CN112168855B - A composition for preparing intestinal tract and treating constipation - Google Patents

A composition for preparing intestinal tract and treating constipation Download PDF

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Publication number
CN112168855B
CN112168855B CN202010851993.9A CN202010851993A CN112168855B CN 112168855 B CN112168855 B CN 112168855B CN 202010851993 A CN202010851993 A CN 202010851993A CN 112168855 B CN112168855 B CN 112168855B
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composition
sunflower
extract
arabinose
sorbitol
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CN112168855A (en
Inventor
林卫军
石国良
陈旭
王羽娟
洪诗群
蔡许彬
萧舜之
郭志坚
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Thomson Biotech Xiamen Pte Ltd
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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
    • A61K31/732—Pectin
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, 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
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, 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
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Abstract

The present invention relates to a composition for bowel preparation and treatment of constipation. Specifically, the invention provides a composition comprising a sugar alcohol and arabinose. The composition of the present invention has excellent bowel cleansing effect and patient compliance.

Description

A composition for preparing intestinal tract and treating constipation
Technical Field
The invention relates to the field of medicines, in particular to a composition for preparing intestinal tracts and treating constipation.
Background
The intestinal tract preparation methods are different, the effects are different, and the selection of the intestinal tract preparation method with good intestinal tract clearing effect, small side effect and wide application range is very important.
Although a plurality of medicines for preparing the intestinal tract exist in the prior art, such as compound polyethylene glycol electrolyte powder, magnesium sulfate, sodium sulfate, polyethylene glycol and the like, the medicines are often poor in taste and large in dosage, adverse reaction symptoms such as nausea, vomiting, abdominal distension and the like are easy to occur, an intestinal tract cleaning effect is not ideal, the effect of enteroscopy observation cannot be achieved, the repeated intestinal tract preparation process of a patient is caused, the psychology of the intestinal tract preparation before enteroscopy of the patient is influenced, the compliance of the patient is greatly reduced, the preparation effect of a medicament description cannot be achieved, and the medical burden of the enteroscopy can be increased.
Therefore, there is a need in the art to develop a bowel clearing drug with excellent bowel clearing effect and good patient compliance.
Disclosure of Invention
The invention aims to provide a bowel clearing composition containing sugar alcohol and arabinose, which has excellent bowel clearing effect and good patient compliance.
In a first aspect of the invention, there is provided a composition comprising a sugar alcohol and arabinose.
Preferably, the arabinose comprises L-arabinose.
Preferably, the sugar alcohol comprises one or more of sorbitol and mannitol.
Preferably, the weight ratio of sugar alcohol to arabinose is 1:0.5-40, preferably 1:0.5-20, more preferably 1:1-10, more preferably 1:1-8, more preferably 1: 2-6.
Preferably, the composition further comprises sunflower flower extract.
Preferably, the sunflower flower extract is a dry extract.
Preferably, the weight ratio of said sugar alcohol to sunflower extract is 1:0.2-20, preferably 1:0.5-10, more preferably 1:0.8-6, more preferably 1:1-5, more preferably 1: 1-3.
Preferably, the weight ratio of the sugar alcohol to the arabinose to the sunflower flower extract is 1 (1-10): (0.8-6), preferably 1 (1-8): (1-5), more preferably 1 (2-6): (1-3).
Preferably, said sunflower extract is prepared by solvent extraction selected from the group consisting of: water, C1-C4 lower alcohol or C1-C4 lower alcohol aqueous solution.
Preferably, the sunflower flower extract is prepared by the following method:
extracting sunflower with aqueous solution of C1-C4 lower alcohol, filtering, concentrating the filtrate, and drying to obtain the extract.
Preferably, the sunflower flower extract is prepared by the following method:
adding 4-6 times of 70-80% (v/v) ethanol water solution into sunflower, heating and reflux extracting for 6-10 hr, filtering, concentrating the filtrate under reduced pressure, and drying to obtain dry extract, i.e. sunflower extract.
Preferably, the C1-C4 lower alcohol comprises one or more of methanol, ethanol, propanol and butanol.
Preferably, the aqueous solution of C1-C4 lower alcohol is 30-95% (v/v) aqueous ethanol, preferably 50-90% (v/v) aqueous ethanol, more preferably 60-85% (v/v) aqueous ethanol, preferably 70-80% (v/v) aqueous ethanol.
Preferably, the sugar alcohol is present in an amount of 1 to 99 wt%, preferably 10 to 90 wt%, more preferably 20 to 80 wt%, based on the total weight of the composition.
Preferably, the arabinose is present in an amount of 1 to 99 wt%, preferably 10 to 90 wt%, more preferably 20 to 80 wt%, based on the total weight of the composition.
Preferably, said sunflower extract is present in an amount of 1-99 wt%, preferably 10-90 wt%, more preferably 20-80 wt%, based on the total weight of the composition.
Preferably, the composition is a pharmaceutical composition, a food composition or a health care composition.
Preferably, the composition further comprises a pharmaceutically, food or nutraceutical acceptable carrier.
Preferably, the composition is in a solid or liquid form.
Preferably, the composition is in the form of oral preparation or injection preparation.
Preferably, the composition is in the form of tablets, capsules, oral liquid, granules, powder or syrup.
In a second aspect of the invention, there is provided the use of a composition according to the first aspect of the invention for the preparation of a composition for one or more uses selected from the group consisting of: (a) as a laxative; (b) for bowel preparation.
In a third aspect of the invention, there is provided the use of a sunflower flower extract for the preparation of a composition for one or more uses selected from the group consisting of: (i) as a laxative; (ii) for bowel preparation; (iii) it can be used for enhancing excretion and intestinal tract preparation of sugar alcohol and L-arabinose.
It is to be understood that within the scope of the present invention, the above-described features of the present invention and those specifically described below (e.g., in the examples) may be combined with each other to form new or preferred embodiments. Not to be reiterated herein, but to the extent of space.
Detailed Description
The invention finds that the combination of the sorbitol and the L-arabinose, as well as the sorbitol, the L-arabinose and the sunflower flower extract has excellent synergistic effect on promoting excretion and relaxing bowel, thereby being used for treating constipation, playing a role in cathartic and also being used for intestinal tract preparation and intestinal tract related operation (such as high-frequency electrocoagulation and/or high-frequency electrosection) treatment after the intestinal tract preparation.
Term(s) for
As used herein, the terms "comprising," including, "and" containing "are used interchangeably and include not only open-ended definitions, but also semi-closed and closed-ended definitions, and include" consisting of … …, "" consisting essentially of … ….
As used herein, "sunflower" is the flower bud of the plant sunflower of the family asteraceae.
The following description of the exemplary embodiments of the present application, including various details of the embodiments of the present application to assist in understanding, should be taken as exemplary only. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the present application. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.
Composition comprising a metal oxide and a metal oxide
The invention also provides a composition which can be a pharmaceutical composition, a food composition or a health-care product composition.
Typically, the composition comprises a sugar alcohol and arabinose.
The composition also comprises a carrier acceptable in pharmacy, food or health care products.
In the present invention, the pharmaceutically acceptable carrier is not particularly limited, and may be prepared from materials commonly used in the art, or prepared by conventional methods, or commercially available. Examples of the pharmaceutically acceptable carrier moiety are cellulose and its derivatives (e.g., methylcellulose, ethylcellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, etc.), gelatin, talc, solid lubricants (e.g., stearic acid, magnesium stearate), calcium sulfate, vegetable oils (e.g., soybean oil, sesame oil, etc.), polyols (e.g., propylene glycol, glycerin, sorbitol, etc.), emulsifiers (e.g., tween), wetting agents (e.g., sodium laurylsulfate), buffers, chelating agents, thickeners, pH adjusters, transdermal enhancers, colorants, flavors, stabilizers, antioxidants, preservatives, bacteriostats, pyrogen-free water, etc.
In the present invention, the dosage form of the composition is not particularly limited, and is preferably a solid preparation or a liquid preparation.
Preferably, the dosage form of the composition of the present invention is an oral preparation. Typically, the composition is in the form of an oral aqueous solution.
In the composition of the present invention, the amount of arabinose and sugar alcohol is not particularly limited, and preferably, the weight ratio of sugar alcohol and arabinose is 1:0.5-40, preferably 1:0.5-20, more preferably 1:1-10, more preferably 1:1-8, more preferably 1: 2-6.
In a preferred embodiment, the sugar alcohol is present in the composition in an amount of 10 to 90 wt.%, preferably 20 to 80 wt.%, more preferably 30 to 70 wt.%, based on the total weight of the composition.
In a preferred embodiment, the arabinose is present in the composition in an amount of 10 to 90 wt%, preferably 20 to 80 wt%, more preferably 30 to 70 wt%, based on the total weight of the composition.
In another preferred embodiment of the present invention, the composition further comprises sunflower flower extract. Preferably, the sunflower flower extract is dry extract.
Preferably, the weight ratio of said sugar alcohol to sunflower extract is 1:0.2-20, preferably 1:0.5-10, more preferably 1:0.8-6, more preferably 1:1-5, more preferably 1: 1-3.
Preferably, the weight ratio of the sugar alcohol to the arabinose to the sunflower extract is 1 (1-10): (0.8-6), preferably 1 (1-8): (1-5), more preferably 1 (2-6): (1-3).
In the present invention, the sunflower flower extract is preferably an aqueous extract, a C1-C4 lower alcohol extract or a C1-C4 lower alcohol aqueous solution extract.
Typically, the sunflower extract according to the invention is prepared by solvent extraction selected from the group consisting of: water, C1-C4 lower alcohol or C1-C4 lower alcohol aqueous solution.
Preferably, the C1-C4 lower alcohol comprises one or more of methanol, ethanol, propanol and butanol.
Typically, the aqueous solution of C1-C4 lower alcohol is 30-95% (v/v) aqueous ethanol, preferably 50-90% (v/v) aqueous ethanol, more preferably 60-85% (v/v) aqueous ethanol, preferably 70-80% (v/v) aqueous ethanol.
Preferably, in the composition of the present invention, the sunflower flower extract is present in an amount of 1-99 wt%, preferably 10-90 wt%, more preferably 20-80 wt%, based on the total weight of the composition.
The compositions of the present invention may be prepared by methods conventional in the art, for example, by simply mixing the components.
Use of
The present invention provides a use of the composition of the invention for use as a laxative and/or for bowel preparation.
Experiments conducted in the examples of the present invention show that the combination of sorbitol and L-arabinose with sorbitol, L-arabinose and sunflower extract has an excellent synergistic effect in relaxing bowel and, therefore, can be used for facilitating excretion and bowel preparation, as well as for electrocoagulation and/or electrosection after bowel preparation.
The experiment of the embodiment of the invention shows that the sunflower extract has the effect of relaxing bowel, can be used as a cathartic and intestinal tract preparation, and has the effects of enhancing and promoting the excretion and intestinal tract preparation of sugar alcohol and L-arabinose.
The main technical effects obtained by the invention comprise:
1. the invention discovers for the first time that the combination of sorbitol and L-arabinose, as well as sorbitol, L-arabinose and sunflower flower extract has excellent synergistic effect on promoting excretion and relaxing bowel, thus being used for treating constipation, playing a role in cathartic and also being used for intestinal preparation and intestinal related surgery (such as high-frequency electrocoagulation and/or high-frequency electrosection) treatment.
2. In the composition, the sorbitol and the L-arabinose have fresh, sweet and cool mouthfeel, so that the composition is comfortable to take, can avoid the feeling that the existing intestine clearing medicaments such as PEG, magnesium sulfate and other chemical medicaments are difficult to swallow, greatly improves the compliance of patients, and improves the compliance of the intestine clearing and intestinal tract preparation of the patients.
Example 1 examination of the Effect of sorbitol, L-arabinose and sunflower extract on mouse excretion production of sunflower extract
Adding 75% ethanol water solution 5 times by weight into sunflower, heating and reflux extracting for 8h, filtering, concentrating the filtrate under reduced pressure, and drying to obtain dry extract, i.e. sunflower extract.
Experimental method
Experimental animals and their rearing: c57BL/6J mice, Specific Pathogen Free (SPF) grade, male, 6 weeks old; the common feed is D12450-B feed: 67.35 wt% carbohydrate, 19.2 wt% crude protein, 4.3 wt% fat. The temperature of the room is kept at 24-26 ℃ and the humidity is 40-60%.
Constructing a mouse constipation model: the mice are gavaged with loperamide suspension of 9mg/kg. body weight for 2 times/d, the first administration is doubled, and the constipation is established for 8 days continuously.
Experimental investigation:
constipation mice were randomly divided into model group, trial group 1, trial group 2, trial group 3, trial group 4 and trial group 5, with 8 mice per group. In addition, 8 normal healthy non-constipated mice were randomly selected as a blank control group.
The mice in each group were fasted without water prohibition before administration 12 times, and then, the mice in the placebo group, the model group, the test group 1, the test group 2, the test group 3, the test group 4 and the test group 5 were administered with gavage normal saline, sorbitol, L-arabinose, sorbitol + L-arabinose, sunflower flower extract, sorbitol + L-arabinose + sunflower flower extract, and after 0.5h, with ink containing montmorillonite powder (10mg/kg. bw), and the mice in each group were fed water normally. Starting from ink filling, recording the black excrement discharging time of the first grains of each group of animals, and detecting the water content of excrement in 5 hours.
The effect of the mode of administration on defecation time, stool grain number and stool weight for the different groups of mice is shown in table 1:
TABLE 1 Effect of the administration of different groups of mice on defecation time, stool size and stool weight (n. 8)
Figure BDA0002645046880000061
Figure BDA0002645046880000071
Note: comparing to the model group, "# is P < 0.05," # is P < 0.01; the extract is sunflower flower extract (dry extract), and the dosage is calculated according to the amount of the sunflower flower extract.
As can be seen from Table 1, the blank control group and the model group have significant differences (P < 0.01) in the detection results of the first defecation time, the fecal water content and the fecal weight, which indicates that the constipation model of the mouse is established. Compared with the model group mice, the test group mice 1-5 have the advantages of shortened defecation time, increased water content of excrement and quality of excrement, and the sorbitol, the L-arabinose and the sunflower flower extract have the effects of promoting excretion and relaxing bowel. As can be seen from the data in the test groups 1-3, the combination of sorbitol and L-arabinose had a synergistic effect on facilitating excretion and relaxing bowel compared to the administration of sorbitol, L-arabinose alone. Furthermore, as can be seen from the data in table 1, sorbitol, L-arabinose and sunflower extracts also have excellent synergistic effects on the promotion of excretion and defecation compared to the administration of sorbitol, L-arabinose and sunflower extracts alone, thus being useful for the treatment of constipation, as a laxative, and also for the preparation of intestinal tracts and for the performance of intestinal tract-related operations.
The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims (8)

1. A composition comprising sorbitol, L-arabinose and sunflower extract;
the sunflower flower extract is prepared by extracting 60-85% (v/v) ethanol water solution;
the weight ratio of the sorbitol to the L-arabinose to the sunflower extract is 1 (1-8): (1-5).
2. A composition according to claim 1, wherein the sunflower extract is a dry extract.
3. A composition according to claim 1, wherein the sunflower extract is prepared by extraction with 70-80% (v/v) aqueous ethanol.
4. The composition of claim 1, wherein said sunflower extract is prepared by the following method:
adding 4-6 times of 70-80% (v/v) ethanol water solution into sunflower, heating and reflux extracting for 6-10 hr, filtering, concentrating the filtrate under reduced pressure, and drying to obtain dry extract, i.e. sunflower extract.
5. The composition of claim 1, wherein the weight ratio of sorbitol, L-arabinose and sunflower extract is 1 (2-6): (1-3).
6. The composition of claim 1, wherein the composition is in the form of an oral formulation.
7. The composition of claim 1, wherein the composition is in the form of a tablet, capsule, oral liquid, granule, powder, or syrup.
8. The composition of claim 1, wherein the composition is a pharmaceutical composition, a food composition, or a nutraceutical composition.
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CN112089717B (en) * 2020-08-25 2022-02-22 唐传生物科技（厦门）有限公司 Application of arabinose and composition for preparing intestinal tract
CN112206236A (en) * 2020-08-28 2021-01-12 唐传生物科技（厦门）有限公司 Application of L-arabinose in inhibiting intestinal gas production of sorbitol

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