CN102416071B - Medicinal composition with effect of treating insomnia, preparation method and application of medicinal composition - Google Patents
Medicinal composition with effect of treating insomnia, preparation method and application of medicinal composition Download PDFInfo
- Publication number
- CN102416071B CN102416071B CN2011103987793A CN201110398779A CN102416071B CN 102416071 B CN102416071 B CN 102416071B CN 2011103987793 A CN2011103987793 A CN 2011103987793A CN 201110398779 A CN201110398779 A CN 201110398779A CN 102416071 B CN102416071 B CN 102416071B
- Authority
- CN
- China
- Prior art keywords
- parts
- concentrated
- effect
- weight
- insomnia
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a medicinal composition with an effect of treating insomnia, a preparation method and application of the medicinal composition. The medicinal composition is prepared from the following Chinese herbal medicines in part by weight: 1 to 5 parts of astragalus, 1 to 5 parts of largehead atractylodes rhizome, 1 to 5 parts of gensing, 1 to 5 parts of sweet wormwood herb, 1 to 5 parts of lycium bark, 1 to 6 parts of turtle shell, 1 to 5 parts of raw liquoric root and 1 to 5 parts of tuckahoe. In the medicinal composition, according to the theory of traditional Chinese medicine, Chinese medicines are prepared by adopting a theory with syndrome differentiation; and clinical experiment results indicate that the medicinal composition can improve sleep quality obviously, has a good effect of treating insomnia, is convenient to take clinically and low in relapse rate and does not have toxic or side effect after being used for a long term. In addition, the preparation method for the medicinal composition is stable, is high in operability and is suitable for large-scale industrial production, the content of extracted active ingredients is high, and impurities are few.
Description
Technical field
The present invention relates to a kind of medicine, be specifically related to a kind of pharmaceutical composition with effect for the treatment of insomnia and preparation method thereof and its application.
Background technology
Existing modern society, people's pressure is large, and work, life all are in a kind of very nervous state, and many people have sleep disorder." World Sleep Day " investigation according to psychiatry branch of Chinese Medical Association issue shows, in state-owned 45% people have sleep disorder---500,000,000 people are not sleep well, and this numeral is also in continuous rising.Because sleep quality is not high, cause gradually variation of people's health, work and life are caused larger negative effect, major part exists the people of sleeping problems to select chemical drugs, such as the stable medicine assisting sleep that waits, but there is larger untoward reaction in chemical drugs, and some has stronger according to patience, and sleep quality is poor all the better after the drug withdrawal.
Chinese patent medicine is as the traditional disease treatment means of China, because of its to the many-sided integrally-regulated effect of human body, toxic and side effects is little, treating both the principal and secondary aspects of a disease, and the insomniac generally believes that insomnia belongs to neurasthenia's (autonomic nerve disorder), and is therefore necessary on the theory of Chinese medical science basis, according to the principle of determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, it is effective to research and develop a kind of Cure for insomnia, the Chinese medicine composition that untoward reaction is low.
Summary of the invention
Goal of the invention: the objective of the invention is in order to solve the deficiencies in the prior art, provide a kind of proportioning scientific and reasonable, Cure for insomnia definite effect, clinical practice safety, the pharmaceutical composition that untoward reaction is low, another object of the present invention provide preparation method and the application thereof of this pharmaceutical composition.
Technical scheme: in order to realize above purpose, the technical scheme that the present invention takes is:
A kind of pharmaceutical composition with effect for the treatment of insomnia, it is to be made by the crude drug of following parts by weight: 1 ~ 5 part of the Radix Astragali, 1 ~ 5 part of the Rhizoma Atractylodis Macrocephalae, 1 ~ 5 part of Radix Codonopsis, 1 ~ 5 part of Herba Artemisiae Annuae, 1 ~ 5 part of Cortex Lycii, 1 ~ 6 part of Carapax Trionycis, 1 ~ 5 part of Radix Glycyrrhizae, 1 ~ 5 part in Poria.
As preferred version, above-described pharmaceutical composition with effect for the treatment of insomnia, it is to be made by the crude drug of following parts by weight: 1 ~ 2 part of the Radix Astragali, 1 ~ 2 part of the Rhizoma Atractylodis Macrocephalae, 1 ~ 2 part of Radix Codonopsis, 1 ~ 2 part of Herba Artemisiae Annuae, 1 ~ 2 part of Cortex Lycii, 1 ~ 3 part of Carapax Trionycis, 1 ~ 2 part of Radix Glycyrrhizae, 1 ~ 2 part in Poria.
As more preferably scheme, above-described pharmaceutical composition with effect for the treatment of insomnia, it is to be made by the crude drug of following parts by weight: 1.5 parts of the Radixs Astragali, 1.5 parts of the Rhizoma Atractylodis Macrocephalaes, 1.5 parts of Radix Codonopsis, 1.5 parts of Herba Artemisiae Annuaes, 1.5 parts of Cortex Lycii, 2 parts of Carapax Trionycis, 1.2 parts of Radix Glycyrrhizae, 1.5 parts in Poria.
As further preferred version, above-described pharmaceutical composition with effect for the treatment of insomnia, it is to be made by the crude drug of following parts by weight: 1.55 parts of the Radixs Astragali, 1.55 parts of the Rhizoma Atractylodis Macrocephalaes, 1.55 parts of Radix Codonopsis, 1.55 parts of Herba Artemisiae Annuaes, 1.55 parts of Cortex Lycii, 2.1 parts of Carapax Trionycis, 1.25 parts of Radix Glycyrrhizae, 1.55 parts in Poria.
Pharmaceutical composition with effect for the treatment of insomnia of the present invention, with the medicine that extract and the pharmaceutically acceptable carrier of each crude drug is prepared into oral liquid, granule, capsule or Tabules etc., convenient clinical taking.
Chinese prescription provided by the invention according to Chinese medical theory, adopts determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs to carry out composition of prescription, Radix Astragali sweet in the mouth wherein, feeble QI temperature, start with lunar, foot is lunar, the hands warp of the moon less, the Radix Astragali is the panacea of invigorating QI to consolidate the body surface resistance; The Rhizoma Atractylodis Macrocephalae is bitter, sweet, temperature.Return spleen, stomach warp; Has invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis effect; Radix Codonopsis, property is flat, and spleen, lung meridian are returned in sweet in the mouth, little acid, have good invigorating the spleen and replenishing QI, spleen invigorating lung benefiting effect; Herba Artemisiae Annuae, hardship, suffering, cold, return liver, gallbladder meridian, have clearly thoroughly deficiency-heat, removing heat from blood is except steaming the effects such as removing heat from blood; Cortex Lycii, nature and flavor are cold in nature, and sweet in the mouth has removing heat from blood except steaming lung heat clearing pathogenic fire reducing effect; Carapax Trionycis is salty, cold, has the nourishing kidney YANG hyperactivity suppressing, the effects such as hard masses softening and resolving; The Poria nature and flavor are sweet, light, flat, and GUIXIN warp, lung meridian, spleen channel, kidney channel have the effects such as promoting diuresis to eliminate damp pathogen; Radix Glycyrrhizae, property is sweet, and is flat, GUIXIN, lung, spleen, stomach warp, invigorating the spleen and replenishing QI has heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription effect; Perfect square adopts determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs to carry out composition of prescription according to Chinese medical theory, and clinical experiment shows to have good benefiting QI for strengthening the superficies, and the effects such as spleen invigorating lung benefiting, heat clearing and blood cooling, nourishing kidney YANG hyperactivity suppressing can obviously be improved sleep quality.
Pharmaceutical composition with effect for the treatment of insomnia provided by the invention can be prepared into oral liquid, granule, capsule, Tabules medicine with extract and the pharmaceutically acceptable carrier of each crude drug.
When the extract of each raw material of pharmaceutical composition provided by the invention is made oral liquid, with the extract adding distil water dissolving of each raw material, filter, add syrup, regulate pH value, make oral liquid.
During the extract granulation agent of each raw material of pharmaceutical composition provided by the invention, the extract of each raw material and diluent lactose or corn starch mix homogeneously, granulate, drying, granulation agent.
When the extract of pharmaceutical composition provided by the invention is made capsule the extract of each raw material and carrier lactose or corn starch mix homogeneously, granulate, the then encapsulated capsule of making.
When the extract of each raw material of pharmaceutical composition provided by the invention is made tablet, each raw material and lactose or corn starch, add magnesium stearate lubricant when needing, mix homogeneously, granulate, then tabletting is made tablet.
Preparation method with pharmaceutical composition of effect for the treatment of insomnia of the present invention, it may further comprise the steps:
(1) get by weight the Radix Astragali and the Rhizoma Atractylodis Macrocephalae, with 6 to 8 times of amounts of medical material, concentration is 80% to 85% alcohol reflux 2 to 3 times, each 2 to 3 hours, be evaporated to without alcohol flavor, sucking filtration, namely get the alcohol extract of the Radix Astragali and the Rhizoma Atractylodis Macrocephalae, then thin up goes up the D101 macroporous adsorptive resins to containing crude drug amount 40g/L, with 6 to 10 times of column volume 70% ethanol elution resins, collect each eluent, be evaporated to without the alcohol flavor, drying under reduced pressure, for subsequent use;
(2) get by weight Radix Codonopsis, add 6 ~ 10 times of water gagings and decoct each 1 ~ 2 hour three times, merge three times fried liquid, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 60% ~ 90%, after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, get filtrate, concentrated, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, for subsequent use;
(3) get by weight Herba Artemisiae Annuae, be ground into coarse powder, add the petroleum ether reflux, extract, three times of 5 ~ 8 times of amounts, each 2 to 3 hours, merge three times extracting solution, extracting solution filters after with activated carbon decolorizing, and steaming petroleum ether is concentrated into the thick paste shape, and is for subsequent use;
(4) get by weight Cortex Lycii, with 8 to 10 times of amount 75% to 85% alcohol reflux 2 to 3 times, each 2 to 3 hours, merge extractive liquid, filtered, Recycled ethanol, and concentrating under reduced pressure becomes extractum, and is for subsequent use;
(5) get by weight Carapax Trionycis, be ground into coarse powder, add 6 ~ 10 times of water gagings and decoct three times, each 2 to 4 hours, merge fried liquid, for subsequent use;
(6) get by weight the Radix Glycyrrhizae coarse powder, add 80% alcoholic solution that contains 1% ammonia of 8 to 10 times of amounts, supersound extraction is 2 times in the time of 40 ℃, each 1 to 2 hour, merge extractive liquid,, filter, be concentrated into paste, add concentrated sulphuric acid and transfer pH to 2 ~ 3, fully stir, leave standstill filtration, get precipitation reduced vacuum drying, for subsequent use;
(7) get by weight the Poria coarse powder, add 4 ~ 6 times of water gagings and decoct each 1 ~ 2 hour three times, merge three times fried liquid, filter, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 60% ~ 90%, and after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, taking precipitate is dissolved in water, adding ethanol makes and contains alcohol amount and reach 70% again, leave standstill filtration, the taking precipitate drying under reduced pressure, for subsequent use;
Each extract spray drying that combining step (1) to step (7) obtains gets the medicine that extract powder and pharmaceutically acceptable carrier are prepared into oral liquid, granule, capsule or Tabules.
The preparation method of pharmaceutical composition provided by the invention is according to the physicochemical property of different medical material effective ingredient, and it is high to optimize the active component extraction efficiency for each medical material by great many of experiments, the preparation method that impurity content is low.
Pharmaceutical composition with effect for the treatment of insomnia provided by the invention can be used as the application in the preparation control insomnia drug.
Beneficial effect: the present invention is according to Chinese medical theory, adopt the theory of determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs to carry out the Chinese prescription screening, the pharmaceutical composition proportioning that provides is scientific and reasonable, clinical experiment is the result show, pharmaceutical composition provided by the invention has good dispersing the stagnated live-QI to relieve the stagnation of QI, the effect of nourishing YIN for tranquillization, can obviously shorten time for falling asleep, prolong the length of one's sleep, significantly improve sleep quality, improve the quality of living, and the extract of pharmaceutical composition provided by the invention can make things convenient for and pharmaceutical carriers is prepared into multiple dosage form, taking convenience clinically, and it is controlled that experimental result shows that pharmaceutical composition provided by the invention has quality safety, is easy to absorb the characteristics that life-time service has no side effect.The preparation method of while pharmaceutical composition provided by the invention, process stabilizing, effective component extracting content is high, and impurity is few, and is workable, is fit to industrialized great production.
The specific embodiment:
Further illustrate the present invention below in conjunction with specific embodiment, should understand these embodiment only is used for explanation the present invention and is not used in and limits the scope of the invention, after having read the present invention, those skilled in the art all fall within the application's claims limited range to the modification of the various equivalent form of values of the present invention.
Embodiment 1
1, the crude drug that has the pharmaceutical composition of effect for the treatment of insomnia: 1.5 parts of the Radixs Astragali, 1.5 parts of the Rhizoma Atractylodis Macrocephalaes, 1.5 parts of Radix Codonopsis, 1.5 parts of Herba Artemisiae Annuaes, 1.5 parts of Cortex Lycii, 2 parts of Carapax Trionycis, 1.2 parts of Radix Glycyrrhizae, 1.5 parts in Poria.
2, the preparation method that has the pharmaceutical composition of effect for the treatment of insomnia:
(1) get 1.5 parts of 1.5 parts of the Radixs Astragali and the Rhizoma Atractylodis Macrocephalaes, add 8 times of amounts, concentration is 80% alcohol reflux 2 times, each 2 hours, be evaporated to without alcohol flavor, sucking filtration, namely get the alcohol extract of the Radix Astragali and the Rhizoma Atractylodis Macrocephalae, then thin up goes up the D101 macroporous adsorptive resins to containing crude drug amount 40g/L, with 6 times of column volumes, 70% ethanol elution resin, collect each eluent, be evaporated to without the alcohol flavor, drying under reduced pressure, for subsequent use;
(2) get 1.5 parts of Radix Codonopsis, add 8 times of water gagings and decoct each 2 hours three times, merge three times fried liquid, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 80%, after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, get filtrate, concentrated, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, for subsequent use;
(3) get 1.5 parts of Herba Artemisiae Annuaes, be ground into coarse powder, add the petroleum ether reflux, extract, three times of 8 times of amounts, each 2 hours, merge three times extracting solution, extracting solution filters after with activated carbon decolorizing, and steaming petroleum ether is concentrated into the thick paste shape, and is for subsequent use;
(4) get 1.5 parts of Cortex Lycii, with 10 times of amount 75% alcohol reflux 2 times, each 2 hours, merge extractive liquid, filtered, Recycled ethanol, and concentrating under reduced pressure becomes extractum, and is for subsequent use;
(5) get 2 parts of Carapax Trionycis, be ground into coarse powder, add 6 times of water gagings and decoct three times, each 3 hours, merge fried liquid, for subsequent use;
(6) get 1.2 parts of Radix Glycyrrhizae coarse powder, add 80% alcoholic solution that contains 1% ammonia of 8 times of amounts, supersound extraction is 2 times in the time of 40 ℃, each 2 hours, merge extractive liquid, filters, and is concentrated into paste, adds concentrated sulphuric acid and transfers pH to 2 ~ 3, fully stir, leave standstill filtration, get precipitation reduced vacuum drying, for subsequent use;
(7) get Poria coarse powder 1.5, add 6 times of water gagings and decoct each 2 hours three times, merge three times fried liquid, filter, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 70%, and after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, taking precipitate is dissolved in water, adding ethanol makes and contains alcohol amount and reach 70% again, leave standstill filtration, the taking precipitate drying under reduced pressure, for subsequent use;
Each extract spray drying that combining step (1) to step (7) obtains gets the dissolving of extract powder adding distil water, filters, and adds syrup, regulates pH value, makes oral liquid.(lot number: 001)
Embodiment 2
1, the crude drug that has the pharmaceutical composition of effect for the treatment of insomnia: 1.55 parts of the Radixs Astragali, 1.55 parts of the Rhizoma Atractylodis Macrocephalaes, 1.55 parts of Radix Codonopsis, 1.55 parts of Herba Artemisiae Annuaes, 1.55 parts of Cortex Lycii, 2.1 parts of Carapax Trionycis, 1.25 parts of Radix Glycyrrhizae, 1.55 parts in Poria.
2, the preparation method that has the pharmaceutical composition of effect for the treatment of insomnia:
(1) get 1.55 parts of 1.55 parts of the Radixs Astragali and the Rhizoma Atractylodis Macrocephalaes, add 6 times of amounts, concentration is 85% alcohol reflux 3 times, each 2 hours, be evaporated to without alcohol flavor, sucking filtration, namely get the alcohol extract of the Radix Astragali and the Rhizoma Atractylodis Macrocephalae, then thin up goes up the D101 macroporous adsorptive resins to containing crude drug amount 40g/L, with 10 times of column volumes, 70% ethanol elution resin, collect each eluent, be evaporated to without the alcohol flavor, drying under reduced pressure, for subsequent use;
(2) get 1.55 parts of Radix Codonopsis, add 10 times of water gagings and decoct each 2 hours three times, merge three times fried liquid, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 90%, after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, get filtrate, concentrated, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, for subsequent use;
(3) get 1.55 parts of Herba Artemisiae Annuaes, be ground into coarse powder, add the petroleum ether reflux, extract, three times of 6 times of amounts, each 3 hours, merge three times extracting solution, extracting solution filters after with activated carbon decolorizing, and steaming petroleum ether is concentrated into the thick paste shape, and is for subsequent use;
(4) get 1.55 parts of Cortex Lycii, with 8 times of amount 85% alcohol reflux 3 times, each 2 hours, merge extractive liquid, filtered, Recycled ethanol, and concentrating under reduced pressure becomes extractum, and is for subsequent use;
(5) get 2.1 parts of Carapax Trionycis, be ground into coarse powder, add 10 times of water gagings and decoct three times, each 2 hours, merge fried liquid, for subsequent use;
(6) get 1.25 parts of Radix Glycyrrhizae coarse powder, add 80% alcoholic solution that contains 1% ammonia of 10 times of amounts, supersound extraction is 2 times in the time of 40 ℃, each 1 hour, merge extractive liquid, filters, and is concentrated into paste, adds concentrated sulphuric acid and transfers pH to 2 ~ 3, fully stir, leave standstill filtration, get precipitation reduced vacuum drying, for subsequent use;
(7) get Poria coarse powder 1.55, add 4 times of water gagings and decoct each 2 hours three times, merge three times fried liquid, filter, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 90%, and after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, taking precipitate is dissolved in water, adding ethanol makes and contains alcohol amount and reach 70% again, leave standstill filtration, the taking precipitate drying under reduced pressure, for subsequent use;
Each extract spray drying that combining step (1) to step (7) obtains gets extract powder and adds diluent lactose or corn starch mix homogeneously, granulate, drying, granulation agent.(lot number: 002)
Embodiment 3
1, the crude drug that has the pharmaceutical composition of effect for the treatment of insomnia: 2 parts of the Radixs Astragali, 2 parts of the Rhizoma Atractylodis Macrocephalaes, 2 parts of Radix Codonopsis, 2 parts of Herba Artemisiae Annuaes, 2 parts of Cortex Lycii, 3 parts of Carapax Trionycis, 2 parts of Radix Glycyrrhizae, 2 parts in Poria.
2, the preparation method that has the pharmaceutical composition of effect for the treatment of insomnia:
(1) get 2 parts of 2 parts of the Radixs Astragali and the Rhizoma Atractylodis Macrocephalaes, add 8 times of amounts, concentration is 80% alcohol reflux 3 times, each 2 hours, be evaporated to without alcohol flavor, sucking filtration, namely get the alcohol extract of the Radix Astragali and the Rhizoma Atractylodis Macrocephalae, then thin up goes up the D101 macroporous adsorptive resins to containing crude drug amount 40g/L, with 8 times of column volumes, 70% ethanol elution resin, collect each eluent, be evaporated to without the alcohol flavor, drying under reduced pressure, for subsequent use;
(2) get 2 parts of Radix Codonopsis, add 8 times of water gagings and decoct each 2 hours three times, merge three times fried liquid, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 60%, after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, get filtrate, concentrated, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, for subsequent use;
(3) get 2 parts of Herba Artemisiae Annuaes, be ground into coarse powder, add the petroleum ether reflux, extract, three times of 5 times of amounts, each 2 hours, merge three times extracting solution, extracting solution filters after with activated carbon decolorizing, and steaming petroleum ether is concentrated into the thick paste shape, and is for subsequent use;
(4) get 2 parts of Cortex Lycii, with 8 times of amount 80% alcohol reflux 2 times, each 3 hours, merge extractive liquid, filtered, Recycled ethanol, and concentrating under reduced pressure becomes extractum, and is for subsequent use;
(5) get 3 parts of Carapax Trionycis, be ground into coarse powder, add 6 times of water gagings and decoct three times, each 4 hours, merge fried liquid, for subsequent use;
(6) get 2 parts of Radix Glycyrrhizae coarse powder, add 80% alcoholic solution that contains 1% ammonia of 8 times of amounts, supersound extraction is 2 times in the time of 40 ℃, each 2 hours, merge extractive liquid, filters, and is concentrated into paste, adds concentrated sulphuric acid and transfers pH to 2 ~ 3, fully stir, leave standstill filtration, get precipitation reduced vacuum drying, for subsequent use;
(7) get 2 parts of Poria coarse powder, add 6 times of water gagings and decoct each 1 hour three times, merge three times fried liquid, filter, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 80%, and after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, taking precipitate is dissolved in water, adding ethanol makes and contains alcohol amount and reach 70% again, leave standstill filtration, the taking precipitate drying under reduced pressure, for subsequent use;
Each extract spray drying that combining step (1) to step (7) obtains gets extract powder and adds lactose, and the corn starch mix homogeneously adds magnesium stearate lubricant, mix homogeneously, and granulate, then tabletting is made tablet.(lot number: 003)
Embodiment 4
1, the crude drug that has the pharmaceutical composition of effect for the treatment of insomnia: 5 parts of the Radixs Astragali, 5 parts of the Rhizoma Atractylodis Macrocephalaes, 4 parts of Radix Codonopsis, 4 parts of Herba Artemisiae Annuaes, 3 parts of Cortex Lycii, 6 parts of Carapax Trionycis, 5 parts of Radix Glycyrrhizae, 5 parts in Poria.
2, the preparation method that has the pharmaceutical composition of effect for the treatment of insomnia:
(1) get 5 parts of 5 parts of the Radixs Astragali and the Rhizoma Atractylodis Macrocephalaes, add 8 times of amounts, concentration is 80% alcohol reflux 3 times, each 2 hours, be evaporated to without alcohol flavor, sucking filtration, namely get the alcohol extract of the Radix Astragali and the Rhizoma Atractylodis Macrocephalae, then thin up goes up the D101 macroporous adsorptive resins to containing crude drug amount 40g/L, with 8 times of column volumes, 70% ethanol elution resin, collect each eluent, be evaporated to without the alcohol flavor, drying under reduced pressure, for subsequent use;
(2) get 4 parts of Radix Codonopsis, add 8 times of water gagings and decoct each 2 hours three times, merge three times fried liquid, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 60%, after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, get filtrate, concentrated, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, for subsequent use;
(3) get 4 parts of Herba Artemisiae Annuaes, be ground into coarse powder, add the petroleum ether reflux, extract, three times of 6 times of amounts, each 2 hours, merge three times extracting solution, extracting solution filters after with activated carbon decolorizing, and steaming petroleum ether is concentrated into the thick paste shape, and is for subsequent use;
(4) get 3 parts of Cortex Lycii, with 8 times of amount 80% alcohol reflux 2 times, each 3 hours, merge extractive liquid, filtered, Recycled ethanol, and concentrating under reduced pressure becomes extractum, and is for subsequent use;
(5) get 6 parts of Carapax Trionycis, be ground into coarse powder, add 6 times of water gagings and decoct three times, each 4 hours, merge fried liquid, for subsequent use;
(6) get 5 parts of Radix Glycyrrhizae coarse powder, add 80% alcoholic solution that contains 1% ammonia of 8 times of amounts, supersound extraction is 2 times in the time of 40 ℃, each 2 hours, merge extractive liquid, filters, and is concentrated into paste, adds concentrated sulphuric acid and transfers pH to 2 ~ 3, fully stir, leave standstill filtration, get precipitation reduced vacuum drying, for subsequent use;
(7) get 5 parts of Poria coarse powder, add 6 times of water gagings and decoct each 2 hours three times, merge three times fried liquid, filter, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 85%, and after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, taking precipitate is dissolved in water, adding ethanol makes and contains alcohol amount and reach 70% again, leave standstill filtration, the taking precipitate drying under reduced pressure, for subsequent use;
Each extract spray drying that combining step (1) to step (7) obtains,, get extract powder and lactose, corn starch mix all with, granulate, the then encapsulated capsule of making.(lot number: 004)
Embodiment 5 evaluation of clinical curative effect
1, data and method
Object of study and grouping
Collect outpatient service and inpatient 60 examples of insomnia poor sleeping quality more than 3 months, male 38 examples, women 22 examples, 18～58 years old age.Treatment group 40 examples, matched group 20 examples.
2, method
2.1 Therapeutic Method
Treatment group is selected pharmaceutical composition provided by the invention (embodiment 1 lot number 001), and consumption is that the 15g crude drug is each, 3 times/days.Matched group is taken stable, 1 times/day, all serve on for 4 weeks.
2.2 observational technique
Observe respectively treatment Patients Before And After time for falling asleep in evening, the symptoms such as the continuously length of one's sleep, and the giddy of performance, nervous, agitation, appetite, and record performance after 4 weeks of taking medicine.
3, result
Medicine composite for curing group provided by the invention take medicine after 4 weeks sleep qualities be improved significantly, time for falling asleep is short, in 20 to 30 minutes, the length of one's sleep was greater than 7 hours, total effective rate is 85.6%, with giddy, nervous, night sweat, agitation, anxiety, emotional, the transference cures such as poor appetite, wherein the matched group total effective rate is 84%; And 4 all treatment group relapse rates only are 2% after taking medicine, and the matched group relapse rate is 60%.
And experimental result shows that the pharmaceutical composition that the embodiment of the invention 2 to 4 prepares has the effect that good improvement is slept equally, and drug withdrawal had no recurrence in 6 months after sleep was normal.
Show that by above experimental result pharmaceutical composition provided by the invention has the effect of good raising sleep quality, and do not find in the clinical experiment that the patient has obvious untoward reaction, clinical drug safety, and gradually rehabilitation after patient's produce effects, relapse rate is low.
The above only is preferred implementation of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (7)
1. pharmaceutical composition with effect for the treatment of insomnia, it is characterized in that it is to be made by the crude drug of following parts by weight: 1 ~ 5 part of the Radix Astragali, 1 ~ 5 part of the Rhizoma Atractylodis Macrocephalae, 1 ~ 5 part of Radix Codonopsis, 1 ~ 5 part of Herba Artemisiae Annuae, 1 ~ 5 part of Cortex Lycii, 1 ~ 6 part of Carapax Trionycis, 1 ~ 5 part of Radix Glycyrrhizae, 1 ~ 5 part in Poria.
2. the pharmaceutical composition with effect for the treatment of insomnia according to claim 1, it is characterized in that it is to be made by the crude drug of following parts by weight: 1 ~ 2 part of the Radix Astragali, 1 ~ 2 part of the Rhizoma Atractylodis Macrocephalae, 1 ~ 2 part of Radix Codonopsis, 1 ~ 2 part of Herba Artemisiae Annuae, 1 ~ 2 part of Cortex Lycii, 1 ~ 3 part of Carapax Trionycis, 1 ~ 2 part of Radix Glycyrrhizae, 1 ~ 2 part in Poria.
3. the pharmaceutical composition with effect for the treatment of insomnia according to claim 2, it is characterized in that it is to be made by the crude drug of following parts by weight: 1.5 parts of the Radixs Astragali, 1.5 parts of the Rhizoma Atractylodis Macrocephalaes, 1.5 parts of Radix Codonopsis, 1.5 parts of Herba Artemisiae Annuaes, 1.5 parts of Cortex Lycii, 2 parts of Carapax Trionycis, 1.2 parts of Radix Glycyrrhizae, 1.5 parts in Poria.
4. the pharmaceutical composition with effect for the treatment of insomnia according to claim 2, it is characterized in that it is to be made by the crude drug of following parts by weight: 1.55 parts of the Radixs Astragali, 1.55 parts of the Rhizoma Atractylodis Macrocephalaes, 1.55 parts of Radix Codonopsis, 1.55 parts of Herba Artemisiae Annuaes, 1.55 parts of Cortex Lycii, 2.1 parts of Carapax Trionycis, 1.25 parts of Radix Glycyrrhizae, 1.55 parts in Poria.
5. each described pharmaceutical composition with effect for the treatment of insomnia of claim 1 to 4 is characterized in that, the medicine that extract and the pharmaceutically acceptable carrier of each crude drug is prepared into oral liquid, granule, capsule or Tabules.
6. each described preparation method with pharmaceutical composition of effect for the treatment of insomnia of claim 1 to 4 is characterized in that may further comprise the steps:
(1) gets the Radix Astragali and the Rhizoma Atractylodis Macrocephalae by each described parts by weight of claim 1 to 4, the alcohol reflux of take 6 to 8 times of amount concentration as 80% to 85% 2 to 3 times, each 2 to 3 hours, be evaporated to without the alcohol flavor, sucking filtration namely gets the Radix Astragali, Rhizoma Atractylodis Macrocephalae alcohol extract, and thin up is to containing crude drug amount 40g/L, then go up the D101 macroporous adsorptive resins, with 6 to 10 times of column volume 70% ethanol elution resins, collect each eluent, be evaporated to without the alcohol flavor, drying under reduced pressure, for subsequent use;
(2) get Radix Codonopsis by each described parts by weight of claim 1 to 4, add 6 ~ 10 times of water gagings and decoct each 1 ~ 2 hour three times, merge three times fried liquid, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 60% ~ 90%, after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, get filtrate, concentrated, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, for subsequent use;
(3) get Herba Artemisiae Annuae by each described parts by weight of claim 1 to 4, be ground into coarse powder, add the petroleum ether reflux, extract, three times of 5 ~ 8 times of amounts, each 2 to 3 hours, merge three times extracting solution, extracting solution filters after with activated carbon decolorizing, steaming petroleum ether is concentrated into the thick paste shape, and is for subsequent use;
(4) get Cortex Lycii by each described parts by weight of claim 1 to 4, with 8 to 10 times of amount 75% to 85% alcohol reflux 2 to 3 times, each 2 to 3 hours, merge extractive liquid, filtered, Recycled ethanol, and concentrating under reduced pressure becomes extractum, and is for subsequent use;
(5) get Carapax Trionycis by each described parts by weight of claim 1 to 4, be ground into coarse powder, add 6 ~ 10 times of water gagings and decoct three times, each 2 to 4 hours, merge fried liquid, for subsequent use;
(6) get the Radix Glycyrrhizae coarse powder by each described parts by weight of claim 1 to 4, add 80% alcoholic solution that contains 1% ammonia of 8 to 10 times of amounts, supersound extraction is 2 times in the time of 40 ℃, each 1 to 2 hour, merge extractive liquid,, filter, be concentrated into paste, add concentrated sulphuric acid and transfer pH to 2 ~ 3, fully stir, leave standstill filtration, get precipitation reduced vacuum drying, for subsequent use;
(7) get the Poria coarse powder by each described parts by weight of claim 1 to 4, add 4 ~ 6 times of water gagings and decoct each 1 ~ 2 hour three times, merge three times fried liquid, filter, concentrated, concentrated medicament slowly adds ethanol under constantly stirring to make the concentration of ethanol be 60% ~ 90%, and after stirring, medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filter, taking precipitate is dissolved in water, adding ethanol makes and contains alcohol amount and reach 70% again, leave standstill filtration, the taking precipitate drying under reduced pressure, for subsequent use;
Each extract spray drying that combining step (1) to step (7) obtains gets the medicine that extract powder and pharmaceutically acceptable carrier are prepared into oral liquid, granule, capsule or Tabules.
7. each described pharmaceutical composition application in preparation control insomnia drug with effect for the treatment of insomnia of claim 1 to 4.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011103987793A CN102416071B (en) | 2011-12-06 | 2011-12-06 | Medicinal composition with effect of treating insomnia, preparation method and application of medicinal composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011103987793A CN102416071B (en) | 2011-12-06 | 2011-12-06 | Medicinal composition with effect of treating insomnia, preparation method and application of medicinal composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102416071A CN102416071A (en) | 2012-04-18 |
| CN102416071B true CN102416071B (en) | 2013-05-01 |
Family
ID=45940872
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011103987793A Expired - Fee Related CN102416071B (en) | 2011-12-06 | 2011-12-06 | Medicinal composition with effect of treating insomnia, preparation method and application of medicinal composition |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102416071B (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104982777A (en) * | 2015-06-17 | 2015-10-21 | 蚌埠市天星树脂有限责任公司 | Resin for original material extraction of spleen invigorating and qi benefiting health care medicine and preparation method thereof |
| CN106038978A (en) * | 2016-06-08 | 2016-10-26 | 郭小宁 | Pharmaceutical composition for treating insomnia |
| CN111991474A (en) * | 2020-09-07 | 2020-11-27 | 深圳市桦健量子生物科技有限公司 | Lucid ganoderma oral liquid and preparation method thereof |
| CN113440554A (en) * | 2021-07-08 | 2021-09-28 | 杭州世子合德生物科技有限公司 | Formula, preparation method and application of health-care product |
| CN115590932A (en) * | 2022-10-10 | 2023-01-13 | 韩封三祝（Cn） | Traditional Chinese medicine composition for treating insomnia, dreaminess and easy wakening |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101439120A (en) * | 2007-11-20 | 2009-05-27 | 马东君 | Chinese medicine composing prescription for treating heart-spleen deficiency induced insomnia |
-
2011
- 2011-12-06 CN CN2011103987793A patent/CN102416071B/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101439120A (en) * | 2007-11-20 | 2009-05-27 | 马东君 | Chinese medicine composing prescription for treating heart-spleen deficiency induced insomnia |
Non-Patent Citations (8)
| Title |
|---|
| 周平安诊治失眠经验;杨效华等;《北京中医药》;20100331;第29卷(第3期);第178-179页 * |
| 失眠症治疗方剂用药特点浅析;赵建军等;《云南中医学院学报》;20100228;第33卷(第1期);第14页表1，第15页表2 * |
| 杨效华等.周平安诊治失眠经验.《北京中医药》.2010,第29卷(第3期),第178-179页. |
| 甘草中有效成分甘草酸的提取和测定方法研究概况;鲁守平等;《中国中药杂志》;20060315;第31卷(第5期);第357页摘要 * |
| 赵建军等.失眠症治疗方剂用药特点浅析.《云南中医学院学报》.2010,第33卷(第1期),第14页表1，第15页表2. |
| 邓素兰登.青蒿中青蒿素的提取分离研究.《安徽农学通报》.2007,第13卷(第5期),第31页摘要. |
| 青蒿中青蒿素的提取分离研究;邓素兰登;《安徽农学通报》;20070531;第13卷(第5期);第31页摘要 * |
| 鲁守平等.甘草中有效成分甘草酸的提取和测定方法研究概况.《中国中药杂志》.2006,第31卷(第5期),第357页摘要. |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102416071A (en) | 2012-04-18 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101095736B (en) | Chinese traditional medicine composition for treating acute and chronic pharyngitis, tonsillitis and method of making the same | |
| CN102416071B (en) | Medicinal composition with effect of treating insomnia, preparation method and application of medicinal composition | |
| CN113521232B (en) | A Chinese medicinal composition containing Atractylodis rhizoma | |
| CN101637546B (en) | Medicine for treating acute and chronic rhinitis and sinusitis | |
| CN102284022A (en) | Cough medicament and preparation method thereof | |
| CN102319294A (en) | Double-vanilla preparation and preparation method thereof | |
| CN105031218A (en) | Traditional Chinese medicine formula for treating diabetes induced by deficiency of both qi and yin as well as preparation method and application thereof | |
| CN105250427A (en) | Pharmaceutical composition for treating heart diseases | |
| CN101982194B (en) | Coptis root compound preparation for treating dampness-heat spleen encumbering type diabetes | |
| CN101129615A (en) | Caulis spatholobi oral liquid | |
| CN103432386B (en) | A kind of Chinese medicine preparation for the treatment of cough and preparation method thereof | |
| CN102349979A (en) | Oral traditional Chinese medicine composition for treating bitter taste in mouth | |
| CN1660260A (en) | Effervescence grains of reducing fever and relieving a cough for infant and preparation method | |
| CN105031219A (en) | Traditional Chinese medicine compound preparation for treating diabetes induced by deficiency of both qi and yin as well as preparation method and application thereof | |
| CN110946950A (en) | A Chinese medicinal composition for treating senile vascular dementia, and its preparation method | |
| CN104825784B (en) | A kind of Chinese medicine composition with anti-gastric cancer activity and its preparation method and application | |
| CN107669865A (en) | A kind of anti-senile dementia disease oral agents | |
| CN102716448A (en) | Chinese patent medicine and TCM decoction capable of effectively curing nausea and vomiting | |
| CN103006950A (en) | Traditional Chinese medicine for treating pharyngolaryngitis and preparation process thereof | |
| CN116850224B (en) | Traditional Chinese medicine composition for preventing and treating epidemic disease and preparation method thereof | |
| CN113181259B (en) | Children's astragalus-ginseng cold-treating granule and its prepn | |
| CN1672722A (en) | Heart-nourishing and tranquilizing medicine and its prepn process | |
| CN105456447A (en) | Folium artemisiae argyi-containing traditional Chinese medicine composition with function of promoting blood circulation to remove stasis and preparation method thereof | |
| CN102274428A (en) | Pharmaceutical composition with effect on treating irritable bowel syndrome and preparation method and application thereof | |
| CN107519370B (en) | Compound preparation for treating non-allergic purpura caused by deficiency of spleen and kidney and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20130501 Termination date: 20151206 |
|
| EXPY | Termination of patent right or utility model |