Preparation for prevention and healing of inflammation...

Details Preparation for prevention and healing of inflammation... Preparation for prevention and healing of inflammation...

2000-07-27

2003-08-26

Spear, James M. (Department: 1615)

Drug, bio-affecting and body treating compositions

Solid synthetic organic polymer as designated organic active...

Aftertreated polymer

C424S078050, C424S078080, C424S078140

Reexamination Certificate

active

06610284

ABSTRACT:

This application is a 371 of PCT/CZ98/00046 filed Oct. 2, 1998.
TECHNICAL FIELD
The invention relates to a preparation for prevention and healing of inflammation affections having a radical scavenging capacity with a large biological spectrum coverage. The preparation is applicable to the prevention and healing of skin, hide, fascia and muscle surface injuries and wounds extending in various depths which are accompanied by a massive proliferation of radicals due to the oxygen reduction and by generation of reactive oxygen products.
BACKGROUND ART
Due to the effect of various types of radiation such as UV, gamma, X-ray and similar radiation as well as hyperoxia, xenobiotic, upon injury or as a result of certain diseases, the living organisms, may suffer from surface lesion affecting the skin, fascia, and muscle in different depth. Upon-any injury a massive proliferation of radicals occurs due to the oxygen reduction accompanied by generation of reactive oxygen compounds. The reason for the radical proliferation is a defect in coordination of redox enzymatic systems of the living tissue under injury as well as the activity of the leukocytes present. The reactive oxygen compounds, mostly of radical nature, have aggressive impact on biological systems and produce often irreparable changes, for example in reaction with lipids, proteins, or DNA and cause damage to physiological protective mechanisms preventing the biological systems from the adverse effect of reactive oxygen products. Simultaneously, enzymatic systems are activated, Which contributes to the generation of the reactive oxygen products.
The protective systems present physiologically in the living organisms are low-molecular weight compounds such as vitamins C, E, glutathione or macromolecular compounds such as enzymes, catalase, superoxide dismutase, glutathione, reductase, peroxidase or cyclooxygenases. In the event of a deep tissue damage the aforesaid compounds align with the phagocyte activity of leukocytes are not able to control the proliferation of free radicals to the extent which could ensure a satisfactory healing effect.
If a wound is attacked by bacteria, the reactive oxygen radicals may cause damage to the tissue but, on the other hand, they are not enough to stop the bacteria growth, which results in the degradation of the tissue macromolecules and in the accompanying penetration of leukocytes, which is the major reason for a pyogenic process. Subsequently, even if the production of bacterial flora is controlled, such radicals cause an excessive cytokine production, which promotes the growth of fibroblasts and, due to copious granulation, the epithelization is going down, which again results in a delayed healing process.
The conventional medical treatment mostly concentrates on the inflammation stage (using bacteria eliminating antibiotics, granulation medicaments, including prostaglandins) and is mostly insufficient in the epithelization stage, for example, a treatment of the wound may occur, however, granulations are poor or granulations are copious but the wound fails to come to epithelization.
SUMMARY OF INVENTION
The object of the invention of a preparation for prevention and healing of inflammation affections is to eliminate, to a considerable extent, the above inconvenience. The preparation comprises 0.1 to 99.9% by weight, derivatives of sterically hindered amines selected from the group consisting of:
soluble polymers or copolymers prepared by radical polymerization in the presence of 0.01 to 10% by weight of initiators in polymerization mixture comprising individually or in combination an aliphatic amine monomer of the general formula (A):
where R
A
to R
F
are: alkyl C
1
-C
4
,—(CH
2
)
n
— and n=3, 4, 5, polymerizable vinyl group in various combination and representation, R
6
is alkyl C
1
-C
4
, individually or in any combination, H, OH or oxygen radical obtained by additional oxidation; soluble polymers or copolymers prepared by radical polymerization in the presence of 0.01 to 10% by weight of initiators, from monomers of cyclic sterically hindered amines of general formula (B)
where R
1
to R
4
are: alkyl C
1
-C
4
, —(CH
2
)
n
— and n=3, 4, 5, R
6
is alkyl C
1
-C
4
, individually or in any combination, H, OH or oxygen radical obtained by additional oxidation and W is selected from the group including —CH(X)— a —CH(X)CH
2
— where X is:
—N(X)— and —N(X)CH
2
— where X is:
—O—, —OCH
2
—, and R
1
to R
4
is a radical having one polymerizable vinyl group; soluble polymers prepared by polycondensation of difunctional sterically hindered amimes of the general formula (F)
where R
A
to R
F
are: alkyl C
1
to C
4
, —(CH
2
)
n
— and n=3, 4, 5, hydroxyalkyl, aminoalkyl, carboxyalkyl (halogenide, activated ester, azide), isocyanatoalkyl in various combination and representation, R
6
is alkyl C
1
-C
4
, individually or in combination H, OH or oxygen radical obtained by additional oxidation;
soluble polymers or copolymers prepared by polycondensation of difunctional cyclic sterically hindered amines of the general formula ((G)
where R
1
to R
4
are: alkyl C
1
-C
4
, —(CH
2
)
n
— and n=3, 4, 5, hydroxyalkyl, aminoalkyl, carboxyalkyl (halogenide, activated ester, azide), isocyanatoalkyl, R
6
is alkyl C
1
-C
4
, individually or in combination H, OH or oxygen radical obtained by additional oxidation and W is selected from the group —O—, —OCH
2
—, —NH—, —NHCH
2
— where R
1
-R
4
is hydroxyalkyl, aminoalkyl, carboxyalkyl (halogenide, activated ester, azide), isocyanatoalkyl) —CH(X)—, —CH(X)CH
2
—, where X is:
n is 1 to 10, m is 2 to 10
where A, B are —OH, —NH
2
, —COOH;
soluble copolymers prepared by polycondensation of difunctional cyclic, sterically hindered amines of the general formula (G) and monofunctional cyclic sterically hindered amines in an amount of 0.1 to 15%. by weight, based on the total polymerization mixture of the general formula (H)
where R
1
to R
4
are: alkyl C
1
-C
4
, —(CH
2
)
n
and n=4 or 5, hydroxyalkyl, aminoalkyl, carbokyalkyl, ore their reactive derivatives, R
6
is alkyl C
1
-C
4
, individually or in combination H, OH or oxygen radical obtained by additional oxidation and W is selected from the group consisting of: —O—, OCH
2
—, —NH—, —NHCH
2
—, where R
1
to R
4
is hydroxyalkyl, aminoalkyl, carboxyalkyl, CH(X)— a CH(X)CH
2
— where X: —COOH (halogenide, activated ester, mixed anhydride, azide), —NCO,
where n is 2-10, m is 1-10;
derivatives of sterically hindered cyclic amines of general formula
where R
1
to R
4
are: alkyl C
1
-C
4
, —(CH
2
)
n
— and n=3 to 5, hydroxyalkyl, aminoalkyl, carboxyalkyl, in combination and any representation R
6
is alkyl C
1
to C
4
, H, OH or oxygen radical in any representation and W is represented by following groups: —O—, —OCH
2
—, —NH—, —NHCH
2
—, —CH(X)—. —CH(X)CH
2
—, where X=
and R
1
, R
2
are alkyl C
1
-C
10
;
polymers, copolymers, natural compounds comprising free reactive groups —OH, —NH
2
, —COOH, —CHO, oxiran, selected from the group consisting of poly(vinyl alcohol), cellulose, (2-hydroxyethyl)cellulose, (carboxymethyl)celullose, agar derivatives, polymers obtained by condensation, using dihydroxyalkane derivatives, oligomers and polymers of ethylene glycol or propylene glycol, natural o synthetic polymers, comprising a free carboxyl group, amino group or aldehyde group, prepared by additional functionalization of polymers or natural compounds by polymer-analogous reaction with a suitable sterically hindered amine selected from the group comprising:
4-X-1-R
6
-2,2,6,6-tetramethyl-piperidine
where X is —NH
2,i
—OH, -halogen, —NCO, —COOH (halogenide, activated ester, mixed anhydride, azide), —CH
2
Br and R
6
is alkyl C
1
-C
4
, individually or in combination, H, OH or oxygen radical obtained by additional oxidation;
(n-X-alkyl)-1-R
6
-(2,2,6,6-tetramethyl-piperidin-4-yl)amine of the general formula
where n=1 to 10, X is halogen, —OH, —NH
2
, —COOH, (halogenide, mixed anhydride, activated ester, azide), R
6
is alkyl C
1
-C
4
, individually or in combination,

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