CN100500171C - Tranquilizing Chinese medicine composition and its preparing method and application - Google Patents
Tranquilizing Chinese medicine composition and its preparing method and application Download PDFInfo
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Abstract
The present invention provides a kind of tranquilizing Chinese medicine composition and its preparation process and application. The Chinese medicine composition is prepared with glossy ganoderma 12-18 weight portions, astragalus root 6-14 weight portions and manyprickle acanthopanax root 30-50 weight portions. It is prepared into oral liquid, tablet, capsule or granule. The present invention also provides the application of the Chinese medicine composition in preparing medicine for treating palpitation, insomnia, spontaneous perspiration, fatigue, food deficiency and loose stool.
Description
Technical field
The present invention relates to field of medicaments, specifically, relate to a kind of strengthening the body resistance, strengthening by means of tonics, the abirritative Chinese medicine composition and its production and application of calming the nerves.
Background technology
Traditional medicine think " taste are source of generating QI and blood, insufficiency of the spleen then weakness of QI insufficiency of blood, the heart do not have support, can not the house mind, thus severe palpitation, forgetful insomnia, the tired lack of appetite of body, pale tongue with thin fur is white, thready and weak pulse.Control should vigorate qi and replenish the blood and invigorating spleen and nourishing heart take into account." and Ganoderma, the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi are product on the nourishing qi and blood; modern study thinks that this three flavors Chinese medicine all has the effect of nourishing spleen and stomach; have especially after scientific composition that antitumor and antithrombotic form and tool protection gastric mucosa and promote the effect and the calming soporific of ulcer healing; and can alleviate the damage of virus or chemical toxicant, protection hepatocyte to liver.Coronary artery dilating, coronary blood flow increasing and myocardial nutrition blood flow.Resist myocardial ischemia and increase the contractility of heart.The protection kidney reduces renal damage, improves renal function, effects such as diuresis detumescent and reduction urine protein.Can also enhancing human body immunity power.Defying age and strong effect, and calmness, analgesic activity are arranged can be relievingd asthma, cough-relieving, eliminate the phlegm and treat chronic tracheitis, and be had the effect of blood sugar lowering, blood fat reducing, blood pressure lowering
Summary of the invention
(1) technical problem that will solve
Purpose of the present invention aims to provide a kind of strengthening the body resistance, strengthening by means of tonics, the abirritative Chinese medicine composition and its production and application of calming the nerves.
(2) technical scheme
For achieving the above object, Chinese medicine composition provided by the invention, the effective ingredient that it is characterized in that described Chinese medicine composition are that by weight ratio following raw materials according is made: Ganoderma 12-18 part, Radix Astragali 6-14 part, Radix Et Caulis Acanthopanacis Senticosi 30-50 part.
Preferred proportioning raw materials is: Ganoderma 14-16 part, Radix Astragali 8-12 part, Radix Et Caulis Acanthopanacis Senticosi 36-44 part.
Radix Astragali sweet in the mouth slightly warm in nature in the medicine of the present invention is used for the card of deficiency of both the splenic and pulmonary QI.The gas of Radix Astragali energy spleen reinforcing lung is the key medicine of invigorating the spleen and replenishing QI; The Ganoderma sweet in the mouth is flat, the energy invigorating QI and tranquilization, and relieving cough and asthma is used for dizzy sleeplessness, cards such as shortness of breath and palpitation, energy reinforcing the heart blood, the beneficial motive, tranquilizing mind 5 is played vigorate qi and replenish the blood mutually altogether with the Radix Astragali, the merit of invigorating spleen and nourishing heart, both are monarch drug altogether.The little bitterness temperature of Radix Et Caulis Acanthopanacis Senticosi acrid in the mouth can replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization, and the body void that is used for due to the deficiency of spleen-YANG and kidneyYANG is weak, and cards such as insomnia and dreamful sleep have obvious anti-fatigue, resisting oxygen lack; Can improve corticocerebral excitement, process of inhibition, improve effects such as mental work usefulness, be ministerial drug, principal drug assistance benefiting qi and nourishing blood, tranquilizing the mind.
We's compatibility characteristics are: heart spleen is ruled together, and emphasis makes the prosperous then QI and blood of spleen biochemistry active at spleen, and the prosperous then blood of gas is spontaneous, and the hemapodium then heart is foster to some extent, so this side really is the special agent of tonification blood.It is the tonification good recipe that the palpitation and insomnia of treatment due to the deficiency of both the heart and spleen, fatigue and weakness, anorexia and loose stool medicine etc. belong to QI and blood deficiency person.
The present invention also provides the preparation method of this Chinese medicine composition, and it may further comprise the steps:
(1) get above medical material, pulverize, decoct with water 1-3 time, each 1-2h, collecting decoction filters, and relative density was the fluid extract of 1.10-1.20 when filtrate was concentrated into 70 ℃;
(2) add 95% ethanol, making ethanol content is 60-70%, and adjust pH is 6.5-7.0, leaves standstill 24-48h;
(3) filter, filtrate adds ethanol again, and making concentration of alcohol is 75-80%, leave standstill 12-36h, filter filtrate recycling ethanol, relative density is the extractum of 1.02-1.10 when being concentrated into 70 ℃, is prepared into or adds suitable adjuvant to make pharmaceutically acceptable dosage form.
Wherein the relative density of gained extractum in the time of 70 ℃ is 1.15-1.18 in the step (1).
Wherein time of repose is 36h in the step (2), and time of repose is 24h in the step (3).
Wherein the relative density of gained extractum in the time of 70 ℃ is 1.05-1.08 in the step (3).
Chinese medicine composition of the present invention can be oral liquid, tablet, capsule or granule.Wherein used carrier is conventional carrier in the preparation, filler commonly used is sucrose, starch etc., wetting agent is water, ethanol etc., binding agent is starch slurry, hypromellose (HPMC), dextrin etc., disintegrating agent is crosslinked sodium hydroxyl cellulose, surfactant, sodium citrate and sodium carbonate etc., and lubricant is Pulvis Talci, magnesium stearate etc.
Chinese medicine composition of the present invention has strengthening the body resistance, strengthening by means of tonics, the abirritative effect of calming the nerves.Be applicable to the medicine of palpitation and insomnia due to the preparation treatment deficiency of both the heart and spleen, fatigue and weakness, anorexia and loose stool.
The discrimination method of medicine of the present invention is:
(1) it is an amount of to get this product, extracts 2 times with the chloroform jolting, each 20ml, and combined chloroform liquid, evaporate to dryness (water liquid is standby), residue adds methanol 1ml makes dissolving, as need testing solution.Other gets Radix Et Caulis Acanthopanacis Senticosi control medicinal material 5g, adds methanol 20ml, and supersound process 30 minutes filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 3 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, upper solution with benzene-ethyl acetate-formic acid (8: 1: 1) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
(2) get the aqueous solution behind the chloroform extraction under discriminating (1) item, extract 2 times with water saturated n-butyl alcohol jolting, each 25ml merges n-butyl alcohol liquid, with the saturated water washing of n-butyl alcohol 2 times, each 15ml discards water liquid, n-butyl alcohol liquid evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets the astragaloside reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw above-mentioned need testing solution 3 μ l, reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, lower floor's solution with chloroform-methanol-water (13:7:2) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(3) get this product 10ml, add ethyl acetate extraction 2 times, each 20ml, merge extractive liquid,, water bath method, residue add methanol 1ml makes dissolving, as need testing solution.Other gets Ganoderma control medicinal material 0.5g, adds ethyl acetate 20ml, and reflux, extract, 30 minutes filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2000 B) test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-methanol-water (15:2:0.1) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show an identical aubergine speckle.
The content assaying method of Chinese medicine composition of the present invention is:
The extractum that takes by weighing this product effective ingredient is an amount of, is equivalent to astragaloside 1mg approximately, and accurate the title decides, extract 2 times with the chloroform jolting, each 25ml discards chloroform solution, water liquid extracts 3 times with water saturated n-butyl alcohol jolting, and each 20ml merges n-butyl alcohol liquid, with ammonia solution washing 2 times, each 20ml discards ammonia solution, n-butyl alcohol liquid evaporate to dryness, residue adds water 5ml makes dissolving, passes through D
101Type macroporous adsorptive resins (internal diameter 1cm, long 12cm) is with water 50ml eluting, discard water liquid, reuse 30% ethanol 50ml eluting discards eluent, continues with 70% ethanol 50ml eluting, collect eluent, evaporate to dryness, residue add dissolve with methanol and are transferred in the 2ml measuring bottle, add methanol and are diluted to scale, shake up, as need testing solution.Other gets the astragaloside reference substance, and accurate the title decides, and adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), accurate need testing solution 4 μ l, reference substance solution 2 μ l and the 4 μ l of drawing, respectively the cross point in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, lower floor's solution of placing below 10 ℃ with chloroform-methanol-water (13: 6: 2) is developing solvent, launch, take out, dry, spray is with 20% ethanol solution of sulfuric acid, it is clear to be heated to speckle colour developing at 105 ℃, take out, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side.Scan wavelength according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B thin layer chromatography scanning): λ
S=395nm, λ
R=700nm measures test sample trap integrated value and reference substance trap integrated value, calculates, promptly.
Containing astragaloside in the every 1g extractum of this product is 0.15-0.60mg.
The every 1ml of this product oral liquid contains astragaloside 0.01-0.10mg, and per 1 of tablet contains astragaloside 0.05-0.50mg, and per 1 of capsule contains astragaloside 0.05-0.50mg, and the every 1g of granule contains astragaloside 0.05-0.30mg.
(3) beneficial effect
Chinese medicine composition of the present invention is used for treatment of diseases such as the palpitation and insomnia, fatigue and weakness, anorexia and loose stool due to the deficiency of both the heart and spleen, and it is little to have toxic and side effects, the characteristics of determined curative effect.
The specific embodiment
Following examples are used for understanding better the present invention, but are not used for limiting the scope of the invention.
The preparation of embodiment 1 Chinese medicine composition oral liquid of the present invention
Get Ganoderma 150g, Radix Astragali 100g, Radix Et Caulis Acanthopanacis Senticosi 400g pulverizes, more than three flavor medical materials, decoct with water 2 times, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and relative density was 1.17 fluid extract when filtrate was concentrated into 70 ℃, add 95% ethanol, making ethanol content is 65%, and regulating pH value with 8% sodium hydroxide solution is 6.7, left standstill 36 hours, and filtered, filtrate adds ethanol again, making concentration of alcohol is 77%, leaves standstill 24 hours, filters, filtrate recycling ethanol, relative density is 1.06 extractum when being concentrated into 70 ℃, adds sucrose 100g, heat little boiling 15 minutes, stir evenly, add water to ormal weight, stir evenly, filter, embedding, promptly.
The preparation of embodiment 2 Chinese medicine composition tablets of the present invention
Get Ganoderma 120g, Radix Astragali 140g, Radix Et Caulis Acanthopanacis Senticosi 500g pulverizes, more than three flavor medical materials, decoct with water 3 times, each 1 hour, collecting decoction, filter, relative density was 1.20 fluid extract when filtrate was concentrated into 70 ℃, added 95% ethanol, making ethanol content is 60%, and regulating pH value with 8% sodium hydroxide solution is 7.0, leaves standstill 24 hours, filter, filtrate adds ethanol again, and making concentration of alcohol is 75%, leaves standstill 12 hours, filter, filtrate recycling ethanol, relative density is 1.10 extractum when being concentrated into 70 ℃, drying, adding starch granulates, add magnesium stearate, mixing, tabletting, promptly.
The preparation of embodiment 3 Chinese medicinal composition capsules agent of the present invention
Get Ganoderma 180g, Radix Astragali 60g, Radix Et Caulis Acanthopanacis Senticosi 300g, pulverize, more than three flavor medical materials, decoct with water 2 times, each 2 hours, collecting decoction, filter, relative density was 1.10 fluid extract when filtrate was concentrated into 70 ℃, added 95% ethanol, making ethanol content is 70%, and regulating pH value with 8% sodium hydroxide solution is 6.5, leaves standstill 48 hours, filter, filtrate adds ethanol again, and making concentration of alcohol is 80%, left standstill 36 hours, filter, filtrate recycling ethanol, relative density is 1.02 extractum when being concentrated into 70 ℃, dry, pulverize, sieve mixing, incapsulate, promptly.
The preparation of embodiment 4 Chinese medicinal composition granules of the present invention
Get Ganoderma 160g, Radix Astragali 80g, Radix Et Caulis Acanthopanacis Senticosi 360g pulverizes, more than three flavor medical materials, decoct with water 1 time, decocted 2 hours, filter, relative density was 1.18 fluid extract when filtrate was concentrated into 70 ℃, added 95% ethanol, and making ethanol content is 63%, regulating pH value with 8% sodium hydroxide solution is 6.8, leaves standstill 30 hours, filters, filtrate adds ethanol again, making concentration of alcohol is 78%, leaves standstill 18 hours, filters, filtrate recycling ethanol, relative density is 1.05 extractum when being concentrated into 70 ℃, adds sucrose, dextrin, mixing, make granule, drying is in the compound membrane bag of packing into, promptly.
The preparation of embodiment 5 Chinese medicine composition oral liquids of the present invention
Get Ganoderma 140g, Radix Astragali 120g, Radix Et Caulis Acanthopanacis Senticosi 440g pulverizes, more than three flavor medical materials, decoct with water 2 times, each 1.5 hours, collecting decoction, filter, relative density was 1.15 fluid extract when filtrate was concentrated into 70 ℃, added 95% ethanol, making ethanol content is 67%, and regulating pH value with 8% sodium hydroxide solution is 6.6, leaves standstill 42 hours, filter, filtrate adds ethanol again, and making concentration of alcohol is 76%, left standstill 30 hours, and filtered filtrate recycling ethanol, relative density is 1.08 extractum when being concentrated into 70 ℃, adds sucrose 100g, heats little boiling 15 minutes, stir evenly, add water to ormal weight, stir evenly, filter, embedding, promptly.
Below set forth the effect of this Chinese medicine composition by test.
The influence of 1 pair of pentobarbital sodium in mice of experimental example length of one's sleep
50 of Kunming mouses, body weight 18--22g, male and female half and half are divided into 5 groups by weight average, 10 every group, are respectively blank group, the stable group of positive control and Chinese medicine composition of the present invention 3,6 and 12g crude drug/kg group.Every day, each administration group of Chinese medicine composition of the present invention is the medicine of orally give variable concentrations respectively, continuous 5 days except that the blank group gives isometric ordinary water.Positive controls was administered once in the 5th day, and dosage is 1mg/kg.After the last administration 45 minutes, lumbar injection 60mg/kg pentobarbital sodium as sleeping index, reverts to the length of one's sleep to righting reflex with righting reflex loss.
Table 1. Chinese medicine composition of the present invention is to the pentobarbital sodium in mice influence of the length of one's sleep
Compare with the blank group,
*P＜0.05,
*P＜0.01
Result of the test shows that Chinese medicine composition 6 of the present invention and 12g crude drug/kg group can obviously prolong pentobarbital sodium in mice length of one's sleep.
The influence of 2 pairs of mice autonomic activitieses of experimental example number of times
50 of Kunming mouses, body weight 18-22g, male and female half and half are divided into 5 groups at random, 10 every group, are respectively blank group, positive control compound Semen Ziziphi Spinosae Capsules group, Chinese medicine composition of the present invention 3,6 and 12g crude drug/kg group.Every day, each administration group of Chinese medicine composition of the present invention was irritated the medicine that stomach gives variable concentrations respectively, and positive controls is irritated stomach and given compound Semen Ziziphi Spinosae capsule 15g crude drug/kg, and blank group gives isometric ordinary water, successive administration 5 days.Behind the last administration 30min, mice is put in the toy analyzer, make it adapt to 3min after, movable number of times in the record 5min.The results are shown in Table 2.
Table 2. Chinese medicine composition of the present invention is to the influence of mice autonomic activities number of times
Compare with the blank group,
*P＜0.05,
*P＜0.01
Compare with the blank group, Chinese medicine composition 6 of the present invention and 12g crude drug/kg group can significantly reduce mice autonomic activities number of times, show that Chinese medicine composition of the present invention has tangible sedation to mice.
The influence of 3 pairs of mice swimming times of experimental example
50 of Kunming mouses, body weight 18-22g, male and female half and half are divided into 5 groups at random, 10 every group, are respectively blank group, positive control Ganoderma oral liquid group, Chinese medicine composition of the present invention 3,6 and 12g crude drug/kg group.Every day, each administration group of Chinese medicine composition of the present invention was irritated the medicine that stomach gives variable concentrations respectively, and positive controls is irritated stomach and given compound Semen Ziziphi Spinosae capsule 12g crude drug/kg, and blank group gives isometric ordinary water, successive administration 7 days.Behind the last administration 30nin, with Mus tail heavy burden 3g paperclip. put into tank, 25-30 ℃ of depth of water 25cm. water temperature calculate animal from the beginning of falling into water to nostril submerged 10 seconds, the time that can not emerge. as mice swimming time index, the results are shown in Table 3
Table 3. Chinese medicine composition of the present invention is to the influence of mice swimming time
Compare with the blank group,
*P＜0.05,
** p＜0.01
Compare with the blank group, Chinese medicine composition 6 of the present invention and 12g crude drug/kg group can significantly increase the mice swimming time, show that Chinese medicine composition of the present invention has strengthening the body resistance, the effect of strengthening by means of tonics.
Experimental example 4 Chinese medicine compositions of the present invention are to the influence of mice normal pressure anoxia enduring
Get 50 of Kunming mouses, body weight 17-21g, male and female half and half are divided into five groups at random after weighing, 10 every group, be respectively blank group, positive control Ganoderma oral liquid group, Chinese medicine composition of the present invention 3,6 and 12g crude drug/kg group.Every day, each administration group of Chinese medicine composition of the present invention was irritated the medicine that stomach gives variable concentrations respectively, positive controls is irritated stomach and is given compound Semen Ziziphi Spinosae capsule 12g crude drug/kg, blank group gives isometric ordinary water, administration was put into mice in the 250ml wide mouthed bottle that 15g sodica calx and a round filter paper are housed in advance after 20 minutes, bottleneck is coated with vaseline, tightens bottle cap, clocks immediately, to put into that mice ceases breathing to mice to the tight bottle cap of Cover inside the bottle is the hypoxia endurance time of mice, the results are shown in Table 4.
Table 1 Chinese medicine composition of the present invention is to mice normal pressure hypoxia endurance time
Annotate:
*Compare P＜0.05 with the normal saline group
Compare with the blank group, Chinese medicine composition 6 of the present invention and 12g crude drug/kg group can obviously prolong the mice hypoxia endurance time, have strengthening the body resistance, anti-stress effect.
Claims (2)
1, a kind of Chinese medicine composition oral liquid of tranquillizing and allaying excitement is characterized in that, described Chinese medicine composition oral liquid is made in accordance with the following methods: Ganoderma 140g, Radix Astragali 120g, Radix Et Caulis Acanthopanacis Senticosi 440g, pulverize, decoct with water each 1.5 hours 2 times, collecting decoction filters, and relative density was 1.15 fluid extract when filtrate was concentrated into 70 ℃, add 95% ethanol, making ethanol content is 67%, and regulating pH value with 8% sodium hydroxide solution is 6.6, left standstill 42 hours, filter, filtrate adds ethanol again, and making concentration of alcohol is 76%, left standstill 30 hours, filter, filtrate recycling ethanol, relative density is 1.08 extractum when being concentrated into 70 ℃, add sucrose 100g, heat little boiling 15 minutes, stir evenly, add water to ormal weight, stir evenly, filter, embedding, promptly.
2, the preparation method of Chinese medicine composition oral liquid as claimed in claim 1 is characterized in that, may further comprise the steps:
(1) get above medical material, pulverize, decoct with water 2 times, each 1.5 hours, collecting decoction filtered, and relative density was 1.15 fluid extract when filtrate was concentrated into 70 ℃;
(2) add 95% ethanol, making ethanol content is 67%, and regulating pH value with 8% sodium hydroxide solution is 6.6, leaves standstill 42 hours;
(3) filter, filtrate adds ethanol again, and making concentration of alcohol is 76%, leaves standstill 30 hours, filters, filtrate recycling ethanol, relative density is 1.08 extractum when being concentrated into 70 ℃, adds sucrose 100g, heats little boiling 15 minutes, stirs evenly, add water to ormal weight, stir evenly, filter embedding.
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| CN108434152A (en) * | 2018-03-26 | 2018-08-24 | 黑龙江珍宝岛药业股份有限公司 | A kind of pharmaceutical composition and its preparation method and application for improving sleep |
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| 国家中成药标准汇编 儿科 口腔科 肿瘤科分册. 国家药品监督管理局，403，404. 2002 |
| 国家中成药标准汇编 儿科 口腔科 肿瘤科分册. 国家药品监督管理局，403，404. 2002 * |
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