CN105596605A - Composition with bowel relaxing and sleep improving functions and preparation method thereof - Google Patents
Composition with bowel relaxing and sleep improving functions and preparation method thereof Download PDFInfo
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- CN105596605A CN105596605A CN201610060137.5A CN201610060137A CN105596605A CN 105596605 A CN105596605 A CN 105596605A CN 201610060137 A CN201610060137 A CN 201610060137A CN 105596605 A CN105596605 A CN 105596605A
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- 230000002889 sympathetic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000001550 time effect Effects 0.000 description 1
- 230000002936 tranquilizing effect Effects 0.000 description 1
- 239000000052 vinegar Substances 0.000 description 1
- 235000021419 vinegar Nutrition 0.000 description 1
- 239000011800 void material Substances 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
- 230000002618 waking effect Effects 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
- 229960003487 xylose Drugs 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/254—Acanthopanax or Eleutherococcus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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Abstract
The invention relates to a composition with bowel relaxing and sleep improving functions. The composition is prepared from, by weight, 15-28% of isomaltooligosacharide, 4-15% of fructo-oligosaccharide, 1-10% of xylooligosaccharide, 20-35% of aloe extract and 20-35% of radix et caulis acanthopanacis senticosi extract. The unexpected effect is achieved by compounding compound oligosaccharide, aloe extract and radix et caulis acanthopanacis senticosi extract, the obvious promoting effect is achieved for the bowel relaxing effect by adding aloe extract and radix et caulis acanthopanacis senticosi extract, the sleeping quality and the sleeping time are improved by regulating intestinal function, insomnia caused by heat accumulation constipation can be treated, insomnia caused by various other causes can be improved, and therefore the dual functions of treating constipation and insomnia are achieved, the effect of getting twofold results with half the effort is achieved, and the composition has the advantages of being safe, effective, free of toxic and side effects, convenient to carry and convenient to take.
Description
Technical field
The present invention relates to a kind of composition and method of making the same that there is defaecation and improve sleep, belong to health food technology field.
Background technology
Constipation (constipaion), refers to that the times of defecation that caused by many reasons reduces and ight soil is dry to be difficult to resolve, and comprises that ight soil doesThe smooth and two kinds of situations of the dry also difficult discharge of ight soil of dry discharge, it is not a kind of concrete disease, but a disease of various diseasesShape, habits and customs are bad also easily causes constipation. The people more than half that has an appointment according to statistics suffered the torment of constipation, especially goodIn work strain stress crowd large and old, Lack of Movement. Constipation often affects appetite and enteral nutrition materialAbsorb, noxious material in body extended in the time of staying of enteron aisle, and absorbed in a large number, cause toxic reaction, can bring out inflammation,The generation of tumour and increase the weight of the symptom of cardiovascular and cerebrovascular disease, can also cause the change of people's mood, has a strong impact on work and life.
People in life, account for the length of one's sleep wherein 1/3, the therefore height of sleep quality, affects all one's life of people, comprisesLearning efficiency, operating efficiency, quality of life, the every aspects such as health. Modern modal sleep-disorder is insomnia, losesThe symptom main manifestations of sleeping is that the length of one's sleep is not enough or sleep not yet done. At present, if the drug main of Cure for insomnia is both at home and abroadTaking Western medicine as main, Chinese medicine is auxiliary, but Western medicine, and as stable and epiphysin etc., long-term taking has certain habituation, dependenceAnd the insomnia side effect such as rebound and bad answer after drug withdrawal, and deriving from the Chinese medicine of natural plants, is comparatively safe clinicalMedication, more worth being exploited.
The traditional Chinese medical science thinks, with the passing of time, enteron aisle mechanism of qi blocks distention and fullness in the abdomen in constipation, the vexed belch of gastral cavity, and anorexia, even stomachache vomiting,Failure in sending down turbid yin, lucid yang failing to raise, can cause dizziness, alliteration, insomnia, agitation etc., modern medicine study also shows, sleep-disorderHave significant correlation with intestinal dysfunction, constipation patient often shows difficulty falling asleep, the length of one's sleep short and Depth of sleep notThe sleeping problems such as foot, and the poor periphery autonomic nerve that suppresses of sleep state is to human colorectal dominating role, also can act on autonomous godThrough system and parasympathetic nerve, cause tying rectal delivery speed slow, thereby make gastrointestinal function abnormal, constipation situation is increased the weight of.Therefore, between constipation and insomnia, there is certain correlation, treat constipation and insomnia simultaneously, can play thing half and merit effect doublyReally.
Prebiotics, refer to can selective stimulating enteron aisle in breeding or active a kind of meal supplement of the profitable strain of field plantingAgent, comprises functional oligose, inulin, dietary fiber and sugar alcohol etc., and wherein functional oligose has production cost because of itLow, definite functions, the advantage such as have no side effect, has now become the main fresh combatants in prebiotics market. Normal on domestic and international marketThe functional oligose of seeing mainly comprises oligoisomaltose (IMO), FOS (ROS), galactooligosaccharide (GOS)And xylo-oligosaccharide (XOS) etc.
Different compound sugar is because of the difference of its structure, composition and glycosidic bond, and its prebiotic effect can present to a certain extent notBe embodied in the difference of propagation degree, the inhibition degree of harmful bacteria, the sour amount of product and gas production to different beneficial bacteriums together.Oligoisomaltose (IMO) all has good increment efficiency to various Bifidobacteriums, Lactobacillus acidophilus, lactobacillus fermenti,Be described as " intestinal cleaning agents "; FOS also to multiple Bifidobacterium (particularly bifidobacterium adolescentis and bifidobacterium longum),Lactobacillus acidophilus, Lactobacillus salivarius have good proliferation of probiotics effect, are called as " Super Life-benefit Material-X ylo "; Although oligomeric woodSugar can only be utilized by bifidobacterium adolescentis, bifidobacterium longum and Lactobacillus salivarius, but its at human body digestive ferment degradation rate by being gained meritCan property minimum in compound sugar, thus its colon arrival rate for the highest, the amount of having advantages of is few and imitate high. 3 kinds of functional oligoses pairHarmful bacteria clostridium and amphimicrobe all have good inhibitory action. 3 kinds of sugared good product acid that also all have are measured, wherein oligomeric fruitThe product acetic acid amount of sugar is the highest in three, and the lactic acid producing amount of xylo-oligosaccharide and propionic acid amount are the highest in three. Oligomeric different Fructus Hordei GerminatusSugar is the minimum functional oligose of gas production.
Therefore because the prebiotic effect of three kinds of functional oligoses shows certain difference, three's compound use, can be better more completeProliferation of probiotics in the promotion body of face, adjusts gut flora balance, can also promote that in body, organic acid generates simultaneously, reduces in enteron aislePH value, suppresses the growth of harmful bacteria, reduces the activity of harmful enzyme, ensures its superiority in host's enteron aisle, and can carryOsmotic pressure in high enteron aisle, makes intestinal contents absorb in a large number moisture, makes faecal volume increase, springy texture, can also stimulate enteron aisleWriggle fast, promote defecation. Simultaneously three's consumption, through scientific matching, can finally be realized dose few, gas production low andThe object that defaecation is effective.
Aloe is the juice of liliaceous plant aloe barbadensis Miller AloebarbadensisMiller and Aloe ferox Miller A.feraxMillerLiquid is through concentrated dry thing. This product can be used for treating pyrolysis constipation. Traditional medicine think aloe have catharsis action temperature and, useThe advantage such as convenient and acceptant, is widely used in treating constipation clinically. Its main effective component is aloe rheochrysin, reedThe compositions such as luxuriant growth archen, can directly act on enteron aisle, increase enteric cavity moisture, promote enterocinesia, performance excitant discharge function.The mechanism (be mainly and promote proliferation of probiotics in enteron aisle) of its mechanism and the promotion defecation of composite oligosaccharide has obvious different,Two classes are share, and can comprehensively regulate the function of human body intestinal canal.
Wilsonii is Araliaceae wilsonii Acanthooanaxsenticosus (Rupr.etMaxim.) Har-ms, its root,Stem, leaf, flower and fruit all can be used as medicine, and are a kind of conventional tonifying Qi class medicine, have effect of kidney and spleen invigorating, intelligence promoting and tranquilization.It is " herbal classic is top grade " that Compendium of Materia Medica becomes wilsonii, and energy " clothes are made light of one's life by commiting suicide resistance to old for a long time for tonifying middle-Jiao and Qi, hard muscles and bones, strong will ", cures mainlyThe insufficiency of both the spleen and the kindey, soreness and weakness of waist and knees, body void is weak, insomnia, dreaminess, poor appetite etc.
Modern pharmacological research shows, excitement and the process of inhibition of wilsonii to nervous centralis all has a certain impact, and once gives separatelyMedicine demonstrates the spread effect of central nervous system, and successive administration is strengthened maincenter process of inhibition. Modern clinic is applied and is also shown,Wilsonii simple all has good result for the treatment of to the insomnia of many reasons, as middle severe insomnia, old intractable aypnia,Type of deficiency of both the heart and spleen insomnia, climacteric insomnia and vertebral-basilar artery insufficiency institute induced insomnia etc. It improves the mechanism of sleep effectMay be can be for passing through to raise benzene phenodiazineReceptoroid, promote 5-HT content increase, reduce NO level in brain, IL-1 β andTNF-alpha content, reduce in full brain SP content and OrexinA content and by with dopamine D1And D2The association of receptor antagonistThe effect of multiple the performance tranquilizing soporific such as same-action.
At present relevant bowel relaxing functions or to improve the health food kind of sleep function more, differs from one another, and is mainly divided three classes: seekSupport plain class (functional oligose, probio, epiphysin etc.), Chinese medicine class and both mixing classes, but current compound meritThe product that energy property compound sugar combines with medicinal and edible Chinese medicine is less, and composite functional compound sugar can more fully promote usefulIn the propagation of bacterium and body, organic acid generates, and by rational allocation, can make to reach between dose, effect and gas productionRatio of greater inequality example, realizes the object that dose is few, bowel relaxing functions is strong and gas production is low; And at present for defaecation and two kinds of merits of improvement sleepThe health food of energy is also relatively less, and because constipation and insomnia exist certain correlation between the two, therefore simultaneously to constipationTreat with insomnia, can play thing half and merit result for the treatment of doubly.
Summary of the invention
For the deficiencies in the prior art, the first object of the present invention provides a kind of composition that has defaecation and improve sleep, thisBright composition enters with composite oligosaccharide (oligoisomaltose, FOS, xylo-oligosaccharide) and medicinal and edible Chinese medicine extractThe scientific and reasonable proportioning of row, has defaecation and improves sleep dual-use function, and human body is had no adverse reaction.
Technical scheme of the present invention is as follows:
Have defaecation and improve a composition of sleeping, raw material components and percentage by weight thereof are composed as follows: oligomeric different Fructus Hordei GerminatusSugar 15～28%, FOS 4～15%, xylo-oligosaccharide 1～10%, aloe extract 20～35%, siberian Ginseng P.E20～35％。
The preferred technical scheme of the present invention, a kind of composition, raw material components and weight hundred thereof that there is defaecation and improve sleepProportion by subtraction is composed as follows: oligoisomaltose 18～25%, and FOS 5～12%, xylo-oligosaccharide 3～8%, aloe is extractedThing 23～32%, siberian Ginseng P.E 23～32%.
The preferred technical scheme of the present invention, a kind of composition, raw material components and weight hundred thereof that there is defaecation and improve sleepProportion by subtraction is composed as follows: oligoisomaltose 15～25%, and FOS 4～10%, xylo-oligosaccharide 1～5%, aloe is extractedThing 28～35%, siberian Ginseng P.E 28～35%.
The present invention is highly preferred, a kind of composition that has defaecation and improve sleep, raw material components and percentage by weight composition thereofAs follows: oligoisomaltose 20.83%, FOS 6.25%, xylo-oligosaccharide 2.92%, aloe extract 35%, thorn fiveAdd extract 35%.
The present invention is preferred, and in aloe extract, barbaloin content is more than or equal to 17wt%.
The present invention is preferred, and in siberian Ginseng P.E, the content of Syringin and eleutheroside E is more than or equal to 0.8wt%.
Second object of the present invention aim to provide a kind of have defaecation and improve sleep health food, with above-mentioned have defaecation andThe composition that improves sleep is active ingredient, adds corresponding pharmaceutical necessities, can be made into tablet, granule or capsule, auxiliary materialAddition account for the 16-25% of active ingredient and auxiliary material gross weight.
More than one state the composition that has defaecation and the improve sleep tablet that is active ingredient, has defaecation and improvement is slept by above-mentionedThe composition of sleeping adds diluent, adhesive, disintegrant and flavouring to make through granulation, compressing tablet, wherein diluent, adhesiveAccount for the 15-22% of tablet total amount with the addition of disintegrant, the addition of flavouring accounts for the 0.5-2% of tablet total amount, and described is rareReleasing agent is cornstarch, and adhesive is maltodextrin, and disintegrant is dried starch, the mass ratio of diluent, adhesive, disintegrantFor 3:1:1～1:3:3, flavouring is the mixture of Aspartame, citric acid and orange flavor, Aspartame and citric acidMass ratio be 1:1～1:2, the addition of orange flavor accounts for the 0.5-1% of tablet total amount.
Above-mentionedly also comprise lubricant taking the composition that there is defaecation and improve sleep as the tablet of active ingredient, the adding of lubricantAmount accounts for the 1-3% of tablet total amount, and described lubricant is dolomol.
Above-mentioned to there is defaecation and to improve the composition of sleep as the preparation method of the tablet of active ingredient, comprise that step is as follows:
1) oligoisomaltose, FOS, xylo-oligosaccharide, aloe extract and siberian Ginseng P.E were pulverized respectively to 60-80Mesh sieve, takes respectively screened material by proportioning, mixes to obtain mixed material powder;
2) in above-mentioned mixed material powder, add diluent, adhesive and disintegrant by amount ratio, mix 20～30 minutes, mixedClose evenly, obtain mixed material;
3) mixed material is added in granulator and heat granulation, first mix 5～15 minutes, when leaving air temp reaches 30～60 DEG CTime, spray ethanolic solution is dried material moisture is controlled at below 5.0wt% at 50～80 DEG C, then crosses 14～20 ordersSieve carries out whole grain;
4) by step 3) particle after whole grain adds flavouring and mix lubricant 10-15 minute, compressing tablet make have defaecation andImprove the compressing tablet of sleep.
The present invention is preferred, and this has defaecation and improves the tablet weight of sleeping is 1g, and tablet weight variation limit is ± 5%, every dayTake 3 times, each 4, can meet defaecation and improve the health care of sleeping.
The present invention is preferred, step 3) in the concentration of ethanolic solution be 70～90wt%, preferably, the concentration of ethanolic solution is80wt％。
The present invention is preferred, and having defaecation and improving the compressing tablet sheet of sleeping is heavily 1.0-1.2g, and tablet weight variation limit is ± 5%.
The present invention is preferred, and having defaecation and improving the compressing tablet of sleeping is compressing tablet or chewable tablets.
Of the present invention have defaecation and improve the compressing tablet of sleeping while use, and day takes 3 times, each 4, can meet defaecationWith the health care that improves sleep.
Through great many of experiments, the present inventor surprisingly finds that composite oligosaccharide and aloe extract, siberian Ginseng P.E are compositeReached unexpected effect, adding of aloe extract and siberian Ginseng P.E has obvious promotion work to defecating feces excretionWith, thereby improving sleep quality and the length of one's sleep by adjusting function of intestinal canal, composite functional compound sugar, can more fully promoteOrganic acid generates in the propagation of beneficial bacterium and body, makes to reach between dose, effect and gas production ratio of greater inequality by rational allocationExample, realizes the object that dose is few, bowel relaxing functions is strong and gas production is low; Aloe extract, makes complete square never Tongfang in the face of constipationPlay certain regulating action, and can play certain mitigation to the insomnia due to pyrolysis constipation. Siberian Ginseng P.E,Further strengthen the sleep function that improves of this product, promoted the adding of aloe extract of the present invention, siberian Ginseng P.E compound lowThe defaecation effect of glycan, improves constipation symptom from regulating intestinal canal flora and increase intestinal motive force two aspects, makes defaecation better effects if, withTime reduce the side effect of diarrhoea and the flatulence of FOS, patient is more prone to accept, and has fundamentally improved sleep simultaneously, fromAnd fundamentally constipation and insomnia are played to double effects, reach defaecation, improved the effect that sleep is run neck and neck, thisBright can eating for a long time, can not produce any dependence effect, to conscience taste kidney intestines bootstrap, can effectively improve constipation and insomnia,Can also strengthen immunity of organisms, Other diseases is had to the effect of supplemental treatment simultaneously.
Advantage of the present invention:
1, the defaecation effect of composite oligosaccharide of the present invention is better than single compound sugar, and through rational formula, can realize and takingAmount is few, and effect is strong, the advantage that gas production is low.
2, the present invention is by composite oligosaccharide and aloe extract combination drug, from regulating intestinal canal flora and increase intestinal motive force two aspectsImprove constipation symptom, make defaecation better effects if.
3, the present invention adds the siberian Ginseng P.E that improves sleep in formula, not only can treat the insomnia being caused by constipation with heat retention,Can also improve the insomnia that other many reasons cause, thereby realize the present invention and treat the double effects of constipation and insomnia, play thingHalf and merit effect doubly.
4, said composition tablet has safe and effectively, has no side effect, easy to carry, the feature of being convenient to take.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is further illustrated.
The raw material using in embodiment:
Oligoisomaltose, FOS, xylo-oligosaccharide are delicatessen food level powder, 3 kinds of compound sugar in embodiment all purchased fromShandong Baolingbao Biotechnology Co., Ltd., content is 95%.
Aloe extract is purchased from Shaanxi Heng Detang plant material Co., Ltd, and specification is 10:1 (1 part of extraction of 10 parts of crude drug outputsThing), barbaloin content is not less than 17%.
Siberian Ginseng P.E is purchased from Shaanxi Heng Detang plant material Co., Ltd, and specification is that 10:1 (carry by 1 part of 10 parts of crude drug outputGet thing), Syringin and eleutheroside E content are not less than 0.8%.
Embodiment 1
Have defaecation and improve a composition of sleeping, raw material components and percentage by weight thereof are composed as follows: oligoisomaltose24.20%, FOS 9.00%, xylo-oligosaccharide 6.80%, aloe extract 30.00%, siberian Ginseng P.E 30.00%,Above-mentioned raw materials is fully mixed, both must there is defaecation and improve the composition of sleeping.
Taking the above-mentioned composition that there is defaecation and improve sleep as the tablet of active ingredient, there is defaecation and improve sleep above-mentionedComposition adds diluent, adhesive, disintegrant and flavouring to make through granulation, compressing tablet, wherein diluent, adhesive and collapseThe addition of separating agent accounts for 20% of tablet total amount, and the addition of flavouring accounts for 1% of tablet total amount, and described diluent is cornStarch, adhesive is maltodextrin, and disintegrant is dried starch, and the mass ratio of diluent, adhesive, disintegrant is 3:1:1,Flavouring is the mixture of Aspartame, citric acid and orange flavor, and the mass ratio of Aspartame and citric acid is 1:1, accounts for sheet0.5% of agent total amount, orange flavor accounts for 0.5% of tablet total amount.
Also comprise lubricant, the addition of lubricant accounts for 2% of tablet total amount, and described lubricant is dolomol.
Above-mentioned to there is defaecation and to improve the composition of sleep as the preparation method of the tablet of active ingredient, comprise that step is as follows:
1) oligoisomaltose, FOS, xylo-oligosaccharide, aloe extract and siberian Ginseng P.E were pulverized respectively to 80Mesh sieve, takes respectively screened material by proportioning, mixes to obtain mixed material powder;
2) in above-mentioned mixed material powder, add diluent, adhesive and disintegrant by amount ratio, mix 30 minutes, mix allEven, obtain mixed material;
3) mixed material is added in granulator and heat granulation, first mix 10 minutes, in the time that leaving air temp reaches 43 DEG C, spray95wt% ethanolic solution is dried material moisture is controlled at below 5.0wt% at 55 DEG C, then crosses 14 order nylon mesh and entersThe whole grain of row;
4) by step 3) particle after whole grain adds flavouring and mix lubricant 12 minutes, and compressing tablet makes to be had defaecation and changesThe compressing tablet of kind sleep.
Embodiment 2
Have defaecation and improve a composition of sleeping, raw material components and percentage by weight thereof are composed as follows: oligoisomaltose22%, FOS 8.54%, xylo-oligosaccharide 5.18%, aloe extract 32.28%, siberian Ginseng P.E 31%, by upperState raw material and fully mix, both must there is defaecation and improve the composition of sleeping.
Taking the above-mentioned composition that there is defaecation and improve sleep as the tablet of active ingredient, there is defaecation and improve sleep above-mentionedComposition adds diluent, adhesive, disintegrant and flavouring to make through granulation, compressing tablet, wherein diluent, adhesive and collapseThe addition of separating agent accounts for 20% of tablet total amount, and the addition of flavouring accounts for 1% of tablet total amount, and described diluent is cornStarch, adhesive is maltodextrin, and disintegrant is dried starch, and the mass ratio of diluent, adhesive is 3:1, accounts for tablet total amount17%, disintegrant is additional dried starch, accounts for 3% of tablet total amount; Flavouring is Aspartame, citric acid and orange flavor,Aspartame: the mass ratio of citric acid is 1:1, accounts for 0.5% of tablet total amount, and orange flavor accounts for 0.5% of tablet total amount.
Also comprise lubricant, the addition of lubricant accounts for 2% of tablet total amount, and described lubricant is dolomol.
Preparation method is with embodiment 1.
Embodiment 3
There is defaecation and improve a composition of sleeping, comprising the raw material components of following percentage by weight: oligoisomaltose20.83%, FOS 6.25%, xylo-oligosaccharide 2.92%, aloe extract 35%, siberian Ginseng P.E 35%, by upperState raw material and fully mix, both must there is defaecation and improve the composition of sleeping.
Taking the above-mentioned composition that there is defaecation and improve sleep as the tablet of active ingredient, there is defaecation and improve sleep above-mentionedComposition adds diluent, adhesive, disintegrant and flavouring to make through granulation, compressing tablet, wherein diluent, adhesive and collapseThe addition of separating agent accounts for 20% of tablet total amount, and the addition of flavouring accounts for 1% of tablet total amount, and described diluent is cornStarch, adhesive is maltodextrin, and disintegrant is dried starch, and the mass ratio of diluent, adhesive is 3:1, accounts for tablet total amount16%, disintegrant is additional dried starch, accounts for 4% of tablet total amount; Flavouring is Aspartame, citric acid and orange flavor,Aspartame: the mass ratio of citric acid is 1:1, accounts for 0.5% of tablet total amount, and orange flavor accounts for 0.5% of tablet total amount.
Also comprise lubricant, the addition of lubricant accounts for 2% of tablet total amount, and described lubricant is dolomol.
Preparation method is with embodiment 1.
Comparative example 1
There is defaecation and improve a composition of sleeping, comprising the raw material components of following percentage by weight: oligoisomaltose20.83%, FOS 6.25%, xylo-oligosaccharide 2.92%, aloe extract 70%.
Preparation method:
1) oligoisomaltose, FOS, xylo-oligosaccharide and aloe extract were pulverized respectively to 80 mesh sieves, divided by proportioningAnother name is got screened material, mixes to obtain mixed material powder.
2) account for the cornstarch of tablet total weight amount 40% and the mass ratio 3:1 of maltodextrin to adding in above-mentioned mixed material powderMixture, mixes 20-30 minute, mixes, and obtains mixed material.
3) mixed material is added in granulator and heat granulation, first mix 10 minutes, in the time going out a point temperature and reach 45 DEG C, sprayThe ethanolic solution of 95wt%, in 60 DEG C dry, water content in material is controlled at below 5.0%, then cross 14 order nylon meshCarry out whole grain.
4) by step 3) particle after whole grain adds dried starch, dolomol, Aspartame, citric acid and orange flavor to mix12 minutes, compressing tablet made the not mixing tablet containing wilsonii raw material.
Experimental example
Composition tablet defaecation and improve the test-meal of sleep function effect on human body and zoopery.
Experimental example 1
Get 50 of mouse, male and female half and half, are divided into 5 groups at random after weighing, and 10 every group, before test, the 24h feedwater of stopping eating, removesOutside blank group, respectively organize mouse according to its body weight, by the dosage of 10mg/kg, the fragrant promise vinegar suspension in gavage compound ground, copies constipationModel. After modeling 30min, the suspension of model group gavage water and starch, sheet prepared by the test group gavage embodiment of the present invention 3The suspension of agent, according to Mouse Weight, by 4g/kg dosage gastric infusion. That in contrast groups gavage comparative example, prepares does not contain and stings fiveAdd the suspension of the tablet of extract, according to Mouse Weight, by 4g/kg dosage gastric infusion. Composite oligosaccharide group gavage and sheetThe suspension of oligoisomaltose powder, FOS powder and the xylo-oligosaccharide powder of agent same ratio, quality, according to Mouse Weight,Press 4g/kg dosage gastric infusion. In the suspension of all experiment use, all add eosin as indicator, the first grain of observed and recorded is just redEfflux time, 6h in defecation grain number, proterties and dry weight. The results are shown in Table 1.
Table 1: experimental result
Note: * representative has significant difference, p < 0.05 compared with model group;
Representative has significant difference, p < 0.05 compared with composite oligosaccharide group;
Representative has significant difference, p < 0.05 compared with contrast groups.
Experimental result shows, when the red ight soil of first grain of composition of the present invention (test group), contrast groups and composite oligosaccharide groupBetween than the obvious shortening of model control group, ight soil dry mass showed increased, and there is significant difference (p < 0.05); Of the present invention groupCompound (test group) is compared with contrast groups, and there is shortening to a certain degree the first just time compared with contrast groups, and has significant difference(p < 0.05), shows adding of siberian Ginseng P.E bowel relaxing functions to be had a certain impact, thereby may be that it is slept by improvementThe reason of remote-effects intestines function; Composition of the present invention (test group) compared with composite oligosaccharide group, also tool of its defecating feces excretionThere is significant difference (p < 0.05), show that have adding of aloe extract and siberian Ginseng P.E to defecating feces excretion significantly shortEnter effect, stronger than the defaecation effect of the composite oligosaccharide powder mixture of Isodose.
Experimental example 2
Extend the yellow Jackets experiment length of one's sleep
Get 50 of mouse, male and female half and half, are divided into 5 groups at random after weighing, and 10 every group, animal is weighed every day, and presses 2.0mL/100G body weight per os gavage, continuous 30 days. Blank group gavage distilled water every day, prepared by the test group gavage every day embodiment of the present invention 3Tablet suspension, in siberian Ginseng P.E group gavage every day and tablet, the siberian Ginseng P.E of contained siberian Ginseng P.E equivalent is moltenLiquid, the solution that does not contain the tablet of siberian Ginseng P.E of preparing in contrast groups gavage every day comparative example, composite oligosaccharide group is filled with every dayThe suspension of oligoisomaltose powder, FOS powder and the xylo-oligosaccharide powder of stomach and tablet same ratio, quality, continuous 30My god. After last gavage 15min, give each treated animal lumbar injection 45mg/kgBW yellow Jackets, injection volume is 0.2mL/20GBW,, observes given the test agent and whether extends yellow Jackets lengths of one's sleep, experiment for the criterion of falling asleep with righting reflex lossThe results are shown in Table 2.
Table 2: experimental result
Note: * representative has significant difference, p < 0.05 compared with blank group;
Representative has significant difference, p < 0.05 compared with contrast groups;
Representative has significant difference, p < 0.05 compared with composite oligosaccharide group.
Experimental result shows, compared with blank group, test group and siberian Ginseng P.E group all have good prolongation mouse penta bar ratioThe effect length of one's sleep of appropriate sodium, and there is significant difference, show that this compound composition has the function of improving sleep. And test groupCompared with contrast groups, composite oligosaccharide group, test group has the effect of the length of one's sleep of better prolongation mouse yellow Jackets, and toolHave significant difference, further show, the main component that extends the sleep of mouse yellow Jackets is wilsonii. Contrast groups and compoundCompound sugar group, compared with blank group, has the effect of certain Sleeping Time Prolong Ed, but unknown significance difference, and showing canWith by adjust function of intestinal canal on producing certain impact the length of one's sleep.
Experimental example 3
The experiment of barbital sodium Sleep latency
Get 50 of mouse, male and female half and half, are divided into 5 groups at random after weighing, and 10 every group, animal is weighed every day, and presses 2.0mL/100G body weight per os gavage, continuous 30 days. Blank group gavage distilled water every day, prepared by the test group gavage every day embodiment of the present invention 3Tablet suspension, in siberian Ginseng P.E group gavage every day and tablet, the siberian Ginseng P.E of contained siberian Ginseng P.E equivalent is moltenLiquid, in contrast groups gavage every day comparative example, prepare not containing the suspension of the tablet of siberian Ginseng P.E, composite oligosaccharide group every dayThe suspension of oligoisomaltose powder, FOS powder and the xylo-oligosaccharide powder of gavage and tablet same ratio, quality, continuous 30My god. After last gavage 15min, give each treated animal lumbar injection 280mg/kgBW barbital sodium, injection volume is 0.2mL/20GBW, taking righting reflex loss as index, observes the impact of given the test agent on barbital sodium Sleep latency, and experimental result is in Table3。
Table 3: experimental result
Note: * representative has significant difference, p < 0.05 compared with blank group;
Representative has significant difference, p < 0.05 compared with contrast groups;
Representative has significant difference, p < 0.05 compared with composite oligosaccharide group.
Experimental result shows, compared with blank group, test group and siberian Ginseng P.E group all have good reduction mouse penta bar ratioThe effect length of one's sleep of appropriate sodium, and there is significant difference, show that this compound composition has the function that promotion is fallen asleep, and whereinMain active ingredient is siberian Ginseng P.E. Test group is compared with siberian Ginseng P.E group, and test group can better reduce mouseYellow Jackets lengths of one's sleep, but the effect unknown significance difference of both reduction lengths of one's sleep shows by adjusting enteron aisle meritMouse time for falling asleep can indirectly be affected; Test group is compared with contrast groups, composite oligosaccharide group, and test group has better reductionThe effect length of one's sleep of mouse yellow Jackets, and there is significant difference, further show, reduce the sleep of mouse yellow JacketsThe main component of time effect is wilsonii; Contrast groups compared with blank group, has certain reduction mouse with composite oligosaccharide groupThe yellow Jackets effect length of one's sleep, but unknown significance difference, show by adjusting function of intestinal canal, mouse time for falling asleep also canHave a certain impact.
Experimental example 4
Crowd's test group 30 examples, contrast groups 30 examples, tested crowd meets following standard:
1) age: 18-70 one full year of life, men and women all can.
2) stool is less than person for one week 3 times, and without organic constipation person, habitual constipation person or defecation frequency minimizing and ight soil are hardDegree enhancer.
3) difficulty falling asleep, the length of one's sleep is too short, and easily wake up night, the person of having difficulty in going to sleep after waking up.
Employing double-blind study is observed, and test group is taken tablet prepared by the embodiment of the present invention 3, and contrast groups is taken comparative example not containing spinosityThe tablet of slender acanthopanax extract, wilsonii group is taken the tablet that siberian Ginseng P.E powder is made, every day 2 times, each 3,Take continuously 4 weeks, average defecation frequency it is carried out to statistical analysis weekly before and after record examination trencherman test-meal, experimental result is shown inTable 4. The examination trencherman who takes medicine after surrounding is carried out to Pittsburgh's sleep scale detection, insomnia total mark subtracts few≤95% simultaneouslyThink that clinical recovery, insomnia total mark Jian Shao≤30% think that effective ，≤70% think significantly effectively, < 30%Think invalid, according to result of calculation, add up the result for the treatment of of each administration group, experimental result is in table 5, and computing formula is as follows.
Table 4: defecation frequency statistics
Note: * represents before and after self relatively utmost point significant difference p < 0.01;
Representative has significant difference, p < 0.05 compared with contrast groups.
Experimental result shows, compares with defecation frequency before and after self, and test group and contrast groups all have good defaecation and improve effectReally, and have utmost point significant difference (p < 0.01), siberian Ginseng P.E group has certain defaecation effect, but unknown significance difference,Show that this compound composition has the function that promotes defecation, wherein composite oligosaccharide and aloe extract are main active ingredient,And test group is compared with contrast groups, and test group has better promotion defecation, and siberian Ginseng P.E may also have some improvementEffect, its principle may be by affecting sympathetic nerve and parasympathetic nerve etc., thus remote-effects function of intestinal canal.
Table 5: Insomnia therapy statistical effect result
Experimental result shows, test group and siberian Ginseng P.E group, and to the total effective rate of sleep improvement, up to more than 80%, this is joinedSide has the function of good improvement sleep, and siberian Ginseng P.E is the component that main improvement is had a sleepless night. Contrast groups also has certainImprove function (> 50%), further show by improving constipation energy remote-effects insomnia.
Claims (10)
1. have defaecation and improve a composition of sleeping, raw material components and percentage by weight thereof are composed as follows: oligomeric different wheatBud sugar 15～28%, FOS 4～15%, xylo-oligosaccharide 1～10%, aloe extract 20～35%, wilsonii extractsThing 20～35%.
2. a composition that has defaecation and improve sleep claimed in claim 1, is characterized in that raw material components and heavyAmount percentage is composed as follows: oligoisomaltose 18～25%, FOS 5～12%, xylo-oligosaccharide 3～8%, aloeExtract 23～32%, siberian Ginseng P.E 23～32%.
3. a composition that has defaecation and improve sleep claimed in claim 1, is characterized in that raw material components and heavyAmount percentage is composed as follows: oligoisomaltose 15～25%, FOS 4～10%, xylo-oligosaccharide 1～5%, aloeExtract 28～35%, siberian Ginseng P.E 28～35%.
4. a composition that has defaecation and improve sleep claimed in claim 1, is characterized in that raw material components and heavyAmount percentage is composed as follows: oligoisomaltose 20.83%, and FOS 6.25%, xylo-oligosaccharide 2.92%, aloe is extractedThing 35%, siberian Ginseng P.E 35%.
5. a composition that has defaecation and improve sleep claimed in claim 1, is characterized in that reed in aloe extractLuxuriant growth glycosides content is more than or equal to 17wt%; In siberian Ginseng P.E, the content of Syringin and eleutheroside E is more than or equal to0.8wt％。
6. have defaecation and improve sleep a health food, with claimed in claim 1 have defaecation and improve sleepComposition is active ingredient, adds corresponding pharmaceutical necessities, can be made into tablet, granule or capsule, and the addition of auxiliary material accounts forThe 16-25% of active ingredient and auxiliary material gross weight.
7. one kind has defaecation and improves composition the having defaecation and changing as active ingredient of sleeping taking claimed in claim 1The tablet of kind sleep, is characterized in that, claim 1 is had to defaecation and improves the composition of sleeping add diluent, bondingAgent, disintegrant and flavouring make through granulation, compressing tablet, and wherein the addition of diluent, adhesive and disintegrant accounts for tablet total amount15-22%, the addition of flavouring accounts for the 0.5-2% of tablet total amount, described diluent is cornstarch, adhesive is wheatBud dextrin, disintegrant is dried starch, the mass ratio of diluent, adhesive, disintegrant is 3:1:1～1:3:3, flavouringFor the mixture of Aspartame, citric acid and orange flavor, the mass ratio of Aspartame and citric acid is 1:1～1:2, sweet orangeThe addition of essence accounts for the 0.5-1% of tablet total amount.
8. the tablet that has defaecation and improve sleep according to claim 8, is characterized in that, also comprises lubricant,The addition of lubricant accounts for the 1-3% of tablet total amount, and described lubricant is dolomol.
9. the preparation method who has defaecation and improve the tablet of sleep claimed in claim 7, comprises that step is as follows:
1) oligoisomaltose, FOS, xylo-oligosaccharide, aloe extract and siberian Ginseng P.E were pulverized respectively to 60-80Mesh sieve, takes respectively screened material by proportioning, mixes to obtain mixed material powder;
2) in above-mentioned mixed material powder, add diluent, adhesive and disintegrant by amount ratio, mix 20～30 minutes, mixedClose evenly, obtain mixed material;
3) mixed material is added in granulator and heat granulation, first mix 5～15 minutes, when leaving air temp reaches 30～60 DEG CTime, spray ethanolic solution is dried material moisture is controlled at below 5.0wt% at 50～80 DEG C, then crosses 14～20 ordersSieve carries out whole grain;
4) by step 3) particle after whole grain adds flavouring and mix lubricant 10-15 minute, compressing tablet make have defaecation andImprove the compressing tablet of sleep.
10. the preparation method who has defaecation and improve the tablet of sleep according to claim 9, is characterized in that step3) in, the concentration of ethanolic solution is 70～90wt%, and preferably, the concentration of ethanolic solution is 80wt%, and sheet is heavily 1.0-1.2g, sheetThe different limit of the method for double differences is ± 5%, and described tablet is compressing tablet or chewable tablets.
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