CN110934971A - Composition with digestion promoting function and preparation method and application thereof - Google Patents

Composition with digestion promoting function and preparation method and application thereof Download PDF

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Publication number
CN110934971A
CN110934971A CN201911229074.1A CN201911229074A CN110934971A CN 110934971 A CN110934971 A CN 110934971A CN 201911229074 A CN201911229074 A CN 201911229074A CN 110934971 A CN110934971 A CN 110934971A
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parts
composition
food
test
malt
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肖伟
高如意
曹苗苗
郭小莉
邓辰辰
许明君
刘文英
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Jiangsu Kanion Pharmaceutical Co Ltd
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Jiangsu Kanion Pharmaceutical Co Ltd
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Priority to PCT/CN2020/094730 priority patent/WO2021109510A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/734Crataegus (hawthorn)
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
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    • A23L33/105Plant extracts, their artificial duplicates or their derivatives
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    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284Atractylodes
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/36Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/899Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A61K36/8998Hordeum (barley)
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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    • A61P1/14Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
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    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps

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Abstract

The invention provides a composition with digestion promoting function, which is characterized by comprising the following components in parts by weight: 1-10 parts of hawthorn, 1-15 parts of malt, 1-10 parts of bighead atractylodes rhizome, 1-15 parts of dried orange peel and 1-10 parts of radix pseudostellariae. According to the invention, through multiple experimental researches, types, proportions and dosage proportions of auxiliary materials are preferably obtained, so that the problem of bitter and astringent taste after the chewing tablet prepared from the traditional Chinese medicine extract is usually eaten, namely, the chewing tablet does not feel greasy, and the prepared tablet has good chewing feeling, is sour, sweet, delicious and attractive in appearance. In addition, the tablet prepared from the composition has the health-care function of promoting digestion proved by human body function experiments.

Description

Composition with digestion promoting function and preparation method and application thereof
Technical Field
The invention relates to the field of medicines or health-care foods, in particular to a composition with a digestion promoting and health-care function and a preparation method and application thereof.
Background
Modern people are under heavy stress, are nervous, have irregular working and life, often eat one meal and full one meal, have high fat, high protein and low fiber diet and increased drinking amount, have high incidence of digestive system diseases, and almost half of patients in clinic diagnosis in various medical institutions belong to the digestive system according to incomplete statistics.
Dyspepsia refers to a group of clinical syndromes which have uncomfortable symptoms such as epigastric pain, epigastric distension, early satiety, eructation, inappetence, nausea, vomiting and the like, and organic diseases causing the symptoms are eliminated through examination, and the symptoms of dyspepsia can continuously or repeatedly attack, and is the most common functional gastrointestinal disease in clinic. Dyspepsia belongs to the categories of symptoms such as fullness, stomachache and epigastric upset in the traditional Chinese medicine, and the disease is in the stomach, relates to organs such as liver and spleen, and is suitable for treatment based on syndrome differentiation, strengthening spleen and stomach, soothing liver and regulating qi, promoting digestion and removing food stagnation and the like.
Disclosure of Invention
The invention aims to provide a composition with dual purposes of medicine and food and having the function of promoting digestion, and simultaneously provides a chewable tablet preparation based on the composition, and solves the problems that the general chewable tablet containing traditional Chinese medicine components has poor taste and chewing feeling, insufficient friability can not meet the requirement and the like by screening auxiliary material diluents, flavoring agents and the like.
Specifically, the invention provides a composition with digestion promoting function, which comprises the following components in percentage by weight: 1-10 parts of hawthorn, 1-15 parts of malt, 1-10 parts of bighead atractylodes rhizome, 1-15 parts of dried orange peel and 1-10 parts of radix pseudostellariae. The composition of the present invention may be directly ground into powder, or may be an extract prepared by a conventional method in the art, etc. The traditional Chinese medicine used in the composition of the present invention can also be used by directly grinding into powder, extract or other processing forms.
In another embodiment of the present invention, the composition comprises by weight: 3-7 parts of hawthorn, 3-7 parts of malt, 3-7 parts of bighead atractylodes rhizome, 1-5 parts of dried orange peel and 1-5 parts of radix pseudostellariae.
In another embodiment of the present invention, the Chinese medicinal composition comprises, by weight: 4-6 parts of hawthorn, 4-6 parts of malt, 4-6 parts of bighead atractylodes rhizome, 1-3 parts of dried orange peel and 1-3 parts of radix pseudostellariae.
In another embodiment of the present invention, the Chinese medicinal composition comprises, by weight: 5 parts of hawthorn, 5 parts of malt, 5 parts of bighead atractylodes rhizome, 2 parts of dried orange peel and 2 parts of radix pseudostellariae.
The invention also provides application of the composition in preparing a medicament, a health-care product or food with the function of promoting digestion.
The invention also provides a medicament, health-care product or food comprising the composition as described in any one of the preceding items.
In another embodiment of the present invention, the pharmaceutical, health product or food can be in the form of oral, topical or injectable administration, such as capsule, tablet, granule, decoction, pill, oral liquid, tincture, syrup, suppository, gel, spray or injection; optionally chewable tablets.
In another embodiment of the present invention, the pharmaceutical, health product or food comprises pharmaceutically or dietetically acceptable excipients; examples of such compounds include sucrose, mannitol, sorbitol, dextrin, magnesium stearate, lactose, microcrystalline cellulose, starch, white sugar, xylitol, sucralose, and steviol glycosides.
In another embodiment of the present invention, in the medicine, health product or food, the composition may be prepared into extract powder, and the mass ratio of the extract powder to the auxiliary material is preferably 10: 1-5, more preferably 10: 3.5.
in another embodiment of the present invention, the pharmaceutical, nutraceutical or food additive is selected from microcrystalline cellulose, stevioside, citric acid and magnesium stearate.
As a preferred embodiment, the weight ratio of the composition, the microcrystalline cellulose, the stevioside, the citric acid and the magnesium stearate is preferably 50-70: 10-50: 0.5-2: 1-5: 0.5 to 2, more preferably 56 or 40: 1: 2: 1.
the invention also provides a preparation method of the composition, which comprises the steps of adding water into hawthorn, malt, bighead atractylodes rhizome, dried orange peel and radix pseudostellariae according to the proportion, decocting, filtering, and spray-drying the concentrated solution.
In another specific embodiment of the invention, the adding amount of the water is 10 times of the weight of the medicinal materials, and the decocting and extracting times are 2 times and 1 hour each time.
In another specific embodiment of the invention, the concentrated solution is concentrated under reduced pressure at 70 +/-5 ℃ until the relative density is 1.1-1.15 (60 +/-5 ℃), and the concentrated solution is subjected to spray drying and sieving (80 meshes) to obtain dry extract powder.
The invention also provides a preparation method of the medicine, the health-care product or the food, which is characterized in that when the medicine, the health-care product or the food is a tablet, the preparation method comprises the following steps:
weighing 5 parts of hawthorn, 5 parts of malt, 5 parts of bighead atractylodes rhizome, 2 parts of radix pseudostellariae and 2 parts of dried orange peel according to the formula, adding 10 times of water, decocting and extracting for 2 times, each time for 1 hour, filtering, combining extracting solutions, concentrating under reduced pressure at 70 +/-5 ℃, concentrating to relative density of 1.8-1.12 at 60 +/-5 ℃, spray drying, crushing spray-dried powder, and sieving by a 80-mesh sieve to obtain dry paste powder;
mixing the dry extract powder with 2% citric acid, 1% stevioside and 40% microcrystalline cellulose, making soft mass with 90% ethanol, granulating with 16 mesh sieve, drying, grading, adding 1% magnesium stearate into the obtained granule, mixing, and tabletting.
In another embodiment of the present invention, when the pharmaceutical, health product or food is a tablet, such as a chewable tablet, the preparation method thereof comprises:
(1) weighing the raw medicinal materials according to a proportion, adding 10 times of water for decocting and extracting for 2 times, each time for 1 hour, filtering, combining extracting solutions, concentrating under reduced pressure at 70 +/-5 ℃, and concentrating to relative density of 1.1-1.15 (60 +/-5 ℃). Spray drying to obtain dry extract powder;
(2) mixing the above ⑴ dried powders with appropriate amount of diluent and correctant to make soft mass.
(3) Sieving the prepared soft material with 16 mesh sieve, and controlling the water content of the granules below 5.0% at the temperature of 60 + -5 ℃;
(4) granulating with 16 mesh sieve, adding lubricant, and mixing with the granules;
(5) compressing to obtain plain tablet.
(6) And (6) bottling.
The invention provides a composition for promoting digestion and a preparation method thereof, wherein hawthorn, malt, bighead atractylodes rhizome, dried orange peel and radix pseudostellariae are used as main raw materials, medicinal auxiliary materials meeting the requirements in Chinese pharmacopoeia or food additives in GB2760 are added to prepare tablets, the tablets are convenient to take and carry, and the problems that the compliance of a user is poor due to poor taste and the friability cannot meet the requirements of the pharmacopoeia when the traditional Chinese medicine extract is prepared into chewable tablets are solved.
The hawthorn, the malt, the bighead atractylodes rhizome, the dried orange peel and the radix pseudostellariae in the invention are medicinal and edible health food raw materials published by Ministry of health, and the five traditional Chinese medicines of the hawthorn, the malt, the bighead atractylodes rhizome, the dried orange peel and the radix pseudostellariae in the formula have no incompatibility of eighteen antagonisms and nineteen incompatibilities, so that the safety of the product is ensured without toxic and side effects. The hawthorn fruit in the prescription is used for treating food retention and gastric cavity fullness; the malt can promote qi circulation and promote digestion, invigorate the spleen and stimulate the appetite, contains amylase and vitamin B, and is good at digesting the five-cereal rice flour; the dried orange peel is a traditional Chinese medicine for regulating qi, can invigorate spleen and regulate qi, and is used for treating abdominal distension, anorexia, vomiting and diarrhea; radix pseudostellariae can tonify middle-jiao and qi, invigorate spleen and benefit lung, and is used for treating spleen-lung weakness, poor appetite and loose stool; the bighead atractylodes rhizome can invigorate the spleen and replenish qi, is used for treating spleen deficiency and anorexia, and is a common traditional Chinese medicine for tonifying the spleen and qi. The formula is prepared by the compatibility of the five medicinal materials, and achieves the effect of promoting digestion by promoting digestion and relieving stasis, strengthening spleen and replenishing qi, nourishing stomach and stimulating appetite, enhancing gastric motility, promoting gastrointestinal evacuation and the like, so the formula is scientifically prepared by selecting medicinal materials which are both edible and medicinal and can be used as health-care food and are issued by the state bureau according to the mechanism of dyspepsia by applying the theories of traditional Chinese medicine and modern medicine. The formula has definite function, no incompatibility, is safe and effective to eat, and can play a good role in health care.
The 5 traditional Chinese medicines of the product are prepared into chewable tablets by combining the modern technology of extraction and concentration, the traditional Chinese medicine water extract is bitter and astringent when directly taken and has gritty feel, and if the traditional Chinese medicine water extract is directly prepared into a dosage form, the compliance of a user is poor. In the invention, the types, the proportion and the proportion of the using amount of the auxiliary materials are preferably obtained through a plurality of experimental researches, so that the problem of bitter and astringent taste after the chewing tablets prepared from the traditional Chinese medicine extract are often eaten, namely, the chewing tablets do not feel greasy, and the prepared tablets have good chewing feeling, are sour, sweet, delicious and beautiful in appearance. In addition, the chewable tablet prepared from the composition has the health-care function of promoting digestion proved by human body function experiments.
Detailed Description
As mentioned above, the invention aims to provide a composition with dual purposes of medicine and food and having the function of promoting digestion, and a preparation method and application thereof. The following will specifically describe the contents of the experimental examples.
If the specific conditions are not indicated, the method is carried out according to the conventional conditions or the conditions suggested by manufacturers, and the used raw material medicines or auxiliary materials and the used reagents or instruments are the conventional products which can be obtained commercially.
It is particularly pointed out that the present invention is described in more detail below by means of specific embodiments in order to be able to better understand the solution of the invention and the advantages of its various aspects. The present invention is not limited by the following examples, and specific embodiments may be determined according to the technical solutions and practical situations of the present invention.
Example 1 screening of pharmaceutical excipients having digestion promoting efficacy
Weighing 5 parts of hawthorn, 5 parts of malt, 5 parts of bighead atractylodes rhizome, 2 parts of radix pseudostellariae and 2 parts of dried orange peel, weighing the five medicinal materials according to the formula, adding 10 times of water, decocting and extracting for 2 times, each time for 1 hour, filtering, combining extracting solutions, concentrating under reduced pressure at 70 +/-5 ℃, concentrating to relative density of 1.8-1.12 (60 +/-5 ℃), performing spray drying, crushing spray-dried powder, and sieving with a 80-mesh sieve to obtain the dry paste powder.
Mixing the above dry extract powder with adjuvants, making soft mass with 90% ethanol, granulating with 16 mesh sieve, drying, grading, adding lubricant into the obtained granule, mixing, and tabletting.
1. Adjuvant screening protocol
The variety and the approximate dosage of the added auxiliary materials are determined by adopting a single-factor test, and then the problems which are difficult to quantify or are fuzzy can be digitalized by the fuzzy evaluation through an orthogonal test and a fuzzy evaluation method, and the accurate and reliable optimal process can be screened out by the result obtained by the fuzzy evaluation of a multi-factor horizontal test set by the orthogonal test.
2. Single factor test
2.1 Diluent screening
The dry paste powder in example 1 is bitter and astringent, so a diluent is required to be added to mask bitter taste and improve granulation and tabletting effects, and the influence of auxiliary materials such as microcrystalline cellulose, starch, dextrin, maltodextrin, powdered sugar, lactose and the like on granulation, tabletting and taste is mainly considered, wherein the addition amount accounts for 30% of the total weight.
Table 1 filler investigation
Figure BDA0002303030890000061
According to the results of diluent investigation in table 1, and the combination of the tissue morphology of the chewable tablet, the granulation and tabletting effects of the microcrystalline cellulose are the best, the chewing feeling of the product is good, the product does not stick to teeth, and the friability is lower than 1%.
2.2 taste-modifying agent screening
After 30% of microcrystalline cellulose is added into the dry paste in the embodiment, the granulation effect and the tabletting effect are good, but the taste is slightly bitter, the best chewing state is not achieved, the chewable tablet with better taste can be obtained under the condition of adding the sweetening agent and the sour agent, the influence of different sweetening agents and sour agents on the taste of the chewable tablet is mainly considered for enabling the chewable tablet to be sour, sweet and delicious, and as a result, the dry paste with better taste is respectively citric acid and stevioside, and the result is shown in table 2.
TABLE 2 taste-modifying agent screening
Figure BDA0002303030890000062
Figure BDA0002303030890000071
2.3 Lubricant screening
The proper amount of lubricant is added into the granulated particles, so that the appearance of the chewable tablet is smooth and complete, and the talc powder, the magnesium stearate and the silicon dioxide are mainly considered, and as a result, the effect of the magnesium stearate is optimal.
3. Design of orthogonal experiments
On the basis of a single-factor test, the influence of the addition amounts of stevioside, citric acid, microcrystalline cellulose and magnesium stearate relative to dry paste powder on the sensory evaluation of the chewable tablets is respectively considered, and the levels of all factors are shown in table 3.
TABLE 3 levels of orthogonal experimental factors
Figure BDA0002303030890000072
4. Fuzzy mathematic model building
4.1 evaluation personnel selection and evaluation method
10 food professionals, 5 men and 5 women and the panelists are healthy, have no bad hobbies such as alcohol addiction, tobacco addiction and the like, can independently evaluate and analyze the sensory indexes of the chewable tablets, and give reasonable scores according to different formulas of the chewable tablets.
4.2 sensory evaluation criteria
According to the characteristics of the product, the sensory evaluation standard of the product is determined to be composed of four factors of color, texture, mouthfeel and chewiness, namely X ═ color, texture, mouthfeel and chewiness.
Panelists gave scores for chewable tablets of different formulations according to established sensory evaluation criteria, see table 4 for reference.
TABLE 4 sensory evaluation criteria
Figure BDA0002303030890000081
4.3 determination of the weighting coefficients
The product determines the color, the form, the tissue structure and the taste and smell as main sensory evaluation indexes, the weight distribution scheme aims to reflect the importance reaction degree of four factors, and when the sensory evaluation is carried out on the taste-comfortable chewable tablet, the weight of the color, the form, the tissue structure and the taste and smell is determined by adopting a forced decision method and a binary comparison decision method. Selecting 10 panelists in different age groups, comparing the factors of the flavor-soothing chewable tablets in evaluation one by one, wherein the important factor is 1 point, the secondary factor is 0 point, the self comparison is 1 point, and the weight distribution is shown in table 5.
TABLE 5 sensory evaluation weight distribution
Figure BDA0002303030890000091
The total score of 10 members was 100, the specific gravity of the four evaluation factors and the total score was the weight, the weight of each factor was represented by the letter K, and K ═ K (K) was calculated1,K2,K3,K4)=(0.15,0.20,0.35,0.30)
5. Results and analysis
5.1 establishing fuzzy comprehensive evaluation mathematic model
5.1.2 establishing a fuzzy evaluation matrix
According to the orthogonality test Table L9(34) The middle combination is tested to prepare 9 groups of flavor-soothing chewable tablet samples, 10 panelists respectively score the color, the tissue form, the mouthfeel and the chewiness of the chewable tablets, and the evaluation results are shown in table 6.
TABLE 6 sensory evaluation results of different formulations
Figure BDA0002303030890000092
Figure BDA0002303030890000101
Dividing the data of 9 groups of experiments by 10 people to obtain 9 fuzzy evaluation matrixes which respectively correspond to No. 1-9 experiments, wherein for example, the fuzzy matrix of the No. 1 sample is as follows:
Figure BDA0002303030890000102
the same can be obtained:
Figure BDA0002303030890000103
according to the fuzzy change principle, fuzzy calculation is carried out on data in the matrix by using a membership function, and the comprehensive membership degree Y of each sample to evaluation factors is calculated to be K multiplied by R, such as:
Figure BDA0002303030890000104
the same can be obtained:
Y2=(0.375,0.33,0.225,0.07),Y3=(0.24,0.225,0.22,0.315),
Y4=(0.495,0.27,0.235,0),Y5=(0.675,0.225,0.1,0),
Y6=(0.265,0.295,0.41,0.03);Y7=(0.285,0.315,0.315,0.085)
Y8=(0.31,0.29,0.335,0.065),Y9=(0.175,0.22,0.33,0.275)。
5.1.3 fuzzy evaluation Total score calculation
The four evaluation grades of excellence, goodness, middle and difference of each factor correspond to scores of 90, 80, 70 and 60. And multiplying the comprehensive evaluation results by corresponding scores respectively and adding the scores to obtain the final total score of each sample. Such as: the final sensory score of sample No. 1 was 0.13 × 90+0.14 × 80+0.385 × 70+0.345 × 60 and 70.55 ═ g
The calculation methods of nos. 2 to 9 are the same, and the results of orthogonality are shown in table 7.
TABLE 7 results of comprehensive evaluation of orthogonal test
Figure BDA0002303030890000111
The experiment adopts a range analysis method, the range reflects the influence degree of each factor on the sensory evaluation of the chewable tablets, and the influence factors are citric acid > stevioside > microcrystalline cellulose > magnesium stearate in the range of the magnitude, and the optimal combination is A2B2C3D2, namely 2% of citric acid, 1% of stevioside, 40% of microcrystalline cellulose and 1% of magnesium stearate are added.
5.2 validation test
Three sets of validation tests were performed on combination number A2B2C3D2 according to the above test procedure, in combination with the fuzzy evaluation test and orthogonal test results, and scored, the results are shown in table 8.
Table 8 shows the results of the test
Figure BDA0002303030890000121
Therefore, the screening result according to the test scheme is used as the preparation scheme of the product, the process is stable and reliable, and the scale-up production can be realized.
Example 2 digestion promoting function human eating trial
Mixing the dry extract powder prepared in the example 1 with 2% of citric acid, 1% of stevioside and 40% of microcrystalline cellulose, wherein the citric acid needs to be crushed, and sieving the crushed citric acid by a 80-mesh sieve. Making soft material with 90% ethanol, granulating with 16 mesh sieve, drying, grading, adding 1% magnesium stearate into the obtained granules, mixing, and tabletting to obtain the chewable tablet.
1. General conditions
The sample prepared in example 2 was used as a test substance to conduct a human feeding test. The test subjects were included in 112 cases, and were randomly divided into a test diet group and a control group, and 3 cases of the test diet group and 3 cases of the control group were excluded during the test, 106 cases of the actual test subjects, 53 cases of the test diet group, and 53 cases of the control group. See table 9 for details.
TABLE 9 comparison of age, sex, course of disease and clinical symptom balance in the two groups before eating trial
Figure BDA0002303030890000122
Figure BDA0002303030890000123
Comparison between pre-treatment groups P >0.05
As can be seen from Table 9, the age, sex, course and clinical symptoms of the pre-test groups were not significantly different from those of the control group (P > 0.05). The results show that the age, sex, course and clinical symptoms of the two groups before eating the test are balanced and comparable.
The subjects were asked to investigate their mental, sleep, diet and urine conditions, and counted on a good, normal and differential scale, and their blood pressure and heart rate were measured, the results are shown in Table 10.
TABLE 10 comparison of general conditions of two groups before and after test
Figure BDA0002303030890000131
Figure BDA0002303030890000132
As can be seen from Table 10, most subjects had good general condition, and before and after the test, the subjects had normal mental, sleep, diet and urination. Compared with the two groups of subjects before and after the test eating, all index differences have no significance (P is more than 0.05), which shows that the chewable tablets have no adverse effect on the general condition of the human body after the test eating.
2. Safety index observation
2.1 routine changes of blood, urine and feces before and after eating test
TABLE 11 routine changes of blood, urine and feces before and after eating test
Figure BDA0002303030890000133
Figure BDA0002303030890000134
Figure BDA0002303030890000141
From table 11, it can be seen that the blood routine of the two groups of subjects is in the normal range, and the comparison difference between the two groups before and after the test feeding is not significant (P > 0.05); the two groups of subjects had normal urine and normal stool before and after the routine test.
2.2 Biochemical indicators of blood and changes of liver and kidney function before and after eating
TABLE 12 Change in Biochemical index of blood before and after eating trial
Figure BDA0002303030890000142
Figure BDA0002303030890000143
Table 12 shows that the blood biochemical indicators for both groups of subjects were within the normal range; and the comparison difference between the two groups before and after the test feeding is not significant (P is more than 0.05). The results show that the product prepared by the invention has no adverse effect on the physical health of the testee.
2.3 chest X-ray, electrocardiogram and B-ultrasonic examination of abdomen
The chest X-ray, electrocardiogram and B-ultrasonic examination of abdomen of the subject are all within normal range.
3. Observation of efficacy index
3.1 comparison of the degree of gastrointestinal symptoms in the two groups before tasting
TABLE 13 comparison of degree of gastrointestinal symptoms in the pre-test group with the control group
Figure BDA0002303030890000151
() Internal control group data
As can be seen from Table 13, there was no significant difference in the degree of gastrointestinal symptoms between the pre-test group and the control group (P > 0.05).
3.2 improvement of gastrointestinal symptoms after eating trial
TABLE 14 comparison of gastrointestinal symptom levels in the post-test group and the control group
Figure BDA0002303030890000152
() Internal control group data
TABLE 15 improvement of gastrointestinal symptoms after test feeding
Figure BDA0002303030890000153
Figure BDA0002303030890000161
() Internal control group data
As can be seen from Table 15, the improvement of abdominal pain, belching, acid regurgitation, abdominal distention, appetite, diarrhea or constipation after eating the trial group was significantly different from that of the control group (P < 0.001).
3.3 score statistics of clinical symptoms before and after the test
TABLE 16 statistics of the integral of clinical symptoms of two groups before and after a test meal
Figure BDA0002303030890000162
Figure BDA0002303030890000163
Self-comparison ## P <0.001, and inter-comparison ## P <0.001
As can be seen from Table 16, the clinical symptom scores of the two groups before test feeding have no significant difference, the clinical symptom scores of the test feeding group after the test feeding are obviously lower than those of the control group, and the difference is significant (P is less than 0.001); compared with the test group, the clinical symptom score after the test feeding is significantly different from that before the test feeding (P is less than 0.001).
3.4 Change in gastric/intestinal motility before and after eating trial
The evacuation rate of 20 barium bars from the stomach at 3 hours was used as an index reflecting the gastric/intestinal motility of the subjects. The results of the gastric emptying tests before and after the test are shown in Table 17.
TABLE 17 gastric emptying before and after test feedingResults of rate measurement
Figure BDA0002303030890000164
Figure BDA0002303030890000165
Self-comparison # P <0.001, inter-comparison # P <0.01
As can be seen from Table 17, there was no significant difference in gastric emptying rate between the two groups before the test feeding, and the gastric emptying rate after the test feeding was significantly greater than that of the control group, and the difference was significant (P < 0.01); compared with the test-feeding group, the gastric emptying rate after test feeding is obviously greater than the difference before test feeding, and the difference is significant (P is less than 0.001).
4. Loss rate of subject
The test subjects comprise 112 cases, 56 cases of test food groups and 56 cases of control groups, 3 cases of test food groups and 3 cases of control groups are not reviewed at the specified time, the test food groups meet the exclusion standard of the subjects, and 53 cases of effective test food groups and 53 cases of control groups of the subjects. The loss rates of the subjects in the test group and the control group are 5.4 percent and 5.4 percent respectively.
5. Observation of adverse reactions
No allergy and other adverse reactions are seen.
TABLE 18 post-test two groups had allergies and other adverse reactions during the test period
Figure BDA0002303030890000171
According to the judgment standard of the human body eating trial test for promoting the digestion function in the technical Specification for health food inspection and evaluation (2003 edition), the result shows that the chewable tablet of the invention has the digestion promoting function.
Finally, it should be noted that: it should be understood that the above examples are only for clearly illustrating the present invention and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications of the invention may be made without departing from the scope of the invention.

Claims (10)

1. A composition having digestion promoting function, wherein the composition comprises by weight: 1-10 parts of hawthorn, 1-15 parts of malt, 1-10 parts of bighead atractylodes rhizome, 1-15 parts of dried orange peel and 1-10 parts of radix pseudostellariae.
2. The composition as claimed in claim 1, wherein said composition comprises: 3-7 parts of hawthorn, 3-7 parts of malt, 3-7 parts of bighead atractylodes rhizome, 1-5 parts of dried orange peel and 1-5 parts of radix pseudostellariae.
3. The composition of claim 1, wherein the traditional Chinese medicine composition comprises, by weight: 5 parts of hawthorn, 5 parts of malt, 5 parts of bighead atractylodes rhizome, 2 parts of dried orange peel and 2 parts of radix pseudostellariae.
4. Use of the composition of any one of claims 1 to 3 for the preparation of a medicament, health product or food having digestive function promoting effect.
5. A pharmaceutical, nutraceutical or food product comprising a composition according to any of claims 1 to 3.
6. The drug, health product or food according to claim 5, wherein the adjuvant in the drug, health product or food comprises sucrose, mannitol, sorbitol, dextrin, magnesium stearate, lactose, microcrystalline cellulose, starch, white granulated sugar, xylitol, sucralose, or stevioside.
7. The drug, health product or food of claim 5, wherein the excipient is selected from the group consisting of microcrystalline cellulose, stevioside, citric acid and magnesium stearate.
8. The medicine, health product or food according to claim 7, wherein the weight ratio of the composition, the microcrystalline cellulose, the stevioside, the citric acid and the magnesium stearate is preferably 50-70: 10-50: 0.5-2: 1-5: 0.5 to 2, more preferably 56 or 40: 1: 2: 1.
9. a process for preparing a composition as claimed in any one of claims 1 to 3, wherein the hawthorn fruit, malt, white atractylodes rhizome, dried orange peel and pseudostellaria root are decocted in water for extraction, filtered and the concentrated solution is spray dried.
10. The preparation method of the medicine, the health-care product or the food is characterized in that when the medicine, the health-care product or the food is a tablet, the preparation method comprises the following steps:
weighing 5 parts of hawthorn, 5 parts of malt, 5 parts of bighead atractylodes rhizome, 2 parts of radix pseudostellariae and 2 parts of dried orange peel according to the formula, adding 10 times of water, decocting and extracting for 2 times, each time for 1 hour, filtering, combining extracting solutions, concentrating under reduced pressure at 70 +/-5 ℃, concentrating to relative density of 1.8-1.12 at 60 +/-5 ℃, spray drying, crushing spray-dried powder, and sieving by a 80-mesh sieve to obtain dry paste powder;
mixing the dry extract powder with 2% citric acid, 1% stevioside and 40% microcrystalline cellulose, making soft mass with 90% ethanol, granulating with 16 mesh sieve, drying, grading, adding 1% magnesium stearate into the obtained granule, mixing, and tabletting.
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