CN102247456B - Chinese medicinal composition for treating stress sleep disorder - Google Patents
Chinese medicinal composition for treating stress sleep disorder Download PDFInfo
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- CN102247456B CN102247456B CN 201010173770 CN201010173770A CN102247456B CN 102247456 B CN102247456 B CN 102247456B CN 201010173770 CN201010173770 CN 201010173770 CN 201010173770 A CN201010173770 A CN 201010173770A CN 102247456 B CN102247456 B CN 102247456B
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Abstract
The invention discloses a Chinese medicinal composition for treating stress sleep disorder. The active ingredients of the Chinese medicinal composition are prepared from the following raw material in part by weight: 10 to 60 grams of hypericum perforatum, 10 to 60 parts of spina date seed and 20 to 80 parts of Morinda officinalis. The Chinese medicinal composition can be prepared into capsules, particles, soft capsules, pills, tablets or decoction. In the invention, a Chinese medicinal formula is formed on the basis of a theory that liver governs regulating and emotion and a principle of tonifying liver, promoting function of liver, regulating liver qi and clearing depression and heat. The formula is refined, simple and practical.
Description
Technical field
The invention belongs to medical technical field, particularly a kind of Chinese medicine composition that is used for the treatment of the irritability sleep disorder.
Background technology
The medicine for the treatment of sleep disorder is many on the market now, great majority are for suppressing central nervous system's (CNS) medicine, when using, larger dose can more deeply suppress CNS, can promote and keep approximate physiologic sleep, such as Benzodiazepines, barbiturates and other sedative hypnotic drugs, but this type of medicine is sleepy, dizzy in the m seq performance of taking medicine, lassitude, the after effect such as be still drank after a night.The allergic symptoms such as dermatitis, vasodilation can appear in a few peoples, accidental exfoliative dermatitis, n of high dose oral or intravenous injection are too fast all can to produce obvious inhibitory action to breathing, and can cause respiratory failure and death when seriously poisoning, and the popularity of its clinical practice is restricted.At present, the pure Chinese medicinal preparation for the treatment of sleep is less, is guidance mainly with tradition " brain master gods " and " The heart controls mental activities ", and prescription is complicated, has no the Chinese medicine of simple and clear " controlling from the liver opinion " the irritability sleep disorder of prescription.
The present invention is on the basis of a large amount of clinical practices and research, the condensed pathogenesis key that goes out the irritability sleep disorder is " liver damage ", transferring the liver treatment is the reasonable cognition of the method for effect victory, through repeatedly groping checking, develop and can embody " the tonifying liver body, help liver usefulness, dispersing liver-energy, let out hot and suffocating " Chinese medicine composition.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition that is used for the treatment of the irritability sleep disorder.
The present invention is as instructing take the theory of the traditional Chinese medical science " liver controlling conveyance and dispersion ", " liver master feelings will ", with " the tonifying liver body, help liver with, dispersing liver-energy, let out hot and suffocating " develop pure Chinese prescription, with pure Chinese medicine be Herba Hyperici perforati, Radix Morindae Officinalis and Semen Ziziphi Spinosae as active component, refining formula, simple.
Implementation procedure of the present invention is as follows:
A kind of Chinese medicine composition that is used for the treatment of the irritability sleep disorder, the effective ingredient that it is characterized in that described Chinese medicine composition is that following raw materials according is made by weight ratio: Herba Hyperici perforati 10-60 part, Semen Ziziphi Spinosae 10-60 part, Radix Morindae Officinalis 20-80 part.
Preferred proportioning raw materials is: Herba Hyperici perforati 30-40 part, Semen Ziziphi Spinosae 30-40 part, Radix Morindae Officinalis 35-55 part.
The preparation method of Chinese medicine composition of the present invention may further comprise the steps:
(1) use 60%-90% ethanol extraction Herba Hyperici perforati and Semen Ziziphi Spinosae 1～3 time, each 1～3 hour, merge extractive liquid,, Recycled ethanol, relative density is that 1.1-1.2 extractum is for subsequent use when being condensed into 75 ℃;
(2) above-mentioned residue medicinal residues and Radix Morindae Officinalis are mixed, extract take 8～12 times of water gagings as solvent, extract 1～3 time, each 1～3 hour, merge extractive liquid,, relative density is that 1.1-1.2 extractum is for subsequent use when being condensed into 75 ℃;
(3) above-mentioned two kinds of extractum are mixed, add suitable adjuvant and make medically acceptable dosage form.
Chinese medicine composition of the present invention can be capsule, granule, soft capsule, drop pill or tablet, wherein used carrier is conventional carrier in the preparation, filler commonly used is sucrose, starch, dextrin, 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., lubricant is Pulvis Talci, magnesium stearate etc., water-soluble base is Macrogol 4000, polyethylene glycol 6000, glycerol etc., coolant are simethicone, paraffin etc.
The present invention can also be mixed with Chinese medicine decoction, and is specific as follows: crude drug is mixed in the marmite, adds blister thoroughly (crude drug is 1: 2～4 with the water quality ratio), first intense fire is fried boiling, and with half an hour at a simmer, leaches medicinal liquid again; Add water in the medicinal residues and fry in shallow oil half an hour more in right amount, leach medicinal liquid; Twice medicinal liquid mixing.
Chinese medicine composition of the present invention is applicable to the treatment of the sleep disorder disease that causes because of psychological stress, has clinical refining formula, and curative effect is reliable, the characteristics that toxic and side effects is little.
The specific embodiment
Embodiment 1: the preparation of Chinese medicinal composition capsules agent of the present invention
Get Herba Hyperici perforati 200 grams, Semen Ziziphi Spinosae 200 grams, Radix Morindae Officinalis 300 grams three flavor Chinese crude drugs, with 60%-90% ethanol extraction Herba Hyperici perforati and Semen Ziziphi Spinosae, extract each 1.5 hours 2 times, merge extractive liquid,, Recycled ethanol, being condensed into relative density is 1.1-1.2 (50-60 ℃) clear paste.Above-mentioned medicinal residues and Radix Morindae Officinalis are mixed, extract take 10 times of water gagings as solvent, extract 2 times, each 1.5 hours, merge extractive liquid,, being condensed into relative density is 1.1-1.2 (50-60 ℃) clear paste.With above-mentioned two kinds of clear paste, respectively cold drying is pulverized, and sieves, and mix homogeneously incapsulates, and get final product.
Embodiment 2: the preparation of Chinese medicinal composition granules of the present invention
Get Herba Hyperici perforati 300 grams, Semen Ziziphi Spinosae 300 grams, Radix Morindae Officinalis 400 grams three flavor Chinese crude drugs, with 60%-90% ethanol extraction Herba Hyperici perforati and Semen Ziziphi Spinosae, extract each 1.5 hours 2 times, merge extractive liquid,, Recycled ethanol, being condensed into relative density is 1.0-1.2 (50-60 ℃) clear paste.Above-mentioned medicinal residues and Radix Morindae Officinalis are mixed, extract take 10 times of water gagings as solvent, extract 2 times, each 2 hours, merge extractive liquid,, being condensed into relative density is 1.1-1.2 (50-60 ℃) clear paste.With above-mentioned two kinds of clear paste mixings, add dextrin, mix homogeneously, wet granulation, drying, granulate in the compound membrane bag of packing into, and get final product.
Embodiment 3: the preparation of Chinese medicine composition soft capsule of the present invention
Get Herba Hyperici perforati 500 grams, Semen Ziziphi Spinosae 500 grams, Radix Morindae Officinalis 800 grams three flavor Chinese crude drugs, with 60%-90% ethanol extraction Herba Hyperici perforati and Semen Ziziphi Spinosae, extract each 1.5 hours 2 times, merge extractive liquid,, Recycled ethanol, being condensed into relative density is 1.0-1.2 (50-60 ℃) clear paste.Above-mentioned medicinal residues and Radix Morindae Officinalis are mixed, extract take 10 times of water gagings as solvent, extract 2 times, each 1.5 hours, merge extractive liquid,, being condensed into relative density is 1.1-1.3 (50-60 ℃) clear paste.With above-mentioned two kinds of clear paste mix homogeneously, cold drying is pulverized, and crosses sieve No. five, and is for subsequent use with an amount of vegetable oil mix homogeneously.Ratio with 100 parts in gelatin, 30 parts of glycerol, 130 parts in water prepares capsule material liquid.The dripping soft capsule, and with 95% washing with alcohol surface, 40-50 ℃ dries up, and get final product.
Embodiment 4: the preparation of Chinese medicine composition pill agent of the present invention
Get Herba Hyperici perforati 400 grams, Semen Ziziphi Spinosae 300 grams, Radix Morindae Officinalis 600 grams three flavor Chinese crude drugs, with 60%-90% ethanol extraction Herba Hyperici perforati and Semen Ziziphi Spinosae, extract each 1.5 hours 2 times, merge extractive liquid,, Recycled ethanol, being condensed into relative density is 1.0-1.1 (50-60 ℃) clear paste.Above-mentioned medicinal residues and Radix Morindae Officinalis are mixed, extract take 10 times of water gagings as solvent, extract 2 times, each 1.5 hours, merge extractive liquid,, being condensed into relative density is 1.1-1.2 (50-60 ℃) clear paste.With above-mentioned two kinds of clear paste mix homogeneously, add with Macrogol 4000 and polyethylene glycol 6000 medicine carrying body according to a certain ratio, take simethicone as coolant, keeping the dripping temperature is 80-100 ℃, take out, drying, and get final product.
Embodiment 5: the preparation of Chinese medicine composition tablet of the present invention
Get Herba Hyperici perforati 300 grams, Semen Ziziphi Spinosae 300 grams, Radix Morindae Officinalis 500 grams three flavor Chinese crude drugs with 60%-90% ethanol extraction Herba Hyperici perforati and Semen Ziziphi Spinosae, extract 2 times, and each 2 hours, merge extractive liquid,, Recycled ethanol is concentrated into the clear paste without the alcohol flavor.Above-mentioned medicinal residues and Radix Morindae Officinalis are mixed, extract take 10 times of water gagings as solvent, extract 2 times, each 1.5 hours, merge extractive liquid,, being condensed into relative density is 1.1-1.3 (50-60 ℃) clear paste.Above-mentioned two kinds of clear paste are dry respectively, add starch, magnesium stearate, mixing, tabletting, and get final product.
The Preliminary Clinical Observation result of embodiment 6 Chinese medicine compositions of the present invention
Year April in June, 2006 to 2007, or/and the 57 routine Psychophysiological insomnia patients that are in hospital, treatment group gave the decoction (each 250 milliliters, 2/ day) of Chinese medicine composition in the HC outpatient service of inventor place; Matched group gives Stilnox sheet (10mg 1/ day)
The total Clinical efficacy comparison for the treatment of number of table 1
Annotate: relatively front with treatment, P＜0.05, there were significant differences.
The Clinical efficacy comparison of table 2 Polysomnography (x ± s)
Annotate: relatively front with treatment, * P＜0.05, there were significant differences.
Table 3 sleep scale monitoring minute change relatively (minute, x ± s)
Annotate: paired comparison t check before the treatment: P＜0.05
The comparison of table 4 clinical side effects evaluation result (x ± s)
Annotate: relatively front with treatment, P＜0.05, there were significant differences.
Show by clinical observation result: from Clinical efficacy comparison, the treatment group total effective rate is greater than matched group; Go out from the Monitoring Indexes of Polysomnography: Sleep latency was in normal range, and REM shortens than matched group incubation period, and total sleep time prolongs, and Sleep efficiency obviously improves than matched group; Although the score value of sleep scale monitoring is large than matched group, still obviously reduced as the clinical side effects of Chinese medicine composition.
Above-mentioned experiment has confirmed that further the present invention has definite curative effect to the irritability sleep disorder.
Claims (5)
1. Chinese medicine composition that is used for the treatment of the irritability sleep disorder, the effective ingredient that it is characterized in that described Chinese medicine composition are that by weight ratio following raw materials according is made: Herba Hyperici perforati 30-40 part, Semen Ziziphi Spinosae 30-40 part, Radix Morindae Officinalis 35-55 part.
2. the preparation method of Chinese medicine composition claimed in claim 1 may further comprise the steps:
(1) use 60%-90% ethanol extraction Herba Hyperici perforati and Semen Ziziphi Spinosae 1～3 time, each 1～3 hour, merge extractive liquid,, Recycled ethanol, relative density is that 1.1-1.2 extractum is for subsequent use when being condensed into 75 ℃;
(2) above-mentioned residue medicinal residues and Radix Morindae Officinalis are mixed, extract take 8～12 times of water gagings as solvent, extract 1～3 time, each 1～3 hour, merge extractive liquid,, relative density is that 1.1-1.2 extractum is for subsequent use when being condensed into 75 ℃;
(3) above-mentioned two kinds of extractum are mixed, add suitable adjuvant and make medically acceptable dosage form.
3. Chinese medicine composition according to claim 1 is characterized in that it is capsule, granule, soft capsule, drop pill or tablet.
4. Chinese medicine composition according to claim 1 is characterized in that it is Chinese medicine decoction.
5. the application of Chinese medicine composition claimed in claim 1 in preparation treatment irritability sleep disorder medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010173770 CN102247456B (en) | 2010-05-17 | 2010-05-17 | Chinese medicinal composition for treating stress sleep disorder |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 201010173770 CN102247456B (en) | 2010-05-17 | 2010-05-17 | Chinese medicinal composition for treating stress sleep disorder |
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| CN102247456A CN102247456A (en) | 2011-11-23 |
| CN102247456B true CN102247456B (en) | 2013-01-30 |
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| CN 201010173770 Expired - Fee Related CN102247456B (en) | 2010-05-17 | 2010-05-17 | Chinese medicinal composition for treating stress sleep disorder |
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