CN114053342A - Composition for promoting defecation and application thereof - Google Patents

Composition for promoting defecation and application thereof Download PDF

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Publication number
CN114053342A
CN114053342A CN202010774369.3A CN202010774369A CN114053342A CN 114053342 A CN114053342 A CN 114053342A CN 202010774369 A CN202010774369 A CN 202010774369A CN 114053342 A CN114053342 A CN 114053342A
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Prior art keywords
culture
lactic acid
composition
extract
bacterial strain
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Chinese (zh)
Inventor
何协勋
陈敬伟
郭易纬
黄玉芬
林钲棋
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Jinqiao Biotechnology Co ltd
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Glac Biotech Co Ltd
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    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/72Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
    • A61K36/725Ziziphus, e.g. jujube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • A61K35/741Probiotics
    • A61K35/744Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/745Bifidobacteria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • A61K35/741Probiotics
    • A61K35/744Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747Lactobacilli, e.g. L. acidophilus or L. brevis
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/482Cassia, e.g. golden shower tree
    • AHUMAN NECESSITIES
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/62Nymphaeaceae (Water-lily family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10Laxatives

Abstract

The present invention relates to a composition for promoting defecation and its application. The invention discloses a composition for promoting defecation, which comprises a dateplum persimmon extract, a cassia seed extract, a lotus leaf extract and a culture of a lactic acid bacteria strain, wherein the lactic acid bacteria strain is selected from the group consisting of: lactobacillus salivarius subspecies salicin AP-32(CCTCC M2011127), Bifidobacterium animalis subspecies lactis CP-9(CCTCC M2014588), Lactobacillus acidophilus TYCA06(CGMCC NO.15210), and combinations thereof, and the culture is substantially free of thalli. The invention also discloses a culture of the lactobacillus strain and the application of the composition in promoting defecation and treating and/or preventing constipation.

Description

Composition for promoting defecation and application thereof
Technical Field
The present invention relates to a composition for promoting defecation and use thereof.
Background
Constipation (constipation) is a symptom that stool stays in the large intestine for a long time due to the functional disorder of gastrointestinal motility (gastrointestinal motility), and water contained in the stool is absorbed to be dry and hard, thereby causing reduction in the number of times or amount of defecation, difficulty in defecation, or abdominal distension and pain. In addition, food ingested by the human body is easily decomposed by bacterial fermentation in the intestinal tract to produce toxic substances (e.g., aldehydes, ketones, ammonia, etc.), and when these toxic substances are not normally excreted, they are reabsorbed by the intestinal tract and enter the blood circulation, thereby causing various metabolic diseases (metabolic diseases).
The cause of constipation has a high correlation with dietary habits, and for example, insufficient intake of dietary fiber (dietary fiber) and water, lack of exercise, pregnancy, stress, anxiety, and irregular life may cause constipation. In addition, drugs such as analgesics (analgesic), diuretics (diuretics), antidepressants (anti-depressants) or hypotensive agents (hypotensive agents) may also cause constipation side effects (side effects) in patients.
The current methods for improving constipation mainly adjust diet and daily work and rest, for example, increase the intake of dietary fiber and water and proper exercise. When the above methods fail to achieve the desired effect, they are often used in combination with drugs such as cathartics (cathartics) or faecal agents (faecal agents). Although these drugs exert their therapeutic effects immediately, they tend to cause serious side effects in patients [ such as intestinal colic (intestinal colic), impairment of the enteric nervous system (enteric nervous system) ]. Therefore, related researchers in the field have attempted to find active components (active components) from natural sources (natural sources) that are available for treating constipation.
Related researchers have taken extracts from Chinese herbs such as black date, cassia seed, lotus leaf powder, hawthorn, plum, etc. or lactic acid bacteria such as Lactobacillus (Lactobacillus), Bifidobacterium (Bifidobacterium), etc. to be applied to the treatment of constipation (Jang s.h.et al (2018), Korean j.food & nutr.,31: 640-; and eriini Dimidi et al (2017), adv.nutr.,8: 484-494). However, the Chinese herbal medicines are generally not effective in a short period of time and need to be taken for a relatively long period of time. As for lactic acid bacteria, it is mainly used to colonize the intestinal tract to regulate the intestinal bacterial phase and further improve the intestinal health, but lactic acid bacteria are easily damaged by gastric acid and bile salt after being taken by human body, so that the number of lactic acid bacteria colonized in the intestinal tract is insufficient and the effect cannot be effectively exerted.
Therefore, how to treat constipation quickly and effectively without causing undesirable side effects has become an important research and development issue.
Disclosure of Invention
Accordingly, in a first aspect, the present invention provides a composition for promoting defecation, comprising an extract of dateplum persimmon, an extract of cassia seed, an extract of lotus leaf, and a culture of a lactic acid bacterial strain selected from the group consisting of: lactobacillus salivarius subsp.salicinus AP-32(CCTCC M2011127), Bifidobacterium animalis subsp.lactis CP-9(CCTCC M2014588), Lactobacillus acidophilus (Lactobacillus acidophilus) TYCA06(CGMCC NO.15210), and combinations thereof, and the culture is substantially free of bacterial cells.
The composition comprises 1-20% (w/w) of black date extract, 0.1-10% (w/w) of cassia seed extract, 0.1-10% (w/w) of lotus leaf extract and 1-10% (w/w) of culture of lactobacillus strains, based on the total weight of the composition.
In a second aspect, the present invention provides a food product comprising a composition as described above.
In a third aspect, the present invention provides the use of a supply of a composition as described above for the preparation of a medicament for promoting defecation.
In a fourth aspect, the present invention provides the use of a composition as described above for the preparation of a medicament for the treatment and/or prevention of constipation.
In a fifth aspect, the present invention provides the use of a culture of a lactic acid bacterial strain for the preparation of a medicament for promoting defecation, wherein the lactic acid bacterial strain is a strain selected from the group consisting of: lactobacillus salivarius subspecies salicin AP-32(CCTCC M2011127), Bifidobacterium animalis subspecies lactis CP-9(CCTCC M2014588), Lactobacillus acidophilus TYCA06(CGMCC NO.15210), and combinations thereof, and the culture is substantially free of thalli.
In a sixth aspect, the present invention provides the use of a culture of a lactic acid bacterial strain for the preparation of a medicament for the treatment and/or prevention of constipation, wherein the lactic acid bacterial strain is a strain selected from the group consisting of: lactobacillus salivarius subspecies salicin AP-32(CCTCC M2011127), Bifidobacterium animalis subspecies lactis CP-9(CCTCC M2014588), Lactobacillus acidophilus TYCA06(CGMCC NO.15210), and combinations thereof, and the culture is substantially free of thalli.
In a seventh aspect, the present invention provides a method for promoting defecation, comprising administering to an individual in need thereof a culture or composition of a lactic acid bacterial strain as described above.
In an eighth aspect, the invention provides a method for treating an individual having or suspected of having constipation, comprising administering to the individual a culture or composition of a lactic acid bacterial strain as described above.
The medicine is in a dosage form for oral administration.
Drawings
The above and other objects and features of the present invention will become more apparent by referring to the following description, claims accompanied with text and accompanying drawings, wherein:
figure 1 shows the percentage of people who increased and decreased the number of bowel movements in each group before and after taking the lactic acid bacteria drink of the present invention, wherein "+" indicates that p < 0.01 when compared to the control group; and ". x" indicates that p <0.001 when compared to the control group.
Detailed Description
For the purposes of this specification, it will be clearly understood that: the word "comprising" means "including but not limited to", and the word "comprising" has a corresponding meaning.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Those skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which can be used in the practice of the present invention. Of course, the present invention is in no way limited to the methods and materials described.
In developing a drug useful for treating and/or preventing constipation, the applicant found through experiments that a composition comprising an extract of dateplum persimmon, an extract of cassia seed, an extract of lotus leaf, and a culture of a lactic acid bacterium strain is effective in increasing the number of stools of a subject in a short time, and thus is expected to have the potential of promoting defecation (defecation) and treating and/or preventing constipation (constipation).
Accordingly, the present invention provides a composition for promoting defecation, comprising an extract of dateplum persimmon, an extract of cassia seed, an extract of lotus leaf, and a culture of a lactic acid bacterial strain selected from the group consisting of: lactobacillus salivarius subsp.salicinus AP-32(CCTCC M2011127), Bifidobacterium animalis subsp.lactis CP-9(CCTCC M2014588), Lactobacillus acidophilus (Lactobacillus acidophilus) TYCA06(CGMCC NO.15210), and combinations thereof, and the culture is substantially free of bacterial cells.
Preferably, the composition comprises, based on the total weight of the composition: 1-20% (w/w) of black date extract; 0.1-10% (w/w) of semen Cassiae extract; 0.1-10% (w/w) of lotus leaf extract; and 1-10% (w/w) of a culture of a lactic acid bacterial strain.
More preferably, the composition comprises, based on the total weight of the composition: 1-10% (w/w) of black date extract; 0.1-1% (w/w) of semen Cassiae extract; 0.1-1% (w/w) of lotus leaf extract; and 1-10% (w/w) of a culture of a lactic acid bacterial strain.
According to the invention, the extraction process of the black date extract can be carried out using a solvent selected from the group consisting of: water, methanol, ethanol, ethyl acetate, and combinations thereof. In a preferred embodiment of the present invention, the black date extract is prepared by extracting black dates (black dates) using water.
According to the present invention, the extraction process of the cassia seed extract can be carried out using a solvent selected from the group consisting of: water, methanol, ethanol, ethyl acetate, and combinations thereof. In a preferred embodiment of the present invention, the cassia seed extract is prepared by extracting cassia seed (cassia seed) with water.
According to the invention, the extraction process of the lotus leaf extract can be carried out using a solvent selected from the group consisting of: water, methanol, ethanol, ethyl acetate, and combinations thereof. In a preferred embodiment of the invention, the lotus leaf extract is prepared by extracting lotus leaves (lotus leaves) with water.
It can be understood that the operating conditions related to the above extraction method will further vary depending on the treatment method of the Chinese herbal medicine used, the dosage ratio of the Chinese herbal medicine, and other factors, so as to achieve the best extraction effect. The choice of these operating conditions is within the routine discretion of the skilled person.
In addition, the compositions according to the present invention may further comprise other additional extracts, including, but not limited to: plum extract, hawthorn extract, kiwi extract, sweet potato extract, and apple extract.
According to the invention, the culture of the lactic acid bacterial strain is obtained by culturing Lactobacillus salivarius subspecies salicin AP-32(CCTCC M2011127), Bifidobacterium animalis subspecies Lactobacillus lactis CP-9(CCTCC M2014588) and Lactobacillus acidophilus TYCA06(CGMCC NO.15210) in a liquid medium suitable for the growth of these strains, followed by the removal of the bacterial bodies using a separation treatment.
As used herein, the terms "culturing", "fermentation" and "cultivation" are used interchangeably.
Liquid media suitable for culturing these strains according to the present invention are well known to those skilled in the art and include, but are not limited to: MRS broth (MRS broth).
According to the present invention, the liquid medium suitable for use in the present invention comprises a carbon source selected from the group consisting of: glucose (glucose), fructose (fructose), lactose (lactose), sucrose (sucrose), maltose (maltose), galactose (galactose), mannose (mannose), trehalose (trehalase), starch (starch), molasses (molasses), potato starch (potatoto starch), corn starch (corn starch), malt extract (maltextract), maltodextrin (maltdextrin), and combinations thereof.
According to the invention, the liquid medium suitable for use in the invention comprises a nitrogen source selected from the group consisting of: (NH4)2SO4、(NH4)3PO4、NH4NO3、NH4Cl, casamino acids (casamino acids), urea (urea), peptones (peptones), polypeptones (polypeptones), tryptones (tryptones), meat extracts (meat extracts), yeast extracts (yeast extracts), yeast powders (yeast powder), milk powder, soy flour (soybean flours) or other legume products, whey, and combinations thereof. Preferably, the nitrogen source comprises milk, milk powder, casein, soybean powder and legumes.
The procedures and parameters concerning the cultivation, and the like, are within the scope of professional literacy and routine skill of those skilled in the art. In this regard, reference may be made, for example, to Hsieh P.S.et al. (2013), New Microbiol.,36: 167-.
According to the invention, the cultivation is carried out at a temperature falling within the range of 30 ℃ to 40 ℃.
According to the invention, the cultivation is carried out for a period of time falling within the range of 12 to 24 hours.
According to the present invention, the separation treatment can be carried out by a technique known and used by those skilled in the art so that the culture is substantially free of bacterial cells, and includes, but is not limited to: filtration (filtration), centrifugation (centrifugation), and concentration (concentration), and combinations thereof.
As used herein, the term "substantially free" means that the specifically identified component lacks a significant amount. Preferably, the content of the component has no measurable effect on the properties of the culture (measureable effect). More preferably, the culture is completely free of the component.
According to the invention, the culture is further subjected to a drying treatment to obtain a product in the form of a powder. The drying process may be carried out using techniques well known and customary to those skilled in the art, including, but not limited to: freeze-drying (lyophilization) process, low temperature spray-drying (low temperature spray-drying) process, vacuum evaporation (vacuum evaporation) process, and combinations thereof.
According to the present invention, the composition may be added to edible material (edible material) using standard techniques well known to those skilled in the art, for example, it may be added directly to the edible material, or it may be used to prepare an intermediate composition (premix) such as premix, which is then added to the edible material.
In addition, the composition according to the present invention may further comprise a food additive (food additive) selected from the group consisting of: sorbitol (sorbitol), lactitol (lactitol), lactose (lactise), lactic acid (lactic acid), acesulfame potassium (acesulfame potassium), sucralose (sucralose), and combinations thereof.
Accordingly, the present invention also provides a food product comprising a composition as described above.
According to the present invention, the food product categories include, but are not limited to: milk powder (milk powder), fermented milk (fermented milk), yogurt (yogurt), cheese (butter), beverages (beverages) (e.g., tea, coffee), functional beverages (functional beverages), pasta (flow product), baked foods (baker's), desserts (confectionery), candies (confections), fermented foods (fermented foods), animal feeds (animal feeds), health foods (health foods), and dietary supplements (dietary supplements).
The culture of the lactic acid bacterial strain and the composition according to the present invention were confirmed to be effective in increasing the number of stools through in vivo experiments. Accordingly, the culture of the lactic acid bacterium strain and the composition according to the present invention are expected to have the effect of promoting defecation, and thus can be supplied for use in the preparation of a medicament for promoting defecation.
According to the present invention, the pharmaceutical can be manufactured into a dosage form (nasal form) suitable for oral administration (oral administration) by using techniques well known to those skilled in the art, which include, but are not limited to: sterile powders (shelf powder), lozenges (tablet), tablets (troche), buccal tablets (Lozenge), pills (pellet), capsules (capsule), dispersible powders (dispersible granules) or granules (granules), solutions, suspensions (suspension), emulsions (emulsion), syrups (syrup), elixirs (elixir), syrups (syrup) and the like.
According to the present invention, the pharmaceutical may further comprise a pharmaceutically acceptable carrier (pharmaceutically acceptable carrier) which is widely used in pharmaceutical manufacturing technology. For example, the pharmaceutically acceptable carrier may comprise one or more agents selected from the group consisting of: solvents (solvents), buffers (buffers), emulsifiers (emulsifiers), suspending agents (suspending agents), disintegrating agents (disintegrants), disintegrating agents (disintegrating agents), dispersing agents (dispersing agents), binding agents (binding agents), excipients (excipients), stabilizers (stabilizing agents), chelating agents (chelating agents), diluents (diluents), gelling agents (gelling agents), preservatives (preserving agents) [ e.g. potassium hexadienate ], wetting agents (wetting agents), lubricants (lubricants), absorption delaying agents (absorbing delaying agents), liposomes (lipids), and the like. The selection and amounts of such agents are within the skill and routine skill of those in the art.
The present invention also provides a method for promoting defecation, comprising administering to an individual in need thereof a culture or composition of a lactic acid bacterial strain as described above.
As used herein, the terms "administration" and "administration" are used interchangeably.
According to the invention, the dosage and frequency of administration of the culture of the lactic acid bacterial strain and the composition may vary depending on the following factors: the severity of the disease to be ameliorated, the route of administration, and the weight, age, condition and response of the individual to be ameliorated. Selection of dosages and times for administration is well within the skill and routine skill of those in the art.
The invention also provides the application of the culture and the composition of the lactobacillus strain in preparing medicines for treating and/or preventing constipation. Furthermore, the present invention also provides a method for treating an individual having or suspected of having constipation comprising administering to the individual a culture or composition of a lactic acid bacterial strain as described above.
As used herein, the term "treating" or "treatment" of constipation means that the severity of the constipation (severity) or symptoms of the constipation (symptom) is reduced (reduced), or the constipation is partially (parallel) or completely (incident) eliminated (affected).
As used herein, the terms "preventing" or "prevention" of constipation means eliminating (eliminite) or reducing (reduce) the incidence (incidence) of the constipation, and slowing (slow), delaying (delay), controlling (control) or reducing (clear) the likelihood (likelihood) or probability (probability) of the constipation, when an individual has not been diagnosed with the constipation.
According to the present invention, the culture of the lactic acid bacterial strain and the administration form, administration route and pharmaceutically acceptable carrier for use of the composition are as described above.
The invention will be further described with respect to the following examples, but it should be understood that the examples are for illustration only and should not be construed as limiting the practice of the invention.
< example >
General experimental materials:
1. lactobacillus salivarius subsp. sp.salicinus AP-32, Bifidobacterium animalis subsp.lactis CP-9, and Lactobacillus acidophilus (Lactobacillus acidophilus) TYCA06 used in this example have been deposited respectively at the biological resource preservation and Research Center (Bioresource Collection and Research Center, BCRC) of Food Industry Development Institute (Food Industry Research and Development Institute, FIRDI) in taiwan (300 new bamboo Food road No. 331, taiwan), the common microbial Center of the microbial species management society of China (ceramic biological Culture Collection Center, cc), and the Collection Center of typical Culture Collection (ccttype Collection), and are available. For clarity, information on the respective strains of lactic acid bacteria (including accession numbers and accession dates, etc.) is shown in Table 1 below.
TABLE 1 accession number and accession date of the respective strains of lactic acid bacteria
Figure BDA0002617845730000091
2. The Lactobacillus salivarius subspecies Salicariin L-333 and Lactobacillus acidophilus L-6 used in this example were isolated by the applicant from the intestinal tract of healthy humans, and the Bifidobacterium animalis subspecies Lactobacillus L-53 was isolated by the applicant from the breast milk of healthy humans.
3. The components of the extract used in this example and their sources have been integrated in table 2 below.
TABLE 2 components of the extract and their sources
Components Source
Black date extract (product name is black date extract) Hippodamia Biotech Co Ltd
Cassia seed extract Light products Co Ltd
Lotus leaf extract Xinle kang Co., Ltd
4. The types and sources of dietary supplements used in this example are integrated in Table 3 below.
TABLE 3 type and Source of dietary supplement
Figure BDA0002617845730000101
Example 1 preparation of the cultured product of lactic acid bacteria of the present invention
First, 6 lactobacillus strains described in items 1 and 2 above were inoculated into MRS medium (purchased from shin-biosciences, Inc.) respectively and cultured at 30-40 ℃ for 12-24 hours, and the resulting culture was used as an inoculum (inoculum). Then, each inoculum source was inoculated into MRS medium separately and cultured at 30-40 ℃ for 12-24 hours. Thereafter, the cells were precipitated by centrifugation, and the supernatant was collected and subjected to heat sterilization treatment. Subsequently, the obtained filtrate containing no cell bodies was subjected to spray-drying treatment (spray-drying treatment), thereby obtaining each of the cultured lactic acid bacteria products.
In a preliminary test, the applicant mixed each lactic acid bacteria culture with maltodextrin (maltodextrin) to prepare capsules containing different cultures and then allowed the subjects to take these capsules 3 times a day for a total of 1 month. During the last week of the dosing period, it was found by recording the number of bowel movements of the subject: the culture products of Lactobacillus salivarius subspecies salicin AP-32(CCTCC M2011127), Bifidobacterium animalis subspecies Lactobacillus lactis CP-9(CCTCC M2014588) and Lactobacillus acidophilus TYCA06(CGMCC NO.15210) have better defecation-promoting effect (data not shown). Therefore, the applicant selected these 3 lactic acid bacteria culture products to perform the following experiments.
Example 2 preparation of a lactic acid bacteria beverage according to the invention
The experimental method comprises the following steps:
first, the extract according to item 3 of the above "experimental material" and the dietary supplement according to item 4 were prepared into a control drink containing no cultured product of lactic acid bacteria according to the following table 4.
TABLE 4 formulation of control drink
Figure BDA0002617845730000111
Next, 3 lactic acid bacteria beverages were formulated, substantially in reference to the formulation of the control beverage above, except that: these 3 lactic acid bacteria drinks were additionally supplemented with the lactic acid bacteria culture product obtained according to example 1 above, as shown in table 5 below.
TABLE 5 Lactobacillus culture products contained in different Lactobacillus drinks
Figure BDA0002617845730000112
Example 3 evaluation of the effectiveness of the lactic acid bacteria drink of the present invention in promoting defecation
Experimental subjects:
the subjects participating in the test were employees from toyowa biotechnology, ltd, and after screening with the exclusion criteria (exclusion criteria) shown in table 6 below, the test consisted of 36 subjects aged 25 to 50 years, including 13 males and 23 females.
TABLE 6 exclusion criteria for screening of experimental individuals
Order of item Description of the invention
1 Pregnant woman
2 Lactating women
3 Smoker's mouth
4 Abuse or addiction to alcohol, drugs
The experimental method comprises the following steps:
first, before all subjects were tested, their number of bowel movements within 24 hours was recorded. Next, all subjects were randomly divided into 4 groups (each group n-9) including 3 experimental groups (i.e., experimental groups 1 to 3) and 1 control group, wherein subjects in experimental groups 1 to 3 were administered 50mL of lactic acid bacteria drinks 1 to 3, respectively, and subjects in the control group were administered 50mL of control drinks. Within 24 hours after administration, their number of stools was recorded. The above experiment was repeated 3 times, each time interval was 1 week, and each subject was assigned to different groups in turn in different experiments, so as to avoid the influence of individual differences of the subjects on the experiment results.
Then, the percentage (%) of the number of the persons who increased and decreased the number of the stools in each group was calculated according to the change of the number of the stools recorded before and after the administration of all the subjects.
The experimental data obtained are expressed as "standard error of the mean (SEM)" as the mean ± the standard error of the mean. All data were analyzed by two-tailed Steed Student's t-test to assess variability between groups. If the statistical analysis result obtained is p < 0.05, it indicates statistical significance (statistical significance).
As a result:
FIG. 1 shows the percentage of people who increased or decreased the number of stools for each group before and after taking the medicine. As can be seen from FIG. 1, the percentage of the population in each experimental group was significantly higher than that in the control group, with the increase being most significant in experimental group 3. The percentage of the population in the control group was significantly higher than that in each of the experimental groups, as far as the number of people who had a decreased number of stools was concerned. The results of this experiment show that: the effect of the combination of any one of the culture products of the subspecies salicylide AP-32(CCTCC M2011127), the subspecies lacticum Lactobacillus animalis CP-9(CCTCC M2014588) and the Lactobacillus acidophilus TYCA06(CGMCC NO.15210) and the three extracts of the dateplum persimmon extract, the cassia seed extract and the lotus leaf extract on the defecation promotion is obviously better than the effect of the combination only containing the three extracts. In particular, a change in the number of stools was observed after one day of administration. Therefore, these lactic acid bacteria culture products and extracts are expected to be used in combination to effectively promote defecation and treat and/or prevent constipation (constipation).
All patents and publications cited in this specification are herein incorporated by reference in their entirety. In conflict, the present specification, including definitions, will control.
While the invention has been described with reference to the specific embodiments described above, it will be apparent that numerous modifications and variations can be made without departing from the scope and spirit of the invention. It is therefore intended that the invention be limited only as indicated by the claims appended hereto.
Biological material preservation information description
The preservation number is: CCTCC NO: m2011127
And (3) classification and naming: lactobacillus salivarius subsp.salicinus (AP-32)
The preservation date is as follows: 2011 4 months and 10 days
The preservation unit: china center for type culture Collection
The address of the depository: chinese Wuhan dynasty
The preservation number is: CCTCC NO: m2014588
And (3) classification and naming: bifidobacterium animalis subsp.lactis CP-9
The preservation date is as follows: 11/24/2014
The preservation unit: china center for type culture Collection
The address of the depository: chinese Wuhan dynasty
The preservation number is: CGMCC No.15210
And (3) classification and naming: lactobacillus acidophilus (Lactobacillus acidophilus) TYCA06
The preservation date is as follows: 15/1/2018
The preservation unit: china general microbiological culture Collection center
The address of the depository: chinese Beijing

Claims (8)

1. A composition for promoting defecation, characterized by: the composition comprises:
black date extract;
a cassia seed extract;
a lotus leaf extract; and
a culture of a lactic acid bacterial strain, wherein said lactic acid bacterial strain is selected from the group consisting of: lactobacillus salivarius subsp.salicinus AP-32(CCTCC M2011127), Bifidobacterium animalis subsp.lactis CP-9(CCTCC M2014588), Lactobacillus acidophilus (Lactobacillus acidophilus) TYCA06(CGMCC NO.15210), and combinations thereof, and the culture is substantially free of bacterial cells.
2. The composition of claim 1, wherein: the composition comprises, based on the total weight of the composition:
1-20% (w/w) of black date extract;
0.1-10% (w/w) of semen Cassiae extract;
0.1-10% (w/w) of lotus leaf extract; and
1-10% (w/w) of a culture of a lactic acid bacterial strain.
3. A food product characterized by: the food product comprising the composition according to any one of claims 1 to 2.
4. Use of a composition according to any one of claims 1 to 2 for the preparation of a medicament for promoting defecation.
5. Use of a composition according to any one of claims 1 to 2 for the preparation of a medicament for the treatment and/or prevention of constipation.
6. Use of a culture supply of a lactic acid bacterial strain for the preparation of a medicament for promoting defecation, characterized in that: the lactic acid bacterial strain is a bacterial strain selected from the group consisting of: lactobacillus salivarius subspecies salicin AP-32(CCTCC M2011127), Bifidobacterium animalis subspecies lactis CP-9(CCTCC M2014588), Lactobacillus acidophilus TYCA06(CGMCC NO.15210), and combinations thereof, and the culture is substantially free of thalli.
7. Use of a culture supply of a lactic acid bacterial strain for the preparation of a medicament for the treatment and/or prevention of constipation, characterized in that: the lactic acid bacterial strain is a bacterial strain selected from the group consisting of: lactobacillus salivarius subspecies salicin AP-32(CCTCC M2011127), Bifidobacterium animalis subspecies lactis CP-9(CCTCC M2014588), Lactobacillus acidophilus TYCA06(CGMCC NO.15210), and combinations thereof, and the culture is substantially free of thalli.
8. Use according to any one of claims 4 to 7, characterized in that: the pharmaceutical is in a dosage form for oral administration.
CN202010774369.3A 2020-08-04 2020-08-04 Composition for promoting defecation and application thereof Pending CN114053342A (en)

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CN202010774369.3A CN114053342A (en) 2020-08-04 2020-08-04 Composition for promoting defecation and application thereof

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CN114053342A true CN114053342A (en) 2022-02-18

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103798392A (en) * 2014-03-07 2014-05-21 内蒙古伊利实业集团股份有限公司 Probiotics food composition with function of relieving inflammation of throat and food
CN105985918A (en) * 2014-10-31 2016-10-05 安徽锦乔生物科技有限公司 Anti-obesity lactic acid bacteria strain and application thereof in food composition and medical composition

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103798392A (en) * 2014-03-07 2014-05-21 内蒙古伊利实业集团股份有限公司 Probiotics food composition with function of relieving inflammation of throat and food
CN105985918A (en) * 2014-10-31 2016-10-05 安徽锦乔生物科技有限公司 Anti-obesity lactic acid bacteria strain and application thereof in food composition and medical composition

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
孙定人等, 天津科技翻译出版公司 *

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