CN102058771A - Chinese medicine preparation for treating insomnia and preparation method thereof - Google Patents

Abstract

The invention discloses a Chinese medicine preparation for treating insomnia, which comprises raw medicines or active extracts thereof used as active components and medicinal carriers, wherein the raw medicines comprise the following components: 60 parts of polygala tenuifolia, 60 parts of rhizoma alismatis, 60 parts of radix ophiopogonis, 60 parts of codonopsis pilosula, 60 parts of cortex albiziae, 120 parts of poria cocos, 120 parts of liquorice, 120 parts of cinnabar, 40 parts of spina date seed, 120 parts of nacre mother of pearl, 60 parts of Chinese magnoliavine fruit, 120 parts of multiflower knotweed vine, 60 parts of prepared polygonum multiflorum, 120 parts of light wheat and 120 parts of uncaria. The preparation of the invention has no toxic or side effect, has the effects of nourishing yin, eliminating dysphoria and calming the nerves, is used for treating menopause hot flash sweating, dizziness, tinnitus, irritability and insomnia, has the advantages of convenience of taking and high curative effect, is commonly used in clinic and has the efficiency of more than 90 percent.

Description

Chinese medicine preparation of a kind of Cure for insomnia and preparation method thereof

Technical field

The invention belongs to the Chinese medicine preparation technical field, relate to Chinese medicine preparation of a kind of Cure for insomnia and its production and use.

Background technology

Summary of the invention

Clinical sleeping to be difficult for, easily wake up in the back of sleeping, can not sleep again after waking up, and sometimes sleeping and sometimes waking, or be insomnia all night and be its syndrome characteristics, and often with lassitude in the daytime, bradykinesia, fatigue and asthenia, very then vexed annoyance has a strong impact on physical and mental health and work, studying and living.Ancient Chinese medicine doctor think the etiology and pathogenesis of insomnia be main diseases with the internal injury caused by excess of seven emotions because of, its internal organs that relate to are unfaithful intention, spleen, liver, gallbladder, kidney not, its pathogenesis always belongs to battalion to be defended and becomes estranged, imbalance of YIN and YANG be disease, or the deficiency of YIN can not receive sun, or the excess of YANG must not be gone into the moon.As " Ling Shu Miraculous Pivot or Divine Axis greatly puzzled opinion " institute's cloud: " defending gas must not people Yu Yin, often stays in sun.Stay that then yang-energy is full in sun, yang-energy completely then sun is lifted up Sheng; Must not go into the then cloudy deficiency of vital energy of the moon, so the unable to close the eyes." " Ling Shu Miraculous Pivot or Divine Axis evil visitor a piece of writing " point out: " and the present gas visitor that faints hides six mansions in five, then defend gas walk alone in outside, row must not be gone into Yu Yin in sun.Row in sun then yang-energy contain, yang-energy Sheng Zeyang lifts up sunken, must not go into Yu Yin, the deficiency of YIN is not so close the eyes." as seen, it is the key point of insomnia that negative and positive are become estranged.

Insomnia can cause that people's feeling of fatigue, uneasiness, general malaise, listless, delay of response, headache, attention can not concentrate, its maximum effect is spiritual aspect, seriously a bit can cause functional diseases such as schizophrenia and depression, anxiety neurosis, autonomic nervous dysfunction, and each systemic disease, as cardiovascular system, digestive system or the like.After evening insomnia, can have a poor memory in second day.The up-to-date zoopery of carrying out of the U.S. and Britain research personnel has disclosed physiological mechanism wherein, and finds and can offset the harmful effect that insomnia causes memory with medicine.Can endocrine regulation and health blood circulation as Fa Linkani, Cure for insomnia disease has significant curative effect.

Univ Pennsylvania USA's research worker and Britain go together with publishing thesis on Britain's " nature " magazine of publication on the 22nd and introduce, and they have deprived experimental mouse sleep in 5 hours in experiment.Found that increasing all appears in the content of the enzyme of a kind of PDE4 by name and activity in the experimental mouse brain, and this kind of enzyme can keep the molecule of memory to impact to helping, thereby weaken memory.Further experiment is found, after use can suppress the related drugs of this kind of enzyme, just can not occurred the phenomenon of hypomnesis again by the experimental mouse of sleep deprivation.This shows on this basis can find effective therapeutic scheme, helps those people that had a sleepless night puzzlement to improve memory.The typing one of insomnia. from traditional Chinese medical science angle, insomnia is five types substantially: one: pathogenic fire derived from stagnation of liver-QI: how to be given birth to by angry unhappiness, show as less and sleep, being irritable and getting angry easily, red eyes and bitter taste in the mouth, constipation with dry stool, red tongue with yellow fur, stringy and rapid pulse.The side is based on Decoction of Gentiana for Purging the Liver-fire.

The detailed technical scheme of the present invention is as follows: the invention discloses a kind of Chinese medicine preparation of Cure for insomnia, it comprises that described raw medicinal material comprises as the raw medicinal material of the following parts by weight of active ingredient or its activity extract and pharmaceutically useful carrier:

Radix Polygalae 20-80 part Rhizoma Alismatis 20-80 part 20-80 Radix Ophiopogonis part

Radix Codonopsis 20-80 part Cortex Albiziae 20-80 part Poria 60-150 part

Radix Glycyrrhizae 60-150 part Cinnabaris 60-150 part Semen Ziziphi Spinosae 10-60 part.

The preferred Cure for insomnia of the present invention, wherein the raw medicinal material ratio of weight and number is:

Radix Polygalae 40-80 part Rhizoma Alismatis 40-80 part 40-80 Radix Ophiopogonis part

Radix Codonopsis 40-80 part Cortex Albiziae 40-80 part Poria 100-150 part

Radix Glycyrrhizae 100-150 part Cinnabaris 100-150 part Semen Ziziphi Spinosae 30-60 part.

The Cure for insomnia that the present invention is more preferably, wherein the raw medicinal material ratio of weight and number is:

60 parts of 60 portions of Rhizoma Alismatis of Radix Polygalae 60 parts of Radix Ophiopogonis

120 parts in 60 parts of Poria of 60 portions of Cortex Albiziaes of Radix Codonopsis

40 parts of 120 parts of Semen Ziziphi Spinosaes of 120 parts of Cinnabaris of Radix Glycyrrhizae

In a preferred embodiment of the present invention,, make activity extract with described raw medicinal material solvent extraction.Preferred solvent is selected from water, ethanol or their mixture.

Chinese medicine preparation of the present invention can be any dosage form of intestinal canal administration and parenterai administration, preferably raw medicinal material or its activity extract and any or several pharmaceutically acceptable carrier fully is mixed and made into oral formulations.Preferred oral formulations is tablet, granule, drop pill, pill or capsule.

The invention also discloses the preparation method of Cure for insomnia Chinese medicine preparation, comprising:

A. the raw medicinal material with recipe quantity drops in the extraction pot, adds to be selected from water, and ethanol or its mixture reflux as solvent, collect filtrate, and 2-3 time so repeatedly, the filtration back concentrates and obtains activity extract; With activity extract with make oral formulations after pharmaceutically acceptable carrier fully mixes; Perhaps

B. Fructus Tritici Levis, Radix Glycyrrhizae, the Concha Margaritifera powder with recipe quantity is broken into fine powder, sieves, and be standby; With adding Radix Polygalae, Cortex Albiziae, Radix Codonopsis, Poria, Cinnabaris, Radix Ophiopogonis water 1000-3000ml, decoct 2-3 time, filter, filtrate is condensed into clear paste; Fructus Schisandrae Chinensis, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata, Rhizoma Alismatis, Semen Ziziphi Spinosae, Ramulus Uncariae Cum Uncis carry out percolation with 75-95% ethanol as solvent, and diacolation liquid recycling ethanol is condensed into clear paste; With above-mentioned two kinds of clear paste and above-mentioned fine powder mixing, make coarse granule, drying is pulverized, and sieves, and makes granule, and cold drying is sieved, and adds magnesium stearate, mixing, compacting is in flakes.

The present invention when with the mixture of second alcohol and water when extracting solvent, concentration of ethanol is 75～95% (V/V).

In a preferred embodiment of the present invention, the activity extract that obtains among the method a further through organic solvent extraction, is made refining extract; Be that 1: 1.0～2.0 ratio is fully mixed them according to refining extract and Polyethylene Glycol ratio of weight and number then, make drop pill.Wherein organic solvent is methanol, ethanol, chloroform, ethyl acetate or n-butyl alcohol.Preferred alcohol or ethyl acetate and n-butyl alcohol.Polyethylene Glycol wherein can be a Polyethylene Glycol-6000, the mixture of Polyethylene Glycol-4000 or Polyethylene Glycol-6000 and Polyethylene Glycol-4000.Wherein the weight ratio of Macrogol 4000 and polyethylene glycol 6000 mixture is generally 1: 0.1-10.

Chinese medicine preparation of the present invention can be mixed and made into oral formulations with above-mentioned each medical material and any or several pharmaceutically acceptable pharmaceutical carrier.For example decoction, tablet, granule, drop pill, pill or capsule or the like.For example above-mentioned all flavor medical materials are mixed grinding to the powder altogether, be respectively charged into capsule, each 3 grams, day 2-4 time.Special situation can suitable being regulated according to patient's the state of an illness.

Pharmaceutical carrier of the present invention comprises: lactose, sucrose, starch, microcrystalline Cellulose, sorbitol, calcium phosphate; Binding agent, for example syrup, gelatin, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, starch, dextrin; Disintegrating agent, for example microcrystalline Cellulose, carboxymethyl starch sodium, sodium carboxymethyl cellulose, crospolyvinylpyrrolidone; Lubricant, for example magnesium stearate; High-molecular bone frame material, for example hydroxypropyl emthylcellulose, hydroxypropyl cellulose, ethyl cellulose, Brazil wax, hydrogenated vegetable oil, acrylic resin; Filmogen for example, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, acrylic resin or the like.

The specific embodiment

The following examples can help those skilled in the art more fully to understand the present invention.But do not limit the present invention in any way, the umber in the embodiment of the invention can be chosen as gram or kilogram according to the actual needs.

Embodiment 1

[prescription] Radix Polygalae 60g Rhizoma Alismatis 60g 60g Radix Ophiopogonis Radix Codonopsis 60g

Cortex Albiziae 60g Poria 120g Radix Glycyrrhizae 120g Cinnabaris 120g

Semen Ziziphi Spinosae 40g Concha Margaritifera 120g Fructus Schisandrae Chinensis 60g Caulis Polygoni Multiflori 120g

Radix Polygoni Multiflori Preparata 60g Fructus Tritici Levis 120g Ramulus Uncariae Cum Uncis 120g

[method for making] drops into the raw medicinal material of above-mentioned recipe quantity in the extraction pot, adds 2000ml water, decocts 50 minutes, uses 85% ethanol 3000ml then, refluxes, and collects filtrate, and 2-3 time so repeatedly, the filtration back concentrates and obtains activity extract; With activity extract, drying is pulverized, and sieves, and makes granule, and cold drying is sieved, and adds magnesium stearate, mixing, and compacting is made sheet in flakes.The bag film-coat, promptly.

Embodiment 2

[prescription] Radix Polygalae 60g Rhizoma Alismatis 60g 60g Radix Ophiopogonis Radix Codonopsis 60g

Cortex Albiziae 60g Poria 120g Radix Glycyrrhizae 120g Cinnabaris 120g

Semen Ziziphi Spinosae 40g Concha Margaritifera 120g Fructus Schisandrae Chinensis 60g Caulis Polygoni Multiflori 120g

Radix Polygoni Multiflori Preparata 60g Fructus Tritici Levis 120g Ramulus Uncariae Cum Uncis 120g

[method for making] above ten five tastes, Fructus Tritici Levis, Radix Glycyrrhizae, Concha Margaritifera powder are broken into fine powder, sieve, and be standby; Radix Polygalae, Cortex Albiziae, Radix Codonopsis, Poria, Cinnabaris, Radix Ophiopogonis add the 3000ml decocting and boil secondary, 3 hours for the first time, 2 hours for the second time, filter, it is 1.8 clear paste that filtrate is condensed into relative density;

Fructus Schisandrae Chinensis, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata, Rhizoma Alismatis, Semen Ziziphi Spinosae, Ramulus Uncariae Cum Uncis carry out percolation with 90% ethanol as solvent, and diacolation liquid recycling ethanol is condensed into relative density and is 1.25 clear paste.With above-mentioned two kinds of clear paste and above-mentioned fine powder mixing, make coarse granule, drying is pulverized, and sieves, and makes granule, and cold drying is sieved, and adds magnesium stearate, mixing, compacting is in flakes.The bag film-coat, promptly.

Embodiment 3

[prescription] Radix Polygalae 40g Rhizoma Alismatis 40g 40g Radix Ophiopogonis Radix Codonopsis 40g

Cortex Albiziae 40g Poria 100g Radix Glycyrrhizae 100g Cinnabaris 100g

Semen Ziziphi Spinosae 40g Concha Margaritifera 100g Fructus Schisandrae Chinensis 30g Caulis Polygoni Multiflori 100g

Radix Polygoni Multiflori Preparata 40g Fructus Tritici Levis 100g Ramulus Uncariae Cum Uncis 100g

[method for making] above ten five tastes, Fructus Tritici Levis, Radix Glycyrrhizae, Concha Margaritifera powder are broken into fine powder, sieve, and be standby; Radix Polygalae, Cortex Albiziae, Radix Codonopsis, Poria, Cinnabaris, Radix Ophiopogonis add the 1000ml decocting and boil secondary, 3 hours for the first time, 2 hours for the second time, filter, it is 1.2 clear paste that filtrate is condensed into relative density; Fructus Schisandrae Chinensis, Caulis Polygoni Multiflori, Radix Polygoni Multiflori Preparata, Rhizoma Alismatis, Semen Ziziphi Spinosae, Ramulus Uncariae Cum Uncis carry out percolation with 75% ethanol as solvent, and diacolation liquid recycling ethanol is condensed into relative density and is 1.20 clear paste.With above-mentioned two kinds of clear paste and above-mentioned fine powder mixing, granulate, sieve, drying, encapsulated, promptly.

Embodiment 4

[prescription] Radix Polygalae 80g Rhizoma Alismatis 80g 80g Radix Ophiopogonis Radix Codonopsis 80g

Cortex Albiziae 80g Poria 150g Radix Glycyrrhizae 150g Cinnabaris 150g

Semen Ziziphi Spinosae 80g Concha Margaritifera 1500g Fructus Schisandrae Chinensis 60g Caulis Polygoni Multiflori 150g

Radix Polygoni Multiflori Preparata 80g Fructus Tritici Levis 150g Ramulus Uncariae Cum Uncis 150g

[method for making] medicinal material extract: according to above-mentioned recipe quantity with the ethanol of 70% weight and aqueous mixtures reflux, extract, 2 times, each mixture with 2100ml second alcohol and water extracted 1 hour, filtrate is condensed into extractum, add 250ml water, make extractum become suspension, reuse ethyl acetate and n-butyl alcohol extract respectively 2 times, and each 250ml, extract are concentrated into the dried refining extract that becomes after filtering and merging.Get substrate 24.9g part, Polyethylene Glycol-6000,54.2 part, Polyethylene Glycol-4000,6.9 part glycerol is put in the container, is heated to 80 ℃ in water-bath, treat whole fusions after, add 21.5 parts of refining extracts, be stirred to dissolving evenly.The medicinal liquid for preparing is transferred in the reservoir, and airtight and insulation is at 80 ℃, and regulator solution titer valve splashes in 25 ℃ of methyl-silicone oils, with the drop pill drop that forms to the greatest extent and wipe methyl-silicone oil, and drying, promptly.

Embodiment 5

Radix Polygalae 60g Rhizoma Alismatis 60g 60g Radix Ophiopogonis Radix Codonopsis 80g

Cortex Albiziae 80g Poria 130g Radix Glycyrrhizae 120g Cinnabaris 100g

Semen Ziziphi Spinosae 40g Concha Margaritifera 100g Fructus Schisandrae Chinensis 70g Caulis Polygoni Multiflori 150g

Radix Polygoni Multiflori Preparata 60g Fructus Tritici Levis 120g Ramulus Uncariae Cum Uncis 100g.

Each component is pulverized, and the mix homogeneously that sieves adds 3.5% Mel then and makes pill.

Embodiment 6

Radix Polygalae 70g Rhizoma Alismatis 60g 80g Radix Ophiopogonis Radix Codonopsis 80g

Cortex Albiziae 80g Poria 100g Radix Glycyrrhizae 100g Cinnabaris 120g

Semen Ziziphi Spinosae 40g Concha Margaritifera 120g Fructus Schisandrae Chinensis 80g Caulis Polygoni Multiflori 120g

Radix Polygoni Multiflori Preparata 60g Fructus Tritici Levis 150g Ramulus Uncariae Cum Uncis 100g.

Make refining extract according to above-mentioned method according to embodiment 2, then with other medical material mix homogeneously, add 3 parts of amylum pregelatinisatums, 2.5 parts of magnesium stearate, mix homogeneously is granulated tabletting bag film-coat.

Claims (4)

1. the Chinese medicine preparation of a Cure for insomnia, it comprises that described raw medicinal material comprises as the raw medicinal material of the following parts by weight of active ingredient or its activity extract and pharmaceutically useful carrier:

Radix Polygalae 20-80 part Rhizoma Alismatis 20-80 part 20-80 Radix Ophiopogonis part

Radix Codonopsis 20-80 part Cortex Albiziae 20-80 part Poria 60-150 part

Radix Glycyrrhizae 60-150 part Cinnabaris 60-150 part Semen Ziziphi Spinosae 10-60 part.

2. the described Chinese medicine preparation of claim 1, wherein the raw medicinal material ratio of weight and number is:

Radix Polygalae 40-80 part Rhizoma Alismatis 40-80 part 40-80 Radix Ophiopogonis part

Radix Codonopsis 40-80 part Cortex Albiziae 40-80 part Poria 100-150 part

Radix Glycyrrhizae 100-150 part Cinnabaris 100-150 part Semen Ziziphi Spinosae 30-60 part.

3. the described Chinese medicine preparation of claim 1, raw medicinal material ratio of weight and number wherein is:

60 parts of 60 portions of Rhizoma Alismatis of Radix Polygalae 60 parts of Radix Ophiopogonis

120 parts in 60 parts of Poria of 60 portions of Cortex Albiziaes of Radix Codonopsis

40 parts of 120 parts of Semen Ziziphi Spinosaes of 120 parts of Cinnabaris of Radix Glycyrrhizae.

4. the described Chinese medicine preparation of claim 1, wherein said activity extract are to adopt water, ethanol or their mixture as solvent extraction.