Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/66—Microorganisms or materials therefrom
  • A61K35/74—Bacteria
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/66—Microorganisms or materials therefrom
  • A61K35/74—Bacteria
  • A61K35/741—Probiotics
  • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
  • A61K35/745—Bifidobacteria
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/66—Microorganisms or materials therefrom
  • A61K35/74—Bacteria
  • A61K35/741—Probiotics
  • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
  • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
• • 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
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/04—Anorexiants; Antiobesity agents

Definitions

• the present invention relates to an adjunctive agent for use in lavaging the alimentary canal which is carried out as a pretreatment of alimentary canal radiographic inspection, alimentary canal endoscopy, alimentary canal operation, and the like.
• cleaning agents to be used for lavaging the alimentary canal conducted as a pre-treatment of alimentary canal radiographic inspection, alimentary canal endoscopy, alimentary canal operation, and the like have been known.
• cleaning agents for lavaging the alimentary canal for example, those comprising a combination of polyethylene glycol (PEG) and electrolyte (see, for example, JP-A-63-500523, JP-A-1-125319, JP-A-1-132527, JP-A-2-292223 (specification of U.S. Pat. No.
• an object of the present invention is to provide an adjunctive agent for lavaging the alimentary canal which is capable of reducing a dose of oral cleaning agent for lavaging the alimentary canal, and of realizing excellent cleaning effect without being accompanied by nausea, etc. at the time of use of the oral cleaning agent for lavaging the alimentary canal.
• the present inventors have intensively studied to solve the above-described problems, and found that, by taking an adjunctive agent for lavaging the alimentary canal containing butyric acid bacterium and/or lactic acid bacterium before taking an oral cleaning agent for alimentary canal, dosage of the oral cleaning agent for the alimentary canal can be reduced, and at the time of use of said oral cleaning agent for lavaging the alimentary canal, excellent cleaning effects such as reduction of residual substances and air bubbles can be achieved, and have thus completed the present invention.
• the present invention comprises:
• An adjunctive agent for lavaging the alimentary canal comprising butyric acid bacterium and/or lactic acid bacterium.
• dose of an oral cleaning agent for lavaging the alimentary canal can be reduced, and excellent cleaning effects such as reduction of residual substances and air bubbles can be achieved without being accompanied by nausea etc. at the time of use of the oral cleaning agent for the alimentary canal.
• the adjunctive agent for lavaging the alimentary canal of the present invention comprises butyric acid bacterium and/or lactic acid bacterium, and includes those which comprise at least one species of bacterial cell selected from a group consisted of butyric acid bacterium and lactic acid bacterium together with additives if necessary, to prepare solid preparations such as powders, granules, fine granules or tablets, and the like.
• the adjunctive agent for lavaging the alimentary canal of the present invention may be in a form of a dispersion of at least one species of bacterial cell selected from a group consisted of butyric acid bacterium and lactic acid bacterium and other additives if necessary in water or the like filled in a container such as aluminium can, flexible container, and rigid or semi-rigid container, and the like.
• a container such as aluminium can, flexible container, and rigid or semi-rigid container, and the like.
• the aforementioned dispersion is disinfected or sterilized by a traditional method.
• Butyric acid bacterium to be used in the present invention include, for example, those belonging to the genus Clostridium having no pathogenicity, specifically, the species Clostridium butyricum and the like.
• Specific examples of the aforementioned Clostridium butyricum strain include Clostridium butyricum MIYAIRI 588 (FERM BP-2789), Clostridium butyricum (FERM P-11868), Clostridium butyricum (FERM P-11868), Clostridium butyricum (FERM P-11869), Clostridium butyricum (FERM P-11870), and soon, and these are all deposited and stored in the NITE Patent Microorganisms Depositary of the National Institute of Technology and Evaluation.
• Lactic acid bacterium to be used in the present invention include, for example, those belonging to the genus Lactobacillus and the genus Bifidobacterium having no pathogenicity, and specifically, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus bulgericus, Bifidobacterium bifidum, Bifidobacterium infantis , and so on. These are all known lactic acid bacteria, and available in the usual manner.
• Method for obtaining large quantity of the bacterial cells of butyric acid bacterium and lactic acid bacterium to be used in the present invention includes a method using the known cultivation technique and the like.
• the bacterial cell can be obtained by the following process: using culture medium comprising carbon source such as cornstarch, powdered candy, potato starch, soluble starch and glucose; nitrogen source such as meat extract, peptone, casamino acids, solution of amino acids mixture, corn steep liquor and yeast extract; and inorganic salts such as manganese sulfate, ferrous sulfate and calcium carbonate, and using a culture vessel sterilized by autoclaving at 120° C., the seed bacterial cells are inoculated into the culture medium, and cultured at 37° C. for 20-50 hours. After that, the bacterial cells are harvested by centrifugal separation or the like and dried.
• carbon source such as cornstarch, powdered candy, potato starch, soluble starch and glucose
• nitrogen source such as meat extract, peptone, casa
• additives there is no particular limitation as long as they have no adverse effect on the adjunctive agent for lavaging the alimentary canal of the present invention; for example, lactose, cornstarch, microcrystalline cellulose, magnesium stearate, precipitated calcium carbonate, sucrose, trehalose and the like are included.
• butyric acid bacterium includes, for example, a formulation comprising Clostridium butyricum MIYAIRI (product name: “Miya BM” (registered trademark), produced by MIYARISAN Pharmaceutical Co.).
• the adjunctive agent for lavaging the alimentary canal of the present invention is to be employed as a cleaning aid for lavaging the alimentary canal using a cleaning agent for the alimentary canal, which is conducted as a pretreatment for X-ray examination, endoscopic examination, surgery of the alimentary canal, and the like, and the aforementioned adjunctive agent for lavaging the alimentary canal is used prior to the use of the above-described cleaning agent for the alimentary canal.
• the adjunctive agent for lavaging the alimentary canal of the present invention can be applied to animals which have the gastrointestinal tract, and specifically, to various mammals including human and the like.
• Amount of the adjunctive agent for lavaging the alimentary canal of the present invention to be used can be determined appropriately according to the subject to be applied, etc.
• a preferable amount to be used is generally in a range of 0.1 to 0.3 g/kg, and a range of 0.25 to 0.1 g/kg is more preferable.
• Mode of administration is typically oral administration, but transnasal or enema administration is also applicable.
• timing for administration preferably, administration is performed from 2 days before to the previous day of the alimentary canal lavage.
• the aforementioned alimentary canal lavage can be performed in the usual manner using known cleaning agent for the alimentary canal (for example, product name “Niflec” (registered trademark), produced by Ajinomoto Pharma Co., Ltd.).
• a dosage of the cleaning agent for the alimentary canal can be reduced, and an excellent cleaning effect such as reduction of residual substances and air bubbles can be achieved without being accompanied by nausea etc. at the time of use of the aforementioned cleaning agent for the alimentary canal.
• the upper alimentary canal refers to the esophagus, the stomach and the duodenum
• the lower alimentary canal refers to the small intestine and the large intestine (the vermiform appendix, the ascending colon, the transverse colon, the descending colon, the sigmoid colon, the rectum and the anal canal).
• application to the lower alimentary canal is preferable, and application to the large intestine is more preferable.
• Rats (Wister, 18-week age, male) were divided into 8 groups with 5 rats in each group, and each group was assigned to a group receiving the adjunctive agent for lavaging the alimentary canal comprising butyric acid bacterium of Clostridium butyricum MIYAIRI (herein after, sometimes abbreviated as “butyric acid bacterium group”), a group receiving the adjunctive agent for lavaging the alimentary canal comprising lactic acid bacterium of Lactobacillus acidophilus (herein after, sometimes abbreviated as “lactic acid bacterium group”), a group receiving the adjunctive agent for lavaging the alimentary canal comprising lactic acid bacterium of Bifidobacterium bifidum (herein after, sometimes abbreviated as “bifidus bacterium group”) and a group receiving physiological saline (herein after, sometimes abbreviated as “control group”).
• lactic acid bacterium group lactic acid bacterium group
• lactic acid bacterium group
• solutions comprising 10 8 cells/cm 3 of butyric acid bacterium and each lactic acid bacterium were administered orally to the above-described each group every 2 cm 3 per head twice per day, and the same volume of physiological saline was administered orally to the control group in the same manner.
• oral cleaning agent for the alimentary canal product name “Niflec” (registered trademark), produced by Ajinomoto Pharma Co., Ltd.
• the rats were slaughtered 60 minutes after the last administration, and the tract from the cecum to short of the anus was immediately stopped using forceps and isolated. Contents were collected separately for the cecum and the large intestine. Each content collected was centrifuged at 6,000 rpm for 15 minutes, and after the precipitate (content residue) was freeze-dried, the mass was determined. The results are shown in the following table 1.
• the mass of content residue was also decreased in the groups which used the adjunctive agent for lavaging the alimentary canal, namely, in every group of butyric acid bacterium group, lactic acid bacterium group and bifidus bacterium group, as compared with control group.
• the mass of the content residue in the butyric acid bacterium group was smaller as compared with that in the control group which used 20 cm 3 /kg of the cleaning agent for lavaging the alimentary canal.
• the subjects belonging to Course A took a laxative of sodium picosulfate on the previous day of the large intestine endoscopy, and took an oral cleaning agent for lavaging the alimentary canal (product name “Niflec”, 2 L (2 ⁇ 10 ⁇ 3 m 3 ), produced by Ajinomoto Pharma Co., Ltd.) on the test day.
• the subjects belonging to Course B took a diet for the large intestine examination, and further took a laxative of sodium picosulfate on the previous day of the large intestine endoscopy, and took an oral cleaning agent for lavaging the alimentary canal (product name “Niflec”, 2 L (2 ⁇ 10 ⁇ 3 m 3 ), produced by Ajinomoto Pharma Co., Ltd.) on the test day.
• the large intestine was categorized into the rectum, the sigmoid colon, the descending colon, the transverse colon, the ascending colon, and the cecum, and cleaning effect and existence of air bubbles of each site were evaluated using the following criteria based on the results of endoscopic observations.
• the adjunctive agent for lavaging the alimentary canal of the present invention is useful as an adjunctive agent to be used for the alimentary canal cleaning which is performed as a pretreatment of alimentary canal radiographic inspection, alimentary canal endoscopy, and alimentary canal operation and the like.

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• Health & Medical Sciences (AREA)
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• Bioinformatics & Cheminformatics (AREA)
• Engineering & Computer Science (AREA)
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• Child & Adolescent Psychology (AREA)
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• 2006
  • 2006-08-28 JP JP2006230810A patent/JP4572185B2/ja active Active
• 2007
  • 2007-08-10 US US12/439,406 patent/US20090257992A1/en not_active Abandoned
  • 2007-08-10 WO PCT/JP2007/065779 patent/WO2008026444A1/ja active Application Filing
  • 2007-08-10 EP EP07792422.3A patent/EP2057991B1/en active Active
• 2011
  • 2011-10-04 US US13/252,622 patent/US8597639B2/en active Active

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