Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a seed or nut
Reexamination Certificate
2002-05-22
2002-12-03
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from a seed or nut
C424S725000, C424S439000
Reexamination Certificate
active
06488969
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Technical Field
The present invention relates to a pharmaceutical, food or drink, and feedstuff, which contain a cocoa component and have an effect for eradicating
Helicobacter pylori,
a wound healing-promoting effect and an effect for reducing blood ammonia concentration.
2. Background Art
Helicobacter pylori
is a Gram-negative spirillo bacillus separated from gastric mucosa of chronic gastritis patients by Warren and Marshall of Australia in 1983, and it has been reported that this bacillus is separated from gastritis patients and duodenal ulcer patients at high rate.
It has been known that the infection of this bacillus induces acute gastritis and chronic gastritis, and also acts as a recurrence factor and a healing-delay factor of gastroduodenal ulcer. It has been reported by many researchers that the recurrence rate of gastroduodenal ulcer (usually recurred at a rate of 70 to 80% after 1 year) can remarkably be decreased (recurrence rate: 0 to 30%).
Incidentally, the infection rate of
Helicobacter pylori
in Japan increases with age and is as high as about 75% at the age of 40 or higher.
As described above, the elimination of
Helicobacter pylori
has large merit in therapeutics of peptic ulcer, but in reality, the elimination method has been changed with the relation between the merit and side effects.
Firstly, three agents combination therapy using bismuth, tetracycline and metronidazole, recommended in World Society of Digestive System Diseases held in Sydney in 1990, has a merit such that the elimination rate is high (the elimination rate is at least 90%), but it tends to bring about side effects at a high rate and there were many cases that its application can not be continued. After that, in the United States, by the unified view of NIH (National Institute of Health) in 1994, a report was announced that for the
Helicobacter pylori
-positive ulcer patients, therapeutics with an antibacterial agent is needed in addition to therapeutics with an acid secretion inhibitor, irrespective of initiation or recurrence. According to this report, it is firstly reported that the use of a proton pump inhibitor (hereinafter referred to as PPI) as the acid secretion inhibitor and one antibacterial agent in combination is effective and shows less side effect. However, the elimination rate of this method is not necessarily high and can not be said adequate, whereby it has been attempted to change the type of antibacterial agent variously.
It has recently been reported that another one antibacterial agent is further added, namely the use of PPI and two types of antibacterial agents in combination. However, at the present stage, its effectiveness and side effect will be evaluated in the future.
Further, JP-A-11-1429 discloses an anti-
Helicobacter pylori
agent comprising as an active ingredient at least one member selected from peppermint oil, spearmint oil, various types of flavor components and extracts of various natural materials. It also describes in vitro experimental results that an extract obtained from cacao husk or cacao nibs by ethanol extraction shows a growth-inhibiting action against
Helicobacter pylori.
However, in JP-A-11-1429, with respect to the extract obtained from cacao husk or cacao nibs by ethanol extraction, only in vitro experimental results are indicated, and no effect in clinical tests is confirmed. Further, in Test Example 2 of this publication, results of antibacterial test on humans using limonene and an ethanol extract of cardamon in combination, which shows the highest antibacterial effect, are described. The numerical value of elimination rate of 35% thereby obtained can be evaluated from the viewpoint of no anxiety about side effect, but this elimination rate is so low that its usefulness is considered to be low.
As described in the foregoing, no elimination therapy having both antibacterial effect of 100% against
Helicobacter pylori
and adequate safety, has been established. Accordingly, it is demanded to avoid a multiple agents combination therapy which is complicated and provides large side effect and to establish an elimination therapy which is as simple as possible and provides a high elimination effect and little side effect.
On the other hand, therapies of injuries of surface tissues, i.e. so-called wound, such as surgical incision, gastrointestinal ulcer, burn, laceration or ulcer of skin (e.g. bedsore), are roughly classified into a surgical treatment such as ablation of ulcer tissues, epidermization or suturing, or a conservative treatment mainly made by using an external agent such as an antibiotic agent-containing ointment.
However, these conventional therapies of wound are ones of only awaiting the healing of wound by natural recovery power of organism after all, and therefore a long time is required for recovery and these therapies accompany pains such as soreness.
Accordingly, in order to accelerate the repair and regeneration of tissues at the wound portions positively and directly without relying on the natural recovery power, pharmaceuticals which stimulate or promote steps of differentiation, propagation and the like of cells, have been developed, and frequent use thereof was recently started.
For example, in a local treatment of the conservative treatment, an external agent having actions such as promotion of granulation, improvement of local circulation, or promotion of epidermization, has been used after depuration of wound surface such as protection of the wound surface, removal of slough tissues, or prevention of secondary infection. As such an external agent, an extract from hemolysed blood of young calves (sorcoseryl) (Applied Pharmacology, vol.22, pp 565-579, 1981), tocoretinate (orsenone ointment) (Applied Pharmacology, vol.43, pp 121-127, 1992), and the like have been known. Further, as an internal agent, a decomposition product of lactoferrins (JP-A-8-81387), dehydro epiandrosterone as a steroid hormone secreted from adrenal cortex and its derivatives (JP-A-11-193236), and the like have been proposed.
However, the above agents are not fully satisfactory in all of healing effect, safety, production costs and the like. For example, the above external agents can not be said adequate in the healing effect, the decomposition products of lactoferrins accompany trouble and cost for purification of lactoferrin, and dehydro epiandrosterone has a problem in the safety.
Further, foods that we ingest are degraded to low molecular weight substances such as amino acids and glucose, by the action of digestive enzymes in stomach and small intestine, and absorbed as nutrients in intestinal canal. Residues not digested and absorbed in the intestinal canal are transferred to large intestine, and after moisture content and the like are absorbed, excreted to outside of the body as feces. In large intestine, a lot of enterobacteria exist. Among the enterobacteria, harmful bacteria represented by Welch's bacillus and colibacilli act to degrade and ferment undigested proteins and lipids in the residues, and resultingly produce harmful putrefaction such as ammonia, amine, mercaptan, hydrogen sulfide, indole or scatole, which is a cause of offensive odor of feces (hereinafter referred to as an enteral putrefaction). A part of the enteral putrefaction is absorbed through intestinal wall and enters the blood, but it is usually detoxicated in liver and excreted to outside of the body together with urine by kidney, whereby no serious influence to the human body is caused.
However, it is known that if the putrefaction is stored in the blood by the hypoactivity of liver and kidney, congenital disease (hyperammonemia plasma I and II types, congenital urea cycle enzyme deficiency, and the like) and the like, various adverse effects are caused. For example, it is known that increase of the blood ammonia concentration causes emesis, fever or pyrexia, and in serious cases, hepato celebral encephalopathy.
Accordingly, with persons having the functions of liver or kidney deteriorated or the above congenital disease
Hashizume Shuichi
Ito Ryouichi
Kamei Masanori
Mato Takashi
Tsutsumi Haruhiko
Coe Susan D.
Frishauf Holtz Goodman & Chick P.C.
Lankford , Jr. Leon B.
Morinaga & Co., Ltd.
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