CN1582980A - Chinese medicinal composition for improving sleep and relaxing fatigue and its preparation - Google Patents
Chinese medicinal composition for improving sleep and relaxing fatigue and its preparation Download PDFInfo
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- CN1582980A CN1582980A CN 03150419 CN03150419A CN1582980A CN 1582980 A CN1582980 A CN 1582980A CN 03150419 CN03150419 CN 03150419 CN 03150419 A CN03150419 A CN 03150419A CN 1582980 A CN1582980 A CN 1582980A
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- ziziphi spinosae
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Abstract
A Chinese medicine for improving sleep and immunity and relieving fitigue is prepared from ledebouriella root, wild jujube kernel and medicinal additives.
Description
Technical field:
The present invention relates to Chinese medicine composition, be specifically related to a kind of compositions and preparation method of improving sleep, resisting fatigue, raising immunologic function.
Background technology:
Semen Ziziphi Spinosae (SEMEN ZIZIPHI SPINOSAE) medically is being commonly used for tonifying liver, mind tranquilizing and the heart calming and is being used as medicine; And ledebouriella root is taken from the root of the wide Radix Saposhnikoviae Epimeredi of medicinal plant indica (L.) Rothmalex in the bibliographical information.The wide Radix Saposhnikoviae medicinal part of commonly using among the people in the bibliographical information, except having the effect of " dispel the wind, dehumidify, detoxify ", has also been put down in writing the effect of " the kidney invigorating, excitement, strong " for the herb of its plant.Still have no way of at present ledebouriella root and Semen Ziziphi Spinosae prescription is used to prepare the medicine that improves sleep, resisting fatigue and raising immunologic function.
Summary of the invention:
Technical problem to be solved by this invention is wide Radix Saposhnikoviae and Semen Ziziphi Spinosae reasonable formula, and a kind of new medicine compositions with obvious improvement sleep, resisting fatigue and raising immunologic function is provided.
Disclosed by the invention have a middle compositions that improves sleep, resisting fatigue and raising immunologic function, is that the extract with ledebouriella root and Semen Ziziphi Spinosae is the oral formulations that active ingredient and pharmaceutic adjuvant are formed.
Ledebouriella root of the present invention and Ziziphi Spinosae extract, be meant jointly or the respectively water concentration extract that the back obtains that contracts of ledebouriella root and Semen Ziziphi Spinosae, wherein total saponin content 0.50～2.00%, general flavone content 0.10～1.00%, and wide Radix Saposhnikoviae glycosides A content is 0.10～1.50%.
Oral formulations of the present invention is acceptable various dosage forms on the clinical medicine, comprises oral liquid, granule, capsule or tablet etc.
Another technical problem to be solved by this invention is to provide the preparation method of above-mentioned Chinese medicine composition.
Preparation with the middle compositions that improves sleep and resisting fatigue, raising immunity function disclosed by the invention comprises the following steps:
1, extract preparation
Get ledebouriella root and Semen Ziziphi Spinosae and pulverize, add 10 times of water gagings, decoct, extract 2～3 times, merging filtrate concentrates, and spraying or vacuum drying get extract;
Or get respectively ledebouriella root and Semen Ziziphi Spinosae as stated above water carry concentrate drying, united extraction thing;
2, formulation preparation
Said extracted thing and pharmaceutic adjuvant are made various oral formulations according to a conventional method.
A technical problem more to be solved by this invention is that the Chinese medicine composition that discloses above-mentioned ledebouriella root and Semen Ziziphi Spinosae composition improves the medicine of sleep, resisting fatigue, raising immunologic function or the application in the health product in preparation.
Wide Radix Saposhnikoviae nature and flavor are arduous, warm, books on Chinese herbal medicine in ancient times " the SHENGCAO property of medicine fully will " record, and horsecloth leaf (wide Radix Saposhnikoviae) has the effect of strengthening bone and muscle, the kidney invigorating void: " people that suffers from a deficiency of the kidney gets its infusing drugs in wine drink for pain relieving, strengthening bone and muscle ".Theory of Chinese medical science thinks that the kidney being the origin of congenital constitution, and the function of internal organs is relied on kidney qi to inspire, the health of kidney and human body, growth, growth, aging have confidential relation, and promptly then life is vigorous for the prosperous human body of kidney qi, and is energetic, be difficult for ageing, old and feeble speed is slower, and the life-span is longer; Otherwise kidney qi declines, and the easy body of people tired god decline, ageing easily, and the life-span is also shorter.Modern medicine study proves that the kidney of traditional Chinese medical science indication is not only close with endocrine relationship, and relevant with the immunologic function of human body.Theory of Chinese medical science thinks that kidney is hidden vigour, and vigour is the main component of healthy energy, and healthy energy is equivalent to the function of exempting from service of human body.So deficiency of kidney-QI, vigour just declines, first weakness of QI, healthy energy also just a little less than, human body shows immunologic function to be reduced, tired and sick easily.So inspire healthy energy by the kidney invigorating on the tcm clinical practice, improve the immunologic function of human body, make the human activity vigorous, indefatigability.So the empty medicine of the kidney invigorating of the traditional Chinese medical science has the antifatigue effect.
The Semen Ziziphi Spinosae nature and flavor do, put down into the heart, spleen, liver, gallbladder meridian function and cure mainly nourishing the liver, mind calming, calm the nerves, arresting sweating.Record in " not Lu " " main vexatious insomnia, umbilicus is pain up and down, and blood changes chronic diarrhea, the sweating due to debility excessive thirst, invigorating middle warmer, the liver benefiting gas, hard muscles and bones are helped cloudy gas, the people is fertile strong in addition ".
Ledebouriella root and Semen Ziziphi Spinosae share, the ledebouriella root bitter in the mouth warm in nature with the merit of strengthening bone and muscle, the kidney invigorating void monarch drug in the side of serving as; The Semen Ziziphi Spinosae nature and flavor are done flat, function nourishing the liver, mind calming.Both can strengthen the hard muscles and bones clothes of monarch drug healthy energy, but the liver benefiting gas again.Two medicines share, and play the merit of nourishing the liver and kidney altogether.
Entrust Shanghai City preventive medicine academy to carry out relevant resisting fatigue and improvement sleep efficacy test with Chinese medicine composition of the present invention:
1, antifatigue effect
1.1. sample character: the capsule preparations of compositions among the present invention, content are brown yellow granule.
1.2. dosage design: sample human body recommended dose is that basic, normal, high three dosage groups are established in this experiment of 4g/60kg. every day, is respectively 0.35,0.7,2g/kg establishes matched group (giving pre-distillation water) in addition.
1.3. sample treatment: sample thief 0.35,0.7,2g adding distil water are the test liquid of basic, normal, high three dosage to 20ml.
1.4. laboratory animal: Kunming kind white mice, male, 18-22 gram, the cleaning level animal that provides by Fudan University in Shanghai medical college laboratory animal portion.22 ± 2 ℃ of laboratory animal breeding room's temperature, relative humidity 50～70%, the animal feeding material, technology ﹠ development Co. provides by the Su Hang laboratory animal.
1.5. give the sample approach: irritate stomach, irritate gastric capacity 0.4ml/20g body weight.
1.6. experimental technique and result
1.6.1 body weight
Get 120 of Kunming kind white mice,, be divided into 12 groups by the body weight stratified random, 10 every group by only weighing.With per four groups be an experimental group, design was according to dosage fed 30 days continuously.
Sample is to the influence of the weight of animals
Group number of animals (only) body weight (gram)
Experiment experiment just experiment in mid-term end
Contrast 30 19 ± 0.8 30 ± 0.5 34 ± 0.7
Low dosage 30 19 ± 0.6 30 ± 0.5 33 ± 0.9
Middle dosage 30 19 ± 0.7 29 ± 0.8 34 ± 1.1
High dose 30 19 ± 0.7 29 ± 0.9 34 ± 1.1
As seen from the above table: sample does not have obvious influence to the weight of animals.
1.6.2 swimming with a load attached to the body test:
Get above-mentioned design according to dosage and feed continuously each one group of three dosage groups after 30 days and control animals, after last is irritated stomach 30 minutes, mice is put into water swim, depth of water 30cm, 25 ± 0.5 ℃ of water temperatures, the load sheet lead of 5% body weight of Mus root of the tail portion, the record mice from the swimming beginning to the dead time.
Sample is to the influence of mice swimming with a load attached to the body time (X ± SD)
Group number of animals (only) swimming with a load attached to the body time (second)
Contrast 10 548 ± 150
Low dosage 10 550 ± 175
Middle dosage 10 627 ± 178
High dose 10 773 ± 236
*
*(through variance analysis) compared in P＜0.05 with matched group
As seen from the above table, the sample high dose group is compared with matched group, and significant difference is arranged.
1.6.3 blood lactic acid is measured: get above-mentioned design according to dosage and feed each one group of three dosage groups after 30 days and control animals continuously, survey blood lactic acid and after last is given sample 30 minutes, 2% (body weight) of bearing a heavy burden swum 30 minutes in temperature 25-30 ℃ water, take out, survey blood lactic acid, hot-air seasoning after quiet 30 minutes, is surveyed blood lactic acid again.
Sample is to the influence of mouse movement bleeding from anus lactic acid rising amplitude (X ± SD)
Group number of animals blood lactic acid (mmol/l)
0 minute difference (before the 0 minute-experiment) behind the animal before (only) motion
Contrast 10 4.22 ± 0.32 10.94 ± 0.63 6.72 ± 0.81
Low dosage 10 4.35 ± 0.14 11.25 ± 0.87 6.90 ± 0.91
Middle dosage 10 4.28 ± 0.14 11.22 ± 0.78 6.94 ± 0.74
High dose 10 4.31 ± 0.15 11.18 ± 0.49 6.87 ± 0.46
As seen from the above table, each dosage group of sample is tested back 0 minute animal blood lactic acid rising amplitude and is compared difference that there are no significant with matched group.
Sample is eliminated the influence (X ± SD) of amplitude to mice animal bleeding from anus lactic acid
Group number of animals blood lactic acid (mmol/l)
0 minute difference (before the 0 minute-experiment) behind the animal before (only) motion
Contrast 10 10.94 ± 0.63 7.77 ± 0.47 3.17 ± 0.71
Low dosage 10 11.25 ± 0.87 7.43 ± 0.48 3.82 ± 0.93
Middle dosage 10 11.22 ± 0.78 7.03 ± 0.45 4.19 ± 0.80
High dose 10 11.18 ± 0.49 5.52 ± 0.78
*5.66 ± 1.14
*
*(through variance analysis) compared in P＜0.05 with matched group
As seen from the above table, the sample high dose group is tested back 30 minutes animal blood lactic acid elimination amplitudes and is compared with matched group, and significant difference is arranged.
1.6.4 determination of urea nitrogen:
Get above-mentioned design according to dosage and feed continuously each one group of three dosage groups after 30 days and control animals, irritated stomach 30 minutes in last, mice is put into 30 ℃ of water swimming 90 minutes, take out, hot-air seasoning makes peace and quiet, gets Mus blood, and is centrifugal, gets serum and surveys blood urea nitrogen.
Sample to mouse movement after the influence (X ± SD) of serum urea nitrogen
Group number of animals (only) blood urea nitrogen (mmol/l)
Contrast 10 9.21 ± 0.58
Low dosage 10 8.72 ± 0.85
Middle dosage 10 8.63 ± 0.83
High dose 10 6.63 ± 1.20
*
*(through variance analysis) compared in P＜0.05 with matched group
As seen from the above table, the sample high dose group is compared with matched group, and significant difference is arranged.
1.7. sum up: per os gave mice various dose sample after 30 days, had antifatigue effect.
2. improve the sleep effect
2.1. sample character: the capsule preparations of compositions among the present invention, content are brown yellow granule.
2.2. animal origin: Kunming kind white mice, 18-22 gram, male, the cleaning level animal that provides by Fudan University in Shanghai medical college laboratory animal portion.22 ± 2 ℃ of laboratory animal breeding room's temperature, relative humidity 50-70%, the animal feeding material, technology ﹠ development Co. provides by the Su Hang laboratory animal.
Establish basic, normal, high three dosage groups 2.3. sample human body recommended dose is this experiment of 4g/60kg. every day, be respectively 0.35,0.7,2g/kg, be equivalent to 5 times, 10 times and 30 times of people's recommended amounts respectively, other establishes the distilled water matched group.
2.4. sample treatment: sample thief 0.35,0.7,2g add respectively and steam water to 20ml, make into even suspension, basic, normal, high three dosage, for examination.
2.5 give the sample approach: irritate stomach, irritate gastric capacity 0.4ml/20g.bw
2.6 experimental technique:
2.6.1 pentobarbital sodium dosage hypnosis above threshold test:
Select 40 of body weight 18-22g male mices for use, be divided into four groups at random, every group 10, give sample 30 days continuously, irritate stomach after 15 minutes in the 30th day sample, give the pentobarbital sodium lumbar injection of each treated animal 50mg/kg.b.w, injection volume is 0.2ml/20g.b.w, reach more than 1 minute as sleeping criterion with the mice righting reflex loss, observe the time for falling asleep and the length of one's sleep of giving each treated animal in the pentobarbital sodium 60 minutes.
2.6.1.1. result:
Sample is to the influence of the weight of animals
Group number of animals body weight (gram)
(only) test test just test in mid-term end
Matched group 20 20 ± 1.4 27 ± 1.6 35 ± 2.0
Low dose group 20 20 ± 1.5 27 ± 1.3 35 ± 1.6
Middle dosage group 20 20 ± 1.3 27 ± 1.6 35 ± 2.3
High dose group 20 20 ± 1.2 27 ± 1.2 35 ± 2.4
As seen from the above table, each dosage treated animal body weight of sample is compared difference that there are no significant with matched group.
The influence of pentobarbital sodium inducing mouse length of one's sleep of dosage above threshold
Dosage treated animal number (only) time for falling asleep (branch) length of one's sleep (branch)
Matched group 10 5.79 ± 2.05 40.96 ± 8.16
Low dose group 10 4.88 ± 1.88 43.16 ± 7.80
Middle dosage group 10 4.68 ± 1.35 45.48 ± 11.23
High dose group 10 3.91 ± 0.99
*53.28 ± 11.12
*
*(through variance analysis) compared in P＜0.05 with matched group
As seen from the above table, the time for falling asleep of sample high dose animal under above threshold the dosage pentobarbital sodium is induced compared with matched group with the length of one's sleep, and significant difference is all arranged.
2.6.2 pentobarbital sodium sub-threshold dose hypnosis test
Select 40 of body weight 18-22g male mices for use, be divided into four groups at random, every group 10, give sample 28 days continuously, irritate stomach after 15 minutes in the 28th day sample, give the pentobarbital sodium lumbar injection of each treated animal 30mg/kg.b.w, injection volume is 0.2ml/20g.b.w, reaches more than 1 minute as sleeping criterion with the mice righting reflex loss and observes the number of animals that takes place to sleep to each treated animal in the pentobarbital sodium 25 minutes.
2.6.2.1 result:
The influence of the pentobarbital sodium inducing mouse sleep incidence rate of sub-threshold dose
Sleeping number of animals (only) sleep of dosage treated animal number (only) incidence rate (only)
Matched group 10 2 20
Low dose group 10 3 30
Middle dosage group 10 5 50
High dose group 10 8
*80
*
*(through X 2 test) compared in P＜0.05 with matched group
As seen from the above table, the sleeping number of animals of sample high dose animal under the sub-threshold dose pentobarbital sodium is induced compared with matched group with the sleep incidence rate, all has significance poor.
2.7. sum up: per os gave the mice sample after 30 days, had the sleep of improvement effect
Above-mentioned test shows that Chinese medicine composition of the present invention can obviously prolong mice and revisit the swimming time, increases motion back mice blood lactic acid and eliminates amplitude, reduces the serum urea nitrogen content; Can obviously increase the sleeping number of animals and the sleep incidence rate of the pentobarbital sodium inducing mouse of sub-threshold dose, shorten the time for falling asleep of the pentobarbital sodium inducing mouse of dosage above threshold, prolong the length of one's sleep of the pentobarbital sodium inducing mouse of dosage above threshold.
Chinese medicine composition of the present invention has remarkable improvement sleep, resisting fatigue, raising immunization, studies show that safe without toxic side effect through long term toxicity, detect through national drug-testing center not contain any hormone, and be the health preparation of a kind of safety, exact efficacy.
The specific embodiment:
The preparation of embodiment 1, extract
Get ledebouriella root, pulverize, add the water of 10 times of amounts, decocted 2 hours, filtrate is stand-by, and residue adds 8 times of water gagings, decocts 2 hours, filter, and merging filtrate, filtrate concentrates, and spray drying or vacuum drying get the ledebouriella root extract.
Get Semen Ziziphi Spinosae, pulverize, add the water of 10 times of amounts, decocted 2 hours, filtrate is stand-by, and residue adds 8 times of water gagings, decocts 2 hours, filter, and merging filtrate, filtrate concentrates, and spray drying or vacuum drying get Semen Ziziphi Spinosae extract.
Merge ledebouriella root extract and Semen Ziziphi Spinosae extract, wherein total saponin content 0.61%, general flavone content 0.27%, and wide Radix Saposhnikoviae glycosides A content is 0.22%.
The preparation of embodiment 2, extract
Take by weighing pulverizing back ledebouriella root and Semen Ziziphi Spinosae in the prescription ratio, add the water extraction twice of 10 times of amounts, each 1-2 hour, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.01～1.08 (25～30 ℃ of surveys), spray drying or vacuum drying get extract.Active component content is total saponin content 0.7% wherein, general flavone content 0.13%, and wide Radix Saposhnikoviae glycosides content is 0.35%.
The preparation of embodiment 3, granule
Prescription:
Ledebouriella root extract 150g
Semen Ziziphi Spinosae extract 150g
Lactose 100g
Magnesium stearate 2g
Method: with the auxiliary materials and mixing such as ledebouriella root extract, Semen Ziziphi Spinosae extract and lactose that embodiment 1 method obtains, sieve, the system granule is after the sieve screening, promptly.
Embodiment 4,
Prescription:
Ledebouriella root extract 130g
Semen Ziziphi Spinosae extract 200g
Lactose 160g
Magnesium stearate 1g
Method: with the auxiliary materials and mixing such as ledebouriella root extract, Semen Ziziphi Spinosae extract and lactose that embodiment 1 method obtains, sieve, the system granule is after the sieve screening, promptly.
The preparation of embodiment 5, capsule
Prescription:
Ledebouriella root, Semen Ziziphi Spinosae extract 160g
Lactose 70g
Magnesium stearate 1g
Method: with the auxiliary materials and mixing such as ledebouriella root extract, Semen Ziziphi Spinosae extract and lactose that embodiment 2 methods obtain, cross 60 mesh sieves, the system granule, after the sieve screening, promptly encapsulated.
The preparation of embodiment 6, tablet
Prescription:
Ledebouriella root extract 230g
Semen Ziziphi Spinosae extract 200g
Microcrystalline Cellulose 40g
Carboxymethyl starch sodium 3g
Polyvinylpyrrolidone 1g
Pulvis Talci 1g
Magnesium stearate 1g
Method: take by weighing adjuvants such as microcrystalline Cellulose, carboxymethyl starch sodium and place mortar to mix, add ledebouriella root extract and Semen Ziziphi Spinosae extract that embodiment 1 method obtains, in oscillating mill, ground several minutes at a high speed, take out.Granulate, carry out drying, arrangement adds a small amount of magnesium, tabletting, and the bag film-coat, promptly.
Embodiment 7, preparation tablets
Prescription:
Ledebouriella root extract 300g
Semen Ziziphi Spinosae extract 100g
Microcrystalline Cellulose 36g
Carboxymethyl starch sodium 2.8g
Polyvinylpyrrolidone 2.8g
Pulvis Talci 2.8g
Magnesium stearate 1g
Method is with embodiment 6.
Claims (5)
1, a kind of Chinese medicine composition is characterized in that said composition is that extract with ledebouriella root and Semen Ziziphi Spinosae is the oral formulations that active ingredient and pharmaceutic adjuvant are formed.
2, Chinese medicine composition according to claim 1, it is characterized in that wherein said ledebouriella root and Ziziphi Spinosae extract, be meant jointly or the respectively water concentration extract that the back obtains that contracts of ledebouriella root and Semen Ziziphi Spinosae, wherein total saponin content 0.50～2.00%, general flavone content 0.10～1.00%, wide Radix Saposhnikoviae glycosides A content is 0.10～1.50%.
3, Chinese medicine composition according to claim 1 is characterized in that wherein said oral formulations is medically acceptable various dosage forms, comprises granule, capsule or tablet.
4, the preparation method of Chinese medicine composition according to claim 1 is characterized in that the preparation of said composition comprises the following steps:
1) extract preparation
Get ledebouriella root and Semen Ziziphi Spinosae and pulverize, add 10 times of water, decoct, extract 2～3 times, merging filtrate concentrates, and spraying or vacuum drying get extract;
Or get respectively ledebouriella root and Semen Ziziphi Spinosae as stated above water carry concentrate drying, united extraction thing;
2) formulation preparation
Said extracted thing and pharmaceutic adjuvant are made various oral formulations according to a conventional method.
5, Chinese medicine composition according to claim 1 improves the medicine of sleep, resisting fatigue, raising immunologic function or the application in the health product in preparation.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03150419 CN1582980A (en) | 2003-08-18 | 2003-08-18 | Chinese medicinal composition for improving sleep and relaxing fatigue and its preparation |
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|---|---|---|---|
| CN 03150419 CN1582980A (en) | 2003-08-18 | 2003-08-18 | Chinese medicinal composition for improving sleep and relaxing fatigue and its preparation |
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| CN1582980A true CN1582980A (en) | 2005-02-23 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101926865A (en) * | 2010-09-11 | 2010-12-29 | 天津医科大学 | Spina date seed depression-resolving and nerve-soothing composition and preparation method thereof |
| CN117018125A (en) * | 2023-10-09 | 2023-11-10 | 吉林浩泰健康产业发展股份有限公司 | Anti-fatigue pharmaceutical composition |
-
2003
- 2003-08-18 CN CN 03150419 patent/CN1582980A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101926865A (en) * | 2010-09-11 | 2010-12-29 | 天津医科大学 | Spina date seed depression-resolving and nerve-soothing composition and preparation method thereof |
| CN101926865B (en) * | 2010-09-11 | 2012-01-25 | 天津医科大学 | Spina date seed depression-resolving and nerve-soothing composition and preparation method thereof |
| CN117018125A (en) * | 2023-10-09 | 2023-11-10 | 吉林浩泰健康产业发展股份有限公司 | Anti-fatigue pharmaceutical composition |
| CN117018125B (en) * | 2023-10-09 | 2023-12-19 | 吉林浩泰健康产业发展股份有限公司 | Anti-fatigue pharmaceutical composition |
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