Chelate compound-containing antibacterial agent for...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heavy metal containing doai

Reexamination Certificate

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C514S566000, C514S925000

Reexamination Certificate

active

06429225

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to an antibacterial agent for
Helicobacter pylori
, in more detail, to an antibacterial agent for
Helicobacter pylori
, said agent contains as an effective component achelate compound, safety of which against human bodies is confirmed.
BACKGROUND OF THE INVENTION
Recently, it has been found that
Helicobacter pylori
is much participated to occurrence of chronic gastritis and gastric ulcer. In Japan, it is said that about 60 millions people corresponding to an about half of total populations are infected with
Helicobacter pylori
(Shokunokagaku, Vol. 265, pages 87-99, 2000).
Cure of chronic gastritis and gastric ulcer can be attained by removing the bacterium from stomach by means of administration of antibiotics etc. However, there are some cases wherein the bacterium is hard to be removed depending on patients. Further, as to antibiotics, there are some problems concerning appearance of resistant bacteria and side effects.
Further, it is desirable to remove the bacterium not only on people being attacked with a disease but also on people infected with a disease, but it is economically difficult because the number of objectives is quite large.
Therefore, an antibacterial agent for
Helicobacter pylori
which is highly safe and which can be taken easily is required.
Ethylenediaminetetraacetic acid (hereinafter, sometimes abbreviated to EDTA) has a chelating action on various metal ions and it is known as a reaction inhibitor of enzymes requiring metal ions. Further, EDTA and its metal salts are approved as a food additive in many countries since they have a stabilizing effect for food colors.
Thus, evaluation for safety of EDTA etc. has been already established and an acceptable daily intake (ADI) as a food additive is 2.5 mg/kg of weight (FAO/WHO: Codex Alimentarius Commission, List of additives evaluated for their safety in use in food. CAC/FAL 1-1973, 1973).
Further, in the U.S.A., it is approved that EDTA disodium salt is added to foods within a concentration range of 36-500 ppm (Code of Federal Regulations, Title 21: Food and Drugs, US Government Printing Office, 1988).
SUMMARY OF THE INVENTION
An object of the invention is to provide an antibacterial agent which has an action for growth inhibition of
Helicobacter pylori
which participates to occurrence of chronic gastritis and gastric ulcer and in which a highly safe substance is used as an effective component.
The inventors of the present invention have searched for antibacterial substances for
Helicobacter pylori
among of substances accepted as food additives in order to solve the above-mentioned problem, and found that one kind of a chelating agent, EDTA, and its metal salts. have an action for growth inhibition of
Helicobacter pylori
. Thus, the present invention has been completed based on this finding.
That is, the present invention relates to an antibacterial agent for
Helicobacter pylori
, characterized in that at least one substance selected from ethylenediaminetetraacetic acid and its metal salts is contained as an effective component.


REFERENCES:
DATABASE PubMed, Whittaker et al, Regul. Toxicol. Pharmacol , Dec. 1993, 18(3), 419-27, abstract.*
MEDLINE 86242415, Cardan et al, Arzneimittle-forschunhg, Apr. 1986, 36(4), 756-8, abstract.*
BIOSUS PREV199497124372, Perez-Perez et al, Infection and Immunity, 1994, 62(1), 299-302, abstract.*
Y. Koga and A. Takagi, “Anti-Helicobacter pyloriActivity of a Lactic Acid Bacillus”,Shokunokagaku, 265, 87-89 (2000).

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