CN105168972A - Health care product promoting sleep and preparation method therefor - Google Patents

Abstract

The invention provides a health care product promoting sleep and a preparation method therefor. The raw materials comprise spine date seeds, polygala tenuifolia, platycladi seed and rhizoma gastrodiae, and further comprise yerbadetajo herbs, beta-eucalyptol, lignum dalbergiae odoriferae and moutan barks. Furthermore, the health care product also can comprise longan aril, lilium brownii, mulberries, walnut meat, tremella, dates, cortex albiziae, poria with hostwood and poria cocos. The health care product also can comprise auxiliary materials of rice bran oil, beeswax, glycerin, purified water, gelatin and iron oxide red. The health care product is a pure traditional Chinese medicine preparation, contains no sugar, and is convenient to take for the elderly and diabetes patients. The health care product is prepared through a pressing method or a dropping preparation method, is formed at one time and has a whole sealing dosage form, and an unqualified phenomenon of disintegration after long time storage is avoided. Foreign odor and peculiar smell of some contents can be covered, the traditional Chinese medicine volatile components, traditional Chinese medicine components with adverse smell and traditional Chinese medicine preparations have special smell, after preparation into soft capsules, volatilization is not easy, adverse smell can be covered, and the drug quality is raised.

Description

Health product of a kind of hypnotic and preparation method thereof

Technical field

The present invention relates to health product of a kind of hypnotic and preparation method thereof, belong to technical field of health care food.

Background technology

The normal sleep times of the mankind should be six to eight hours, if sleep time reaches more than couple of days lower than physiological need, on physiology for have the demand of supplying sleep there will be a lot of immediately and significantly change, affected is at first attention, be absorbed in power, accurate operation ability, the thinking of high intelligence and memory, the learning efficiency and creative thinking also to show and go down subsequently.And when sleep wretched insufficiency, also likely bring out mental disorder.

In addition, Sweden medical researchers also finds, the harm of chronic insomnia may be fatal.The sclerosis of blood vessels of the bad person of extended sleep is obvious, bore narrows, have a strong impact on blood supply and make the function generation obstacle of some organs, all kinds of metabolites of body can not excrete in time, quantity of leucocyte reduces, immunologic function obviously reduces, and long-term and serious not having enough sleep can cause blood middle cholesterol content to increase, and making that cardiopathic chance occurs increases; The cell division of human body is many to carry out in sleep, does not have enough sleep or sleep disordered, can affect the proper splitting of cell, likely produces the sudden change of cancerous cell thus and causes the generation of cancer; Sleep minimizing can affect memory, causes feeling depressed, so that endocrine stress being activated and exhaustion and occur to regulate the disorderly generation causing cardiovascular disease gradually by regulator control system that affect the nerves.

The insomnia cause of disease has the following aspects:

A. environment reason: the flip-flop that common are sleep environment.

B. individual factors: bad living habit, drinks tea before sleeping, drink coffee, smoking etc.

C. body reason: in a broad sense, the discomfort of any body all can cause insomnia.

D. Nervous and Mental Factors: comprise because certain special event causes excitement, the opportunistic insomnia caused by worry.

E. emotional factor: the change in the mental state that can cause of losing one's temper, this change can show when emotional lability especially, and it can be caused by some accident, as special happy event or special sad, angry etc. all can cause having a sleepless night.This insomnia caused because of accident is a kind of phenomenon, may be occurrent, temporary transient; More serious insomnia is then long-term existence phenomenon not sleep well, their emotion is routinely in low state, nervous, fear, worry, suspect, indignation, hate, sensory organ that depression, anxiety etc. emotion not only occupies their daytime, and even also still to try to stop but cannot evening.

F. the withdrawal symptom of sleeping pill or alcoholic.

According to seminar of Finland, experimenter is divided into 3 groups by sleep quality by research worker, the number of wherein sleeping accounts for 48%, and general number of sleeping accounts for 40%, and the number of sleep difference accounts for 12%.The general people that sleeps on average has a sleepless night once weekly, and the people of sleep difference almost insomnia every day.Result of study shows, insomnia will increase mortality risk.Compared with the people slept, the risk that the women of slight insomnia is short-lived increases by 7%, and male increases by 22%; The short-lived risk of the people of serious insomnia is then high than the people slept 1.5 times.Insomnia and mortality risk link together by this research first.The great attention of people should be caused.Therefore the health food market demand of improving water flood is very big.

Summary of the invention

Sleep quality problem is ubiquity in people's daily life, and common people think that what large defect this is not, so all can not directly go to go to a doctor to hospital, but carries out self regulation health care to the product that pharmacy or supermarket buy some health care productses.The present invention is directed to above-mentioned problems faced, by inspection information and zoopery, a large amount of Chinese medicine formulas is screened, finally determine the formula of this health food.Basic components of the present invention selects Semen Ziziphi Spinosae, Radix Polygalae, Semen Platycladi, Rhizoma Gastrodiae to be raw material, adopts suitable extraction process, and the physicochemical property of bonded products, considers from function, absorption, stability etc. are many-sided, or again through soft capsule that rational technique is made.Prove through animal safety toxicology test, this product has the health care of improving water flood, has the advantages such as bioavailability is high, taking convenience simultaneously.Concrete formula is as follows:

Health product for hypnotic, comprise the raw material composition of following weight portion: Semen Ziziphi Spinosae 1-4 part, Radix Polygalae 1-3 part, Semen Platycladi 2-5 part, Rhizoma Gastrodiae 0.1-2.0 part.

More preferably the weight portion of each raw material is 3.2 parts, Radix Polygalae 1.6 parts, Semen Platycladi 2.4 parts, 0.8 part, Rhizoma Gastrodiae.

The health product of above-mentioned hypnotic, the health product of this hypnotic also comprise Herba Ecliptae 1-4 part, β-eucalyptus leaves oleyl alcohol 0.1-1 part, deep red fragrant 2-5 part, Cortex Moutan 1-4 part.

There is Herba Ecliptae 2.3 parts in the health product electing this hypnotic as further, β-eucalyptus leaves oleyl alcohol 0.2 part, deep red fragrant 2.4 parts, Cortex Moutan 1.8 parts.

The health product of this hypnotic can also comprise Arillus Longan 1-3 part, Bulbus Lilii 2-5 part, Fructus Mori 4-8 part, Semen Juglandis 2-5 part, Tremella 1-5 part, Fructus Jujubae 5-10 part, Cortex Albiziae 5-10 part, Poria cum Radix Pini 0.7-1.2 part, Poria 3-6 part.

In above-mentioned raw materials, the health product of this hypnotic of the application are Semen Ziziphi Spinosae 1.7 parts, Radix Polygalae 1.2 parts, Semen Platycladi 2.0 parts, 0.4 part, Rhizoma Gastrodiae, Arillus Longan 2.5 parts, Bulbus Lilii 3.7 parts, 4.5 parts, Fructus Mori, Semen Juglandis 4.5 parts, 3.1 parts, Tremella, 8.5 parts, Fructus Jujubae, Cortex Albiziae 6.5 parts, Poria cum Radix Pini 1.0 parts, 5 parts, Poria.

The preparation method of the health product of above-mentioned hypnotic, comprises the steps:

1) be broken into fritter according to each raw material meeting States Pharmacopoeia specifications or be broken into granularity and cross 60 object coarse powder, obtaining raw material;

2) learn from else's experience the raw material of cutting or pulverizing, reflux 2 times with 7 times amount 70% edible ethanols, return time is respectively 1.5h and 1h, filters, merging filtrate;

3) by step 2) in filtrate at-0.065 to-0.075Mpa and 65 DEG C, reclaim ethanol, then at 60 DEG C, being concentrated into relative density is 1.30 to 1.35, obtains extractum;

4) by the clear paste in above-mentioned-0.075 to-0.085Mpa, drying under reduced pressure at 70 DEG C, pulverizes, and crosses 100 mesh sieves, and packaging is for subsequent use, can obtain the health product with complementary blood fat reducing.

Health product of the present invention can also add adjuvant, and adjuvant of the present invention is the adjuvant that food formulation technique accepts.

Further, this adjuvant of the present invention comprises: Testa oryzae oil, Cera Flava, glycerol, purified water, gelatin, iron oxide red; Wherein, the extract of Testa oryzae oil and health product raw material adds by weight 1-5:1; Cera Flava accounts for the 1-5% of raw material gross weight; Glycerol, purified water, gelatin accounts for the 18-25% of raw material gross weight, and the weight ratio of gelatin, glycerol, purified water is 1:0.3-0.5:0.8-1.5; Iron oxide red presses the 0.8-2.5 ‰ of gelatin gross weight.

On the basis of above-mentioned adjuvant, the preparation method of the health product of hypnotic of the present invention, comprises the steps:

1) be broken into fritter according to the raw material meeting States Pharmacopoeia specifications or be broken into granularity and cross 60 object coarse powder, obtain raw material, this raw material 7 times amount 70% edible ethanols are refluxed 2 times, return time is respectively 1.5h and 1h, filter, merging filtrate, again filtrate is reclaimed ethanol at-0.065 to-0.075Mpa and 65 DEG C, then at 60 DEG C, be concentrated into relative density is 1.30 to 1.35, obtain clear paste, further by clear paste-0.075 to-0.085Mpa, drying under reduced pressure at 70 DEG C, pulverize, cross 100 mesh sieves and obtain Chinese medicine extract powder, again by Testa oryzae oil, Cera Flava, gelatin, glycerol, purified water, iron oxide red is in strict accordance with the program entering 100,000 grades of clean areas, clean area is entered for subsequent use through pass-through box,

2) preparation of content, after appropriate Testa oryzae oil Cera Flava being joined 70 DEG C dissolves completely, then adds residue Testa oryzae oil, mix homogeneously, obtained oily wax liquid; Joined in oily wax liquid by Chinese medicine extract powder, be uniformly mixed colloid mill 3 times, each 30min, under-0.06 to-0.08Mpa, vacuumize degassing bubble, obtains Contents Fill liquid;

3) preparation of glue, purified water, iron oxide red are mixed well in rear glycerol adding inputization glue tank, after mix homogeneously, 70-75 DEG C of heating, adds gelatin after stirring, is stirred to gelatin entirely molten, glue bubble-free is evacuated under-0.06 to-0.08Mpa, after crossing 100 orders, glue is placed in the 55 DEG C of insulations of storage glue tank, stand-by;

4) pelleting, soft capsule implant, glue are pressed into soft capsule by encapsulating machine by 0.5g/ grain, the rotating speed keeping encapsulating machine is that 1.5-3.5 turns/min, the sprinkler body temperature of encapsulating machine keeps 35-50 DEG C, the rubber thickness of soft capsule of compacting is 0.80 to 0.85mm, by the soft capsule that presses in rotating cage, at temperature 18-26 DEG C, shape under relative humidity 30-40% 2-3h, obtains soft capsule;

5) wash ball, pour in soft capsule pot by the soft gelatin capsule after sizing, wash soft capsule twice with 95% ethanol, the time is 4-6 minute, and drop goes out ethanol, is dried by washed soft gelatin capsule uniform spreading on yarn jiggering;

6) dry, select ball, by washed soft capsule at temperature 25-28 DEG C, relative humidity 25%-35% carries out drying, drying time 18-24 hour, be dried to softgel shell moisture Control scope 9%-12%, can be promoted the health product of sleep, these health product with hypnotic are capsule preparations.

Present invention process route is defined as:

Wherein must operate 100,000 grades of clean areas from Chinese medicine extract and Testa oryzae oil mixed processes to operation of bottling.Process design and appointed condition meet health food GMP requirement.

In the application, soft capsule belongs to the one of capsule, and it is by liquid medicine or juicy fruit body medicine is treated is sealed in a kind of capsule made in soft capsule material.The capsule material of soft capsule is made up of glycerol and gelatin etc., and wall is thicker, and again without breathability, therefore soft capsule is the elegant formulations preventing oxidation of drug.

The beneficial effect that soft capsule in the application produces on the health product of the application is as follows:

Pure Chinese medicinal preparation, not sugary, be convenient to old people and diabetics is taken.Active constituent content is high, and it remains volatile effective component to greatest extent.Bioavailability is high, and impurity content is low, without crude drug powder, more easily meets Hygienic Index.Absorb the advantage such as fast and easily reach effective blood drug concentration.Prepared by pressing or dropping preparation method, one-shot forming, totally-enclosed dosage form, after avoiding being long placed in, occur the defective phenomenon of disintegrate.Can hide some content foreign odor, abnormal flavour, the Chinese medicine ingredients of Chinese medicine volatile ingredient and tool bad smell has special odor containing the Chinese medicine preparation of volatile oil, makes soft capsule not volatile, and can cover bad smell, improves drug quality.Dose is few, easy to carry.Dosage form technological process is short, simply.

Various oils can be filled or to oily liquids, the suspension of softgel shell without dissolution, capsule 's content generally comprises raw material (Chinese medicine extract), diluent, emulsifying agent and suspending agent in soft capsule.When preparing soft capsule, no matter Chinese medicine or its extract are powder or extractum, easily deposit when only mixing with oils substrate, and loading amount can be caused when fill to be forbidden.Therefore; in order to keep suspension to have good mobility, usually adding emulsifying agent, suspending agent and substrate melting, after the equipment such as colloid mill, emulsification instrument mixing dispersion, obtaining comparatively fine and smooth content; thus change the mobility of content, improve the stability that settling ratio guarantees suspension.In the health food of the application, use Cera Flava, effectively raise the uniformity of medicinal liquid.

Content adjuvant in the application select and the experimental study of uniformity as follows:

Testa oryzae oil is diluent, and Testa oryzae oil itself has good stability, and is a kind of nutritious vegetable oil, and after food, absorbance reaches more than 90%.The absorption that Testa oryzae oil is made up of fatty acid, vitamin E, sterol, oryzanol etc. are conducive to human body, has the cholesterol removed in blood, reduces blood fat, promotes the beneficial effects such as growth in humans's growth, and thus Testa oryzae oil is the nutrient health oil of generally acknowledging both at home and abroad.Its quality meets the requirement of relevant criterion.Production conditional operation is strong, can controlling extent high, better can control product quality.

Cera Flava is suspending agent.Worker bee to construct Nidus Vespae and capping Nidus Vespae and from honeybee glandular secretion fatty waxy solid out.It is the organic compound that a kind of chemical composition is very complicated.Generally speaking, the fat of main component synthesized by higher fatty acids and high alcohol of Cera Flava, accounts for 70% ~ 75%, free fatty accounts for 12% ~ 15%, carbohydrate accounts for 11% ~ 17%, and water accounts for 2.5%, also has a small amount of aromatic substance, pigment and trace element etc.The wax class that Cera Flava and other plant wax, mineral wax, fatty acid, fatty alcohol, glyceride, hydrocarbon and synthetic wax etc. are nearly all and oil and fat product have good intermiscibility.

For adapting to the needs that soft capsule is produced, this technique is using Testa oryzae oil as diluent, and Cera Flava is as suspending agent.Require to be soluble in homogenizing, good fluidity when Testa oryzae oil, Cera Flava and Chinese medicine dried cream powder (i.e. raw extract) make suspension.In 3.6% situation that fixing Cera Flava consumption is content, to the ratio research experiment of dried cream powder, Testa oryzae oil.Chinese medicine extract dried cream powder and Testa oryzae oil mix in the ratio of 1:1-5 respectively, observe mobility and the homogeneity of medicinal liquid.

Result of the test shows, when Chinese medicine dried cream powder (i.e. raw extract) is 1:4 or 1:5 with the ratio of Testa oryzae oil, contents mixed liquid viscosity is moderate, good fluidity, meets the fill requirement of soft capsule, selects the ratio adopting Chinese medicine dried cream powder and Testa oryzae oil to be that 1:4 feeds intake.

The determination of soft capsule formula proportion is as follows:

According to this toward knowhow, work as gelatin: glycerol: purified water is 1:0.4:1, the soft capsule skin of applicable technological requirement can be obtained.Iron oxide red adds by 2 ‰ of gelatin amount.

Accompanying drawing explanation

Fig. 1 is the health product raw material powder of hypnotic in the application or the preparation technology of extractum.

Fig. 2 is the preparation technology of the health product of hypnotic in the application.

Detailed description of the invention

Embodiment 1

Formula:

Content formula:

Soft capsule skin formula:

1) be broken into fritter according to the raw material meeting States Pharmacopoeia specifications or be broken into granularity and cross 60 object coarse powder, obtaining raw material;

2) learn from else's experience the raw material of cutting or pulverizing, reflux 2 times with 6-8 times amount 70% edible ethanol, return time is respectively 1-2h and 1h, filters, merging filtrate;

3) by step 2) in filtrate at-0.065 to-0.075Mpa and 65 DEG C, reclaim ethanol, then at 60 DEG C, being concentrated into relative density is 1.30 to 1.35, obtains extractum;

4) by the clear paste in above-mentioned-0.075 to-0.085Mpa, drying under reduced pressure at 70 DEG C, pulverizes, and crosses 100 mesh sieves, packaging, for subsequent use, the health product with complementary blood fat reducing can be obtained, this dosage form is powder, and this programme can be also extractum type, namely deletes this step.

Subordinate list: the selection of Chinese medicine ethanol extraction process parameter

Total flavones in comprehensive dried cream powder, gastrodin content, production cycle and energy consumption cost, determine above-mentioned raw material of Chinese medicine alcohol reflux 2 times, for the first time alcohol adding amount 7 times, 1.5h; Second time alcohol adding amount 7 times, 1h.

5) preparation of content, by Testa oryzae oil on the basis of above-mentioned steps, Cera Flava, gelatin, glycerol, purified water, iron oxide red, in strict accordance with the program entering 100,000 grades of clean areas, enter clean area through pass-through box for subsequent use.After appropriate Testa oryzae oil Cera Flava being joined 70 DEG C dissolves completely, then add residue Testa oryzae oil, mix homogeneously, obtained oily wax liquid; Joined in oily wax liquid by Chinese medicine extract powder, be uniformly mixed colloid mill 3 times, each 30min, under-0.06Mpa, vacuumize degassing bubble, obtains Contents Fill liquid;

6) preparation of glue, purified water, iron oxide red are mixed well in rear glycerol adding inputization glue tank, after mix homogeneously, 70-75 DEG C of heating, adds gelatin after stirring, is stirred to gelatin entirely molten, glue bubble-free is evacuated under-0.08Mpa, after crossing 100 orders, glue is placed in the 55 DEG C of insulations of storage glue tank, stand-by;

7) pelleting, soft capsule implant, glue are pressed into soft capsule by encapsulating machine by 0.5g/ grain, the rotating speed keeping encapsulating machine is that 1.5-3.5 turns/min, the sprinkler body temperature of encapsulating machine keeps 35-50 DEG C, the rubber thickness of soft capsule of compacting is 0.85mm, by the soft capsule that presses in rotating cage, at temperature 18-26 DEG C, shape under relative humidity 30-40% 2-3h, obtains soft capsule;

8) wash ball, pour in soft capsule pot by the soft gelatin capsule after sizing, wash soft capsule twice with 95% ethanol, the time is 4-6 minute, and drop goes out ethanol, is dried by washed soft gelatin capsule uniform spreading on yarn jiggering;

9) dry, select ball, by washed soft capsule temperature 26 DEG C, relative humidity 23.5% carries out drying, 24 hours drying times, be dried to softgel shell moisture Control scope 12%, can obtain the health product of hypnotic of the present invention, the health product of this hypnotic are capsule preparations.

Contain in every 100g in the said goods: total flavones >=0.3g; Total saponins (in ginsenoside Re g/100g) >=0.2; Gastrodine (mg/100g) >=10.

Each supplementary material consumption and safety

This product is soft capsule, 2 times/day, 4 tablets/time, and without incompatibility between each raw material, consumption per day and reference quantity see attached list.

Subordinate list: each raw material consumption per day and pharmacopeia consumption synopsis

Raw material	Semen Ziziphi Spinosae	Semen Platycladi	Radix Polygalae	Rhizoma Gastrodiae
					Medical material consumption per day (g/ day)	3.2	2.4	1.6	0.8
Pharmacopeia consumption (g/ day)	9-15	3-9	3-9	3-9

As can be seen from the above, four kinds of Chinese medicine consumption per days are all lower than pharmacopeia lower limit.This product adjuvant Testa oryzae oil used, Cera Flava, gelatin, glycerol, iron oxide red all meet healthy food material regulation.This product shows through Disease Prevention Control Center, Hubei Prov's laboratory test, animal safety toxicology test no abnormality seen, shows that product is safe, is applicable to long-term edible.

The physical and chemical index of embodiment 1

The microbiological indicator of embodiment 1

Embodiment 2

Formula:

Content formula:

Soft capsule skin formula:

1) be broken into fritter according to the raw material meeting States Pharmacopoeia specifications or be broken into granularity and cross 60 object coarse powder, obtaining raw material;

2) learn from else's experience the raw material of cutting or pulverizing, reflux 2 times with 7 times amount 70% edible ethanols, return time is respectively 1.5h and 1h, filters, merging filtrate;

3) by step 2) in filtrate at-0.065 to-0.075Mpa and 65 DEG C, reclaim ethanol, then at 60 DEG C, being concentrated into relative density is 1.30 to 1.35, obtains extractum;

4) by the clear paste in above-mentioned-0.075 to-0.085Mpa, drying under reduced pressure at 70 DEG C, pulverizes, and crosses 100 mesh sieves, packaging, for subsequent use, the health product with complementary blood fat reducing can be obtained, this dosage form is powder, and this programme can be also extractum type, namely deletes this step.

5) preparation of content, by Testa oryzae oil on the basis of above-mentioned steps, Cera Flava, gelatin, glycerol, purified water, iron oxide red, in strict accordance with the program entering 100,000 grades of clean areas, enter clean area through pass-through box for subsequent use.After appropriate Testa oryzae oil Cera Flava being joined 70 DEG C dissolves completely, then add residue Testa oryzae oil, mix homogeneously, obtained oily wax liquid; Joined in oily wax liquid by Chinese medicine extract powder, be uniformly mixed colloid mill 3 times, each 30min, under-0.06Mpa, vacuumize degassing bubble, obtains Contents Fill liquid;

6) preparation of glue, purified water, iron oxide red are mixed well in rear glycerol adding inputization glue tank, after mix homogeneously, 70-75 DEG C of heating, adds gelatin after stirring, is stirred to gelatin entirely molten, glue bubble-free is evacuated under-0.08Mpa, after crossing 100 orders, glue is placed in the 55 DEG C of insulations of storage glue tank, stand-by;

7) pelleting, soft capsule implant, glue are pressed into soft capsule by encapsulating machine by 0.5g/ grain, the rotating speed keeping encapsulating machine is that 1.5-3.5 turns/min, the sprinkler body temperature of encapsulating machine keeps 35-50 DEG C, the rubber thickness of soft capsule of compacting is 0.85mm, by the soft capsule that presses in rotating cage, at temperature 18-26 DEG C, shape under relative humidity 30-40% 2-3h, obtains soft capsule;

8) wash ball, pour in soft capsule pot by the soft gelatin capsule after sizing, wash soft capsule twice with 95% ethanol, the time is 4-6 minute, and drop goes out ethanol, is dried by washed soft gelatin capsule uniform spreading on yarn jiggering;

9) dry, select ball, by washed soft capsule temperature 26 DEG C, relative humidity 23.5% carries out drying, 24 hours drying times, be dried to softgel shell moisture Control scope 12%, can obtain the health product of hypnotic of the present invention, the health product of this hypnotic are capsule preparations.

Contain in every 100g in the said goods: total flavones >=0.28g; Total saponins (in ginsenoside Re g/100g) >=0.15; Gastrodine (mg/100g) >=11.

Embodiment 3

Formula:

Content formula:

Soft capsule skin formula:

1) be broken into fritter according to the raw material meeting States Pharmacopoeia specifications or be broken into granularity and cross 60 object coarse powder, obtaining raw material;

2) learn from else's experience the raw material of cutting or pulverizing, reflux 2 times with 7 times amount 70% edible ethanols, return time is respectively 1.5h and 1h, filters, merging filtrate;

3) by step 2) in filtrate at-0.065 to-0.075Mpa and 65 DEG C, reclaim ethanol, then at 60 DEG C, being concentrated into relative density is 1.30 to 1.35, obtains extractum;

4) by the clear paste in above-mentioned-0.075 to-0.085Mpa, drying under reduced pressure at 70 DEG C, pulverizes, and crosses 100 mesh sieves, packaging, for subsequent use, the health product with complementary blood fat reducing can be obtained, this dosage form is powder, and this programme can be also extractum type, namely deletes this step.

5) preparation of content, by Testa oryzae oil on the basis of above-mentioned steps, Cera Flava, gelatin, glycerol, purified water, iron oxide red, in strict accordance with the program entering 100,000 grades of clean areas, enter clean area through pass-through box for subsequent use.After appropriate Testa oryzae oil Cera Flava being joined 70 DEG C dissolves completely, then add residue Testa oryzae oil, mix homogeneously, obtained oily wax liquid; Joined in oily wax liquid by Chinese medicine extract powder, be uniformly mixed colloid mill 3 times, each 30min, under-0.06Mpa, vacuumize degassing bubble, obtains Contents Fill liquid;

6) preparation of glue, purified water, iron oxide red are mixed well in rear glycerol adding inputization glue tank, after mix homogeneously, 70-75 DEG C of heating, adds gelatin after stirring, is stirred to gelatin entirely molten, glue bubble-free is evacuated under-0.08Mpa, after crossing 100 orders, glue is placed in the 55 DEG C of insulations of storage glue tank, stand-by;

7) pelleting, soft capsule implant, glue are pressed into soft capsule by encapsulating machine by 0.5g/ grain, the rotating speed keeping encapsulating machine is that 1.5-3.5 turns/min, the sprinkler body temperature of encapsulating machine keeps 35-50 DEG C, the rubber thickness of soft capsule of compacting is 0.85mm, by the soft capsule that presses in rotating cage, at temperature 18-26 DEG C, shape under relative humidity 30-40% 2-3h, obtains soft capsule;

8) wash ball, pour in soft capsule pot by the soft gelatin capsule after sizing, wash soft capsule twice with 95% ethanol, the time is 4-6 minute, and drop goes out ethanol, is dried by washed soft gelatin capsule uniform spreading on yarn jiggering;

9) dry, select ball, by washed soft capsule temperature 26 DEG C, relative humidity 23.5% carries out drying, 24 hours drying times, be dried to softgel shell moisture Control scope 12%, can obtain the health product of hypnotic of the present invention, the health product of this hypnotic are capsule preparations.

Contain in every 100g in the said goods: total flavones >=0.33g; Total saponins (in ginsenoside Re g/100g) >=0.22; Gastrodine (mg/100g) >=15.

In the present embodiment, the product that embodiment 1 obtains by we carries out zoopery, in this experiment, and the smooth dormancy soft capsule of product called after that we will obtain in embodiment 1.Specific experiment process is as follows:

One. Mouse Acute Toxicity, Micronucleus test, mouse inbred strain and rat 30 days feeding trials.

1 materials and methods

1.1 samples and the smooth dormancy soft capsule of process, by Hubei, Kun Yan Pharmaceutical Co., Ltd provides.Crowd's maximum recommended daily intaking amount is 0.067g/kgBW (according to adult 60kg body weight mean value computation).

1.2 animal varietiess and source: SPF level Kunming mouse, Wistar rat and feedstuff provide by Animal Experimental Study center, Hubei Province, laboratory animal and Feed Manufacturing credit number: SCXK (Hubei Province) 2008-0005.Large and small Mus is raised in the large and small Mus laboratory of our unit's SPF level respectively, laboratory animal occupancy permit number: SYXK (Hubei Province) 2012-0065.The weight of animals is determined according to every test requirements document.Laboratory temperature 20 ~ 25 DEG C, humidity 40 ~ 70%.

1.3 chmice acute Oral toxicity tests

1.3.1 dosage is arranged: given the test agent mouse stomach dosage is 20.0g/kgBW, is equivalent to 300.0 times of adult's maximum recommended daily intaking amount 0.067g/kgBW.

1.3.2 sample preparation: correct amount sample thief 20ml, weighing its quality is 21.6g, and its density is 1.08g/ml, by the direct gavage of tested material stock solution.

1.3.3 test method: select SPF level Kunming mouse, body weight is 18 ~ 20g, each 10 of male and female, and water is can't help in gavage animal fasting in first 16 hours, and give tested material single oral gavage after weighing, gavage capacity is 18.5ml/kgBW, and dosage is 20.0g/kgBW.Gavage Continuous Observation on the same day, observe later every day 2 times until the 14th day, and record animal poisoning symptom and death toll, during off-test, non-dead animal is weighed.

1.4 genetic toxicity test

1.4.1 mouse marrow cell micro nuclear test

1.4.1.1 experimental animal: select body weight to be the Kunming mouse of 25 ~ 30g, each 25 of male and female, are divided into 5 groups at random, often organize each 5 of male and female.

1.4.1.2 reagent and instrument: cyclophosphamide, lot number 12022725, is provided by Hengrui Medicine Co., Ltd., Jiangsu Prov.; Olympus microscope (Japan produces).

1.4.1.3 dosage grouping: (1) negative control group gives salad oil; (2) positive controls per os gavage gives cyclophosphamide 40mg/kgBW; (3) basic, normal, high three the dosage groups of given the test agent, are respectively 2.5g/kgBW, 5.0g/kgBW, 10.0g/kgBW.

1.4.1.4 sample preparation: given the test agent salad oil is mixed with the concentration of 0.125g/ml, 0.25g/ml, 0.50g/ml respectively, makes basic, normal, high dosage group, and positive substrate concentration is 0.002g/ml.

1.4.1.5 test method: adopt 30 h run methods, namely gavage gives tested material at twice, 24 hours, interval, given the test agent is respectively organized each mouse stomach capacity and is 20ml/kgBW.Within 6 hours after second time gives tested material, put to death animal, get femur and make bone marrow smear, fix after natural drying with methanol, Giemsa dyes.Every animal oil Microscopic observation 1000 polychromatic erythrocytes, there is the polychromatic erythrocyte number of micronucleus in record, its microkernel incidence is in the PCE permillage containing micronucleus; Count 200 polychromatic erythrocyte numbers (PCE), count ripe RBC number (NCE) simultaneously, and calculate PCE and account for Erythrocytes (PCE+NCE) total percentage ratio.

1.4.1.6 data statistics processing method: SPSS software building database, adopts X 2 test to add up respectively by Animal Sex micronuclear rates.

1.4.2 mouse inbred strain

1.4.2.1 experimental animal: select body weight to be the Male Kunming strain mice 25 of 25 ~ 35g, be divided into 5 groups at random, often organize 5.

1.4.2.2 reagent and instrument: same to 1.4.1.2.

1.4.2.3 dosage divides into groups: same to 1.4.1.3.

1.4.2.4 sample preparation: same to 1.4.1.4.

1.4.2.5 test method: each test group mice gives corresponding tested material in all continuous 5 days, and mouse stomach capacity is 20ml/kgBW, continuation nursing is (the 35th day namely after giving tested material first) execution animal after 30 days.Get both sides epididymis and be placed in 0.5ml normal saline, with eye scissors, epididymis is longitudinally cut 1-2 cutter, smear after filtering with four layers of lens paper, after air drying, methanol is fixed, then uses 1% eosin stains.Every animal high power Microscopic observation 1000 sperms, record teratospermia number, calculates teratospermia incidence rate (in permillage), and carries out statistical disposition.

1.4.2.6 data statistics processing method: SPSS software building database, each dosage component does not compare with corresponding negative control group, with X 2 test method evaluation sperm deformity positive rate.

1.530 it feeding trial

1.5.1 dosage and grouping; Select 80 body weight 60 ~ 80gWistar rats, male and female half and half, be divided into a negative control group and three dosage groups at random, i.e. 0.0g/kgBW, 1.68g/kgBW, 3.35g/kgBW, 6.70g/kgBW, the basic, normal, high dosage component of given the test agent is not equivalent to 25,50,100 times of adult's maximum recommended daily intaking amount 0.067g/kgBW.Negative control group gives the salad oil waiting capacity.Often organize each 10 rats of male and female, method for breeding is that single cage is fed.

1.5.2 sample preparation and giving: accurately take given the test agent 16.8,33.5,67.0g and put into beaker respectively, add appropriate salad oil, be finally settled to 100ml, shake up, concentration is respectively 0.168,0.335,0.67g/ml.Gavage capacity is 10.0ml/kgBW.

1.5.2 sample preparation and giving: accurately take given the test agent 16.8,33.5,67.0g and put into beaker respectively, add appropriate salad oil, be finally settled to 100ml, shake up, concentration is respectively 0.168,0.335,0.67g/ml.Gavage capacity is 10.0ml/kgBW.

1.5.3 observation index: comprise

1. general clinical symptoms: generally show, behavior, poisoning symptom and death condition.

2. body weight, food-intake and food utilization.

3. hematological examination: Measuring hemoglobin (HB) during off-test, red blood cell count(RBC) (RBC), leukocyte (WBC) counting and classification, lymphocyte (LY%), mononuclear cell (MO%), granulocyte (GR%), all measure with Japanese photoelectricity MEK-6318K type automatic hemacytometer.

4. blood biochemistry checking: measure the indexs such as serum glutamic pyruvic transminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), serum urea nitrogen (BUN), T-CHOL (TCH), triglyceride (TG), creatinine (Cr), blood glucose (GLu), serum albumin (Alb), total protein (TP) during off-test.Detecting instrument is: Hitachi 7020 type automatic clinical chemistry analyzer.Detectable is: the test kit that Fenghui Medical Science and Technology Co., Ltd., Shanghai produces.

5. organ weights and dirty/body ratio (be the body weight after fasting, namely cut open and kill heavily).

6. histopathologic examination: gross anatomy: to SPF level Wistar rat each dosage group fasting 16h of 30 days feeding trials, 3% Nembutal sodium solution (80mg/kgBW) is anaesthetized, and ventral aorta is taken a blood sample.Then sacrificed by exsanguination animal immediately, dissect, in the splanchnocoels such as perusal every the animal heart, liver, spleen, lung, kidney, gastrointestinal, organ is with or without pathological changes such as color change, transudate, edema, hypertrophy, atrophys, makes a record.The internal organs such as liver,spleen,kidney, gastrointestinal, testis (male) are separated with eye scissors with ophthalmic tweezers, remove clean each internal organs surrounding connective tissue and fatty tissue, with electronic balance (degree of accuracy is 0.01g) weigh one by one (except gastrointestinal), then fix immediately with 10% formalin solution.

Check pathological section: gross anatomy naked eyes no abnormality seen, therefore choose negative control group and high dose group makes pathological section.

Choose negative control group and high dose group each 20 animals (male and female half and half) part internal organs (liver, spleen, kidney, gastrointestinal, ovary and testis), after drawing materials, conventional dehydration, transparent, waxdip, film-making and HE dyeing, observed the morphological change of each tissue under an optical microscope by low power to high power, and viewed morphological change is described itemized record.

Pathological examination evaluation criterion: compare with negative control group, is described judgement with morphological change under mirror.

Pathologic examination: different according to each internal organs morphological structure, but mainly using the degeneration of cell as observation index, and according to pathological change degree "-", "+", " ++ ", " +++ " quantize, this test obtain the evaluation that data acquisition nonparametric methods in statistics (Nonparametricstatistic) carries out pathological change.

Cytopathy: comprise cloudy swelling, the change of cavity sample, hydropic degeneration and steatosis, inflammatory cell infiltration, (still need cloudy swelling, the bent tiny pipe main detection water sample of far-end of observing not of uniform size, the bent tiny pipe main detection cell of near-end of its mesonephric glomerulus becomes and steatosis, gastrointestinal tissue with under observing mucosa, mucosa, the position such as muscle layer, placenta percreta) be divided into 3 grades.

+ individual cells the cloudy swelling, the fat that are dispersed in drips and born of the same parents' slurry and stove shape inflammatory cell infiltration.

(comprising glomerule not of uniform size, the degeneration of gastrointestinal mucosa epithelium)-----------------------------------1 point

++ stove shape cell cloudy swelling, fat drips or forms transparence cavity.

(3-5 cell forms stove shape and glomerule is not of uniform size more than 3-5)---------------------------2 points

+++ several cell melts slabbing cavity mutually and entire fat drips, in glomerular capsule visible obviously inflammatory cell infiltration or glomerule obviously not of uniform size, the pathological changes such as the visible multiple inflammatory cell infiltration stove of each layer of gastrointestinal mucosa.3 points

Necrocytosis: be dispersed in that respective cells accounts for the whole visual field 1/4,2 points; Non-viable non-apoptotic cell accounts for 1/2 of the whole visual field, 4 points; Non-viable non-apoptotic cell accounts for 3/4 of the whole visual field, 6 points; Non-viable non-apoptotic cell fills the air existence and accounts for the whole visual field, 8 points.

1.6 experimental data statistical experiment data MicrosoftExcel software building databases, add up with SPSS.Measurement data adopts variance test, and enumeration data adopts non parametric tests, and adds up respectively by Animal Sex.

2 results

2.1 chmice acute Oral toxicity result of the tests are in table 1.

The smooth dormancy soft capsule of table 1 is to acute toxicity test in mice result (mean ± standard deviation)

Conclusion: animal has no obvious poisoning symptom within two week observation period, also without animal dead, MTD value is greater than 20.0g/kgBW, and by acute toxicity grading criteria evaluation, this given the test agent belongs to nontoxic level.

2.2 genetic toxicity test

2.2.1 mouse marrow cell micro nuclear test the results are shown in Table 2.

The smooth dormancy soft capsule of table 2 is to mouse marrow cell micro nuclear test result

^*: compare with negative control group, P < 0.01; PCE: polychromatic erythrocyte, NCE: mature erythrocyte.

Conclusion: compare with negative control group, positive controls male and female micronuclei in mice rate has significant difference (P < 0.01), and given the test agent each dosage group male and female micronuclei in mice rate difference there are no significant (P > 0.05), and all within this experimental determination value normal range, show that this given the test agent Micronucleus test result is for negative.Tested material is respectively organized the ratio [PCE/ (PCE+NCE) sum] that immature erythrocyte accounts for Erythrocytes and is all no less than 20% of negative control group.

2.2.2. mouse inbred strain the results are shown in Table 3.

The smooth dormancy soft capsule of table 3 is to mouse inbred strain result

^▲other deformities: comprise that tail is folding, double end, two tails etc.; ^*: compare with negative control group, P < 0.01.

Conclusion: compare with negative control group, positive controls Sperm Abnormalities of Mice has significant difference (P < 0.01); And given the test agent each dosage group difference there are no significant (P > 0.05), and within this experimental determination value normal range, show that this given the test agent sperm malformation test result is for negative.

2.330 it feeding trial

2.3.1 animal generally to show in process of the test animal without death, and hair is normal, behavior expression without exception.

2.3.2 on rat body weight, food-intake, food utilization affect given the test agent each dosage group rat weekly body weight, food-intake, food utilization and negative control group comparing difference there are no significant (P > 0.05).(see table 4-6)

The smooth dormancy soft capsule of table 4 is on the impact (mean ± standard deviation) of rat body weight

Each dosage group compares with negative control group, P > 0.05

The smooth dormancy soft capsule of table 5 is on the impact (mean ± standard deviation) of rats eating amount

Each dosage group compares with negative control group, P > 0.05

The smooth dormancy soft capsule of table 6 is on the impact (mean ± standard deviation) of rat chow utilization rate

Each dosage group compares with negative control group, P > 0.05

2.3.3 7 be the results are shown in Table on the impact of rat weightening finish and total foodstuff utilization rate.

The smooth dormancy soft capsule of table 7 is on the impact (mean ± standard deviation) of rat weightening finish and total foodstuff utilization rate

Each dosage group compares with negative control group, P > 0.05

As seen from Table 7, given the test agent each dosage group rat total foodstuff utilization rate and weightening finish are compared with negative control group, and there are no significant for difference (P > 0.05).

2.3.4 hematological examination result

2.3.4.1 affect each dosage group of given the test agent and negative control group numeric ratio comparatively on rat serum routine, there are no significant for difference (P > 0.05), and all in range of normal value.(see table 8)

The smooth dormancy soft capsule of table 8 is on the impact (mean ± standard deviation) of rat serum routine examination result

Each dosage group compares with negative control group, P > 0.05

2.3.4.2 affect each dosage group of given the test agent and negative control group numeric ratio comparatively on rat leukocyte classification, there are no significant for difference (P > 0.05), and all in range of normal value.(see table 9)

The impact (mean ± standard deviation) that the smooth dormancy soft capsule of table 9 is classified on rat leukocyte

Each dosage group compares with negative control group, P > 0.05

2.3.5 given the test agent each dosage group rat blood serum ALT, AST, BUN, TCH, TG, Cr, Glu, ALB, TP measurement result and negative control group numeric ratio is affected comparatively on rat blood biochemical analysis, there are no significant for difference (P > 0.05), and all in range of normal value.(see table 10)

The smooth dormancy soft capsule of table 10 is on the impact (mean ± standard deviation) of rat blood biochemistry

Each dosage group compares with negative control group, P > 0.05

The smooth dormancy soft capsule of continued 10 is on the impact (mean ± standard deviation) of rat blood biochemistry

Each dosage group compares with negative control group, P > 0.05

2.3.6 on Rats Organs and Tissues weight and dirty/body ratio affect given the test agent each dosage group organ weights and dirty/body ratio compares with negative control group, there are no significant for difference (P > 0.05).And all in range of normal value.(see table 11)

The smooth dormancy soft capsule of table 11 is on the impact (mean ± standard deviation) of Rats Organs and Tissues weight and dirty/body ratio

Each dosage group compares with negative control group, P > 0.05

The smooth dormancy soft capsule of continued 11 is on the impact (mean ± standard deviation) of Rats Organs and Tissues weight and dirty/body ratio

Each dosage group compares with negative control group, P > 0.05

2.3.7 pathologic diagnosis

Gross anatomy finding of naked eye:

Organ in the splanchnocoel such as the heart, liver, spleen, lung, kidney, gastrointestinal of the female male rat of each test dose group compares its appearance color and Organ size with negative control group normal, be showed no obviously ooze out, hypertrophy, edema, the pathological changes such as atrophy.

Finding under mirror: in Table 12-15.High dose group and negative control group often organize 20, ♀ half and half, two groups are compared: result, all within the scope of normal morphology, has no obvious toxic pathological change, wherein: liver: lobules of liver structure is normal, and hepatocyte radially arranges, partial rat hepatocyte is cut into slices, and (Normal group 3 is routine in visible mild fatty degeneration, ♀ 2 high dose group 2 example, ♀ 2, ).

Kidney: have no obvious pathological change.

Spleen: have no chronic spleen congestion and inflammatory cell infiltration.Have no obvious pathological change.

Gastrointestinal: under mucosa, mucosa, muscle layer, placenta percreta be showed no inflammatory cell infiltration and hemorrhagic focus, and mucous epithelium is complete.Negative control group and high dose group are showed no obvious pathological change.

Ovary: the growth corpus luteum differed in size in a large number as seen and the growing follicle (based on secondary follicle or mature follicle) of different developmental phases.Negative control group and high dose group are showed no obvious pathological change.

Testis: convoluted seminiferous tubule includes the spermatid of normal spermatocyte at different levels and maturation, arrange in concentric circles, interstitial tissue of testis hypertrophy is not obvious.Negative control group and high dose group are showed no obvious pathological change.

Smooth dormancy soft capsule 30 days feeding trial rat liver histopathologic examinations result (n=10) of table 12

Smooth dormancy soft capsule 30 days feeding trial rat kidney histopathologic examinations result (n=10) of table 13

Smooth dormancy soft capsule 30 days feeding trial Rats Spleen histopathologic examinations result (n=10) of table 14

The smooth dormancy soft capsule of table 15 30 days feeding trial rat each internal organs histopathologic examination tables of integrals

3 brief summaries

(1) the SPF level Kunming mouse acute oral toxicity test of dormancy soft capsule to two kinds of sexes is razed, one time given low reaches 20.0g/kgBW (being equivalent to 300.0 times of adult's maximum recommended daily intaking amount 0.067g/kgBW), within the observation period of 14 days, animal has no obvious poisoning symptom and death, this product MTD value is greater than 20.0g/kgBW, according to acute toxicity grading evaluation criteria regulation, this given the test agent belongs to nontoxic level;

(2) binomial mutagenicity test (mouse marrow cell micro nuclear test and sperm malformation test) result is feminine gender;

Within (3) 30 days, feeding trial result shows: by given the test agent by 1.68,3.35,6.70g/kgBW dosage (be equivalent to respectively be grown up maximum recommended daily intaking amount 0.067g/kgBW 25,50,100 times) gives 30 days continuously to SPF level Wistar rat, animal has no obvious poisoning symptom and death.Given the test agent each dosage group rat body weight, food-intake, food utilization, hematology, blood biochemical, organ weights, dirty/index such as body ratio and histopathology compare with negative control group, there are no significant for difference, and result is: do not find that this given the test agent has obvious toxic action.

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Two. improving water flood function (animal experiment)

1 materials and methods

1.1 sample sources and process:

Smooth dormancy soft capsule, character is soft capsule (content is brown oil), and Hubei Kun Yan Pharmaceutical Co., Ltd provides, and crowd's recommended intake is 0.033g/kgBW.

Sample preparation: accurately take given the test agent 3.33,6.67,10.0g, be settled to 200ml with edible oil respectively, for basic, normal, high dosage group mouse stomach.

1.2 animal varietiess and source:

SPF level Kunming kind female mice 140, body weight 18-22g, is provided by Animal Experimental Study center, Hubei Province.Laboratory animal production licence number: SCXK (Hubei Province) 2008-0005; Laboratory animal occupancy permit number:

SYXK (Hubei Province) 2012-0065; Animal feeding room temperature is 20 ~ 25 DEG C, and humidity is 40 ~ 70%.

1.3 dosage groupings:

Recommend daily intaking amount 0.033g/kgBW to expand 10,20,30 times by crowd and basic, normal, high three dosage groups are set, i.e. 0.33g, 0.67g, 1.00g/kgBW, be divided into three experimental grouies, every experimental group comprises negative control group (giving edible oil), basic, normal, high dosage group.Test one group of each contrast and each 10 of dosage group, carry out direct sleep experiments and the experiment of barbital sodium Sleep latency, test two groups of each contrasts and each 15 of dosage group, carry out pentobarbital sodium sub-threshold dose hypnosis experiment, test three groups of each contrasts and each 10 of dosage group, carry out the experiment length of one's sleep of prolongation pentobarbital sodium.The continuous gavage of mice starts experiment after 30 days.Each experimental group all gives by 0.20ml/10gBW capacity mouse stomach.

1.4 experimental technique

1.4.1 direct sleep experiments

Method: direct observation experiment one group of mice after giving tested material, each dosage group mice is movable normal, does not all occur the phenomenon of righting reflex loss, has not observed direct sleep effect.Experimentally animal uses 3R principle, tests a treated animal and proceeds " experiment of barbital sodium Sleep latency ".

1.4.2 the experiment length of one's sleep of pentobarbital sodium inducing mouse is extended

Method: last is to after tested material 15min, by 45mg/kgBW dosage lumbar injection pentobarbital sodium, (pentobarbital sodium uses normal saline to each treated animal before use, its concentration is 0.45%), injection volume is 0.1ml/10gBW, reach more than 1min for sleep index with mice righting reflex loss, observe tested material to the prolongation effect of the pentobarbital sodium length of one's sleep.

1.4.3 pentobarbital sodium sub-threshold dose hypnosis experiment

Method: last is to after tested material 15min, by 30mg/kgBW dosage lumbar injection pentobarbital sodium, (pentobarbital sodium uses normal saline to each treated animal before use, its concentration is 0.30%), injection volume is 0.1ml/10gBW, reach more than 1min as sleep criterion using mice righting reflex loss, observe to treated animal sleep incidence rate each in pentobarbital sodium 30min.

1.4.4 barbital sodium Sleep latency is tested

Method: last is to after tested material 15min, by 250mg/kgBW dosage lumbar injection barbital sodium, (barbital sodium uses normal saline to each treated animal before use, its concentration is 2.5%), injection volume is 0.1ml/10gBW, reach more than 1min as sleep criterion using mice righting reflex loss, observe tested material to the impact of barbital sodium Sleep latency.

1.5 Data Processing in Experiment

Continuous data variance analysis, enumeration data exact method method is checked.

2 results

2.1 smooth dormancy soft capsules are on the impact of Mouse Weight and direct sleep experiments result

Smooth dormancy soft capsule has no significant effect Mouse Weight growth, the forward and backward body weight of each test group mouse test and the more equal no significant difference of matched group (see table 1,2,3).

Movable normal to dosage group mice each after tested material; In direct sleep experiments, do not occur the phenomenon of mice righting reflex loss, not observing given the test agent has direct sleep effect (see table 4).

The smooth dormancy soft capsule of table 1 is on the impact extending pentobarbital sodium induced hypnotic time experiment mice body weight

The smooth dormancy soft capsule of table 2 is on the impact of pentobarbital sodium sub-threshold dose hypnosis experiment mice body weight

The smooth dormancy soft capsule of table 3 is on directly sleeping and the impact of barbital sodium Sleep latency experiment mice body weight

The impact that the smooth dormancy soft capsule of table 4 is directly slept on mice

The mouse sleep time experimental result of 2.2 prolongation pentobarbital sodium inductions

Smooth dormancy soft capsule high dose group has the obviously prolongation pentobarbital sodium inducing mouse effect length of one's sleep, and compare with negative control group, difference has significance (P < 0.01, in table 5).

The smooth dormancy soft capsule of table 5 is on the impact extending the pentobarbital sodium inducing mouse length of one's sleep

2.3 pentobarbital sodium sub-threshold dose hypnosis experimental results

The middle and high dosage group of smooth dormancy soft capsule can significantly improve the mice sleep incidence rate effect of sub-threshold dose pentobarbital sodium induction, compare with negative control group, difference has significance (P < 0.05, P < 0.01, in table 6).

The smooth dormancy soft capsule of table 6 is on the impact of pentobarbital sodium sub-threshold dose inducing mouse sleep incidence rate

Remarks: * compares with negative control group, P < 0.05, * * compares with negative control group, P < 0.01

2.4 barbital sodium Sleep latency experimental results

The middle and high dosage group of smooth dormancy soft capsule can obviously shorten the barbital sodium Sleep latency time, and compare with negative control group, difference has significance (P < 0.05, P < 0.01, in table 7).

The smooth dormancy soft capsule of table 7 is on the impact of barbital sodium Sleep latency

3 brief summaries

The crowd provided according to censorship unit recommends daily intaking amount 0.033g/60kgBW to expand 10,20,30 times of designs, three dosage groups, be respectively 0.33,0.67,1.00g/kgBW, establish negative control group simultaneously.Adopt SPF level Kunming mouse, continuous gavage gives, and starts test after 30 days.Experimental result is judged as significant difference with P < 0.05, and each dosage group compares with negative control group, and result shows:

1) each dosage group Mouse Weight no significant difference; After giving tested material, each group mice is movable normal, does not observe direct sleep effect;

2) high dose group has the effect length of one's sleep of prolongation mice pentobarbital sodium, and difference has significance;

3) middle and high dosage group is improved the mice sleep incidence rate effect of sub-threshold dose pentobarbital sodium induction, and difference has significance;

4) middle and high dosage group has the effect shortening barbital sodium Sleep latency, and difference has significance;

According to improving water flood functional evaluation procedure stipulation, smooth dormancy soft capsule improving water flood function animal test results is positive.

Claims (10)

1. health product for hypnotic, is characterized in that, comprise the raw material composition of following weight portion: Semen Ziziphi Spinosae 1-4 part, Radix Polygalae 1-3 part, Semen Platycladi 2-5 part, Rhizoma Gastrodiae 0.1-2.0 part.

2. the health product of hypnotic according to claim 1, is characterized in that, the weight portion of each raw material is Semen Ziziphi Spinosae 3.2 parts, Radix Polygalae 1.6 parts, Semen Platycladi 2.4 parts, 0.8 part, Rhizoma Gastrodiae.

3. the health product of the hypnotic described in claim 1 or 2, is characterized in that, the health product of this hypnotic also comprise Herba Ecliptae 1-4 part, β-eucalyptus leaves oleyl alcohol 0.1-1 part, deep red fragrant 2-5 part, Cortex Moutan 1-4 part.

4. the health product of hypnotic according to claim 3, is characterized in that, the health product of this hypnotic also comprise Herba Ecliptae 2.3 parts, β-eucalyptus leaves oleyl alcohol 0.2 part, deep red fragrant 2.4 parts, Cortex Moutan 1.8 parts.

5. the health product of the hypnotic described in any one of claim 1-4, it is characterized in that, the health product of this hypnotic also comprise Arillus Longan 1-3 part, Bulbus Lilii 2-5 part, Fructus Mori 4-8 part, Semen Juglandis 2-5 part, Tremella 1-5 part, Fructus Jujubae 5-10 part, Cortex Albiziae 5-10 part, Poria cum Radix Pini 0.7-1.2 part, Poria 3-6 part.

6. the health product of the hypnotic described in any one of claim 5, is characterized in that, the health product of this hypnotic are Semen Ziziphi Spinosae 1.7 parts, Radix Polygalae 1.2 parts, Semen Platycladi 2.0 parts, 0.4 part, Rhizoma Gastrodiae, Arillus Longan 2.5 parts, Bulbus Lilii 3.7 parts, 4.5 parts, Fructus Mori, Semen Juglandis 4.5 parts, 3.1 parts, Tremella, 8.5 parts, Fructus Jujubae, Cortex Albiziae 6.5 parts, Poria cum Radix Pini 1.0 parts, 5 parts, Poria.

7. the preparation method of the health product of the hypnotic described in any one of claim 1-6, is characterized in that, comprises the steps:

1) be broken into fritter according to each raw material meeting States Pharmacopoeia specifications or be broken into granularity and cross 60 object coarse powder, obtaining raw material;

2) learn from else's experience the raw material of cutting or pulverizing, reflux 2 times with 7 times amount 70% edible ethanols, return time is respectively 1.5h and 1h, filters, merging filtrate;

3) by step 2) in filtrate at-0.065 to-0.075Mpa and 65 DEG C, reclaim ethanol, then at 60 DEG C, being concentrated into relative density is 1.30 to 1.35, obtains extractum;

4) by the clear paste in above-mentioned-0.075 to-0.085Mpa, drying under reduced pressure at 70 DEG C, pulverizes, and crosses 100 mesh sieves, and packaging is for subsequent use, can obtain the health product of complementary blood fat reducing.

8. the health product of the hypnotic described in any one of claim 1-6, is characterized in that, add the adjuvant that preparation process accepts and make in described health product.

9. the health product of hypnotic according to claim 8, is characterized in that, this adjuvant comprises: Testa oryzae oil, Cera Flava, glycerol, purified water, gelatin, iron oxide red; Wherein, the extract of Testa oryzae oil and health product raw material adds by weight 1-5:1; Cera Flava accounts for the 1-5% of raw material gross weight; Glycerol, purified water, gelatin accounts for the 18-25% of raw material gross weight, and the weight ratio of gelatin, glycerol, purified water is 1:0.3-0.5:0.8-1.5; Iron oxide red presses the 0.8-2.5 ‰ of gelatin gross weight.

10. the preparation method of the health product of hypnotic according to claim 9, is characterized in that, comprises the steps:

1) be broken into fritter according to the raw material meeting States Pharmacopoeia specifications or be broken into granularity and cross 60 object coarse powder, obtain raw material, this raw material 7 times amount 70% edible ethanols are refluxed 2 times, return time is respectively 1.5h and 1h, filter, merging filtrate, again filtrate is reclaimed ethanol at-0.065 to-0.075Mpa and 65 DEG C, then at 60 DEG C, be concentrated into relative density is 1.30 to 1.35, obtain clear paste, further by clear paste-0.075 to-0.085Mpa, drying under reduced pressure at 70 DEG C, pulverize, cross 100 mesh sieves and obtain Chinese medicine extract powder, again by Testa oryzae oil, Cera Flava, gelatin, glycerol, purified water, iron oxide red is in strict accordance with the program entering 100,000 grades of clean areas, clean area is entered for subsequent use through pass-through box,

2) preparation of content, after appropriate Testa oryzae oil Cera Flava being joined 70 DEG C dissolves completely, then adds residue Testa oryzae oil, mix homogeneously, obtained oily wax liquid; Joined in oily wax liquid by Chinese medicine extract powder, be uniformly mixed colloid mill 3 times, each 30min, under-0.06 to-0.08Mpa, vacuumize degassing bubble, obtains Contents Fill liquid;

3) preparation of glue, purified water, iron oxide red are mixed well in rear glycerol adding inputization glue tank, after mix homogeneously, 70-75 DEG C of heating, adds gelatin after stirring, is stirred to gelatin entirely molten, glue bubble-free is evacuated under-0.06 to-0.08Mpa, after crossing 100 orders, glue is placed in the 55 DEG C of insulations of storage glue tank, stand-by;

4) pelleting, soft capsule implant, glue are pressed into soft capsule by encapsulating machine by 0.5g ∕ grain, the rotating speed keeping encapsulating machine is 1.5-3.5 Zhuan ∕ min, the sprinkler body temperature of encapsulating machine keeps 35-50 DEG C, the rubber thickness of soft capsule of compacting is 0.80 to 0.85mm, by the soft capsule that presses in rotating cage, at temperature 18-26 DEG C, shape under relative humidity 30-40% 2-3h, obtains soft capsule;

5) wash ball, pour in soft capsule pot by the soft gelatin capsule after sizing, wash soft capsule twice with 95% ethanol, the time is 4-6 minute, and drop goes out ethanol, is dried by washed soft gelatin capsule uniform spreading on yarn jiggering;

6) dry, select ball, by washed soft capsule at temperature 25-28 DEG C, relative humidity 25%-35% carries out drying, drying time 18-24 hour, be dried to softgel shell moisture Control scope 9%-12%, can be promoted the health product of sleep, these health product with hypnotic are capsule preparations.