CN104784393B - A kind of Chinese goldthread colla corii asini composition for the treatment of of insomnia patients and preparation method thereof - Google Patents

Abstract

The invention discloses Chinese goldthread colla corii asini composition of a kind for the treatment of of insomnia patients and preparation method thereof, belong to the field of Chinese medicines.The Chinese goldthread colla corii asini composition, it is made up of each bulk drug of following parts by weight：6 10 parts of the coptis, 7 12 parts of donkey-hide gelatin, 48 parts of the radix paeoniae rubrathe, 4 16 parts of Semen Ziziphi Spinosae (parched), 0.5 4 parts of Chinese cassia tree, 48 parts of cortex albiziae, 4 10 parts of radix cynanchi atrati, 26 parts of Chinese ephedra, 48 parts of cicada slough, 8 12 parts of grass-leaved sweetflag, 10 20 parts of cultivated land.The present invention has nourishing yin and nourishing blood, a surname hot and suffocating, restoring normal coordination between heart and kidney work(thoroughly, has good effect to various sleep-disorder and insomnia, has the characteristics that positive effect, efficient height, short treating period, has no side effect.

Description

A kind of Chinese goldthread colla corii asini composition for the treatment of of insomnia patients and preparation method thereof

Technical field

The invention belongs to technical field of traditional Chinese medicines, more particularly to the Chinese goldthread colla corii asini composition and its system of a kind for the treatment of of insomnia patients Preparation Method.

Background technology

Insomnia is a kind of illness characterized by it can not often obtain ortho, is mainly shown as the length of one's sleep, depth Deficiency, the lighter's difficulty falling asleep, 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.Insomnia is to face Common disease on bed, the human body and spiritual pain are brought to patient, drastically influence the quality of life and labour capacity of patient. Insomnia makes one to have a dizzy spell, palpitation, fatigue and asthenia, forgetful, apocleisis, tinnitus, anxious make an uproar irritability, nauseous bitter taste, pain in low back and legs； Insomnia causes absent minded, work and study efficiency to decline, and permanent insomnia causes immunity degradation, endocrine disturbance, spirit It is fidgety, easily cause cardiovascular accident, gastrointestinal disease, hypertension, hypogona dism and psychological disease etc., make under quality of life Drop, or even cause to die suddenly.In addition, patient's daytime sleepiness is also it occur frequently that production and traffic accident.It is modern that insomnia has turned into puzzlement People, have a strong impact on the physically and mentally healthy big illness of human body.And with the development of human society, the change of living environment, life The quickening of rhythm, the increase of life stress, the incidence of disease of insomnia are just in rising trend.

Western medicine is in terms of insomnia is treated at present, in spite of spreading out for the adverse reaction Benzodiazepines light compared with barbiturate Biology (stable class medicine).It is well known that stable class medicine uses in a small amount, short can play certain effect, but together When also hide certain harmfulness.It is considered that such medicine safety, will not habituation, but have the case report of habituation repeatly in recent years Accuse, it sometimes appear that withrawal symptom, such as anxiety, sleep-disorder；More common is psychological dependence, can cause mistake after giving up medicine Sleep, thus it is long-term use of and be difficult to cut off, and Recent study also found, such medicine can cause memory disorders, especially take Class medicine easily occurs in short-term.Some other people take rear next day and have incoordination phenomenon, such as indescribable wrestling, therefore not Preferably serve as driving task.Simultaneously pregnant woman, nursing women, elderly and infirm, have heart, liver and nephropathy person, sleep-respiratory Obstacle person etc. should not take stable class medicine.It is many adverse reactions of stable class medicine and its tolerance, additive very big Its market competitiveness is limited in degree.

Traditional Chinese medicine has obvious advantage in terms of sleep quality and treatment sleep-disorder is improved, and Chinese medicine is in terms of action Though it is fast to be not so good as Western medicine, without obvious adverse reaction, it is adapted to patient to take the long period, the function that can adjust patient is gentle The operation of blood body fluid, QI invigorating of calming the nerves, patient is possessed good sleep, nourish brain because of chronic insomnia and impaired, recover people The self-regeneration function of body, fundamentally releases sufferer, reaches the purpose treated both principal and secondary aspect of disease.The Chinese patent drug clinically commonly used at present has Tianwang Buxin Dan, Baizi Yangxin Pills, sedative and heart-invigorating pill (capsule, particle), nourishing blood and tranquilization piece, sedative jujube kernel particle, seven leaves god's peace Piece, MIANANNING oral liquid, fruit of Chinese magnoliavine syrup, Anshen Bunao mixture, resolving stagnation for tranquilization particle etc..Nevertheless, these Chinese medicine preparations Curative effect is still unsatisfactory.

The content of the invention

The invention provides a kind of positive effect, efficient high, the Chinese medicine composition for the treatment of insomnia patients having no side effect and Its preparation method.

The present invention is achieved by the following technical solutions：

The Chinese goldthread colla corii asini composition of a kind for the treatment of of insomnia patients, it is characterised in that be made up of each bulk drug of following parts by weight： Coptis 6-10 parts, donkey-hide gelatin 7-12 parts, radix paeoniae rubrathe 4-8 parts, Semen Ziziphi Spinosae (parched) 4-16 parts, Chinese cassia tree 0.5-4 parts, cortex albiziae 4-8 parts, radix cynanchi atrati 4- 10 parts, Chinese ephedra 2-6 parts, cicada slough 4-8 parts, grass-leaved sweetflag 8-12 parts, cultivated land 10-20 parts.

Preferably, described Chinese goldthread colla corii asini composition, it is characterised in that the parts by weight of each bulk drug are：8 parts of the coptis, Ah 9 parts of glue, 6 parts of the radix paeoniae rubrathe, 10 parts of Semen Ziziphi Spinosae (parched), 2 parts of Chinese cassia tree, 6 parts of cortex albiziae, 7 parts of radix cynanchi atrati, 4 parts of Chinese ephedra, 6 parts of cicada slough, grass-leaved sweetflag 10 Part, 15 parts of cultivated land.

Medicine activity component of the present invention can add various auxiliary materials required when preparing different dosage forms, such as disintegrant, profit Lubrication prescription, binder etc., any suitable clinical preparation is prepared into the method for Chinese medicinal of routine, such as can be glue Wafer, pill, powder, granule, tablet, oral liquid or pill etc., preferably capsule or granule.

A kind of preparation method of Chinese medicine composition of the present invention：Each bulk drug is weighed by the parts by weight；By each raw material medicinal powder It is broken, sieving, the auxiliary material or excipients needed for preparations shaping are added, is prepared into capsule, tablet or pill.

Preferably, the method for described Chinese goldthread colla corii asini composition, it is characterised in that comprise the following steps：

(1) each bulk drug is weighed by the parts by weight；

(2) Chinese cassia tree, grass-leaved sweetflag are extracted into volatile oil, will be crushed after inclusion essential oil, it is standby；

(3) dregs of a decoction after extraction volatile oil and Chinese ephedra, cicada slough, cultivated land, cortex albiziae, Chinese ephedra one are reinstated into water extraction, by water Extract solution is spray-dried, standby；

(4) coptis, the radix paeoniae rubrathe, radix cynanchi atrati and Semen Ziziphi Spinosae (parched) are extracted with 30-85% ethanol, ethanol extract is reclaimed into ethanol Afterwards, it is spray-dried, it is standby；

(5) it is well mixed after donkey-hide gelatin is crushed with the product obtained by step (2), (3) and (4), it is auxiliary adds pharmaceutical preparation Intermediate formulations are made in material mixing, then finished dosage form is made through preparations shaping technique.

Present invention also offers application of the described Chinese goldthread colla corii asini composition in disease drug of having a sleepless night is prepared.

The compatibility foundation of Chinese medicine composition of the present invention：

Insomnia, the traditional Chinese medical science referred to as " being insomnia ", " must not sleep ", " must not crouch ", " insomnia ", insomnia is to find out its cause, total comes Still " sun is not as the moon " is said, daytime, then yang-energy occupy body surface, and night, then yang-energy entered body.Interpretation of the cause, onset and process of an illness core of having a sleepless night is that deficiency of Yin fire is strongly fragrant, simultaneous to see gas The friendships such as stagnant, blood stasis, phlegm are turbid, dampness are mutually trouble.Strongly fragrant more then fire is more vehement, and more, with the passing of time yang-energy must not reach the more vehement then deficiency of Yin of fire outside, Mechanism of qi loses freely forms the stagnation of the circulation of vital energy in tune；Fire for heat very, heat stop up blood stasis；Qi depression to blood stasis, the positive defeated cloth in Tianjin is not normal to cause dampness, phlegm to coagulate then； Phlegm wet and heat symptoms caused by an exopathgen are harmonious visible convulsive seizure due to phlegm-fire, damp and hot, the deficiency of Yin etc..Donkey-hide gelatin, cultivated land, the radix paeoniae rubrathe, radix cynanchi atrati, clearing heat and cooling blood, nourishing yin and nourishing blood in side For monarch drug in a prescription；The coptis, Chinese cassia tree restoring normal coordination between heart and kidney, it can make to meet at kidney under internal heat, and can makes kidney is waterborne to meet at the heart；Opened with grass-leaved sweetflag resolving sputum Key, dampness elimination promoting the circulation of qi, can tranquilizing and allaying excitement, inducing resuscitation bidirectional modulation nervous centralis, cortex albiziae resolving stagnation for tranquilization, promoting blood circulation and removing blood stasis, spina date seed is held back Gas is calmed the nerves, kidney of feeling at ease, and is altogether ministerial drug, and coordination between the heart and kidney fire is certainly flat；Chinese ephedra and cicada slough declare the saturating strongly fragrant and diathermanous heresy of game clock, have heat symptoms caused by an exopathgen outer Saturating machine, with up to " fire stagnation requiring dissipation " harmonizing the functional activities of vital QI, and cultivated land phase 5, but loosing the interspaces of skin and muscles is without stagnant not sweat；Chinese ephedra is alternatively arranged as inducing resuscitation Medicine is to coordinate grass-leaved sweetflag calmness, inducing resuscitation bidirectional modulation nervous centralis, so that yin and yang in equilibrium；All medicines share, relieving exterior-interior syndrome, fever and chills are simultaneously With, reinforcing and reducing methods with applying, ascending the clear and descending the turbid, harmonizing the functional activities of vital QI, tremble with fear without injuring one's stomach, mend greasy without growing, play nourishing yin and nourishing blood altogether, a surname is thoroughly hot and suffocating, hands over Various sleep-disorder and insomnia are had good effect by the work(of logical heart kidney.

In general insomniac is not sleep well at night, and daytime is out of spirits.Daytime has dizzy spells, absolutely clear at night to sleep not , depression and stagnation of QI in the abnormal insomniac's body of this sleep rhythm, excessive qi causing fire, qi depression transforming into fire, upset the mind, yang-energy It is excluded from outer, makes caused by sun do not enter the moon.Insomniac also has difficulty in going to sleep at night, or even egersis whole night, but second day essence Refreshing not tired out, still excited person, caused by being mostly the deficiency of Yin.Treatment insomnia, conventional spirit quieting medicine often unsatisfactory curative effect, this hair The natural inducing resuscitation drug anesthesia of bright innovative addition in prescription is yellow（Chinese ephedra has central excitation effect, for treating the enuresis, lethargic sleep）, Unexpected technique effect is achieved, the effect for having crucial touch, not only for complete in treating various types of insomniacs Have no side effect, and clinical therapeutic efficacy is achieved significant progress.Present invention treatment insomnia effect is good, and achieving comparison expires The clinical effectiveness of meaning, total effective rate 98.1%, effective and clinical recovery rate are 92.6%.Chinese ephedra coordinates grass-leaved sweetflag can be calm, awake Refreshing bidirectional modulation nervous centralis improves sleep-disorder, coordinates cicada slough to declare the saturating strongly fragrant and diathermanous heresy of game clock, heat symptoms caused by an exopathgen is passed through inside, adjust smooth gas Machine, and cultivated land phase 5, but loosing the interspaces of skin and muscles is without stagnant not sweat.Chinese medicine composition Clinical practice safety of the present invention, patient have no after Obvious adverse reaction, and the sleep-disorder symptom of patient can be effectively improved, any dependence is not produced yet after disabling medicine of the present invention Reaction.

The usage and dosage of Chinese medicine composition of the present invention：The present invention dosage depend on specific formulation, patient age, The factors such as health status.As guidance：Usage and dosage：Capsule, oral 5 every time, three times per day.

Cicada slough：It is sweet, it is cold in nature；Return lung, Liver Channel；Function is with curing mainly：Dispelling wind and heat from the body, relieving sore-throat, promoting eruption, removing nebula, spasmolysis. For anemopyretic cold, pharyngalgia sound is mute, measles without adequate eruption, rubella itch, cataract, convulsion, lockjaw.《Compendium of Materia Medica》： Cicada, on the whole main treatment all wind-heat syndromes, ancients' body, descendants control dirty mansion channels and collaterals with sloughing off, when with cicada body；Skin ulcer wind-heat is controlled, When with cicada slough.《Haigoushen》：Children's high fever frightened epilepsy from head to foot is controlled, and can be quenched the thirst.《Amplification on Materia Medica》：Control blurred vision screen.Decocting shell juice again, Controlling children, to go out sore rash unhappy..

The coptis：Bitter, it is cold in nature.The thoughts of returning home, spleen, stomach, liver, courage, large intestine channel.Major function：Heat-clearing and damp-drying drug, purging intense heat and detonicating.With In damp and hot feeling of fullness, acid regurgitation is vomitted, rush down dysentery, jaundice, unconsciousness due to high fever, heart-fire hyperactivity, dysphoria and insomnia, blood-head tells nosebleed, hot eyes, is had a toothache, Quench one's thirst, carbuncle swells furunculosis；Eczema, wet sore are controlled outside, duct is suppurated.《This warp》：Main hot gas mesh pain, corner of the eyes wound weep, and improving eyesight, intestines debate stomachache Diarrhea, swell and ache in married woman's the moon.《Essentials of Materia Medica》：Control ulcer sore scabies, wine poison, the skin infections of newborn infants.Except infantile malnutrition due to digestive disturbances or intestinalparasites, ascarid is killed.

Chinese cassia tree：It is acrid flavour, sweet, it is warm-natured.The thoughts of returning home, lung, bladder warp.Major function：Complement sun, warming spleen and stomach, removing internal cold, leads to blood Arteries and veins.Control the Yang-function insufficiency of kidneyzang, cold weak pulse of limb, yang depletion collapse, diarrhea of suffering from abdominal pain, cold hernia run quickly globefish, waist and knee crymodynia, Amenorrhea abdominal mass, cloudy subcutaneous ulcer, stream Note, and empty sun are floating more, heat in the upper and cold in the lower.《This warp》：Your Majesty's gas cough is inverse, and knot gas larynx numbness tells suction, sharp joint, tonifying middle-Jiao and Qi.《Do not record》： Master is pained, coerces wind, hypochondriac pain, warm muscle, promotes blood circulation, and is only tired of, perspires.Main middle benefit gas, benefitting liver and lung gas, trusted subordinate's fever and chills, cold disease, choleraic myospasm, Headache, pain in the back, only saliva, cough , Bi Weng：It can have an abortion, hard joint, promoting blood circulation, manage and dredge deficiency；A surname leads hundred medicines, without being feared.《Solar corona Sub- book on Chinese herbal medicine》：All general mood are controlled, mend general debility, leads to nine orifices, sharp joint, strengthening the essence, improving eyesight, warms up waist and knee, break Xuan addiction abdominal mass, dispersing blood stasis Blood, control wandering arthritis joint contracture, continuous muscles and bones, myogenic meat.《Medicine origin》：Lower burnt deficiency is mended, controls that heavy cold shoulder is cold and exterior deficiency spontaneous perspiration. 《Cure mainly secret want》：Ooze and let out, quench the thirst.Wang Haogu：Mend gate of vitality's deficiency, boosting source of fire for eliminating abundance of yin.

The radix paeoniae rubrathe：Nature and flavor are bitter, cool.Enter liver, the spleen channel.Effect row stasis of blood, analgesic, cool blood, detumescence.Control the stagnant Amenorrhea of the stasis of blood, hernia lump in the abdomen product It is poly-, stomachache, hypochondriac pain, bleeding from five sense organs or subcutaneous tissue, bloody flux, discharging fresh blood stool, hot eyes, carbuncle swells.《This warp》：Main perverse trend stomachache, except blood-arthralgia, hard product is broken, is trembled with fear Hot hernia lump in the abdomen, analgesic, diuresis, QI invigorating.《Do not record》：Clear and coherent blood vessels, in delaying, dispelling malignant blood, expelling extravasated blood, go aqueous vapor, sharp bladder size Intestines, subduing inflammation, when row fever and chills, it is middle dislike stomachache, pain in the back.《The southern regions of the Yunnan Province book on Chinese herbal medicine》：Spleen fire is rushed down, sending down abnormally ascending, promoting circulation of blood, broken stasis of blood, dissipates clot, only abdomen Bitterly, blood-head is moved back, attacks ulcerative carbuncle, controls scabies leprosy.

Donkey-hide gelatin：It is sweet, it is mild-natured.Return lung, liver and kidney channel.Major function：Enrich blood enriching yin, moisturize, stop blooding.For blood deficiency chlorosis, Dizziness palpitaition, impotence weakness, dysphoria and insomnia, endogenous deficient wind, xeropulmonary cough, overstrain cough spitting of blood, haematemesis hematuria, uterine bleeding of having blood in stool, gestation Threatened abortion.《This warp》：Collapsed in main trusted subordinate, the extremely voluminous symptoms like malaria of labor, waist stomachache, painful limbs, blood under woman.It is antiabortive.Long term usage QI invigorating. 《Haigoushen》：Main hard muscles and bones, QI invigorating stop dysentery.《A thousand pieces of gold food therapy》：Control strong wind.《Japan hanako materia medica》：Control a wind cutting, and profuse nasal bleeding, Under haematemesis, intestines wind, bloody flux and metrorrhagia band.《Detailed outline is picked up any lost article from the road》：Lumbago caused by internal damage is controlled, strongly stretches muscle, adds essence and reinforces the kidney.

Cortex albiziae：It is mild-natured, it is sweet.The thoughts of returning home, liver, lung channel.Major function：Resolving stagnation for tranquilization, activating blood circulation and reducing swelling.For the mind not Peace, melancholy Sjogren syndrome, lung carbuncle sore swells, the pain of injury caused by falling and tumbling.《This warp》：Main five viscera settling, and will, make us happy carefree.《Solar corona Sub- book on Chinese herbal medicine》：Soft extracts, subduing inflammation and continuous muscles and bones.《Detailed outline》：And blood, subside a swelling, analgesic.

Spina date seed：It is mild-natured, it is sweet, sour.Return liver, courage, the heart channel of Hang-Shaoyin.Major function：Tonifying liver, calming heart, arrest sweating, promote the production of body fluid.For void Tired egersis, horrified to much dream, body void hidrosis, injury thirst.《This warp》：Main trusted subordinate's fever and chills, heresy knot gas gather, painful limbs, arthritis with fixed pain caused by dampness. 《Do not record》：Master is vexatious to sleep, and pain, blood turn to let out long, abnormal sweating polydipsia, bowl spares, beneficial irritability, hard muscles and bones, helps cloudy gas, make us navel up and down Fertilizer is strong.《Haigoushen》：Cage bar bone wind, fry end and take it as soup.Wang Haogu：Milk-livered egersis is controlled, is trembled with fear, fries clothes；Somnolence due to gallbladder-excess is controlled, heat , it is raw to use.《Collected statements on the herbal foundation》：Hold back gas to calm the nerves, flourish muscle supports marrow, and stomach fortune spleen.《Book on Chinese herbal medicine is new again》：Soothing the liver qi-regulating, moistens the lung and nourish yin, temperature Middle dampness removing, gas hidroschesis is held back, beneficial will is breathed out surely, hearing-improing and eyesight improving.

Radix cynanchi atrati：It is bitter, salty, it is cold in nature.Return stomach, liver and kidney channel.Function is with curing mainly：Clearing heat and cooling blood, inducing diuresis for treating strangurtia, detoxification sore treatment. For warm evil wound battalion heating, fever due to yin deficiency, hectic fever due to yin labor heat, postpartum fever caused by blood deficiency, heat gonorrhea, blood strangury, swollen ulcer drug.《This warp》：It is main Sudden and violent apoplexy, the hot limb of body are expired, before we notice it does not know people, mad puzzled perverse trend, fever and chills ache, a kind of malaria washes, disease appearing at regular intervals,disease breaking out at interval time.《Do not record》：In curing the wound Leaching dew.Lower aqueous vapor, Li Yin gas, strengthening the essence, long term usage profit people.Tao Hongjing：Frightened heresy is treated, wind is mad, Election diseases.《Detailed outline》：It is scorching hot more to control wind-warm syndrome Sleep, and heat gonorrhea, the enuresis, metal-inflicted wound bleeding.《Book on Chinese herbal medicine is stated》：Cure mainly and suffer from phlegm dysphoria.《Key medicine divides agent》：The clear fire of deficiency type, except blood-head.Radix cynanchi atrati is clear Liver heat, there is good effect to dreaminess.

Cicada slough：It is sweet, it is cold in nature；Return lung, Liver Channel；Function is with curing mainly：Dispelling wind and heat from the body, relieving sore-throat, promoting eruption, removing nebula, spasmolysis. For anemopyretic cold, pharyngalgia sound is mute, measles without adequate eruption, rubella itch, cataract, convulsion, lockjaw.《Compendium of Materia Medica》： Cicada, on the whole main treatment all wind-heat syndromes, ancients' body, descendants control dirty mansion channels and collaterals with sloughing off, when with cicada body；Skin ulcer wind-heat is controlled, When with cicada slough.《Haigoushen》：Children's high fever frightened epilepsy from head to foot is controlled, and can be quenched the thirst.《Amplification on Materia Medica》：Control blurred vision screen.Decocting shell juice again, Controlling children, to go out sore rash unhappy.

Chinese ephedra：Acrid flavour, slight bitter, it is warm-natured.Return lung, bladder warp.Function is with curing mainly：Sweating cold dispelling, freeings lung and relieving asthma, and Li Shui disappears It is swollen.It is uncomfortable in chest to breath with cough for anemofrigid cold, geomantic omen edema.Herba ephedrae moistens the lung and relieve the cough.It is used for exterior syndrome to have solved, asthma and cough.Chinese ephedra There is stimulating central nervous system：To brain, midbrain and medulla oblongata, breathing have excitation with circulating maincenter；Also similar to kidney The effect of upper gland, it is by discharging mediator (indirectly-acting), and directly exciting α and B-adrenergic receptor, relaxation branch gas Pipe smooth muscle, excited heart, blood pressure is raised, can be used to treat bronchial astehma and low blood pressure, and can stimulating central nervous system system.

Cultivated land：It is sweet, slightly warm in nature；Return liver and kidney channel；Function is with curing mainly：Enrich blood enriching yin, beneficial to spirit and marrow.For blood deficiency chlorosis, Palpitation and severe palpitation, irregular menstruation, metrostaxis, the deficiency of liver-yin and kidney-yin, soreness and weakness of waist and knees, osteopyrexia and fever, night sweat seminal emission, Heat Diabetes, dizziness, Tinnitus, chin hair are early white.《Pearl sac》：Big empty deficiency of enriching blood, promoting blood circulation, benefiting energy.《Cure mainly secret want》Cloud：It is with having five：Kidney-nourishing Water is Kidney-Yin one, and postpartum qi and blood two, goes navel abdomen shoot three, and sun four is moved back in yin-nourishing, strengthens the source five of water.《Detailed outline》：Fill out Marrow, long muscle, promoting vital essence and blood genernation.Tonifying five zang organs internal injury deficiency, promoting blood circulation, sharp knowledge, black beard and hair, man's general debility, during woman hinders Threatened abortion, irregular menorrhea, tire produce all kinds of diseases and ailments.《The new compilation of materia medica》：Kidney nourishing water, packing marrow, sharp blood vessels, help is Kidney-Yin, hearing-improing and eyesight improving, black Send out palpus black.And can tonifying spleen-yin, only chronic diarrhea.Internal lesion caused by overexertion wandering arthritis, yin deficiency heating are controlled, dry cough phlegm is coughed, and dyspnea with shortness of breath, emptiness of the stomach feels hungry, Acne demonstrate,proves no purulence of having a guilty conscience, and shin stock is ached after being ill, and postpartum navel abdomen suddenly aches, sense card yin deficiency, lossless constipation, all kinds of dynamic blood, all liver kidney yins Thanks to, deficient all kinds of diseases and ailments, to strengthen the main ingredient of water.

Grass-leaved sweetflag：Acrid flavour；It is bitter；Slightly warm in nature；Channel tropism：The heart；Liver；The spleen channel.Effect：Dissipating phlegm for resuscitation；Dampness elimination promoting the circulation of qi；Wind-dispelling profit Numbness；Swelling and pain relieving；Cure mainly：Pyreticosis coma；Coma due to blocking of the respiratory system；It is forgetful；Tinnitus；It is deaf；Abdominal distention；Dysentery with vomiting；Arthralgia pain due to rheumatism；Bruise is damaged Wound；Ulcer mange.Grass-leaved sweetflag Central nervous plays the role of calm bidirectional modulation：Essential Oil of Acorus tatarinowii, Aqueous extracts, decocting of deoiling Liquid can substantially reduce the incidence of the mice convulsion caused by sodium glutamate, during convulsivus caused by substantially shortening strychnine Between, show maincenter calmness and to anticonvulsant effect.The alcohol extracting thing of grass-leaved sweetflag has obvious anticonvulsant action, and prompts Its site of action is probably Alcohol soluble composition.And volatile oil may not play a major role.Moved by grass-leaved sweetflag water decoction anti-epileptic The pharmacodynamic experiment of thing model finds that grass-leaved sweetflag water portion has significant anticonvulsant action.

Embodiment

With reference to embodiment, the present invention is further described.

Embodiment 1：The preparation of capsule

(1) each raw material is weighed by following weight：Coptis 800g, donkey-hide gelatin 900g, radix paeoniae rubrathe 600g, Semen Ziziphi Spinosae (parched) 1000g, meat Osmanthus 200g, cortex albiziae 600g, radix cynanchi atrati 700g, Chinese ephedra 400g, cicada slough 600g, grass-leaved sweetflag 1000g, cultivated land 1500g；

(2) Chinese cassia tree, grass-leaved sweetflag are extracted into volatile oil, it is standby by volatile oil with being crushed after beta-cyclodextrin inclusion compound；

(3) it is the dregs of a decoction after extraction volatile oil and cortex albiziae, cicada slough, cultivated land, Chinese ephedra are secondary with water extraction, add for the first time 8 times of weight of water, decoct 2 hours, second plus 6 times of weight of water, decoct 1 hour；Decoction liquor is merged, filtered, filtrate is concentrated into Relative density is 1.30-1.35 (55 DEG C) clear cream, spray drying, standby；

(4) it is the coptis, the radix paeoniae rubrathe, radix cynanchi atrati and Semen Ziziphi Spinosae (parched) is secondary with 6 times of amount 85% ethanol extractions, 1 hour every time, extraction Liquid reclaims ethanol, and spray drying is standby；

(5) it is well mixed after donkey-hide gelatin is crushed with the product obtained by step (2), (3) and (4), adds appropriate breast Sugar, mix, dry-pressing is into particle, and filling into capsule 5000, every fills 0.5g, produces.

Embodiment 2：The preparation of capsule

Composition：

Coptis 200g donkey-hide gelatin 225g radix paeoniae rubrathe 150g radix cynanchi atrati 175g Chinese ephedras 100g

Cultivated land 375g Chinese cassia tree 50g cortex albiziae 150g cicada slough 150g grass-leaved sweetflags 250g

Semen Ziziphi Spinosae (parched) 250g

Preparation technology：

(1) coptis, the radix paeoniae rubrathe, Semen Ziziphi Spinosae (parched) and radix cynanchi atrati add the amount extraction 2 times of 6 times of 70% ethanol, 1.5 hours every time, filter, filter After liquid recovery ethanol, relative density 1.08~1.10 is concentrated into（60℃）, it is standby to be spray-dried obtained fine powder；

(2) Chinese cassia tree, grass-leaved sweetflag add 12 times of amounts of water, and immersion extracts volatile oil 3.5 hours after 3 hours, volatile oil, Aqueous extracts point Do not place standby, the dregs of a decoction are separately deposited standby；Volatile oil is taken to add the 20% of 3 times of amounts of beta-schardinger dextrin after adding 10 times of amount beta-schardinger dextrins Ethanol mix after, milled 15 minutes with colloid mill and filtered after refrigerating 24 hours, the 40 DEG C of drying of inclusion compound after filtration, crush it is standby With；

(3) dregs of a decoction after cortex albiziae, cultivated land, cicada slough, Chinese ephedra and volatile oil extracting, the amount extraction 2 times of 6 times of water is added, 1 is small every time When, filtration, filtrate is concentrated into relative density 1.08~1.10（60℃）, it is standby to be spray-dried obtained fine powder；

(4) alcohol extract spray drying fine powder, Aqueous extracts spray drying fine powder, Benexate Hydrochloride, gelatin powder is taken to mix After pelletize, it is filling, be made capsule 1000, produce.

Embodiment 3：The preparation of powder

Each bulk drug is weighed by following weight：Coptis 600g, donkey-hide gelatin 700g, radix paeoniae rubrathe 400g Semen Ziziphi Spinosae (parched)s 400g, Chinese cassia tree 50g, cortex albiziae 400g, radix cynanchi atrati 400g, Chinese ephedra 200g, cicada slough 400g, grass-leaved sweetflag 800g, cultivated land 1000g；By above-mentioned each bulk drug After crushing, 80 mesh sieves are crossed, subpackage dress, are produced.

Embodiment 4：The preparation of granule

(1) each raw material is weighed by following weight：Coptis 1000g, donkey-hide gelatin 1200g, radix paeoniae rubrathe 800g, radix cynanchi atrati 1000g, Chinese ephedra 600g, Semen Ziziphi Spinosae (parched) 1600g, Chinese cassia tree 400g, cortex albiziae 800g, cicada slough 800g, grass-leaved sweetflag 1200g, cultivated land 2000g；

(2) Chinese cassia tree, grass-leaved sweetflag are added into 15 times of amounts, immersion extracts volatile oil 5 hours after 3 hours, volatile oil, Aqueous extracts point Do not place standby, the dregs of a decoction are separately deposited standby；Volatile oil is taken to add the 20% of 3 times of amounts of beta-schardinger dextrin after adding 10 times of amount beta-schardinger dextrins Ethanol mix after, milled 15 minutes with colloid mill and filtered after refrigerating 24 hours, the 40 DEG C of drying of inclusion compound after filtration, crush it is standby With；

(3) the Chinese cassia tree dregs of a decoction after extraction volatile oil are reinstated into water with radix scutellariae, cortex albiziae one and extracts secondary, first time plus water 10 times of weight, decoct 2 hours, second plus 8 times of weight of water, decoct 1 hour；Decoction liquor and Chinese cassia tree, grass-leaved sweetflag extraction are volatilized Aqueous extracts after oil merge, filtration, and filtrate is concentrated into the clear cream that relative density is 1.30-1.35 (55 DEG C)；Spray drying, it is standby With；

(4) coptis, the radix paeoniae rubrathe, radix cynanchi atrati and Semen Ziziphi Spinosae (parched) are extracted with 60% ethanol, are spray-dried after extract solution recovery ethanol, It is standby；

(5) it is well mixed after donkey-hide gelatin is crushed with the product obtained by step (2), (3) and (4), adds soluble form sediment Powder, sucrose, mix, dry, crush, add appropriate amount of ethanol that particle is made, dry, whole grain, whole grain, packing, be made 1000 bags, i.e., .

Embodiment 5：Clinical research is tested

First, clinical data

1st, general information：

Totally 94 patients, wherein qualified 94 patients are randomly divided into Chinese medicine according to single even numbers of medical order and controlled Treatment group 55, control group 40.Chinese herbs group male 27, women 28, -73 years old 20 years old age, average age 37 years old, disease Journey -5 years 3 months, it is average 3.4 years.Control group male 20, women 20, -75 years old 21 years old age, average age 38 years old, the course of disease It is -4.5 years 3 months, average 3.3 years.Two groups in sex, age, the course of disease etc., are statistically analyzed that there was no significant difference（P ＞ 0.05）, there is comparativity.

2nd, diagnostic criteria：

Meet the diagnostic criteria of Chinese Spirit Obstacles classification and diagnostic criteria (the 3rd edition) (CCMD-3) insomnia (F51.0), (1) time for falling asleep：Difficulty falling asleep (＞ 30 minutes)；(2) sleep quality：Dreaminess, easily awake (＞ 2 times), early awakening, wake up after be not easy Sleep again；(3) total sleep time：Every night and great organic disease and patient with phychlogical problems.Sleep insufficiency 5 hours；Exclude second Alcohol, coffee, tea or drug-induced insomnia and great organic disease and patient with phychlogical problems.

2nd, test method

Control group：Oral melatonin piece, just before going to bed 1 time, every time 2 daily.

Treatment group：Capsule prepared by the embodiment of the present invention 2；Orally, one time 5,3 times on the one.

Withdraw other calming soporific medicines or possible cause insomnia during all patient's researchs and there is syngignoscism Medicine；Avoid strong tea, coffee, raw and cold maror.Even served 15 days is 1 course for the treatment of.Ortho is gradually discontinued after recovering, continuously 3 courses for the treatment of of treatment carry out efficacy evaluation.

3rd, observation of curative effect

Curative effect determinate standard according to《New Chinese medicine guideline of clinical investigations》Evaluation.

Clinical cure：The length of one's sleep recovers, or Nighttime sleep, in more than 6h, sleep is deep, hale and hearty after waking up；

It is effective：Sleep is clearly better, length of one's sleep increase more than 3h, Depth of sleep increase；

Effectively：Symptom mitigation, sleep increase less than 3h earlier above；

It is invalid：Insomnia is not improved or instead adds severe one after treatment.

4th, treatment results

Therapeutic evaluation is carried out according to curative effect judging standard, the results are shown in Table 1.

The clinical treatment outcome table of the present invention of table 1

Group	Number of cases	Recovery from illness	It is effective	Effectively	It is invalid	It is efficient（%）
							Treatment group	55	34(63.0)	16(29.6)	4(7.4)	1(1.9)	98.1%
Control group	40	15(37.5)	7(17.5)	12(30.0)	6(15.0)	85.0%

Treatment group totally 55, wherein recovery from illness 34, accounts for 63.0%；Effective 16, account for 29.6%；Effective 4, account for 7.4%；Nothing Effect 1,1.9% is accounted for, total effective rate 98.1%, effective and clinical recovery rate is 92.6%；And the total effective rate of control group is 85.0%, effective and clinical recovery rate is 55.0%.Two groups are compared, and difference has the meaning (P ＜ 0.005) of highly significant.

Safety observations：55 patients for the treatment of group are taken without any adverse reaction after medicine of the present invention, on the contrary, treatment The state of mind and immunity function of each patient of group are substantially better than the state before treatment, are not produced after disabling medicine of the present invention Any dependent reaction, rebound insomnia phenomenon are slight.

Embodiment 6：Model case

1st, Zhao, female, 38 years old, certain outer duty enterprise marketing line manager.In September, 2013 is gone to a doctor.Patient's half a year cause works Occurs difficulty falling asleep after pressure.Starting to take Western medicine has alleviation, aggravates within nearly five days, takes western medicine result and do not show, almost all night difficult Sleep, pole sense on daytime is tired, yawns incessantly.It is partially red to look into face burnout, tongue nature.Take sleep after 7 doses of capsule of the present invention it is i.e. normal, Institute is with symptom eliminates.Follow-up is not recurred after half a year.

2nd, Zhang, female, 52 years old, in October, 2013 went to a doctor.Patient's cause fatigue in 2 months occurs falling asleep relatively slowly, and sleep is shallower, Night easily wakes up and sleeps difficulty again, thus often feels weak, headache.Row electrocardiogram, blood pressure etc. check without exception.It is light dark to look into tongue nature, arteries and veins String is slided.Take and sleep after 10 doses of capsule of the present invention i.e. normal, institute is with symptom eliminates.Follow-up is not recurred after half a year.

3rd, Liu, female, 38 years old, 2 months 2013 medical.Patient suffers from " depression " more than 5 years, takes Chinese and western drugses control effect Can.January early awakening, sleeps the discomforts such as difficult, dormancy is shallow, dream is more, vexed, paroxysm pectoralgia again because difficulty falling asleep gradually occurs in anger, looks into Dark tongue quality without tongue, arteries and veins in knot as.Take capsule of the present invention after 1 month above-mentioned symptom substantially mitigate, the state of an illness is completely slow after 3 months Solution.Follow-up is not recurred over 2 years.

Claims (6)

1. the Chinese goldthread colla corii asini composition of a kind for the treatment of of insomnia patients, it is characterised in that by each bulk drug of following parts by weight according to Chinese medicine Preparation is prepared into clinically suitable preparation：Coptis 6-10 parts, donkey-hide gelatin 7-12 parts, radix paeoniae rubrathe 4-8 parts, Semen Ziziphi Spinosae (parched) 4-16 parts, meat Osmanthus 0.5-4 parts, cortex albiziae 4-8 parts, radix cynanchi atrati 4-10 parts, Chinese ephedra 2-6 parts, cicada slough 4-8 parts, grass-leaved sweetflag 8-12 parts, cultivated land 10-20 Part.

2. according to the Chinese goldthread colla corii asini composition described in claim 1, it is characterised in that the parts by weight of each bulk drug are：The coptis 8 Part, 9 parts of donkey-hide gelatin, 6 parts of the radix paeoniae rubrathe, 10 parts of Semen Ziziphi Spinosae (parched), 2 parts of Chinese cassia tree, 6 parts of cortex albiziae, 7 parts of radix cynanchi atrati, 4 parts of Chinese ephedra, 6 parts of cicada slough, stone 10 parts of calamus, 15 parts of cultivated land.

3. according to the Chinese goldthread colla corii asini composition described in claim 1 or 2, it is characterised in that：Described preparation includes capsule, ball Agent, powder, granule, tablet, oral liquid or pill.

A kind of 4. method of the Chinese goldthread colla corii asini composition prepared described in claim 1 or 2, it is characterised in that：By the parts by weight Weigh each bulk drug；Each bulk drug is crushed, sieved, the auxiliary material or excipients needed for preparations shaping is added, is prepared into capsule Agent, tablet or pill.

A kind of 5. method of the Chinese goldthread colla corii asini composition prepared described in claim 1 or 2, it is characterised in that comprise the following steps：

(1) each bulk drug is weighed by the parts by weight；

(2) Chinese cassia tree, grass-leaved sweetflag are extracted into volatile oil, will be crushed after inclusion essential oil, it is standby；

(3) dregs of a decoction after extraction volatile oil and cicada slough, cultivated land, cortex albiziae, Chinese ephedra one are reinstated into water extraction, aqueous extract is sprayed Dry, it is standby；

(4) coptis, the radix paeoniae rubrathe, radix cynanchi atrati and Semen Ziziphi Spinosae (parched) are extracted with 30-85% ethanol, after ethanol extract is reclaimed into ethanol, spray Mist is dried, standby；

(5) it is well mixed after donkey-hide gelatin is crushed with the product obtained by step (2), (3) and (4), adds pharmaceutical preparation auxiliary material and mix It is even that intermediate formulations are made, then finished dosage form is made through preparations shaping technique.

6. application of the Chinese goldthread colla corii asini composition in treatment of insomnia patients medicine is prepared described in claim 1 or 2.