CN101919962A - Medicine for curing insomnia and preparation method thereof - Google Patents
Medicine for curing insomnia and preparation method thereof Download PDFInfo
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Abstract
The invention provides a medicine for curing insomnia and a preparation method thereof. The medicine contains natural vegetable drugs such as polygonum multiflorum, spina date seed, mulberry, lucid ganoderma, lily, rhizoma anemarrhenae, the root of red-rooted salvia, and the like. The medicine of the invention has the functions of tonifying the kidney, strengthening brain, nourishing heart, tonifying spleen, appetizing, invigorating the circulation of blood, regulating the functions of the five internal organs, and treating insomnia, amnesia, dizziness, fatigue, lumbar knee aching and limp.
Description
Technical field
The present invention relates to a kind of medicine that is used for the treatment of insomnia and preparation method thereof, belong to the Chinese herbal and crude drugs preparations technical field.
Background technology
The insomnia is the dissatisfied situation to the quality and quantity of sleep that continues the long duration.The insomnia is common clinical, frequently-occurring disease, clinical symptoms can show as: difficulty falling asleep, sleep and can not sleep again after easily waking up, waking up, wake up too early morning, the time wake up when sleeping, can not fall asleep whole night, insomnia-middle or sleep sense lose, can be with dreaminess, in addition, can cause wake up that the back is uncomfortable, tired, ergasia decrease in efficiency or obstruction social function.There is data to show, has 20% people that sleep disorder is arranged in the time of 20 years old approximately; Increased to 50% by 55 years old; Be elevated to 90% in the time of 80 years old.According to statistics demonstration recently, there is the sleep disorder of the people's various degrees more than 42.5% in China; Insomnia's sickness rate is up to 10%-20%.The result of mental science branch of Chinese Medical Association in 2002 " Sai Nuofei sleep investigation " shows, has 25.9% people to think that oneself has sleep disorder, and start from before 2 years (median).But it should be noted that the scale according to athene, have 45.4% quality of human sleeping undesirable, wherein 28% belongs to insomnia, 17.4% belong to suspicious insomnia [Zhang Xiaohong. the Chinese medicine Tribune phase 10 days the 831st October in 2002].In recent years, along with the increase, particularly working and learning hypertonicity with social competition's pressure of improving constantly of living standards of the people, the sickness rate of primary disease is in rising trend, have a strong impact on patient's life, working and learning quality, work, study and social communication are caused harmful effect.45% traffic accident with do not have enough sleep relevant, 50% industrial accident with do not have enough sleep relevant, the relative risk that the chronic insomnia person has an accident be 4.5 times of the normal person [quiet reaching. Chinese medicine Tribune 03 month 20 the 853rd phase in 2003].
With the quickening pace of modern life, the increasing of operating pressure, insomniac is more and more, and the patient is also more and more urgent to the requirement of effective control primary disease.Recent study, single not good enough with the downern curative effect, particularly chemosynthesis medicine becomes clear day by day to the toxic and side effects of human body, human body dependency, withdrawal symptom and drug withdrawal knock-on also receive numerous medical personnels and patient's concern day by day, people seek to prevent and treat primary disease under the guidance of traditional Chinese medicine theory, and the demand of this disease of Chinese patent drugs for treatment of utilization employing natural Chinese medicine development is also more strong.
The traditional Chinese medical science thinks, diseases such as insomnia, forgetful, dizzy, cardiopalmus, spiritlessness and weakness, soreness of the waist and knees appear in the insomniac, surely belong to " being insomnia " and demonstrate,prove category.Being insomnia is often can not obtaining a kind of disease that ortho sleep is a feature, to be insomnia with the passing of time, and the function long-run disturbance dizziness, forgetful, spiritlessness and weakness, headache, agitation then occur, is easy to clinical manifestations such as excitement.Though the generation of primary disease has the branch of deficiency and excess, with deficiency syndrome for seeing at most.As " Ling Shu Miraculous Pivot or Divine Axis greatly puzzled opinion " cloud: " the cloudy deficiency of vital energy is not so order sets "." a Ling Shu Miraculous Pivot or Divine Axis battalion health meeting piece of writing " title " the old's QI and blood declines, and its muscle is withered, stagnant QI-passage, and the gas phase of five Tibetan is fought, its deficiency of nutrient QI with inner disturbance of defensive QI, so brightlessness in the daytime, be insomnia night ".Think that the five internal organs become estranged, the vital essence blood deficiency is its main etiology and pathogenesis, and is wherein close with heart kidney relation especially.People's spirit, consciousness and thinking activities are the physiological functions of brain, and The heart controls mental activities but then it is belonged in the Chinese medicine state of internal organs, and " element asks LINGLAN secret allusion quotation opinion " said: " heart person, the viscus likened to the monarch in the body also, here gods go out." " Ling Shu Miraculous Pivot or Divine Axis evil visitor " say: " heart person, the big master of the vital organs of the human body also, spirit give up also ".So deficiency of heart-blood, the heart is become homeless foster, refreshing do not have give up, insomnia, dreaminess, dizziness, all diseases of spiritlessness and weakness then appear, " Jing Yue's complete work is insomnia ": " naivete and the person of being insomnia, must nutrient QI and blood being insufficient also, seek main blood, blood deficiency then is difficult to nourish heart, the then mental derangement of having a guilty conscience ".On the other hand, people's ergasia is also inseparable with the function of kidney and brain.The kidney being the origin of congenital constitution, main store essential substances, and main bone is given birth to marrow, brain being the marrow sea, kidney essense is full, and then brain must be supported, and just can give full play to the physiological function of its " house of intelligence ", otherwise, deficiency of kidney-essence, then brain is lost fosterly, diseases such as forgetful, dizzy, soreness of the waist and knees can occur.Just as " well-known doctor of Qing Dynasty case elite " cloud: " the awake drowsirness is few, and it is not peaceful to palpitate from nervousness, and very then frightened cautious is the high of the heart, and also kidney water loses also.And it is then sad to work hard, and ponders over the then impairment of the spleen, and two through the cloudy blood of special department, and the master of the particularly cloudy liquid of kidney ".As seen the main diseases movement deficiency of the kidney void of primary disease, painstaking effort are lost few, deficiency of kidney-essence, brain is lost and is supported, so that is insomnia.
The Chinese medicine disease of being insomnia has long history, there are many prescriptions to apply in insomnia's the treatment in recent years and have been proved to be curative effect preferably, many Chinese medicine preparation that studies confirm that have the central neurotransmitter of improvement, prolong the length of one's sleep, improve effects such as memory ability.The Chinese traditional treatment insomnia is from organic conception, determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, and determined curative effect is lasting, and safety is good, patient's compliance height.
Summary of the invention
The object of the present invention is to provide medicine of a kind of Cure for insomnia evident in efficacy and preparation method thereof.
This drug invention people professor Wu Yiling according to Chinese traditional treatment insomnia's theoretic discussion, in conjunction with clinical, repeatedly practises gained in practice.Observe in clinical, can effectively improve diseases such as insomnia due to insomnia's heart deficiency of the kidney deficiency syndrome, forgetful, dizzy, cardiopalmus, spiritlessness and weakness, soreness of the waist and knees.
Stagnation of liver-QI with deficiency of the spleen is the common pathogenesis of idiopathic edema, and this disease is more common in the not smooth middle-aged women of menoxenia, emotion, and symptoms such as the performance emotion is not smooth, anorexia, abdominal distention are relevant with menstrual cycle.The woman is congenital with liver, blood stored in the liver, and main catharsis, property happiness bar reaches, and stagnation of QI due to depression of the liver, the mechanism of qi disorder, the three warmers water channel is obstructed, and water liquid does not follow Chang Dao and overflows will send out in skin and is edema; " General Treatise on the Cause and Symptoms of Diseases ten water time " said: " blue or green water person, swollen all over the whole body from appearance earlier, its root is liver " illustrates that the liver failing to maintain the normal flow of QI can cause stagnation of QI water retention.Plain body weakness or stagnation of liver-QI all can cause spleen fortune not normal, through cloud: " all damp-edema completely all belong to spleen ", insufficiency of the spleen then can not transmitting and distributing the fluids, water is wet to stop poly-spreading unchecked and overflows so edema.Thereby the idiopathic edema pathologic basis is a stagnation of liver-QI with deficiency of the spleen.
It is an important step of morbidity that the channels stasis of blood stagnates, and channels is the hinge and the path of the defeated cloth circulation of qi-blood-body fluid, current QI and blood is arranged, ooze and moisten perfusion, Tianjin blood and effect such as ooze mutually.The operation of the network of meridians is called the gas network through gas, gas network depression and stagnation of QI, and it is warm supplements nutrition, defend to protect, information is passed on, regulate the control malfunction, the internal organs disfunction, the liver network stagnation of QI is smooth, the sighing frequently of emotion then, the tried out then abdominal distension and anorexia of the network gas of spleen; The network operation blood of venation also has gas in the blood, the venation depression and stagnation of QI, and regulatory function is not normal, and imbalance is oozed in the channels stasis of blood resistance then impaired Tianjin of its function blood mutually, and shows as " congestion water ", facial edema occurs, and both hands are swollen, afternoon lower extremity swelling and distension, the diseases such as depression of pressing.
This drug invention people Wu Yiling professor controls with soothing liver and strengthening spleen at this pathologic basis of stagnation of liver-QI with deficiency of the spleen, and the strong then liver catharsis function of spleen fortune could be normal, liver mechanism of qi bar reaches and is to keep normally fortune function of taste, harmonizing the functional activities of vital QI, tonneau three warmers, the essential condition that unclogs the channel; Simultaneously,, nourish blood and blood collateral dredging, the smooth network of gas, disperse blood stasis and dredge collateral, diuretic collateral dredging, recover the channels normal function to control all methods of network, it is stable to keep function, and edema is disappeared, and channels is logical, and liver mechanism of qi bar reaches, spleen fortune is strong, amounts to soothing liver and strengthening spleen, the effect of collateral dredging diuretic.
According to the main pathogenic characteristic of this disease " painstaking effort are lost few, deficiency of kidney-essence ", support congenital the moon essence, the short fortuneization of the day after tomorrow is so tonify deficiency is main, nourish painstaking effort, fill up kidney essense, regulate the five internal organs, the mind is complied with to some extent, brain must be filled, and coordination between the heart and kidney is insomnia to such an extent that remove, and recovers normal physiological function.Lose void at essence and blood simultaneously and with the passing of time give birth to heat, cause the pathological characteristic of the stasis of blood, the prescription compatibility is invigorated blood circulation, the product of pathogenic fire reducing, and the conditioning cardiorenal function amounts to the effect of calming the nerves.
We's monarch drug: Radix Polygoni Multiflori, bitter in the mouth, sweet, puckery, slightly warm in nature, return liver, kidney channel, the invigorating the liver and kidney of Radix Polygoni Multiflori energy, benefiting essence-blood, hold concurrently and to restrain, not cold, not dry, oiliness, be tonic medicine, so with being monarch drug, lose void originally to control essence and blood, Compendium of Material Medica cloud: " Radix Polygoni Multiflori ... the liver benefiting that can nourish blood, the controlling nocturnal emission with astringent drugs kidney tonifying is tonic medicine ".Ministerial drug: Semen Ziziphi Spinosae, Fructus Mori.Semen Ziziphi Spinosae, sweet in the mouth, property is flat, and GUIXIN, Liver Channel nourish heart cloudy the liver benefiting blood and mind tranquilizing and the heart calming is the key medicine of treatment deficiency dysphoric insomnia." Mingyi Bielu " says its " main vexatious insomnia ".The Zhong Jing suanzaoren decoction is promptly controlled the name side of " consumptive disease with restlessness insomnia ".Fructus Mori, sweet in the mouth acid, cold in nature, go into liver, kidney channel, but merit tonifying liver kidney yin essence, " kidney tonifying dirty and controlling nocturnal emission with astringent drugs obey hair color for a long time and make eye bright " (" the southern regions of the Yunnan Province book on Chinese herbal medicine ").Smart sufficient brain must be filled, and then " soul peace and refreshing from clear peaceful is sent out in god is clearly then clever in coordination between the heart and kidney." (" Bencao Jingshu "), " the south of Fujian Province traditional herbal medicine " be cloud also: " controlling heart nephrasthenia is insomnia ".Semen Ziziphi Spinosae, Fructus Mori two medicines share, altogether principal drug assistance Radix Polygoni Multiflori kidney tonifying brain-strengthening, tranquilizing by nourishing the heart.Adjuvant drug: Ganoderma, Bulbus Lilii, the Rhizoma Anemarrhenae, Radix Salviae Miltiorrhizae, Flos Chrysanthemi, Poria.Ganoderma, sweet in the mouth, property is flat, goes into the heart, spleen channel, and replenishing QI and blood, tranquilizing mind, " Chinese traditional tonic tonic " are said its energy " tranquilizing by nourishing the heart, tonifying the lung the liver benefiting ", can " treat chronic diseases such as neurasthenia, insomnia, dyspepsia " (" Chinese medicinal plants illustrated handbook ").The auxiliary all medicines of the monarch and his subjects make heart temper blood fill Sheng, and are refreshing from peaceful.Bulbus Lilii, sweet in the mouth, property is flat, GUIXIN, lung meridian, the function clearing away heart-fire for tranquillization can " be felt at ease, decide gallbladder, beneficial will, foster the five internal organs " (" solar corona ")." Xinjiang Chinese herbal medicine handbook is cloud also: " training the mind through weak, vexed insomnia ".The Rhizoma Anemarrhenae, bitter in the mouth, cold in nature, go into lung, stomach, kidney channel, the function nourishing YIN to lower pathogenic fire, Li Gao has cloud: " Rhizoma Anemarrhenae its with having four: the kidney fire that rushes down unrooted ... the moon in tasteization source.Zhong Jing goes into the Baihu Tang person that controls the insomnia with this ", share nourishing YIN to lower pathogenic fire with Bulbus Lilii, restoring normal coordination between the heart and kidney and reach the merit of mind tranquilizing and the heart calming.Radix Salviae Miltiorrhizae, bitter in the mouth, slightly warm in nature is gone into the heart, Liver Channel, blood circulation promoting and blood stasis dispelling, mind tranquilizing and the heart calming, " the southern regions of the Yunnan Province book on Chinese herbal medicine " has cloud: " reinforcing the heart sedate, calming heart and tranquilizing mind are controlled forgetful palpitation with a distress feeling, and palpitation with fear is insomnia." heart governing blood and vessels, deficiency of heart-blood, the heart is become homeless foster, the capable unable and hyperamization stasis of blood of blood, thus use with activating blood circulation and dissipating blood stasis, unobstructed vessel then the heart from peaceful, refreshing from peace.Flos Chrysanthemi, sweet in the mouth, hardship, cool in nature, go into lung, Liver Channel, the function liver heat removing and eyesight improving." remove irritable feverish sensation in the chest, the peace the intestines and stomach, sharp five pulse conditions of ZANG-organs is transferred extremity." (" not Lu "), " suppressing the hyperactive liver be dredged lung, the pathogenic heat of the clear part of the body cavity above the diaphragm housing the heart and lungs ... the tonifying YIN nourishing kidney." (" herbal usage studies "), this product can suppressing the hyperactive liver to relieve the wind syndrome, liver heat removing and eyesight improving, and correct headache, dizzy disease.Poria, sweet in the mouth, light, GUIXIN, spleen, lung, kidney channel, the function invigorating the spleen and regulating the stomach, mind tranquilizing and the heart calming helps the merit of transporting and transforming function of the spleen and stomach, and increases the source of the day after tomorrow.The Shennong's Herbal cloud: " clothes peace soul is reposed for a long time ", " property of medicine opinion " are sayed its " appetizing, preventing or arresting vomiting is contrary, kind tranquilizing mind ".All medicines are adjuvant drug altogether, help the monarch-minister drug the kidney invigorating to nourish heart, the clearing away heart-fire for tranquillization of invigorating blood circulation.Messenger drug: Flos Albiziae, sweet in the mouth, property is flat, goes into heart channel, have calm the nerves, the merit of resolving depression.Its " resolving stagnation for tranquilization and network pain relieving is sayed in Jiangxi " Chinese herbology ".Treating the liver is strongly fragrant uncomfortable in chest, melancholy and discomfort, forgetful insomnia ", Flos Albiziae is nourished heart and settling five organs, with being messenger drug.All medicines share, the kidney tonifying brain-strengthening, and tranquilizing by nourishing the heart, the while spleen benefiting and stimulating the appetite, invigorating blood circulation clears away heart-fire, regulate function of five internal organs, invigorating middle warmer has logical, and tonify without causing stagnation is logical and just do not hinder, and then heart kidney must be supported, the five internal organs fill Sheng, the QI and blood smoothness, and brain god must fill, and oneself removes insomnia, forgetful, dizzy, spiritlessness and weakness, all diseases of soreness of the waist and knees.
Chinese medicine of the present invention can be had the Chinese medicine of same or similar effect fruit to replace, and these medical materials all can be concocted according to " national Chinese medicine processing standard " or " Chinese medicine voluminous dictionary ".Such as: Radix Polygoni Multiflori can be replaced with Radix Polygoni Multiflori Preparata, and Semen Ziziphi Spinosae can be replaced with Semen Ziziphi Spinosae (parched), and the comparable use crude drug in whole of the drug effect after replacement effect is better, but all belongs to content of the present invention.
Medicine of the present invention is made by following bulk drugs:
Radix Polygoni Multiflori 150-270 Semen Ziziphi Spinosae 145-275 Fructus Mori 160-255 Ganoderma 80-135
Bulbus Lilii 75-160 Rhizoma Anemarrhenae 50-110 Radix Salviae Miltiorrhizae 120-200 Flos Chrysanthemi 45-120
Poria 75-145 Flos Albiziae 165-288.
The weight ratio of medicine material medicine of the present invention is preferably:
Radix Polygoni Multiflori 158 Semen Ziziphi Spinosaes 270 Fructus Moris 165 Ganodermas 135 Bulbus Liliies 80
The Rhizoma Anemarrhenae 110 Radix Salviae Miltiorrhizaes 125 Flos Chrysanthemis 118 Poria 80 Flos Albiziaes 280.
The weight ratio of crude drug also is preferably in the Chinese medicine composition of the present invention:
Radix Polygoni Multiflori 265 Semen Ziziphi Spinosaes 147 Fructus Moris 250 Ganodermas 81 Bulbus Liliies 158
The Rhizoma Anemarrhenae 55 Radix Salviae Miltiorrhizaes 188 Flos Chrysanthemis 50 Poria 145 Flos Albiziaes 170.
The weight ratio of crude drug also is preferably in the Chinese medicine composition of the present invention:
Radix Polygoni Multiflori 225 Semen Ziziphi Spinosaes 163 Fructus Moris 220 Ganodermas 83 Bulbus Liliies 113
The Rhizoma Anemarrhenae 50 Radix Salviae Miltiorrhizaes 190 Flos Chrysanthemis 45 Poria 113 Flos Albiziaes 178.
The weight ratio of crude drug also is preferably in the Chinese medicine composition of the present invention:
Radix Polygoni Multiflori 165 Semen Ziziphi Spinosaes 228 Fructus Moris 173 Ganodermas 110 Bulbus Liliies 75
The Rhizoma Anemarrhenae 75 Radix Salviae Miltiorrhizaes 150 Flos Chrysanthemis 78 Poria 78 Flos Albiziaes 218.
The weight ratio of crude drug also is preferably in the Chinese medicine composition of the present invention:
Radix Polygoni Multiflori 200 Semen Ziziphi Spinosaes 200 Fructus Moris 200 Ganodermas 100 Bulbus Liliies 100
The Rhizoma Anemarrhenae 66.7 Radix Salviae Miltiorrhizaes 166.7 Flos Chrysanthemis 66.7 Poria 100 Flos Albiziaes 200.
The active component of medicine of the present invention is made by the following step:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 6-12 and doubly measure 30%-70% ethanol, heating and refluxing extraction 1-3 time, each 1-3 hour, extracting liquid filtering merged, decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, gets alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 10-15 times of water gaging and extract 1-3 time, extracted 1-3 hour at every turn, extracting solution filters, and merges, and is concentrated into 60 ℃ of mensuration relative densities to be about 1.10-1.15, get the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
The water extracted immersing paste of step a) gained alcohol-extracted extract and step b) and step c) gained Bulbus Lilii fine powder constitute the active component of this medicine jointly.
Pharmaceutical dosage form of the present invention is a capsule, tablet, powder, oral liquid, soft capsule, pill, tincture, syrup, suppository, gel, a kind of in spray or the injection, for above-mentioned dosage form can be realized, need when these dosage forms of preparation, to add the pharmacy acceptable auxiliary, for example: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic etc., filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc., disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc., lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc., suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc., binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc., sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc., correctives comprises: sweeting agent and various essence, and antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, the acetic acid chloroethene is fixed, the Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods.
The preparation method of medicinal tablet of the present invention is made by the following step:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 6-12 and doubly measure 30%-70% ethanol, heating and refluxing extraction 1-3 time, each 1-3 hour, extracting liquid filtering merged, decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, gets alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 10-15 times of water gaging and extract 1-3 time, extracted 1-3 hour at every turn, extracting solution filters, and merges, and is concentrated into 60 ℃ of mensuration relative densities to be about 1.10-1.15, get the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
D) with the water extracted immersing paste and the step c) gained Bulbus Lilii fine powder drying and granulating of step a) gained alcohol-extracted extract and step b), behind the granulate, add suitable adjuvant, mixing, tabletting, coating, promptly.
The preparation method of medicinal tablet of the present invention is preferably:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 60% ethanol, heating and refluxing extraction 2 times, add for the first time 10 times of amounts, extracted 2 hours, and added 8 times of amounts for the second time, extracted 1 hour, extracting liquid filtering, merge, decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, get alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 11 times of water gagings and extract 2 times, each 1.5 hours, extracting liquid filtering merged, be concentrated into to measure relative densities at 60 ℃ and be about 1.10-1.15, the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
D) step c) gained Bulbus Lilii fine powder is added in the spray-drying pelleting machine material container, the water extracted immersing paste of step a) gained alcohol-extracted extract and step b) is sprayed into, spray granulation behind the granulate, adds 0.5% magnesium stearate, mixing, and tabletting, coating, promptly.
Medicine capsule of the present invention, powder, oral liquid, soft capsule, pill, tincture, syrup, suppository, gel, spray and injection all can be prepared from according to the conventional pharmaceutical method by medicine material medicine of the present invention or active constituents of medicine of the present invention.
Amount of drug of the present invention by active component crude drug gross weight, is 14-20 gram/day, but takes every day once or divide and take for 2-4 time, is preferably for 16.8 gram/days, divides and takes for 3 times.
For confirming the activity of Drug therapy insomnia of the present invention, use the tablet (to call medicine of the present invention in the following text) that makes by embodiment 1 method to carry out following pharmacological testing.
One, the sedation of medicine of the present invention
1. experiment material
1.1 laboratory animal
Healthy kunming mice, the cleaning level, male, 90, body weight 18～22g, purchase Experimental Animal Center, credit number: SCXK (Ji) 2003-1-003, quality certification numbering: DK0409-0040 in Hebei province, raising is with mountain range academy pharmacological room, illumination 12 hours/day, 20～23 ℃ of temperature, relative humidity 40～60%.Mice is raised in cages, 6/cage.Mouse feed is a full-valence pellet feed, is provided by Hebei province's Experimental Animal Center, keeps competent drinking-water.Adaptability was raised three days.
1.2 experiment medicine
Medicine of the present invention is equivalent to 3.47g crude drug/g, people's consumption 17.0g crude drug/sky, i.e. 0.28g crude drug/kg body weight (standard body weight 60kg).Provide lot number by Shijiazhuang Yiling Pharmaceutical Co., Ltd: 20040201.Make suspension with 0.5%CMC-Na, 4 ℃ of preservations.
ANSHEN BUNAO YE, by Cornu Cervi Pantotrichum, Radix Polygoni Multiflori Preparata, Herba Epimedii, Rhizoma Zingiberis, Fructus Jujubae, vitamin B1 are formed, and effect cures mainly: invigorating brain and relieving mental uneasiness, spermatogenesis is mended marrow, benefiting QI and nourishing blood is usually used in neural decline, insomnia, forgetful, dizzy, weak, produce by Aodong, Jilin Yan Bian pharmaceutcal corporation, Ltd, the accurate word of traditional Chinese medicines: Z22022453, clinical consumption: the 20ml/d that is grown up, lot number: 040269.
Estazolam tablets is the Benzodiazepines antianxiety drugs, can cause the inhibition of central nervous system's different parts, and along with the increasing of dosage, clinical manifestation can be from slight calmness to hypnosis even stupor.Provide by Shijiazhuang Pharmaceutical Group Co Ltd, the accurate word H13020974 of traditional Chinese medicines, specification: 1 milligram, the clinical consumption of being grown up: hypnosis 2～4mg/ time, calm 1～2mg/ time, 3 times/day, lot number 040101.
1.3 experimental apparatus
Mice autonomic activities instrument (autonomic activities case, autonomic activities software) is purchased the large forestry garden Science and Technology Ltd. in Beijing.
AB204-N type electronic analytical balance is purchased in Mettler-Toledo Instrument (Shanghai) Co., Ltd..
2. experimental technique
2.1 dosage setting principle
Medicine of the present invention is established 5.6g crude drug/kg, 2.8g crude drug/kg and 1.4g crude drug/kg group in the experiment, is equivalent to intend clinical human dosage (20,10,5 times of 0.28g crude drug/kg) respectively.According to the result of preliminary experiment, establish ANSHEN BUNAO YE 13ml/kg group and estazolam 2.67mg/kg group.According to above dosage situation is set, mice is divided into 6 groups, as table 1.
Table 1 medicine of the present invention is to the influence experiment grouping and the dosage of mice autonomic activities
2.2 medication
The administration concentration of each group of medicine of the present invention is respectively 0.08g dry powder/ml, 0.04g dry powder/ml, 0.02g dry powder/ml, and the administration concentration of ANSHEN BUNAO YE group is 0.65ml medicinal liquid/ml, and the administration concentration of estazolam group is 0.13mg/ml.Every day, gastric infusion 0.2ml/10g was consistent with the oral route of clinical recommendation, and continuous 7 days, the estazolam group was only 1 administration in the 7th day.
2.3 experimental period
7 days.
2.4 detect index and detection method
Mice was respectively trained 1 time in 1 day the morning, afternoon, the evening, adapted to 5min at every turn, autonomic activities number in the record 10min is got 72 averages and is participated in the experiment the mice of 150～250 times/10min.Test autonomic activities number adapts to 5min earlier behind last 1 administration 1h, writes down the autonomic activities number of mice in the 10min again.
2.5 statistical method
Carry out one factor analysis of variance with the spss11.5 statistical software.
3. experimental result
Compare with the blank group, the autonomic activities number average of ANSHEN BUNAO YE group and estazolam group mice reduces (P＜0.01 or P＜0.05).Medicine 5.6g crude drug/kg of the present invention, 2.8g crude drug/kg group and blank group ratio, mice autonomic activities number obviously reduces (P＜0.05), and suppression ratio is respectively 27.5%, 23.4%, and the autonomic activities number of 1.4g crude drug/kg group mice has the trend of reduction, suppression ratio is 9.7%, the results are shown in Table 2.
Table 2 medicine of the present invention to the influence of mice autonomic activities number (
N=12)
Annotate: compare with the blank group,
*P＜0.05,
*P＜0.01
4. conclusion
Medicine of the present invention can reduce mice autonomic activities number, confirms that medicine of the present invention has sedation.
Two, the syngignoscism of medicine of the present invention
2.1 experiment material
2.1.1 laboratory animal
Healthy kunming mice, the cleaning level, male, 72, body weight 18～22g purchases the Experimental Animal Center in Hebei province, credit number: SCXK (Ji) 2003-1-003, quality certification numbering: DK0409-0016.Raising is with mountain range academy pharmacological room, illumination 12 hours/day, 20～23 ℃ of temperature, relative humidity 40～60%.Mice is raised in cages, 6/cage.Mouse feed is a full-valence pellet feed, is provided by Hebei province's Experimental Animal Center, keeps competent drinking-water.Adaptability was raised three days.
2.1.2 experiment medicine
Medicine of the present invention is equivalent to 3.47g crude drug/g dry powder, people's consumption 17.0g crude drug/sky, i.e. 0.28g crude drug/kg body weight (standard body weight 60kg).Provide lot number by Shijiazhuang Yiling Pharmaceutical Co., Ltd: 20040201.Make suspension with 0.5%CMC-Na, 4 ℃ of preservations.
ANSHEN BUNAO YE, by Cornu Cervi Pantotrichum, Radix Polygoni Multiflori Preparata, Herba Epimedii, Rhizoma Zingiberis, Fructus Jujubae, vitamin B1 are formed, and effect cures mainly: invigorating brain and relieving mental uneasiness, spermatogenesis is mended marrow, benefiting QI and nourishing blood is usually used in neural decline, insomnia, forgetful, dizzy, weak, produce by Aodong, Jilin Yan Bian pharmaceutcal corporation, Ltd, the accurate word of traditional Chinese medicines: Z22022453, clinical consumption: the 20ml/d that is grown up, lot number: 040269.
Estazolam tablets is the Benzodiazepines antianxiety drugs, can cause the inhibition of central nervous system's different parts, and along with the increasing of dosage, clinical manifestation can be from slight calmness to hypnosis even stupor.Provide by Shijiazhuang Pharmaceutical Group Co Ltd, the accurate word H13020974 of traditional Chinese medicines, specification: 1 milligram, the clinical consumption of being grown up: hypnosis 2～4mg/ time, calm 1～2mg/ time, 3 times/day, lot number 040101.
2.1.3 experiment reagent
Pentobarbital sodium is provided by China Medicine (Group) Shanghai Chemical Reagent Co.,, lot number: F20030816.
2.2 experimental technique
2.2.1 dosage setting principle
Medicine of the present invention is established 5.6g crude drug/kg, 2.8g crude drug/kg and 1.4g crude drug/kg group in the experiment, is equivalent to intend clinical human dosage (20,10,5 times of 0.28g crude drug/kg) respectively.According to the result of preliminary experiment, establish ANSHEN BUNAO YE 13ml/kg group and estazolam 2.67mg/kg group.According to above dosage situation is set, mice is divided into 6 groups, as table 3.
Table 3 medicine of the present invention is to the influence experiment grouping and the dosage of pentobarbital sodium mouse sleep time
2.2.2 medication
The administration concentration of each group of medicine of the present invention is respectively 0.08g dry powder/ml, 0.04g dry powder/ml, 0.02g dry powder/ml, and the administration concentration of ANSHEN BUNAO YE group is 0.65ml medicinal liquid/ml, and the administration concentration of estazolam group is 0.13mg/ml.Every day, gastric infusion 0.2ml/10g was consistent with the oral route of clinical recommendation, and continuous 7 days, the estazolam group was only 1 administration in the 7th day.
2.2.3 modeling method
Each organizes 1h after last 1 administration, lumbar injection pentobarbital sodium 45mg/kg.
2.2.4 experimental period
7 days.
2.2.5 detect index and detection method
Laboratory reference " pharmacological experimental methodology " (third edition).Determining to make 100% mice sleeping through preliminary experiment, is 45mg/kg but do not make the length of one's sleep long pentobarbital sodium lumbar injection dosage.Each organizes 1h after last 1 administration, lumbar injection pentobarbital sodium 45mg/kg, record mouse sleep time (righting reflex loss to time that righting reflex recovers).
2.2.6 statistical method
Carry out the t check with the spss11.5 statistical software.
2.3 experimental result
Compare with model control group, estazolam group mouse sleep time prolongs (P＜0.01).Compare with model group, medicine 5.6g crude drug/kg of the present invention, 2.8g crude drug/kg group mouse sleep time prolong (P＜0.05 or 0.01), the results are shown in Table 4.
Table 4 medicine of the present invention to the pentobarbital sodium in mice influence of the length of one's sleep (
N=12)
Annotate: compare with model control group,
*P＜0.05,
*P＜0.01
2.4 conclusion
Medicine of the present invention has the effect of the length of one's sleep of prolongation pentobarbital sodium in mice.
Three, medicine of the present invention promotes memory effect
3.1 experiment material
3.1.1 laboratory animal
Healthy kunming mice, the cleaning level, male, 72, body weight 18～22g purchases the Experimental Animal Center in Hebei province, credit number: SCXK (Ji) 2003-1-003, numbering: DK0504-0019.Raising is with mountain range academy pharmacological room, illumination 12 hours/day, 20～23 ℃ of temperature, relative humidity 40～60%.Mice is raised in cages, 6/cage.Mouse feed is a full-valence pellet feed, is provided by Hebei province's Experimental Animal Center, keeps competent drinking-water.Adaptability was raised three days.
3.1.2 experiment medicine
Medicine of the present invention is provided by Shijiazhuang Yiling Pharmaceutical Co., Ltd, lot number: 20040201.Make suspension with 0.5%CMC-Na, 4 ℃ of preservations before using.
Huperzine A-Zhulin Antun (huperzine A sheet), huperzine A are reversible, high selectivity acetylcholinesteraseinhibitors inhibitors.He'nan Zhulin Zhongsheng Pharmaceutical Industry Co. Ltd produces, the accurate word H10940156 of traditional Chinese medicines, specification: 0.05mg/ sheet, lot number: 050201.
Scopolamine hydrobromide injection, the accurate word H31021519 of traditional Chinese medicines, Shanghai Hefeng Pharmaceutical Co., Ltd., lot number: 4A18003.Specification: 0.3mg.
3.1.3 experimental apparatus
The program control water maze of SMG-2, the institute of Materia Medica,Chinese Academy of Medical Sciences manufacturing.
3.2 experimental technique
3.2.1 dosage setting principle
Medicine of the present invention is established 5.6g crude drug/kg, 2.8g crude drug/kg and 1.4g crude drug/kg group in the experiment, is equivalent to intend clinical human dosage (20,10,5 times of 0.28g crude drug/kg) respectively.Other establishes the blank group, model control group, huperzine A 0.4mg/kg group.According to above dosage situation is set, mice is divided into 6 groups, as table 5.
Table 5 medicine of the present invention causes the thin and dosage of influence experiment branch that mouse memory reproduces obstacle to eastern scopola alkali
3.2.2 medication
The administration concentration of each group of medicine of the present invention is respectively 0.08g dry powder/ml, 0.04g dry powder/ml, 0.02g dry powder/ml, and the administration concentration of huperzine A group is 0.02mg/ml.Every day, gastric infusion 0.2ml/10g was consistent with the oral route of clinical recommendation, continuous 14 days.
3.2.3 modeling method
30min is except that the blank group after the administration in the 14th day, and mouse peritoneal injection 2mg/kg scopolamine hydrobromide is made memory represents obstacle model.
3.2.4 experimental period
14 days.
3.2.5 detect index and detection method
Training mice (24～26 ℃ of water temperatures, depth of water 10cm) earlier places 10 seconds on the step with mice during training, makes its existence of understanding this place of safety, is placed on then near the step, allows its cat ladder 2 times voluntarily, to be familiar with means of escape.Whole training divides to be carried out in 5 days, the 9th day A point, and the 10th day B point, the 11st day B point, the 12nd day S point, the 13rd day S point trained 1 every day, limits 2 minutes at every turn, overtimely swims over to step with glass rod guiding animal.Mouse head is towards the wall of starting point when beginning to swim.Carry out requiring mice in 2min, to swim over to step otherwise rejecting after the training of S point.30min is except that matched group after the administration in the 14th day, and mouse peritoneal injection 2mg/kg scopolamine hydrobromide is made memory represents obstacle model.30min tests after the modeling, and mice begins swimming, misregistration number of times (entering the number of times of cecum) and incubation period (being swum over to the time of step by the S point) by the S point.
3.2.6 statistical method
Carry out non parametric tests with the spss11.5 statistical software.
3.3 experimental result
Compare model group mice swimming prolongation of latency (P＜0.01) with the blank group.Compare huperzine A group mice swimming shortening incubation period (P＜0.01) with model group.Medicine 5.6g crude drug of the present invention/kg group shortening incubation period (P＜0.05).The results are shown in Table 6.
Table 6 medicine of the present invention to scopolamine cause the influence that mouse memory reproduces obstacle (
N=12)
Annotate: compare △ △ P＜0.01 with the blank group;
Compare with model control group,
*P＜0.05,
*P＜0.01
3.4 conclusion
Name medicine of the present invention has the effect that improves the mouse memory obstacle that scopolamine causes.
In addition, cause mouse memory at scopolamine and reproduce in the obstacle model, medicine 5.6g crude drug of the present invention/kg group mice swimming shortening incubation period.Cause in the mouse memory acquired disturbance model medicine 5.6g crude drug of the present invention/kg group and 2.8g crude drug/kg group mice swimming shortening incubation period at scopolamine.Illustrate that medicine of the present invention has the enhancement memory effect.
In mice swimming with a load attached to the body experiment, medicine 5.6g crude drug of the present invention/kg group mice swimming time prolongs, and medicine 2.8g crude drug/kg of the present invention, 1.4g crude drug/kg group have the trend that prolongs swimming time, be respectively 25.5% and 11.3%.In the transfer rod experiment, medicine 5.6,2.8 of the present invention, 1.4g crude drug/kg group all have the trend that prolongs the transfer rod time, are respectively 93.6%, 55.9% and 3.0%.Illustrate that medicine of the present invention has certain antifatigue effect.
Medicine 5.6g crude drug of the present invention in turning round body experiment/kg group mice turn round the body prolongation of latency, turn round the body number of times and reduce, 2.8g crude drug/kg group mice turn round the body prolongation of latency, turn round the body number of times and reduce.The threshold of pain of medicine 2.8g crude drug of the present invention in the hot plate experiment/kg group mice prolongs.Illustrate that medicine of the present invention has analgesic activity.
In a word, medicine of the present invention has calmness, hypnosis, promotion memory, resisting fatigue and analgesic activity.
It is 17.0g crude drug/sky (standard body weight 60kg) that medicine of the present invention is recommended clinical using dosage, and drug toxicology test of the present invention confirms that its maximum dosage-feeding is 166.80g crude drug/kg, and mice does not see acute toxic reaction; 5.6,11.2,22.4g crude drug/kg continuous irrigation stomach 3 months, rat does not see the overt toxicity reaction, can recommend clinical use.
The specific embodiment
Following embodiment is used to illustrate the preparation of medicine of the present invention, but it can not constitute any restriction to scope of the present invention.
Embodiment 1
The preparation of medicinal tablet of the present invention (temporary called after: the invigorating brain and relieving mental uneasiness sheet):
Prescription:
Radix Polygoni Multiflori 200 gram Semen Ziziphi Spinosaes 200 gram Fructus Moris 200 kairine sesames 100 gram Bulbus Liliies 100 grams
The Rhizoma Anemarrhenae 66.7 gram Radix Salviae Miltiorrhizaes 166.7 gram Flos Chrysanthemis 66.7 gram Poria 100 gram Flos Albiziaes 200 grams
Preparation method:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 60% ethanol, heating and refluxing extraction 2 times, add for the first time 10 times of amounts, extracted 2 hours, and added 8 times of amounts for the second time, extracted 1 hour, extracting liquid filtering, merge, decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, get alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 11 times of water gagings and extract 2 times, each 1.5 hours, extracting liquid filtering merged, be concentrated into to measure relative densities at 60 ℃ and be about 1.10-1.15, the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
D) step c) gained Bulbus Lilii fine powder is added in the spray-drying pelleting machine material container, the water extracted immersing paste of step a) gained alcohol-extracted extract and step b) is sprayed into, spray granulation behind the granulate, adds 0.5% magnesium stearate, mixing, and tabletting, coating, promptly.
Embodiment 2
The preparation of medicine capsule of the present invention:
Prescription:
Radix Polygoni Multiflori 158 gram Semen Ziziphi Spinosaes 270 gram Fructus Moris 165 kairine sesames 135 gram Bulbus Liliies 80 grams
The Rhizoma Anemarrhenae 110 gram Radix Salviae Miltiorrhizaes 125 gram Flos Chrysanthemis 118 gram Poria 80 gram Flos Albiziaes 280 grams.
Preparation method:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 6 times of amount 30% ethanol, heating and refluxing extraction 3 times, each 3 hours, extracting liquid filtering merges decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, gets alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 10 times of water gagings and extract 3 times, extracted 3 hours at every turn, extracting solution filters, and merges, be concentrated into to measure relative densities at 60 ℃ and be about 1.10-1.15, the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
D) with the water extracted immersing paste and the step c) gained Bulbus Lilii fine powder drying and granulating of step a) gained alcohol-extracted extract and step b), behind the granulate, add suitable adjuvant, mixing, filled capsules, promptly.
Embodiment 3
The preparation of drug powder of the present invention:
Prescription:
Radix Polygoni Multiflori 265 gram Semen Ziziphi Spinosaes 147 gram Fructus Moris 250 kairine sesames 81 gram Bulbus Liliies 158 grams
The Rhizoma Anemarrhenae 55 gram Radix Salviae Miltiorrhizaes 188 gram Flos Chrysanthemis 50 gram Poria 145 gram Flos Albiziaes 170 grams.
Preparation method:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 12 times of amount 70% ethanol, heating and refluxing extraction 2 times, each 2 hours, extracting liquid filtering merges decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, gets alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 15 times of water gagings and extract 2 times, extracted 2 hours at every turn, extracting solution filters, and merges, be concentrated into to measure relative densities at 60 ℃ and be about 1.10-1.15, the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
D) with the water extracted immersing paste and the step c) gained Bulbus Lilii fine powder drying and crushing of step a) gained alcohol-extracted extract and step b), promptly.
Embodiment 4
The preparation of medicine oral liquid of the present invention:
Prescription:
Radix Polygoni Multiflori 225 gram Semen Ziziphi Spinosaes 163 gram Fructus Moris 220 kairine sesames 83 gram Bulbus Liliies 113 grams
The Rhizoma Anemarrhenae 50 gram Radix Salviae Miltiorrhizaes 190 gram Flos Chrysanthemis 45 gram Poria 113 gram Flos Albiziaes 178 grams.
Preparation method:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 10 times of amount 50% ethanol, heating and refluxing extraction 3 hours, extracting liquid filtering, decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, get alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 12 times of water gagings and extracted 3 hours, extracting solution filters, be concentrated into to measure relative densities at 60 ℃ and be about 1.10-1.15, the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
D) the water extracted immersing paste and the step c) gained Bulbus Lilii fine powder of step a) gained alcohol-extracted extract and step b) are made oral liquid according to conventional method, promptly.
Embodiment 5
The preparation of medicinal soft capsule of the present invention:
Prescription:
Radix Polygoni Multiflori 225 gram Semen Ziziphi Spinosaes 163 gram Fructus Moris 220 kairine sesames 83 gram Bulbus Liliies 113 grams
The Rhizoma Anemarrhenae 50 gram Radix Salviae Miltiorrhizaes 190 gram Flos Chrysanthemis 45 gram Poria 113 gram Flos Albiziaes 178 grams.
Preparation method:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 12 times of amount 70% ethanol, heating and refluxing extraction 1.5 hours, extracting liquid filtering merges decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, gets alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 15 times of water gagings and extract 3 times, extracted 1 hour at every turn, extracting solution filters, and merges, be concentrated into to measure relative densities at 60 ℃ and be about 1.10-1.15, the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
D) the water extracted immersing paste and the step c) gained Bulbus Lilii fine powder of step a) gained alcohol-extracted extract and step b) are made soft capsule according to conventional method, promptly.
Embodiment 6
The preparation of bolus of drug of the present invention:
Prescription:
Radix Polygoni Multiflori 165 gram Semen Ziziphi Spinosaes 228 gram Fructus Moris 173 kairine sesames 110 gram Bulbus Liliies 75 grams
The Rhizoma Anemarrhenae 75 gram Radix Salviae Miltiorrhizaes 150 gram Flos Chrysanthemis 78 gram Poria 78 gram Flos Albiziaes 218 grams.
Preparation method:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 8 times of amount 40% ethanol, heating and refluxing extraction 2 times, each 2 hours, extracting liquid filtering merges decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, gets alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 12 times of water gagings and extract 2 times, extracted 1.5 hours at every turn, extracting solution filters, and merges, and is concentrated into 60 ℃ of mensuration relative densities to be about 1.10-1.15, get the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
D) the water extracted immersing paste and the step c) gained Bulbus Lilii fine powder of step a) gained alcohol-extracted extract and step b) are made pill according to conventional method, promptly.
Embodiment 7
The preparation of medicinal tincture of the present invention:
Prescription:
Radix Polygoni Multiflori 158 gram Semen Ziziphi Spinosaes 270 gram Fructus Moris 165 kairine sesames 135 gram Bulbus Liliies 80 grams
The Rhizoma Anemarrhenae 110 gram Radix Salviae Miltiorrhizaes 125 gram Flos Chrysanthemis 118 gram Poria 80 gram Flos Albiziaes 280 grams.
Preparation method:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 11 times of amount 60% ethanol, heating and refluxing extraction 3 times, each 1 hour, extracting liquid filtering merges decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, gets alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 14 times of water gagings and extract 3 times, extracted 1.5 hours at every turn, extracting solution filters, and merges, and is concentrated into 60 ℃ of mensuration relative densities to be about 1.10-1.15, get the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
D) the water extracted immersing paste and the step c) gained Bulbus Lilii fine powder of step a) gained alcohol-extracted extract and step b) are made tincture according to conventional method, promptly.
Embodiment 8
The preparation of medical syrup agent of the present invention:
Prescription:
Radix Polygoni Multiflori 265 gram Semen Ziziphi Spinosaes 147 gram Fructus Moris 250 kairine sesames 81 gram Bulbus Liliies 158 grams
The Rhizoma Anemarrhenae 55 gram Radix Salviae Miltiorrhizaes 188 gram Flos Chrysanthemis 50 gram Poria 145 gram Flos Albiziaes 170 grams.
Preparation method:
Make syrup according to a conventional method.
Embodiment 9
The preparation of drug suppository of the present invention:
Prescription:
Radix Polygoni Multiflori 158 gram Semen Ziziphi Spinosaes 270 gram Fructus Moris 165 kairine sesames 135 gram Bulbus Liliies 80 grams
The Rhizoma Anemarrhenae 110 gram Radix Salviae Miltiorrhizaes 125 gram Flos Chrysanthemis 118 gram Poria 80 gram Flos Albiziaes 280 grams.
Preparation method:
Make suppository according to a conventional method.
Embodiment 10
The preparation of medicament gelling agent of the present invention:
Prescription:
Radix Polygoni Multiflori 225 gram Semen Ziziphi Spinosaes 163 gram Fructus Moris 220 kairine sesames 83 gram Bulbus Liliies 113 grams
The Rhizoma Anemarrhenae 50 gram Radix Salviae Miltiorrhizaes 190 gram Flos Chrysanthemis 45 gram Poria 113 gram Flos Albiziaes 178 grams.
Preparation method:
Make gel according to a conventional method.
Embodiment 11
The preparation of medicament spraying agent of the present invention:
Prescription:
Radix Polygoni Multiflori 225 gram Semen Ziziphi Spinosaes 163 gram Fructus Moris 220 kairine sesames 83 gram Bulbus Liliies 113 grams
The Rhizoma Anemarrhenae 50 gram Radix Salviae Miltiorrhizaes 190 gram Flos Chrysanthemis 45 gram Poria 113 gram Flos Albiziaes 178 grams.
Preparation method:
Make spray according to a conventional method.
Embodiment 12
The preparation of drug injection of the present invention:
Prescription:
Radix Polygoni Multiflori 165 gram Semen Ziziphi Spinosaes 228 gram Fructus Moris 173 kairine sesames 110 gram Bulbus Liliies 75 grams
The Rhizoma Anemarrhenae 75 gram Radix Salviae Miltiorrhizaes 150 gram Flos Chrysanthemis 78 gram Poria 78 gram Flos Albiziaes 218 grams.
Preparation method:
Make injection according to a conventional method.
Claims (10)
1. the medicine of a Cure for insomnia is characterized in that being being made by the crude drug of following weight portion ratio:
Radix Polygoni Multiflori 150-270 Semen Ziziphi Spinosae 145-275 Fructus Mori 160-255 Ganoderma 80-135
Bulbus Lilii 75-160 Rhizoma Anemarrhenae 50-110 Radix Salviae Miltiorrhizae 120-200 Flos Chrysanthemi 45-120
Poria 75-145 Flos Albiziae 165-288.
2. medicine according to claim 1, the weight portion ratio of its crude drug is:
Radix Polygoni Multiflori 158 Semen Ziziphi Spinosaes 270 Fructus Moris 165 Ganodermas 135 Bulbus Liliies 80
The Rhizoma Anemarrhenae 110 Radix Salviae Miltiorrhizaes 125 Flos Chrysanthemis 118 Poria 80 Flos Albiziaes 280.
3. medicine according to claim 1, the weight portion ratio of its crude drug is:
Radix Polygoni Multiflori 265 Semen Ziziphi Spinosaes 147 Fructus Moris 250 Ganodermas 81 Bulbus Liliies 158
The Rhizoma Anemarrhenae 55 Radix Salviae Miltiorrhizaes 188 Flos Chrysanthemis 50 Poria 145 Flos Albiziaes 170.
4. medicine according to claim 1, the weight portion ratio of its crude drug is:
Radix Polygoni Multiflori 225 Semen Ziziphi Spinosaes 163 Fructus Moris 220 Ganodermas 83 Bulbus Liliies 113
The Rhizoma Anemarrhenae 50 Radix Salviae Miltiorrhizaes 190 Flos Chrysanthemis 45 Poria 113 Flos Albiziaes 178.
5. medicine according to claim 1, the weight portion ratio of its crude drug is:
Radix Polygoni Multiflori 165 Semen Ziziphi Spinosaes 228 Fructus Moris 173 Ganodermas 110 Bulbus Liliies 75
The Rhizoma Anemarrhenae 75 Radix Salviae Miltiorrhizaes 150 Flos Chrysanthemis 78 Poria 78 Flos Albiziaes 218.
6. medicine according to claim 1, the weight portion ratio of its crude drug is:
Radix Polygoni Multiflori 200 Semen Ziziphi Spinosaes 200 Fructus Moris 200 Ganodermas 100 Bulbus Liliies 100
The Rhizoma Anemarrhenae 66.7 Radix Salviae Miltiorrhizaes 166.7 Flos Chrysanthemis 66.7 Poria 100 Flos Albiziaes 200.
7. according to the arbitrary described pharmaceutical preparation of claim 1-6, it is characterized in that this pharmaceutical dosage form is capsule, tablet, powder, oral liquid, soft capsule, pill, tincture, syrup, suppository, gel, spray or injection.
8. according to the active component of the arbitrary described medicine of claim 1-6, it is characterized in that the active component of this medicine is made by the following step:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 6-12 and doubly measure 30%-70% ethanol, heating and refluxing extraction 1-3 time, each 1-3 hour, extracting liquid filtering merged, decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, gets alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 10-15 times of water gaging and extract 1-3 time, extracted 1-3 hour at every turn, extracting solution filters, and merges, and is concentrated into 60 ℃ of mensuration relative densities to be about 1.10-1.15, get the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
The water extracted immersing paste of step a) gained alcohol-extracted extract and step b) and step c) gained Bulbus Lilii fine powder constitute the active component of this medicine jointly.
9. the preparation method of the described medicine of claim 7 is characterized in that may further comprise the steps:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 6-12 and doubly measure 30%-70% ethanol, heating and refluxing extraction 1-3 time, each 1-3 hour, extracting liquid filtering merged, decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, gets alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 10-15 times of water gaging and extract 1-3 time, extracted 1-3 hour at every turn, extracting solution filters, and merges, and is concentrated into 60 ℃ of mensuration relative densities to be about 1.10-1.15, get the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
D) with the water extracted immersing paste and the step c) gained Bulbus Lilii fine powder drying and granulating of step a) gained alcohol-extracted extract and step b), behind the granulate, add suitable adjuvant, mixing, tabletting, coating, promptly.
10. according to the preparation method of the described medicine of claim 9, it is characterized in that may further comprise the steps:
A) take by weighing the Semen Ziziphi Spinosae that selects clean Radix Polygoni Multiflori, the Rhizoma Anemarrhenae and select clean coarse crushing in proportion, add 60% ethanol, heating and refluxing extraction 2 times, add for the first time 10 times of amounts, extracted 2 hours, and added 8 times of amounts for the second time, extracted 1 hour, extracting liquid filtering, merge, decompression recycling ethanol, being concentrated into and measuring relative density at 60 ℃ is 1.10-1.15, get alcohol-extracted extract, standby;
B) take by weighing in proportion and select clean Fructus Mori, Poria, Ganoderma, Radix Salviae Miltiorrhizae, Flos Albiziae, Flos Chrysanthemi, add 11 times of water gagings and extract 2 times, each 1.5 hours, extracting liquid filtering merged, be concentrated into to measure relative densities at 60 ℃ and be about 1.10-1.15, the water extracted immersing paste, standby;
C) take by weighing in proportion and select clean Bulbus Lilii, be ground into 100 order powder, standby;
D) step c) gained Bulbus Lilii fine powder is added in the spray-drying pelleting machine material container, the water extracted immersing paste of step a) gained alcohol-extracted extract and step b) is sprayed into, spray granulation behind the granulate, adds 0.5% magnesium stearate, mixing, and tabletting, coating, promptly.
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| CN2009100747023A CN101919962B (en) | 2009-06-10 | 2009-06-10 | Medicine for curing insomnia and preparation method thereof |
| HK11104933.9A HK1150778A1 (en) | 2009-06-10 | 2011-05-19 | A drug for the treatment of insomnia and the process for preparing the same |
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| CN2009100747023A CN101919962B (en) | 2009-06-10 | 2009-06-10 | Medicine for curing insomnia and preparation method thereof |
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| CN101919962B CN101919962B (en) | 2012-01-25 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103385274A (en) * | 2013-06-27 | 2013-11-13 | 吴祥忠 | Pan-fried dumpling made of coarse cereals |
| CN103416753A (en) * | 2013-08-20 | 2013-12-04 | 苏州普纳斯电子有限公司 | Sleep improvement preparation |
| CN104345110A (en) * | 2013-08-08 | 2015-02-11 | 河北以岭医药研究院有限公司 | Content determination method for seven compositions in traditional Chinese medicine composition preparation |
| CN110354200A (en) * | 2019-06-30 | 2019-10-22 | 杨顺平 | Jujube kernel water lily beans |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1238033C (en) * | 2002-10-28 | 2006-01-25 | 河北以岭医药研究院有限公司 | Medicine composition for treating neurasthenia |
| CN1660398B (en) * | 2004-12-23 | 2011-02-16 | 杨雄志 | Combination of medication for treating sleep disorder |
| CN101444583A (en) * | 2008-11-18 | 2009-06-03 | 山西蜀中制药有限公司 | Medicament for curing neurasthenia |
-
2009
- 2009-06-10 CN CN2009100747023A patent/CN101919962B/en active Active
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103385274A (en) * | 2013-06-27 | 2013-11-13 | 吴祥忠 | Pan-fried dumpling made of coarse cereals |
| CN104345110A (en) * | 2013-08-08 | 2015-02-11 | 河北以岭医药研究院有限公司 | Content determination method for seven compositions in traditional Chinese medicine composition preparation |
| CN104345110B (en) * | 2013-08-08 | 2017-06-16 | 河北以岭医药研究院有限公司 | Seven kinds of content assaying methods of composition in a kind of Chinese medicinal composition preparation |
| CN103416753A (en) * | 2013-08-20 | 2013-12-04 | 苏州普纳斯电子有限公司 | Sleep improvement preparation |
| CN110354200A (en) * | 2019-06-30 | 2019-10-22 | 杨顺平 | Jujube kernel water lily beans |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101919962B (en) | 2012-01-25 |
| HK1150778A1 (en) | 2012-01-13 |
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