood.Modern medicine does not still have a specially good effect to insomnia, and western medicine is many to be kept with anxiety and sedative hypnotic, and drug withdrawal is then recurred even be more serious, and take for a long time that headache and dizzy appears in patient behind this type of medicine, feel sick, the soft side effect such as weak of gastrointestinal upset and body.Therefore and Chinese medicine plays an important role in insomnia's treatment with its special advantages, develops that determined curative effect, safety are good, the Chinese medicine preparation of the Cure for insomnia that can be accepted extensively by the patient has great importance.
Summary of the invention
Technical problem to be solved by this invention is easily to recur in order to overcome western medicine insomnia drug withdrawal, takes the big defective of side effect for a long time, and a kind of effect with tranquillizing and allaying excitement, blood-activating and qi-promoting is provided, effectively the Chinese medicine composition of Cure for insomnia.
Chinese medicine composition of the present invention mainly is to be made by following bulk drugs: 5～15 parts of Radix dactylicapni (Radix Dactylicapnotis)s (Dactylicapnos scandens (D.Don) Hutch.), 3～10 parts of Rhizoma Acori Graminei (Rhizoma AcoriTatarinawii), 1～5 part of Rhizoma Chuanxiong (Rhizoma Chuanxiong), better mainly is to be made by following bulk drugs: 8～12 parts of Radix dactylicapni (Radix Dactylicapnotis)s, 5～8 parts of Rhizoma Acori Graminei, 1～3 part of Rhizoma Chuanxiong, best mainly is to be made by following bulk drugs: 10 parts of Radix dactylicapni (Radix Dactylicapnotis)s, 6 parts of Rhizoma Acori Graminei, 2 parts of Rhizoma Chuanxiongs.
The characteristics of Chinese medicine composition of the present invention are for being principal agent with Yunnan medicinal herbs most in use Radix dactylicapni (Radix Dactylicapnotis) among the people.Radix dactylicapni (Radix Dactylicapnotis) Dactylicapnos scandens (D.Don) Hutch. is the dry root of bloodroot Radix dactylicapni (Radix Dactylicapnotis) Dactylicapnosscandens (D.Don) Hutchins, is Yunnan Bai nationality medicinal herbs most in use, and Bai nationality's language claims " growing hard wheel ".Mainly being distributed in the ground such as Yunlong, Wei Shan, Nan Jian, Eryuan in western part, Yunnan, is that Yunnan Province of China is economized folk tradition and commonly used Chinese herbal medicine, and Xia Qiu gathers its root, be used as medicine after drying, bitter in the mouth, cool in nature has the effect of analgesia, hemostasis, antiinflammatory, calmness, Bai nationality pain easing and hemostasis that is widely used among the people.All on the books in " Yunnan Province's drug standard " and " Yunnan natural resources of Chinese medicinal materials register ", once by " Chinese pharmacopoeia version in 1977 is recorded.The present invention finds that by pharmacodynamic experiment and clinical verification Radix dactylicapni (Radix Dactylicapnotis) has excellent curative for the insomnia, is principal agent with the Radix dactylicapni (Radix Dactylicapnotis) therefore, has formed the Chinese medicine composition that is used for insomnia's treatment.
In the Chinese medicine composition of the present invention, Radix dactylicapni (Radix Dactylicapnotis) tranquillizing and allaying excitement, blood circulation promoting and blood stasis dispelling; The Rhizoma Chuanxiong blood-activating and qi-promoting makes unobstructed vessel, and gas is along then liver is easypro, and freely then the heart is peaceful for blood, the comfortable rather then refreshing peace of liver; The removing dampness of Rhizoma Acori Graminei causing resuscitation with aromatic drugs can excited mind and the refreshment analepsia, again can calm mind, and the diseases such as palpitation with fear insomnia due to the kind training the mind will obstacle irritability.All medicines share, and tranquillizing and allaying excitement, blood-activating and qi-promoting, tranquilizing by nourishing the heart can reach the merit of sleeping peacefully.
The crude drug powder of Chinese medicine composition of the present invention, active component medicinal liquid and dry extract etc. can with mixing acceptable accessories, adopt conventional method to make various oral formulations, preferable is tablet, capsule, granule, oral liquid, syrup, drop pill or powder, and best is tablet or capsule.Described adjuvant can be the conventional adjuvant that uses in this area, as in the following adjuvant one or more: starch, dextrin, microcrystalline Cellulose, lactose, sucrose, xanthan gum, Polyethylene Glycol, polyvinylpyrrolidone, magnesium stearate and Pulvis Talci.
Chinese medicine composition of the present invention can be made by following method:
1, the preparation of crude drug powder
Three kinds of crude drug pulverize separately are become 60～120 purpose powder, by the prescription mixed make the crude drug powder, three kinds of crude drug mixing of the ratio of perhaps will write out a prescription are ground into 60～120 purpose powder.The crude drug powder that makes can adopt conventional method to make capsule, tablet or powder.
2, the preparation of active component medicinal liquid
Method one: three kinds of medical materials of the ratio of will writing out a prescription, decoct with water 2～3 times, amount of water is 8～12 times of medical material amount, decocting time is 1～2 hour at every turn, decocting temperature is the little temperature of boiling of decoction liquor, and merge extractive liquid, filters, it is 1.02～1.15 concentrated solution that filtrate is condensed into relative density, promptly gets the active component medicinal liquid of described Chinese medicine composition.
Method two: add ethanol in the above-mentioned active component medicinal liquid that makes, make to contain alcohol amount and reach percent by volume 50%～80%, cold preservation is after 12～36 hours, filter, filtrate recycling ethanol, and be condensed into the concentrated solution of relative density 1.02～1.10, be active component medicinal liquid of the present invention.
The active component medicinal liquid that makes can add one or more adjuvants, makes peroral dosage forms such as tablet, granule, capsule or oral liquid according to a conventional method.
3, the preparation of dry extract
Method one: will carry out drying with spray drying or vacuum drying method by the active component medicinal liquid that said method makes, and pulverize afterwards, and sieve, and promptly get the dry extract of described Chinese medicine composition.The dry extract that makes can add one or more adjuvants, makes peroral dosage forms such as tablet, granule, capsule or oral liquid according to a conventional method.
Method two:
(1) with Radix dactylicapni (Radix Dactylicapnotis) with the ethanol water heating and refluxing extraction of percent by volume 50%～90% 2～3 times, the consumption of ethanol water is 6～10 times of medical material weight, extraction time is 1～2 hour at every turn, keeping decoction liquor during extraction is slight boiling condition, merge extractive liquid,, filter, it is 1.02～1.08 concentrated solution that filtrate is condensed into relative density;
(2) get Rhizoma Acori Graminei and Rhizoma Chuanxiong medical material in addition, add medical material weight 8-12 water doubly, soaked 1～2 hour, steam distillation extracted volatile oil 8～12 hours, obtained volatile oil and aqueous extract;
(3) with 1 milliliter of volatile oil: the ratio of 5～10 grams is got beta-schardinger dextrin-, the water mixing that adds 2～5 times of beta-schardinger dextrin-weight gets the beta-schardinger dextrin-aqueous solution, the volatile oil of step (2) gained is added in this beta-schardinger dextrin-aqueous solution, and mixed grinding becomes pastel, and 30～50 ℃ of dryings obtain clathrate;
(4) with Rhizoma Acori Graminei, Rhizoma Chuanxiong medical material residue decocts with water 1-2 time again, the consumption of each water is 8～12 times of medical material weight, each time that decocts is 1-2 hour, decocting temperature is slight boiling condition for keeping decoction liquor, merge extractive liquid,, filter, the aqueous extract of filtrate and step (2) gained is merged, be concentrated into the concentrated solution of relative density 1.02～1.10, behind the Radix dactylicapni (Radix Dactylicapnotis) concentrated solution mix homogeneously with itself and step (1) gained, with spray drying or vacuum drying method drying, pulverize, after sieving,, promptly get the dry extract of described Chinese medicine composition with the clathrate mix homogeneously of step (3) gained.
This method adopts alcohol extraction to follow the example of and extracts effective ingredient in the Radix dactylicapni (Radix Dactylicapnotis), the decocting cooking method is extracted the effective ingredient in Rhizoma Acori Graminei and the Rhizoma Chuanxiong, steam distillation extracts the volatile oil in Rhizoma Acori Graminei and the Rhizoma Chuanxiong, and adopts inclusion technique that volatile oil is made Benexate Hydrochloride, to improve stability.After the Benexate Hydrochloride of the water extract of Radix dactylicapni (Radix Dactylicapnotis) alcohol extract, Rhizoma Acori Graminei and Rhizoma Chuanxiong and volatile oil mixed, add one or more adjuvants, make peroral dosage forms such as tablet, granule, capsule, oral liquid according to a conventional method.
The present invention is raw materials used and reagent is all commercially available gets.Among the present invention, described relative density is under 60 ℃～65 ℃, the density of this material with at normal atmosphere, pure H 3.98 ℃ the time
2Density (the 999.972kg/m of O
3) ratio.
Positive progressive effect of the present invention is: Chinese medicine composition prescription of the present invention is simple, has the effect of tranquillizing and allaying excitement, blood-activating and qi-promoting.Pharmacodynamic study is the result show, Chinese medicine composition of the present invention is through gastric infusion, can significantly shorten the inductive mice sleep of threshold dose pentobarbital sodium incubation period, prolongs the length of one's sleep, strengthens the syngignoscism of threshold dose pentobarbital sodium; Induce mice to fall asleep, strengthen the syngignoscism of sub-threshold dose pentobarbital sodium to the sub-threshold dose pentobarbital sodium.Use the statistical analysis that patient that these Chinese medicine compositions carry out Insomnia therapy carries out clinical therapeutic efficacy to 175, with reference in 1993 Ministry of Public Health " new Chinese medicine clinical research guideline " " curative effect determinate standard of insomnia, wherein produce effects 69 examples account for 39%; Effective 85 examples account for 52%; Invalid 21 examples account for 12%; Total effective rate is 88%.
The specific embodiment
Mode below by embodiment further specifies the present invention, but does not therefore limit the present invention among the described scope of embodiments.
The preparation of embodiment 1 crude drug powder
Radix dactylicapni (Radix Dactylicapnotis), Rhizoma Acori Graminei and Rhizoma Chuanxiong are cleaned respectively, dried, after the chopping, pulverized 60 mesh sieves.Take by weighing three kinds of medicinal powders by following weight ratio: Radix dactylicapni (Radix Dactylicapnotis) 200g, Rhizoma Acori Graminei 120g, Rhizoma Chuanxiong 40g, mix homogeneously promptly makes the crude drug powder.
The preparation of embodiment 2 capsules
(1) will write out a prescription in three kinds of medical materials, clean respectively, dry, after the chopping, pulverized 60 mesh sieves.
(2) take by weighing three kinds of medicinal powders by following weight ratio: Radix dactylicapni (Radix Dactylicapnotis) 200g, Rhizoma Acori Graminei 120g, Rhizoma Chuanxiong 40g add microcrystalline Cellulose 30g, magnesium stearate 2g, mix homogeneously.
(3) the said mixture powder is packed into No. 0 capsule (about 0.4g) amounts to 1000.
The preparation of embodiment 3 active component medicinal liquids
Get Radix dactylicapni (Radix Dactylicapnotis) 100g, Rhizoma Acori Graminei 50g, Rhizoma Chuanxiong 30g, decoct with water 2 times, add the water of 8 times of medical material weight at every turn, decocting time is 1 hour at every turn, and decocting temperature is the solution boiling temperature.Merge secondary raffinate, filter, be evaporated to the concentrated solution of relative density 1.04, be active component medicinal liquid of the present invention.
The preparation of embodiment 4 dry extracts
The active component medicinal liquid that method embodiment 3 is made continues to be evaporated to relative density 1.10, and 60 ℃ of vacuum dryings are pulverized afterwards, sieve, and are dry extract of the present invention.
The preparation of embodiment 5 active component medicinal liquids
Get Radix dactylicapni (Radix Dactylicapnotis) 900g, Rhizoma Acori Graminei 600g, Rhizoma Chuanxiong 300g, decoct with water 2 times, add the water of 12 times of medical material weight for the first time, the water that adds for the second time 10 times of medical material weight, decocting time is 2 hours each time, is 1 hour for the second time, and decocting temperature is the solution boiling temperature.Merge secondary raffinate, filter, be evaporated to relative density 1.08, add ethanol and make and contain the alcohol amount and reach percent by volume 60%, behind the cold preservation 24h, filter, filtrate recycling ethanol, and be condensed into the concentrated solution of relative density 1.05, be active component medicinal liquid of the present invention.
The preparation of embodiment 6 dry extracts
The active component medicinal liquid continuation concentrating under reduced pressure that method embodiment 5 is made becomes thick paste, and 60 ℃ of vacuum dryings are pulverized, and sieve, and are dry extract of the present invention.
The preparation of embodiment 7 active component medicinal liquids
Get Radix dactylicapni (Radix Dactylicapnotis) 500g, Rhizoma Acori Graminei 200g, Rhizoma Chuanxiong 200g, decoct with water 3 times, add the water of 10 times of medical material weight for the first time, second and third time adds the water of 8 times of medical material weight respectively, and decocting time is 1 hour at every turn.Merge three times extracting solution, filter, be evaporated to the concentrated solution of relative density 1.02, be active component medicinal liquid of the present invention.
The preparation of embodiment 8 dry extracts
Active component medicine liquid spray drying with method embodiment 7 makes is dry extract of the present invention.
The preparation of embodiment 9 dry extracts
(1) gets Radix dactylicapni (Radix Dactylicapnotis) medical material 100g, the alcohol reflux 2 times that adds percent by volume 70%, each ethanol water consumption is 8 times of quality of medicinal material, decoct temperature for keeping the little temperature of boiling of decoction liquor, merge extracted twice liquid, filter, decompression recycling ethanol, it is 1.05 concentrated solution that filtrate is condensed into relative density.
(2) get Rhizoma Acori Graminei 50g, Rhizoma Chuanxiong 30g in addition, add the water of 8 times of weight, soaked 2 hours, steam distillation extracted volatile oil 8 hours, collected volatile oil and aqueous extract respectively.
(3) get beta-schardinger dextrin-with the ratio of 1 milliliter of volatile oil: 6g, the water that adds 4 times of weight stirs and makes the beta-schardinger dextrin-aqueous solution, and the volatile oil of step (2) gained is added in this beta-schardinger dextrin-aqueous solution, become pastel with the abundant mixed grinding of mortar, 40 ℃ of cold drying obtain clathrate;
(4) decocting that Rhizoma Acori Graminei, Rhizoma Chuanxiong medical material residue is added again 8 times of medical material weight boils 1 time, decocting time 1 hour, decocting temperature is slight boiling condition for keeping decoction liquor, decoction liquor is filtered, the aqueous extract of filtrate and step (2) gained merges, and is concentrated into the concentrated solution (60 ℃ of surveys) of relative density 1.03, merges with the Radix dactylicapni (Radix Dactylicapnotis) concentrated solution of step (1) gained and the clathrate of step (3) gained again, mix homogeneously can get the comprehensive extracting solution of Chinese medicine composition of the present invention.Perhaps the filtrate of step (4) and the aqueous extract of step (2) gained are merged, be concentrated into the concentrated solution of relative density 1.02, behind the Radix dactylicapni (Radix Dactylicapnotis) concentrated solution mix homogeneously with itself and step (1) gained, spray drying, pulverize, after sieving,, promptly get the dry extract of Chinese medicine composition with the clathrate mix homogeneously of step (3) gained.
The preparation of embodiment 10 dry extracts
(1) gets Radix dactylicapni (Radix Dactylicapnotis) medical material 800g, the alcohol reflux 3 times that adds percent by volume 50%, each water that adds 10 times of medical material weight, 2 hours for the first time, 1 hour for the second time, decoct temperature for keeping the little temperature of boiling of decoction liquor, merge extracted twice liquid, filter, decompression recycling ethanol, it is 1.08 concentrated solution that filtrate is condensed into relative density.
(2) get Rhizoma Acori Graminei 600g, Rhizoma Chuanxiong 300g in addition, add the water of 10 times of weight, soaked 2 hours, steam distillation extracted volatile oil 10 hours, collect volatile oil and aqueous extract.
The ratio of (3) 1 milliliters of volatile oil: 5g is got beta-schardinger dextrin-, and the water mixing that adds 2 times of beta-schardinger dextrin-weight gets the beta-schardinger dextrin-aqueous solution, and volatile oil is added in this beta-schardinger dextrin-aqueous solution, and mixed grinding becomes pastel, and 30 ℃ of dryings obtain clathrate.
(4) decocting that Rhizoma Acori Graminei, Rhizoma Chuanxiong medical material residue is added again 10 times of medical material weight boiled 2 hours, and decocting temperature is slight boiling condition for keeping decoction liquor, repeated to decoct once, filter, merging filtrate merges the aqueous extract of itself and step (2) gained, is concentrated into the concentrated solution of relative density 1.08, behind the Radix dactylicapni (Radix Dactylicapnotis) concentrated solution mix homogeneously with itself and step (1) gained, spray drying is pulverized, after sieving, with the clathrate mix homogeneously of step (3) gained, promptly get the dry extract of Chinese medicine composition.
The preparation of embodiment 11 dry extracts
(1) gets Radix dactylicapni (Radix Dactylicapnotis) medical material 800g, the alcohol reflux 2 times that adds percent by volume 90%, each water that adds 6 times of medical material weight, 2 hours for the first time, 1 hour for the second time, decoct temperature for keeping the little temperature of boiling of decoction liquor, merge extracted twice liquid, filter, decompression recycling ethanol, it is 1.02 concentrated solution that filtrate is condensed into relative density.
(2) get Rhizoma Acori Graminei 600g, Rhizoma Chuanxiong 300g in addition, add the water of 12 times of weight, soaked 1 hour, steam distillation extracted volatile oil 12 hours, collect volatile oil and aqueous extract.
The ratio of (3) 1 milliliters of volatile oil: 10g is got beta-schardinger dextrin-, and the water mixing that adds 5 times of beta-schardinger dextrin-weight gets the beta-schardinger dextrin-aqueous solution, and volatile oil is added in this beta-schardinger dextrin-aqueous solution, and mixed grinding becomes pastel, and 50 ℃ of dryings obtain clathrate.
(4) decocting that Rhizoma Acori Graminei, Rhizoma Chuanxiong medical material residue is added again 12 times of medical material weight boiled 2 hours, and decocting temperature is slight boiling condition for keeping decoction liquor, repeated to decoct once, filter, merging filtrate merges the aqueous extract of itself and step (2) gained, is concentrated into the concentrated solution of relative density 1.10, behind the Radix dactylicapni (Radix Dactylicapnotis) concentrated solution mix homogeneously with itself and step (1) gained, spray drying is pulverized, after sieving, with the clathrate mix homogeneously of step (3) gained, promptly get the dry extract of Chinese medicine composition.
The preparation of embodiment 12 crude drug powder
Radix dactylicapni (Radix Dactylicapnotis), Rhizoma Acori Graminei and Rhizoma Chuanxiong are cleaned respectively, dried, after the chopping, pulverized 100 mesh sieves.Take by weighing three kinds of medicinal powders by following weight ratio: Radix dactylicapni (Radix Dactylicapnotis) 100g, Rhizoma Acori Graminei 50g, Rhizoma Chuanxiong 30g, mix homogeneously promptly makes the crude drug powder.
The preparation of embodiment 13 powders
Radix dactylicapni (Radix Dactylicapnotis), Rhizoma Acori Graminei and Rhizoma Chuanxiong are cleaned respectively, dried, take by weighing three kinds of medicinal powders by following weight ratio: Radix dactylicapni (Radix Dactylicapnotis) 200g, Rhizoma Acori Graminei 120g, Rhizoma Chuanxiong 40g, mix, after the chopping, pulverized 120 mesh sieves, promptly make powder of the present invention.
The preparation of embodiment 14 capsules
Add the 100g dextrin in the dry extract (about 120g) that embodiment 4,6,8 or 9 makes, mix, granulate, drying is sieved, and adorns 1000 capsules, is capsule of the present invention.
The preparation of embodiment 15 tablets
In the dry extract (about 120g) that embodiment 4,6,8 or 9 makes, add 100g starch, the 50g microcrystalline Cellulose, mixing is a binding agent with 2% polyvinylpyrrolidone alcoholic solution, granulates, oven dry, granulate adds 2g magnesium stearate or Pulvis Talci, mixing, be pressed into 1000, be tablet of the present invention.
The preparation of embodiment 16 granules
The dry extract (about 30g) that makes to embodiment 4,6,8 or 9 adds the 200g lactose, the 300g dextrin, and mixing is granulated, oven dry, granulate is made the 1000g granule, is granule of the present invention.
The preparation of embodiment 17 oral liquids
In the active component medicinal liquid that embodiment 3,5 or 7 makes, add 0.3% sodium benzoate, 0.2% polyoxyethylene sorbitan monoleate (g/mL), mixing filters, the 1000mL oral liquid is made in fill, oral liquid of the present invention.
The preparation of embodiment 18 drop pill
To the dry extract (about 300g) that embodiment 4,6,8 or 9 makes, be added in the 700g polyethylene glycol 6000 of heating and melting, stirring and dissolving is dripped and is made the 1000g pill, is drop pill of the present invention.
The preparation of embodiment 19～30 crude drug powder
Radix dactylicapni (Radix Dactylicapnotis), Rhizoma Acori Graminei and Rhizoma Chuanxiong are cleaned respectively, dried, after the chopping, pulverized 60 mesh sieves.Take by weighing three kinds of medicinal powders by prescription in the table 1, mix homogeneously promptly makes the crude drug powder of each embodiment.
| Embodiment | Radix dactylicapni (Radix Dactylicapnotis)/g | Rhizoma Acori Graminei/g | Rhizoma Chuanxiong/g | Embodiment | Radix dactylicapni (Radix Dactylicapnotis)/g | Rhizoma Acori Graminei/g | Rhizoma Chuanxiong/g |
| 19 | 5 | 10 | 5 | 25 | 8 | 8 | 3 |
| 20 | 15 | 3 | 1 | 26 | 12 | 5 | 1 |
| 21 | 15 | 3 | 5 | 27 | 12 | 5 | 3 |
| 22 | 5 | 10 | 1 | 28 | 8 | 8 | 1 |
| 23 | 15 | 10 | 1 | 29 | 12 | 8 | 1 |
| 24 | 5 | 3 | 5 | 30 | 8 | 5 | 3 |
The preparation of embodiment 31 syrups
In the active component medicinal liquid that embodiment 3,5 or 7 makes, add sucrose, stirring makes dissolving fully, make sugar content reach about 50% (g/mL), other adds 0.3% sodium benzoate, 0.2% polyoxyethylene sorbitan monoleate (g/mL), mixing, filter, the 1000mL oral liquid is made in fill, oral liquid of the present invention.
The preparation of embodiment 32 active component medicinal liquids
Get Radix dactylicapni (Radix Dactylicapnotis) 900g, Rhizoma Acori Graminei 600g, Rhizoma Chuanxiong 300g, decoct with water 3 times, add the water of 8 times of medical material weight at every turn, each 1 hour of decocting time, decocting temperature is the solution boiling temperature.Merge extractive liquid, filters, and is evaporated to relative density 1.15, adds ethanol and makes and contain the alcohol amount and reach percent by volume 50%, behind the cold preservation 12h, filter, and filtrate recycling ethanol, and be condensed into the concentrated solution of relative density 1.02, be active component medicinal liquid of the present invention.
The preparation of embodiment 33 active component medicinal liquids
Get Radix dactylicapni (Radix Dactylicapnotis) 900g, Rhizoma Acori Graminei 600g, Rhizoma Chuanxiong 300g, decoct with water 3 times, add the water of 8 times of medical material weight at every turn, each 1 hour of decocting time, decocting temperature is the solution boiling temperature.Merge extractive liquid, filters, and is evaporated to relative density 1.15, adds ethanol and makes and contain the alcohol amount and reach percent by volume 80%, behind the cold preservation 36h, filter, and filtrate recycling ethanol, and be condensed into the concentrated solution of relative density 1.10, be active component medicinal liquid of the present invention.
Effect embodiment
The applicating cooperation pentobarbital sodium sub-threshold lull dosage is to the influence of mouse sleep time test, and the pharmacodynamics of the Chinese medicinal composition preparation of the present invention that adopts the different process preparation is verified:
(1) pharmacodynamics test of the full crude drug powder of Chinese medicine composition of the present invention
(1) trial drug: full the crude drug powder of Chinese medicine preparation of the present invention (embodiment 1), with 1% sodium carboxymethyl cellulose (CMC) (g/mL) distilled water be mixed with concentration be 5,10,20% (g/mL) be subjected to reagent liquid, with joining with usefulness.
(2) test method: mice is divided into 5 groups at random by body weight, 10 every group.If various dose medication group, positive controls and blank group are irritated stomach (ig) respectively and are subjected to reagent thing 1,2,4g/kg, diazepam 2mg/kg, 1%CMC 20ml/kg.50 animals in back are female, irritate stomach respectively and are subjected to reagent thing 0.5,1,2g/kg, diazepam 2mg/kg, 1%CMC 20ml/kg.After the administration 1 hour, subcutaneous injection pentobarbital sodium 30mg/kg was an observation index with the sleep time, record and the difference between each group relatively.
(3) result of the test: irritate stomach and be subjected to reagent thing 1,2,4g/kg to mice, after the administration 1 hour, ip pentobarbital sodium 30mg/kg, the result can obviously prolong the sleep time (P＜0.05) of mice.The results are shown in Table 1, table 2.
Table 1 Chinese medicine composition of the present invention is worked in coordination with pentobarbital sodium sub-threshold lull dosage
Influence to the male mice sleep
(n＝10，X±SD)
| Group | Dosage g/kg | Sleep time | |
| Min | ％ | ||
| Blank low dose group low dose group high dose group diazepam | \ 1 2 4 0.002 | 98±23 143±30 174±42 * 154±59 201±35 ** | \ 25.4 56.8 36.4 105.4 |
*P＜0.05,
*P＜0.01 is with the blank ratio
Table 2 Chinese medicine composition of the present invention is worked in coordination with pentobarbital sodium sub-threshold lull dosage
Influence to the female mice sleep
(n＝10，X±SD)
| Group | Dosage g/kg | Sleep time | |
| Min | ％ | ||
| Blank low dose group low dose group high dose group diazepam | \ 0.5 1 2 0.002 | 57±16 116±29 ** 128±20 ** 110±41 * 148±46 ** | \ 67.6 55.0 57.7 159.6 |
*P＜0.05,
*P＜0.01 is with the blank ratio
(2) pharmacodynamics test of the Chinese medicine composition of the present invention of different preparations
(1) test method: get 50 of mices, male and female half and half are divided into 5 groups at random by body weight, 10 every group.If crude drug powder group (embodiment 12), water extract group (embodiment 3), comprehensive three of extraction groups (embodiment 9) are subjected to reagent thing group, positive controls and blank group, irritate stomach respectively and be subjected to reagent thing 2g/kg (in medical material), diazepam 2mg/kg (positive controls), normal saline 20ml/kg (blank group).With animal dropping asleep latency and sleep time is observation index, the difference between writing down and relatively respectively organizing.
(2) result of the test: the crude drug powder group of Chinese medicine composition of the present invention, water extract group and comprehensive extracting solution group all can significant prolongation pentobarbital sodium threshold dose under length of one's sleep of mice, shorten dropping asleep latency, show that compound preparation of the present invention has good Insomnia therapy effect.
The Chinese medicine composition of the present invention of the different preparations of table 3 is worked in coordination with pentobarbital sodium sub-threshold lull dosage
To the influence of mice sleep (n=10, X ± SD)
| Group | Time for falling asleep ± SD (min) | Sleeping latent time ± SD (min) |
| The blank group | 103.57±38.55 | 5.29±2.63 |
| Crude drug powder group | 132.86±41.78 * | 4.37±2.15 * |
| Water extract group | 149.71±47.44 ** | 3.29±2.06 * |
| Comprehensive extract group | 143.58±42.38 ** | 3.71±2.66 * |
| Diazepam | 154.8±36.56 ** | 3.09±1.65 ** |
Compare with blank,
*P＜0.05,
*P＜0.01
Claims (8)
1. the Chinese medicine composition of a Cure for insomnia, it is characterized in that: it is made by following bulk drugs: 5～15 parts of Radix dactylicapni (Radix Dactylicapnotis)s, 3～10 parts of Rhizoma Acori Graminei, 1～5 part of Rhizoma Chuanxiong.
2. Chinese medicine composition as claimed in claim 1 is characterized in that: it is made by following bulk drugs: 8～12 parts of Radix dactylicapni (Radix Dactylicapnotis)s, 5～8 parts of Rhizoma Acori Graminei, 1～3 part of Rhizoma Chuanxiong.
3. Chinese medicine composition as claimed in claim 2 is characterized in that: it is made by following bulk drugs: 10 parts of Radix dactylicapni (Radix Dactylicapnotis)s, 6 parts of Rhizoma Acori Graminei, 2 parts of Rhizoma Chuanxiongs.
4. as each described Chinese medicine composition in the claim 1～3, it is characterized in that: the dosage form of described Chinese medicine composition is tablet, capsule, granule, oral liquid, syrup, drop pill or powder.
5. Chinese medicine composition as claimed in claim 4 is characterized in that: contain in the following adjuvant one or more in the dosage form of described Chinese medicine composition: starch, dextrin, microcrystalline Cellulose, lactose, sucrose, xanthan gum, Polyethylene Glycol, polyvinylpyrrolidone, magnesium stearate and Pulvis Talci.
6. preparation method as each described Chinese medicine composition in the claim 1～3, it is characterized in that: three kinds of crude drug pulverize separately are become 60～120 purpose powder, by the crude drug powder that makes of prescription mixed, three kinds of crude drug of the ratio of perhaps will writing out a prescription mix, be ground into 60～120 purpose powder, promptly get the crude drug powder of described Chinese medicine composition.
7. preparation method as each described Chinese medicine composition in the claim 1～3, it is characterized in that: three kinds of crude drug of the ratio of will writing out a prescription, decoct with water 2～3 times, amount of water is 8～12 times of medical material weight, and decocting time is 1～2 hour at every turn, decocts temperature and keeps slight boiling condition for making decoction liquor, merge extractive liquid,, filter, it is 1.02～1.15 concentrated solution that filtrate is condensed into relative density, promptly gets the active component medicinal liquid of described Chinese medicine composition.
8. preparation method as claimed in claim 7, it is characterized in that: in described active component medicinal liquid, add ethanol, make the alcohol amount of containing reach percent by volume 50%～80%, after the cold preservation 12～36 hours, filter, filtrate recycling ethanol, and be condensed into the concentrated solution of relative density 1.02～1.10, be active component medicinal liquid of the present invention.
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Non-Patent Citations (2)
| Title |
|---|
| 金业全等.紫金龙药酒的研制及临床应用.《蚌埠医学院学报》.1996,第21卷(第1期),第49页. * |
| 钱金栿等.白族草药紫金龙成分的研究.《西北药学杂志》.2000,第15卷(第2期),第57-58页. * |
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