CN105168972B - A kind of health care product and preparation method thereof promoting sleep - Google Patents

Abstract

The present invention provides a kind of health care products for promoting sleep, and raw material includes semen ziziphi spinosae, Radix Polygalae, the seed of Oriental arborvitae, Rhizoma Gastrodiae.It further can also include eclipta, β-eucalyptus leaves oleyl alcohol, deep red perfume (or spice), cortex moutan.Further, which can also contain arillus longan, lily, mulberry fruit, walnut meat, tremella, jujube, cortex albiziae, fushen, Poria cocos.In health care product among the above, rice bran oil, beeswax, glycerol, purified water, gelatin, the auxiliary material of iron oxide red can also be contained.Health care product of the invention is that pure Chinese medicinal preparation is taken without sugar convenient for the elderly and diabetic.It is prepared by pressing or dropping preparation method, one-pass molding, totally-enclosed dosage form, avoids occurring being disintegrated unqualified phenomenon after being long placed in.Certain content foreign odors, peculiar smell can be covered, Chinese medicine volatile component and Chinese materia medica preparation of the traditional Chinese medicine ingredients containing volatile oil for having bad smell have special odor, it is not volatile that soft capsule be made, and can cover bad smell, improve drug quality.

Description

A kind of health care product and preparation method thereof promoting sleep

Technical field

The present invention relates to a kind of health care products and preparation method thereof for promoting sleep, belong to technical field of health care food.

Background technique

The normal sleep times of the mankind should be six to eight hours, if sleep time is lower than physiological requirements up to two or three More than it, physiologically much change immediately and significantly for there is the demand for supplying sleep will appear, it is affected at first to be Attention, concentration, accurate operation ability, the thinking of high intelligence and memory, subsequent learning efficiency and creative thinking also can Significant decline.And when sleep wretched insufficiency when, it is also possible to induce amentia.

In addition, Sweden medical researchers also found, the harm of chronic insomnia may be fatal.The bad person of extended sleep Vascular sclerosis it is obvious, bore narrows, seriously affect blood supply and make some organs function occur obstacle, all kinds of metabolism of body Product cannot excrete in time, and quantity of leucocyte is reduced, and immune function is substantially reduced, and long-term and serious sleep insufficiency can draw It plays blood middle cholesterol content to increase, increase so that cardiopathic chance occurs；The cell division of human body carries out mostly in sleep, sleeps It sleeps insufficient or sleep disordered, will affect the proper splitting of cell, be thus possible to generate the mutation of cancer cell and lead to cancer Occur；Sleep reduce will affect memory, cause to feel depressed, thus influence it is neuroendocrine stress regulator control system be activated And gradually failure and occurring to adjust disorder leads to the generation of cardiovascular disease.

The insomnia cause of disease has the following aspects:

A. environment reason: it common are the sudden change of sleep environment.

B. individual factors: undesirable living habit, such as drinking tea before sleeping, drink coffee, smoking etc..

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

D. mental element: including causing excitement because of some special events, it is worried caused by opportunistic insomnia.

E. emotional factor: lose one's temper can caused by change in mental state, this change especially can in emotional lability table Reveal and, it can be is caused by certain emergency events, such as special happy event or special sad, anger all can lead to mistake It sleeps.It is this because insomnia caused by emergency event is a kind of phenomenon, it may be possible to it is occurrent, temporary；And more serious mistake Dormancy is then long-term existence phenomenon not sleep well, their mood is routinely in low state, and anxiety is feared, worries, cherishing Doubtful, indignation, hatred, depression and anxiety etc. emotion not only occupy the sense organ on their daytimes, but also even remain on desire at night Stopping cannot.

F. hypnotic or the abstinence reaction of wine-head.

Subject is divided into 3 groups by sleep quality by researcher according to seminar of Finland, wherein good number of sleeping accounts for 48%, general number of sleeping accounts for 40%, and the number for difference of sleeping accounts for 12%.Sleeping, averagely insomnia is primary weekly by general people, And the people for difference of sleeping almost has a sleepless night daily.Result of study shows that insomnia will increase mortality risk.Compared with the people to have slept, gently The short-lived risk of the women of micro- insomnia increases by 7%, and male increases by 22%；And the short-lived risk of the people of serious insomnia is then better than sleeping People it is 1.5 times high.The research for the first time links together insomnia with mortality risk.It should cause the great attention of people.Therefore The health food market demand for improving sleep is very big.

Summary of the invention

Sleep quality problem is generally existing in people's daily life, and it is that common people think this not for what big hair Disease so all directly will not go to go to a doctor to hospital, but carries out self to the product that pharmacy or supermarket buy some health care products Adjust health care.The present invention is directed to above-mentioned problems faced, by inspection information and zoopery, carries out to a large amount of Chinese medicine preparation Screening, finally determines the formula of this health food.It is original that basic components of the invention, which select semen ziziphi spinosae, Radix Polygalae, the seed of Oriental arborvitae, Rhizoma Gastrodiae, Material, using suitable extraction process, and the physicochemical property of combination product, consider from function, absorption, stability etc. are many-sided, or Using soft capsule made of reasonable technique.It is proved through animal safety toxicology test, this product has the guarantor for improving sleep Health-care function, while having many advantages, such as that bioavilability is high, convenient to take.Specific formula is as follows:

A kind of health care product promoting sleep, the raw material composition including following parts by weight: 1-4 parts of semen ziziphi spinosae, 1-3 parts of Radix Polygalae, 2-5 parts of the seed of Oriental arborvitae, 0.1-2.0 parts of Rhizoma Gastrodiae.

The parts by weight of further preferably each raw material are 3.2 parts, 1.6 parts of Radix Polygalae, 2.4 parts of the seed of Oriental arborvitae, 0.8 part of Rhizoma Gastrodiae.

The health care product of above-mentioned promotion sleep, the health care product of promotion sleep further includes 1-4 parts of eclipta, β-eucalyptus leaves oleyl alcohol 0.1-1 parts, deep red 2-5 parts of perfume, 1-4 parts of cortex moutan.

Further have be selected as the promotion sleep health care product in 2.3 parts of eclipta, β -0.2 part of eucalyptus leaves oleyl alcohol, deep red fragrant 2.4 Part, 1.8 parts of cortex moutan.

The promotion sleep health care product can also include arillus longan 1-3 parts, 2-5 parts of lily, 4-8 parts of mulberry fruit, walnut meat 2-5 Part, 1-5 parts of tremella, 5-10 parts of jujube, 5-10 parts of cortex albiziae, 0.7-1.2 parts of fushen, 3-6 parts of Poria cocos.

In above-mentioned raw materials, the application promotion sleep health care product be 1.7 parts of semen ziziphi spinosae, 1.2 parts of Radix Polygalae, the seed of Oriental arborvitae 2.0 parts, 0.4 part of Rhizoma Gastrodiae, 2.5 parts of arillus longan, 3.7 parts of lily, 4.5 parts of mulberry fruit, 4.5 parts of walnut meat, 3.1 parts of tremella, jujube 8.5 Part, 6.5 parts of cortex albiziae, 1.0 parts of fushen, 5 parts of Poria cocos.

The preparation method of the health care product of above-mentioned promotion sleep, includes the following steps:

1) fritter is broken into according to each raw material for meeting States Pharmacopoeia specifications or is broken into the coarse powder that granularity crosses 60 mesh, obtain raw material；

2) it learns from else's experience the raw material of cutting or crushing, is flowed back 2 times with 7 times of 70% edible ethanols of amount, return time is respectively 1.5h And 1h, filtration, merging filtrate；

3) filtrate in step 2) is recycled into ethyl alcohol at -0.065 to -0.075Mpa and 65 DEG C, it is then dense at 60 DEG C Being reduced to relative density is 1.30 to 1.35, obtains medicinal extract；

4) clear cream among the above is dried under reduced pressure at -0.075 to -0.085Mpa, 70 DEG C, crushes, sieves with 100 mesh sieve, wrapped Dress, it is spare, the health care product with complementary reducing blood lipid can be obtained.

Health care product of the present invention can also add auxiliary material, and auxiliary material of the invention is auxiliary to receive in food formulation technique Material.

Further, the auxiliary material of the invention includes: rice bran oil, beeswax, glycerol, purified water, gelatin, iron oxide red；Its In, the extract of rice bran oil and health product raw material is added by weight 1-5:1；Beeswax accounts for the 1-5% of raw material gross weight；Glycerol, Purified water, gelatin account for the 18-25% of raw material gross weight, and, gelatin, glycerol, purified water weight ratio be 1:0.3-0.5:0.8- 1.5；Iron oxide red presses the 0.8-2.5 ‰ of gelatin total weight.

On the basis of above-mentioned auxiliary material, the present invention promotes the preparation method of the health care product of sleep, includes the following steps:

1) fritter is broken into according to the raw material for meeting States Pharmacopoeia specifications or is broken into the coarse powder that granularity crosses 60 mesh, obtain raw material, by the original Material 7 times of 70% edible ethanols of amount reflux 2 times, return time is respectively 1.5h and 1h, is filtered, merging filtrate, then by filtrate- Ethyl alcohol is recycled at 0.065 to -0.075Mpa and 65 DEG C, it is 1.30 to 1.35 that relative density is then concentrated at 60 DEG C, is obtained Clear cream is further dried under reduced pressure by clear cream at -0.075 to -0.085Mpa, 70 DEG C, is crushed, and is sieved with 100 mesh sieve to obtain Chinese medicine and is mentioned Object powder is taken, then by rice bran oil, beeswax, gelatin, glycerol, purified water, iron oxide red are in strict accordance with the journey for entering 100,000 grades of clean areas It is spare to enter clean area through pass-through box for sequence；

2) preparation of content adds remaining rice bran after being completely dissolved the appropriate rice bran oil that beeswax is added to 70 DEG C Oil is uniformly mixed, and oil wax liquor is made；Chinese medical extract powder is added in oily wax liquor, was uniformly mixed colloid mill 3 times, Each 30min vacuumizes de-bubbled under -0.06 to -0.08Mpa to get Contents Fill liquid；

3) preparation of glue mixes well purified water, iron oxide red in rear glycerol adding investmentization glue tank, after mixing, 70- 75 DEG C of heating are stirring evenly and then adding into gelatin, and stirring is entirely molten to gelatin, and glue is evacuated under -0.06 to -0.08Mpa without gas Glue after crossing 100 mesh, is placed in 55 DEG C of heat preservations in storage glue tank, for use by bubble；

4) soft capsule filler, glue are pressed into soft capsule by 0.5g/ by encapsulating machine, keep flexible glue by pelleting The revolving speed of capsule machine is that 1.5-3.5 turns/min, and the sprinkler body temperature of encapsulating machine is kept for 35-50 DEG C, and the rubber of the soft capsule of compacting is thick Degree is 0.80 to 0.85mm, and by the soft capsule pressed in rotating cage, be formed 2- under 18-26 DEG C of temperature, relative humidity 30-40% 3h obtains soft capsule；

5) ball is washed, the capsule and pill after sizing is poured into soft capsule pot, is washed twice of soft capsule with 95% ethyl alcohol, the time is 4- 6 minutes, ethyl alcohol is leached, washed capsule and pill is uniformly layered on yarn jiggering and is dried；

6) it dries, select ball, by washed soft capsule at 25-28 DEG C of temperature, relative humidity 25%-35% is dried, and is done It is dry time 18-24 hours, dry to softgel shell moisture control range 9%-12%, the health care product for promoting sleep, the tool can be obtained Having the health care product for promoting to sleep is capsule preparations.

Present invention process route determination are as follows:

It must wherein be operated from Chinese medical extract and rice bran oil mixed processes to bottling process in 100,000 grades of clean areas. Process design and appointed condition meet health food GMP requirement.

Soft capsule belongs to one kind of capsule in the application, it is to be sealed in liquid medicine or juicy fruit body drug through processing Manufactured a kind of capsule in soft capsule material.The capsule material of soft capsule is made of glycerol and gelatin etc., and wall is thicker, and without ventilative Property, therefore soft capsule is the elegant formulations for preventing oxidation of drug.

What the soft capsule in the application generated on the health care product of the application has the beneficial effect that:

Pure Chinese medicinal preparation is taken without sugar convenient for the elderly and diabetic.Active constituent content is high, maximum limit Degree remains volatile effective component.Bioavilability is high, and impurity content is low, and no crude drug powder is easier to meet Hygienic Index.It inhales It receives the advantages such as fast and easily reaches effective blood drug concentration.It is prepared, one-pass molding, totally-enclosed dosage form, is avoided long by pressing or dropping preparation method It postpones appearance and is disintegrated unqualified phenomenon.The certain content foreign odors of energy covering, peculiar smell, Chinese medicine volatile component and tool bad smell Chinese materia medica preparation of the traditional Chinese medicine ingredients containing volatile oil has special odor, it is not volatile that soft capsule is made, and can cover bad smell, mentions High drug quality.Dose is few, easy to carry.Dosage form process flow is short, simply.

Various oils or the oily liquids to softgel shell without dissolution, suspension, capsule 's content can be filled in soft capsule Generally comprise raw material (Chinese medical extract), diluent, emulsifier and suspending agent.When preparing soft capsule, Chinese medicine or its extract Either powder or medicinal extract are easy deposition when only mixing with oils matrix, it is inaccurate to will lead to loading amount when filling.Therefore, it is Holding suspension has good mobility, is usually added into emulsifier, suspending agent and matrix and melts, through colloid mill, emulsification instrument etc. Equipment obtains more fine and smooth content after mixing dispersion, to change the mobility of content, improving settling ratio ensures to be suspended The stability of liquid.Beeswax is used in the health food of the application, effectively raises the uniformity of medical fluid.

The selection of content auxiliary material and the experimental study of uniformity in the application is as follows:

Rice bran oil is diluent, and rice bran oil itself has good stability, and is a kind of vegetable oil full of nutrition, absorptivity after food Up to 90% or more.Rice bran oil is made of fatty acid, vitamin E, sterol, oryzanol etc. are conducive to the absorption of human body, has and removes The beneficial effects such as cholesterol, reduction blood lipid, promotion growth in humans's development in blood, thus rice bran oil is battalion generally acknowledged both at home and abroad Support healthy oil.Its quality meets the requirement of relevant criterion.Production conditional operation is strong, can control degree high, can preferably control Product quality processed.

Beeswax is suspending agent.It is worker bee in order to which the fatty for constructing honeycomb and covering honeycomb and coming out from bee glandular secretion is wax-like Solid.It is a kind of organic compound that chemical component is sufficiently complex.Generally speaking, the main component of beeswax by higher fatty acids and Rouge synthesized by high alcohol, accounts for 70%~75%, and free fatty acid accounts for 12%~15%, and carbohydrate accounts for 11%~ 17%, water accounts for about 2.5%, and there are also a small amount of aromatic substance, pigment and microelements etc..Beeswax and other plant wax, mineral wax, The almost all of wax class such as fatty acid, fatty alcohol, glycerolipid, hydrocarbon and synthetic wax and oil and fat product have good intermiscibility.

For the needs for adapting to soft capsule production, this technique is using rice bran oil as diluent, and beeswax is as suspending agent.In rice bran It requires to be soluble in homogeneous, good fluidity when suspension is made in oil, beeswax and Chinese medicine dried cream powder (i.e. raw extract).In fixed bee In the case of wax dosage is the 3.6% of content, experimental study is carried out to the ratio of dried cream powder, rice bran oil.Chinese medical extract dry cream Powder and rice bran oil are mixed in the ratio of 1:1-5 respectively, observe the mobility and homogeneity of medical fluid.

Test result shows the content when the ratio of Chinese medicine dried cream powder (i.e. raw extract) and rice bran oil is 1:4 or 1:5 Object mixed liquor viscosity is moderate, good fluidity, meets the filling requirement of soft capsule, and selection is using Chinese medicine dried cream powder and rice bran oil Ratio is that 1:4 feeds intake.

The determination of soft capsule formula rate is as follows:

Accordingly toward knowhow, work as gelatin: glycerol: the soft capsule that suitable technique requires can be made in purified water 1:0.4:1 Skin.Iron oxide red is added by the 2 ‰ of gelatin amount.

Detailed description of the invention

Fig. 1 is the preparation process for promoting the health product raw material pulvis or medicinal extract of sleep in the application.

Fig. 2 is the preparation process for promoting the health care product of sleep in the application.

Specific embodiment

Embodiment 1

Formula:

Content composition formula:

Soft capsule skin formula:

1) fritter is broken into according to the raw material for meeting States Pharmacopoeia specifications or is broken into the coarse powder that granularity crosses 60 mesh, obtain raw material；

2) it learns from else's experience the raw material of cutting or crushing, measures 70% edible ethanol with 6-8 times and flow back 2 times, return time is respectively 1- 2h and 1h, filtration, merging filtrate；

3) filtrate in step 2) is recycled into ethyl alcohol at -0.065 to -0.075Mpa and 65 DEG C, it is then dense at 60 DEG C Being reduced to relative density is 1.30 to 1.35, obtains medicinal extract；

4) clear cream among the above is dried under reduced pressure at -0.075 to -0.085Mpa, 70 DEG C, crushes, sieves with 100 mesh sieve, wrapped Dress, it is spare, the health care product with complementary reducing blood lipid can be obtained, which is pulvis, and this programme may be medicinal extract dosage form, Delete the step.

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

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

5) preparation of content, by rice bran oil, beeswax, gelatin, glycerol, purified water, oxidation on the basis of above-mentioned steps It is spare to enter clean area through pass-through box in strict accordance with the program for entering 100,000 grades of clean areas for iron oxide red.Beeswax is added to 70 DEG C After appropriate rice bran oil is completely dissolved, remaining rice bran oil is added, is uniformly mixed, oil wax liquor is made；Chinese medical extract powder is added Into oily wax liquor, it was uniformly mixed colloid mill 3 times, each 30min vacuumizes de-bubbled at -0.06Mpa to get interior Tolerant filling liquid；

6) preparation of glue mixes well purified water, iron oxide red in rear glycerol adding investmentization glue tank, after mixing, 70- 75 DEG C of heating are stirring evenly and then adding into gelatin, and stirring is entirely molten to gelatin, and glue bubble-free is evacuated under -0.08Mpa, cross 100 After mesh, glue is placed in 55 DEG C of heat preservations in storage glue tank, for use；

7) soft capsule filler, glue are pressed into soft capsule by 0.5g/ by encapsulating machine, keep flexible glue by pelleting The revolving speed of capsule machine is that 1.5-3.5 turns/min, and the sprinkler body temperature of encapsulating machine is kept for 35-50 DEG C, and the rubber of the soft capsule of compacting is thick Degree is 0.85mm, and by the soft capsule pressed in rotating cage, be formed 2-3h under 18-26 DEG C of temperature, relative humidity 30-40%, obtains To soft capsule；

8) ball is washed, the capsule and pill after sizing is poured into soft capsule pot, is washed twice of soft capsule with 95% ethyl alcohol, the time is 4- 6 minutes, ethyl alcohol is leached, washed capsule and pill is uniformly layered on yarn jiggering and is dried；

9) it dries, select ball, by washed soft capsule at 26 DEG C of temperature, relative humidity 23.5% is dried, drying time It is 24 hours, dry to softgel shell moisture control range 12%, the health care product of promotion sleep of the invention, promotion sleep can be obtained Health care product be capsule preparations.

Contain in every 100g in the said goods: general flavone >=0.3g；Total saposins (g/100g in terms of ginsenoside Re) >=0.2； Gastrodin (mg/100g) >=10.

Each supplementary material dosage and safety

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

Subordinate list: each raw material consumption per day and the pharmacopeia dosage table of comparisons

Raw material	Semen ziziphi spinosae	The seed of Oriental arborvitae	Radix Polygalae	Rhizoma Gastrodiae
					Medicinal material consumption per day (g/ days)	3.2	2.4	1.6	0.8
Pharmacopeia dosage (g/ days)	9-15	3-9	3-9	3-9

From the above, it can be seen that four kinds of Chinese medicine consumption per days are below pharmacopeia lower limit.Auxiliary material rice bran oil, beeswax used in this product, Gelatin, glycerol, iron oxide red meet healthy food material regulation.This product is tried through Disease Prevention Control Center, Hubei Prov laboratory It tests and shows animal safety toxicology test no abnormality seen, show that product is safe, suitable long-term consumption.

The physical and chemical index of embodiment 1

The microbiological indicator of embodiment 1

Embodiment 2

Formula:

Content composition formula:

Soft capsule skin formula:

1) fritter is broken into according to the raw material for meeting States Pharmacopoeia specifications or is broken into the coarse powder that granularity crosses 60 mesh, obtain raw material；

2) it learns from else's experience the raw material of cutting or crushing, is flowed back 2 times with 7 times of 70% edible ethanols of amount, return time is respectively 1.5h And 1h, filtration, merging filtrate；

3) filtrate in step 2) is recycled into ethyl alcohol at -0.065 to -0.075Mpa and 65 DEG C, it is then dense at 60 DEG C Being reduced to relative density is 1.30 to 1.35, obtains medicinal extract；

4) clear cream among the above is dried under reduced pressure at -0.075 to -0.085Mpa, 70 DEG C, crushes, sieves with 100 mesh sieve, wrapped Dress, it is spare, the health care product with complementary reducing blood lipid can be obtained, which is pulvis, and this programme may be medicinal extract dosage form, Delete the step.

5) preparation of content, by rice bran oil, beeswax, gelatin, glycerol, purified water, oxidation on the basis of above-mentioned steps It is spare to enter clean area through pass-through box in strict accordance with the program for entering 100,000 grades of clean areas for iron oxide red.Beeswax is added to 70 DEG C After appropriate rice bran oil is completely dissolved, remaining rice bran oil is added, is uniformly mixed, oil wax liquor is made；Chinese medical extract powder is added Into oily wax liquor, it was uniformly mixed colloid mill 3 times, each 30min vacuumizes de-bubbled at -0.06Mpa to get interior Tolerant filling liquid；

6) preparation of glue mixes well purified water, iron oxide red in rear glycerol adding investmentization glue tank, after mixing, 70- 75 DEG C of heating are stirring evenly and then adding into gelatin, and stirring is entirely molten to gelatin, and glue bubble-free is evacuated under -0.08Mpa, cross 100 After mesh, glue is placed in 55 DEG C of heat preservations in storage glue tank, for use；

7) soft capsule filler, glue are pressed into soft capsule by 0.5g/ by encapsulating machine, keep flexible glue by pelleting The revolving speed of capsule machine is that 1.5-3.5 turns/min, and the sprinkler body temperature of encapsulating machine is kept for 35-50 DEG C, and the rubber of the soft capsule of compacting is thick Degree is 0.85mm, and by the soft capsule pressed in rotating cage, be formed 2-3h under 18-26 DEG C of temperature, relative humidity 30-40%, obtains To soft capsule；

8) ball is washed, the capsule and pill after sizing is poured into soft capsule pot, is washed twice of soft capsule with 95% ethyl alcohol, the time is 4- 6 minutes, ethyl alcohol is leached, washed capsule and pill is uniformly layered on yarn jiggering and is dried；

9) it dries, select ball, by washed soft capsule at 26 DEG C of temperature, relative humidity 23.5% is dried, drying time It is 24 hours, dry to softgel shell moisture control range 12%, the health care product of promotion sleep of the invention, promotion sleep can be obtained Health care product be capsule preparations.

Contain in every 100g in the said goods: general flavone >=0.28g；Total saposins (g/100g in terms of ginsenoside Re) >= 0.15；Gastrodin (mg/100g) >=11.

Embodiment 3

Formula:

Content composition formula:

Soft capsule skin formula:

1) fritter is broken into according to the raw material for meeting States Pharmacopoeia specifications or is broken into the coarse powder that granularity crosses 60 mesh, obtain raw material；

2) it learns from else's experience the raw material of cutting or crushing, is flowed back 2 times with 7 times of 70% edible ethanols of amount, return time is respectively 1.5h And 1h, filtration, merging filtrate；

3) filtrate in step 2) is recycled into ethyl alcohol at -0.065 to -0.075Mpa and 65 DEG C, it is then dense at 60 DEG C Being reduced to relative density is 1.30 to 1.35, obtains medicinal extract；

4) clear cream among the above is dried under reduced pressure at -0.075 to -0.085Mpa, 70 DEG C, crushes, sieves with 100 mesh sieve, wrapped Dress, it is spare, the health care product with complementary reducing blood lipid can be obtained, which is pulvis, and this programme may be medicinal extract dosage form, Delete the step.

5) preparation of content, by rice bran oil, beeswax, gelatin, glycerol, purified water, oxidation on the basis of above-mentioned steps It is spare to enter clean area through pass-through box in strict accordance with the program for entering 100,000 grades of clean areas for iron oxide red.Beeswax is added to 70 DEG C After appropriate rice bran oil is completely dissolved, remaining rice bran oil is added, is uniformly mixed, oil wax liquor is made；Chinese medical extract powder is added Into oily wax liquor, it was uniformly mixed colloid mill 3 times, each 30min vacuumizes de-bubbled at -0.06Mpa to get interior Tolerant filling liquid；

6) preparation of glue mixes well purified water, iron oxide red in rear glycerol adding investmentization glue tank, after mixing, 70- 75 DEG C of heating are stirring evenly and then adding into gelatin, and stirring is entirely molten to gelatin, and glue bubble-free is evacuated under -0.08Mpa, cross 100 After mesh, glue is placed in 55 DEG C of heat preservations in storage glue tank, for use；

7) soft capsule filler, glue are pressed into soft capsule by 0.5g/ by encapsulating machine, keep flexible glue by pelleting The revolving speed of capsule machine is that 1.5-3.5 turns/min, and the sprinkler body temperature of encapsulating machine is kept for 35-50 DEG C, and the rubber of the soft capsule of compacting is thick Degree is 0.85mm, and by the soft capsule pressed in rotating cage, be formed 2-3h under 18-26 DEG C of temperature, relative humidity 30-40%, obtains To soft capsule；

8) ball is washed, the capsule and pill after sizing is poured into soft capsule pot, is washed twice of soft capsule with 95% ethyl alcohol, the time is 4- 6 minutes, ethyl alcohol is leached, washed capsule and pill is uniformly layered on yarn jiggering and is dried；

9) it dries, select ball, by washed soft capsule at 26 DEG C of temperature, relative humidity 23.5% is dried, drying time It is 24 hours, dry to softgel shell moisture control range 12%, the health care product of promotion sleep of the invention, promotion sleep can be obtained Health care product be capsule preparations.

Contain in every 100g in the said goods: general flavone >=0.33g；Total saposins (g/100g in terms of ginsenoside Re) >= 0.22；Gastrodin (mg/100g) >=15.

In the present embodiment, the product that we obtain embodiment 1 carries out zoopery, and in this experiment, we are by embodiment 1 Obtained in product be named as smooth dormancy soft capsule.Specific experiment process is as follows:

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

1 material and method

1.1 samples and the smooth dormancy soft capsule of processing, are provided by Hubei Kun Yan medicine company Co., Ltd.Crowd's maximum recommended Daily intaking amount is 0.067g/kg BW (according to adult 60kg weight mean value computation).

1.2 animal varieties and source: SPF Kunming mice, Wistar rat and feed are by Hubei Province experimental animal Research center provides, experimental animal and Feed Manufacturing credit number: SCXK (Hubei Province) 2008-0005.Large and small mouse is raised respectively in this SPF grades of unit large and small mouse laboratories, experimental animal use credit number: SYXK (Hubei Province) 2012-0065.The weight of animals is according to items Depending on test requirements document.20~25 DEG C of laboratory temperature, humidity 40~70%.

The test of 1.3 chmice acute Oral toxicities

1.3.1 dosage is arranged: given the test agent intragastric administration on mice dosage is 20.0g/kg BW, is equivalent to adult maximum recommended day 300.0 times of intake 0.067g/kg BW.

1.3.2 sample preparation: correct amount takes sample 20ml, and weighing its quality is 21.6g, density 1.08g/ml, use The direct stomach-filling of tested material stoste.

1.3.3 test method: selecting SPF Kunming mice, and weight is 18~20g, and male and female each 10,16 is small before stomach-filling When animal be deprived of food but not water, give tested material single oral gavage after weighing, stomach-filling capacity is 18.5ml/kg BW, dosage 20.0g/ kgBW.It is observed continuously on the day of stomach-filling, observes 2 times daily later up to the 14th day, and record animal poisoning symptom and death toll, try Non- dead animal weighing at the end of testing.

1.4 genetic toxicity test

1.4.1 mouse marrow cell micro nuclear test

1.4.1.1 experimental animal: selecting weight is the Kunming mouse of 25~30g, male and female each 25, is randomly divided into 5 groups, Every group of male and female each 5.

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

1.4.1.3 dosage is grouped: (1) negative control group gives salad oil；(2) ring phosphorus is given in the oral stomach-filling of positive controls Amide 40mg/kgBW；(3) basic, normal, high three dosage groups of given the test agent, respectively 2.5g/kg BW, 5.0g/kg BW, 10.0g/kg BW。

1.4.1.4 sample preparation: given the test agent is configured to 0.125g/ml, 0.25g/ml, 0.50g/ml with salad oil respectively Concentration, make low, middle and high dose groups, positive substance concentration is 0.002g/ml.

1.4.1.5 test method: using 30 hours test method(s)s, i.e., tested material is given in stomach-filling in two times, is spaced 24 hours, by The each intragastric administration on mice capacity of test agent each group is 20ml/kg BW.6 hours execution animals, take after giving tested material for the second time Femur makees bone marrow smear, is fixed after natural drying with methanol, Giemsa dyeing.Every animal oil 1000 thermophilic polychromatophilia of microscopic observation There is the polychromatic erythrocyte number of micronucleus in red blood cell, record, and microkernel incidence is in terms of the PCE permillage containing micronucleus；Count 200 A polychromatic erythrocyte number (PCE), while mature erythrocyte number (NCE) is counted, and calculate PCE and account for Erythrocytes (PCE+ NCE) total percentage.

1.4.1.6 data statistics processing method: SPSS software establishes database, presses animal to micronuclear rates using Chi-square Test Gender counts respectively.

1.4.2 mouse inbred strain

1.4.2.1 experimental animal: selecting weight is male Kunming strain mice 25 of 25~35g, is randomly divided into 5 groups, often Group 5.

1.4.2.2 reagent and instrument: same to 1.4.1.2.

1.4.2.3 dosage is grouped: same to 1.4.1.3.

1.4.2.4 sample preparation: same to 1.4.1.4.

1.4.2.5 test method: corresponding tested material is given within each test group mouse continuous 5 days, intragastric administration on mice capacity is equal For 20ml/kg BW, continue after feeding 30 days to put to death animal (i.e. for the first time to the 35th day after tested material).Two sides epididymis is taken to set In 0.5ml physiological saline, epididymis is longitudinally cut to 1-2 knife with eye scissors, smear after being filtered with four layers of lens wiping paper is air-dried Afterwards, methanol is fixed, then with 1% eosin stains.Every animal high power under the microscope count by 1000 sperms, record defective sperm number It calculates defective sperm incidence (in terms of permillage), and carries out statistical disposition.

1.4.2.6 data statistics processing method: SPSS software establishes database, each dosage group respectively with corresponding feminine gender Control group compares, and evaluates teratospermia positive rate with Chi-square Test method.

1.5 30 days feeding trials

1.5.1 dosage and grouping；80 weight 60~80g Wistar rats are selected, half male and half female is randomly divided into a yin Property control group and three dosage groups, i.e. 0.0g/kg BW, 1.68g/kg BW, 3.35g/kg BW, 6.70g/kg BW, test sample Product low, middle and high dose groups are respectively equivalent to 25,50,100 times of adult maximum recommended daily intaking amount 0.067g/kg BW.It is negative Control group gives the salad oil of equal capacity.Each 10 rats of every group of male and female, method for breeding are single cage nursing.

1.5.2 it sample preparation and gives: accurately weighing given the test agent 16.8,33.5,67.0g and be respectively put into beaker, add Enter appropriate salad oil, be finally settled to 100ml, shake up, concentration is respectively 0.168,0.335,0.67g/ml.Stomach-filling capacity is 10.0ml/kg BW。

1.5.2 it sample preparation and gives: accurately weighing given the test agent 16.8,33.5,67.0g and be respectively put into beaker, add Enter appropriate salad oil, be finally settled to 100ml, shake up, concentration is respectively 0.168,0.335,0.67g/ml.Stomach-filling capacity is 10.0ml/kg BW。

1.5.3 observation index: including

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

2. weight, food-intake and food utilization.

3. hematological examination: measuring hemoglobin (HB), red blood cell count(RBC) (RBC), leucocyte (WBC) meter when off-test Several and classification, lymphocyte (LY%), monocyte (MO%), granulocyte (GR%), certainly with Japanese photoelectricity MEK-6318K type Dynamic blood counting instrument measurement.

4. blood biochemistry checking: measuring serum glutamic pyruvic transminase (ALT), glutamic-oxalacetic transaminease (AST), serum when off-test It is urea nitrogen (BUN), total cholesterol (TCH), triglycerides (TG), creatinine (Cr), blood glucose (GLu), seralbumin (Alb), total The indexs such as albumen (TP).Detecting instrument are as follows: 7020 type automatic clinical chemistry analyzer of Hitachi.Detection reagent are as follows: upper Haifeng county remittance medicine The kit of Science and Technology Ltd.'s production.

5. organ weights and dirty/body ratio (for the weight after fasting, that is, cut open and kill weight).

6. histopathologic examination: gross anatomy: each dosage group fasting of SPF grade Wistar rat to 30 days feeding trials 16h, 3% Nembutal sodium solution (80mg/kg BW) anesthesia, abdominal aorta blood sampling.Then sacrificed by exsanguination animal immediately, dissection, Visually observing organ in the splanchnocoels such as every the animal heart, liver, spleen, lung, kidney, stomach and intestine, whether there is or not color change, diffusate, oedema, increasings The lesions such as life, atrophy, make a record.The internal organs such as liver,spleen,kidney, stomach and intestine, testis (male) are separated with ophthalmic tweezers and eye scissors, clearly Except clean each internal organs surrounding connective tissue and adipose tissue, being weighed one by one with electronic balance (accuracy 0.01g), (stomach and intestine are removed Outside), then with 10% formalin solution it fixes immediately.

Check pathological section: gross anatomy naked eyes no abnormality seen, therefore selection negative control group and high dose group are cut as pathology Piece.

Choose negative control group and each 20 animals (half male and half female) part internal organs of high dose group (liver, spleen, kidney, stomach and intestine, Ovary and testis), after materials, conventional dehydration, transparent, waxdip, film-making and HE are dyed, under an optical microscope by low power to high power Observe the morphological change of each tissue, and morphological change observed by record description in detail.

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

Pathologic examination: it is different according to each internal organs morphological structure, but mainly refer to using the denaturation of cell as observation Mark, and according to pathological change degree "-", "+", " ++ ", " +++ " quantization, this test data acquired uses nonparametric methods in statistics The evaluation of (Nonparametric statistic) progress pathological change.

Cell degeneration: including cloudy swelling, the change of vacuole sample, hydropic degeneration and steatosis, inflammatory cell infiltration, (wherein kidney is small It is still necessary to observe not of uniform size, the bent tiny pipe main detection cell in proximal end cloudy swelling, the bent tiny pipe main detection water in distal end for ball Sample becomes and steatosis, gastrointestinal tissue to observe under mucous membrane, mucous membrane, the positions such as muscle layer, placenta percreta) be divided into 3 grades.

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

(including glomerulus is not of uniform size, the denaturation of gastrointestinal mucosa epithelium) --- --- --- --- --- --- --- 1 point of --- ---

++ stove shape cell cloudy swelling, fat drips or formation transparence vacuole.

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

+++ several cells mutually melt the fat drips of slabbing vacuole and the smooth of the edge, visible obvious inflammatory cell in Bowman's capsule Infiltration or glomerulus are not of uniform size obvious, the pathological changes such as visible multiple inflammatory cell infiltration stoves of each layer of gastrointestinal mucosa.3 points

Meronecrosis: respective cells account for whole visual field 1/4,2 points are dispersed in；Non-viable non-apoptotic cell accounts for the 1/2 of whole visual field, and 4 points； Non-viable non-apoptotic cell accounts for the 3/4 of whole visual field, and 6 points；Non-viable non-apoptotic cell, which diffuses to exist, accounts for whole visual field, and 8 points.

1.6 experimental data statistical experiment data establish database with Microsoft Excel software, are united with SPSS Meter.Measurement data uses variance test, and enumeration data uses non-parametric test, and counts respectively by Animal Sex.

2 results

2.1 chmice acute Oral toxicity test results are shown 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, and also without animal dead, MTD value is greater than 20.0g/ Kg BW, is evaluated by acute toxicity grading criteria, which belongs to nontoxic grade.

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

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

Conclusion: compared with negative control group, positive controls male and female micronuclei in mice rate has significant difference (P < 0.01), And there are no significant (P > 0.05) for each dosage group male and female micronuclei in mice rate difference of given the test agent, and in this experimental determination value In normal range (NR), show the given the test agent Micronucleus test result for feminine gender.Tested material each group immature erythrocyte accounts for The ratio [PCE/ (PCE+NCE) sum] of Erythrocytes is no less than the 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: including tail folding, double end, double tails etc.；^**: compared with negative control group, P < 0.01.

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

2.3 30 days feeding trials

2.3.1 animal is without death during animal generally shows test, and hair is normal, behavior expression without exception.

2.3.2 to rat body weight, food-intake, food utilization each dosage group rat of influence given the test agent weekly weight, There are no significant for food-intake, food utilization and negative control group comparing difference (P > 0.05).(being shown in Table 4-6)

Influence (mean ± standard deviation) of the smooth dormancy soft capsule of table 4 to rat body weight

Each dosage group is compared with negative control group, P > 0.05

Influence (mean ± standard deviation) of the smooth dormancy soft capsule of table 5 to rats eating amount

Each dosage group is compared with negative control group, P > 0.05

Influence (mean ± standard deviation) of the smooth dormancy soft capsule of table 6 to rat chow utilization rate

Each dosage group is compared with negative control group, P > 0.05

2.3.3 7 the results are shown in Table to rat weight gain and the influence of total food utilization rate.

The smooth dormancy soft capsule of table 7 increases weight to rat and the influence (mean ± standard deviation) of total food utilization rate

Each dosage group is compared with negative control group, P > 0.05

As seen from Table 7, each dosage group rat total food utilization rate of given the test agent and weight gain are compared with negative control group, difference There are no significant (P > 0.05).

2.3.4 hematological examination result

2.3.4.1 for each dosage group of influence given the test agent to rat blood routine compared with negative control group numerical value, difference is equal Without conspicuousness (P > 0.05), and in range of normal value.(being shown in Table 8)

Influence (mean ± standard deviation) of the smooth dormancy soft capsule of table 8 to rat blood routine examination result

Each dosage group is compared with negative control group, P > 0.05

2.3.4.2 poor to each dosage group of influence given the test agent of rat leukocyte classification compared with negative control group numerical value Different there are no significant (P > 0.05), and in range of normal value.(being shown in Table 9)

The influence (mean ± standard deviation) that the smooth dormancy soft capsule of table 9 classifies to rat leukocyte

Each dosage group is compared with negative control group, P > 0.05

Each dosage group rat blood serum ALT, AST of influence given the test agent, BUN 2.3.5 to rat blood biochemical analysis, TCH, TG, Cr, Glu, ALB, TP measurement result are compared with negative control group numerical value, and there are no significant for difference (P > 0.05), and In range of normal value.(being shown in Table 10)

Influence (mean ± standard deviation) of the smooth dormancy soft capsule of table 10 to rat blood biochemistry

Each dosage group is compared with negative control group, P > 0.05

Influence (mean ± standard deviation) of the smooth dormancy soft capsule of continued 10 to rat blood biochemistry

Each dosage group is compared with negative control group, P > 0.05

2.3.6 to each dosage group organ weights of the influence given the test agent of Rats Organs and Tissues weight and dirty/body ratio and dirty/body Ratio is compared with negative control group, and there are no significant for difference (P > 0.05).And in range of normal value.(being shown in Table 11)

Influence (mean ± standard deviation) of the smooth dormancy soft capsule of table 11 to Rats Organs and Tissues weight and dirty/body ratio

Each dosage group is compared with negative control group, P > 0.05

Influence (mean ± standard deviation) of the smooth dormancy soft capsule of continued 11 to Rats Organs and Tissues weight and dirty/body ratio

Each dosage group is compared with negative control group, P > 0.05

2.3.7 pathologic diagnosis

Gross anatomy finding of naked eye:

Organ and negative control in the splanchnocoels such as the heart, liver, spleen, lung, kidney, the stomach and intestine of each female male rat of test dose group Group compares its appearance color and Organ size is normal, is showed no the lesions such as obvious exudation, hyperplasia, oedema, atrophy.

Seen under mirror: being shown in Table 12-15.High dose group with negative control group every group 20, ♀Fifty-fifty, two groups are compared: knot Fruit has no that obvious Poisoning pathological change changes, in which: liver: lobuli hepatis structure is normal, liver cell within the scope of normal morphology It is arranged radially, the visible mild fatty denaturation of partial rat liver cell slice (Normal group 3, ♀ 2,High dose group 2, ♀ 2,)。

Kidney: obvious pathological change is had no.

Spleen: chronic spleen extravasated blood and inflammatory cell infiltration are had no.Have no obvious pathological change.

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

Ovary: the visible development corpus luteum largely to differ in size and different developmental phases growing follicle (with secondary follicle or Based on graaffian follicle).Negative control group and high dose group are showed no obvious pathological change.

Testis: convoluted seminiferous tubule includes the spermatid of normal sperm mother cells at different levels and maturation, arranges in concentric circles, testis Interstitial proliferation is unobvious.Negative control group and high dose group are showed no obvious pathological change.

Table 12 razes 30 days feeding trial rat liver histopathologic examination results (n=10) of dormancy soft capsule

Table 13 razes 30 days feeding trial rat kidney histopathologic examination results (n=10) of dormancy soft capsule

Table 14 razes 30 days feeding trial Rats Spleen histopathologic examination results (n=10) of dormancy soft capsule

Table 15 razes each internal organs histopathologic examination table of integrals of 30 days feeding trial rats of dormancy soft capsule

3 brief summaries

(1) SPF Kunming mice acute oral toxicity test of the smooth dormancy soft capsule to two kinds of genders, a given low Up to 20.0g/kg BW (300.0 times that are equivalent to adult maximum recommended daily intaking amount 0.067g/kg BW), in 14 days observation periods Interior animal has no obvious poisoning symptom and death, and product MTD value is greater than 20.0g/kg BW, according to acute toxicity grading evaluation Standard regulation, the given the test agent belong to nontoxic grade；

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

(3) 30 days feeding trials the result shows that: by given the test agent by 1.68,3.35,6.70g/kg BW dosage (phase respectively When in 25,50,100 times of adult maximum recommended daily intaking amount 0.067g/kg BW) 30 are continuously given to SPF grades of Wistar rats It, animal has no apparent poisoning symptom and death.Each dosage group rat body weight of given the test agent, food-intake, food utilization, blood Liquid, blood biochemical, organ weights, dirty/indexs such as body ratio and Histopathology are compared with negative control group, the equal nothing of difference Conspicuousness, as a result are as follows: do not find that the given the test agent has apparent toxic effect.

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Two, improve sleep function (animal experiment)

1 material and method

1.1 sample sources and processing:

Smooth dormancy soft capsule, character is soft capsule (content is brown oil), and Hubei Kun Yan medicine company Co., Ltd mentions For crowd's recommended intake is 0.033g/kg BW.

Sample preparation: accurately weighing given the test agent 3.33,6.67,10.0g, be settled to 200ml with edible oil respectively, supplies Low, middle and high dose groups intragastric administration on mice is used.

1.2 animal varieties and source:

It SPF grades Kunming kind female mice 140, weight 18-22g, is provided by Hubei Province Animal Experimental Study center.Experiment Animal productiong licensing number: SCXK (Hubei Province) 2008-0005；Experimental animal uses credit number:

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

The grouping of 1.3 dosage:

Daily intaking amount 0.033g/kg BW is recommended to expand 10,20,30 times of basic, normal, high three dosage groups of setting by crowd, i.e., 0.33g, 0.67g, 1.00g/kg BW, are divided into three experimental groups, every experimental group include negative control group (giving edible oil), it is low, Middle and high dosage group.One group of each control and dosage group each 10 are tested, direct sleep experiments and barbital sodium sleep latency are carried out Phase experiment tests two groups of each controls and dosage group each 15, carries out yellow Jackets sub-threshold dose hypnosis experiment, test three groups It is each control and dosage group each 10, carry out extend yellow Jackets sleeping time experiment.Mouse continuous gavage starts after 30 days Experiment.Each experimental group is given by 0.20ml/10g BW capacity intragastric administration on mice.

1.4 experimental method

1.4.1 direct sleep experiments

Method: directly one group of mouse of observation experiment, each dosage group mouse activity normally, does not occur after giving tested material The phenomenon that righting reflex loss, has not observed direct sleep effect.3R principle is used according to experimental animal, tests one group of animal Continue " experiment of barbital sodium Sleep latency ".

1.4.2 extend the experiment of yellow Jackets inducing mouse sleeping time

Method: after last is to tested material 15min, yellow Jackets are injected intraperitoneally by 45mg/kg BW dosage in groups of animals (yellow Jackets use normal saline, concentration 0.45% before use), injection volume are 0.1ml/10g BW, are turned over mouse Positive reflection disappears up to 1min the above are sleep index, and observation tested material acts on the extension of yellow Jackets sleeping time.

1.4.3 the hypnosis of yellow Jackets sub-threshold dose is tested

Method: after last is to tested material 15min, yellow Jackets are injected intraperitoneally by 30mg/kg BW dosage in groups of animals (yellow Jackets use normal saline, concentration 0.30% before use), injection volume are 0.1ml/10g BW, are turned over mouse Positive reflection, which disappears, is used as sleep judgment criteria up to 1min or more, and observation occurs to groups of animals sleep in yellow Jackets 30min Rate.

1.4.4 barbital sodium Sleep latency is tested

Method: after last is to tested material 15min, groups of animals by 250mg/kg BW dosage intraperitoneal injection barbital sodium (bar Normal saline, concentration 2.5% are used before use than appropriate sodium), injection volume is 0.1ml/10g BW, with mouse righting reflex It disappears and is used as sleep judgment criteria up to 1min or more, observe influence of the tested material to barbital sodium Sleep latency.

1.5 Data Processing in Experiment

Continuous data variance analysis, enumeration data are examined with exact propability.

2 results

Influence and direct sleep experiments result of the 2.1 smooth dormancy soft capsules to mouse weight

Smooth dormancy soft capsule has no significant effect mouse weight growth, the forward and backward weight of each test group mouse test and control group Compare equal no significant difference (being shown in Table 1,2,3).

It is normal to dosage group mouse activity each after tested material；In direct sleep experiments, do not occur mouse righting reflex loss The phenomenon that, do not observe that given the test agent has direct sleep effect (being shown in Table 4).

Influence of the smooth dormancy soft capsule of table 1 to yellow Jackets induced hypnotic time experiment mice weight is extended

Influence of the smooth dormancy soft capsule of table 2 to yellow Jackets sub-threshold dose hypnosis experiment mice weight

Influence of the smooth dormancy soft capsule of table 3 to directly sleep and barbital sodium Sleep latency experiment mice weight

The influence that the smooth dormancy soft capsule of table 4 directly sleeps to mouse

2.2 extend the mouse sleep time experimental result of yellow Jackets induction

Smooth dormancy soft capsule high dose group is obviously prolonged the effect of yellow Jackets inducing mouse sleeping time, with negative control Group compares, and difference has conspicuousness, and (5) P < 0.01, is shown in Table.

Influence of the smooth dormancy soft capsule of table 5 to yellow Jackets inducing mouse sleeping time is extended

2.3 yellow Jackets sub-threshold dose hypnosis experimental results

The smooth middle and high dosage group of dormancy soft capsule can significantly improve the mice sleep incidence of sub-threshold dose yellow Jackets induction Effect, compared with negative control group, difference has conspicuousness, and (6) P < 0.05, P < 0.01, are shown in Table.

The smooth dormancy soft capsule of table 6 influences yellow Jackets sub-threshold dose inducing mouse sleep incidence

Remarks: * is compared with negative control group, P < 0.05, and * * is compared with negative control group, P < 0.01

2.4 barbital sodium Sleep latency experimental results

The smooth middle and high dosage group of dormancy soft capsule can be obviously shortened the barbital sodium Sleep latency time, with negative control group ratio Compared with difference has conspicuousness, and (7) P < 0.05, P < 0.01, are shown in Table.

Influence of the smooth dormancy soft capsule of table 7 to barbital sodium Sleep latency

3 brief summaries

Daily intaking amount 0.033g/60kg BW is recommended to expand 10,20,30 times of designs three according to the crowd that censorship unit provides A dosage group, respectively 0.33,0.67,1.00g/kg BW, while setting negative control group.Using SPF Kunming mice, even Continuous stomach-filling is given, and starts to test after 30 days.Experimental result is judged as that significant difference, each dosage group and feminine gender are right with P < 0.05 Compare according to group, as the result is shown:

1) each dosage group mouse weight no significant difference；Each group mouse activity is normal after giving tested material, does not observe Direct sleep effect；

2) high dose group, which has, extends the effect of mouse yellow Jackets sleeping time, and difference has conspicuousness；

3) middle and high dosage group is improved the mice sleep incidence effect of sub-threshold dose yellow Jackets induction, and difference has Conspicuousness；

4) middle and high dosage group plays the role of shortening barbital sodium Sleep latency, and difference has conspicuousness；

According to sleep function assessment process regulation is improved, it is sun that smooth dormancy soft capsule, which improves sleep function animal test results, Property.

Claims (1)

1. a kind of health care product for promoting sleep, which is characterized in that be made of the following raw material: semen ziziphi spinosae 320g, Radix Polygalae 160g, cedar seed Benevolence 240g, Rhizoma Gastrodiae 80g are added the auxiliary material that receives on preparation process and are made, the auxiliary material are as follows: and rice bran oil 350g, beeswax 12g are sweet Oily 34g, purified water 83g, gelatin 83g, iron oxide red 0.2g；The preparation method of the health care product of the promotion sleep, including such as Lower step:

(1) fritter is broken into according to the raw material for meeting States Pharmacopoeia specifications or is broken into the coarse powder that granularity crosses 60 mesh, obtain raw material, which is used 7 times of 70% edible ethanols of amount flow back 2 times, and return time is respectively 1.5h and 1h, filtration, merging filtrate, then by filtrate -0.065 Ethyl alcohol is recycled to -0.075Mpa and 65 DEG C, it is 1.30 to 1.35 that relative density is then concentrated at 60 DEG C, clear cream is obtained, Clear cream is dried under reduced pressure at -0.075 to -0.085Mpa, 70 DEG C further, crushes, sieves with 100 mesh sieve to obtain Chinese medical extract Powder, then by rice bran oil, beeswax, gelatin, glycerol, purified water, iron oxide red is in strict accordance with the program for entering 100,000 grades of clean areas, warp It is spare that pass-through box enters clean area；

(2) preparation of content adds remaining rice bran oil after being completely dissolved the appropriate rice bran oil that beeswax is added to 70 DEG C, It is uniformly mixed, oil wax liquor is made；Chinese medical extract powder is added in oily wax liquor, was uniformly mixed colloid mill 3 times, every time 30min vacuumizes de-bubbled under -0.06 to -0.08Mpa to get Contents Fill liquid；

(3) preparation of glue mixes well purified water, iron oxide red in rear glycerol adding investmentization glue tank, after mixing, 70-75 DEG C heating, is stirring evenly and then adding into gelatin, stirs entirely molten to gelatin, and glue bubble-free is evacuated under -0.06 to -0.08Mpa, After crossing 100 mesh, glue is placed in 55 DEG C of heat preservations in storage glue tank, for use；

(4) Contents Fill liquid, glue are pressed into soft capsule by 0.5g ∕ by encapsulating machine, keep soft capsule by pelleting The revolving speed of machine is 1.5-3.5 Zhuan ∕ min, and the sprinkler body temperature of encapsulating machine is kept for 35-50 DEG C, the rubber thickness of the soft capsule of compacting It is 0.80 to 0.85mm, by the soft capsule pressed in rotating cage, be formed 2-3h under 18-26 DEG C of temperature, relative humidity 30-40% ；

(5) ball is washed, the soft capsule after sizing is poured into soft capsule pot, is washed twice of soft capsule with 95% ethyl alcohol, the time is 4-6 Minute, ethyl alcohol is leached, washed soft capsule is uniformly layered on yarn jiggering and is dried；

(6) it dries, select ball, by washed soft capsule at 25-28 DEG C of temperature, relative humidity 25%-35% is dried, drying time 18-24 hours, the dry health care product that promotion sleep is arrived to softgel shell moisture control range 9%-12%, there is promotion to sleep for this Health care product be soft capsule preparation.