Drug – bio-affecting and body treating compositions – Topical body preparation containing solid synthetic organic...
Reexamination Certificate
1999-07-01
2003-05-27
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Topical body preparation containing solid synthetic organic...
C424S195110, C514S456000
Reexamination Certificate
active
06569416
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to synthetic soil extract substances comprised of phenolic polymers, to the procedures for the preparation thereof, to the processes for the purification and isolation as aqueous solutions or dried powders of the synthetic materials, to compositions and methods for employing these synthetic phenolic polymers for reducing or eliminating viral activity in blood products, anti-viral compositions for treating or preventing human or animal viral diseases and antimicrobial compositions for treating or preventing human or animal microbial diseases.
BACKGROUND OF THE INVENTION
Soil extract materials, particularly the classes of substances known collectively as “humus,” “humics,” “humic acid(s),” or “humates,” have been widely used in a number of applications for many years, as reviewed by F. J. Stevenson,
Humus Chemistry. Genesis Composition Reactions
; New York: Wiley, 1964; and, more recently, by A. Piccolo,
Humic Substances in Terrestrial Ecosystems
; New York: Elsevier, 1996.
Natural and synthetic soil extracts have already been used extensively in horticultural and related industries, particularly as soil enhancement as well as soil remediation agents. In addition, natural and synthetic soil extracts have been employed as additives in organic gardening and landscaping; and in fresh-water aquaria. Some medicinal benefits have also been claimed for both synthetic- and naturally-occurring soil extract substances.
R. H. Faust, in a paper presented at the
Conference of the International Federation of Organic Agriculture Movements; Copenhagen, Denmark: October,
1996; P2, 20, has documented the benefits of humates in agriculture. In general, it has been found that humic materials can stimulate plant growth, including crop yield, by about 10-30%.
Soil extracts, and humic acid in particular, chelate a variety of metals. As a result, humic materials have been employed in soil remediation to remove heavy-metal contamination, as reported by M. A. Rashid,
Soil Sci.
1971, 111, 298-306. Humic acid has also been used to enhance the removal of aromatic hydrocarbons from aquifers contaminated with petroleum products: H. Xu, S. Lesage, L. Durham, and K. Novakowski, in
Proceedings of the Fourth Annual Symposium on Groundwater and Soil Remediation; Calgary Alberta: Sep.
21-23, 1994; 635-646; S. Lesage, H. Xu, K. S. Novakowski, S. Brown, and L. Durham, in
Proceedings of the Fifth Annual Symposium on Groundwater and Soil Remediation
; Toronto, Ontario: Oct. 2-6, 1995.
Humate materials have been used as poultry feed additives. Adding humate materials to the fodder of broiler chickens increases the yield mass on average by 5-7%, and also provides for a 3-5% gain in poultry safety: L. M. Stepchenko, L. V. Zhorina, and L. V. Kravtsova,
Biol. Nauki
1991, 10, 90-95.
T. A. Huck, N. Porter, and M. E. Bushell,
J. Gen. Microbiol.
1991, 137(10), 2321-2329, have reported that soil isolates are effective media additives for the production of antibiotics, and that the extent of microbial growth stimulation can be quite large depending upon the species, the culture medium, and the environment. The use of selected batches of soil lignite humate as culture media for isolating thermophilic Campylobacter species extracts has also been documented by K. Weinrich, K. Winkler, and E. Heberer,
DTW Dtsch. Tierarztl Wochenschr.
1990, 97(12), 511-515. In addition, B. Grunda,
Zentralbl. Bakteriol. Parasitenkd. Infektionskr. Hyg.
1970, 125(6), 584-593, has described the effects of humic acid on the count of soil microorganisms in culture.
Humates have long been used as folk remedies for a wide variety of illnesses (F. K. Achard,
Crells Chem. Ann.
1786, 11, 391-403), as recounted by T. D. Lotosh,
Biol. Nauki
1991, 10, 99-103.
Humic acids isolated from peat exhibited significant efficacy for adhesions when tested on female rats that had standardized lesions placed on both uterine horns and the peritoneum of the anterior abdominal wall: M. Mesrogli, D. H. Maas, B. Mauss, S. Plogmann, W. Ziechmann, and J. Schneider,
Zentralbl. Gynakol.
1991, 113(10), 583-590.
The ability of natural humic acid to affect anaphylactic sensitization and mast cell secretory function has been established by J. Wyczolkowska, T. Michon, Z. Slusarczyk, B. Kolago, and C. Maslinski,
Acta Pol. Pharm.
1993, 50(6), 475-480. Humic substances in doses of 20 and 50 milligrams per kilogram body weight reduced histamine release from mouse peritoneal mast cells challenged with anti-IgE or concanavalin A in vitro.
Humic substances, including peats and sodium humates, are known to exhibit anti-inflammatory properties: M. Kuhnert, V. Fuchs, and S. Golbs,
Arch. Exp. Veterinarmed.
1982, 36(2), 169-177; S. B. Ye, J. Y. Chen, and Z. X. Zeng,
Ssu Chuan I Hsueh Yuan Hsueh Pao
1985, 16(2), 127-129. Inflammatory states of the cervix, especially cervical erosion (known generally as cervicitis), can be treated with humic preparations: J. Woyton, M. Gabrys, T. Bielanow, M. Zimmer, J. Sokalski, R. Geneja, and M. Zborowski,
Arch. Immunol. Ther. Exp.
(
Warsz
) 1993, 41(1), 99-103.
Humic substances have been known to exhibit anti-microbial properties. Species for which natural as well as synthetic humic substances have been shown to be inhibitory include
C. albicans, Ent. cloacae, Prot. vulgaris, Ps. aeruginosa, S. typhimurium, St. aureus, St. epidermidis, Str. pyogenes
(R. Ansorg and W. Rochus,
Arzneimittelforschung
1978, 28(12), 2195-2198;
E. coli
and
Str. faecalis
were not affected), and
Str. mutans
(
sobrinus
) (Y. Nakamura, H. Kuwashima, S. Aoki, and T. Masuhara,
Shika Kiso Igakkai Zasshi
1989, 31(3), 329-332). Broadly speaking, concentrations in the range 50-2000 parts per million (ppm) are usually effective, yet are not cytotoxic: K. D. Thiel, B. Helbig, R. Klocking, P. Wutzler, M. Sprossig, and H. Schweizer,
Pharmazie
1981, 36(1), 50-53.
Humic substances have long been known to exhibit anti-viral properties (H. Schultz,
Dtsch. Tierarztl. Wochenschr.
1962, 69, 613; 1965, 72(13), 294-297; R. Klocking and M. Sprossig,
Experientia
1972, 28(5), 607-608), particularly retroviruses (G. Sydow, V. Wunderlich, R. Klocking, and B. Helbig,
Pharmazie
1986, 41(12), 865-868). Viral pathogens for which soil-extract materials have been shown to be effective include in particular Coxsackie virus A9 (Griggs-Baylor) (R. Klocking and M. Sprossig,
Experientia
1972, 28(5), 607-608), herpes simplex virus type 1 (B. T. Rouse (Ed.), Herpes Simplex Virus; Berlin: Springer-Verlag, 1992; R. Klocking, K. D. Thiel, P. Wutzler, B. Helbig, and P. Drabke,
Pharmazie
1978, 33(8), 539; F. Schiller, R. Klocking, P. Wutzler, and I. Farber,
Dermatol. Monatsschr.
1979, 165(7), 505-509; B. Helbig, A. Sauerbrei, R. Klocking, P. Wutzler, N. Wicht, U. Wiedemann, and G. Herrmann,
J. Med. Virol.
1987, 23(3), 303-309; R. Klocking and B. Helbig, in
Humic Substances in the Aquatic and Terrestrial Environment
; Berlin: Springer-Verlag, 1991; 407-412;) and type 2 (anon.
Zentralbl. Bakteriol [Orig. A]
1976, 234(2), 159-169; K. D. Thiel, R. Klocking, H. Schweizer, and M. Sprossig,
Zentralbl. Bakteriol [Orig. A]
1977, 239(3), 304-321; K. D. Thiel, B. Helbig, R. Klocking, P. Wutzler, M. Sprossig, and H. Schweizer,
Pharmazie
1981, 36(1), 50-53; K. D. Thiel, B. Helbig, M. Sprossig, R. Klocking, and P. Wutzler,
Acta Virol.
1983, 27(3), 200-208; K. D. Thiel, P. Wutzler, B. Helbig, R. Klocking, M. Sprossig, and H. Schweizer,
Pharmazie
1984, 39(11), 781-782); human immunodeficiency virus (HIV) (M. Cushman, P. Wang, S. H. Chang, C. Wild, E. De Clercq, D. Schols, M. E. Goldman, and J. A. Bowen,
J. Med Chem.
1991, 34(1), 329-337; M. Cushman, S. Kanamathareddy, E. De Clercq, D. Schols, M. E. Goldman, and J. A. Bowen,
J. Med Chem.
1991, 34(1), 337-342; D. Schols, P. Wutzler, R. Klocking, B. Helbig, and E. De Clercq,
J. Acquir. Immune Defic. Syndr.
1991, 4(7), 677-685; S. Loya, R. Tal, A. Hizi, S. Issacs, Y. Kashman, and Y. Loya,
J. Nat. Prod
1993, 56(12), 2120-2125; J. Schneider, R. Weis, C. Manner, B, K
Fubara Blessing
Lamb Biochemicals Corp.
Page Thurman K.
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