CN109010419A - A kind of anti-drug or health care product to treat constipation - Google Patents
A kind of anti-drug or health care product to treat constipation Download PDFInfo
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- CN109010419A CN109010419A CN201710434437.XA CN201710434437A CN109010419A CN 109010419 A CN109010419 A CN 109010419A CN 201710434437 A CN201710434437 A CN 201710434437A CN 109010419 A CN109010419 A CN 109010419A
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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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/733—Fructosans, e.g. inulin
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Abstract
Gastrointestinal function, the anti-drug or health care product to treat constipation are obviously improved the present invention relates to a kind of.Contain Radix Astragali and Girasole synanthrin in the drug or health care product, can also can improve gastrointestinal function, the anti-other active constituents to treat constipation containing soyabean oligosaccharides etc..Inventor's, studies have shown that the drug or health care product taken in the present invention can effectively improve gastrointestinal function, has the effect of good relax bowel and defecation.Raw material composition of the present invention is simple, reasonable, and ingredient is natural, convenient to take, highly-safe, without toxic side effect, has no adverse reaction, and will not generate dependence effect, and suitable constipation patient is taken.
Description
Technical field
The invention discloses a kind of anti-drug or health care product to treat constipation, this drug or health care product are containing with Radix Astragali and chrysanthemum
Sugar composition as main component.
Background technique
Radix Astragali, also known as continuous stilbene.Main root is plump, wooden, normal branch, canescence.Stem is upright, and top multi-branched has thin rib, quilt
White pubescence.The medicinal of Radix Astragali has more than 2000 years history so far, there is enhancing body's immunity, liver protection, diuresis, anti-ageing
Always, the effects of resisting stress, decompression.But table is real evil to be contained, and retention of dampness due to stagnation of QI, dyspepsia is stagnated, ulcer from the beginning of or after bursting heat toxin still contain etc. it is real
Card and hyperactivity of yang due to yin deficiency person, must prohibit clothes.
Synanthrin, also known as inulin, main component are the similar polysaccharides of a class formation.Synanthrin is presently found rare
Several soluble dietary fibers are internal Bifidobacterium and lactic acid bacteria proliferation factor, in addition there is low in calories, non-insulin to rely on
The features such as property and non-saprodontia, the field of food such as dairy products, bread, candy, beverage and flavouring are widely used in, as excellent
The dietary fiber sources and fat substitute of matter.Numerous reports think that synanthrin has improvement intestinal microenvironment, adjusts blood lipid, prevention
Fat, the promotion physiological activity such as mineral absorption and vitamin metabolism.
Constipation is clinically one of most common chronic digestible road symptom, the incidence in China is about 10%~
15%, constipation number is more than 1.3 hundred million at present.Domestic constipation survey data shows, the incidence of constipation and age, gender,
The factors such as domain, occupation, schooling are related.With the improvement of people ' s living standards and the change of eating habit, constipation patient
Age just gradually develops to rejuvenation, and the constipation incidence in city is significantly larger than rural area.Research data shows that aging is
One high-incidence factor of constipation, constipation patient increase with the age and increased significantly.Most of epidemiologic data think constipation and
Gender has substantial connection, and women is people at highest risk.The chronic constipation ratio of China 60 years old or more the elderly is up to 15%-20%.
And carry out to the 18-70 years old adult in Beijing area one is random, layering, classification investigation show that the disease incidence of chronic constipation is
6.07%, women is 4 times of male or more, and mental element is one of Risk factors.The disease incidence of constipation is different because of region, and
City, village people group disease incidence there are significant differences.
Constipation is to allow people i.e. pain and a kind of awkward illness, the drug of traditional treatment constipation, most of for containing rushing down
The ingredient of lower effect, long-term use can generate very strong dependence, secondary constipation then easily be formed, so such drug is uncomfortable
It closes and takes for a long time.Present people are more likely to select pure natural, green, Small side effects, the good product of effect.
One text of clinical observation of astragali seu Hedysari Decoction plus-minus treatment senile constipation discloses astragali seu Hedysari Decoction and can treat senile constipation,
And treatment senile constipation is added and subtracted with astragali seu Hedysari Decoction and is better than Cisapride, the group of such astragali seu Hedysari Decoction becomes Radix Astragali, dried orange peel, fire fiber crops
Benevolence, whitish honey, wherein Radix Astragali is the main component (clinical observation [J] of astragali seu Hedysari Decoction plus-minus treatment senile constipation.Liu Ming, Li Zhuoran,
Huang Shuming.Traditional Chinese medicine information, 2010,4 (27): 64-65)；Chinese patent CN201410293960.1 is disclosed and one kind is used for
The astragali seu Hedysari Decoction of constipation is treated, such astragali seu Hedysari Decoction is prepared from the following components: 25 grams of Radix Astragali, 15 grams of dried orange peel and 20 grams of fructus cannabis.
There is not the report using Radix Astragali and synanthrin as main component for the treatment of constipation so far.
Summary of the invention
The purpose of the present invention is to provide a kind of new anti-drugs or health care product to treat constipation, and the drug or health care product include
Radix Astragali and synanthrin, synanthrin therein is Girasole synanthrin, in addition, can also contain soyabean oligosaccharides in this drug or health care product.
In the technical solution provided by the present invention, the preparation of drug or health care product in the present invention is provided, wherein containing Huang
Stilbene and synanthrin weight fraction ratio can be 0.1:1-10:1, preferably 1:1.
Drug or health care product in the present invention can only include active constituent may also comprise excipient, antioxidant, PH regulator,
Acceptable in any pharmacy such as preservative, isotonic agent and nutrition, the guaranteed auxiliary material of safety.Health care product therein may be used also
It is used so that other nutritional ingredients are added when being finally prepared as product, these nutriments include starch, glucose, lactose, sweet
Reveal sugar, sucrose, syrup, honey, a variety of amino acid, calcium iron zinc, vitamin etc..
Drug or health care product of the present invention can be prepared as multiple types, including capsule, tablet, pulvis, granule, oral solution
Or syrup etc., preferably pulvis and oral solution.The appearance existence form for changing product, which belongs to those skilled in the art, to be associated
The technical solution arrived, therefore the shape for changing final products belongs to coverage area of the invention.
Applicant studies product of the present invention function, finds compared with Radix Astragali and Girasole synanthrin are used alone, this
Inventive composition can significantly promote the wriggling of Constipation Model mouse intestinal, have the curative effect of collaboration.The present composition can be obvious
Shorten Constipation Model mouse defecation time, defecation frequency and weight, softer stool in increase by 6 hours for the first time, there is the treatment of collaboration
Effect.
Raw material composition of the present invention is simple, reasonable, and ingredient is natural, convenient to take, highly-safe, without toxic side effect, invariably
Good reaction has effects that improve gastrointestinal function, relax bowel and defecation.
Specific embodiment
The present invention is further described below by way of specific embodiment, but application range of the invention is not limited only to following reality
Apply example.In the contents of the present invention, spirit and/or range, replacement and/or combination to the technology of the present invention feature, to this field
Technical staff for be all it is clear that and include the present invention among.
Prepare a kind of pulvis for treating constipation of embodiment 1
Drug or health care product provided in this embodiment are made of the raw material of following weight percentage: Radix Astragali 50%, jerusalem artichoke
Synanthrin 50%.
Drug or health care product provided in this embodiment are pulvis, and preparation method includes the following steps:
(1) Radix Astragali, Girasole synanthrin are weighed respectively by the above weight percentage.
(2) raw material crushes: the weighed raw material of step (1) being crushed, 80 meshes are then crossed, screenings is collected, obtains pulvis.
Prepare a kind of oral solution for treating constipation of embodiment 2
Radix Astragali 54mg
Girasole synanthrin 9mg
Preparation process: mentioned component mixing grind into powder is dissolved in deionized water to 1000ml, is carried out after filtering close
Envelope, sterilizing and packing, are prepared as meeting the oral solution of specific standard.
The present invention prepares oral solution and can amplify in dosage in large-scale production, carries out after completely dissolution canned
Then seal, sterilize and be packed as oral solution up to specification, such as 500ml, 1L etc..
Prepare a kind of tablet for treating constipation of embodiment 3
Preparation process: above-mentioned raw materials are uniformly mixed, and 5% starch slurry is added, and 20 meshes squeeze sieving granulation, 60 DEG C of perseverances
Temperature is 2 hours dry, 20 mesh sieve of dry particl, and magnesium stearate 1% is added and mixes, tabletted on tablet press machine.
Prepare a kind of tablet for treating constipation of embodiment 4
Preparation process: above-mentioned raw materials are uniformly mixed, and 5% starch slurry is added, and 20 meshes squeeze sieving granulation, 60 DEG C of perseverances
Temperature is 2 hours dry, 20 mesh sieve of dry particl, and magnesium stearate 1% is added and mixes, tabletted on tablet press machine.
Prepare a kind of capsule for treating constipation of embodiment 5
Preparation process: Radix Astragali, Girasole synanthrin and soybean lecithin are allowed to be dissolved in 20 times under the conditions of 50 DEG C of return stirrings
In dehydrated alcohol, after sixty minutes, ethyl alcohol is evaporated for reaction, 50 DEG C vacuum drying 10 hours Radix Astragali, Girasole synanthrin phosphatide are compound
Object, ground 120 mesh；Radix Astragali, Girasole synanthrin phosphatide complexes and superfine silica gel powder, lactose, starch is taken to mix, and take 50% alcohol
It is added in said mixture, mixes after being mixed with polyoxyethylene sorbitan monoleate, then do adhesive softwood with 70% syrup, cross 20 meshes
Pelleting, 55 DEG C drying 6 hours, cross 20 mesh sieves, be added 5 grams of talcum powder, by every Radix Astragali containing 0.03g, Girasole synanthrin dress
Entering hard capsule case must lose weight oral capsule.
Prepare a kind of injection for treating constipation of embodiment 6
Preparation process: being added Radix Astragali, Girasole synanthrin for the ethyl alcohol of recipe quantity, stirring and dissolving, water for injection is added to 10L,
It stirs evenly, filters, 0.5% needle-use activated carbon is added, stirring takes off charcoal to get injection.
The research that 1 present composition of experimental example acts on Constipation Model
1. mouse small intestine Promoting Experiment
Healthy ICR mouse 50, half male and half female are taken, 18~22g of weight is randomly divided into 5 groups, every group 10, is positive respectively
Normal control group, model control group, Radix Astragali group, Girasole synanthrin group, Radix Astragali Girasole synanthrin composition group.
After mouse is deprived of food but not water 12h, loperamide hydrochloride is given in stomach-filling to each administration group in addition to Normal group respectively
(3.0mg/kg), Normal group give the distilled water of respective volume.Each dosage group respectively give containing prepared Chinese ink by stomach-filling after 30min
The drug of suspension (2% prepared Chinese ink 100mL+1g sodium carboxymethylcellulose) corresponding dosage, Normal group and model control group are given
Respective volume prepared Chinese ink suspension is given, stomach-filling volume is 0.2mL/10g.
Groups of animals administrations:
Normal group: isometric distilled water is given in stomach-filling
Model control group: isometric distilled water is given in stomach-filling
Radix Astragali group: 0.54g/kg Radix Astragali is given in stomach-filling
Girasole synanthrin group: 0.9g/kg Girasole synanthrin is given in stomach-filling
Composition group: the composition containing Radix Astragali and Girasole synanthrin in preparation embodiment 2 is given in stomach-filling
Cervical dislocation puts to death mouse after 30min is administered, and opens abdominal cavity and separates mesenterium, clip upper end is from pylorus, lower end
To the intestinal tube of ileocecus, measuring Length of intestine is " total small intestinal length ", and it is " carbon juice that measurement pylorus to carbon juice, which promotes the distance in forward position,
Promote length ", calculate carbon juice propulsion rate.Carbon juice propulsion rate (%)=carbon juice propulsion length (cm)/total small intestinal length (cm) ×
100。
2. mouse defecation is tested
Healthy ICR mouse 50, half male and half female are taken, 18~22g of weight is randomly divided into 5 groups, every group 10, is positive respectively
Normal control group, model control group, Radix Astragali group, Girasole synanthrin group, Radix Astragali Girasole synanthrin composition group.
Hydrochloric acid Lip river is given in stomach-filling to each administration group after mouse fasting 12h overnight (drinking-water is unlimited) in addition to Normal group respectively
Piperazine butylamine (3.0mg/kg), Normal group give the distilled water of respective volume.Each dosage group respectively give and contain by stomach-filling after 30min
There is the drug of prepared Chinese ink suspension corresponding dosage, Normal group and model control group give respective volume prepared Chinese ink suspension, stomach-filling
Volume is 0.2mL/10g.
Groups of animals administrations:
Normal group: isometric distilled water is given in stomach-filling
Model control group: isometric distilled water is given in stomach-filling
Soyabean oligosaccharides group: 0.54g/kg soyabean oligosaccharides are given in stomach-filling
Girasole synanthrin group: 0.9g/kg Girasole synanthrin is given in stomach-filling
Composition group: the composition containing Radix Astragali and Girasole synanthrin in preparation embodiment 2 is given in stomach-filling
After administration, since the timing giving prepared Chinese ink suspension, every mouse is placed individually into the band small mouse cage of interlayer, and (cage bottom is spread
Blotting paper), normal water, feed observe and record the time that melena is discharged in every mouse for the first time respectively, defecation frequency in 6h, again
Amount and fecal character.
3. data processing
Data mean ± standard deviationIt indicates, data analysis is analyzed with SPSS15.0 statistical software.Between two groups
The significance analysis of difference is examined with sided t.
4. experimental result
The influence that 1 composition of table promotes Constipation Model mouse small intestine
Compared with Normal group,★P < 0.05,★★P < 0.01；Compared with model control group,&&P < 0.01；With Radix Astragali
Group is compared,#P < 0.05；Compared with Girasole synanthrin group,$P < 0.05.
By the result of above-mentioned table 1 it can be seen that (1) is compared with normal group, the propulsion rate of the small enteral carbon juice of model group is aobvious
Writing reduces, and the propulsion rate of each small enteral carbon juice of administration group significantly increases, and shows modeling success；
(2) compared with model control group, the propulsion rate of each small enteral carbon juice of administration group is significantly increased, and shows Radix Astragali, chrysanthemum
Taro synanthrin and Radix Astragali and Girasole synanthrin composition play the role of significantly promoting small bowel peristalsis；
(3) compared with individually giving Radix Astragali or Girasole synanthrin, Radix Astragali and Girasole synanthrin composition group carbon juice propulsion rate are improved
More significant, composition group is more preferable to the effect for promoting intestines peristalsis, and difference has statistical significance (P < 0.05).This shows Radix Astragali
There can be significant therapeutic effect to mice with constipation with Girasole synanthrin composition group, the two combination has synergistic function.
Influence of 2 composition of table to Constipation Model mouse defecation
Compared with Normal group,★P < 0.05,★★P < 0.01；Compared with model control group,&P < 0.05,&&P <
0.01；Compared with Radix Astragali group,##P < 0.01；Compared with Girasole synanthrin group,$$P < 0.01.
By the result of above-mentioned table 2 it can be seen that (1) is compared with normal group, defecation time is obviously prolonged model group for the first time,
Defecation frequency and defecation weight significantly reduce, and show modeling success；
(2) compared with model control group, defecation time is obviously shortened each administration group for the first time, and defecation frequency and defecation weight are equal
It obviously increases, shows that Radix Astragali, Girasole synanthrin and Radix Astragali and Girasole synanthrin composition can obviously improve constipation symptom；
(3) compared with individually giving Radix Astragali or Girasole synanthrin, the defecation time shortening for the first time of composition group is become apparent from, defecation
Several and defecation weight increase is more significant, and difference has statistical significance (P < 0.01).And with Normal group no difference of science of statistics.
This shows that Radix Astragali and Girasole synanthrin composition group can have significant therapeutic effect to mice with constipation, and the two combination has collaboration
Synergistic effect.
The clinical trial of the composition of the present invention of experimental example 2
Clinical research is carried out with preparation made of embodiment 4, is reported as follows:
1, subject selects
1.1 are included in subject's standard:
A) defecation frequency is reduced and stool hardness enhancer；
B) one week is defecated less than three times；
C) without organic constipation person；
D) habitual constipation person；
1.2 Subject Exclusion Criteria
A) person that is unable to oral feeding or the person that cannot take given the test agent by regulation；
B) the unclear person of main suit；
C) experimenter can not be carried out by having a delicate constitution；
D) constipation symptom generator caused by surgical operation is carried out in 30 days；
E) difficult defecation person (colon cancer, serious enteritis, intestinal obstruction and inflammatory in the recent period caused by serious organic disease
Enteropathy etc.)
F) constipation is difficult and with pain person
G) acute enterogastric diseases person occurred in 30 days；
H) pregnancy period or menstrual woman；
I) it is associated with the severe totals disease patient such as angiocarpy, liver, kidney and hemopoietic system；
J) there are other with disease just in curer；
K) article related with tested function is taken in a short time, influences result judgement person.
Patient 100 are selected with exclusion criteria according to above-mentioned be included in, wherein male 33, women 67；Youngest person
22 years old, the maximum 80 years old, defecation time most short person 3 days, the longest 10 days；Shortest course of disease 60 days, the longest 30 years.
2, experimental design, grouping and data processing
The situation of front and back is taken drugs from check experiment design, comparative study is set using test front and back.Data with
It indicates, own control test uses paired t-test.
Observation index: a blood, urine, stool routine and hepatic and renal function inspection are done before treatment.Observation administration front and back defecation frequency,
The variation of duration, defecation situation and fecal character.
Defecation condition according to difficult defecation degree, (whether there is or not just frequency but arrange by abdominal pain or anus burning sensation, sense of discomfort, bearing down
Just difficult and measure the symptoms such as few) it is divided into I-IV grade, count integrated value.
I grade (0 point): defecation is normal；
II grade (1 point): only bearing down, sense of discomfort；
III grade (2 points): tenesmus sense of discomfort is obvious, or just frequency but difficult defecation and measure few, less there is abdominal pain or anus burns
Burn sense；
IV grade (3 points): abdominal pain or anus burning sensation often occur；
Fecal character is divided into I-III grade according to Bristol (Bristol) fecal character classification by fecal character.
I grade (0 point): smooth and soft as sausage or snake；There is slight crack on surface but has limbus (being easily drained)；
II grade (1 point): sausage shape, but have agglomerate；Loose blocky, edge is rough, as slimy excrement；
III grade (2 points): the hard group of separation, as fruit stone (being not easy to be discharged).
3, treatment method:
All patients take preparation made of the embodiment of the present invention 4, and 1 tablet once, once a day, and deactivate other defaecations
Drug, dose can improve situation according to patient's constitution situation and constipation symptom and take the circumstances into consideration to increase and decrease.Curative effect determinate standard is as follows:
Clinical cure: stool does soft, daily defecation 1 time, and other symptoms all disappear；
Effective: constipation is clearly better, and just matter is normal, and time interval 1~2 day, other symptoms 2/3 disappear；
Effective: just matter is dry and hard makes moderate progress, and the stool intermittent time shortens 1~2 day more originally, and other symptoms are set
Turn；
Invalid: constipation and other symptoms are without improvement.
4, result:
The subjective symptoms such as poor, abdominal pain, dizziness headache, bitter taste that patient's abdominal distension is received be improved significantly.Compared with pre-treatment, it takes
It increased significantly with the defecation frequency of drug future trouble person, defecation decreased duration, difficult defecation degree and fecal character face are obvious
It improves (table 3).100 patients fully recover 46, and effective 34, effective 18, invalid 2, total effective rate 98%.
Table 3 changes (n=100) with patient's defecation situation after continuous take 14 and fecal character using before drug of the present invention
Compared with before use,**P < 0.01
Above-mentioned clinical effectiveness shows that the various constipation symptoms of patients with chronic constipation before and after medication significantly improve (P <
0.01), the present composition can dramatically increase the defecation frequency of patients with chronic constipation, shorten the defecation duration, mitigate row
Just degree of difficulty improves fecal character.
Claims (7)
1. a kind of anti-drug or health care product to treat constipation, it is characterised in that include Radix Astragali and synanthrin in the drug or health care product.
2. drug as described in claim 1 or health care product, it is characterised in that soybean can also be contained in this drug or health care product
Oligosaccharide.
3. drug as described in claim 1 or health care product, it is characterised in that synanthrin therein is Girasole synanthrin or chicory inulin.
4. drug or health care product as described in right 1, it is characterised in that wherein also include pharmaceutically acceptable auxiliary material or health care product
Acceptable additive.
5. drug as described in claim 1 or health care product, it is characterised in that wherein the weight ratio of Radix Astragali and synanthrin is 0.1:1-
10:1。
6. drug as claimed in claim 5 or health care product, it is characterised in that wherein the weight ratio of Radix Astragali and synanthrin is 1:1.
7. drug as described in claim 1 or health care product, it is characterised in that it is tablet, capsule, pulvis, oral solution or note
Penetrate liquid.
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