CN102416071A - 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
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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 and preparation method thereof and its application with Cure for insomnia effect.
Background technology
Existing modern society, people's pressure is big, 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 people's health variation gradually, cause bigger negative effect, major part to exist the people of sleeping problems to select chemical drugs work and life; Like the stable medicine assisting sleep that waits; But there is bigger 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 of treatment 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 deficiency of 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 this preparation of drug combination method and application thereof.
Technical scheme: in order to realize above purpose, the technical scheme that the present invention takes is:
A kind of pharmaceutical composition with Cure for insomnia effect, it is to be processed 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 Cure for insomnia effect, it is to be processed 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 Cure for insomnia effect, it is to be processed 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 Cure for insomnia effect, it is to be processed 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 Cure for insomnia effect of the present invention becomes the medicine of oral liquid, granule, capsule or Tabules etc. with each extracts of bulk drugs with pharmaceutically acceptable preparing carriers, convenient clinical taking.
Chinese prescription provided by the invention according to Chinese medical theory, adopts determination of treatment 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 and pass through deficiency-heat clearly, removing heat from blood removes and steams 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 and removes steaming, lung heat clearing pathogenic fire reducing effect; Carapax Trionycis property is salty, cold, has the nourishing kidney YANG hyperactivity suppressing, 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 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 of treatment 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 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 Cure for insomnia effect provided by the invention can become oral liquid, granule, capsule, Tabules medicine with each extracts of bulk drugs with pharmaceutically acceptable preparing carriers.
When the extract of each raw material of pharmaceutical composition provided by the invention is processed oral liquid,, filter, add syrup, regulate pH value, process oral liquid the extract adding distil water dissolving of each raw material.
When the extract of each raw material of pharmaceutical composition provided by the invention is processed granule, the extract of each raw material and diluent lactose or corn starch mix homogeneously, granulate, drying is processed granule.
When the extract of pharmaceutical composition provided by the invention is processed capsule the extract of each raw material and carrier lactose or corn starch mix homogeneously, granulate, the encapsulated then capsule of processing.
When the extract of each raw material of pharmaceutical composition provided by the invention is processed tablet,, add magnesium stearate lubricant when needing each raw material and lactose or corn starch, mix homogeneously, granulate, tabletting is processed tablet then.
Preparation of drug combination method with Cure for insomnia effect of the present invention, it may further comprise the steps:
(1) get the Radix Astragali and the Rhizoma Atractylodis Macrocephalae by weight, 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; Being evaporated to does not have the alcohol flavor, and sucking filtration promptly gets the alcohol extract of the Radix Astragali and the Rhizoma Atractylodis Macrocephalae, and thin up is to containing crude drug amount 40g/L; Go up the D101 macroporous adsorptive resins then,, collect each eluent with 6 to 10 times of column volume 70% ethanol elution resins; Being evaporated to does not have the alcohol flavor, and drying under reduced pressure is subsequent use;
(2) get Radix Codonopsis by weight, add 6 ~ 10 times of water gagings and decoct three times, each 1 ~ 2 hour, merge three times fried liquid; Concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 60% ~ 90%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and gets filtrating; Concentrate, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, subsequent use;
(3) get Herba Artemisiae Annuae by weight, 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 is used the activated carbon decolorizing after-filtration, and steaming petroleum ether is concentrated into the thick paste shape, and is subsequent use;
(4) get Cortex Lycii by weight, 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, and reclaims ethanol, and concentrating under reduced pressure becomes extractum, and is subsequent use;
(5) get Carapax Trionycis by weight, be ground into coarse powder, add 6 ~ 10 times of water gagings and decoct three times, each 2 to 4 hours, merge fried liquid, subsequent use;
(6) get the Radix Glycyrrhizae coarse powder by weight, 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, filtered; Be concentrated into paste, add concentrated sulphuric acid and transfer pH to 2 ~ 3, fully stir; Leave standstill filtration, get deposition reduced vacuum drying, subsequent use;
(7) get the Poria coarse powder by weight, add 4 ~ 6 times of water gagings and decoct three times, each 1 ~ 2 hour, merge three times fried liquid; Filter, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 60% ~ 90%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and taking precipitate is dissolved in water; Add ethanol again and make and contain alcohol amount and reach 70%, leave standstill filtration, the taking precipitate drying under reduced pressure, subsequent use;
Each extract spray drying that combining step (1) to step (7) obtains gets extract powder becomes oral liquid, granule, capsule or Tabules with pharmaceutically acceptable preparing carriers medicine.
Preparation of drug combination method provided by the invention optimizes active component extraction efficiency height, method for preparing that impurity content low to each medical material through a large amount of experiments according to the physicochemical property of different medical material effective ingredient.
Pharmaceutical composition with Cure for insomnia effect provided by the invention can be used as the application in the preparation control insomnia drug.
Beneficial effect: the present invention adopts the theory of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs to carry out the Chinese prescription screening according to Chinese medical theory, and the pharmaceutical composition proportioning that provides is scientific and reasonable; Clinical experiment is the result show, pharmaceutical composition provided by the invention has the effect of good dispersing the stagnated live-QI to relieve the stagnation of QI, 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 pharmaceutical carriers and is prepared into multiple dosage form, and it is controlled that taking convenience, and experimental result clinically shows that pharmaceutical composition provided by the invention has quality safety; Be easy to absorb the characteristics that life-time service has no side effect.While preparation of drug combination method 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 be used to the present invention is described and be not used in the restriction scope of the present invention; After having read the present invention, those skilled in the art all fall within the application's accompanying claims institute restricted portion 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 Cure for insomnia effect: 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 of drug combination method that has the Cure for insomnia effect:
(1) get 1.5 parts of the Radixs Astragali and 1.5 parts of the Rhizoma Atractylodis Macrocephalaes, add 8 times of amounts, concentration is 80% alcohol reflux 2 times, each 2 hours; Being evaporated to does not have the alcohol flavor, and sucking filtration promptly gets the alcohol extract of the Radix Astragali and the Rhizoma Atractylodis Macrocephalae, and thin up is to containing crude drug amount 40g/L; Go up the D101 macroporous adsorptive resins then,, collect each eluent with 6 times of column volumes, 70% ethanol elution resin; Being evaporated to does not have the alcohol flavor, and drying under reduced pressure is subsequent use;
(2) get 1.5 parts of Radix Codonopsis, add 8 times of water gagings and decoct three times, each 2 hours, merge three times fried liquid; Concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 80%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and gets filtrating; Concentrate, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, 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 is used the activated carbon decolorizing after-filtration, and steaming petroleum ether is concentrated into the thick paste shape, and is 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, and reclaims ethanol, and concentrating under reduced pressure becomes extractum, and is 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, 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 deposition reduced vacuum drying, subsequent use;
(7) get Poria coarse powder 1.5, add 6 times of water gagings and decoct three times, each 2 hours, merge three times fried liquid; Filter, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 70%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and taking precipitate is dissolved in water; Add ethanol again and make and contain alcohol amount and reach 70%, leave standstill filtration, the taking precipitate drying under reduced pressure, 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, processes oral liquid.(lot number: 001)
Embodiment 2
1, the crude drug that has the pharmaceutical composition of Cure for insomnia effect: 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 of drug combination method that has the Cure for insomnia effect:
(1) get 1.55 parts of the Radixs Astragali and 1.55 parts of the Rhizoma Atractylodis Macrocephalaes, add 6 times of amounts, concentration is 85% alcohol reflux 3 times, each 2 hours; Being evaporated to does not have the alcohol flavor, and sucking filtration promptly gets the alcohol extract of the Radix Astragali and the Rhizoma Atractylodis Macrocephalae, and thin up is to containing crude drug amount 40g/L; Go up the D101 macroporous adsorptive resins then,, collect each eluent with 10 times of column volumes, 70% ethanol elution resin; Being evaporated to does not have the alcohol flavor, and drying under reduced pressure is subsequent use;
(2) get 1.55 parts of Radix Codonopsis, add 10 times of water gagings and decoct three times, each 2 hours, merge three times fried liquid; Concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 90%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and gets filtrating; Concentrate, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, 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 is used the activated carbon decolorizing after-filtration, and steaming petroleum ether is concentrated into the thick paste shape, and is 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, and reclaims ethanol, and concentrating under reduced pressure becomes extractum, and is 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, 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 deposition reduced vacuum drying, subsequent use;
(7) get Poria coarse powder 1.55, add 4 times of water gagings and decoct three times, each 2 hours, merge three times fried liquid; Filter, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 90%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and taking precipitate is dissolved in water; Add ethanol again and make and contain alcohol amount and reach 70%, leave standstill filtration, the taking precipitate drying under reduced pressure, 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, and drying is processed granule.(lot number: 002)
Embodiment 3
1, the crude drug that has the pharmaceutical composition of Cure for insomnia effect: 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 of drug combination method that has the Cure for insomnia effect:
(1) get 2 parts of the Radixs Astragali and 2 parts of the Rhizoma Atractylodis Macrocephalaes, add 8 times of amounts, concentration is 80% alcohol reflux 3 times, each 2 hours; Being evaporated to does not have the alcohol flavor, and sucking filtration promptly gets the alcohol extract of the Radix Astragali and the Rhizoma Atractylodis Macrocephalae, and thin up is to containing crude drug amount 40g/L; Go up the D101 macroporous adsorptive resins then,, collect each eluent with 8 times of column volumes, 70% ethanol elution resin; Being evaporated to does not have the alcohol flavor, and drying under reduced pressure is subsequent use;
(2) get 2 parts of Radix Codonopsis, add 8 times of water gagings and decoct three times, each 2 hours, merge three times fried liquid; Concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 60%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and gets filtrating; Concentrate, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, 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 is used the activated carbon decolorizing after-filtration, and steaming petroleum ether is concentrated into the thick paste shape, and is 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, and reclaims ethanol, and concentrating under reduced pressure becomes extractum, and is 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, 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 deposition reduced vacuum drying, subsequent use;
(7) get 2 parts of Poria coarse powder, add 6 times of water gagings and decoct three times, each 1 hour, merge three times fried liquid; Filter, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 80%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and taking precipitate is dissolved in water; Add ethanol again and make and contain alcohol amount and reach 70%, leave standstill filtration, the taking precipitate drying under reduced pressure, 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, tabletting is processed tablet then.(lot number: 003)
Embodiment 4
1, the crude drug that has the pharmaceutical composition of Cure for insomnia effect: 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 of drug combination method that has the Cure for insomnia effect:
(1) get 5 parts of the Radixs Astragali and 5 parts of the Rhizoma Atractylodis Macrocephalaes, add 8 times of amounts, concentration is 80% alcohol reflux 3 times, each 2 hours; Being evaporated to does not have the alcohol flavor, and sucking filtration promptly gets the alcohol extract of the Radix Astragali and the Rhizoma Atractylodis Macrocephalae, and thin up is to containing crude drug amount 40g/L; Go up the D101 macroporous adsorptive resins then,, collect each eluent with 8 times of column volumes, 70% ethanol elution resin; Being evaporated to does not have the alcohol flavor, and drying under reduced pressure is subsequent use;
(2) get 4 parts of Radix Codonopsis, add 8 times of water gagings and decoct three times, each 2 hours, merge three times fried liquid; Concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 60%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and gets filtrating; Concentrate, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, 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 is used the activated carbon decolorizing after-filtration, and steaming petroleum ether is concentrated into the thick paste shape, and is 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, and reclaims ethanol, and concentrating under reduced pressure becomes extractum, and is 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, 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 deposition reduced vacuum drying, subsequent use;
(7) get 5 parts of Poria coarse powder, add 6 times of water gagings and decoct three times, each 2 hours, merge three times fried liquid; Filter, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 85%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and taking precipitate is dissolved in water; Add ethanol again and make and contain alcohol amount and reach 70%, leave standstill filtration, the taking precipitate drying under reduced pressure, subsequent use;
Each extract spray drying that combining step (1) to step (7) obtains,, extract powder and lactose, corn starch mix all with, granulate, the encapsulated then capsule of processing.(lot number: 004)
Embodiment 5 evaluation of clinical curative effect
1, data and method
Object of study and grouping
Collect the 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.40 examples are organized in treatment, matched group 20 examples.
2, method
2.1 Therapeutic Method
The treatment group is selected pharmaceutical composition provided by the invention (embodiment 1 lot number 001) for use, and consumption is that the 15g crude drug is each, 3 times/day.Matched group is taken stable, 1 time/day, all serve on for 4 weeks.
2.2 observational technique
Observe patient's time for falling asleep in evening before and after the treatment respectively, symptoms such as the length of one's sleep, and the giddy of performance continuously, nervous, agitation, appetite, and write down the performance after 4 weeks of taking medicine.
3, result
Medicine composite for curing group provided by the invention take medicine 4 week back 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, transference cures such as poor appetite, wherein the matched group total effective rate is 84%; And the back 4 all treatment group relapse rates of taking medicine are merely 2%, 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 recurrence was not seen in the normal back drug withdrawal of sleep in 6 months.
Show that through 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 tangible untoward reaction, clinical drug safety, and rehabilitation gradually after patient's produce effects, relapse rate is low.
The above only is a 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 improvement and retouching, these improvement and retouching also should be regarded as protection scope of the present invention.
Claims (7)
1. pharmaceutical composition with Cure for insomnia effect; It is characterized in that it is to be processed 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 Cure for insomnia effect according to claim 1; It is characterized in that it is to be processed 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 Cure for insomnia effect according to claim 2; It is characterized in that it is to be processed 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 Cure for insomnia effect according to claim 2; It is characterized in that it is to be processed 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 Cure for insomnia effect of claim 1 to 4 is characterized in that, each extracts of bulk drugs is become the medicine of oral liquid, granule, capsule or Tabules with pharmaceutically acceptable preparing carriers.
6. each described preparation of drug combination method with Cure for insomnia effect of claim 1 to 4 is characterized in that may further comprise the steps:
(1) getting the Radix Astragali and the Rhizoma Atractylodis Macrocephalae by each described parts by weight of claim 1 to 4, is 80% to 85% alcohol reflux 2 to 3 times with 6 to 8 times of amount concentration, and each 2 to 3 hours, being evaporated to did not have the alcohol flavor; Sucking filtration promptly gets the Radix Astragali, Rhizoma Atractylodis Macrocephalae alcohol extract, and thin up is to containing crude drug amount 40g/L; Go up the D101 macroporous adsorptive resins then,, collect each eluent with 6 to 10 times of column volume 70% ethanol elution resins; Being evaporated to does not have the alcohol flavor, and drying under reduced pressure is 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 three times, each 1 ~ 2 hour, merge three times fried liquid; Concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 60% ~ 90%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and gets filtrating; Concentrate, make relative density in the time of 60 ℃, be 1.10 ~ 1.12, 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 is used the activated carbon decolorizing after-filtration; Steaming petroleum ether is concentrated into the thick paste shape, and is 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, and reclaims ethanol, and concentrating under reduced pressure becomes extractum, and is 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, 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, filtered; Be concentrated into paste, add concentrated sulphuric acid and transfer pH to 2 ~ 3, fully stir; Leave standstill filtration, get deposition reduced vacuum drying, 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 three times, each 1 ~ 2 hour, merge three times fried liquid; Filter, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 60% ~ 90%, after stirring; Medicinal liquid spends the night in 0 ~ 4 ℃ of cold preservation, filters, and taking precipitate is dissolved in water; Add ethanol again and make and contain alcohol amount and reach 70%, leave standstill filtration, the taking precipitate drying under reduced pressure, subsequent use;
Each extract spray drying that combining step (1) to step (7) obtains gets extract powder becomes oral liquid, granule, capsule or Tabules with pharmaceutically acceptable preparing carriers medicine.
7. each described pharmaceutical composition application in preparation control insomnia drug of claim 1 to 4 with Cure for insomnia effect.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
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| CN101439120A (en) * | 2007-11-20 | 2009-05-27 | 马东君 | Chinese medicine composing prescription for treating heart-spleen deficiency induced insomnia |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
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| CN102416071B (en) | 2013-05-01 |
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