CN109125617A

CN109125617A - A kind of Rhizoma Gastrodiae composition being effectively improved sleep and preparation method, preparation and application

Info

Publication number: CN109125617A
Application number: CN201811155340.6A
Authority: CN
Inventors: 田孟华; 刘金美; 张昌飞; 余显伦
Original assignee: Zhaotong Tianma Research Institute
Current assignee: Zhaotong Tianma Research Institute
Priority date: 2018-09-30
Filing date: 2018-09-30
Publication date: 2019-01-04

Abstract

The invention discloses a kind of Rhizoma Gastrodiae composition for being effectively improved sleep and preparation methods, preparation and application, the composition includes the raw material of following parts by weight: 4-16 parts of Rhizoma Gastrodiae extract, 16-33 parts of Wild jujube seeds extract, 13-33 parts of siberian Ginseng P.E, 8-25 parts of extract of licorice root.Composition of the invention has the advantages that safely, effectively, wide application of the crowd using dual-purpose of drug and food and the Chinese medicine that can be used for health food as raw material.Efficacy assessments and toxicology test show that the composition has remarkable efficacy, and safety non-toxic for improving sleep function.

Description

A kind of Rhizoma Gastrodiae composition being effectively improved sleep and preparation method, preparation and application

Technical field

The invention belongs to technical field of health care food, and in particular to a kind of Rhizoma Gastrodiae composition for being effectively improved sleep and preparation Method, preparation and application.

Background technique

Sleep is the particularly important a part of health, and sufficient sleep helps to improve memory and creativity, subtract It light weight and relieves stress, obtains more outstanding school grade, improve working efficiency, the service life can also be extended.In recent years, with People's life, the increase of working and learning pressure, the burden at heart of people, the quantity of insomniac is on constantly It rises, insomnia has seriously affected people's lives, work and physical and mental health.WHO's research shows that: the whole world there are about 27% people incidents By the puzzlement of sleep disorder, studies in China is shown: there are about 300,000,000 adults to suffer from insomnia for China, and the disease incidence of serious insomnia is 9.38%.Although the tranquilizing and allaying excitement hypnotic drug based on Western medicine has extraordinary curative effect, much all there is side effect, It is easy habituation, the obvious disadvantage of after effect, some excessive uses are also possible to threat to life.

Rhizoma Gastrodiae (Gastrodia elata) also known as rhizoma gastrodiae are the dry tuber of orchid Rhizoma Gastrodiae.Rhizoma Gastrodiae existing more than 2,000 Year applicating history, the successive dynasties are on the books and are classified as top grade, Shennong's Herbal cloud: long term usage benefiting energy, and long yin fertilizer is good for, increasing of making light of one's life by commiting suicide Year.Modern pharmacological studies have shown that Rhizoma Gastrodiae has the function of tranquilizing soporific, improves sleep.In the prior art, it is multiple to have other Rhizoma Gastrodiaes The products such as square capsule, but there is larger problem, some effects are not significant enough, need to largely take, and What is more can bring pair Reaction." bier battalion health can a piece " think the interpretation of the cause, onset and process of an illness of people " night does not set " be " qi and blood of the old declines, and muscle is withered, and air flue is puckery, five Dirty gas phase is fought, deficiency of nutrient QI with inner disturbance of defensive QI, brightlessness in the daytime, and night is insomnia ".Occur physiological function with advancing age and subtract It moves back and the influence of various chronic diseases to hepatic and renal function declines.Blood stored in the liver, kidney storing essence, caused by liver and kidney deficiency, asthenia of essence and blood, mind dystrophy It then sleeps uneasiness, the deficiency of liver-yin and kidney-yin, liver-yang hyperactivity upsets the mind also to having a sleepless night.And the prior art not can solve above-mentioned ask Topic.

For above situation, it is necessary to invent a kind of Rhizoma Gastrodiae composition for being effectively improved sleep and preparation method, preparation with Using.Rhizoma Gastrodiae, semen ziziphi spinosae, wilsonii and Radix Glycyrrhizae are had not yet to see with the use of the report for improving sleep.

Summary of the invention

The first object of the present invention is to provide a kind of Rhizoma Gastrodiae composition for being effectively improved sleep, and second is designed to provide A kind of preparation method for the Rhizoma Gastrodiae composition being effectively improved sleep, third are designed to provide a kind of Rhizoma Gastrodiae for being effectively improved sleep The preparation of composition, the 4th is designed to provide a kind of application of Rhizoma Gastrodiae composition for being effectively improved sleep.

The first object of the present invention is achieved in that the raw material including following parts by weight: 4-16 parts of Rhizoma Gastrodiae extract, sour 16-33 parts of jujube kernel extract, 13-33 parts of siberian Ginseng P.E, 8-25 parts of extract of licorice root.

The second object of the present invention be achieved in that the following steps are included:

1) raw material preparation: taking that meat is thick and solid, Gastrodia Elata Stem Tuber of no disease and pests harm, 55-65 DEG C low temperature drying 24 hours, crush, cross 8- 12 meshes, adding the 8-12 times of 65-75% ethyl alcohol measured is Extraction solvent, and heating and refluxing extraction 2-4 times is 0.5-1.5 hours each, is closed And extracting solution, ethyl alcohol is recovered under reduced pressure, is concentrated into and is equivalent to crude drug 0.4-0.6g/mL, 4000-6000 r/min is centrifuged 10-20 points Clock takes supernatant, is concentrated under reduced pressure into and is equivalent to crude drug 3-5g/mL, adds ethyl alcohol to alcohol content 65-75%, stands 22-26h, filter It crosses, adds 35-45%NaOH solution tune pH value to 8.0, stand 22-26h, filtration, filtrate is concentrated under reduced pressure into paste in 45-55 DEG C And ethyl alcohol is recycled, 45-55 DEG C or less vacuum drying obtains Rhizoma Gastrodiae extract, spare；Semen ziziphi spinosae seed is taken, is crushed into powder, 7- is added The 55-65% ethyl alcohol of 9 times of amounts is Extraction solvent, heating and refluxing extraction 2-4 hours after impregnating 25-35 minutes, filtration；5-7 times is added to measure 55-65% ethyl alcohol be Extraction solvent, heating and refluxing extraction 1-3 times is 1.5-2.5 hours each；Filtration, combined extract, decompression Ethyl alcohol is recycled, being concentrated into relative density is 1.20-1.24, adds ethyl alcohol to alcohol content 65-75%, stands 22-26h, filter, filter Liquid is concentrated under reduced pressure into paste in 45-55 DEG C and recycles ethyl alcohol, and 45-55 DEG C or less vacuum drying obtains Wild jujube seeds extract, standby With；Wilsonii rhizome is taken, is cleaned out, is crushed into powder, adding the 8-12 times of 75-85% ethyl alcohol measured is Extraction solvent, is heated to reflux and mentions It takes 2-4 hours, filters；Adding the 8-12 times of 70-80% ethyl alcohol measured is Extraction solvent, heating and refluxing extraction 1-3 times, each 1.5-2.5 Hour；Ethyl alcohol is recovered under reduced pressure in filtration, combined extract, and being concentrated into relative density is 1.20-1.24, adds ethyl alcohol to alcohol content 65-75% stands 22-26h, filtration, and filtrate is concentrated under reduced pressure into paste in 45-55 DEG C and recycles ethyl alcohol, and 45-55 DEG C or less true Sky is dry, obtains siberian Ginseng P.E, spare；It takes that matter is hard, taste is pure, Radix Glycyrrhizae without mildew, moisturizes, be sliced, add water to cook 2-4 Secondary, 1.5-2.5 hours each, collecting decoction, standing overnight makes to precipitate, and supernatant is taken to be concentrated into paste, and measurement liquiritin contains Must not measure less than 0 .5%, glycyrrhizic acid must not be less than 7.0%, obtain extract of licorice root, spare；

2) mix: by raw material obtained in step (1) first cross 60 meshes, then weigh respectively formula rate Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root are sufficiently mixed uniformly.

The third object of the present invention be achieved in that the preparation of the Rhizoma Gastrodiae composition for being effectively improved sleep be The auxiliary material pharmaceutically received is added in the composition and is prepared into capsule, tablet, pulvis, granule, liquid preparation, ball Agent.

The fourth object of the present invention is achieved in that described having improves the Rhizoma Gastrodiae composition of function in prevention/auxiliary Help the application on treatment of insomnia patients.

Compared with prior art, the present invention has following technical effect that

1, composition of the invention has safe and effective using dual-purpose of drug and food and the Chinese medicine that can be used for health food as raw material Advantage, wide application of the crowd.Efficacy assessments and toxicology test show that the composition has significant function for improving sleep function Effect, and safety non-toxic.

2, direction treatment insomnia of the present invention from tonify the liver and kidney, calm down liver-yang, mental-tranquilization, mutually auxiliary phase between each raw material At in this formula, wilsonii pharmacological property temperature, acrid flavour, slight bitter is nontoxic, enters spleen, kidney channel, can strengthen the body resistance to consolidate the constitution, kidney and spleen invigorating, intelligence development peace Mind is monarch drug in a prescription；Rhizoma Gastrodiae safety relieves dizziness, high fever, infantile convulsions, epilepsy, etc. checking exuberance of yang, is ministerial drug；Semen ziziphi spinosae nourishing the liver, calming heart, tranquilizing the mind are adjutant；Radix Glycyrrhizae coordinating the drug actions of a prescription.Four Medicine play altogether tonify the liver and kidney, be calming the liver, antitoxic heart-soothing and sedative the benefits of.Meanwhile modern pharmacological research proves, wilsonii has adjusting maincenter Nervous system excitability fights central excitation caused by caffeine and extends the sleeping time of amobarbital；Semen ziziphi spinosae can contract Short sleep latency.Therefore, four medicines share can adjust body function state on the whole, fundamentally improve sleep quality.

3, the present invention first prepares Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, preparation side The advantages that method makes full use of modern Chinese herbal medicine processing technology means, has and extracts completely, easy to operate, and extractant is non-toxic, obtains Extract and medicinal extract guarantee that the effective component in raw material is not easy to lose, while convenient for saving.

Detailed description of the invention

Fig. 1 is the preparation technology flow chart of capsule or tablet of the invention；

Fig. 2 is the production technological process of Rhizoma Gastrodiae extract of the invention；

Fig. 3 is the production technological process of Wild jujube seeds extract of the invention；

Fig. 4 is the production technological process of siberian Ginseng P.E of the invention.

Specific embodiment

Below with reference to embodiment and attached drawing, the present invention is further illustrated, but is not subject in any way to the present invention Limitation, based on present invention teach that it is made it is any transform or replace, all belong to the scope of protection of the present invention.

The Rhizoma Gastrodiae composition of the present invention for being effectively improved sleep, the raw material including following parts by weight: Rhizoma Gastrodiae extract 4-16 parts, 16-33 parts of Wild jujube seeds extract, 13-33 parts of siberian Ginseng P.E, 8-25 parts of extract of licorice root.

Further, the composition includes the raw material of following parts by weight: 8-16 parts of Rhizoma Gastrodiae extract, Wild jujube seeds extract 25-33 parts, 13-25 parts of siberian Ginseng P.E, 8-16 parts of extract of licorice root, 10-30 parts of pregelatinized starch, cross-linked carboxymethyl cellulose 1.0-5.0 parts of sodium, 0.5-1.5 parts of silica, 0.5-1.5 parts of magnesium stearate.

Further, the composition includes the raw material of following parts by weight: 8-16 parts of Rhizoma Gastrodiae extract, Wild jujube seeds extract 25-33 parts, 13-25 parts of siberian Ginseng P.E, 8-16 parts of extract of licorice root, 32-38 parts of microcrystalline cellulose, cross-linked carboxymethyl cellulose 2.0-3.0 parts of sodium, 6.0-10 parts of silica, 6.0-10 parts of magnesium stearate, 2.5-3.5 parts of coating powder.

The preparation method of the Rhizoma Gastrodiae composition of the present invention for being effectively improved sleep, comprising the following steps:

The preparation of the Rhizoma Gastrodiae composition of the present invention for being effectively improved sleep is that pharmacy is added in the composition The auxiliary material of upper receiving is prepared into capsule, tablet, pulvis, granule, liquid preparation, pill.

Further, the capsule includes the raw material of following parts by weight: 8-16 parts of Rhizoma Gastrodiae extract, semen ziziphi spinosae extracts 25-33 parts of object, 13-25 parts of siberian Ginseng P.E, 8-16 parts of extract of licorice root, 10-30 parts of pregelatinized starch, cross-linked carboxymethyl fiber Plain sodium 1.0-5.0 parts, 0.5-1.5 parts of silica, 0.5-1.5 parts of magnesium stearate；The preparation method of the capsule includes Following steps:

1) it is sieved: Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root is crossed into 60 meshes respectively, it is spare；

2) it weighs: weighing Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, pregelatinated by formula rate Starch, croscarmellose sodium, silica, magnesium stearate are spare；

3) it mixes: first by Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, pregelatinized starch, crosslinking Sodium carboxymethylcellulose, silica mix 25 ~ 35min, obtain mixed powder；

4) softwood processed: mixed powder softwood is added in 65-75% ethyl alcohol, additional amount is that 65-75% ethyl alcohol is added in every 100g mixed powder 28 ~ 32ml, be uniformly mixed, be allowed to hold it is agglomerating, gently pinch i.e. dissipate；

5) it pelletizes, dry, whole grain: the softwood made being pelletized by 16-20 mesh, then places 50 ~ 60 DEG C of dryings in baking oven 1.5 ~ 2.5h crosses 16-20 mesh sieve；

6) total mix: the particle after whole grain is mixed into 3 ~ 7min with magnesium stearate, obtains total hybrid particles；

7) capsule is filling: gained always being mixed granule filling, obtains capsule.

Further, the filling specification of the capsule is 0.6g/, is filled in 0# capsule, packing specification 60 Grain/bottle is packed using oral stable medicinal polythene bottle with high density；The amount and eating method of the capsule be 2 times a day, 2 tablets each time, each 1 time of morning and evening.

Further, the tablet includes the raw material of following parts by weight: 8-16 parts of Rhizoma Gastrodiae extract, Wild jujube seeds extract 25-33 parts, 13-25 parts of siberian Ginseng P.E, 8-16 parts of extract of licorice root, 32-38 parts of microcrystalline cellulose, cross-linked carboxymethyl cellulose 2.0-3.0 parts of sodium, 6.0-10 parts of silica, 6.0-10 parts of magnesium stearate, 2.5-3.5 parts of coating powder；The system of the tablet Preparation Method the following steps are included:

1) be sieved: Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root cross 60 meshes respectively, spare；

2) weigh: it is fine to weigh Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, crystallite by formula rate It is spare to tie up element, croscarmellose sodium, silica, magnesium stearate, coating powder；

3) it mixes: first by Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, microcrystalline cellulose, crosslinking Sodium carboxymethylcellulose, silica mix 25 ~ 35min, obtain mixed powder；

4) softwood processed: mixed powder softwood is added in 65-75% ethyl alcohol, additional amount is that 65-75% ethyl alcohol is added in every 100g mixed powder 28 ~ 32ml, be allowed to hold it is agglomerating, gently pinch i.e. dissipate；

7) granulation will always tabletting, coating, bottling: be mixed；Then coating powder is configured to 8-12% coating with 65-75% ethyl alcohol Liquid is coated tabletting, coating weight gain 2-4%, bottling.

Further, the tabletting specification of the tablet is 0.6g/ piece, and the bottling is using the medicinal height of oral administration solid Density polyethylene bottle carries out, and bottling specification is 80 pieces/bottle；The amount and eating method of the tablet: 2 times a day, every time 2 Piece, each 1 time sooner or later.

The application of the present invention that there is the Rhizoma Gastrodiae composition for improving function on prevention/auxiliary treatment of insomnia disease.

Embodiment 1

A kind of Rhizoma Gastrodiae composition being effectively improved sleep, the raw material including following parts by weight: 10 parts of Rhizoma Gastrodiae extract, semen ziziphi spinosae mentions Take 24 parts of object, 25 parts of siberian Ginseng P.E, 16 parts of extract of licorice root.

A kind of preparation method for the Rhizoma Gastrodiae composition being effectively improved sleep, it is characterised in that the following steps are included:

1) raw material preparation: taking that meat is thick and solid, Gastrodia Elata Stem Tuber of no disease and pests harm, 60 DEG C low temperature drying 24 hours, crush, cross 10 mesh Sieve, adding 70% ethyl alcohol of 10 times of amounts is Extraction solvent, and 3 hours of heating and refluxing extraction, 1 hour every time, combined extract depressurized Ethyl alcohol is recycled, is concentrated into and is equivalent to crude drug 0.5g/mL, 5000 r/min are centrifuged 15 minutes, are taken supernatant, are concentrated under reduced pressure into phase When adding ethyl alcohol to alcohol content 70% in crude drug 4g/mL, 24 h of standing are filtered, and are added 40%NaOH solution tune pH value to 8.0, are stood For 24 hours, it filters, filtrate is concentrated under reduced pressure into paste in 50 DEG C and recycles ethyl alcohol, and 50 DEG C or less vacuum drying obtain Rhizoma Gastrodiae extraction Object, it is spare；Semen ziziphi spinosae seed is taken, is crushed into powder, adding 60% ethyl alcohol of 8 times of amounts is Extraction solvent, is heated back after impregnating 0.5 hour Stream extracts 3 hours, filtration；Add 60% ethyl alcohol of 6 times of amounts for Extraction solvent, heating and refluxing extraction 2 times, every time 2 hours；Filtration is closed And extracting solution, ethyl alcohol is recovered under reduced pressure, being concentrated into relative density is 1.20, adds ethyl alcohol to alcohol content 70%, and standing for 24 hours, filters, Filtrate is concentrated under reduced pressure into paste in 50 DEG C and recycles ethyl alcohol, and 50 DEG C or less vacuum drying obtain Wild jujube seeds extract, spare； Wilsonii rhizome is taken, is cleaned out, is crushed into powder, adds 80% ethyl alcohol of 10 times of amounts for Extraction solvent, heating and refluxing extraction 3 hours, Filtration；Add 75% ethyl alcohol of 10 times of amounts for Extraction solvent, heating and refluxing extraction 2 times, every time 2 hours；Filtration, combined extract subtract Push back receipts ethyl alcohol, being concentrated into relative density is 1.20-1.24, adds ethyl alcohol to alcohol content 70%, stand filtration for 24 hours, filtrate in 50 DEG C are concentrated under reduced pressure into paste and recycle ethyl alcohol, and 50 DEG C or less vacuum drying obtain siberian Ginseng P.E, spare；Take matter it is hard, Taste is pure, Radix Glycyrrhizae without mildew, moisturizes, and is sliced, adds water to cook 3 times, 2 hours every time, collecting decoction, standing overnight made to precipitate, and took Supernatant is concentrated into paste, and measurement liquiritin content must not be less than 0 .5%, and glycyrrhizic acid must not be less than 7.0%, obtain Radix Glycyrrhizae Medicinal extract, it is spare；

The auxiliary material pharmaceutically received is added in composition described in the present embodiment can be prepared into granule.The present embodiment institute The Rhizoma Gastrodiae composition stated has good application in prevention insomnia.

Embodiment 2

A kind of Rhizoma Gastrodiae composition being effectively improved sleep, the raw material including following parts by weight: 4 parts of Rhizoma Gastrodiae extract, semen ziziphi spinosae mentions Take 16 parts of object, 13 parts of siberian Ginseng P.E, 8 parts of extract of licorice root.

1) raw material preparation: taking that meat is thick and solid, Gastrodia Elata Stem Tuber of no disease and pests harm, 55 DEG C low temperature drying 22 hours, crush, cross 8 meshes, 65% ethyl alcohol for adding 8 times of amounts is Extraction solvent, and heating and refluxing extraction 2 times, 0.5 hour every time, second was recovered under reduced pressure in combined extract Alcohol is concentrated into and is equivalent to crude drug 0.4g/mL, and 4000r/min is centrifuged 10 minutes, takes supernatant, is concentrated under reduced pressure into and is equivalent to crude drug 3g/mL adds ethyl alcohol to alcohol content 65%, stands 22h, filtration, adds 35%NaOH solution tune pH value to 8.0, stands 22h, filtration, Filtrate is concentrated under reduced pressure into paste in 45 DEG C and recycles ethyl alcohol, and 45 DEG C or less vacuum drying obtain Rhizoma Gastrodiae extract, spare；It takes Semen ziziphi spinosae seed, is crushed into powder, and adding 55% ethyl alcohol of 7 times of amounts is Extraction solvent, heating and refluxing extraction 2 hours after impregnating 25 minutes, Filtration；Add 55% ethyl alcohol of 5 times of amounts for Extraction solvent, heating and refluxing extraction 1 time, every time 1.5 hours；Filtration, combined extract, Ethyl alcohol is recovered under reduced pressure, being concentrated into relative density is 1.22, adds ethyl alcohol to alcohol content 65%, stands 22h, filtration, filtrate is in 45 DEG C It is concentrated under reduced pressure into paste and recycles ethyl alcohol, 45 DEG C or less vacuum drying obtain Wild jujube seeds extract, spare；Take Radix Acanthopanacis Senticosi root Stem is cleaned out, and is crushed into powder, and adding 75% ethyl alcohol of 8 times of amounts is Extraction solvent, heating and refluxing extraction 2 hours, is filtered；Add 8 times Amount 70% ethyl alcohol be Extraction solvent, heating and refluxing extraction 1 time, every time 1.5 hours；Second is recovered under reduced pressure in filtration, combined extract Alcohol, being concentrated into relative density is 1.22, adds ethyl alcohol to alcohol content 65%, stands 22h, filtration, filtrate is concentrated under reduced pressure into 45 DEG C Paste simultaneously recycles ethyl alcohol, and 45 DEG C or less vacuum drying obtain siberian Ginseng P.E, spare；Take matter heavily fortified point, taste pure, without mildew Radix Glycyrrhizae moisturizes, and slice adds water to cook 2 times, 1.5 hours every time, collecting decoction, standing overnight made to precipitate, and supernatant is taken to be concentrated To paste, 0 .5% must not be less than by measuring liquiritin content, and glycyrrhizic acid must not be less than 7.0%, obtain extract of licorice root, spare；

The auxiliary material pharmaceutically received is added in composition described in the present embodiment can be prepared into pulvis.Described in the present embodiment Rhizoma Gastrodiae composition on auxiliary treatment of insomnia disease have good application.

Embodiment 3

A kind of Rhizoma Gastrodiae composition being effectively improved sleep, the raw material including following parts by weight: 16 parts of Rhizoma Gastrodiae extract, semen ziziphi spinosae mentions Take 33 parts of object, 33 parts of siberian Ginseng P.E, 25 parts of extract of licorice root.

1) raw material preparation: taking that meat is thick and solid, Gastrodia Elata Stem Tuber of no disease and pests harm, 65 DEG C low temperature drying 26 hours, crush, cross 12 mesh Sieve, adding 75% ethyl alcohol of 12 times of amounts is Extraction solvent, and heating and refluxing extraction 4 times, 1.5 hours every time, combined extract depressurized back Ethyl alcohol is received, is concentrated into and is equivalent to crude drug 0.6g/mL, 6000 r/min are centrifuged 20 minutes, take supernatant, are concentrated under reduced pressure into quite In crude drug 5g/mL, adding ethyl alcohol to alcohol content 75%, stands 26h, filtration adds 45%NaOH solution tune pH value to stand 26h to 8.0, Filtration, filtrate are concentrated under reduced pressure into paste in 55 DEG C and recycle ethyl alcohol, and 55 DEG C or less vacuum drying obtain Rhizoma Gastrodiae extract, standby With；Semen ziziphi spinosae seed is taken, is crushed into powder, adding 65% ethyl alcohol of 9 times of amounts is Extraction solvent, heating and refluxing extraction 4 after impregnating 35 minutes Hour, filtration；Add 65% ethyl alcohol of 7 times of amounts for Extraction solvent, heating and refluxing extraction 3 times, every time 2.5 hours；Filtration, merging mention Take liquid, ethyl alcohol be recovered under reduced pressure, being concentrated into relative density is 1.24, adds ethyl alcohol to alcohol content 75%, stand 26h, filtration, filtrate in 55 DEG C are concentrated under reduced pressure into paste and recycle ethyl alcohol, and 55 DEG C or less vacuum drying obtain Wild jujube seeds extract, spare；Take thorn five Add rhizome, clean out, be crushed into powder, adding 85% ethyl alcohol of 12 times of amounts is Extraction solvent, heating and refluxing extraction 4 hours, is filtered； Add 80% ethyl alcohol of 12 times of amounts for Extraction solvent, heating and refluxing extraction 3 times, every time 2.5 hours；Filtration, combined extract, decompression Ethyl alcohol is recycled, being concentrated into relative density is 1.24, adds ethyl alcohol to alcohol content 75%, stands 26h, filtration, filtrate is depressurized in 55 DEG C It is concentrated into paste and recycles ethyl alcohol, 55 DEG C or less vacuum drying obtain siberian Ginseng P.E, spare；Take that matter is hard, taste is pure, nothing The Radix Glycyrrhizae of mildew, moisturizes, and slice adds water to cook 4 times, 2.5 hours every time, collecting decoction, standing overnight made to precipitate, and took supernatant Liquid is concentrated into paste, and measurement liquiritin content must not be less than 0 .5%, and glycyrrhizic acid must not be less than 7.0%, obtain extract of licorice root, It is spare；

The auxiliary material pharmaceutically received is added in composition described in the present embodiment can be prepared into liquid preparation.The present embodiment The Rhizoma Gastrodiae composition has good application in prevention insomnia.

Embodiment 4

A kind of Rhizoma Gastrodiae composition being effectively improved sleep, the raw material including following parts by weight: 8 parts of Rhizoma Gastrodiae extract, semen ziziphi spinosae mentions Take 25 parts of object, 13 parts of siberian Ginseng P.E, 8 parts of extract of licorice root, 10 parts of pregelatinized starch, 1.0 parts of croscarmellose sodium, 0.5 part of silica, 0.5 part of magnesium stearate.

A kind of preparation for the Rhizoma Gastrodiae composition being effectively improved sleep, the preparation are capsule.

The preparation method of capsule described in the present embodiment the following steps are included:

1) be sieved: taking that meat is thick and solid, Gastrodia Elata Stem Tuber of no disease and pests harm, 60 DEG C low temperature drying 24 hours, crush, cross 10 meshes, add 70% ethyl alcohol of 10 times of amounts is Extraction solvent, and heating and refluxing extraction 3 times, 1 hour every time, ethyl alcohol was recovered under reduced pressure in combined extract, It is concentrated into and is equivalent to crude drug 0.5g/mL, 5000 r/min are centrifuged 15 minutes, are taken supernatant, are concentrated under reduced pressure into and are equivalent to crude drug 4g/ ML adds ethyl alcohol to alcohol content 70%, stands filtration for 24 hours, add 40%NaOH solution tune pH value to 8.0, stand filtration for 24 hours, filtrate Paste is concentrated under reduced pressure into 50 DEG C and recycles ethyl alcohol, and 50 DEG C or less vacuum drying obtain Rhizoma Gastrodiae extract, spare；Take wild jujube Benevolence seed, is crushed into powder, and adding 60% ethyl alcohol of 8 times of amounts is Extraction solvent, heating and refluxing extraction 3 hours after impregnating 30 minutes, filter It crosses；Add 60% ethyl alcohol of 6 times of amounts for Extraction solvent, heating and refluxing extraction 2 times, every time 2 hours；Filtration, combined extract, decompression Recycle ethyl alcohol, be concentrated into relative density for 1.21-1.23 between, add ethyl alcohol to alcohol content 70%, stand for 24 hours, filter, filtrate in 50 DEG C are concentrated under reduced pressure into paste and recycle ethyl alcohol, and 50 DEG C or less vacuum drying obtain Wild jujube seeds extract, spare；Take thorn five Add rhizome, clean out, be crushed into powder, adding 80% ethyl alcohol of 10 times of amounts is Extraction solvent, heating and refluxing extraction 3 hours, is filtered； Add 75% ethyl alcohol of 10 times of amounts for Extraction solvent, heating and refluxing extraction 2 times, every time 2 hours；Filtration, combined extract depressurize back Receive ethyl alcohol, be concentrated into relative density for 1.21-1.23 between, add ethyl alcohol to alcohol content 70%, stand for 24 hours, filter, filtrate in 50 DEG C are concentrated under reduced pressure into paste and recycle ethyl alcohol, and 50 DEG C or less vacuum drying obtain siberian Ginseng P.E, spare；Take matter it is hard, Taste is pure, Radix Glycyrrhizae without mildew, moisturizes, and is sliced, adds water to cook 3 times, 2 hours every time, collecting decoction, standing overnight made to precipitate, and took Supernatant is concentrated into paste, and measurement liquiritin content must not be less than 0 .5%, and glycyrrhizic acid must not be less than 7.0%, obtain Radix Glycyrrhizae Medicinal extract, it is spare；Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root are crossed into 60 meshes respectively, it is spare；

3) it mixes: first by Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, pregelatinized starch, crosslinking Sodium carboxymethylcellulose, silica mixing 25min, obtain mixed powder；

4) softwood processed: being added mixed powder softwood for 65% ethyl alcohol, and additional amount is that 65% ethyl alcohol 28ml is added in every 100g mixed powder, is mixed Close uniformly, be allowed to hold it is agglomerating, gently pinch i.e. dissipate；

5) it pelletizes, dry, whole grain: the softwood made being pelletized by 16 meshes, then places 50 DEG C of dry 1.5h in baking oven, mistake 16 mesh sieves；

6) by particle and the magnesium stearate mixing 3min after whole grain, total hybrid particles total mix: are obtained；

The filling specification of the capsule is 0.6g/, is filled in 0# capsule, and packing specification is 60/bottle, is used Oral stable medicinal polythene bottle with high density is packed；The amount and eating method of the capsule are 2 times a day, often Secondary 2, sooner or later each 1 time.

Embodiment 5

A kind of Rhizoma Gastrodiae composition being effectively improved sleep, the raw material including following parts by weight: 12 parts of Rhizoma Gastrodiae extract, semen ziziphi spinosae mentions Take 28 parts of object, 16 parts of siberian Ginseng P.E, 10 parts of extract of licorice root, 30 parts of pregelatinized starch, croscarmellose sodium 5.0 Part .5 parts of silica 1,1.5 parts of magnesium stearate.

The preparation method of the capsule the following steps are included:

3) it mixes: first by Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, pregelatinized starch, crosslinking Sodium carboxymethylcellulose, silica mixing 35min, obtain mixed powder；

4) softwood processed: being added mixed powder softwood for 75% ethyl alcohol, and additional amount is that 75% ethyl alcohol 32ml is added in every 100g mixed powder, is mixed Close uniformly, be allowed to hold it is agglomerating, gently pinch i.e. dissipate；

5) it pelletizes, dry, whole grain: the softwood made being pelletized by 20 meshes, then places 60 DEG C of dry 2.5h in baking oven, mistake 20 mesh sieves；

6) by particle and the magnesium stearate mixing 7min after whole grain, total hybrid particles total mix: are obtained；

Embodiment 6

A kind of Rhizoma Gastrodiae composition being effectively improved sleep, the raw material including following parts by weight: 14 parts of Rhizoma Gastrodiae extract, semen ziziphi spinosae mentions Take 30 parts of object, 20 parts of siberian Ginseng P.E, 12 parts of extract of licorice root, 20 parts of pregelatinized starch, croscarmellose sodium 3.0 Part, silica 1 part, 1 part of magnesium stearate.

The preparation method of the capsule the following steps are included:

3) it mixes: first by Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, pregelatinized starch, crosslinking Sodium carboxymethylcellulose, silica mixing 30min, obtain mixed powder；

4) softwood processed: being added mixed powder softwood for 70% ethyl alcohol, and additional amount is that 70% ethyl alcohol 30ml is added in every 100g mixed powder, is mixed Close uniformly, be allowed to hold it is agglomerating, gently pinch i.e. dissipate；

5) it pelletizes, dry, whole grain: the softwood made being pelletized by 18 meshes, 18 DEG C of dry 2h in baking oven is then placed, crosses 18 Mesh sieve；

6) by particle and the magnesium stearate mixing 5min after whole grain, total hybrid particles total mix: are obtained；

Embodiment 7

A kind of Rhizoma Gastrodiae composition being effectively improved sleep, the raw material including following parts by weight: 9 parts of Rhizoma Gastrodiae extract, semen ziziphi spinosae mentions Take 26 parts of object, 15 parts of siberian Ginseng P.E, 9 parts of extract of licorice root, 32 parts of microcrystalline cellulose, 2.0 parts of croscarmellose sodium, 6.0 parts of silica, 6.0 parts of magnesium stearate, 2.5 parts of coating powder.

A kind of preparation for the Rhizoma Gastrodiae composition being effectively improved sleep, the preparation are tablet.

The preparation method of the tablet the following steps are included:

1) be sieved: taking that meat is thick and solid, Gastrodia Elata Stem Tuber of no disease and pests harm, 61 DEG C low temperature drying 24 hours, crush, cross 10 meshes, add 71% ethyl alcohol of 11 times of amounts is Extraction solvent, and heating and refluxing extraction 3 times, 1.2 hours every time, second was recovered under reduced pressure in combined extract Alcohol is concentrated into and is equivalent to crude drug 0.5g/mL, and 5500 r/min are centrifuged 16 minutes, takes supernatant, is concentrated under reduced pressure into and is equivalent to crude drug 4g/mL adds ethyl alcohol to alcohol content 71%, stands filtration for 24 hours, adds 41%NaOH solution tune pH value to 8.0, stands 23h, filtration, Filtrate is concentrated under reduced pressure into paste in 52 DEG C and recycles ethyl alcohol, and 52 DEG C or less vacuum drying obtain Rhizoma Gastrodiae extract, spare；It takes Semen ziziphi spinosae seed, is crushed into powder, and adding 61% ethyl alcohol of 8 times of amounts is Extraction solvent, heating and refluxing extraction 3 hours after impregnating 31 minutes, Filtration；Add 61% ethyl alcohol of 6 times of amounts for Extraction solvent, heating and refluxing extraction 2 times, every time 2.1 hours；Filtration, combined extract, Ethyl alcohol is recovered under reduced pressure, being concentrated into relative density is 1.22, adds ethyl alcohol to alcohol content 71%, stands 23h, filtration, filtrate is in 51 DEG C It is concentrated under reduced pressure into paste and recycles ethyl alcohol, 51 DEG C or less vacuum drying obtain Wild jujube seeds extract, spare；Take Radix Acanthopanacis Senticosi root Stem is cleaned out, and is crushed into powder, and adding 81% ethyl alcohol of 11 times of amounts is Extraction solvent, heating and refluxing extraction 3 hours, is filtered；Add 11 Times amount 75% ethyl alcohol be Extraction solvent, heating and refluxing extraction 2 times, every time 2 hours；Second is recovered under reduced pressure in filtration, combined extract Alcohol, being concentrated into relative density is 1.22, adds ethyl alcohol to alcohol content 70%, stands 25h, filtration, filtrate is concentrated under reduced pressure into 51 DEG C Paste simultaneously recycles ethyl alcohol, and 51 DEG C or less vacuum drying obtain siberian Ginseng P.E, spare；Take matter heavily fortified point, taste pure, without mildew Radix Glycyrrhizae moisturizes, and slice adds water to cook 3 times, 2.2 hours every time, collecting decoction, standing overnight made to precipitate, and supernatant is taken to be concentrated To paste, 0 .5% must not be less than by measuring liquiritin content, and glycyrrhizic acid must not be less than 7.0%, obtain extract of licorice root, spare； Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root cross 60 meshes respectively, spare；

3) it mixes: first by Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, microcrystalline cellulose, crosslinking Sodium carboxymethylcellulose, silica mixing 25min, obtain mixed powder；

4) softwood processed: being added mixed powder softwood for 65% ethyl alcohol, and additional amount is that 65% ethyl alcohol 28ml is added in every 100g mixed powder, is made Hold it is agglomerating, gently pinch i.e. dissipate；

5) it pelletizes, dry, whole grain: the softwood made being pelletized by 16 meshes, then places 50 DEG C of dry 2.5h in baking oven, mistake 20 mesh sieves；

7) granulation will always tabletting, coating, bottling: be mixed；Then coating powder is configured to 8% coating solution with 65% ethyl alcohol, it is right Tabletting is coated, coating weight gain 2%, bottling.

Embodiment 8

A kind of Rhizoma Gastrodiae composition being effectively improved sleep, the raw material including following parts by weight: 13 parts of Rhizoma Gastrodiae extract, semen ziziphi spinosae mentions Take 31 parts of object, 19 parts of siberian Ginseng P.E, 11 parts of extract of licorice root, 38 parts of microcrystalline cellulose, croscarmellose sodium 3.0 Part, 0 part of silica 1,10 parts of magnesium stearate, 3.5 parts of coating powder.

The preparation method of the tablet the following steps are included:

1) it is sieved: Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root being taken to cross 60 meshes respectively, it is spare；

3) it mixes: first by Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, microcrystalline cellulose, crosslinking Sodium carboxymethylcellulose, silica mixing 35min, obtain mixed powder；

4) softwood processed: being added mixed powder softwood for 75% ethyl alcohol, and additional amount is that 75% ethyl alcohol 32ml is added in every 100g mixed powder, is made Hold it is agglomerating, gently pinch i.e. dissipate；

7) granulation will always tabletting, coating, bottling: be mixed；Then coating powder is configured to 12% coating solution with 75% ethyl alcohol, it is right Tabletting is coated, coating weight gain 4%, bottling.

Embodiment 9

A kind of Rhizoma Gastrodiae composition being effectively improved sleep, the raw material including following parts by weight: 15 parts of Rhizoma Gastrodiae extract, semen ziziphi spinosae mentions Take 32 parts of object, 24 parts of siberian Ginseng P.E, 15 parts of extract of licorice root, 35 parts of microcrystalline cellulose, croscarmellose sodium 2.5 Part, 8 parts of silica, 8 parts of magnesium stearate, 3.0 parts of coating powder.

The preparation method of the tablet the following steps are included:

3) it mixes: first by Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, microcrystalline cellulose, crosslinking Sodium carboxymethylcellulose, silica mixing 30min, obtain mixed powder；

4) softwood processed: being added mixed powder softwood for 70% ethyl alcohol, and additional amount is that 70% ethyl alcohol 30ml is added in every 100g mixed powder, is made Hold it is agglomerating, gently pinch i.e. dissipate；

5) it pelletizes, dry, whole grain: the softwood made being pelletized by 18 meshes, 55 DEG C of dry 2h in baking oven is then placed, crosses 18 Mesh sieve；

7) granulation will always tabletting, coating, bottling: be mixed；Then coating powder is configured to 10% coating solution with 70% ethyl alcohol, it is right Tabletting is coated, coating weight gain 3%, bottling.

Embodiment 10

A kind of Rhizoma Gastrodiae composition being effectively improved sleep, capsule agent prescription (by mass percentage):

Rhizoma Gastrodiae extract 8%, Wild jujube seeds extract 30%, siberian Ginseng P.E 17%, extract of licorice root 12%, pregelatinized starch 27.5%, Croscarmellose sodium 4%, silica 0.7%, magnesium stearate 0.8%.

Two, production technology:

(1) be sieved: the supplementary materials such as Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root cross 60 mesh respectively Sieve；

(2) it weighs: according to product formula, the inventory of each supplementary material is calculated according to output, then weighs Rhizoma Gastrodiae extract, acid Jujube kernel extract, siberian Ginseng P.E, extract of licorice root, pregelatinized starch, croscarmellose sodium, silica, tristearin Sour magnesium is spare.

(3) it mixes: first by Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, cross-linked carboxymethyl Sodium cellulosate, silica mix about 30min, obtain mixed powder, spare.

(4) softwood processed: being added mixed powder softwood for 70% ethyl alcohol, and 70% ethyl alcohol is added about according to every 100g mixed powder 30ml, be allowed to hold it is agglomerating, gently pinch i.e. dissipate.

(5) it pelletizes, dry, whole grain: the softwood made being pelletized by 18 meshes, then places 55 DEG C of left and right trunks in baking oven Dry about 2h crosses 18 mesh sieves.

(6) by particle and the magnesium stearate mixing 5min after whole grain, total hybrid particles total mix: are obtained.

(7) capsule is filling: gained hybrid particles are dispensed into 0# capsule using automatic filling machine for capsules is filling, 0.6g/.

(8) it bottles: using oral stable medicinal polythene bottle with high density, packing specification is 60/bottle.

(9) outer packing: select standard compliant carton (quality standard is GB/T 6543) as housing material, packaging It in the process should packaging quality check at any time.

Three, amount and eating method: 2 times a day, 2 tablets each time, each 1 time sooner or later.

Embodiment 11

One, a kind of Rhizoma Gastrodiae composition for being effectively improved sleep, tablet formula (press mass parts):

8 parts of Rhizoma Gastrodiae extract, 30 parts of Wild jujube seeds extract, 17 parts of siberian Ginseng P.E, 12 parts of extract of licorice root, microcrystalline cellulose 32.5 parts, 2 parts of croscarmellose sodium, 8 parts of silica, 7 parts of magnesium stearate, 2.5 parts of coating powder.

Two, production technology:

(2) it weighs: according to product formula, the inventory of each supplementary material is calculated according to output, then weighs Rhizoma Gastrodiae extract, acid Jujube kernel extract, siberian Ginseng P.E, extract of licorice root, microcrystalline cellulose, croscarmellose sodium, silica, tristearin Sour magnesium, coating powder are spare.

(3) mix: first by Rhizoma Gastrodiae extract, Wild jujube seeds extract, siberian Ginseng P.E, extract of licorice root, microcrystalline cellulose, Croscarmellose sodium, silica mix about 30min, obtain mixed powder, spare.

(7) granulation, 0.6g/ piece will always tabletting, coating: be mixed.Coating powder is configured to 10% coating with 70% ethyl alcohol Liquid coating, coating weight gain 3%.

(8) it bottles: using oral stable medicinal polythene bottle with high density, packing specification is 80 pieces/bottle.

Three, amount and eating method: 2 times a day, 2 tablets once, and each 1 time sooner or later.

Test example 1 --- animal experiment

Rhizoma Gastrodiae composition in the embodiment of the present invention 9 is tested by animal efficacy assessments, as the result is shown: the composition 1.2g/ Kg.bw/d test group mouse yellow Jackets sleeping time is longer than 0g/kg.bw/d control group；0.4g/kg.bw/d and 1.2g/ Kg.bw/d test group mouse barbital sodium Sleep latency is shorter than 0g/kg.bw/d control group.The composition to known to has It is significant to improve sleep function.

It is tested by animal toxicology, as the result is shown: the composition acute toxicity dosage is determined as nontoxic；Give rat people 100 times of body recommended dose are fed for 30 days, do not observe toxic effect；The test of animal deformity is feminine gender.

Test portion:

One, toxicological test

(1) acute oral toxicity test

1 material and method

1.1 experimental animals: SPF grades of healthy adult ICR mouse 20, half male and half female, the weight of animals female are 18.4-21.1g, Male is 19.5-21.8g, is provided by Nanjing Medical University's pharmaceutical experiment animal center, production licence number SCXK(Soviet Union) 2016- 0002, quality certification number: 201720235.

The selection of 1.2 dosage gives mode with tested material: carrying out acute toxicity test in mice with maximal tolerance dose method, designs Dosage is 15000mg/kg.bw.Test preceding animal fasting 16 hours, free water.Given the test agent is crushed into powder using pulverizer End, and prepared using sterile water, maximum dose concentration is 750mg/mL, by maximum stomach-filling amount (20mL/kg.bw), sample is once given, Tested material gives dosage 15000mg/kg.bw.To being observed continuously after sample 14 days, poisoning manifestations and death condition are recorded.

1.3 test methods: acute toxicity test in mice is carried out with maximal tolerance dose method.

2. result

During experimental observation, groups of animals diet and activity are normal, well-grown, have no any poisoning manifestations and death.Combination Influence of the object to mouse and death toll is shown in Table 1.

Influence of 1 composition of table to mouse and death toll

3 brief summaries

Obvious poisoning manifestations are had no after this composition of orally administration animal, the weight of animals growth are had no significant effect, in the observation period Without animal dead.This composition is female, male mice acute oral MTD is greater than 15000mg/kgbw, according to acute toxicity dosage point Grade standard, the sample belong to nontoxic grade.

Feeding trial report in (two) 30 days

1 material and method

1.1 experimental animals: SPF grades of healthy height cream SD rat 80, half male and half female are had by the western Poole-Bi Kai experimental animal in Shanghai Limit company provides, the Shanghai production licence number SCXK() 2013-0016, quality certification number: 2008001684028.Animal purchase Afterwards, it quarantines 3 days, junctor is randomly divided into control group, low dose group, middle dose group, 4 groups of high dose group again, every group 20, male, male It is fifty-fifty.Heap animal original body mass is 71~81g；Buck original body mass is 80~92g.

1.2 dosage select to give mode with tested material: composition tablet human body recommended dose is 2.4g/ people/day, with 60kg Weight calculates, and sets 1.2 g/kg.bw/d, 2.6g/kg.bw/d, 4.0 g/ by the 30 of human body recommended dose, 65 and 100 times Tri- dosage groups of kg.bw/d, separately set a blank control group 0gkg.b/wd.Given the test agent is ground into powder using pulverizer, so Afterwards by rat is fed in diluted method incorporation basal feed step by step, when given the test agent mixes feed, converted by the 10% of weight, The percentage composition that low dose group given the test agent mixes basal feed is 1.2%, and middle dose group given the test agent mixes the hundred of basestocks Dividing content is 2.6%, and the percentage composition that high dose group given the test agent mixes basal feed is 4.0%.Control group is basic feed. It is continuous to feed 30 days.Animal ad lib drinking-water.

1.3 test method

Groups of animals gave the continuous feeding of each dosage group feed after 30 days, fasting overnight, by only weighing, 10% chloraldurate abdominal cavity Injecting anesthetic surveys its hematological indices and blood parameters through abdominal aortic blood.

1.3.1 ordinary circumstance is observed: observing and recording general performance, behavior, poisoning manifestations and the dead feelings of animal daily Condition.

1.3.2 weight, food utilization: claiming weekly 1 weight and 2 food intake doses, calculates food weekly and always Utilization rate.

1.3.3 hematological indices: rat blood is taken to measure its blood red egg with SIEMENS ADVIA2120i blood analyser Bai Hanliang, red blood cell count(RBC), from cell count and its classification etc..

1.3.4 blood parameters: taking rat blood serum, measures serum paddy third with 7100 type automatic clinical chemistry analyzer of Hitachi Transaminase, glutamic-oxalacetic transaminease, total protein, albumin, total cholesterol, urea nitrogen, creatinine, blood glucose, triglycerides etc..

1.3.5 organ coefficient: after carrying out gross anatomy inspection Check, careful separation liver, kidney, spleen, testis, ovary are used Physiological saline is cleaned, and is weighed after filter paper water suction, is calculated separately liver, kidney, spleen, testis, ovary relative weight (dirty/body).

1.3.6 pathology are examined: control group and high dose group rat liver, spleen, Stomach duodenum, testis, ovary being taken to use Formaldehyde is fixed, paraffin embedding, slice, carries out histopathological examination after HE dyeing.

1.3.7 test data counts: carrying out homogeneity of variance inspection to each experiment initial data with SPSS software

It tests, meets the data information test groups multiple in one-way analysis of variance method that variance requires together

The comparative approach two-by-two of mean carries out statistical disposition between a control group；To the number of heterogeneity of variance

Statistical disposition is carried out using rank sum test according to data.

2. result

2.1 design dose lonvestions are at actual dose

The dosage set by 30 times, 65 times, 100 times of human body recommended dose 24g/ people/day (weight is based on 60kg) is respectively 1.2 g/kg.bw/d, 2.6 g/kg.bw/d, 4.0 g/kg.bw/d(are basic, normal, high), it is equivalent to 33 times of human body recommended amounts, 73 Again, 115 times, male is that 1.33g/kg.bw/d, 2.83g/kgbw/d, 4.47g/kgbw/d(are basic, normal, high), it is equivalent to people 33 times, 71 times, 112 times of body recommended amounts.

1 dose lonvestion situation of table ()

2.2 overviews: the general appearance and behavior of groups of animals are showed no obvious abnormalities, without poisoning manifestations, without death.

Influence of the composition to rat body weight

As can be seen from Table 2, female male group the 0th day each dosage group of weight of rat is compared with 0g/kgbw/d group, no statistical difference is anticipated Justice (P> 0.05) weight of rat is more balanced between each group before, testing.

Orally administration rat various dose 30 days carries out homogeneity of variance inspection to the rat body weight of each point of observation of each dosage group It tests, each index is all satisfied variance requirement, with mean between test groups multiple in one-way analysis of variance method and a control group Comparative approach carries out statistical disposition two-by-two.By 2 result of table as it can be seen that the weight and 0g/ of each point of observation of each dosage group of female male rat Kgbw/d group compares, difference it is not statistically significant (P> 0.05).

2 composition of table to rat body weight influence ()

Influence of 2.4 compositions to rat chow utilization rate

The composition of orally administration rat various dose 30 days, table 3 are the weight gain of each group rat, and table 4 is each group rat food ration, table 5 be each group rat chow utilization rate, and indices carry out homogeneity test of variance, and the 1st week food ration of female rats is eaten on the the 1st, 3 week Object utilization rate is unsatisfactory for homogeneity of variance requirement, carries out statistical disposition with rank sum test, and other each indexs meet homogeneity of variance requirement, With test groups multiple in one-way analysis of variance method between a control group mean two-by-two compared with carry out statistical disposition.As a result As it can be seen that each index of each dosage is compared with 0g/kgbw/d group, difference it is not statistically significant (P> 0.05).

3 composition each group rat of table weight gain ()

4 composition each group rat of table food ration ()

Influence of 2.5 compositions to rat blood index

The composition of orally administration rat various dose 30 days measures each dosage group rat blood red blood cell count(RBC), hemoglobin The indexs such as horizontal, white blood cell count(WBC) and its classification.Indices carry out homogeneity test of variance, female rats white blood cell count It is unsatisfactory for variance to require together, carries out statistical disposition with rank sum test, other each indexs are all satisfied variance and require together, with single factor test side Mean between multiple test groups and a control group in poor analysis method；Compare carry out statistical disposition two-by-two.It is by table 6 as it can be seen that each Each index of dosage group compared with 0g/kgbw/d group, difference it is not statistically significant (P> 0.05).

5 composition each group rat of table food utilization ()

The hematological indices of 6 composition each group rat of table influence ()

Influence of 2.6 compositions to rat blood biochemical indicator

The composition of orally administration rat various dose 30 days measures each dosage group rat blood serum glutamic-pyruvic transaminase, millet straw turns ammonia The level of enzyme, total protein, albumin, total cholesterol, triglycerides, urea nitrogen, creatinine and blood glucose.It is neat that indices carry out variance Property examine, female rats serum blood glucose, urea nitrogen levels, male rat serum urea nitrogen, total cholesterol level are unsatisfactory for variance It is neat to require, statistical disposition is carried out with rank sum test, other each indexs are all satisfied variance and require together, with one-way analysis of variance method In between multiple test groups and a control group mean comparative approach two-by-two carry out statistical disposition.By table 7 as it can be seen that 4.0g/kg Though bw/d group male rat serum creatinine level has statistical difference compared with 0 g/kgbw/d group, numerical value is in normal value In range, and without dose-response relationship, it is not considered as that there is bad biological significance；Each index and 0g/ of other each dosage groups Kgbw/d group compares, difference it is not statistically significant (P>0.05)。

The hematological indices of 6 composition each group rat of continued influence ()

7 composition of table to blood biochemistry of rats influence ()

2.7 general pathologies and histological examination

2.7.1 influence of the composition to Rats Organs and Tissues absolute weight and relative weight

The composition of orally administration rat various dose 30 days, measurement each group rat liver, kidney, board be dirty, testis, ovary are absolute Weight and relative weight (dirty body).Indices carry out homogeneity test of variance, rat ovary relative weight, male rat spleen Dirty absolute weight is unsatisfactory for variance with relative weight, kidney relative weight and requires together, carries out statistical disposition with rank sum test, other Each index is all satisfied variance and requires together, with two of mean between test groups multiple in one-way analysis of variance method and a control group Two comparative approach carry out statistical disposition.By table 8 as it can be seen that each index of each dosage group is compared with 0g/kgbw/d group, the equal nothing of difference Statistical significance (P>0.05)。

7 composition of continued to blood biochemistry of rats influence ()

Note: * indicate compared with 0 g/kgbw/d group,P<0.05。

8 composition of table Rats Organs and Tissues absolute weight and relative weight are influenced ()

2.7.2 pathological examination

Each dosage group male and female rat gross anatomy observation is showed no abnormal change.

Microscopic examination result is as follows: 0 g/kgbw/d group female rats totally 10:

Liver: lobuli hepatis structure is clear, liver rope marshalling；The almost the same nucleus size of liver cell size is uniform, nuclear membrane, core Benevolence understands, cytoplasm even dyeing.Slight hepatic cell steatosis 2 around portal area.

Kidney: kidney skin, medullary substance boundary clear, nephron structure is normal, and glomerulus is without inflammatory change, fibrosis, hyaloid lesion Deng variation, renal tubule also has no obvious lesion.Renal tubule mild swelling 2.

Spleen: red, white pulp understands that central artery occupies acini lienalis center, and corpusculum is not expanded without obvious atrophy, board sinus, spleen Girder is normal.

Stomach, 12 refer to: surface mucosa is normal, and no inflammatory changes and rotten to the corn, ulcer is formed.Under mucous membrane, muscle layer, placenta percreta it is equal No inflammatory changes.

Ovary: the corpus luteum or lean type formed after the ovarian follicle of visible different developmental phases and ovulation in ovary.

0g/ kgbw/d group male rat totally 10:

Liver: lobuli hepatis structure is clear, liver rope marshalling；Liver cell size is almost the same, and nucleus size is uniform, nuclear membrane, Kernel understands, cytoplasm even dyeing.Kidney victory: kidney skin, medullary substance boundary clear, nephron structure is normal, and glomerulus changes without inflammatory The variation such as change, fibrosis, hyaloid lesion, renal tubule also have no obvious lesion.Board is dirty: red, white pulp understands that central artery occupies Acini lienalis center, corpusculum are not expanded without obvious atrophy, snius lienis, and spleen trabeculae is normal.Stomach duodenum: surface mucosa is normal, no inflammation It sexually revises and rotten to the corn, ulcer is formed under mucous membrane, muscle layer, placenta percreta change without inflammatory.Testis: convoluted tubule of testis is thin by supporting Born of the same parents and epithelial cell, primary, secondary spermatocyte are constituted, and germ cell development is normal.

4.0g/ kgbw/d group female rats totally 10:

Liver: lobuli hepatis structure is clear, liver rope marshalling；Liver cell size is almost the same, and nucleus size is uniform, nuclear membrane, Kernel understands, cytoplasm even dyeing.Around portal area and lobuli hepatis peripheral band slight hepatic cell steatosis 1, lobuli hepatis Peripheral band slight hepatic cell steatosis 2.

Kidney: kidney skin, medullary substance boundary clear, nephron structure is normal, and glomerulus is without inflammatory change, fibrosis, hyaloid The variation such as lesion, renal tubule also have no obvious lesion.Renal tubule mild swelling 1.

Spleen: red, white pulp understands, central artery occupies acini lienalis center, and corpusculum is without obviously withering

Two, animal teratogenesis is tested

1 material and method

1.1 samples: given the test agent is ground into powder, Salmonella reversion test, micronucleus test and mouse inbred strain using pulverizer Tested using smashed powder.

Experimental animal: micronucleus test selects the cleaning grade ICR healthy mice of Yangzhou University's comparative medicine center's breeding, production Credit number SCXK (Soviet Union) 2017-0007, quality certification number: 201726797;Mouse inbred strain selects Yangzhou University's ratio Compared with the cleaning grade ICR healthy mice of medical center breeding, production licence number SCXK (Soviet Union) 2017-0007, the quality certification is numbered: 201726797。

Test method

1.3.1 Salmonella reversion test

Using dressing plate incorporation methods, salmonella typhimurium saltant TA97, TA98, TA100, TA102 are selected, it is identified It is tested after qualification.Activation system is that rats'liver S-9, the 8-9 protein content that β-Cai's flavones and sodium phenobarbital induce is 30mg/mL, vigor have good metabolic activation ability to 2- aminofluorene.Add 10mL S-9 in every 100mL S-9 mixed liquor.Sun Property object: it is 2,4,7- trinitrofluorenones (TA97, TA98) that S-9 person, which is not added, and methyl methylsulfonate (TA100, TA102) adds S-9 person For 2- aminofluorene (TA97, TA98, TA100), 1,8- dihydroxy-anthracene matches (TA102), while setting negative control group (untreated control Group and solvent control group).In the case where adding and S-9 mixed liquor being not added with the progress of 5000,1000,200,40 and 8ug/ ware dosage Test, each dosage group make 3 plates.Sample is placed in high-temperature sterilization 20min under the conditions of 0.103Mpa, aseptically, claims Amount given the test agent is simultaneously configured to solution, and given the test agent is configured to 50mg/mL, i.e. high dose group with DMSO, with DMSO by certain times 10,2,4 0.4,0.08mg/mL dosage groups are configured to than diluting step by step, sample-adding amount is 0.lmL/ ware.In 2mL top agar Middle addition 0.1mL test strain enrichment liquid, 0.1mL given the test agent solution and 0.5mLS-9 mixed liquor are (when needing metabolism activation When).It is poured into after mixing on bottom culture medium flat plate, 37 DEG C are cultivated 48 hours, are counted every ware and are returned change clump count.If given the test agent The change clump count that returns of group is that negative control group returns change clump count 2 times or more, and it is then positive for having dose-response relationship.Entirely Test repeats to do under the same conditions primary.

1.3.2 mouse marrow cell micro nuclear test

25 ~ 30g of weight cleaning grade ICR kind mouse 50 are selected, adapts to be tested for environment 5 days after animal purchase.By weight with Machine is divided into 5 groups, and every group 10, half male and half female.Composition human body recommended intake are as follows: (weight presses 60kg to 2.4g/ people/day Meter), 100 times of given the test agent human body recommended intake are as follows: 4000g/kgbw, therefore maximum dose level is set as 10000g/kgbw, If 2500,5000,3 dosage groups of 1000mg/kgbw, negative control group (sterile water, 20mL/kgbw stomach-filling), positive right According to group (cyclophosphamide, 40mg/kgbw intraperitoneal injection).Select sterile water as solvent according to the dissolubility of sample.Test sample Product are prepared with sterile water, and it is 125,250,500mg/mL that low, middle and high dose groups contain given the test agent concentration respectively, with 20mL/kg Bw stomach-filling gives tested material method using 30h.Twice for 24 hours to given the test agent interval, it is moved to execution in 6 hours after given the test agent for second Object takes the film-making of breastbone routine, microscopy, and every mouse counts 1000 Polychromatic erythrocytes (PCE), observes the thermophilic polychromatophilia containing micronucleus Red blood cell number simultaneously calculates microkernel incidence, in terms of permillage, is as a result examined using U and carries out statistical disposition.Every mouse counting 200 thermophilic Observed mature erythrocyte number (NCE) when Polychromatic erythrocytes, and calculate polychromatic erythrocyte and mature erythrocyte ratio ( PCE/NCE)。

1.3.3 mouse inbred strain

25 ~ 35 cleaning grade ICR sexal maturity of weight male mice 25 is selected, adapts to be tested for environment 5 days after animal purchase.It presses Weight is randomly divided into 5 groups, every group 5.Composition human body recommended intake are as follows: 2.4g/ people/day (weight is based on 60kg), it is tested 100 times of sample human body recommended intake are as follows: 4000g/kgbw, therefore maximum dose level is set as 1000g/kgbw, if 2500, 5000,10000g/kgbw3 dosage group, negative control group (sterile water, 20mL/kgbw stomach-filling), positive controls (ring Phosphamide, 40mg/kgbw intraperitoneal injection).Select sterile water as solvent according to the dissolubility of sample.Given the test agent is with sterile Water is prepared, and it is 125,250,500mg/mL that low, middle and high dose groups contain given the test agent concentration respectively, with 20mL/kgbw stomach-filling, 1 time a day, continuous 5d.The 35th day execution animal after giving given the test agent for the first time, takes two sides epididymal sperm filtrate routinely to make Piece, microscopy.Every mouse counts the sperm of 100 structural integrities, calculates Sperm malformation rate (with percentage), as a result uses sum of ranks It examines and carries out statistical disposition.

1.4 test datas statistics: micronucleus test result is examined using U and carries out statistical disposition, mouse inbred strain knot Fruit carries out statistical disposition using rank sum test.

As a result

2.1Ames test

2.1.1 sterile test result: given the test agent solution, solvent control, buffer and S-9 mixture in aseptic flat board Contaminated bacterium colony is not observed.

2.1.2Ames test result: by table 1, table 2 as it can be seen that each dosage group of composition returns and becomes clump count and be less than feminine gender Control group returns 2 times of change clump count, also without dose-response relationship.I.e. composition to salmonella typhimurium TA97, TA98, Tetra- plants of test strains of TA100, TA102 are showed no when adding and S-9 being not added and cause gene mutation effect.

1 composition Salmonella reversion test of table time change clump count () (first time)

Note: * * is more than negative control group bacterium colony 2 times or more.

2.2 mouse marrow cell micro nuclear test

Seen from table 3, there was no significant difference compared with negative control group (P > 0.05) for each dosage group micronuclear rates of composition, and positive Property control group be higher than negative control group, have significant difference (P < 0.05).The PCE/NCE ratio of each dosage group of tested material with it is right According to group difference within control group 20%, tested material does not have inhibiting effect to proliferation of bone marrow cells.Have no composition to mouse Micronucleus is formed and polychromatic erythrocyte has an impact with mature erythrocyte ratio (PCE/NCE).

2 composition Salmonella reversion test of table time change clump count () (for the second time)

Note: * * is more than negative control group bacterium colony 2 times or more.

3 composition of table is to mouse Bone marrow cells micronucleus incidence and polychromatic erythrocyte and mature erythrocyte ratio (PCE/ NCE influence)

Note: * * compared with negative control group,p< 0.05。

Influence of 4 composition of table to mouse sperm deformity rate

Note: * * compared with negative control group,p< 0.05。

Mouse inbred strain

By table 4, table 5 as it can be seen that each dosage group rate of teratosperm is compared with negative control group, there was no significant difference (P < 0.05), and Positive controls mouse sperm deformity rate is higher than negative control group, there is significant difference (P < 0.05).Therefore magnificent human relations board cordate telosma Mouse sperm deformity rate is not had an impact.

Influence of 5 composition of table to mouse sperm deformity type and ratio

3 brief summaries

3.1 composition Salmonella reversion test results are feminine gender；

3.2 composition mouse marrow cell micro nuclear test results are feminine gender；

3.3 composition mouse inbred strain results are feminine gender.

Three, improve sleep function (animal experiment)

1 material and method

1.1 samples: given the test agent human body recommended dose is 24g/ people/day.

Experimental animal: select the SPF grade CL/F1 of the western Poole Bi Kai experimental animal Co., Ltd breeding in Shanghai for Healthy female Mouse 120, weight be 19.0 ~ 21.8g, experimental animal production licence number be SCXK (Shanghai) 2013-0016, quality certification number: 2008001684293。

Mouse adapts to environment, is randomly divided into three big group by weight after quarantine 3 days, wherein I group mouse 40, it is randomly divided into 4 dosage groups, first carry out direct sleep experiments by every group 10, and next day carries out extending the experiment of yellow Jackets sleeping time again；Ⅱ Group mouse 40 is randomly divided into 4 dosage groups, every group 10, carries out yellow Jackets sub-threshold dose hypnosis experiment；III group of mouse 40,4 dosage groups are randomly divided into, every group 10, carry out the experiment of barbital sodium Sleep latency.

Experimental animal is raised in this center barrier environment that temperature is 20 ~ 26 DEG C, relative humidity is 40% ~ 70%.Experiment Animal uses credit number: SYXK (Soviet Union) 2015-0009.Irradiation sterilization feed cooperates with the limited duty of medical bioengineering by Jiangsu Province Ren company provides, production licence: card (2014) 01008 is raised by Soviet Union.

Dosage selects to give mode with tested material: the human body recommended dose of given the test agent is the 2.4g/ day for human beings (with 60kg weight Meter), if tri- 0.2g/ kgbw/d, 0.4 g/kg bw/d, 1.2g/ kgbw/d dosage groups (are respectively equivalent to tested 5 times, 10 times, 30 times of sample human body recommended intake), it sets 0g/kgbw/d group separately with sterile water and replaces tested material.Sample warp It is prepared after crushing with sterile water, basic, normal, high dosage formulation concentration is respectively 20mg/mL, 40mg/mL, 120mg/mL, oral every Once give the tested material of mouse corresponding dosage day, intragastric administration on mice amount is 01mL/10gbw.

Test method

1.4.1 the direct sleep experiments of mouse

Each dosage group animal continuous gavage one month is slept after the last administration with mouse righting reflex loss 1min to enter, Righting reflex restores to be that mouse is awakened criterion, record each group sleep number of animals and sleeping time.

Compare control group and experimental group sleep number of animals and the difference between sleeping time, if when sleep number of animals or sleep Between increase and have conspicuousness, then experimental result is positive.

Extend the experiment of yellow Jackets sleeping time

Each dosage group animal continuous gavage one month, after last dose 15min, groups of animals presses 45mg/kgbw dosage abdomen Chamber injects yellow Jackets, and injection volume 10mL/kgbw rights disappearance 1min with mouse as sleep index, observes test sample Can product extend yellow Jackets sleeping time.

Compare the difference between control group and the extension of experimental group sleeping time, sleeping time extension has conspicuousness, then tests As a result positive.

Yellow Jackets sub-threshold dose hypnosis experiment

Each dosage group animal continuous gavage one month, after last dose 15min, groups of animals presses 30 mg/kg bw dosage Yellow Jackets are injected intraperitoneally, injection volume 10mL/kgbw rights disappearance 1min with mouse as sleep index, records to penta Each group sleep number of animals in barbital sodium 30min.

Compare the difference between control group and experimental group sleep number of animals, incidence of sleep animals increase has conspicuousness, then Experimental result is positive.

The experiment of barbital sodium Sleep latency

Each dosage group animal continuous gavage one month, after last dose 15min, groups of animals presses 300mg/kgbw dosage abdomen Chamber injects barbital sodium, and injection volume 10mL/kgbw rights disappearance 1min with mouse as sleep index, observes given the test agent Influence to barbital sodium Sleep latency.

Compare the difference between control group and experimental group Sleep latency, Sleep latency shortening has conspicuousness, then tests As a result positive.

Test data statistics: homogeneity test of variance is carried out to each test initial data with SPSS10.0 software, meets variance The data information required together, with test groups multiple in one-way analysis of variance method between a control group mean two-by-two compared with Method carries out statistical disposition；Variable conversion appropriate is carried out to the data information of Non-Gaussian Distribution or heterogeneity of variance, wait meet just After state or variance require together, statistical disposition is carried out with resulting data are converted.

Result judgement: extend the experiment of yellow Jackets sleeping time, yellow Jackets sub-threshold dose hypnosis experiment, barbital It is positive that sodium Sleep latency tests binomial in three experiments, and acts on without obvious directly sleep, can determine that the given the test agent has Improve sleep function effect.

As a result: drinking water for animals is ingested normally in experimentation, and appearance is without exception.

Influence of the composition to mouse weight

Seen from table 1,02 g/kgbw/d of original body mass of mouse, 0.4 g/kgbw/d, 1.2g/kgbw/d group and 0 G/kgbw/d group compares, difference it is not statistically significant (P>0.05).Show that the original body mass of mouse is more equal between each group Weighing apparatus.

Composition one month of orally administration mouse various dose, each dosage group weight gain are full through homogeneity test of variance The requirement of sufficient homogeneity of variance, with experimental groups multiple in one-way analysis of variance method between a control group mean two-by-two relatively just Method carries out statistical disposition.Seen from table 1,0.2g/kgbw/d, 0.4g/ kgbw/d, 1.2g/ kgbw/d group and 0g/ Kgbw/d group compares, difference it is not statistically significant (P>0.05)。

1 composition of table to mouse weight influence ()

。

The influence that composition directly sleeps to mouse

Phenomenon of sleeping does not occur for composition one month of orally administration mouse various dose, after the last administration, each group mouse.By Table 2 is as it can be seen that composition 0.2g/kgbw/d, 0.4g/kgbw/d, 1.2g/kgbw/d group make mouse without directly sleep With.

The influence that 2 composition of table directly sleeps to mouse

Influence of 2.3 compositions to yellow Jackets inducing mouse sleeping time is extended

Composition one month of orally administration mouse various dose is injected intraperitoneally yellow Jackets, observes the sleeping time of mouse. Sleeping time through homogeneity test of variance, meets homogeneity of variance requirement, right with experimental groups multiple in one-way analysis of variance and one Statistical disposition is carried out according to the comparative approach two-by-two of mean between group.By 3 result of table as it can be seen that when 1.2g/kgbw/d group mice sleep Between be longer than 0g/kgbw/d group, difference is statistically significant (P < 0.05).

3 composition of table to extend yellow Jackets inducing mouse sleeping time influence ()

Influence of 2.4 compositions to dosage hypnosis under yellow Jackets

Yellow Jackets are injected intraperitoneally in composition one month of orally administration mouse various dose, observe each group mouse in 30min Sleep incidence.Sleep number of animals carry out statistical disposition with exact propability.By 4 result of table as it can be seen that 0.2g/kgbw/d, 0.4g/ kgbw/d, 1.2g/kgbw/d group animal sleep incidence are compared with 0 g/kgbw/d group, no statistical difference Meaning (P > 0.05).

4 composition of table yellow Jackets sub-threshold dose inducing mouse is slept close incidence influence ()

。

Influence of 2.5 compositions to barbital sodium Sleep latency

Composition one month of orally administration mouse various dose is injected intraperitoneally barbital sodium, observes the Sleep latency of mouse. Sleep latency meets homogeneity of variance requirement through homogeneity test of variance, with experimental groups multiple in one-way analysis of variance method with The comparative approach two-by-two of mean carries out statistical disposition between one control group.By 5 result of table as it can be seen that 0.4 g/kgbw/d, 1.2g/ Kgbw/d group mice sleep incubation period is significantly shorter than 0g/kgb/wd group, and difference is statistically significant (P < 0.05).

5 composition of table to barbital sodium Sleep latency influence ()

3 brief summaries

3.1 direct sleep experiments: 0.2 g/kgbw/d of composition, 0.4 g/kgbw/d, 1.2 g/kgbw/d groups are to small Mouse acts on without direct sleep.Extend brave barbital sodium sleeping time experiment: 1.2g/ kgbw/d group mouse sleep time is long In 0 g/kgbw/d group, difference is statistically significant (P < 0.05).

The eleventh of the twelve Earthly Branches barbital sodium sub-threshold dose hypnosis experiment: 0.2g/ kg bw/d, 04 g/kgbw/d, 1.2 g/kg Bw/d group incidence of sleep animals are compared with 0g/kgbw/d group, no significant difference (P > 0.05).

Barbital sodium Sleep latency experiment: 0.4 g/kgbw/d, 1.2g/ kgbw/d group mice sleep incubation period It is significantly shorter than 0g/ kgbw/d group, difference is statistically significant (P < 0.05).According to " health food is examined advises with assessment technique Model " improvement sleep function test result judgement, under this experiment condition composition have the function of improvement sleep function.

Test example 2 --- animal experiment

Rhizoma Gastrodiae composition in the embodiment of the present invention 1 is tested by animal efficacy assessments, test portion is with test example 1, as a result Display: the composition 1.2g/kg.bw/d test group mouse yellow Jackets sleeping time is longer than 0g/kg.bw/d control group； 0.4g/kg.bw/d and 1.2g/kg.bw/d test group mouse barbital sodium Sleep latency is shorter than 0g/kg.bw/d control group.From And knowing that the composition has improves sleep function.It is tested by animal toxicology, test portion is with test example 1, as the result is shown: The composition acute toxicity dosage is determined as nontoxic；It gives 100 times of rat human body recommended dose to feed for 30 days, not observe toxic Evil effect；The test of animal deformity is feminine gender.

3-animal experiment of test example

The capsule of Rhizoma Gastrodiae composition in the embodiment of the present invention 4 is tested by animal efficacy assessments, test portion is the same as test Example 1, as the result is shown: the composition 1.2g/kg.bw/d test group mouse yellow Jackets sleeping time is longer than 0g/kg.bw/d pairs According to group；0.4g/kg.bw/d and 1.2g/kg.bw/d test group mouse barbital sodium Sleep latency is shorter than 0g/kg.bw/d control Group.The composition, which has, to known to improves sleep function.It is tested by animal toxicology, test portion is with test example 1, as a result Display: the composition acute toxicity dosage is determined as nontoxic；It gives 100 times of rat human body recommended dose to feed for 30 days, not observe To toxic effect；The test of animal deformity is feminine gender.

4-animal experiment of test example

The capsule of Rhizoma Gastrodiae composition in the embodiment of the present invention 6 is tested by animal efficacy assessments, test portion is the same as test Example 1, as the result is shown: the composition 1.2g/kg.bw/d test group mouse yellow Jackets sleeping time is longer than 0g/kg.bw/d pairs According to group；0.4g/kg.bw/d and 1.2g/kg.bw/d test group mouse barbital sodium Sleep latency is shorter than 0g/kg.bw/d control Group.The composition, which has, to known to improves sleep function.It is tested by animal toxicology, test portion is with test example 1, as a result Display: the composition acute toxicity dosage is determined as nontoxic；It gives 100 times of rat human body recommended dose to feed for 30 days, not observe To toxic effect；The test of animal deformity is feminine gender.

Test example 5 --- animal experiment

The tablet of Rhizoma Gastrodiae composition in the embodiment of the present invention 7 is tested by animal efficacy assessments, the same test example of test portion 1, as the result is shown: the composition 1.2g/kg.bw/d test group mouse yellow Jackets sleeping time is longer than 0g/kg.bw/d control Group；0.4g/kg.bw/d and 1.2g/kg.bw/d test group mouse barbital sodium Sleep latency is shorter than 0g/kg.bw/d control Group.The composition, which has, to known to improves sleep function.It is tested by animal toxicology, test portion is with test example 1, as a result Display: the composition acute toxicity dosage is determined as nontoxic；It gives 100 times of rat human body recommended dose to feed for 30 days, not observe To toxic effect；The test of animal deformity is feminine gender.

Test example 6 --- animal experiment

Capsule obtained in the embodiment of the present invention 10 is tested by animal efficacy assessments, test portion is with test example 1, as a result Display: the composition 1.2g/kg.bw/d test group mouse yellow Jackets sleeping time is longer than 0g/kg.bw/d control group； 0.4g/kg.bw/d and 1.2g/kg.bw/d test group mouse barbital sodium Sleep latency is shorter than 0g/kg.bw/d control group.From And knowing that the composition has improves sleep function.It is tested by animal toxicology, test portion is with test example 1, as the result is shown: The composition acute toxicity dosage is determined as nontoxic；It gives 100 times of rat human body recommended dose to feed for 30 days, not observe toxic Evil effect；The test of animal deformity is feminine gender.

Claims

1. a kind of Rhizoma Gastrodiae composition for being effectively improved sleep, it is characterised in that the composition includes the raw material of following parts by weight: 4-16 parts of Rhizoma Gastrodiae extract, 16-33 parts of Wild jujube seeds extract, 13-33 parts of siberian Ginseng P.E, 8-25 parts of extract of licorice root.

2. the Rhizoma Gastrodiae composition according to claim 1 for being effectively improved sleep, it is characterised in that the composition include with The raw material of lower parts by weight: 8-16 parts of Rhizoma Gastrodiae extract, 25-33 parts of Wild jujube seeds extract, 13-25 parts of siberian Ginseng P.E, Radix Glycyrrhizae 8-16 parts of medicinal extract, 10-30 parts of pregelatinized starch, 1.0-5.0 parts of croscarmellose sodium, 0.5-1.5 parts of silica, firmly 0.5-1.5 parts of fatty acid magnesium.

3. the Rhizoma Gastrodiae composition according to claim 1 for being effectively improved sleep, it is characterised in that the composition include with The raw material of lower parts by weight: 8-16 parts of Rhizoma Gastrodiae extract, 25-33 parts of Wild jujube seeds extract, 13-25 parts of siberian Ginseng P.E, Radix Glycyrrhizae 8-16 parts of medicinal extract, 32-38 parts of microcrystalline cellulose, 2.0-3.0 parts of croscarmellose sodium, 6.0-10 parts of silica, firmly 6.0-10 parts of fatty acid magnesium, 2.5-3.5 parts of coating powder.

4. a kind of preparation method of the Rhizoma Gastrodiae composition for being effectively improved sleep any according to claim 1 ~ 3, feature Be the following steps are included:

1) raw material preparation:

Take that meat is thick and solid, Gastrodia Elata Stem Tuber of no disease and pests harm, 55-65 DEG C low temperature drying 22-26 hours, crush, cross 8-12 mesh, add The 8-12 times of 65-75% ethyl alcohol measured is Extraction solvent, and heating and refluxing extraction 2-4 times is 0.5-1.5 hours each, combined extract, Ethyl alcohol is recovered under reduced pressure, is concentrated into and is equivalent to crude drug 0.4-0.6g/mL, 4000-6000 r/min is centrifuged 10-20 minutes, takes supernatant Liquid is concentrated under reduced pressure into and is equivalent to crude drug 3-5g/mL, adds ethyl alcohol to alcohol content 65-75%, stands 22-26h, filtration adds 35-45% NaOH solution tune pH value stands 22-26h, filtration to 8.0, and filtrate is concentrated under reduced pressure into paste in 45-55 DEG C and recycles ethyl alcohol, 45-55 DEG C or less vacuum drying, obtains Rhizoma Gastrodiae extract, spare；

Semen ziziphi spinosae seed is taken, is crushed into powder, adding the 7-9 times of 55-65% ethyl alcohol measured is Extraction solvent, is heated after impregnating 25-35 minutes Refluxing extraction 2-4 hours, filtration；Add the 5-7 times of 55-65% ethyl alcohol measured for Extraction solvent, heating and refluxing extraction 1-3 times, every time 1.5-2.5 hour；Ethyl alcohol is recovered under reduced pressure in filtration, combined extract, and being concentrated into relative density is 1.20-1.24, adds ethyl alcohol to alcohol Content 65-75% stands 22-26h, filtration, and filtrate is concentrated under reduced pressure into paste in 45-55 DEG C and recycles ethyl alcohol, and 45-55 DEG C It is dried in vacuo below, obtains Wild jujube seeds extract, it is spare；

Wilsonii rhizome is taken, is cleaned out, is crushed into powder, adding the 8-12 times of 75-85% ethyl alcohol measured is Extraction solvent, is heated to reflux It extracts 2-4 hours, filtration；Adding the 8-12 times of 70-80% ethyl alcohol measured is Extraction solvent, heating and refluxing extraction 1-3 times, each 1.5- 2.5 hour；Ethyl alcohol is recovered under reduced pressure in filtration, combined extract, and being concentrated into relative density is 1.20-1.24, adds ethyl alcohol to alcohol content 65-75% stands 22-26h, filtration, and filtrate is concentrated under reduced pressure into paste in 45-55 DEG C and recycles ethyl alcohol, and 45-55 DEG C or less true Sky is dry, obtains siberian Ginseng P.E, spare；

It takes that matter is hard, taste is pure, Radix Glycyrrhizae without mildew, moisturizes, be sliced, add water to cook 2-4 time, 1.5-2.5 hour each, merging is pan-fried Liquid, standing overnight makes to precipitate, and supernatant is taken to be concentrated into paste, and measurement liquiritin content must not be less than 0 .5%, and glycyrrhizic acid is not It obtains and is less than 7.0%, obtain extract of licorice root, it is spare；

5. a kind of preparation of the Rhizoma Gastrodiae composition for being effectively improved sleep any according to claim 1 ~ 3, it is characterised in that The preparation is that the auxiliary material pharmaceutically received is added in the composition to be prepared into capsule, tablet, pulvis, particle Agent, liquid preparation, pill.

6. a kind of preparation of the Rhizoma Gastrodiae composition according to claim 5 for being effectively improved sleep, it is characterised in that described Capsule includes the raw material of following parts by weight: 8-16 parts of Rhizoma Gastrodiae extract, 25-33 parts of Wild jujube seeds extract, and siberian Ginseng P.E 13-25 parts, 8-16 parts of extract of licorice root, 10-30 parts of pregelatinized starch, 1.0-5.0 parts of croscarmellose sodium, silica 0.5-1.5 parts, 0.5-1.5 parts of magnesium stearate；The preparation method of the capsule the following steps are included:

7. a kind of preparation of the Rhizoma Gastrodiae composition according to claim 6 for being effectively improved sleep, it is characterised in that described The filling specification of capsule is 0.6g/, is filled in 0# capsule, and packing specification is 60/bottle, using the medicinal height of oral administration solid Density polyethylene bottle is packed；The amount and eating method of the capsule be 2 times a day, 2 tablets each time, sooner or later each 1 It is secondary.

8. a kind of preparation of the Rhizoma Gastrodiae composition according to claim 5 for being effectively improved sleep, it is characterised in that described Tablet includes the raw material of following parts by weight: 8-16 parts of Rhizoma Gastrodiae extract, 25-33 parts of Wild jujube seeds extract, and siberian Ginseng P.E 13- 25 parts, 8-16 parts of extract of licorice root, 32-38 parts of microcrystalline cellulose, 2.0-3.0 parts of croscarmellose sodium, silica 6.0-10 parts, 6.0-10 parts of magnesium stearate, 2.5-3.5 parts of coating powder；The preparation method of the tablet the following steps are included:

9. a kind of preparation of the Rhizoma Gastrodiae composition according to claim 8 for being effectively improved sleep, it is characterised in that described The tabletting specification of tablet is 0.6g/ piece, and the bottling is to be carried out using oral stable medicinal polythene bottle with high density, bottling rule Lattice are 80 pieces/bottle；The amount and eating method of the tablet: 2 times a day, 2 tablets once, and each 1 time sooner or later.

10. a kind of application with the Rhizoma Gastrodiae composition for improving function any according to claim 1 ~ 3, it is characterised in that Application of the Rhizoma Gastrodiae composition on prevention/auxiliary treatment of insomnia disease.