CN102895571B - Chinese medicinal preparation for treating insomnia, method for preparing Chinese medicinal preparation for treating insomnia and application of Chinese medicinal preparation for treating insomnia - Google Patents
Chinese medicinal preparation for treating insomnia, method for preparing Chinese medicinal preparation for treating insomnia and application of Chinese medicinal preparation for treating insomnia Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal preparation for treating insomnia and method for preparing the Chinese medicinal preparation for treating insomnia. The preparation is prepared from fried spina data seed, raw schisandra chinensis, fried fructus hordei germinatus, lilium brownie and poria, the medicinal materials are extracted with ethanol, extract is recycled under a reduced pressure until no ethanol smell, medicinal dregs are decocted with water, the decoction is concentrated and centrifuged, supernatant liquor is continuously concentrated and is mixed with ethanol extracted concentrated liquor, the mixture is concentrated and dried to form extract powder, and an appropriate mount of adjuvants or flavoring agents is added in the extract powder to produce granules, capsules, tablets or pills. Pharmacological tests show that the Chinese medicinal preparation has a good treatment effect on insomnia, and has the effects of relaxing mind and soothing the nerves.
Description
Technical field
The present invention relates to Chinese medicine preparation and preparation method, specifically relate to take Chinese medicine preparation and preparation method and the application thereof of a kind for the treatment of of insomnia patients that Chinese crude drug makes as raw material.
Background technology
Along with the fierceness day by day of social competition, people's work and the quickening of rhythm of life, life style changes, and insomnia's sickness rate constantly raises, and more and more becomes a kind of common, the multiple sleep disorder disease in the modern life.The a statistics of announcing according to China's Ministry of Public Health discloses, and China insomnia number of patients has reached 1,200,000 ~ 2,400,000.
Long-term serious insomnia, all can have a negative impact to body and spirit.Be obstructed because of the secretion of growth hormone the child, affect body growth and grow; Adult's sympathetic hyperfunction, night and metabolism on daytime are increased, and affect functional recovery, weaken the immunocompetence of body, increase the weight of original various body and mental disease.Affect working and learning efficiency, particularly with memory, calculating the ergasia relevant with logical reasoning can be affected.Emotion is dejected, impatient, and then affects inter personal contact and personal lifestyle quality.Do not have enough sleep, greatly increased the generation of contingency.
At first the treatment of insomnia adopts non-drug therapy, comprises Sleep hygiene (daily schedule of rule, comfortable sleep environment etc.), psychotherapy (behavior therapy, time treat mutually etc.), secondly considers to adopt Drug therapy.
In chemical drugs, the barbiturate side effect of early application is large, now less being used.Benzodiazepine is better, safer because of its curative effect, lighter to respiration inhibition, the more difficult formation of toleration comparatively speaking, but this class medicine more or less has the shortcomings such as continuity reaction, withdrawal reaction, dependency and inhibition 3-4 phase sound sleep.The novel Non-benzodiazepine medicine such as zolpidem has overcome the shortcoming of benzodiazepine, is current Europe and U.S. sleeping pill more commonly used.Melatonin belongs to the Non-benzodiazepine medicine, is the short dormancy material of endogenous that body itself exists, and as sleeping pill, its curative effect and mechanism of action are also treated further discussion.Generally, tranquilizing soporific class chemical drugs has inhibitory action widely to the central nervous system, and life-time service nearly all can produce toleration and dependency, can more or less produce the untoward reaction such as withdrawal symptom during drug withdrawal suddenly.
China's Chinese medicine treatment of insomnia patients is with a long history, much Chinese medicine be no matter single medicinal material or compound recipe prescription all to improving insomnia, the treatment neurasthenia, recover tired, calming the nerves nourishes heart etc. all has significant effect.With respect to chemical drugs, it is little that Chinese medicine has side effect, without continuity reaction, withdrawal reaction, dependent advantage.
The Chinese medicine preparation of Cure for insomnia mostly is decoction clinically, so for Su Fen from soup (Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Semen Ziziphi Spinosae, Caulis Polygoni Multiflori, Flos Albiziae, Radix Polygalae, Radix Glycyrrhizae) the treatment deficiency syndrome insomnia good results of intending calming the nerves (Xu Sufen. the soup of calming the nerves treatment 47 examples of being insomnia. practical Chinese medicine magazine, 2006,22 (4): 218 ~ 219).The soup of calming the nerves for Huang Shuling (prescription: Semen Ziziphi Spinosae (parched), Semen Platycladi, Radix Ophiopogonis, Mulberry may, Radix Curcumae, Carapax et Plastrum Testudinis, Concha Margaritifera, Poria Cocos, Fructus Schisandrae Chinensis, CHUANSHAO) the plus-minus treatment, determined curative effect, and can significantly improve patient's the main concomitant symptoms, the raising sleep quality (Huang Shuling. the soup treatment of insomnia patients example of calming the nerves observation of curative effect. the new traditional Chinese medical science, 2005,37 (8): 26 ~ 27).Zheng Shufeng etc. adopt relieving mental strain and helping sleep soup (Semen Ziziphi Spinosae 30g, Caulis Polygoni Multiflori 30g, Cortex Albiziae 20g, Plumula Nelumbinis 3g, Fructus Gardeniae 15g, Fructus Schisandrae Chinensis 15g, Bulbus Lilii 20g, Dens Draconis 20g, Poria cum Radix Pini 20g, Semen Platycladi 15g, Radix Salviae Miltiorrhizae 20g, Radix Angelicae Sinensis 15g, Radix Glycyrrhizae 6g) treatment of insomnia patients 43 examples, obtain good therapeutic effect (Zheng Shufeng, study of the Song Dynasty discrimination. relieving mental strain and helping sleep soup Cure for insomnia 43 examples. practical tcm internal medicine magazine, 2006,20 (1): 58).Wang Changde application is from intending Bulbus Lilii soup (the Bulbus Lilii 20g that calms the nerves, Semen Ziziphi Spinosae 12g, Caulis Polygoni Multiflori 12g, Cortex Albiziae 10g, Radix Salviae Miltiorrhizae 12, Poria cum Radix Pini 10g, Os Draconis 15g, Concha Ostreae 15g, Fructus Schisandrae Chinensis 6g) treatment intractable insomnia, obtain satisfactory effect (Wang Changde. Bulbus Lilii soup treatment intractable insomnia 48 examples of calming the nerves. Jiangxi Chinese medicine, 2005,36 (272): 25).The utilization tonifications such as Long Hong calm the nerves soup (Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Semen Ziziphi Spinosae, Caulis Polygoni Multiflori, Flos Albiziae, each 15g of Rhizoma Acori Graminei, Radix Polygalae, Fructus Schisandrae Chinensis, each 12g of the Radix Rehmanniae, Radix Aucklandiae 10g, Radix Glycyrrhizae 8g) Cure for insomnia, and establish matched group, improve the length of one's sleep (dragon is red, Huang Qidan. the calm the nerves clinical observation of soup Cure for insomnia of tonification. and the Hubei Journal of Traditional Chinese Medicine, 2007,29 (3): 32).
The treatment that market is on sale and the Chinese patent medicine that improves the insomnia have tianwangbuxin pills (composition: the Radix Rehmanniae, Radix Asparagi, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Poria, Semen Platycladi, Semen Ziziphi Spinosae, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Radix Polygalae etc.), Semen Ziziphi Spinosae oral liquid (composition: Semen Ziziphi Spinosae, Radix Glycyrrhizae, the Rhizoma Anemarrhenae, Poria etc.), syrupus schizandrae compositus (composition: Fructus Schisandrae Chinensis, aqueous sodium glycerophosphate, aqueous phosphoglycerol Radix Salviae Miltiorrhizae, potassium, ferric glycerylphosphate), SHENQI WUWEIZI PIAN (composition: Fructus Schisandrae Chinensis, Radix Codonopsis, the Radix Astragali, Semen Ziziphi Spinosae etc.) or capsule, ginseng and schisandra fruit syrup (composition Radix Ginseng, Fructus Schisandrae Chinensis etc.) or electuary, brain-strengthening shenan capsule (Fructus Mori, Radix Polygoni Multiflori Preparata, Rhizoma Chuanxiong, Fructus Schisandrae Chinensis, Flos Albiziae, Semen Ziziphi Spinosae, Arillus Longan), Fructus Schisandrae Chinensis) and syrup etc. Fructus Schisandrae Chinensis granule (composition:, health product have happy Kangping capsule (composition: Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis, Semen Platycladi, Poria, Fructus Crataegi), fragrant dream oral liquid (composition: Fructus Mori, Radix Salviae Miltiorrhizae, Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis), the gold light capsule of board face alive (composition: Radix Ginseng, Semen Ziziphi Spinosae, Radix Asparagi, Fructus Lycii, Colla Plastri Testudinis, Fructus Schisandrae Chinensis, Cortex Cinnamomi, Margarita) etc.
CN0213315.7 discloses a kind of health food that improves sleep, and it is made by Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis, the Radix Paeoniae Alba, Ganoderma, Radix Ginseng; CN0213303.4 discloses a kind of sedative jujube kernel capsule, and it is made by Semen Ziziphi Spinosae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis; CN021166 discloses a kind of formula of medicine preparation Testudinis deer Jiannao Anshen Tablet, and it is made by Carapax Et Plastrum Testudinis, Colla cornus cervi, Radix Ginseng, Semen Ziziphi Spinosae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Radix Polygalae, Medulla Junci; CN93111083.1 discloses a kind of warming gallbladder for tranquilization Chinese medicine preparation, and it is made by Rhizoma Coptidis, Semen Ziziphi Spinosae, Rhizoma Pinelliae, pericarpium citri grandis, Fructus Aurantii Immaturus, Poria, Radix Angelicae Sinensis, the Rhizoma Anemarrhenae, Fructus Schisandrae Chinensis, Rhizoma Acori Graminei, Rhizoma Chuanxiong, Radix Glycyrrhizae, calcium carbonate, starch; CN95111873.0 discloses a kind of tranquillizing and allaying excitement, anti-ageing anti-old oral liquid, and it is made by a certain percentage by Polyhachis vicina Roger, Semen Ziziphi Spinosae, Armillaria mellea cream, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Radix Ginseng, the Radix Astragali, Radix Polygoni Multiflori Preparata, Fructus Lycii; CN200610016094.7 discloses a kind of Chinese medicine composition of returning liver, kidney channel Cure for insomnia, and it is comprised of Fructus Lycii, Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis, Fructus Aurantii Immaturus, Radix Polygoni Multiflori, Fructus Jujubae;
CN200610069992.9 discloses a kind of health food that improves sleep, and it is comprised of Semen Ziziphi Spinosae, the Radix Paeoniae Alba, Poria, Fructus Schisandrae Chinensis, Radix Ginseng; CN200710115445.4 discloses a kind of medicine of Cure for insomnia.It is comprised of Fructus Schisandrae Chinensis, Semen Ziziphi Spinosae, Radix Glycyrrhizae, Poria, Radix Ophiopogonis, the Rhizoma Anemarrhenae; CN200410031359.1 discloses a kind of tranquilizing by nourishing the heart medicine, and it is comprised of Semen Ziziphi Spinosae, Flos Albiziae, Fructus Mori, Fructus Schisandrae Chinensis, Semen Platycladi; CN200310105399.1 discloses a kind of Chinese medicine preparation of Cure for insomnia, and it is comprised of flavour of a drug such as Fructus Mori, Radix Salviae Miltiorrhizae, Semen Ziziphi Spinosae (stir-fry), Caulis et Folium Arachidis hypogaeae, Fructus Schisandrae Chinensis;
CN200510021085.2 discloses the pharmaceutical composition of a kind of nourishing heart-disney, invigorating brain and relieving mental uneasiness, and it is to be that raw material is prepared from by Radix Polygoni Multiflori Preparata, Rhizoma Acori Graminei, Fructus Psoraleae, Fructus Schisandrae Chinensis, Semen Ziziphi Spinosae, Fructus Ligustri Lucidi, bee pollen, Radix Salviae Miltiorrhizae;
CN200710055269.X discloses a kind of for improving the health food of sleep, walnut oil, Fructus Schisandrae Chinensis, Herb Gynostemmae Pentaphylli, Radix Et Caulis Acanthopanacis Senticosi, Semen Ziziphi Spinosae, consists of.
The prescriptions of Chinese medicine of above-mentioned Cure for insomnia is large, flavour of a drug are many, and major part is decoction, uses inconvenience, and market in urgent need is a kind of effective, treatment of insomnia patients Chinese medicine preparation easy to use.
Three, summary of the invention
For the disappearance of the deficiencies in the prior art and similar products, the object of the invention is to provide a kind of Chinese medicine preparation and preparation method and application in pharmacy thereof for the treatment of of insomnia patients.
The present invention is achieved through the following technical solutions:
A kind of Chinese medicine preparation for the treatment of of insomnia patients, extracted and be prepared from by the crude drug of following weight portion proportioning: Semen Ziziphi Spinosae (parched) 100-480 part, Fructus Schisandrae Chinensis 100-400 part, Fructus Hordei Germinatus (parched) 100-480 part, Bulbus Lilii 100-450 part, Poria 100-480 part.
The Chinese medicine preparation of above-mentioned treatment of insomnia patients, with the conventional agent of formulation method granulation, capsule, tablet or pill.
The method of above-mentioned treatment of insomnia patients Chinese medicine preparation, preparation process is as follows: (1) is got Semen Ziziphi Spinosae (parched), Fructus Schisandrae Chinensis, Fructus Hordei Germinatus (parched), Bulbus Lilii, Poria and is added alcohol reflux, and the alcohol extract reclaim under reduced pressure is to without the alcohol flavor, concentrated, obtains alcohol extraction concentrated solution and medicinal residues standby; (2) above-mentioned medicinal residues are decocted with water, decocting liquid filters, after filtrate is concentrated, centrifugal, after supernatant continues to concentrate, with the alcohol extraction concentrated solution of step (1), merges, concentrated, is dried to extract powder; (3) get above-mentioned extract powder and add the agent of appropriate amount of auxiliary materials granulation, capsule, tablet or pill.
The preparation method of the Chinese medicine preparation of above-mentioned treatment of insomnia patients, add amount of alcohol in step (1) and be the 6-24 of medical material weight doubly, and concentration of alcohol is 50-95%, divides 2-3 reflux, extract,, extracts 1-2 hour at every turn.
The preparation method of the Chinese medicine preparation of above-mentioned treatment of insomnia patients, the 6-24 that the middle amount of water of step (2) is medicinal residues weight doubly, divide and decoct for 2 times, each 1-2 hour, collecting decoction, decocting liquid is concentrated into and is equivalent to medical material weight 0.2g/ml-1g/ml, centrifugal, the alcohol extraction concentrated solution of supernatant and step (1) merges, and while in the time of 50 ℃-70 ℃, being concentrated into 50 ℃, relative density is 1.10-1.15,50 ℃ of-70 ℃ of drying under reduced pressure.
The application of the Chinese medicine preparation of above-mentioned treatment of insomnia patients in preparing the Cure for insomnia disease drug.
The Chinese medicine preparation of above-mentioned treatment of insomnia patients improves the application in insomnia's health product in preparation.
Beneficial effect:
1, the present invention contains Semen Ziziphi Spinosae (stir-fry), Fructus Schisandrae Chinensis, Fructus Hordei Germinatus (stir-fry), Bulbus Lilii, Poria Chinese medicine of the five flavours, and modern pharmacological research shows, Semen Ziziphi Spinosae has the effects such as tranquilizing soporific, analgesia, convulsion, enhancing immunologic function.In Fructus Schisandrae Chinensis, the main lignanoids effective ingredient contained not only has stable effect to the central nervous system, and also has anticonvulsant action.Theory of Chinese medical science thinks, in the present invention, to have tranquilizing soporific be monarch drug to Semen Ziziphi Spinosae, and Fructus Schisandrae Chinensis is ministerial drug, astringe the lung, nourishing kidney, promote the production of body fluid, receive antiperspirant, arresting seminal emission, increase the monarch drug sedative-hypnotic effect, but the Fructus Hordei Germinatus dispersing the stagnated live-QI to relieve the stagnation of QI, Bulbus Lilii has the effect of clearing away heart-fire for tranquillization, and Poria has the effect of tranquillizing and allaying excitement, Fructus Hordei Germinatus (stir-fry), Bulbus Lilii, Poria are adjuvant altogether, full side's compatibility, bring out the best in each other, and plays altogether the mind tranquilizing and the heart calming effect.
2, Chinese medicine is mostly decoction at present, and recipe quantity is large, flavour of a drug are many, use inconvenience, and the present invention only uses five kinds of Chinese medicine, and the pharmacodynamic experiment proof has obvious sedative-hypnotic effect.
3, preparation technology is simple, and flavour of a drug are few, cost-saving, and medicine of the present invention can be made into the dosage forms such as granule, capsule, tablet or pill, patient's taking convenience.
4, the present invention shows to have obvious sedative-hypnotic effect through pharmacological tests, be developed to the health product of improvement sleep or the new drug for the treatment of of insomnia patients, its market capacity is large, and economic benefit and social benefit are obvious, and using value is preferably arranged aspect treatment of insomnia patients.
The specific embodiment
Form by the following examples, foregoing of the present invention is described in further detail again, but this should be interpreted as to the scope of the above-mentioned theme of the present invention only limits to following example, all technology realized based on foregoing of the present invention all belong to scope of the present invention.
1,, in conjunction with the specific embodiment, the present invention is further described as follows:
According to the form below, listed weight proportion takes raw material required for the present invention, unit: part
| Sequence number | Semen Ziziphi Spinosae (parched) | Fructus Schisandrae Chinensis | Fructus Hordei Germinatus (parched) | Bulbus Lilii | Poria |
| 1 | 100 | 400 | 100 | 450 | 100 |
| 2 | 150 | 350 | 150 | 400 | 150 |
| 3 | 200 | 300 | 200 | 350 | 200 |
| 4 | 250 | 250 | 250 | 300 | 250 |
| 5 | 300 | 200 | 300 | 200 | 300 |
| 6 | 400 | 150 | 400 | 150 | 400 |
| 7 | 480 | 100 | 480 | 100 | 480 |
Raw medicine of the present invention is all selected the Chinese Pharmacopoeia kind.
2, Preparation Example
Above table Raw proportioning is example, comprises the following steps:
Embodiment 1:
Semen Ziziphi Spinosae (parched) 100g, Fructus Schisandrae Chinensis 400g, Fructus Hordei Germinatus (parched) 100g, Bulbus Lilii 450g, Poria 100g, add 6 times of amount 95% ethanol reflux, extract, at twice, and each 1.0 hours, filter, merge alcohol extract, decompression recycling ethanol also is concentrated into without the alcohol flavor.Medicinal residues add 6 times of water gagings and extract at twice, each 1 hour, collecting decoction, decocting liquid is concentrated into and is equivalent to medical material weight 0.2g/ml, centrifugal, supernatant and above-mentioned alcohol extraction concentrated solution merge, and are concentrated into relative density 1.15 (50 ℃) in the time of 50 ℃, the dry 560g dry extract that obtains of reduced vacuum, get extract powder, soybean oil, Cera Flava, soybean phospholipid appropriate, make soft capsule content, prepare rubber, make soft capsule.
Embodiment 2:
Semen Ziziphi Spinosae (parched) 150g, Fructus Schisandrae Chinensis 350g, Fructus Hordei Germinatus (parched) 150g, Bulbus Lilii 400g, Poria 150g, add 15 times of amount 80% ethanol reflux, extract, at twice, and each 2.0 hours, filter, merge alcohol extract, decompression recycling ethanol also is concentrated into without the alcohol flavor.Medicinal residues add 10 times of water gagings and extract at twice, and each 1.5 hours, collecting decoction, decocting liquid is concentrated into and is equivalent to medical material weight 0.5g/ml, centrifugal, and supernatant and above-mentioned alcohol extraction concentrated solution merge, be concentrated into relative density 1.12 (50 ℃) in the time of 70 ℃, the dry 328.87g dry extract that obtains of reduced vacuum.It is appropriate that extract powder adds dextrin, mixes and carry out wet granulation, and dry (50 ℃～60 ℃), be distributed into capsule, obtains 1000 of hard capsules.
Embodiment 3:
Semen Ziziphi Spinosae (parched) 200g, Fructus Schisandrae Chinensis 300g, Fructus Hordei Germinatus (parched) 200g, Bulbus Lilii 350g, Poria 200g, add 18 times of amount 85% ethanol reflux, extract, at twice, and each 1.0 hours, filter, merge alcohol extract, decompression recycling ethanol also is concentrated into without the alcohol flavor.Medicinal residues add 15 times of water gagings and extract at twice, and each 2 hours, collecting decoction, decocting liquid is concentrated into and is equivalent to medical material weight 0.45g/ml, centrifugal, and supernatant and above-mentioned alcohol extraction concentrated solution merge, and are concentrated into relative density 1.10 (50 ℃) in the time of 60 ℃.The dry 0.65kg dry extract that obtains of reduced vacuum.Get extract powder and mix in right amount and carry out wet granulation with Icing Sugar, dextrin, dry (50 ℃～60 ℃), make granule 1000g, packing.
Embodiment 4:
Semen Ziziphi Spinosae (parched) 250g, Fructus Schisandrae Chinensis 250g, Fructus Hordei Germinatus (parched) 250g, Bulbus Lilii 300g, Poria 250g, add 24 times of amount 75% ethanol reflux, extract, at twice, and each 1.0 hours, filter, merge alcohol extract, decompression recycling ethanol also is concentrated into without the alcohol flavor.Medicinal residues add 24 times of water gagings and extract at twice, and each 1 hour, collecting decoction, decocting liquid is concentrated into and is equivalent to medical material weight 0.5g/ml, centrifugal, and supernatant and above-mentioned alcohol extraction concentrated solution merge, and are concentrated into relative density 1.15 (50 ℃) in the time of 60 ℃.The dry 560g dry extract that obtains of reduced vacuum.Get extract powder, soybean oil, Cera Flava, soybean phospholipid appropriate, make soft capsule content, prepare rubber, make soft capsule.
Embodiment 5:
Semen Ziziphi Spinosae 300g, Fructus Schisandrae Chinensis 200g, Fructus Hordei Germinatus (parched) 300g, Bulbus Lilii 200g, Poria 300g, add 15 times of amount 80% ethanol reflux, extract, at twice, and each 1.0 hours, filter, merge alcohol extract, decompression recycling ethanol also is concentrated into without the alcohol flavor.Medicinal residues add 18 times of water gagings and extract at twice, and each 1.5 hours, collecting decoction, decocting liquid is concentrated into and is equivalent to medical material weight 1g/ml, centrifugal, and supernatant and above-mentioned alcohol extraction concentrated solution merge, and are concentrated into relative density 1.15 (50 ℃) in the time of 70 ℃.The dry 325.87g dry extract that obtains of reduced vacuum.It is appropriate that extract powder adds dextrin, mixes and carry out wet granulation, and dry (50 ℃～60 ℃), be distributed into capsule, obtains 1000 of hard capsules.
Embodiment 6:
Semen Ziziphi Spinosae (parched) 400g, Fructus Schisandrae Chinensis 150g, Fructus Hordei Germinatus (parched) 400g, Bulbus Lilii 150g, Poria 400g, add 6 times of amount 85% ethanol reflux, extract, at twice, and each 1.0 hours, filter, merge alcohol extract, decompression recycling ethanol also is concentrated into without the alcohol flavor.Medicinal residues add 24 times of water gagings and extract at twice, and each 2 hours, collecting decoction, decocting liquid is concentrated into and is equivalent to medical material weight 0.25g/ml, centrifugal, and supernatant and above-mentioned alcohol extraction concentrated solution merge, and are concentrated into relative density 1.10 (50 ℃) in the time of 60 ℃.The dry 0.66kg dry extract that obtains of reduced vacuum.Get extract powder and mix in right amount and carry out wet granulation with Icing Sugar, dextrin, dry (50 ℃～60 ℃), make granule 1000g, packing.
Embodiment 7:
Semen Ziziphi Spinosae (parched) 480g, Fructus Schisandrae Chinensis 100g, Fructus Hordei Germinatus (parched) 480g, Bulbus Lilii 100g, Poria 480g, add 24 times of amount 50% ethanol reflux, extract, at twice, and each 1.0 hours, filter, merge alcohol extract, decompression recycling ethanol also is concentrated into without the alcohol flavor.Medicinal residues add 6 times of water gagings and extract at twice, and each 1.5 hours, collecting decoction, decocting liquid is concentrated into and is equivalent to medical material weight 0.8g/ml, centrifugal, and the above-mentioned alcohol extraction concentrated solution of supernatant merges, and is concentrated into relative density 1.15 (50 ℃) in the time of 60 ℃.The dry 213.85g dry extract that obtains of reduced vacuum.Extract powder, with dried starch (1:0.1), mixes and carries out wet granulation, and dry (50 ℃～60 ℃), add proper amount of dry starch in dry granule, be mixed, and tabletting, obtain 1000, tablet.
Experimental example 8: pharmacology, toxicology test
1, the impact of different extracting modes on Fructus Jujubae flavor sedative-hypnotic effect
(1) sedative experiment (spontaneous activity in mice experiment)
Experiment material: clean level ICR mice, body weight (20 ± 2) g, ♀, provided by Nanjing University of Traditional Chinese Medicine's Experimental Animal Center, laboratory animal production licence number: SCXK (Soviet Union) 2001-0031.Test is respectively organized mice and is divided cage to feed, free choice feeding drinking-water.Room temperature 18-25 ℃, humidity 30%-50%.The program control autonomic activities case of instrument: ZIL-2, institute of Materia Medica,Chinese Academy of Medical Sciences.The FA1004 electronic balance, Shanghai balance factory.Stopwatch.Medicine and preparation: diazepam tablets, Jiangsu JumpCan Medicines Co., Ltd., lot number: 04052102.Pentobarbital sodium (import packing), China Medicine (Group) Shanghai Chemical Reagent Co.,, lot number: F20020405.
The write out a prescription preparation of water extraction liquid of the present invention: get Semen Ziziphi Spinosae 300g, Fructus Schisandrae Chinensis 200g, Fructus Hordei Germinatus (parched) 300g, Bulbus Lilii 200g, Poria 300g adds the distilled water of 18 times of amounts at every turn, decocts 2 times, each 1.5h, filtrate merges, centrifugal, and the gained supernatant is divided into to three parts, be concentrated into respectively and be equivalent to medical material 0.4g/ml, 0.8g/ml and 1.2g/ml in water-bath, be placed in refrigerator standby.
The write out a prescription preparation of alcohol extract of the present invention: get Semen Ziziphi Spinosae 300g, Fructus Schisandrae Chinensis 200g, Fructus Hordei Germinatus (parched) 300g, Bulbus Lilii 200g, Poria 300g, 80% ethanol that at every turn adds 15 times of amounts, reflux, extract, 2 times, each 1h, filtrate is centrifugal, the gained supernatant is divided into to three parts, in water-bath, is concentrated into respectively and is equivalent to medical material 0.4g/ml, 0.8g/ml and 1.2g/ml, be placed in refrigerator standby.
The present invention's two extracting solution of carrying of pure water of writing out a prescription, be the present invention, press above-described embodiment 5 method preparation, i.e. Semen Ziziphi Spinosae 300g, Fructus Schisandrae Chinensis 200g, Fructus Hordei Germinatus (parched) 300g, Bulbus Lilii 200g, Poria 300g adds 15 times of amount 80% ethanol reflux, extract, at twice, each 1.0 hours, filter, merge alcohol extract, decompression recycling ethanol also is concentrated into without the alcohol flavor.Medicinal residues add 18 times of water gagings and extract at twice, each 1.5 hours, collecting decoction, decocting liquid is evaporated to and is equivalent to medical material weight 1g/ml, centrifugal, supernatant and above-mentioned alcohol extraction concentrated solution merge, and are concentrated into relative density 1.12 (50 ℃) in the time of 70 ℃, continue to be concentrated into and be equivalent to medical material 0.4g/ml, 0.8g/ml and 1.2g/ml, be placed in refrigerator standby.
Grouping and administration: get 280 of healthy ICR mices, be divided at random 14 groups by the body weight equilibrium, be respectively: blank group, stable group, the present invention water extraction liquid, the present invention alcohol extract, the present invention two extracting solution of carrying of pure water of writing out a prescription of writing out a prescription of writing out a prescription, wherein each sample sets is established high, medium and low dosage group again, every group 20, each group is put into again two little mouse cages (be divided into two groups, be denoted as A group, B group) at random.Large, medium and small dosage group gives respectively 10g/kgd
-1, 5g/kgd
-1, 2.5g/kgd
-1The medicinal liquid gavage.Stable group is pressed 1mg/kgd
-1Fill with stomach of the present invention.The normal saline group gavages with other and organizes isometric normal saline.
Method and result: select 18～22g mice, male and female are regardless of, and single sex mice is selected in each test, random packet, 10 every group, every day gastric infusion once, continuous 3 days, the control animals gavage gave the equal-volume normal saline.After mice being put in active box and adapts to 5 minutes before administration, record each treated animal Assay of spontaneous activity of 2 minutes, get its average as administration before normal value.After the last administration 1 hour, measure by the same method the movable number of times of mice, result with
Mean, with the t-check, compare the significance of difference between administration group and matched group.
Result show with the normal saline group relatively, the present invention's alcohol extract high dose group, the present invention two autonomic activities number of times of carrying dosage group mice in extracting solution of pure water of writing out a prescription of writing out a prescription obviously reduce, wherein with the present invention, writing out a prescription, two to put forward extracting solution group effect best for pure water.
After table 1 is respectively organized the mice administration, autonomic activities reduces number of times relatively
Annotate: with blank group, compare * p<0.05**<0.01
Conclusion: the medicinal liquid that utilizes technique of the present invention to prepare can effectively reduce the number of times of spontaneous activity in mice, and it has significant sedation as can be seen here.
(2) extend the experiment length of one's sleep of pentobarbital sodium
Experiment material, grouping administration: same sedative experiment
Method and result: select body weight 18～22g mice, male and female are regardless of, and single sex mice is selected in each test.Random packet, 10 every group.After gastric infusion, 60 minutes lumbar injection threshold dose pentobarbital sodiums (50mg/kg), take righting reflex loss as time for falling asleep, and be sleep time righting reflex loss to recovery time.With matched group, compare, by its significance of difference of t check check between group.
Result shows, with the normal saline group, compares, and except part low dose group and position high dose group, all the other are respectively organized mouse sleep time and obviously extend (P<0.01).Wherein the present invention's write out a prescription middle and high dosage syngignoscism of the two extracts of pure water of alcohol extract and the present invention of writing out a prescription is especially obvious.
The impact of the collaborative pentobarbital sodium hypnosis of each B group mice of table 2
Annotate: with blank group, compare * p<0.05**<0.01
Conclusion: the present invention has the effect of significant Sleeping Time Prolong Ed, and effect is better than the present invention's water extraction liquid and the present invention alcohol extract group of writing out a prescription of writing out a prescription.
Comprehensive two experimental index, the present invention has sedative-hypnotic effect preferably.
2, maximum tolerated dose (MTD) test
Animal subject: the ICR mice, male and female half and half, body weight 18-22g, provided by Nanjing University of Traditional Chinese Medicine's Experimental Animal Center.
Tested medicine: above-described embodiment 5 methods prepare extract powder (3.75g crude drug/g).Adult's consumption 0.125g crude drug/kg.Press the every consumption per day of body surface area conversion mice, be made into desired concn with distilled water before use.
Test method: pharmaceutical formulation of the present invention, because of its concentration and volume restrictions, can't be measured LD50, therefore estimate the acute toxicity of this medicine with mtd test (MTD).Get 20 of above-mentioned mices, before experiment, fasting is 12 hours, with the tolerant Cmax of animal, maximum volume, and each gavage 0.3ml/10g body weight, 3 administrations on the one, Continuous Observation 7 days, record tested mice situation.
Result of the test: one week interior nothing of mice of pressing the administration of 0.3ml/10g body weight is dead, after execution, performs an autopsy on sb．, and each main organs perusal no abnormality seen changes.
Safety evaluatio: result of the test shows that this medicine is used safety, and its mice maximal tolerance times calculates 100 times with equivalent for the people, can be at clinical expansion.
3, the pharmacodynamics of the present invention and sedative jujube kernel capsule relatively
3.1 sample preparation
3.1.1 the preparation of sedative jujube kernel test of pesticide effectiveness sample: get Semen Ziziphi Spinosae (parched) 71g, Radix Salviae Miltiorrhizae 14g, Fructus Schisandrae Chinensis (processed with vinegar) 14g, drink in essence and have no progeny, and adds 6 times of amount 75% alcohol reflux 2 hours, filters filtrate for later use; Medicinal residues add 5 times of amount 60% alcohol reflux 1 hour again, filter, and merge extractive liquid,, filtrate recycling ethanol, be concentrated into the clear paste that relative density is 1.30,60 ℃, standby; The medicinal residues decocting boils twice, and 2 hours for the first time, add 8 times of water gagings, 1 hour for the second time, add 6 times of water gagings, filter, merging filtrate, be concentrated into the thick paste that relative density is 1.40,60 ℃, adds starch appropriate, is dried to dry cream, pulverizes.Get above-mentioned dried cream powder appropriate, be mixed with the solution that is equivalent to 0.1g crude drug/ml, as test of pesticide effectiveness sample.
3.1.2 the preparation of test of pesticide effectiveness sample of the present invention: press above-described embodiment 5 method preparations, get dry extract appropriate, be mixed with the solution that is equivalent to 0.1g crude drug/ml, as test of pesticide effectiveness sample.
3.2 grouping administration: get 80 of healthy ICR mices, be divided at random 4 groups by the body weight equilibrium, be respectively: normal saline group, sedative jujube kernel group, of the present invention group, 20 every group, each group is put into again two little mouse cages (be divided into two groups, be denoted as A group, B group) at random.Two preparation groups are pressed 1.5g crude drug/kgd
-1Dosed administration, stable group is pressed 1mg/kgd
-1Gavage.The normal saline group gavages with other and organizes isometric normal saline.
3.3 experimental result: with the normal saline group, compare, sedative jujube kernel group and of the present invention group of mice autonomic activities number of times obviously reduce, and obviously extend the length of one's sleep, and of the present invention group slightly is better than the sedative jujube kernel group, but there is no significant difference between two groups.
Table 3 reciprocal action result of the test
Annotate: with blank group, compare * p<0.05**<0.01
Conclusion: the drug effect of the present invention aspect tranquilizing soporific is better than commercially available conventional formulation 'Zaorenanshen '.
Claims (5)
1. the Chinese medicine preparation of a treatment of insomnia patients, it is characterized in that being prepared from by the crude drug extraction of following weight portion proportioning: Semen Ziziphi Spinosae (parched) 100-480 part, Fructus Schisandrae Chinensis 100-400 part, Fructus Hordei Germinatus (parched) 100-480 part, Bulbus Lilii 100-450 part, Poria 100-480 part, preparation process is as follows: (1) is got Semen Ziziphi Spinosae (parched), Fructus Schisandrae Chinensis, Fructus Hordei Germinatus (parched), Bulbus Lilii, Poria and is added alcohol reflux, the alcohol extract reclaim under reduced pressure is to without the alcohol flavor, concentrated, obtains alcohol extraction concentrated solution and medicinal residues standby; (2) above-mentioned medicinal residues are decocted with water, decocting liquid filters, after filtrate is concentrated, centrifugal, after supernatant continues to concentrate, with the alcohol extraction concentrated solution of step (1), merges, concentrated, is dried to extract powder; (3) get above-mentioned extract powder and add the agent of appropriate amount of auxiliary materials granulation, capsule, tablet or pill.
2. the preparation method of the Chinese medicine preparation for the treatment of of insomnia patients according to claim 1, is characterized in that in step (1) adding amount of alcohol and be the 6-24 of medical material weight doubly, and concentration of alcohol is 50-95%, divides 2-3 reflux, extract,, extracts 1-2 hour at every turn.
3. the preparation method of the Chinese medicine preparation for the treatment of of insomnia patients according to claim 1, it is characterized in that amount of water in step (2) be medicinal residues weight 6-24 doubly, divide and decoct for 2 times, each 1-2 hour, collecting decoction, decocting liquid is concentrated into and is equivalent to medical material weight 0.2g/ml-1g/ml, centrifugal, the alcohol extraction concentrated solution of supernatant and step (1) merges, and while in the time of 50 ℃-70 ℃, being concentrated into 50 ℃, relative density is 1.10-1.15,50 ℃ of-70 ℃ of drying under reduced pressure.
4. the application of the Chinese medicine preparation for the treatment of of insomnia patients in preparing the Cure for insomnia disease drug as claimed in claim 1.
5. the Chinese medicine preparation for the treatment of of insomnia patients improves the application in insomnia's health product in preparation as claimed in claim 1.
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