Drug – bio-affecting and body treating compositions – Fermentate of unknown chemical structure
Reexamination Certificate
1999-10-05
2001-01-30
Prats, Francisco (Department: 1651)
Drug, bio-affecting and body treating compositions
Fermentate of unknown chemical structure
C424S401000, C424S065000, C424S093300, C424S093400, C424S093450, C552S576000, C514S179000
Reexamination Certificate
active
06180101
ABSTRACT:
TECHNICAL FIELD
The present invention concerns a remedy for tragomaschalia using an adrenocorticosteroidal preparation and, more in particular, it relates to a remedy for tragomaschalia using the adrenocorticosteroidal preparation in combination with an extraction product from lactic acid fermentation.
BACKGROUND ART
Various attempts have been made so far as countermeasures or treatments for tragomaschalia, such as elimination of odor by deodorants, suppression of an environment for bacterial multiplication by antiperspirants and inhibition of bacterial activity and sterilization by antibacterial substances such as antibiotics or bactericides.
Steroid secretory epithelial tissues such as aporine glands attributable to tragomaschalia metabolize and secretes various steroid compounds such as cholesterol and sex hormone.
A kind of steroid compound among them is metabolized by bacterial flora that have rooted and multiplied on the axilla epithelium, thus producing an odoriferous steroid compound 5&agr;-androst-16-en-3-on(5&agr;-A), which causes tragomaschalia. The compound itself however has not been detected in secretions from the secreting tissues concerning tragomaschalia. A general theory suggests that a C
19
steroid compound metabolized and produced in the secretory tissues may be metabolized again and produced by the bacteria rooted in the underarm.
Among the bacteria rooted on epithelia, many propionibacteria or coryneform bacteria and some of staphylococci include species having a steroid metabolism function.
Conventional countermeasures against tragomaschalia have mainly been performed by inhibiting the production of odoriferous steroid by axilla application of antibiotics, to remove bacteria rooted on the axilla epithelia. The effects however are only temporary, and tragomaschalia can be eradicated at present only by a surgical treatment.
The inventors had studied on the subject of finding a remedy capable of rapidly eradicating tragomaschalia without any surgical treatment and, as a result, found it effective to combine an adrenocorticosteroid and an antibacterial substance as a supplemental agent, which has already been proposed (Japanese Patent Unexamined Publication Hei 3-66608).
Adrenocorticosteroidal preparations have not been used at all for treating tragomaschalia and, therefore, concrete pharmaceutical actions of them against tragomaschalia have not yet been clear, but it is supposed that they are due to the sensitivity of propionibacteria to adrenocorticosteroids and, particularly, due to the inhibition of secretion of causal substances for the odoriferous steroid from the axillary epithelial tissues caused by the action of inhibiting living tissues to synthesize and secrete steroids, which is one of physiological actions of adrenocorticosteroids.
The therapeutic effects of the adrenocorticosteroidal preparation for tragomaschalia are extremely remarkable and rapid, and our initial clinical experiments had revealed that several times of application of an effective amount of not more than about 2 mg can heal tragomaschalia very effectively though it depended on symptoms. However, a steroidal preparation itself might possibly cause adverse drug reactions by continuous use, and it is preferable to use it at a high concentration and for a period as short as possible. The dose however was limited since adverse drug reactions such as eczema, erosion and also lichenoid change might occur if the frequency of administration was increased in accordance with constitutions and symptoms, and infectious diseases might also occur in combination.
DISCLOSURE OF THE INVENTION
The inventors have made various experiments taking notice on the fact that metabolism products of lactic acid bacteria obtained by lactic acid fermentation not only have an astriction or reparative action on skins but also shows a bacteriostatic or bacteriocidal action against bacteria, and have found that the use of an adrenocorticosteroid showing a specific therapeutic effect against tragomaschalia in combination with a particular extraction product obtained by lactic acid fermentation substantially inhibits the adverse drug reaction of the adrenocorticosteroid.
That is, the present invention provides a remedy for tragomaschalia characterized in that it contains an effective amount of an adrenocorticosteroid and from 1 to 10% by weight of an extraction product from lactic acid fermentation based on a base (1 g).
BEST MODE FOR CARRYING OUT THE INVENTION
Although an adrenocorticosteroid has a significant effect on propionibacteria, a cause for tragomaschalia, already at a concentration of about 100 ppm based on a base it is preferred to use It at a concentration at least of 300 ppm as a practical remedy for tragomaschalia. On the other hand, administration at a concentration in excess of about 30,000 ppm (30 mg/g) no more increases the effect.
The adrenocorticosteroidal preparations used for the present invention include many commonly known adrenocorticosteroidal preparations showing a similar effect such as prednisolone, cortisone, cortisol, hydrocortisone, prednisone, methylprednisone, methylprednisolone, triamcinolone, dexamethasone, paramethasone, betamethasone and beclomethasone.
On the other hand, adverse drug reactions by such adrenocorticosteroids are remarkably inhibited by the extraction products from lactic acid fermentation. Although the reason is not always clear, it is supposed that the extraction products not only prevent occurrence of skin disorder induced as an adverse drug reaction of the adrenocorticosteroid but also recover the lesion and change of the skins to normal states to inhibit induction of infectious diseases.
The extraction product is used within a range from 1 to 10% by weight based on a base. An intended effect is observed already at 1% by weight and the effect increases with the increase of the concentration, but a stimulative feeling to skins is increased to disturb practical therapy if it exceeds 10% by weight.
As the extraction product by lactic acid fermentation of the present invention, it is preferred to use a mixture of an extraction product obtained from lactic acid fermentation, particularly, a purified lactic acid solution obtained by a heat sterilization and filtration with a membrane filter of a lactic acid fermentation liquid, and an extraction product derived from cytoplasms of bacterial cells obtained by milling lactic acid bacterial cells as a cake.
The extraction products obtained from lactic acid fermentation contain a metabolism product (lactic acid) released from bacterial cells and, in addition, various kinds of amino acids, proteins, nucleic acids, lipids, glycoproteins and polysaccharides derived from the constituents of the bacterial cells, and they are collectively referred to as the extraction product from lactic acid fermentation.
The lactic acid bacteria used in the present invention have a feature in that they are of bacteria strains selectively obtained by simultaneous culturation of different multiple kinds of lactic acid bacteria in a step of mutual competitive growth.
Lactic acid bacteria used for the present invention include various species, and culturing methods therefor are also varied. For example, a preferred result is obtained by primary culturation of a multiplicity strains of lactic acid bacteria in each of groups (I) to (IV), containing at least one strain of lactic acid bacillus and one strain of lactic acid micrococcus in each group, the bacteria strains being different between each of the groups, namely, I (
B. bulgaricus A, B. acidophilus
1,
M. lactisacidi
), II (
B. bulgaricus B, B. acidophilus, M. lactisacidi
), III (Kornchenbacillus A,
B. acidophilus, M. lactisacidi
) and IV (Kornchenbacillus B,
B. acidophilus, W. lactisacidi
), separately under a predetermined condition on every group, and then further simultaneous secondary culturation by collecting the thus obtained culturation products of respective groups together. Preferably, in this case, the metabolism products in the primary culturation are removed by filtratio
Coe Susan D.
Liniak Berenato Longacre & White
Prats Francisco
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