CN114364391B - Compositions and methods for improving or inhibiting gastrointestinal distress - Google Patents
Compositions and methods for improving or inhibiting gastrointestinal distress Download PDFInfo
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Abstract
The present application relates to a composition for improving or inhibiting gastrointestinal discomfort, in particular constipation, and its use.
Description
Technical Field
The benefits and priorities of U.S. provisional application No. 62/871,335, filed on 7/8 at 2019, are claimed herein, and are incorporated by reference in their entirety.
The present application provides a composition and method for ameliorating or inhibiting gastrointestinal distress.
Background
Constipation and/or diarrhea, while not life threatening, have greatly affected quality of life. Recently, functional bowel disorders (functional bowel disorder, FBD) are defined as a condition with mid-or lower-stage gastrointestinal symptoms, including functional constipation, functional diarrhea, and irritable bowel syndrome (irritable bowel syndrome, IBS), although the exact etiology basis of FBD is not clear. In the absence of structural or biochemical interpretation, FBD can be diagnosed by characteristic symptoms; for IBS, the most common symptom is discomfort caused by abdominal pain or alternating constipation and diarrhea. IBS is currently inferred to be a complex disease with both physiological and psychosocial factors, where motor or sensory changes in the gut are regulated by input signals to the central nervous system. The most commonly recommended treatment for FBD is dietary fiber/bulking agents.
Constipation is a gastrointestinal disorder that is clinically manifested by low frequency of bowel movements, difficulty in defecation, and pain and stiffness. The lack of proper definition of constipation results in a wide range of reported prevalence (1% to 80% worldwide). In addition, chronic constipation is a complex symptom in the elderly. In this regard, this condition is intimately related to the quality of life of the patient, as well as the consumption of healthy resources.
The variety of causes of constipation limits the clinical efficacy of current conventional therapies that use a single drug that acts via only a single route. However, herbs have the ability to target multiple routes, becoming an emerging therapy for constipation today.
Cinnamomum is a genus of Lauraceae (Lauraceae), but there are currently relatively few studies on laxative activity from its leaves.
Disclosure of Invention
In the present application, it has been unexpectedly found that the camphor tree leaves or extracts thereof are effective in improving or inhibiting gastrointestinal discomfort, especially constipation.
In the examples, it was confirmed that the leaf of Cinnamomum camphora or its extract has laxative activity.
The application aims to provide the application of camphor tree leaves or extracts thereof in preparing a composition for improving or inhibiting gastrointestinal tract discomfort, especially constipation.
In one embodiment of the application, the gastrointestinal disorder is selected from the group consisting of constipation, reflux esophagitis, autism bowel, flatulence, halitosis, chronic fatigue syndrome (Chronic Fatigue Syndrome, CFS), abdominal distension, temporary anal pain, intestinal bacterial overgrowth (small intestinal bacterial overgrowth, SIBO) and intestinal bacterial overgrowth (large intestinal bacterial overgrowth, LIBO), chronic nausea and functional dyspepsia.
In a particular embodiment of the application, the gastrointestinal tract is not adapted to constipation.
In one embodiment of the application, the Niu Zhangshu leaf extract is an aqueous or alcoholic extract.
In one embodiment of the application, the sassafras leaves or extracts thereof are substantially free of safras.
In one embodiment of the application, the camphor tree leaves or extracts thereof have laxative activity.
In one embodiment, the composition further comprises at least one additional laxative.
In one embodiment, the composition further comprises at least one additional probiotic.
In a preferred embodiment, the composition of the present application is a beverage composition.
In a preferred embodiment, the composition of the present application is formulated into a tea bag of Cinnamomum camphora leaves.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application, as claimed.
Drawings
The foregoing summary, as well as the following detailed description of the application, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the application, there is shown in the drawings embodiments which are presently preferred.
In the drawings:
FIG. 1 is an exemplary gas chromatography-mass spectrometry (GC-MS) chromatogram of LESCT-A, which is an aqueous extract of Cinnamomum camphora leaves.
FIG. 2 is an exemplary GC-MS chromatogram of LESCT-B, which is an ethanol extract of Cinnamomum camphora leaves.
FIG. 3 shows the effect of LESCT-A and LESCT-B on the movement of activated carbon in the intestinal tract. The administration of Loperamide (Loperamide) significantly reduced intestinal activated carbon movement in untreated constipation mice.
Detailed Description
The above summary of the application will be further described with reference to the following exemplary embodiments. However, the present application should not be construed as being limited to the following specific embodiments, and all applications based on the above-described summary of the application fall within the scope of the application.
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 to which this application belongs.
As used herein, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a sample" includes a plurality of such samples and equivalents thereof known to those skilled in the art.
The application provides an application of camphor tree leaves or extracts thereof in medicines for improving or inhibiting gastrointestinal tract discomfort, especially constipation.
As used herein, the term "gastrointestinal discomfort" refers to any symptom that may benefit from acceleration of intestinal transit, including constipation, reflux esophagitis, autism bowel disease, flatulence, halitosis, chronic Fatigue Syndrome (CFS), abdominal distension, temporary anal pain, small Intestinal Bacterial Overgrowth (SIBO) and Large Intestinal Bacterial Overgrowth (LIBO), chronic nausea, functional dyspepsia, and abdominal distension.
As used herein, the term "constipation" refers to constipation, functional constipation, chronic constipation, acute constipation, irritable Bowel Syndrome (IBS) -constipation, diverticulum-related constipation, pseudo-obstruction, slow-transmitting constipation, stasis with diabetes and gastroparesis.
As used herein, the term "ameliorating" refers to treating, curing, alleviating, altering, remediating, ameliorating, augmenting or affecting the effect of the event or feature (e.g., gastrointestinal discomfort).
As used herein, the term "inhibit" refers to the effect of reducing or stopping an event or feature (e.g., gastrointestinal discomfort).
As used herein, the term "individual" includes human or non-human animals, such as companion animals (e.g., dogs, cats, etc.), farm animals (e.g., cows, sheep, pigs, horses, etc.), or laboratory animals (e.g., rats, mice, guinea pigs, etc.).
As used herein, the term "effective amount" refers to a dose that is treating, curing, preventing, ameliorating or inhibiting a disease, symptom or side effect, or reducing the rate of progression of a disease or disorder, as compared to a corresponding individual not receiving such a dose. The term also includes within its scope an amount effective to enhance normal physiological function.
Beverage compositions may also be made in accordance with an embodiment of the present application, such as, but not limited to, tea (e.g., tea beverage or tea bag ingredients), soda, fruit juice (e.g., fruit extracts or fruit juice beverages), milk, coffee. The beverage composition for improving or inhibiting gastrointestinal distress of the present application may be used in any of the foregoing forms to improve or inhibit gastrointestinal distress. According to one embodiment of the application, the tea bag can be made.
The LESCT of the present application may be further formulated into pharmaceutical compositions for administration. Accordingly, the present application further provides a pharmaceutical composition comprising a therapeutically effective amount of camphor tree leaves or extracts thereof and one or more pharmaceutically acceptable carriers.
For delivery and absorption purposes, a therapeutically effective amount of the active ingredients of the present application may be formulated into a pharmaceutical composition in a suitable form together with a pharmaceutically acceptable carrier. Depending on the route of administration, the pharmaceutical compositions of the application preferably comprise from 0.1% to 100% by total weight of active ingredient.
The term "pharmaceutically acceptable carrier" as used herein refers to an acceptable carrier, diluent or excipient that is compatible with the other ingredients of the formulation and not deleterious to the subject to which the pharmaceutical composition is to be administered. Any carrier, diluent or excipient commonly known or used in the art may be used in the present application, depending on the requirements of the pharmaceutical formulation. According to the present application, the pharmaceutical composition may be used for administration via any suitable route, including but not limited to oral, rectal, nasal, topical, vaginal or parenteral routes. In a specific example of the application, the pharmaceutical composition is formulated for oral administration. Such formulations may be prepared by any method known in the pharmaceutical arts.
As used herein, "pharmaceutically acceptable" means that the carrier is compatible with the active ingredient of the composition, preferably stabilizes the active ingredient, and is safe for the individual being treated. The carrier may be a diluent, carrier, excipient or matrix for the active ingredient. Some suitable examples of excipients include lactose, dextrose, sucrose, sorbose, mannose, starch, gum acacia, calcium phosphate, alginates, tragacanth, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, sterile water, syrup, and methyl cellulose. The composition may additionally comprise lubricants such as talc, magnesium stearate and mineral oil; a wetting agent; emulsifying and suspending agents; preservatives, such as methyl hydroxybenzoate and propyl hydroxybenzoate; a sweetener; and a flavoring agent. The compositions of the present application may provide a rapid, sustained or delayed release effect of the active ingredient upon administration to a patient.
According to the application, the compositions may be in the form of lozenges, pills, powders, troches, sachets, troches, elixirs, suspensions, lotions, solutions, syrups, soft and hard gelatine capsules, suppositories, sterile injectable solutions and packaged powders.
The compositions of the present application may be delivered via any physiologically acceptable route, such as oral, parenteral (e.g., intramuscular, intravenous, subcutaneous, and intraperitoneal), transdermal, suppository, and intranasal methods. For parenteral administration, it is preferably used in the form of a sterile aqueous solution which may contain other substances, such as salts or glucose, sufficient to render the solution isotonic with blood. The aqueous solution may be suitably buffered (pH preferably 3 to 9) if necessary. Preparation of a suitable parenteral composition under sterile conditions can be accomplished by standard pharmacological techniques well known to those skilled in the art.
According to the present application, the methods and compositions described herein may further comprise one or more probiotics, wherein optionally the probiotics comprise microorganisms or bacteria, or bacterial components, and optionally bacteria or bacterial components, cultured or extracted from faeces, comprising or derived from bacteroides (bacteriodes), firmicutes, lactobacillus (Lactobacilli), bifidobacteria (Bifidobacterium), escherichia coli and streptococcus faecalis (Strep faecalis), and equivalents thereof.
In accordance with the present application, the methods and compositions described herein may be administered to a subject in combination with at least one additional laxative agent. Exemplary laxatives that are effective include, but are not limited to, bisacodyl (e.g., DULCOLAX) TM 、DUROLAX TM 、FLEET TM 、ALOPHEN TM Or CORRECTOL TM ) Sodium docusate (docusate sodium), poloxamer (poloxamer), ginsenoside, lactulose, sorbitol, sucrose, sterculia or shanhuang (frangula), paraffin oil or equivalents thereof, or combinations thereof.
The application is further illustrated by the following examples, which are provided for purposes of illustration and not limitation.
Examples
Materials and methods
1. Preparation of camphor tree leaf extract
Cinnamomum camphora Leaf Extract (LESCT) is obtained from Gibberella biotechnology Co., ltd (ARJIL PHARMACEUTICALS LLC). To prepare the LESCT, fresh leaves of the cinnamomum camphora tree are subjected to indoor withering/turning (tossing), streaming and rolling. And (3) drying the processed leaves with hot air at 50-150 ℃, and then extracting with ethanol and water to obtain LESCT-A and LESCT-B liquid respectively.
Safrole analysis in LESCT
15g of sassafras leaves were heated to reflux and extracted with 200mL of water or 200mL of 95% ethanol. The extract was then subjected to water/dichloromethane separation and the dichloromethane fraction was analyzed by a gas chromatography-mass spectrometry (GC-MS) system to detect the presence of safrole.
3. Experimental animal
Male ICR mice (7-8 weeks old) were obtained from BioLASCO Taiwan Co., ltd (Taipei, taiwan, china). Prior to the experiment, animals were kept in Plexiglas cages for at least 2 weeks at a constant temperature of 22±1 ℃ and a relative humidity of 55±5% in a dark photoperiod of 12 hours. Animal food and water are provided ad libitum. All experimental procedures were performed according to the guidelines of the animal-related regulatory guidelines, and the procedures were approved by the relevant authorities.
4. Induction of constipation in mice
1mL of loperamide (loperamide) (10 mg/kg body weight, dissolved in 0.9% sodium chloride) was orally administered to induce constipation in animals, while control mice were administered only normal saline. The reduced amount of hard and dry fecal sediment discharged represents constipation in mice.
5. Design of experiment
Mice were divided into six groups of five mice each. Animals in group 1 (control) and group 2 (constipation control) were dosed with distilled water. The 3 rd, 4 th, 5 th and 6 th animals contained constipation mice administered with LESCT-A (0.25, 0.5 th and 1g/kg body weight/day) and LESCT-B (0.5 g/kg body weight/day), respectively. Water intake, feed intake and weight gain were recorded for all mice during the experiment and treatment was continued for 7 days. Each group of mice fasted for 16 hours 7 days after administration of the test sample. After 1 hour, loperamide (10 mg/kg) was administered intragastrically to the model control group (group 2) and to the experimental group (groups 3, 4, 5 and 6), while distilled water was administered to the blank control group (group 1).
6. Total number, time and dry weight of faecal particles
The total number, time and weight of faecal particles were determined. The first defecation time, the number of times of defecation within 6 hours and the defecation weight of the mice were measured to reflect the defecation condition of model mice.
7. Measurement of active carbon movement ratio in intestinal tract
Drinking water was ad libitum 7 days after administration of the test samples. After 0.5 hour of loperamide (loperamide) induced constipation, the animals were fed an activated carbon meal (1 mg/100kg body weight) (5% activated carbon suspension in 10% acacia). After 30 minutes of administration of the activated carbon meal, the animals were sacrificed first by cervical dislocation and then the abdominal cavity was opened. The intestines were removed and the total length of the intestines (from the pyloric sphincter to the cecum) was measured, as well as the distance traveled by the activated carbon meal. The activated carbon movement ratio of the intestinal tract is calculated as follows: activated carbon movement ratio (%) = (distance traveled by activated carbon)/(total length of small intestine) ×100%.
8. Statistical analysis
Data obtained from animal experiments are expressed as mean and standard deviation of the mean (+ -s.e.m). Student's t-test is used to test differences between groups or between groups. Statistical significance is expressed as p <0.05, p <0.01, and p <0.001.
Example 1
Analysis of the presence of safrole in LESCT
Safrole (Safrole) is a phenylpropanoid compound found in a wide range of plants and functions as a natural antifeedant. However, toxicology studies have shown that metabolic transformants of safrole are carcinogenic. To confirm the presence of safrole in LESCT, GC-MS analysis was performed on LESCT-A and LESCT-B, and the results showed that safrole was not detected in both LESCT-A (FIG. 1) and LESCT-B (FIG. 2). Furthermore, no camphor is present in both LESCT-A (FIG. 1) and LESCT-B (FIG. 2). Together, these data show that safrole and camphor are removed during the extraction process of the present application.
Example 2
Effect of LESCT on intestinal activated carbon movement
In the loperamide (loperamide) treated group, a decrease in intestinal activated carbon movement was noted after loperamide (loperamide) administration and was maintained significantly higher (p < 0.001) until day 7 (from 57.63 ±3.32cm to 27.94±3.86 cm) compared to the normal mouse group. The loperamide (loperamide) +lesct-a (0.25, 0.5 and 1 g/kg) (p < 0.001) and LESCT-B (0.5 g/kg) (p < 0.01) detected a statistically significant decrease in intestinal activated carbon movement compared to the loperamide (loperamide) group. The administration of loperamide significantly reduced gastrointestinal motility in untreated constipation mice. However, treatment with extracts (LESCT-A and LESCT-B) increased gastrointestinal motility in a dose dependent manner compared to loperamide-induced constipation in mice.
Example 3
LESCT inhibited the time and stool characteristics of Loperamide (Loperamide) -induced constipation in constipation mice
Constipation was evaluated primarily by time, fecal particle count and weight to determine the effect of LESCT-a and LESCT-B on loperamide (loperamide) induced constipation. Loperamide (loperamide) significantly reduced bowel movement time, number and weight of fecal pellets (table 1), indicating induction of constipation in mice. However, the LESCT-a and LESCT-B extracts significantly reduced the time for loperamide (loperamide) to induce constipation and increased the fecal particle count and weight in constipation mice.
Table 1: effect of LESCT-A and LESCT-B on time and stool characteristics in constipation mice in loperamide-induced constipation
# # p <0.001 was compared to the control samples.
* P <0.001, compared to loperamide alone (loperamide) group.
This study clearly shows that LESCT-A and LESCT-B have laxative activity. This study showed that oral administration of LESCT-a and LESCT-B exhibited laxative activity in loperamide (loperamide) -induced constipation mice. This suggests that the herb has a beneficial effect on improving intestinal motility. However, it is very important to note that 0.5g/kg body weight of LESCT-A will exhibit a better laxative effect than 0.5g/kg body weight of LESCT-B. These findings provide scientific basis for folk therapy use with LESCT as a laxative.
The foregoing description relates only to the preferred embodiments of the present application and it should be noted that certain enhancements and modifications may be made by those skilled in the art without departing from the scope of the present application and are also considered to be within the scope of the present application.
Claims (3)
1. The application of a camphor tree leaf water or ethanol extract for preparing a medicine for treating constipation, wherein the extract does not contain safrole, wherein the extract is prepared by carrying out indoor withering/turning, streaming and rolling processing on fresh leaves of camphor tree, and carrying out hot air drying on the processed leaves at 50-150 ℃ and then carrying out water or ethanol extraction.
2. The use as claimed in claim 1, wherein the water or ethanol extract of Cinnamomum camphora leaves has laxative activity.
3. The use of claim 1, wherein the extract is in the form of a tea bag.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962871335P | 2019-07-08 | 2019-07-08 | |
| US62/871,335 | 2019-07-08 | ||
| PCT/US2020/041198 WO2021007318A1 (en) | 2019-07-08 | 2020-07-08 | Composition and method for treating gastrointestinal disorder |
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| Publication Number | Publication Date |
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| CN114364391A CN114364391A (en) | 2022-04-15 |
| CN114364391B true CN114364391B (en) | 2023-08-11 |
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| CN202080049873.5A Active CN114364391B (en) | 2019-07-08 | 2020-07-08 | Compositions and methods for improving or inhibiting gastrointestinal distress |
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| CN (1) | CN114364391B (en) |
| TW (1) | TW202116342A (en) |
| WO (1) | WO2021007318A1 (en) |
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| TW202116342A (en) | 2021-05-01 |
| CN114364391A (en) | 2022-04-15 |
| WO2021007318A1 (en) | 2021-01-14 |
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