Drug – bio-affecting and body treating compositions – Dentifrices – Plant extract of undetermined constitution
Reexamination Certificate
2002-11-27
2004-11-02
Henley, III, Raymond J. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Plant extract of undetermined constitution
Reexamination Certificate
active
06811769
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an oral composition and an oral hygiene method, and more particularly to an oral composition and oral hygiene method that may be used in the prevention and/or treatment of periodontal disease.
2. Description of the Related Art
Periodontal disease is an affliction that may be referred to separately as periodontitis (or also called alveolar pyorrhea) and gingivitis. The incidence of periodontal disease increases with age. Finding a method of preventing and/or treating periodontal disease is one of the most important problems to be solved in the fields of medical and dental science. Of course, finding medicines or methods of preventing dental caries (e.g., tooth decay) is also one of the most important problems to be solved in the fields of medical and dental science.
Bacteria which may cause periodontal disease (hereinafter referred to as periodontal disease-related bacteria) include:
Porphyromonas gingivarlis,
Porphyromonas endodontalis,
Prevotella intermedia,
Fusobacterium nucleaum
, and
Actinobacillus actinomycetem comitans.
Bacteria which may cause tooth decay (e.g., dental caries) (hereinafter referred to as tooth decay-related bacteria) include:
Streptococcus mutans,
Streptpcoccus sanguis,
Streptococcus mitis,
Actinomyces viscosus,
Actinomyces naeslundii
, and
Lactobacillus casei.
Hitherto to the present invention, gargling with a bactericide is commonly employed for treatment of periodontal disease. However, gargling with such a bactericide causes bactericidal action to affect all the bacteria resided in the oral cavity, thereby causing a transient decrease in the number of bacteria. As a result, the indigenous bacteria beneficial to a human being, which administer the oral immune function, are also controlled together with the periodontal disease-related bacteria.
When the immune function in the entire human body is operating properly, the number of beneficial indigenous bacteria reduced by the bactericide may be raised to the original level in a relatively short period of time. However, when the immune function of a human body is deteriorated by aging or disease, growth of the periodontal disease-related bacteria may exceed that of the indigenous bacteria, thereby resulting in further aggravation of the periodontal disease.
For the prevention and/or treatment of periodontal disease, in addition to cleaning the oral cavity by brushing the teeth, it has been also widely known that enhancement of oral immune function is very important.
For such a reason, it has been desired to develop a medicine useful for the prevention and/or treatment of periodontal disease, which has a selective antibacterial activity capable of sufficiently controlling growth of the periodontal disease-related bacteria but not controlling (e.g., adversely affecting) the beneficial indigenous bacteria.
Under the circumstances, the present inventor found that an oral composition which includes at least two extracts of crude drugs selected from arecae semen (betel nut),
glycyrrhizae radix
(glycyrrhiza),
myristicae semen
(nutmeg) and
leonuri herba
(
leonurus sibiricus
) had the selective antibacterial activity as described above. This is disclosed, for example, in Japanese Laid-open Patent Publication No. H06-157259, hereinafter referred to as the first prior patent application in Japan. Such an oral composition exhibits high antibacterial activity against the periodontal disease-related bacteria, does not deteriorate the oral immune function, and has an action accelerating the healing of the periodontal tissue injured due to periodontal disease and further an action accelerating the growth of fibroblasts (e.g., see Shuji Watanabe, “Periodontal disease can be prevented and treated by oneself”, published by Makino Shuppan, 1999).
Further, the present inventor researched the effect of the above-described extracts of crude drugs on the DNA synthesis in human gingival epithelium cells and on the generation of interleukin-8 (IL-8) in human gingival fibroblast cells, and found that the above-described extracts of crude drugs had the DNA synthesis-accelerating effect and IL-8 generation-accelerating effect (Shuji Watanabe, “TRADITION & MEDICINE”, Vol. 8, No. 1,2002).
However, this conventional oral composition does not have sufficient antibacterial activity against
actinobacillus actinomycetem
comitans, which is often found in patients suffering from vicious periodontal disease, among the periodontal disease-related bacteria.
Therefore, the present inventor searched for a medicine which had sufficient antibacterial activity against actinobacillus actinomycetem comitans, as well as no adverse effect to the periodontal tissue. As a result, the present inventor found that an oil extract of mastic exhibited high antibacterial activities against not only actinobacillus actinomycetem comitans but also the other periodontal disease-related bacteria and the tooth decay-related bacteria as described above. This is disclosed, for example, in Japanese Laid-open Patent Publication No. 2002-29982, hereinafter referred to as the second patent application in Japan. The present inventor demonstrated for the first time, the antibacterial action of mastic against the periodontal disease-related bacteria and the tooth decay-related bacteria.
“Mastic”, which is also called olibanum, is a resinoid exudate obtained from
Pistacia lentiscus
belonging to anacardiaceae, a shrub grown on the coast of the Mediterranean Sea. The mastic resin has a long history from the days of ancient Greece and is used for various purposes. For example, it is used as a gum base for chewing gum, a fragrant material, a food additive, a lustering agent, a coating material, a beverage additive, a coating material for intestines, a medicine, etc. It has been understood that the mastic resin may act to activate the immune system when used for treatment of ulcer, reduction of blood sugar level and cholesterol level, amelioration of diabetes, and treatment of cancer.
The mastic resin has also had applications in the dental field. For example, it has been used as a filler for transiently filling up a carious cavity. Also, it has been believed that the mastic resin acts to strengthen teeth. Further, in the place of origin of the mastic resin, teeth cleaning has been carried out with a toothpick made of Pistacia lentiscus (from which the mastic resin was obtained) since long ago.
Sodis et al. (U.S. Pat. No. 5,637,290) discloses an oral hygiene product (tooth paste or mouth wash) which includes the combination of a toothpaste and an ingredient selected from natural mastic from Chios, extracted mastic oil, and synthetic mastic oil agents. In the invention disclosed by Sodis et al., it is understood that mastic chemically reacts with the polymorph-nucleus causing the gathering of white blood corpuscles, resulting in the increase of the defense system of the tissues in the area, and decreases the formation of plaque and gum disease (periodontal disease). However, Sodis et al. does not disclose nor teach any antibacterial activities of mastic.
SUMMARY OF THE INVENTION
In view of the foregoing problems of the conventional formulations, a purpose of the present invention is to provide a formulation capable of making an oil extract of mastic which may be contained in a high (e.g., higher) concentration and used in the stable state. Another object of the present invention is to develop a method of using the oil extract of mastic and crude drugs, by which superior prevention and/or treatment of periodontal disease can be obtained.
The present inventor studied zealously and as a result, found that it is possible to obtain an oral composition (e.g., an oral composition for prevention and/or treatment of periodontal disease) which includes the oil extract of mastic as a component. Further, the oil extract of mastic can be used in an appropriate amount depending upon the condition of periodontal disease. In addition, the oil extract of mastic can be held in the stable state o
Henley III Raymond J.
McGinn & Gibb PLLC
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