CN105343630A - Pharmaceutic preparation for treating insomnia and preparation method thereof - Google Patents
Pharmaceutic preparation for treating insomnia and preparation method thereof Download PDFInfo
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- CN105343630A CN105343630A CN201510903143.8A CN201510903143A CN105343630A CN 105343630 A CN105343630 A CN 105343630A CN 201510903143 A CN201510903143 A CN 201510903143A CN 105343630 A CN105343630 A CN 105343630A
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Classifications
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- General Health & Medical Sciences (AREA)
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention belongs to the field of traditional Chinese medicine, and relates to a pharmaceutic preparation for treating insomnia and a preparation method thereof. The pharmaceutic preparation is prepared from, by weight, 10-20 parts of suberect spatholobus stems, 10-20 parts of spina date seeds, 10-18 parts of common coltsfoot flowers, 10-18 parts of lilies, 8-18 parts of Indian bread with pine, 8-18 parts of nutmeg, 6-16 parts of radix et caulis acanthopanacis senticosi, 8-16 parts of radix polygalae, 6-12 parts of radix ophiopogonis, 6-18 parts of herba lophatheri, 6-16 parts of longan pulp and 2-10 parts of licorice roots. The pharmaceutic preparation has the effects of clearing away heart-fire, calming the nerves, warming the middle warmer, promoting circulation of Qi, clearing away the heart-fire to relieve restlessness, nourishing the blood and tranquilization and the like, has an effect of treating both symptoms and root causes of the insomnia and is free of toxic and side effects.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to pharmaceutical preparation of a kind for the treatment of of insomnia patients and preparation method thereof.
Background technology
Insomnia is due to feelings will, diet internal injury, and after being ill and old, innate deficiency, the causes of disease such as timidness due to deficiency of the heart, cause lack of preservation of spirit or irritability, thus cause often obtaining the class disease that ortho sleep is feature.Main manifestations is the length of one's sleep, the deficiency of the degree of depth and can not allaying tiredness, regain one's strength and energy, the lighter's difficulty falling asleep, or sleep but not soundly, sometimes sleeping and sometimes waking, or can not sleep again after waking up, heavy then be insomnia all night.Insomnia is one of common clinical card, though do not belong to critical illness, normal hinders people orthobiosis, work, study and health, and can increase the weight of or bring out the diseases such as cardiopalmus, the thoracic obstruction, dizzy, headache, apoplexy.Obstinate insomnia, brings long-term misery to patient, even form the dependence to sleeping medicine, and the sleeping medicine of long-term taking can cause iatrogenic disease.
Chinese medicine passes through the function of adjustment viscera negative and positive of qi and blood, often energy obviously improving water flood situation, and does not cause drug dependence and iatrogenic illness, thus rather well received.The principle of Chinese medicine Cure for insomnia is: at reinforce insufficiency and reduce excessiveness, and the basis of adjustment internal organs negative and positive of qi and blood is aided with the base therapy method that tranquilizing the mind is primary disease.The suitable reducing for the excess syndrome of excess syndrome, as dispersing the stagnated live-QI to relieve the stagnation of QI, pathogenic fire reducing clearing away phlegm, promoting digestion and regulating the middle JIAO.The suitable tonifying for deficiency syndrome of deficiency syndrome, as benefiting QI and nourishing blood, spleen invigorating, tonifying liver, kidney tonifying.With the passing of time, QI and blood consumption wound, also can transfer deficiency syndrome to, simulataneous insufficiency and excessive person to excess syndrome, and controlling should reinforcement and elimination in combination.The use of tranquilizing the mind method in conjunction with clinical, will be selected the concrete method for the treatment of such as nourishing blood to tranquillize the mind, tranquillizing the mind by relieving convulsion, clearing away heart-fire for tranquillization, and notes coordinating spiritual healing respectively, to eliminate nervous anxiety, keeps spirit happy.
At present, clinical treatment insomnia adopts the calm class medicine of Western medicine, can take effect rapidly at the initial stage of taking medicine, but these medicines also exist that side effect is large, Time of Administration long, the shortcoming of easily recurrence after drug withdrawal.Often take sleeping pill and not only can bring drug resistance, dependency, also can bring and be still drank after a night, withdrawal symptom, numerous adverse consequences such as memory impairment.Chinese traditional treatment mainly adopts the methods such as acupuncture, but the course for the treatment of is longer, takes effect not obvious.
Chinese patent application CN201410281941 discloses a kind of Chinese medicine of Cure for insomnia, certain weight ratio is pressed formulated by Yunnan-Tibet square bar cypress, Corallium Japonicum Kishinouye, Fructus Lycii, large thick branch moss, Semen Ziziphi Spinosae, Fructus Gardeniae, the Cortex Eucommiae, Cornu Saigae Tataricae, Semen Platycladi, the Rhizoma Atractylodis Macrocephalae, Folium Mori, Cortex Moutan, Bombyx Batryticatus, Fluoritum, Fructus Arctii and Spica Prunellae, this Drug therapy insomnia instant effect, effective percentage is high, but containing rare medical materials such as Yunnan-Tibet square bar cypress, Corallium Japonicum Kishinouye, Cornu Saigae Tataricae in medicament, adopt destructible ecological environment.
Summary of the invention
For solving the deficiencies in the prior art, the object of this invention is to provide pharmaceutical preparation of a kind for the treatment of of insomnia patients and preparation method thereof.
The pharmaceutical preparation for the treatment of of insomnia patients of the present invention is prepared from by the medical material of following formulation by weight:
Caulis Spatholobi 10-20, Semen Ziziphi Spinosae 10-20, Flos Farfarae 10-18, Bulbus Lilii 10-18, Poria cum Radix Pini 8-18, Semen Myristicae 8-18, Radix Et Caulis Acanthopanacis Senticosi 6-16, Radix Polygalae 8-16, Radix Ophiopogonis 6-12, Herba Lophatheri 6-18, Arillus Longan 6-16 and Radix Glycyrrhizae 2-10.
Preferably, the pharmaceutical preparation for the treatment of of insomnia patients of the present invention is prepared from by the medical material of following formulation by weight:
Caulis Spatholobi 10, Semen Ziziphi Spinosae 10, Flos Farfarae 10, Bulbus Lilii 10, Poria cum Radix Pini 8, Semen Myristicae 8, Radix Et Caulis Acanthopanacis Senticosi 6, Radix Polygalae 8, Radix Ophiopogonis 6, Herba Lophatheri 6, Arillus Longan 6 and Radix Glycyrrhizae 2.
Preferably, the pharmaceutical preparation for the treatment of of insomnia patients of the present invention is prepared from by the medical material of following formulation by weight:
Caulis Spatholobi 20, Semen Ziziphi Spinosae 20, Flos Farfarae 18, Bulbus Lilii 18, Poria cum Radix Pini 18, Semen Myristicae 18, Radix Et Caulis Acanthopanacis Senticosi 16, Radix Polygalae 16, Radix Ophiopogonis 12, Herba Lophatheri 18, Arillus Longan 16 and Radix Glycyrrhizae 10.
Preferably, the pharmaceutical preparation for the treatment of of insomnia patients of the present invention is prepared from by the medical material of following formulation by weight:
Caulis Spatholobi 15, Semen Ziziphi Spinosae 16, Flos Farfarae 14, Bulbus Lilii 14, Poria cum Radix Pini 12, Semen Myristicae 12, Radix Et Caulis Acanthopanacis Senticosi 10, Radix Polygalae 12, Radix Ophiopogonis 10, Herba Lophatheri 12, Arillus Longan 10 and Radix Glycyrrhizae 6.
Source, the nature and flavor of pharmaceutical preparation of the present invention Chinese crude drug used, return through and effect:
Caulis Spatholobi: this product is the plant of pulse family Millettia, bitter in the mouth, sweet, warm in nature; Return liver, kidney channel; Enrich blood, invigorate blood circulation, dredging collateral; Relaxing muscles and tendons to promote blood circulation, nourishing blood for regulating menstruation.
Semen Ziziphi Spinosae: this product is the dry mature seed of Rhamnaceae plant Ziziphi Spinosae; Sweet in the mouth, property is put down; GUIXIN, spleen, liver, gallbladder meridian; Nourishing the liver, mind calming, calms the nerves, arresting sweating.
Flos Farfarae: this product is the dried floral of feverfew coltsfoot; Acrid in the mouth, micro-hardship, warm in nature; Return lung meridian; Nourishing the lung to keep the adverse QI downward, relieving cough and resolving phlegm.
Bulbus Lilii: this product is the dry meat scale leaf of liliaceous plant tiger lily, Bulbus Lilii or Lilium tenuifolium; Sweet in the mouth, cold in nature; GUIXIN, lung meridian; Nourishing YIN and moistening the lung, clearing away heart-fire for tranquillization.
Poria cum Radix Pini: this product is entertain the part of Radix Pini massonianae or fine core person in the middle of poria cocos sclerotium; Acrid in the mouth, hardship, property is put down; GUIXIN, kidney channel; Mind calming, calms the nerves, diuretic.
Semen Myristicae: this product is the myristic dry kernel of Myristicaceae Nutmeg plant; Acrid in the mouth, warm in nature; Return spleen, stomach, large intestine channel; Warming middle-JIAO to promote flow of QI, relieving diarrhea with astringents.
Radix Et Caulis Acanthopanacis Senticosi: this product is the drying of Araliaceae Radix Et Caulis Acanthopanacis Senticosi, root and rhizome or stem; Acrid in the mouth, micro-hardship, warm in nature; Return spleen, kidney, heart channel; Replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization.
Radix Polygalae: this product is milk wort Radix Polygalae or ovum leaf dry root far away; Bitter in the mouth, pungent, warm in nature; GUIXIN, kidney, lung meridian; To calm the nerves Fructus Alpiniae Oxyphyllae, eliminate the phlegm, detumescence.
Radix Ophiopogonis: this product is the tuber of liliaceous plant dwarf lilyturf; Mildly bitter flavor, cold in nature; Return lung, stomach, heart channel; Nourishing YIN and moistening the lung, clear away heart-fire relieving restlessness, reinforcing stomach reg fluid.
Herba Lophatheri: this product is the dry stem and leaf of grass Herba Lophatheri; Sweet in the mouth, light, cold in nature; GUIXIN, stomach, small intestine meridian; Clearing heat and relieving fidgetness, diuresis.
Arillus Longan: this product is the aril of Sapindaceae Euphoria plant Arillus Longan; Sweet in the mouth, warm in nature; GUIXIN, spleen channel; Invigorating the heart and spleen, nourishing blood to tranquillize the mind.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L.; Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The prescription analysis of Chinese medicine of the present invention:
Medicament composing prescription of the present invention with Semen Ziziphi Spinosae, Bulbus Lilii and Poria cum Radix Pini for monarch drug, nourishing YIN and moistening the lung, clearing away heart-fire for tranquillization; With Caulis Spatholobi, Flos Farfarae, Semen Myristicae, Radix Et Caulis Acanthopanacis Senticosi and Radix Polygalae for ministerial drug, nourishing the lung to keep the adverse QI downward, warming middle-JIAO to promote flow of QI, tonifying the kidney for tranquilization, Fructus Alpiniae Oxyphyllae of calming the nerves; With Radix Ophiopogonis, Herba Lophatheri and Arillus Longan for adjuvant drug, clear away heart-fire relieving restlessness, invigorating the heart and spleen, nourishing blood to tranquillize the mind; With Radix Glycyrrhizae for making medicine, mind tranquilizing and the heart calming, coordinating the actions of various ingredients in a prescription; The all medicines of monarch coordinate, and collaborative promotion, complement each other, finally reach clearing away heart-fire for tranquillization, warming middle-JIAO to promote flow of QI, clear away heart-fire the effects such as relieving restlessness, nourishing blood to tranquillize the mind, treatment of insomnia patients had to the effect for the treatment of both the principal and secondary aspects of a disease, have no side effect.
The present invention also provides the preparation method of described pharmaceutical preparation, comprises following steps:
S1: take ingredients respectively in proportion, decontamination, cleans, and dries, and pulverizes, and merges coarse powder, for subsequent use;
S2: get Caulis Spatholobi coarse powder, adding medical material gross weight 8-10 times amount volume fraction is the ethanol of 60-80%, add the cellulase of medical material total amount 0.8-1.2% again, lixiviate 1-2 hour at 38-45 DEG C, then at 85-95 DEG C of reflux, extract, 3-5 hour, filter and retain Caulis Spatholobi filtering residue, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10-1.25, obtained Caulis Spatholobi extract;
S3: get Semen Ziziphi Spinosae, Flos Farfarae, Bulbus Lilii, Poria cum Radix Pini, Semen Myristicae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae, Radix Ophiopogonis, Herba Lophatheri, Arillus Longan and Radix Glycyrrhizae coarse powder, mixing, merge Caulis Spatholobi filtering residue, add the water soaking 2-4 hour of medical material gross weight 8-12 times amount, reflux, extract, 3-4 time, each 4-6 hour, filters and retains filtering residue, merging filtrate, obtains Aqueous extracts;
S4: adding medical material gross weight 8-12 times amount volume fraction in the filtering residue in S3 is the ethanol of 60-85%, reflux, extract, 3-4 time, each 4-6 hour, filter, merging filtrate, obtains alcohol extract;
S5: merge Caulis Spatholobi extract, Aqueous extracts and alcohol extract, at vacuum-concentrcted to 60 DEG C, relative density is the extractum of 1.10-1.25, to obtain final product.
Compared with prior art, pharmaceutical preparation of the present invention has following advantage:
(1) compared with the Western medicine of Current therapeutic insomnia, pharmaceutical preparation of the present invention is made up of pure natural Chinese herbal medicine, all medicines work in coordination with, significantly reduce untoward reaction and toxic and side effects, have good effect, treating both the principal and secondary aspects of a disease, stress nurse one's health treatment advantage;
(2) animal data shows, pharmaceutical preparation of the present invention significantly reduces mice freely movable number of times, shortens mice sleep incubation period and Sleeping Time Prolong Ed and significant sedation, significantly can improve the symptom of insomnia; Clinical data shows, pharmaceutical preparation of the present invention determined curative effect in Cure for insomnia, has no adverse reaction, and has liver heat removing to relieve dizziness, high fever, infantile convulsions, epilepsy, etc., the effect such as QI invigorating is relieving convulsion, nourishing blood to tranquillize the mind, depressed liver-energy dispersing and QI regulating.
(3) simple and easy to do, the efficacy stability of pharmaceutical preparation preparation technology of the present invention, be easy to apply.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change that the present invention is carried out, combination or replacement, for ability threshold technical staff be apparent, be all included within the scope of the present invention.
eXAMPLE l
The embodiment of the present invention 1 pharmaceutical preparation is prepared from by the medical material of following formulation by weight:
Caulis Spatholobi 10, Semen Ziziphi Spinosae 10, Flos Farfarae 10, Bulbus Lilii 10, Poria cum Radix Pini 8, Semen Myristicae 8, Radix Et Caulis Acanthopanacis Senticosi 6, Radix Polygalae 8, Radix Ophiopogonis 6, Herba Lophatheri 6, Arillus Longan 6 and Radix Glycyrrhizae 2.
Preparation method:
S1: take ingredients respectively in proportion, decontamination, cleans, and dries, and pulverizes, and merges coarse powder, for subsequent use;
S2: get Caulis Spatholobi coarse powder, adding medical material gross weight 8 times amount volume fraction is the ethanol of 80%, add the cellulase of medical material total amount 1.2% again, lixiviate 2 hours at 45 DEG C, then 95 DEG C of reflux, extract, 3 hours, filter and retain Caulis Spatholobi filtering residue, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10, obtained Caulis Spatholobi extract;
S3: get Semen Ziziphi Spinosae, Flos Farfarae, Bulbus Lilii, Poria cum Radix Pini, Semen Myristicae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae, Radix Ophiopogonis, Herba Lophatheri, Arillus Longan and Radix Glycyrrhizae coarse powder, mixing, merge Caulis Spatholobi filtering residue, add the water soaking 2 hours of medical material gross weight 8 times amount, reflux, extract, 3 times, each 4 hours, filters and retains filtering residue, merging filtrate, obtains Aqueous extracts;
S4: adding medical material gross weight 12 times amount volume fraction in the filtering residue in S3 is the ethanol of 85%, reflux, extract, 3 times, each 4 hours, filter, merging filtrate, obtains alcohol extract;
S5: merge Caulis Spatholobi extract, Aqueous extracts and alcohol extract, at vacuum-concentrcted to 60 DEG C, relative density is the extractum of 1.10, obtains drug extract;
S6: the drug extract toward S5 gained adds suitable adjuvant, utilizes modern general preparation technique to make tablet.
embodiment 2
The embodiment of the present invention 2 pharmaceutical preparation is prepared from by the medical material of following formulation by weight:
Caulis Spatholobi 20, Semen Ziziphi Spinosae 20, Flos Farfarae 18, Bulbus Lilii 18, Poria cum Radix Pini 18, Semen Myristicae 18, Radix Et Caulis Acanthopanacis Senticosi 16, Radix Polygalae 16, Radix Ophiopogonis 12, Herba Lophatheri 18, Arillus Longan 16 and Radix Glycyrrhizae 10.
Preparation method: with embodiment 1.
embodiment 3
The embodiment of the present invention 3 pharmaceutical preparation is prepared from by the medical material of following formulation by weight:
Caulis Spatholobi 15, Semen Ziziphi Spinosae 16, Flos Farfarae 14, Bulbus Lilii 14, Poria cum Radix Pini 12, Semen Myristicae 12, Radix Et Caulis Acanthopanacis Senticosi 10, Radix Polygalae 12, Radix Ophiopogonis 10, Herba Lophatheri 12, Arillus Longan 10 and Radix Glycyrrhizae 6.
Preparation method: with embodiment 1.
pharmacodynamics test
experimental example 1, pharmaceutical preparation of the present invention are tested the impact of spontaneous activity in mice
1, laboratory animal: get SPF level ICR mice 64, body weight 25-30g, male and female half and half, be divided into 8 groups at random, often organizes 8.
2, Experimental agents and dosage regimen:
A group: Experimental agents is the tablet that the embodiment of the present invention 1 obtains, and is divided into basic, normal, high 3 dosage groups.The using dosage of basic, normal, high dosage group is respectively 1g/kg, 2g/kg, 4g/kg, every day gavage 1 time.
B group: Experimental agents is that in the present invention, embodiment 2 obtains tablet, animal grouping and dosage regimen are with A group.
Normal group: get 1 group of rat, gavage equal-volume normal saline.
Positive controls: Experimental agents is hundred happy dormancy capsules (Yangzijiang Pharmaceutical Group Co., Ltd), and dosage is 4g/kg, every day gavage 1 time.
3, experimental technique: the continuous gavage 7d of mice, in last administration 8h fasting, front 1h prohibits water, to give after mouse stomach 30 minutes, is placed in by mice in autonomic activities instrument, surveys the autonomic activities number of times of mice, and requirement of experiment detects in the environment of quiet, dark.Mice conforms 5min, the movable number of times of mice in counting 10min.
4, experimental result: as shown in table 1.
The comparison of the movable number of times of mice respectively organized by table 1
Note: compare with Normal group,
* p< 0.05,
* p< 0.01,
* * p< 0.001; Compare with positive controls,
# P＜0.05，
## P＜0.01，
### P＜0.001。
From upper table 1, pharmaceutical preparation of the present invention significantly reduce mice autonomic activities number of times (
p< 0.05), dosage is good dose-effect relationship, wherein with A group and the obtained tablet effect of embodiment 1 better.In addition, the middle and high dosage group of pharmaceutical preparation of the present invention compares with positive controls, all have significant difference (
p< 0.05), more excellent to the inhibition of mice autonomic activities.
experimental example 2, pharmaceutical preparation of the present invention are on the impact experiment of mice length of one's sleep incubation period of pentobarbital sodium process
1, laboratory animal: get SPF level ICR mice 40, body weight 25-30g, male and female half and half, be divided into 5 groups at random, often organizes 8.
2, Experimental agents and dosage regimen:
Administration group: Experimental agents is the tablet that the embodiment of the present invention 1 obtains, and is divided into basic, normal, high 3 dosage groups.The using dosage of basic, normal, high dosage group is respectively 1g/kg, 2g/kg, 4g/kg, every day gavage 1 time.
Normal group: get 1 group of rat, gavage equal-volume normal saline.
Positive controls: Experimental agents is hundred happy dormancy capsules (Yangzijiang Pharmaceutical Group Co., Ltd), and dosage is 4g/kg, every day gavage 1 time.
3, experimental technique: mouse stomach administration 30min pneumoretroperitoneum injection pentobarbital sodium 30mg/kg(pentobarbital sodium injection threshold dose), observe sleep number of mice to calculate sleep mice percentage rate, and the length of one's sleep of recording sleep mice, (righting reflex loss was the length of one's sleep to the time of recovering.Righting reflex loss reaches at more than 1min, and person is defined as the positive, namely falls asleep).
4, experimental result: in table 2.
Table 2 pharmaceutical preparation of the present invention is on the impact of the pentobarbital sodium threshold dose length of one's sleep
Note: compare with Normal group,
* p< 0.05,
* p< 0.01; Compare with positive controls,
# p< 0.05.
From upper table 2, the obtained tablet of the embodiment of the present invention 1 can significantly shorten the sleep latency of mice after injection threshold dose pentobarbital sodium and Sleeping Time Prolong Ed (
p< 0.05 or
p< 0.01), and the Be very effective of high doses group of the present invention be better than positive controls (
p< 0.05), the effect of middle dosage group and low dose group is suitable with positive controls.
the clinical experiment of experimental example 3, pharmaceutical preparation of the present invention
(1) study subject is selected
Tcm diagnosis standard:
Diagnostic criteria formulates following standard with reference to the selected reference " insomnia definition, diagnosis and Drug therapy Consensus of experts (draft) " of clinical data case and " Chinese Spirit Obstacles classification and diagnostic criteria (CCMDD ":
1. the long time for falling asleep of Sleep latency is more than 30min;
2. sleep maintains obstacle number of times of awakening night and is greater than 2 times;
3. shallow, the dreaminess of sleep quality decline sleep;
4. total sleep time shortening is less than 5 hours
5. residual effect large sensation giddy in morning in the daytime, lassitude, drowsiness, weak etc.
Exclusion standard: 1. the age is under-18s, over-65s person; 2. severe physical illness and principal characteristic mental sickness person; 3. also with other drug and antipsychotic drug person; 4. serious suicidal attempt and actor is had; 5. gestation and women breast-feeding their children; 6. therapist is mismatched.
(2) clinical experiment scheme
1, physical data
By diagnostic criteria, the insomnia clinical volunteers patients that screening 400 example is medical, men and women half and half, age 30-55 year, 38 years old mean age, the course of disease 6 months-5 years.It is divided at random treatment A, B, C group and matched group four groups, often organizes each 100 examples.Four groups influence factors such as sex, age, the course of disease, the state of an illness, through statistical procedures, aspect, without significant difference, has comparability.
2, Experimental agents and experimental technique
Treatment A, B, C group: take tablet prepared by the embodiment of the present invention 1,2,3 respectively, amount to crude drug content 0.35g/ grain, every day 3 times, each 2; Within 7 days, be a course for the treatment of, after taking for 4 courses for the treatment of continuously, evaluate curative effect.
Matched group: take hundred happy dormancy capsules (Yangzijiang Pharmaceutical Group Co., Ltd).Take according to suggestion taking dose (20mg/kg), 3 times on the one, within 7 days, be a course for the treatment of, after 4 courses for the treatment of, evaluate curative effect.
3, curative effect determinate standard
Diagnostic criteria is by the standard envisages of " guideline of clinical investigations of new Chinese medicine Cure for insomnia " in " new Chinese medicine guideline of clinical investigations ".
Recovery from illness: fall asleep smoothly, recover the length of one's sleep normal, or the length of one's sleep is at more than 6h, sleeps deep, its clinical symptoms disappears substantially.
Effective: sleep is clearly better, and the length of one's sleep increases more than 3h, Depth of sleep increases, and clinical symptoms makes moderate progress.
Effective: symptom alleviates, the length of one's sleep, comparatively front increase was less than 3h.
Invalid: after treatment, insomnia is not improved or instead adds severe one, and clinical symptoms is also not improved.
4, therapeutic outcome
Table 3 therapeutic effect
This clinical experiment matched group is the happy dormancy capsule of medicine hundred of conventional Cure for insomnia, and compared by the treatment clinical effectiveness of itself and pharmaceutical preparation of the present invention, experimental result illustrates that the curative effect of pharmaceutical preparation of the present invention is better than matched group medicine.Clinical laboratory data shows, and matched group Drug therapy insomnia effect cure rate reaches 42.0%; And pharmaceutical preparation Cure for insomnia effect recovery from illness efficiency of the present invention is up to more than 50.0%, total effective rate reaches more than 90.0%, higher than the total effective rate of contrast medicine 85.0%, wherein optimum with the effect for the treatment of A group and embodiment 1.Clinical trial results proves pharmaceutical preparation Cure for insomnia Be very effective of the present invention, can be used as medicament for treating insomnia, has higher clinical generalization value.
Claims (7)
1. a pharmaceutical preparation for treatment of insomnia patients, is characterized in that, described pharmaceutical preparation is made up of the medical material of following formulation by weight:
Caulis Spatholobi 10-20, Semen Ziziphi Spinosae 10-20, Flos Farfarae 10-18, Bulbus Lilii 10-18, Poria cum Radix Pini 8-18, Semen Myristicae 8-18, Radix Et Caulis Acanthopanacis Senticosi 6-16, Radix Polygalae 8-16, Radix Ophiopogonis 6-12, Herba Lophatheri 6-18, Arillus Longan 6-16 and Radix Glycyrrhizae 2-10.
2. the pharmaceutical preparation for the treatment of of insomnia patients as claimed in claim 1, it is characterized in that, described pharmaceutical preparation is made up of the medical material of following formulation by weight:
Caulis Spatholobi 10, Semen Ziziphi Spinosae 10, Flos Farfarae 10, Bulbus Lilii 10, Poria cum Radix Pini 8, Semen Myristicae 8, Radix Et Caulis Acanthopanacis Senticosi 6, Radix Polygalae 8, Radix Ophiopogonis 6, Herba Lophatheri 6, Arillus Longan 6 and Radix Glycyrrhizae 2.
3. the pharmaceutical preparation for the treatment of of insomnia patients as claimed in claim 1, it is characterized in that, described pharmaceutical preparation is made up of the medical material of following formulation by weight:
Caulis Spatholobi 20, Semen Ziziphi Spinosae 20, Flos Farfarae 18, Bulbus Lilii 18, Poria cum Radix Pini 18, Semen Myristicae 18, Radix Et Caulis Acanthopanacis Senticosi 16, Radix Polygalae 16, Radix Ophiopogonis 12, Herba Lophatheri 18, Arillus Longan 16 and Radix Glycyrrhizae 10.
4. the pharmaceutical preparation for the treatment of of insomnia patients as claimed in claim 1, it is characterized in that, described pharmaceutical preparation is made up of the medical material of following formulation by weight:
Caulis Spatholobi 15, Semen Ziziphi Spinosae 16, Flos Farfarae 14, Bulbus Lilii 14, Poria cum Radix Pini 12, Semen Myristicae 12, Radix Et Caulis Acanthopanacis Senticosi 10, Radix Polygalae 12, Radix Ophiopogonis 10, Herba Lophatheri 12, Arillus Longan 10 and Radix Glycyrrhizae 6.
5. the pharmaceutical preparation of the treatment of insomnia patients as described in as arbitrary in claim 1-4, it is characterized in that, the preparation method of described pharmaceutical preparation comprises following steps:
S1: take ingredients respectively in proportion, decontamination, cleans, and dries, and pulverizes, and merges coarse powder, for subsequent use;
S2: get Caulis Spatholobi coarse powder, adding medical material gross weight 8-10 times amount volume fraction is the ethanol of 60-80%, add the cellulase of medical material total amount 0.8-1.2% again, lixiviate 1-2 hour at 38-45 DEG C, then at 85-95 DEG C of reflux, extract, 3-5 hour, filter and retain Caulis Spatholobi filtering residue, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10-1.25, obtained Caulis Spatholobi extract;
S3: get Semen Ziziphi Spinosae, Flos Farfarae, Bulbus Lilii, Poria cum Radix Pini, Semen Myristicae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae, Radix Ophiopogonis, Herba Lophatheri, Arillus Longan and Radix Glycyrrhizae coarse powder, mixing, merge Caulis Spatholobi filtering residue, add the water soaking 2-4 hour of medical material gross weight 8-12 times amount, reflux, extract, 3-4 time, each 4-6 hour, filters and retains filtering residue, merging filtrate, obtains Aqueous extracts;
S4: adding medical material gross weight 8-12 times amount volume fraction in the filtering residue in S3 is the ethanol of 60-85%, reflux, extract, 3-4 time, each 4-6 hour, filter, merging filtrate, obtains alcohol extract;
S5: merge Caulis Spatholobi extract, Aqueous extracts and alcohol extract, at vacuum-concentrcted to 60 DEG C, relative density is the extractum of 1.10-1.25, to obtain final product.
6. the pharmaceutical preparation of the treatment of insomnia patients as described in as arbitrary in claim 1-4, it is characterized in that, described pharmaceutical preparation is made into granule, tablet, capsule, pill, oral liquid or powder.
7. the preparation method of the pharmaceutical preparation of the treatment of insomnia patients as described in as arbitrary in claim 1-4, is characterized in that, comprise following steps:
S1: take ingredients respectively in proportion, decontamination, cleans, and dries, and pulverizes, and merges coarse powder, for subsequent use;
S2: get Caulis Spatholobi coarse powder, adding medical material gross weight 8-10 times amount volume fraction is the ethanol of 60-80%, add the cellulase of medical material total amount 0.8-1.2% again, lixiviate 1-2 hour at 38-45 DEG C, then at 85-95 DEG C of reflux, extract, 3-5 hour, filter and retain Caulis Spatholobi filtering residue, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10-1.25, obtained Caulis Spatholobi extract;
S3: get Semen Ziziphi Spinosae, Flos Farfarae, Bulbus Lilii, Poria cum Radix Pini, Semen Myristicae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae, Radix Ophiopogonis, Herba Lophatheri, Arillus Longan and Radix Glycyrrhizae coarse powder, mixing, merge Caulis Spatholobi filtering residue, add the water soaking 2-4 hour of medical material gross weight 8-12 times amount, reflux, extract, 3-4 time, each 4-6 hour, filters and retains filtering residue, merging filtrate, obtains Aqueous extracts;
S4: adding medical material gross weight 8-12 times amount volume fraction in the filtering residue in S3 is the ethanol of 60-85%, reflux, extract, 3-4 time, each 4-6 hour, filter, merging filtrate, obtains alcohol extract;
S5: merge Caulis Spatholobi extract, Aqueous extracts and alcohol extract, at vacuum-concentrcted to 60 DEG C, relative density is the extractum of 1.10-1.25, to obtain final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201510903143.8A CN105343630A (en) | 2015-12-09 | 2015-12-09 | Pharmaceutic preparation for treating insomnia and preparation method thereof |
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| CN201510903143.8A CN105343630A (en) | 2015-12-09 | 2015-12-09 | Pharmaceutic preparation for treating insomnia and preparation method thereof |
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| CN105343630A true CN105343630A (en) | 2016-02-24 |
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|---|---|---|---|
| CN201510903143.8A Withdrawn CN105343630A (en) | 2015-12-09 | 2015-12-09 | Pharmaceutic preparation for treating insomnia and preparation method thereof |
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| Country | Link |
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| CN (1) | CN105343630A (en) |
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