CN117100764A - Composition used before capsule endoscopy - Google Patents

Composition used before capsule endoscopy Download PDF

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Publication number
CN117100764A
CN117100764A CN202311149909.9A CN202311149909A CN117100764A CN 117100764 A CN117100764 A CN 117100764A CN 202311149909 A CN202311149909 A CN 202311149909A CN 117100764 A CN117100764 A CN 117100764A
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CN
China
Prior art keywords
parts
vitamin
mannitol
composition
capsule endoscopy
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Pending
Application number
CN202311149909.9A
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Chinese (zh)
Inventor
赵玉斌
徐建超
赵一诺
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Shijiazhuang People's Hospital
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Shijiazhuang People's Hospital
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Priority to CN202311149909.9A priority Critical patent/CN117100764A/en
Publication of CN117100764A publication Critical patent/CN117100764A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/375Ascorbic acid, i.e. vitamin C; Salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415Pyridoxine, i.e. Vitamin B6
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7004Monosaccharides having only carbon, hydrogen and oxygen atoms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/10Carbonates; Bicarbonates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/14Alkali metal chlorides; Alkaline earth metal chlorides
    • 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
    • A61P1/12Antidiarrhoeals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis

Abstract

The application relates to a composition for preparing intestinal tracts before capsule endoscopy, which comprises the following raw material components in parts by weight: 125-250 parts of mannitol, 30-70 parts of L-arabinose, 1-2 parts of vitamin C, 0.5-1 part of vitamin B6, 0.3-1.2 parts of calcium carbonate, 1-10 parts of potassium chloride, 0.5-5 parts of magnesium carbonate and 2-10 parts of sodium chloride. The application has better intestinal tract preparation effect before capsule endoscopy, less adverse reaction in the taking process, effectively improves the occurrence of electrolyte disorder caused by intestinal tract cleaning medicine, and has good clinical value.

Description

Composition used before capsule endoscopy
Technical Field
The application relates to the field of medicines, in particular to a composition used before capsule endoscopy.
Background
The gastrointestinal diseases are the countries with higher incidence rate, about 30 percent of people suffer from the gastrointestinal diseases according to relevant epidemiological statistics, since the diagnosis accuracy of the gastrointestinal diseases is greatly improved by the application of the self-digestion endoscope, the currently clinically common digestion endoscopes mainly comprise an electronic gastroscope, an electronic colonoscope, a small intestine endoscope, a capsule endoscope and the like, wherein the capsule endoscope has the advantages of convenient operation, less pain and the like, provides a safe and noninvasive examination means for the examination of the whole digestive tract, and the related research shows that the success rate of the capsule endoscope examination is more than 90 percent, and has good development and application prospect.
Before capsule endoscopy is implemented, intestinal tract preparation is necessary, the feces in the intestinal tract are cleared through various modes, high intestinal tract cleanliness can be obtained through good intestinal tract preparation, and the accuracy of capsule endoscopy can be effectively guaranteed. The ideal intestinal tract preparation method application has the following characteristics: the intestinal tract preparation can empty the excrement in the intestinal tract in a short time, does not cause the change of colon mucous membrane, does not cause the disorder of water electrolyte of patients, has moderate price, but the conventional intestinal tract preparation in clinic at present can not completely meet the above standard, so that it is very important to find a method which meets the characteristics as much as possible.
Mannitol is a clinically common intestinal preparation drug, and can form a hypertonic state in intestinal cavities after oral administration, so that the absorption of water by the intestinal tracts is reduced, the intestinal peristalsis and emptying are stimulated, and related guidelines suggest that mannitol can be used as a diagnostic enteroscope, but mannitol easily causes water electrolyte disorder of patients in the intestinal preparation process, and can cause gastrointestinal discomfort such as nausea, vomiting, abdominal distension and the like.
Therefore, there is a need in the art to develop a medicament that has good bowel cleansing effect and can alleviate symptoms of electrolyte disturbance and gastrointestinal discomfort in patients during bowel preparation.
Disclosure of Invention
The application aims to provide a medicine with good intestine cleaning effect, which can relieve electrolyte disturbance and gastrointestinal discomfort symptoms of patients in the process of preparing the intestinal tract.
The technical scheme of the application is as follows:
the composition for the pre-capsule endoscopy consists of the following raw material components in parts by weight: 125-250 parts of mannitol, 30-70 parts of L-arabinose, 1-2 parts of vitamin C, 0.5-1 part of vitamin B6, 0.3-1.2 parts of calcium carbonate, 1-10 parts of potassium chloride, 0.5-5 parts of magnesium carbonate and 2-10 parts of sodium chloride. Preferably, the material comprises the following raw material components in parts by weight: 150-200 parts of mannitol, 45-60 parts of L-arabinose, 1-2 parts of vitamin C, 0.5-1 part of vitamin B6, 0.6-0.8 part of calcium carbonate, 3-5 parts of potassium chloride, 2-3 parts of magnesium carbonate and 5-6 parts of sodium chloride.
Preferably, the material comprises the following raw material components in parts by weight: 180 parts of mannitol, 49 parts of L-arabinose, 2 parts of vitamin C, 6 1 parts of vitamin B, 0.7 part of calcium carbonate, 4 parts of potassium chloride, 2 parts of magnesium carbonate and 6 parts of sodium chloride.
Preferably, the mannitol is 20% mannitol by mass.
Preferably, the formulation of the composition is a liquid preparation or an oral preparation.
Preferably, for intestinal tract preparation; or as laxatives.
Preferably, also for the prevention and/or treatment of nausea; preventing and/or treating emesis; preventing and/or treating abdominal distention.
The application discovers that mannitol, L-arabinose, vitamin C, vitamin B6, calcium carbonate, potassium chloride, magnesium carbonate and sodium chloride have synergistic cooperation effects on relaxing bowel, promoting intestinal excretion and intestinal preparation when being taken orally, can also improve side effects (electrolyte disorder, nausea, vomiting, abdominal distension and the like) of oral mannitol, and can improve health recovery in the intestinal preparation process of patients.
The application provides a composition, which comprises mannitol, L-arabinose, vitamin C, vitamin B6, calcium carbonate, potassium chloride, magnesium carbonate and sodium chloride.
The mannitol is 20% mannitol, the mannitol is a high-permeability dehydrating agent, and can form a high-permeability state in the intestinal cavity after being orally taken, so that the absorption of water by the intestinal tract is reduced, the liquid is promoted to enter the intestinal cavity, and the peristaltic movement and the evacuation of the intestinal tract are stimulated, so that the aim of cleaning the intestinal tract is fulfilled.
The L-Arabinose is L-Arabinose (L-Arabinose), belongs to aldopentose, is often used as an inducer of a Pbad promoter in an escherichia coli expression system, is also an inhibitor of sucrase, and is proved by researches to promote intestinal peristalsis, relieve constipation, and simultaneously enable the composition to have good taste and relieve discomfort of oral intestinal tract cleaning medicines of patients.
Vitamin C is a water-soluble vitamin, is chemically named as L- (+) -threose type 2,3,4,5, 6-pentahydroxy-2-hexenoic acid-4-lactone, and is also named as L-ascorbic acid, has an antioxidation effect, can effectively maintain the balance of the environment in the intestinal tract, delay the aging and apoptosis of cells, maintain the integrity of the cells and the normal physiological activities of the cells in the preparation process of the intestinal tract, and protect the integrity of intestinal mucosa.
The vitamin B6 is a water-soluble vitamin, also called pyridoxine, which comprises pyridoxine, pyridoxal and pyridoxamine, and the common molecular formula is C8H10NO5P, can exert the effect of maintaining sodium/potassium balance in human body, and can relieve gastrointestinal symptoms such as nausea, vomiting and the like in the process of intestinal tract preparation.
The calcium carbonate is calcium carbonate, so that the loss of calcium ions in the intestinal tract preparation process can be effectively relieved.
The potassium chloride is potassium chloride, so that the loss of potassium ions in the intestinal tract preparation process can be effectively relieved.
The magnesium carbonate is magnesium carbonate, so that the loss of magnesium ions in the intestinal tract preparation process can be effectively relieved.
The sodium chloride is sodium chloride, so that the loss of sodium ions and chloride ions in the intestinal tract preparation process can be effectively relieved.
The main technical effects obtained by the application include:
the oral administration of mannitol, L-arabinose, vitamin C, vitamin B6, calcium carbonate, potassium chloride, magnesium carbonate and sodium chloride can effectively promote the discharge of intestinal excrement, effectively clear the intestinal tract, simultaneously relieve the gastrointestinal reactions such as nausea, vomiting and abdominal distension in the preparation process of the intestinal tract, reduce the loss of electrolyte and improve the health recovery of patients in the preparation process of the intestinal tract.
Detailed Description
The application will be further illustrated with reference to specific examples. It is to be understood that these examples are illustrative of the present application and are not intended to limit the scope of the present application.
Example 1
The prescription of the composition comprises:
composition components Parts by weight of
Mannitol (mannitol) 250
L-arabinose 30
Vitamin C 2
Vitamin B6 1
Calcium carbonate 1.2
Potassium chloride 5
Magnesium carbonate 0.5
Sodium chloride 2
The weight parts are given in grams (g). Mannitol is mannitol aqueous solution with mass content of 20%.
Example 2
The prescription of the composition comprises:
composition components Parts by weight of
Mannitol (mannitol) 125
L-arabinose 70
Vitamin C 1
Vitamin B6 0.5
Calcium carbonate 0.3
Potassium chloride 1
Magnesium carbonate 5
Sodium chloride 2
The weight parts are given in grams (g). Mannitol is mannitol aqueous solution with mass content of 20%.
Example 3
The prescription of the composition comprises:
the weight parts are given in grams (g). Mannitol is mannitol aqueous solution with mass content of 20%.
Example 4
The prescription of the composition comprises:
composition components Parts by weight of
Mannitol (mannitol) 150
L-arabinose 45
Vitamin C 2
Vitamin B6 1
Calcium carbonate 0.6
Potassium chloride 3
Magnesium carbonate 2
Sodium chloride 6
The weight parts are given in grams (g). Mannitol is mannitol aqueous solution with mass content of 20%.
Example 5
The prescription of the composition comprises:
composition components Parts by weight of
Mannitol (mannitol) 200
L-arabinose 60
Vitamin C 1
Vitamin B6 0.5
Calcium carbonate 0.8
Potassium chloride 5
Magnesium carbonate 3
Sodium chloride 5
The weight parts are given in grams (g). Mannitol is mannitol aqueous solution with mass content of 20%.
Example 6
The prescription of the composition comprises:
composition components Parts by weight of
Mannitol (mannitol) 180
L-arabinose 49
Vitamin C 2
Vitamin B6 1
Calcium carbonate 0.7
Potassium chloride 4
Magnesium carbonate 2
Sodium chloride 6
The weight parts are given in grams (g). Mannitol is mannitol aqueous solution with mass content of 20%.
Case example 1
1. Basic information
46 patients receiving capsule endoscopy who were treated by the clinic of the people's hospitals in Shijia city from 10 months 2022 to 9 months 2023 were selected. All patients had no contraindications for enteroscopy. 46 patients were divided into a test group and a control group by a random number table method, wherein 22 test groups and 24 control groups, the test group received the composition of the present application, and the control group received polyethylene glycol 4000 powder. The test group had 10 men, 12 women, and an average age (45.64.+ -. 9.49) years. Control men were 11, women 13, and the average age (46.12.+ -. 10.48) years old. The two groups of patients had no statistical differences (P > 0.05) in baseline data of age, sex, etc.
2. Process and method
Two groups of patients had little grounds and half fluid food in 24 hours prior to the examination, restricted dietary fiber intake, and fasted after dinner the day prior to the examination. Test group: intestinal tract preparation was performed using the composition of example 6 of the present application, and the composition of example 6 of the present application was orally administered for 4 hours before examination, and 150-200ml of water was consumed after 10 minutes. Control group: the polyethylene glycol 4000 powder is taken before examination, 1L of polyethylene glycol 4000 powder is taken at night 1 day before examination, and 2L of polyethylene glycol 4000 powder is taken 4-6 hours before examination.
3. Efficacy evaluation index
1) Boston scale: the Boston scale scores the colon in 3 segments (cecum and ascending colon; liver, transverse and spleen, descending, sigmoid and rectum) with a score of 4 (0-3 points) according to worst-case score, total 0-9 points. (Table 1)
TABLE 1 Boston scale scoring criteria for intestinal preparation quality
Scoring of Description of the application
0 point The whole intestinal mucosa can not be observed due to the solid or liquid feces which can not be cleared
1 minute Part of the intestinal mucosa can not be observed due to dirty spots, turbid liquid and residual feces
2 minutes The intestinal mucosa is observed well, but a small amount of dirty spots, turbid liquid and feces remain
3 minutes The intestinal mucosa is observed well, and no residual dirty spots, turbid liquid and feces are basically generated
2) Wortmawa scale: the wortmax scale scores the colon into 3 segments (rectum and sigmoid; transverse and descending; ascending and cecum) with a clear-to-differential score of 5 (0-4 points, table 2) and adds liquid volume scores (small, medium, large 0, 1, 2 points, respectively) to the whole colon, total score 0-14 points (table 2).
TABLE 2 wortmann scale scoring criteria for intestinal tract preparation quality
3) Electrolyte index: all enterally prepared patients were subjected to four serological examinations of electrolyte, including sodium serum, potassium serum, calcium serum, magnesium serum, and the number of electrolyte disorders was recorded.
4) Adverse reactions including nausea, vomiting, abdominal distension, etc. were evaluated.
4. Results
1) Boston scale comparison
The intestinal tract cleanliness is the worst in 0 and the best in 9, the Boston scale score of the test group is 7.67+/-1.65, the Boston scale score of the control group is 6.45+/-1.02, and the difference has statistical significance after statistical test, P is less than 0.05.
2) Comparison of wortmawa scale
Intestinal cleanliness was rated worst at 0 and best at 14, the wortmax rating of the test group was 13.07±1.58, the wortmax rating of the control group was 11.32±1.56, and the difference was statistically significant (P < 0.05).
3) Serum electrolyte conditions of different groups
The test group showed 11 cases of electrolyte disorder, 4 cases of hypokalemia, 4 cases of hyponatremia, 2 cases of hypocalcemia and 1 case of hypomagnesemia; the control group showed 21 cases of electrolyte disturbance, 8 cases of hypokalemia, 6 cases of hyponatremia, 4 cases of hypocalcemia, 3 cases of hypomagnesemia, and the difference was statistically significant (P < 0.05).
TABLE 3 electrolyte disturbance comparison
4) Adverse reaction comparison
Only 3 of the test groups showed gastrointestinal discomfort symptoms, 2 of them nausea and 1 abdominal distention; the control group showed 16 cases of gastrointestinal discomfort symptoms, 8 cases of nausea, 2 cases of vomiting, 6 cases of abdominal distension; the differences were statistically significant (P < 0.05) for both sets of comparisons.
Table 4 adverse reaction comparison
From the above results, it can be seen that: compared with the currently common intestinal tract preparation drug-polyethylene glycol 4000 powder, the application has better intestinal tract preparation effect before capsule endoscopy, less adverse reaction in the taking process, effectively improves the occurrence of electrolyte disorder caused by intestinal tract cleaning drugs, and has good clinical value.
Case example two
50 constipation sufferers who receive treatment from the medical hospitals of people in Shijia city are selected, and the ages are 10-71 years, wherein 23 women and 27 men.
The composition of the embodiment 1 of the application is taken before sleeping every day in the above cases, 150-200ml of water is drunk after 10min, 50 people constipation is obviously improved, and gastrointestinal symptoms such as nausea and vomiting are avoided in the taking process, so that the application can be used as a cathartic.
The present application is not limited to the above embodiments, but is capable of modification and variation in detail, and other modifications and variations can be made by those skilled in the art without departing from the scope of the present application.

Claims (7)

1. The composition used before capsule endoscopy is characterized by comprising the following raw material components in parts by weight: 125-250 parts of mannitol, 30-70 parts of L-arabinose, 1-2 parts of vitamin C, 0.5-1 part of vitamin B6, 0.3-1.2 parts of calcium carbonate, 1-10 parts of potassium chloride, 0.5-5 parts of magnesium carbonate and 2-10 parts of sodium chloride.
2. The composition for pre-capsule endoscopy of claim 1, wherein the composition comprises the following raw material components in parts by weight: 150-200 parts of mannitol, 45-60 parts of L-arabinose, 1-2 parts of vitamin C, 0.5-1 part of vitamin B6, 0.6-0.8 part of calcium carbonate, 3-5 parts of potassium chloride, 2-3 parts of magnesium carbonate and 5-6 parts of sodium chloride.
3. The composition for pre-capsule endoscopy of claim 1, wherein the composition comprises the following raw material components in parts by weight: 180 parts of mannitol, 49 parts of L-arabinose, 2 parts of vitamin C, 6 1 parts of vitamin B, 0.7 part of calcium carbonate, 4 parts of potassium chloride, 2 parts of magnesium carbonate and 6 parts of sodium chloride.
4. The composition for pre-capsule endoscopy of claim 1, wherein the mannitol is 20% mannitol by mass.
5. The composition for use before capsule endoscopy of claim 1, wherein the formulation of the composition is a liquid formulation or an oral formulation.
6. A pre-capsule endoscopy composition of claim 1, wherein the composition is for intestinal tract preparation; or as laxatives.
7. A pre-capsule endoscopic composition according to claim 1, further for preventing and/or treating nausea; preventing and/or treating emesis; preventing and/or treating abdominal distention.
CN202311149909.9A 2023-09-07 2023-09-07 Composition used before capsule endoscopy Pending CN117100764A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202311149909.9A CN117100764A (en) 2023-09-07 2023-09-07 Composition used before capsule endoscopy

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202311149909.9A CN117100764A (en) 2023-09-07 2023-09-07 Composition used before capsule endoscopy

Publications (1)

Publication Number Publication Date
CN117100764A true CN117100764A (en) 2023-11-24

Family

ID=88799986

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202311149909.9A Pending CN117100764A (en) 2023-09-07 2023-09-07 Composition used before capsule endoscopy

Country Status (1)

Country Link
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