CN102793767B - Radix notoginseng pharmaceutical composition for treating insomnia as well as preparation method and application of pharmaceutical composition - Google Patents
Radix notoginseng pharmaceutical composition for treating insomnia as well as preparation method and application of pharmaceutical composition Download PDFInfo
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Abstract
The invention discloses a radix notoginseng pharmaceutical composition for treating insomnia and a preparation method and application of the pharmaceutical composition. The pharmaceutical composition comprises the following components in parts by weight: 40-80 parts of radix notoginseng, 2-10 parts of lotus plumule, 2-10 parts of pearl powder, 1-5 parts of cinnamon, 50-150 parts of schisandra chinensis and 100-300 parts of fried spina date seeds. The method comprises the procedures of raw material preparation, extract preparation, powder preparation and mixing. Medically acceptable carriers and/or excipients are added in the pharmaceutical composition to prepare pills, ointment, sublimed preparations, tablets, capsules, oral liquid, powder and granules. The pharmaceutical composition is applied to preparation of food or medicaments for improving and/or treating insomnia. The pharmaceutical composition is reasonable in components, simple and convenient to prepare and definite in curative effect. Toxicity tests in mice and sleeping function tests show the pharmaceutical composition does not have toxic or side effect, has obvious effects of improving and treating insomnia and also has the effect of reducing blood sugar in an aided manner.
Description
Technical field
The invention belongs to biological pharmacy technical field, be specifically related to a kind of reasonable recipe, prepare easy, determined curative effect, notoginseng medicine composition of the treatment of insomnia patients having no side effect and preparation method thereof and application.
Background technology
Insomnia is due to feelings will, diet internal injury, or after being ill and old, innate deficiency, the causes of disease such as timidness due to deficiency of the heart, cause lack of preservation of spirit or irritability, thereby cause often can not obtaining the class disease that ortho sleep is feature.Insomnia has become commonly encountered diseases, has 12% ~ 15% people to have serious sleep disorder in advanced industrial country, has more than 10% patient to be repeatedly subject to the torment of this disease.According to World Health Organization's investigation, 27% people has sleep disorder.A survey result of announcing according to psychiatry branch of Chinese Medical Association shows: China has the people of four one-tenth half to have insomnia.Insomnia is one of common clinical disease, though do not belong to critical illness, hinders people orthobiosis, work, study and health, and can increase the weight of or bring out the diseases such as cardiopalmus, the thoracic obstruction, dizzy, headache, apoplexy.
Insomnia's Chinese medicine is referred to as " being insomnia ", and the traditional Chinese medical science is controlled debate from liver and demonstrate,proved common typing and have that excessive rising of liver-YANG, stagnation of liver-QI stasis blocking, pathogenic fire derived from stagnation of liver-QI (wind), stagnation of liver-QI are violated stomach (perverse and unreasonable manner), the anti-heart of stagnation of liver-QI, liver is high suffers from a deficiency of the kidney.Since ancient times, China's traditional Chinese medical science is accumulating rich experience aspect control insomnia, thinks that insomnia is relevant with cold, hot, empty, the real imbalance of the heart, liver,spleen,kidney, stomach, during treatment, internal organs is carried out to determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs.In clinical application, have and take replenishing blood for nourishing heart and calm the nerves as the king of major function and mend a day ball, ANSHEN BUXIN WAN; Take GUIPI WAN, the mind-easing tonic bolus with arborvitate seed filling blood as main; Take kidney tonifying supplementing the brain as main tonifying kidneys and nourishing brain ball, anshen yinao wan; Take stomach function regulating as the main warm gallbladder ball of calming the nerves; Take important city suppressing the hyperactive liver as main NAOLIQING WAN, Cinnabar Sedative Pill; Take purging liver-fire as the main prescriptions such as eliminating pathogen in the liver Anshen Wan, but also have the deficiencies such as drug effect is slow, DeGrain, flavour of a drug are numerous and jumbled, cost is higher, part contains the noxious substances such as cinnabar, curative effect is unstable.
At present, conventional as barbiturates, Benzodiazepines and other non-barbiturates etc. are calm, the western medicine insomnia of hypnosis clinically, there is drug resistance, dependency, addiction and occur ataxia, the untoward reaction such as forgetful in this type of medicine long-term taking, and Liver and kidney is had to infringement in various degree.
For the medicine of current improvement and treatment of insomnia patients or the defect that health food drug effect is slow, uncertain therapeutic efficacy is cut, toxic and side effects is large, the deficiencies such as the drug resistance that particularly Western medicine exists, dependency, addiction, and Chinese medicine is to carry out Coryza Treated by Syndrome Differentiation by adjusting the balance of each systematic function of health, and then improve the physiological function of whole body, and lower than the toxic and side effects of chemical drugs.Therefore, people more wish from Chinese medicine, to search out a kind of can alleviate and the drug effect for the treatment of of insomnia patients soon, the pharmaceutical composition of successful, nontoxic pair or low toxic and side effects.
Summary of the invention
The first object of the present invention is to provide a kind of reasonable recipe, prepare easy, determined curative effect, the notoginseng medicine composition of the treatment of insomnia patients having no side effect, the second object is to provide a kind of preparation method of this pharmaceutical composition, and the 3rd object is to provide a kind of this drug combination preparation; The 4th object is to provide a kind of application of this pharmaceutical composition.
The first object of the present invention is achieved in that described pharmaceutical composition comprises 40～80 parts of weight portion Radix Notoginseng, 2～10 parts of Plumula Nelumbiniss, 2～10 parts of Margarita powder, 1～5 part of Cortex Cinnamomi, 50～150 parts of Fructus Schisandrae Chinensis, 100～300 parts of Semen Ziziphi Spinosae (parched)s.
The second object of the present invention is achieved in that and comprises raw material preparation, extractum preparation, preparation, mixing assembly operation, specifically comprises:
A, raw material are prepared: by prescription, Radix Notoginseng, Plumula Nelumbinis, Cortex Cinnamomi, Fructus Schisandrae Chinensis and Semen Ziziphi Spinosae (parched) got the raw materials ready and pulverize respectively, Margarita powder is got the raw materials ready by prescription;
B, extractum preparation: the Radix Notoginseng of getting ready, Fructus Schisandrae Chinensis, Semen Ziziphi Spinosae (parched) are inserted in extraction vessel, add the alcoholic solution that 4～12 times of weight concentrations are 60～90%, extract 1～5 time, each 0.5～4h obtains leachate, merge extractive liquid, also filters, the concentrated extractum that obtains relative density 1.15～1.40 of filtrate, is dried and pulverizes, crosses 40～200 mesh sieves and obtain extract powder;
C, preparation: the Plumula Nelumbinis of getting ready, Cortex Cinnamomi are crossed respectively to 40～200 mesh sieves and mix to such an extent that mixed powder is standby;
D, mixing assembly: Margarita powder, extract powder and mixed powder are mixed and make object pharmaceutical composition.
The 3rd object of the present invention is achieved in that and in described pharmaceutical composition, adds medically acceptable carrier and/or excipient to make pharmaceutical preparation.
The 4th object of the present invention is achieved in that described pharmaceutical composition improves and/or the food for the treatment of of insomnia patients or the application in medicine in preparation.
Prescription pharmacology foundation of the present invention: Radix Notoginseng is dry root and the rhizome of panax araliaceae plant Panax Notoginseng (Burk.) F.H.Chen.< < Compendium of Materia Medica > > reputation be " Radix Stephaniae Sinicae (Radix Stephaniae Dielsianae) ", be the most precious person of Chinese medicine.Modern medicine study shows, Radix Notoginseng mainly contains Radix Notoginseng total arasaponins, dencichine, flavone, aminoacid, saccharide and various trace element etc., has the myocardial ischemia of improvement, anoxia, blood fat reducing, blood pressure lowering, antithrombotic, shock, fibrosis activity, anti-inflammatory and antalgic, calmness, blood sugar lowering, defying age, enhancing immunity and hepatic cholagogic effect.Radix Notoginseng total arasaponins (PNS), Radix Notoginseng monomer G2Rb1 all have significant sedation, and can work in coordination with the inhibitory action of central depressant, and this central inhibitory action is partly to realize by reducing synaptosomal glutamate content.The pain that PNS, G2Rb1 cause chemical and thermostimulation all has obvious analgesic activity, and PNS is a kind of opioid peptide sample receptor stimulating agent, does not have a side effect of addiction.(Cicero?AF，Vitale?G.，Savion?G.，
et?al.?Panax?notoginseng(Burk)effects?fibrinogen?and?lip?idp?lasma?lever?in?rats?fed?on?a?high2fatdiet[J].?
Phytother.?Res，2003，17:?1742178)
Semen Ziziphi Spinosae, has another name called jujube nucleus, Semen Ziziphi Spinosae etc., has nourishing the liver, mind calming, calms the nerves, the effect of arresting sweating, controls the diseases such as restlessness of asrhenia type and insomnia, palpitation with fear palpitation with a distress feeling, excessive thirst, sweating due to debility.< < Sheng Nong's herbal classic > > carries: " invigorating middle warmer the liver benefiting, hard muscles and bones are helped cloudy gas, and all the merit of Semen Ziziphi Spinosae also." < < Compendium of Materia Medica > > carries, " ripe with treating, insomnia due to insufficiency of the gallbladder-qi, the disease of excessive thirst sweating due to debility for Semen Ziziphi Spinosae; Life is slept well with treating gallbladder-heat, and all foot is fainted cloudy few positive medicine also." Wu Shanglin, Yuan Bingxiang, the impact of inducing sleeping of mice fed Oleum Semen Ziziphi spinosae for ten days [J], northwest pharmacy, 2001, 16(3), 114, research is found, Semen Ziziphi Spinosae oil is by heavy dose of (5.6mg/kg), middle dosage (2.8mg/kg), low dose of (1.4mg/kg) gives the continuous 10d of mouse stomach, test its Sleep latency and the length of one's sleep, result shows, with the comparison of blank group, the Sleep latency of Semen Ziziphi Spinosae line of oils shortens, extend the length of one's sleep, its effect-time dependence analysis shows, with administration time, extend, it is obvious that syngignoscism is tending towards, do not show tolerance phenomenon.
Fructus Schisandrae Chinensis is the dry mature fruit of perennial Magnoliaceae defoliation liana, has that convergence is astringent or styptic treatment for spontaneous sweating, an effect of supplementing QI for promoting the production of body fluid, kidney calming.Fructus Schisandrae Chinensis contains abundant organic acid, vitamin, flavonoid, phytosterol and has the lignan of potent reactivation (as schisandrin, schisandrin B or Fructus Schisandrae Chinensis fat element), is one of minority medical material having concurrently essence, gas, god's three large tonifications.Zhang Linkui, the button heart is virtuous, schisandrin is on the impact of central nervous system's monoamine transmitters [J], Chinese Academy of Medical Sciences's journal, 1991,13(1): 13, research shows, magnolia vine fruit kernel ethanol extraction has central inhibitory action, can extend the length of one's sleep of mice barbital sodium and pentobarbital sodium, reduce autonomic activities, the mice that inhibition electricity irritation or long-term Dan Ju cause enrages behavior; Also further point out the central inhibitory action of magnolia vine fruit kernel ethanol extraction to have necessarily and to contact with dopamine.Other research shows, Fructus Schisandrae Chinensis also has to calm the nerves and protects the liver, resists gastric ulcer and regulate immune effect.
Plumula Nelumbinis is the green plumule in the mature seed kernel of nymphaeaceae plant lotus, has the effect of clearing away heart-fire for tranquillization, restoring normal coordination between the heart and kidney, unsmoothing the sperm and stopping bleeding, for diseases such as heat attacking the pericardium, unconsciousness and delirium, disarmony between the heart and kidney, insomnia seminal emission, heat in blood haematemesis.In clinical practice, Plumula Nelumbinis is applicable to the crowd that slightly has a sleepless night.
Margarita powder is with Margaritas that shell-fish produces such as hydriopsis cumingii, cristaria plicata, pteria martensiis, and grinds the powder forming, and has the effects such as heart tonifying, strong bone, improving eyesight, relieving convulsion, blood pressure lowering, the Fructus Alpiniae Oxyphyllae of calming the nerves, strong body lengthen one's life, skin maintenance, heat-clearing and toxic substances removing.< < Pharmacopoeia of People's Republic of China > > and < < Chinese medicine voluminous dictionary > > also indicate: Margarita has the effects such as the arresting convulsion of calming the nerves, improving eyesight removing nebula, removing toxic substances and promoting granulation.
Cortex Cinnamomi is the bark of canella Cortex Cinnamomi Cinnamomum cassia Presl, have mend that fire is supporing yang, the effect of let the fire back to its origin, dispersing cold for relieving pain, promoting blood circulation to restore menstrual flow, be usually used in that stomach abdomen cold type of pain, deficiency and coldness are had loose bowels, the disease such as insufficiency of kidney-YANG, arthralgia due to cold lumbago, lung cold are breathed with cough, amenorrhea and mass in the abdomen.Its main component of Cortex Cinnamomi is cinnamic aldehyde, research shows, cinnamic aldehyde has obvious sedation to mice, shows as spontaneous activity and reduces, and can resist the hyperactivity due to methamphetamine, the movement disorder that rotating stick test produces, extend the anesthesia duration of ciclobarbital soluble.
Radix Notoginseng, Plumula Nelumbinis, Margarita powder, Cortex Cinnamomi, Fructus Schisandrae Chinensis, Semen Ziziphi Spinosae (parched) are conventional Chinese medicine, there is in the prior art ingredients separately or part and other medical material compatibility are applied to improve and the report for the treatment of of insomnia patients, but Six-element recurrence due to taking drug side has no report for improvement and treatment of insomnia patients thus, and particularly prescription proportioning of the present invention has no report especially.In pharmaceutical composition medical material of the present invention, Plumula Nelumbinis and Cortex Cinnamomi are share, can let the fire back to its origin, and the heart-fire of restriction rising, plays the effect of tranquillizing and allaying excitement; Margarita powder is assisted Plumula Nelumbinis tranquilizing mind; Fructus Schisandrae Chinensis and Semen Ziziphi Spinosae two medicines share, sour and sweet drugs can transforme into YIN, YIN nourishing mind calming.In addition,, according to the viewpoint of old maxim " the many blood stasis of persistent ailment ", long-term intractable insomnia can be controlled from stasis of blood opinion, therefore Radix Notoginseng plays the merit of promoting blood circulation to remove obstruction in the collateral in we.In a word, pharmaceutical composition of the present invention is controlled from this, recuperates under medical treatment emphatically internal organs and negative and positive of qi and blood thereof, by restoring normal coordination between the heart and kidney, YIN nourishing mind calming, promoting blood circulation to remove obstruction in the collateral, makes QI and blood and smooth, and it is normal that function is recovered, and the mind is kept house, and insomnia can be healed.Meanwhile, reasonable recipe of the present invention, prepare easy, determined curative effect, through mice toxicological test, safety is secure, long-term taking has no side effect.Through mice sleep function test, alleviation and treatment of insomnia patients drug effect are fast, successful.
Accompanying drawing explanation
Fig. 1 is pharmaceutical composition extraction process schematic diagram of the present invention.
The specific embodiment
Below the present invention is further illustrated, but never in any form the present invention is limited, any conversion of doing based on training centre of the present invention, all falls into protection scope of the present invention.
Notoginseng medicine composition of the present invention, described pharmaceutical composition comprises 40～80 parts of weight portion Radix Notoginseng, 2～10 parts of Plumula Nelumbiniss, 2～10 parts of Margarita powder, 1～5 part of Cortex Cinnamomi, 50～150 parts of Fructus Schisandrae Chinensis, 100～300 parts of Semen Ziziphi Spinosae (parched)s.
Described pharmaceutical composition comprises 50～70 parts of weight portion Radix Notoginseng, 4～8 parts of Plumula Nelumbiniss, 4～8 parts of Margarita powder, 1～4 part of Cortex Cinnamomi, 70～130 parts of Fructus Schisandrae Chinensis, 140～260 parts of Semen Ziziphi Spinosae (parched)s.
Described pharmaceutical composition comprises 55～65 parts of weight portion Radix Notoginseng, 5～7 parts of Plumula Nelumbiniss, 5～7 parts of Margarita powder, 1～3 part of Cortex Cinnamomi, 85～115 parts of Fructus Schisandrae Chinensis, 180～220 parts of Semen Ziziphi Spinosae (parched)s.
The preparation method of pharmaceutical composition of the present invention, comprises raw material preparation, extractum preparation, preparation, mixing assembly operation, specifically comprises:
A, raw material are prepared: by prescription, Radix Notoginseng, Plumula Nelumbinis, Cortex Cinnamomi, Fructus Schisandrae Chinensis and Semen Ziziphi Spinosae (parched) got the raw materials ready and pulverize respectively, Margarita powder is got the raw materials ready by prescription;
B, extractum preparation: the Radix Notoginseng of getting ready, Fructus Schisandrae Chinensis, Semen Ziziphi Spinosae (parched) are inserted in extraction vessel, add the alcoholic solution that 4～12 times of weight concentrations are 60～90%, extract 1～5 time, each 0.5～4h obtains leachate, merge extractive liquid, also filters, the concentrated extractum that obtains relative density 1.15～1.40 of filtrate, is dried and pulverizes, crosses 40～200 mesh sieves and obtain extract powder;
C, preparation: the Plumula Nelumbinis of getting ready, Cortex Cinnamomi are crossed respectively to 40～200 mesh sieves and mix to such an extent that mixed powder is standby;
D, mixing assembly: Margarita powder, extract powder and mixed powder are mixed and make object pharmaceutical composition.
Described being extracted in ultrasonic extraction, electromagnetic wave extraction or microwave extraction tank completes.
Described concentratedly take that distilling under reduced pressure is concentrated, one or more in membrance concentration or centrifugal concentrating.
Described dryly take lyophilization, drying under reduced pressure, drying with water bath, forced air drying, spraying is dry or microwave drying in one or more.
Pharmaceutical preparation of the present invention adds medically acceptable carrier and/or excipient to make in described pharmaceutical composition; Described carrier comprises liposome, nanocapsule, beta-schardinger dextrin-inclusion, microspheres agent and magnetic microsphere, agar polysaccharide globule etc., and described excipient comprises adhesive, filler, disintegrating agent, lubricant, antiseptic, antioxidant, correctives, aromatic, cosolvent, emulsifying agent, solubilizing agent, osmotic pressure regulator, coloring agent etc.
Described preparation comprises pill, unguentum, sublimed preparation, tablet, capsule, oral liquid, powder, electuary.
Pharmaceutical composition of the present invention improves and/or the food for the treatment of of insomnia patients or the application in medicine in preparation.
embodiment 1:
Radix Notoginseng 400g, Fructus Schisandrae Chinensis 500g and Semen Ziziphi Spinosae (parched) 1000g are crushed to 1mm postposition to be entered in microwave container, adding 228000g concentration is 60% alcoholic solution, natural immersion 4h, obtain leachate, repeat to extract 5 times, merge extractive liquid, filter then, filtrate is 1.15 extractum through the concentrated relative density that obtains of distilling under reduced pressure, extractum, through lyophilization pulverizing, is crossed 40 mesh sieves and is obtained extract powder.More than Plumula Nelumbinis 20g and Cortex Cinnamomi 10g are crushed to 80 orders, cross 40 mesh sieves, mix and obtain mixed powder.The extract powder of gained, mixed powder and Margarita powder 20g are mixed, obtain pharmaceutical composition of the present invention.
embodiment 2:
Radix Notoginseng 8kg, Fructus Schisandrae Chinensis 15kg and Semen Ziziphi Spinosae (parched) 30kg are crushed to 10mm postposition to be entered in ultrasonic container, adding 212kg concentration is 90% alcoholic solution, ultrasonic-leaching 0.5h, then filter leachate and obtain filtrate, it is 1.4 extractum that filtrate obtains relative density through the membrance concentration of 500 molecular weight, extractum, through drying under reduced pressure pulverizing, is crossed 80 mesh sieves and is obtained extract powder.Plumula Nelumbinis 20g and Cortex Cinnamomi 10g are crushed to 200 orders, cross 160 mesh sieves, mix and obtain mixed powder.The extract powder of gained, mixed powder and Margarita powder 20g are mixed, obtain pharmaceutical composition of the present invention.
embodiment 3:
Radix Notoginseng 200g, Fructus Schisandrae Chinensis 280g and Semen Ziziphi Spinosae (parched) 560g are crushed to 5mm postposition to be entered in microwave container, adding 10400g concentration is 80% alcoholic solution, microwave lixiviate 1h, obtain leachate, repeat to extract 2 times, merge extractive liquid, filter then, it is 1.35 extractum that filtrate obtains relative density through centrifugal concentrating, extractum is dried and pulverizes through the spraying of 120 ℃ of air inlets, 50 ℃ of air outlets, crosses 40 mesh sieves and obtains extract powder.Plumula Nelumbinis 16g and Cortex Cinnamomi 4g are crushed to 100 orders, cross 80 mesh sieves, mix and obtain mixed powder.The extract powder of gained, mixed powder, Margarita powder 16g and sucrose are mixed, make according to a conventional method electuary.
embodiment 4:
After being crushed to 2.5mm, Radix Notoginseng 350g, Fructus Schisandrae Chinensis 650g and Semen Ziziphi Spinosae (parched) 1300g insert in electromagnetic wave container, adding 13800g concentration is 65% alcoholic solution, electromagnetic wave lixiviate 1.5h, obtain leachate, repeat to extract 3 times, merge extractive liquid, filter then, it is 1.2 extractum that filtrate obtains relative density through concentrating under reduced pressure, extractum is dried and pulverizes through the spraying of 180 ℃ of air inlets, 100 ℃ of air outlets, crosses 150 mesh sieves and obtains extract powder.Plumula Nelumbinis 40g and Cortex Cinnamomi 20g are crushed to 150 orders, cross 120 mesh sieves, mix and obtain mixed powder.The extract powder of gained, mixed powder, Margarita powder 40g and Mel, antibacterial, water etc. are mixed, make according to a conventional method oral liquid.
embodiment 5:
Radix Notoginseng 550g, Fructus Schisandrae Chinensis 850g and Semen Ziziphi Spinosae (parched) 1800g are crushed to 7.5mm postposition to be entered in ultrasonic container, adding 28800g concentration is 75% alcoholic solution, ultrasonic-leaching 2h, obtain leachate, repeat to extract 4 times, merge extractive liquid, filter then, it is 1.25 extractum that filtrate obtains relative density through centrifugal concentrating, extractum, through forced air drying pulverizing, is crossed 200 mesh sieves and is obtained extract powder.Plumula Nelumbinis 50g and Cortex Cinnamomi 10g are crushed to 250 orders, cross 200 mesh sieves, mix and obtain mixed powder.By the extract powder of gained, mixed powder, Margarita powder 50g and starch, Mel etc., make according to a conventional method pill.
embodiment 6:
Radix Notoginseng 6.5kg, Fructus Schisandrae Chinensis 11.5kg and Semen Ziziphi Spinosae (parched) 22kg are crushed to 2mm postposition to be entered in ultrasonic container, adding 280kg concentration is 85% alcoholic solution, ultrasonic-leaching 3h, obtain leachate, repeat to extract 2 times, then merge leachate and filter, it is 1.3 extractum that filtrate obtains relative density through concentrating under reduced pressure, extractum is dried and pulverizes through the spraying of 160 ℃ of air inlets, 80 ℃ of air outlets, crosses 120 mesh sieves and obtains extract powder.Plumula Nelumbinis 7kg and Cortex Cinnamomi 3kg are crushed to 200 orders, cross 150 mesh sieves, mix and obtain mixed powder.The extract powder of gained, mixed powder, Margarita powder 7kg and corn starch, sucrose, calcium carbonate, sodium carboxymethyl cellulose etc. are mixed, make according to a conventional method tablet.
embodiment 7:
Radix Notoginseng 600g, Fructus Schisandrae Chinensis 1000g and Semen Ziziphi Spinosae (parched) 2000g are crushed to 5mm postposition to be entered in ultrasonic container, adding 28800g concentration is 70% alcoholic solution, ultrasonic-leaching 1h, obtain leachate, repeat to extract 3 times, then merge leachate and filter, it is 1.30 extractum that filtrate obtains relative density through centrifugal concentrating, extractum is dried and pulverizes through the spraying of 150 ℃ of air inlets, 60 ℃ of air outlets, crosses 100 mesh sieves and obtains extract powder.Plumula Nelumbinis 60g and Cortex Cinnamomi 20g are crushed to 120 orders, cross 100 mesh sieves, mix and obtain mixed powder.By the extract powder of gained, mixed powder and according to elutriation, make the Margarita powder 60g of fine powder and dextrin 1700g up to specification mixes, make according to a conventional method hard capsule.
embodiment 8:
Radix Notoginseng 5kg, Fructus Schisandrae Chinensis 12kg and Semen Ziziphi Spinosae (parched) 15kg are crushed to 2.5mm postposition to be entered in ultrasonic container, adding 160kg concentration is 80% alcoholic solution, ultrasonic-leaching 2.5h, obtain leachate, repeat to extract 2 times, then merge leachate and filter, it is 1.25 extractum that filtrate obtains relative density through centrifugal concentrating, extractum, through drying with water bath pulverizing, is crossed 180 mesh sieves and is obtained extract powder.Plumula Nelumbinis 0.8kg and Cortex Cinnamomi 0.3kg are crushed to 200 orders, cross 180 mesh sieves, mix and obtain mixed powder.The extract powder of gained, mixed powder, Margarita powder 0.3kg and edible corn starch up to specification are mixed, make according to a conventional method soft capsule.
test example 1: toxicity test
1 material
1.1 medicines: Yunnan Yun Yao Science and Technology Co., Ltd. entrusts the capsule of producing, and specification is 0.4g/ grain, batch number: 20100710.Putting shady and cool dry and comfortable ventilation preserves.Human oral recommends consumption for everyone (adult) every day 2 times, and each 3, become body weight for humans to press 60kg calculating, amounting to dosage is 40 mg/kg BW.
1.2 animals: the healthy Kunming mouse of SPF level is bred by Guangxi Medical University's Experimental Animal Center, laboratory animal production licence number: SCXK(osmanthus) 2009-0002, the Quality of Experimental Animals quality certification number: 0001564; SD kind rat is bred by Guangdong Medical Lab Animal Center, laboratory animal production licence number: SCXK(Guangdong) 2008-0002, the Quality of Experimental Animals quality certification number: 0072338.Laboratory animal occupancy permit number: SYXK(osmanthus) 2007-0003.Laboratory animal room temperature: 22～25 ℃, relative humidity: 55～70%.
2 chmice acute toxicity tests
Adopt maximum dosage-feeding test method(s), select 20 of the Kunming mouses of body weight 18～22g, male and female half and half.Animal fasting 16h before test, does not limit drinking-water.Take 40.0g sample, add pure water to 80mL, mix, be made into 500 mg/mL concentration suspensions, then give animal gavage 3 times (every minor tick 4h), each gavage amount is 0.4mL/20g BW, and adding up to dosage is 30000mg/kg BW.After gavage, observe, record the poisoning manifestations of animal.Weigh weekly once, observe two time-of-weeks, off-test is dissected animal and is carried out gross examination of skeletal muscle.The acute toxicity of pressing toxicity grading standard evaluation tested material is strong and weak.
Table 1 acute toxicity test in mice result
As seen from Table 1, the sample of maximum dosage-feeding (dosage is 30000 mg/kg BW) of take gives after mouse stomach, and growth of animal is good, has no body weight and is affected.Tested mice has been showed no poisoning symptom, observes 14 days without animal dead.Animal, gross examination of skeletal muscle are dissected in off-test, the main organs such as liver,kidney,spleen, the heart, lung, stomach, intestinal are showed no obvious abnormalities change, according to the acute toxicity grading criteria in the check of < < health food and assessment technique standard > > (version in 2003), the acute oral toxicity of this sample belongs to nontoxic level.
3 genetic toxicity tests
3.1 Ames tests
Employing is tested through identifying satisfactory Salmonella typhimurium histidine defect type TA97a, TA98, TA100, tetra-kinds of bacterial strains of TA102.With pure water, sample is made into respectively to 5 concentration of 50,10,2,0.4,0.08 mg/mL as tested solution, after autoclaving (0.103Mpa 20min) is processed, is for experiment.Rat liver microsomes enzyme (S with Polychlorinated biphenyls induction
-9) as Metabolic Activation of Cyclophosphamide.Adopt flat board to mix method, in the top layer culture medium of insulation, add successively 0.1mL test strain enrichment liquid, 0.1mL tested material solution and 0.5mL S
-9mixed liquor (when needs metabolism activation), pours into after mixing on bottom culture medium flat plate.5 test doses are respectively 5000,1000,200,40,8 μ g/ wares, establish from beaming back simultaneously and become contrast, solvent control and the contrast of positive mutagens.From beaming back, become contrast except not adding sample, all the other conditions are identical with sample sets.Solvent control substitutes sample with sterilizing pure water, and all the other conditions are identical with sample sets.The various bacterial strains of each dosage group are all made 3 parallel wares.At 37 ℃, cultivate 48h, count the clump count of every ware.A whole set of test repeats to do twice under the same conditions.If the clump count that return to become of tested material increases to surpass from beaming back and becomes the more than 2 times of clump count, and the person that has dose-response relationship, be the mutagenesis testing positive.
Table 2 Salmonella reversion test result (for the first time)
Note: 1, above result (clump count) is the means standard deviation of 3 plates.
2, positive control: TA97a+S9, TA98+S9, TA100+S9 adopt 2-aminofluorene (dosage is 10 μ g/ wares); TA98-S9 adopts daunorubicin (dosage is 6 μ g/ wares); TA97a-S9, TA102-S9 adopt fenaminosulf (dosage is 50 μ g/ wares); TA100-S9 adopts sodium azide (dosage is 1.5 μ g/ wares); TA102+S9 adopts 1,8-dihydroxyanthraquinone (dosage is 50 μ g/ wares).Table 3 is same.
Table 3 Salmonella reversion test result (for the second time)
Note: above result (clump count) is the means standard deviation of 3 plates.
From table 2, table 3, to TA97a, TA98, TA100, tetra-kinds of test strains of TA102, no matter whether add S
-9, returning of each dosage group of sample becomes clump count all over from beaming back the twice that becomes clump count, also without dose-response relationship, shows that this tested material mutagenesis testing result is negative.
3.2 mouse marrow cell micro nuclear test
Adopt 24h twice per os administration by gavage in interval to test.Selecting body weight is 50 of the Kunming mouses of 25 ~ 30g, is divided at random 5 groups, 10 every group, and male and female half and half.3 dosage of test group are established respectively 10000,5000,2500 mg/kg BW, and with the negative contrast of pure water, the cyclophosphamide (cp) of 40mg/kg BW dosage is made positive control.Take respectively 20.0,10.0,5.0g sample, respectively add pure water to 40mL, mix, be made into 500,250,125 mg/mL concentration suspensions, then press the volume of 0.4mL/20g BW to animal gavage, negative control group is filled with to isopyknic pure water, and positive controls is filled with to isopyknic 2 mg/mL cyclophosphamide solution.After giving for the second time sample, animal is put to death in the dislocation of 6h cervical vertebra, gets bone marrow of sternum and dilutes smear with calf serum, and methanol is fixed, Giemsa dyeing.Under optical microscope, every animal counting 1000 polychromatic erythrocytes (PCE), micronuclear rates, in the PCE permillage containing micronucleus, is counted 200 polychromatic erythrocytes simultaneously, calculates the ratio (PCE/NCE) of polychromatic erythrocyte and mature erythrocyte.Adopt the statistical disposition of Poisson distribution mean relative method.As the micronuclear rates of test group increases than negative control group, and there are obvious dose-response relationship and statistical significance, are positive findings.
The impact of table 4 on mouse Bone marrow cells micronucleus incidence rate
Note: * * represents this group and negative control group comparison, and difference has utmost point significance (P<0.01); Each dosage group of sample and negative control group comparison, there are no significant for difference (P>0.05); Cp is cyclophosphamide.
As seen from Table 4, bone marrow cell micronucleus rate and the negative control group comparison of each dosage group mice of sample, there are no significant for difference (P>0.05), and cyclophosphamide positive controls and negative control group comparing difference have utmost point significance (P<0.01).Having no this sample has damage the medullary cell of mice.
3.3 mouse sperm deformity tests
Selecting body weight is 50 of the Male Kunming strain mice of 25 ~ 35g, is divided at random 5 groups, 10 every group.3 dosage of test group are established respectively 10000,5000,2500 mg/kg BW, and with the negative contrast of pure water, the cyclophosphamide (cp) of 40mg/kg BW dosage is made positive control.Take respectively 20.0,10.0,5.0g sample, respectively add pure water to 40mL, mix, be made into 500,250,125 mg/mL concentration suspensions, then press the volume of 0.4mL/20g BW to animal gavage, negative control group is filled with to isopyknic pure water, and positive controls is filled with to isopyknic 2 mg/mL cyclophosphamide solution.Every day gavage once, continuous 5 days.Last is put to death animal on the 30th day after to sample, gets the sperm smear of epididymis, and methanol is fixed, Yihong dyeing.Under optical microscope, every zoometer counts up to 1000 of whole sperms, calculates rate of teratosperm, adopts χ
2inspection statistics is processed.As the rate of teratosperm of test group increases than negative control group, and there are obvious dose-response relationship and statistical significance, are positive findings.
The impact of table 5 on Sperm Abnormalities of Mice
Note: * * represents this group and negative control group comparison, and difference has utmost point significance (P<0.01); Each dosage group of sample and negative control group comparison, there are no significant for difference (P>0.05); Cp is cyclophosphamide.
As seen from Table 5, sample does not produce obvious change to Sperm Abnormalities of Mice, the rate of teratosperm of each dosage group of sample and negative control group comparison, there are no significant for difference (P>0.05), and cyclophosphamide positive controls and negative control group comparing difference have utmost point significance (P<0.01).Have no this sample mouse sperm is produced to distortion effect.
Three genetic toxicity tests (Salmonella reversion test, mouse marrow cell micro nuclear test, mouse sperm deformity test) result is all negative.
4 rat 30 days feeding trials
4.1 dosage are selected to give mode with tested material: select 80 of SD kind rats, male and female half and half, male Mus body weight 67.5 ± 4.8g, female Mus body weight 64.8 ± 5.4g.Animal is divided into 4 groups at random, i.e. negative control group and 3 test group, 20 every group, male and female half and half.3 test group dosage are made as respectively 2000,3000,4000 mg/kg BW, are equivalent to respectively 50,75,100 times of human body recommended dose.Take respectively 20.0,30.0,40.0g sample, respectively add pure water to 100mL, mix, be made into 200.0,300.0,400.0 mg/mL concentration suspensions, press the volume of 1.0mL/100g BW to corresponding dosage treated animal gavage, negative control group is filled with the pure water to equivalent, every day gavage once, continuously gavage is 30 days.
4.2 experimental techniques: all animals of experimental session give normal diet, single cage is raised, the drinking-water of freely ingesting.Observe activity and the growing state of animal every day, add weekly food 2 times, record, to appetite and surplus appetite, claims weekly body weight one time, calculates weekly food-intake and food utilization.Experiment finishes animal overnight fasting, claims animal body weight on an empty stomach morning next day, then puts to death rat, adopts 2 parts of blood samples, and a blood anticoagulant detects Hb, RBC, WBC and classification, PLT etc. with blood counting instrument; Another part of not anticoagulant of blood separation of serum, detects the projects such as serum AST, ALT, BUN, Cr, TC, TG, Glu, TP, Alb with test kit and automatic clinical chemistry analyzer.After blood sampling, dissect animal, carry out gross examination of skeletal muscle, get the internal organs such as liver, kidney, spleen and testis and weigh, calculate dirty/body ratio, get the internal organs such as liver, kidney, spleen, Stomach duodenum, testis and ovary and carry out histopathologic examination.When each dosage treated animal made to gross examination do not find obvious pathological changes and Biochemical index change, only carry out the histopathological examination of the main organs of high dose group and control animals, as found, centering, low dose group corresponding organ and tissue check pathological changes.
4.3 experimental data statistics: application SPSS statistical software carries out one factor analysis of variance.When statistical analysis, first data are carried out to homogeneity test of variance, if variance is neat, adopt one factor analysis of variance totally to compare, find differences and with Dunnett check, carry out comparing between two between a plurality of dosage groups and matched group mean again.If heterogeneity of variance carries out suitable variable conversion to data, meet after homogeneity test of variance, by the data after conversion, add up; If translation data does not reach the neat requirement of variance yet, use rank test instead and carry out statistical analysis.
4.4 animals generally show: experimental session, and each treated animal growth promoter is good, and having no animal has Deviant Behavior and poisoning manifestations, and each treated animal is all without dead.
The impact of 4.5 samples on rat body weight and food utilization
The results are shown in Table 6 and table 7, with the capsule of 2000,3000,4000 mg/kg BW dosage to rat oral gavage 30 days, experimental session, body weight and total food-intake, food utilization and total foodstuff utilization rate and the matched group comparison weekly of each dosage group male and female Mus of sample, there are no significant for difference (P>0.05), shows that this sample has no significant effect the body weight gain of rat and food utilization.
The impact of table 6 on rat body weight
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
The impact of table 7 on rat total foodstuff utilization rate
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
The impact of 4.6 samples on rat serum conventional index
30 days feeding trials of table 8 finish rat serum conventional index check result
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
30 days feeding trials of table 9 finish rat serum conventional index check result
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
From table 8, table 9, with the capsule of the present invention of 2000,3000,4000 mg/kg BW dosage to rat oral gavage 30 days, each dosage group of sample is female, the hemoglobin of male rat, erythrocyte sum, total white blood cells and classification, platelet count and matched group comparison, there are no significant for difference (P>0.05), shows that this sample has no significant effect the routine blood test index of rat.
The impact of 4.7 samples on rat blood biochemical indicator
The results are shown in Table 10, table 11, with the capsule of the present invention of 2000,3000,4000 mg/kg BW dosage to rat oral gavage 30 days, each dosage group of sample is female, the serum glutamic oxalacetic transaminase of male rat, glutamate pyruvate transaminase, blood urea nitrogen, creatinine, cholesterol, triglyceride, total protein, albumin, blood glucose and matched group comparison, there are no significant for difference (P>0.05), shows that this sample has no significant effect the blood parameters of rat.
30 days feeding trials of table 10 finish rat blood biochemical indicator check result
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
30 days feeding trials of table 11 finish rat blood biochemical indicator check result
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
The impact of 4.8 samples on Rats Organs and Tissues/body weight ratio
The results are shown in Table 12, with the capsule of the present invention of 2000,3000,4000 mg/kg BW dosage to rat oral gavage 30 days, the liver,kidney,spleen of each dosage group rat of sample, male Mus testicular weight regulating liver-QI/body, kidney/body, spleen/body, male Mus testis/body ratio and matched group comparison, there are no significant for difference, shows that this sample has no significant effect the organ weights of rat and internal organs/body weight ratio.
The impact of table 12 on Rats Organs and Tissues/body weight ratio
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
4.9 dissect gross examination of skeletal muscle and histological examination result
Animal finish is dissected in experiment, and each treated animal of gross examination of skeletal muscle is not all found obvious pathological changes, therefore only the main organs of the high dose group of sampling product and negative control treated animal is carried out tissue pathological slice inspection.Result shows, high dose group has the visible slight hepatic cell fattydegeneration of the liver organization of 1 female rats, high dose group has 2 male, matched groups to have 2 visible hepatocyte spotty necrosis of hepatic tissue male and 1 female rats, and two groups all have 1 visible a small amount of cell infiltration in liver portal area male and 1 female rats; High dose group has 1 male and 1 visible a small amount of cell infiltration of Renal Cortex portion interstitial female, that matched group has 1 male rat; Matched group has visible a small amount of cell infiltration under the gastric mucosa of 1 male and 1 female rats.Above lesion tissue belongs to the spontaneous light-duty pathological changes of animal, and the tissue pathologic change degree of two treated animals is similar, therefore can get rid of, is due to sample, and other organs tissue has no histopathology and changes, and shows the above-mentioned organs and tissues harmless effect of this sample to rat.
5 conclusions
The sample of maximum dosage-feeding (dosage is 30000 mg/kg BW) of take gives after mouse stomach, and having no animal has poisoning symptom and death, and acute oral toxicity belongs to nontoxic level.Three genetic toxicity tests (Salmonella reversion test, mouse marrow cell micro nuclear test, mouse sperm deformity test) result is all negative.30 days feeding trials, with 4000,3000, the sample of 3 dosage of 2000mg/kg BW (be equivalent to respectively human body and recommend 100,75,50 times of consumptions) is continuously to rat oral gavage 30 days, experimental session animal growth is good, and the body weight of each dosage group rat, gain in weight, food-intake, food utilization, routine blood test index, blood parameters, organ weights and internal organs/body weight ratio etc. are not all significantly affected; Gross anatomy observation has no the abnormal change relevant with sample with histopathological examination.Results suggest, this sample is fed the every observation index of rat is not produced to toxic and side effects for 30 days.
test example 2: mice sleep function test
1 medicine: with experimental example 1.
2 animals and grouping: 192 of SPF level healthy adult Male Kunming strain mice selecting Guangdong Medical Lab Animal Center breeding, body weight is 18～22 grams, laboratory animal production licence number: SCXK(Guangdong) 2008-0002, the Quality of Experimental Animals quality certification number: 0076554.Every 48 mices are 1 group, totally 4 groups, carry out respectively directly sleep test, the test length of one's sleep of prolongation pentobarbital sodium, pentobarbital sodium sub-threshold dose hypnosis test, the test of barbital sodium Sleep latency.
3 experimental situation conditions: laboratory animal occupancy permit number: SYXK(osmanthus) 2007-0003.Laboratory animal room temperature: 22～25 ℃, relative humidity: 55～70%.
4 dosage are selected and sample treatment: according to the human body of this sample, recommend consumption, if 200,400,800 mg/kg BW(are equivalent to respectively human body and recommend 5,10,20 times of consumption) test group of 3 dosage, establish a negative control group, every group of 12 animals simultaneously.Take respectively 1.0,2.0,4.0g sample, respectively add pure water to 100mL, mix, be made into 10,20,40 mg/mL concentration solution, give respectively corresponding dosage treated animal gavage, gavage volume is 0.2mL/10g BW, and matched group gives isopyknic pure water, every day gavage once, continuously gavage is 30 days.
5 reagent: pentobarbital sodium (lot number: F20090516), barbital sodium (lot number: F20090216), China Medicine's import packing.
6 experimental techniques
6.1 directly sleep tests: observe the sleep quality of mice after giving last sample, surpass to be judged to for 60 seconds enter sleep with the righting reflex loss of animal, righting reflex recovers to be animal awakening.Result X
2statistical analysis is carried out in check.As test group, fall asleep and number of animals and the length of one's sleep increase and have significant difference with negative control group, judge that this result of the test is positive.
The 6.2 prolongation pentobarbital sodium tests length of one's sleep: giving last sample after 20 minutes, each treated animal is through lumbar injection pentobarbital sodium 45mg/kg BW, and injection volume is 0.2mL/20g BW.Can the righting reflex loss of animal of take be index, observe tested material and extend pentobarbital sodium length of one's sleep.Result is carried out statistical analysis with variance analysis.As extended than negative control group the length of one's sleep of test group mice and having statistical significance, judge that this result of the test is positive.
6.3 pentobarbital sodium sub-threshold dose hypnosis tests: giving last sample after 20 minutes, each treated animal is through lumbar injection pentobarbital sodium 30mg/kg BW.Observe the sleep quality of mice in 30 minutes, with 60 seconds above persons of righting reflex loss, for falling asleep, the number of animals of falling asleep of each group of record, calculates the animal incidence rate of falling asleep.Result X
2check analysis.As test group, fall asleep animal incidence rate higher than negative control group and have statistical significance, judging that this result of the test is positive.
6.4 barbital sodium Sleep latency tests: injection volume was 0.2mL/20g BW to each treated animal through lumbar injection barbital sodium 200mg/kg BW in 20 minutes after giving last sample.Take righting reflex loss as index, observe tested material and can shorten barbital sodium Sleep latency.Result is carried out statistical analysis with variance analysis.As the Sleep latency of test group mice shortens than negative control group and has statistical significance, judge that this result of the test is positive.
7 results are judged
If extend the binomial positive in the pentobarbital sodium experiment length of one's sleep, pentobarbital sodium sub-threshold dose hypnosis experiment, three experiments of barbital sodium Sleep latency experiment, and without obviously directly sleep effect, can judge that this given the test agent has the effect of the sleep function of improvement.
8 results
The impact of 8.1 samples on Mouse Weight
Table 13 improves sleep function test mice body weight
Note: sleep I～III group, initial, mid-term of each dosage group mice and latter stage body weight and weightening finish and negative control group comparison, there are no significant for difference (P>0.05).
Table 14 improves sleep function test mice body weight
Note: initial, mid-term of each dosage group mice and latter stage body weight and weightening finish and negative control group comparison, there are no significant for difference (P>0.05).
From table 13, table 14, experiment just, in, latter stage each dosage group of sample Mouse Weight and experimental session weight of mice and negative control group between relatively, there are no significant for difference (P>0.05), show this sample to the body weight gain of mice without influence.
The direct sleep effect of 8.2 samples
As seen from Table 15, per os gives the capsule 30 days of mice various dose, and each dosage group does not all have animal to occur righting reflex loss, and all animals does not all enter sleep state, points out this sample there is no direct inducing mouse sleep effect.
The table 15 mice result of the test of directly sleeping
8.3 samples are on the pentobarbital sodium impact of the length of one's sleep
Table 16 extends the pentobarbital sodium result of the test length of one's sleep
As seen from Table 16, per os gives the capsule 30 days of mice various dose, the length of one's sleep of each dosage group is all than the prolongation of negative control group, and the difference of height, middle dosage group and negative control group has very significant (P<0.01), point out this sample to have and extend the pentobarbital sodium effect of the length of one's sleep.
The impact of 8.4 samples on pentobarbital sodium sub-threshold dose syngignoscism
As seen from Table 17, per os gives the capsule 30 days of mice various dose, the animal of each dosage group falls asleep rate higher than negative control group, and the difference of high dose group and negative control group has significance (P<0.05), point out the pentobarbital sodium of this sample and sub-threshold dose to have collaborative syngignoscism.
Table 17 capsule pentobarbital sodium sub-threshold dose hypnosis result of the test
8.5 samples are on the preclinical impact of barbital sodium hypnosis
Table 18 capsule barbital sodium Sleep latency result of the test
As seen from Table 18, per os gives the capsule 30 days of mice various dose, the Sleep latency of each dosage group is all than the shortening of negative control group, and the difference of each dosage group and negative control group all has significance (P<0.01 or P<0.05), point out this sample to there is the effect of shortening barbital sodium Sleep latency.
9 results are judged
With 200,400,800 mg/kg BW(, being equivalent to human body respectively and recommending 5,10,20 times of consumption) capsule of the present invention of dosage is continuously to mouse stomach 30 days, can extend pentobarbital sodium length of one's sleep, collaborative pentobarbital sodium sub-threshold dose syngignoscism, shorten barbital sodium Sleep latency, without directly sleep effect, on the body weight gain of mice, without impact, point out this sample to there is the function of improving sleep.
Claims (9)
1. a notoginseng medicine composition for treatment of insomnia patients, is characterized in that: described pharmaceutical composition comprises 40 ~ 80 parts of weight portion Radix Notoginseng, 2 ~ 10 parts of Plumula Nelumbiniss, 2 ~ 10 parts of Margarita powder, 1 ~ 5 part of Cortex Cinnamomi, 50 ~ 150 parts of Fructus Schisandrae Chinensis, 100 ~ 300 parts of Semen Ziziphi Spinosae (parched)s;
The preparation method of described pharmaceutical composition comprises preparation, extractum preparation, preparation, mixing assembly operation, specifically comprises:
A, raw material are prepared: by prescription, Radix Notoginseng, Plumula Nelumbinis, Cortex Cinnamomi, Fructus Schisandrae Chinensis and Semen Ziziphi Spinosae (parched) got the raw materials ready and pulverize respectively, Margarita powder is pressed prescription batching;
B, extractum preparation: the Radix Notoginseng of getting ready, Fructus Schisandrae Chinensis, Semen Ziziphi Spinosae (parched) are inserted in extraction vessel, add the alcoholic solution that 4 ~ 12 times of weight concentrations are 60 ~ 90%, extract 1 ~ 5 time, each 0.5 ~ 4h obtains leachate, merge extractive liquid, also filters, the concentrated extractum that obtains relative density 1.15 ~ 1.40 of filtrate, is dried and pulverizes, crosses 40 ~ 200 mesh sieves and obtain extract powder;
C, pulverizing preparation: the Plumula Nelumbinis of getting ready, Cortex Cinnamomi are crossed respectively to 40 ~ 200 mesh sieves and mix to such an extent that mixed powder is standby;
D, mixing assembly: Margarita powder, extract powder and mixed powder are mixed and make object pharmaceutical composition.
2. the notoginseng medicine composition for the treatment of of insomnia patients according to claim 1, is characterized in that: described pharmaceutical composition comprises 50 ~ 70 parts of weight portion Radix Notoginseng, 4 ~ 8 parts of Plumula Nelumbiniss, 4 ~ 8 parts of Margarita powder, 1 ~ 4 part of Cortex Cinnamomi, 70 ~ 130 parts of Fructus Schisandrae Chinensis, 140 ~ 260 parts of Semen Ziziphi Spinosae (parched)s.
3. the notoginseng medicine composition for the treatment of of insomnia patients according to claim 2, is characterized in that: described pharmaceutical composition comprises 55 ~ 65 parts of weight portion Radix Notoginseng, 5 ~ 7 parts of Plumula Nelumbiniss, 5 ~ 7 parts of Margarita powder, 1 ~ 3 part of Cortex Cinnamomi, 85 ~ 115 parts of Fructus Schisandrae Chinensis, 180 ~ 220 parts of Semen Ziziphi Spinosae (parched)s.
4. the notoginseng medicine composition for the treatment of of insomnia patients according to claim 1, is characterized in that: described being extracted in ultrasonic extraction, electromagnetic wave extraction or microwave extraction tank completes.
5. the notoginseng medicine composition for the treatment of of insomnia patients according to claim 1, is characterized in that: described concentratedly take that distilling under reduced pressure is concentrated, one or more in membrance concentration or centrifugal concentrating.
6. the notoginseng medicine composition for the treatment of of insomnia patients according to claim 1, is characterized in that: described dryly take lyophilization, drying under reduced pressure, drying with water bath, forced air drying, spraying is dry or microwave drying in one or more.
7. a pharmaceutical preparation for pharmaceutical composition described in claim 1 ~ 3 any one, is characterized in that: in described pharmaceutical composition, add medically acceptable carrier and/or excipient to make.
8. pharmaceutical preparation according to claim 7, is characterized in that: described preparation comprises pill, unguentum, sublimed preparation, tablet, capsule, oral liquid, powder, electuary.
Pharmaceutical composition described in claim 1 ~ 3 any one preparation improve and/or the food for the treatment of of insomnia patients or medicine in apply.
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| CN101361840A (en) * | 2007-08-12 | 2009-02-11 | 文山壮族苗族自治州三七科学技术研究所 | Health food capsule capable of improving sleep |
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| CN101361840A (en) * | 2007-08-12 | 2009-02-11 | 文山壮族苗族自治州三七科学技术研究所 | Health food capsule capable of improving sleep |
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| Title |
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| 高学敏主编.肉桂、远志.《中药学（第二版）》.中国中医药出版社,2007,240、394页. * |
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