sign in sign up
<<
Home , Absolmsia, Acokanthera, Angadenia, Anisopus (plant), Antrocaryon, Argylia

US0077.49544B2

(12) Patent (10) Patent No.: US 7,749,544 B2 Asiedu et al. (45) Date of Patent: Jul. 6, 2010

(54) COMPOSITION FORTREATING AIDS AND (56) References Cited ASSOCATED CONDITIONS OTHER PUBLICATIONS (76) Inventors: William Asiedu, H/N B 183/19 Bintu Area, PMB Ministries, Accra (GH): Calderon et al. (Phytotherapy Research (1997), vol. 11, pp. 606 s s s 608).* Rede hist No. 1ntu Ojewole (International Journal of Crude Drug Research (1984), vol. s s ; : 22, No. 3, pp. 121-143).* Manny Ennin, H/N B 183/19 Bintu Ginsberg and Spigelman (Nature Medicine (2007), vol. 13, No.3, pp. Area, PMB Ministries, Accra (GH): 290–294).* Michael Nsiah Doudu, H/N B 183/19 Engler and Prantl, Die Naturlichen. Pflanzenfamilien, 1897, p. 349. Bintu Area, PMB Ministries, Accra Breteler, F.J. “Novitates Gabonenses 47. Another new Dichapetalum (GH); Charles Antwi Boateng, H/N B (Dichapetalaceae) from ' Adansonia, 2003; 25(2):223-227. 183/19 Bintu Area, PMB Ministries, Fedkam Boyometal. "Aromatic of tropical central . Part Accra (GH); Kwasi Appiah-Kubi, H/N XLIII: volatile components from Uvariastrum pierreanum Engl. B 183/19 B int Area. PMB MinistriCS (Engl. & Diels) growing in ' Flavour and Fragrance Jour Accra (GH); Seth Opoku Ware, H/N B nal, 2003; 18:269-298. 183/19 Bintu Area, PMB Ministries, * cited by examiner Accra (GH); Debrah Boateng, H/N B 183/19 Bintu Area, PMB Ministries, Primary Examiner Susan C Hoffman Accra (GH); Kofi Ampim, 2 Kakramadu (74) Attorney, Agent, or Firm—Frommer Lawrence & Haug Ling, P.O. Box CT 245, Cantonments, LLP; Marilyn Matthes Brogan: Heather J. DiPietrantonio PMBOwusu, Ministries, H/N B 183/19 Accra Bintu(GH); Area, William PMB (57) ABSTRACT Ministries, Accra (GH); Akwete Lex Adjei, 15 Tillman Ct. Bridgewater, NJ An Aids and associated conditions related to Aids treating (US)US) 08807 COmoS1t1OnSpositi 1Sis d1SCIOSed.disclosed. ThThe COmoS1t1OnSpositi COmr1Se:pri a (*)*) Notice: SubiectN tO E. disclaite the tfWi. f thi followingmedicament selected families: from an extract of (Pleioscarpa at least one Bicarof the p ls: e O G adjusted under pellata); Annonaceae (Cleistopholis Patens); Dichapetal M YW- (b) by yS. aceae (Dichapetehan Madagasca Riense); Annoceae (Uvaristrum Pierreanum); Cynocynaceae (Strophantus Gra (21) Appl. No.: 10/902,993 tus); Asclepiadaceae ( Latifolium); Combreta (22) Filed: Ul. 30, 2004 ceae (Combretum Racemosum); Apocynaceae (Alostonia 9 Boonei); (Alternanthera Pungens); Aroceae (65) Prior Publication Data (Anchomanes Differmis); Cyperaceae (Seleria Voivinil); (Lannea Acida); (Kigelia Afri US 2005/O181077 A1 Aug. 18, 2005 cana); (Ceiba Pentanota); Anarcardiaceae O O (); Bombacaceae (Bombax Bounopo Related U.S. Application Data zense): Anarcardiaceae (Spondias Mombin); (63) Continuation of application No. 10/241,973, filed on ( ); a glyceryl ester of any of the foregoing Sep. 12, 2002, now abandoned. extracts; a saponin of any of the foregoing extracts; an alka loid of any of the foregoing extracts; a protein of any of the (51) Int. Cl. foregoing extracts; a fat of any of the foregoing extracts; a A6 IK 36/00 (2006.01) Sugar of any of the foregoing extracts; and any mixture of any (52) U.S. Cl...... 424/725 of the foregoing. (58) Field of Classification Search ...... None See application file for complete search history. 3 Claims, No Drawings US 7,749,544 B2 1. 2 COMPOSITION FORTREATING AIDS AND persons are of value. These estimates can be obtained through ASSOCATED CONDITIONS epidemiologic studies or special Surveys in specific popula tions. This application is a continuation of U.S. application Ser. Issues related to the case definition of AIDS were discussed No. 10/241,973, filed Sep. 12, 2002, now abandoned. 5 by the Conference of State and Territorial Epidemiologists (CSTE) at its annual meeting in Madison, Wis., Jun. 2-5. BACKGROUND OF THE INVENTION 1985. The CSTE approved the following resolutions: 1. that the case definition of AIDS used for national report 1. Field of the Invention ing continue to include only the more severe manifesta This invention relates to a composition for treating AIDS 10 tions of HTLV-III/LAV infection; and and related conditions, and more particular, to a composition 2. that the Center For Disease Control (CDC) develop more comprising at least one extract of a selected plant. inclusive definitions and classifications of HTLV-III/ 2. Description of the Prior Art LAV infection for diagnosis, treatment, and prevention, Patients with illnesses that, in retrospect, were manifesta as well as for epidemiologic studies and special Surveys; tions of acquired immunodeficiency syndrome (AIDS) were 15 and first described in the summer of 1981 CDC Pneumocystis 3. that the following refinements be adopted in the case pneumonia Los Angeles. MMWR 1981, 30:250-2; CDC - definition of AIDS used for national reporting: Kaposi's sarcoma and Pneumocystis pneumonia among a. In the absence of the opportunistic diseases required homosexual men—New York City and California. MMWR by the current case definition, any of the following 1981, 30:305-8. A case definition of AIDS for national diseases will be considered indicative of AIDS if the reporting was first published in the MMWR in September patient has a positive serologic or Virologic test for 1982 CDC Hepatitis B virus vaccine safety: report of an HTLV-IIIALAV: inter-agency group MMWR 1982, 31:465-67: CDC Up 1. disseminated histoplasmosis (not confined to lungs or date on acquired immune deficiency syndrome (AIDS)— lymph nodes), diagnosed by culture, histology, or anti United States. MMWR 1982, 31:507-14. Since then the 25 gen detection; definition has undergone minor revisions in the list of dis 2. isosporiasis, causing chronic diarrhea (over 1 month), eases used as indicators of underlying cellular immunodefi diagnosed by histology or stool microscopy; ciency Jaffe HW. Bregman DJ, Selik RM. Acquired immune 3. bronchial or pulmonary candidiasis, diagnosed by deficiency syndrome in the United States: the first 1,000 microscopy or by presence of characteristic white cases. J Infect Dis 1983, 148:339-45; Jaffe H.W. Selik RM. 30 plaques grossly on the bronchial mucosa (not by culture Acquired immune deficiency syndrome. is disseminated alone); aspergillosis predictive of underlying cellular immune defi 4. non-Hodgkins' lymphoma of high-grade pathologic ciency?, (Reply to letter), J Infect Dis 1984, 149:829; Selik R type (diffuse, undifferentiated) and of B-cell unknown M. Haverkos H W. Curran J. W. Acquired immune deficiency immunologic phenotype, diagnosed by biopsy: syndrome (AIDS) trends in the United States, 1978-1982. Am 35 5. histologically confirmed Kaposi's sarcoma in patients J Med 1984, 76:493-500; CDC, Update: acquired immuno who are 60 years old or older when diagnosed. deficiency syndrome (AIDS) United States. MMWR 1984, b. In the absence of the opportunistic diseases required 32:688-91 by the current case definition, a histologically con Since the 1982 definition was published, human T-cell firmed diagnosis of chronic lymphoid interstitial lymphotropic virus type III/lymphadenopathy-associated 40 pneumonitis in a child (under 13 years of age) will be virus (HTLV-III/LAV) has been recognized as the cause of considered indicative of AIDS unless test(s) for AIDS. The clinical manifestations of (HTLV-III/LAV) infec HTLV-III/LAV are negative. tion may be directly attributable to infection with this virus or c. Patients who have a lymphoreticular malignancy the result of secondary conditions occurring as a consequence diagnosed more than 3 months after the diagnosis of of immune dysfunction caused by the underlying infection 45 an opportunistic disease used as a marker for AIDS with (HTLV-III/LAV). The range of manifestations may will no longer be excluded as AIDS cases. include none, nonspecific signs and symptoms of illness, d. To increase the specificity of the case definition, autoimmune and neurologic disorders, a variety of opportu patients will be excluded as AIDS cases if they have a nistic infections, and several types of malignacy. AIDS was negative result on testing for serum antibody to defined for national reporting before its etiology was known 50 HTLV-III/LAV, have no other type of HTLV-III/LAV and has encompassed only certain secondary conditions that test with a positive result, and do not have a low reliably reflected the presence of a sever immune dysfunc number of T-helper lymphocytes or a low ratio of tion. Current laboratory tests to detect (HTLV-III/LAV) anti T-helper to T-Suppressor lymphocytes. In the absence body make it possible to include additional serious conditions of test results, patients satisfying all other criteria in in the syndrome, as well as to further improve the specificity 55 the definition will continue to be included. CDC will of the definition used for reporting cases. immediately adopt the above amendments to the case The current case definition of AIDS has provided useful definition of AIDS for national reporting. data on disease trends, because it is precise, consistently This revision, in the case definition will result in the reclas interpreted, and highly specific. Other manifestations of sification of less than 1% of cases previously reported to HTLV-III/LAV infections than those currently proposed to be 60 CDC. The number of additional new cases reportable as a reported are less specific and less likely to be consistently result of the revision is expected to be small. Cases included reported nationally. Milder disease associated with HTLV-III/ under the revised definition will be distinguishable from cases LAV infections and asymptomatic infections may be report included under the old definition so as to provide a consistent able in some states and cities but will not be nationally report basis for interpretation of trends. CDC will also develop draft able. Because persons with less specific or milder 65 classifications for disease manifestations of HTLV-III/LAV manifestations of HTLV-III/LAV infection may be important infections other than AIDS, distribute these widely for com in transmitting the virus, estimates of the number of Such ment, and publish the results. Reported by Conference of US 7,749,544 B2 3 4 State and Territorial Epidemiologists; AIDS Br., Div of Viral persistent cough, general pain, tuberculosis, and amenorrhea. Diseases, Center for Infectious Disease, CDC. The extract is prepared from the bark, , root and stems of Han et al. Disclosed a process for preparing an extracted at least one plant from within the apocynaceae, annonaceae, Substance from, a mixture of a non-fat starch from Ricini dichapetalaceae, annoceae, cynocynaceae, asclepiadaceae, Semen and a root of Coptis Sp for therapeutic applications of 5 combretaceae, amaranthaceae, araceae, cyperaceae, anacar AIDS U.S. Pat. No. 5,928,645. The authors maintain that diaceae, bignoniaceae, bombacaceae, and caricacea plant the extracted substance was effective in treating AIDS but families. provided no clinical data as to the effect of this substance in A suitable plant is selected. Preferably a mixture of at least AIDS patients. In continuing work, Han et al., demonstrated two plants is selected. Suitable plants are selected from a significantanti-oxidant capacity of their Ricini Semen extract 10 family of plants including (1) apocynaceae, (2) annonaceae, using a chemiluminescence assay Hong, E. K. Kim, Y. K. (3) dichapetalaceae, (4) annoceae, (5) cynocynaceae, (6) ascl Lee, W. C., Shin, H. K., and Kim, J. B. Measurement of epiadaceae, (7) combretaceae, (8) amaranthaceae, (9) antioxidation activity based on chemiluminescence reaction. araceae, (10) cyperaceae, (11) anacardiaceae, (12) bignoni In Bioluminescence and Chemiluminescence (Status aceae, (13) bombacaceae, (14) an arcardiaceae and cari Report), Eds. Szalay, A.A., Kricka, L.J., and Stanley, P. John 15 caceae plant families. Wiley & Sons Ltd. London, England, pp. 244-246, 1993. These plants are tropical herbs that grow naturally and can Antioxidant activity of Ricini Semen extract was compared be thus cultivated in tropical, Savanna, grassland or lightly with t-butylhydroxy toluene (BHT), a potent antioxidant wooded forests of West Africa. These desert plants can also be known to people of ordinary skill in the field of the invention. found in other tropical regions of the world, including Asia, The authors therefore proposed that Ricini Semen extract has Asia Minor, South America and possibly the South-Western, anti-HIV effect although no clinical data was presented. Western and Plains regions of the United States. The active Investigations of the Ricini Semen extract in laboratory ani medicaments from these plants include, but are not limited to mals by Sub-cutaneous injection revealed significant tubular glyceryl esters, Saponins and several derivatives of alkaloids, necrosis, glomerulonephritis, and vacuolation in livers of glycosides, proteins, fats, and Sugars. male and female mice, interstitial nephritis being demon 25 The plants perse are not employed as the requisite medi strated as well in female mice. Rats showed similar symptoms cament, but rather the extract of Such selected plant or plants. in both of the male and female. Mitosis in the liver was The extraction process for the medicaments from the respec typically found, and extramedullary hematopoiesis in the tive plants comprises the following: liver and spleen also were frequently observed. Other organs (a) harvesting the barks, stems, and roots of each were not changed compared to controls U.S. Pat. No. 5,928, 30 plant, and cutting these into chips and chunks; 645. (b) washing and drying the chips and chunks under a con Chen et al., U.S. Pat. No. 6,077,512 disclosed a novel trolled temperature condition, typically about 15° to 68 topical treatment method for curing black foot disease using C. for about 3 days; plant extracts. The extract medicament comprised a basis part (c) proportionally mixing the washed and dried materials consisting of equal amounts of ground, powdered, and mixed 35 from each plant to formulate a mixture needed for each clove, frankincense, myrrha, fhizama arisaematis, pinellia, type of clinical application; monkshood (root) or kusneZoff monkshood (root), and tuber (d) grinding the resultant mixture of plant parts to a powder of bamboo-leaved orchid, and an adjuvant part consisting of composition having a particle size typically ranging in equal amounts of round, powdered, and mixed borneol, pow size from about 100 microns to about 10,000 microns; dered soy bean, borax, coptis root and/or phellodendron 40 amureause, and sepia aculeata. The medicine is used in Such (e) extracting about one part of the resultant powdery mix a manner that the powdered basis part is mixed and stirred ture in about two parts of purified water under slow with tea water until it becomes plaster-like, and the adjuvant percolation for about 1 to about 5 hours under a tem part is scattered in dry form onto the wound or Swollen area perature in the range of about 76° to about 116°C. and caused by the black foot disease before the plaster-like basis 45 allowing the mixture to cool in appropriate containers part is applied to the wound or swollen area about 0.5 cm in under ambient temperature conditions, i.e., about 16° to thickness. The wound is then bandaged and the medicine is about 33°C., for approximately 1 to 2 days; renewed once or twice a day until fresh flesh appears in the (f) re-extracting the resultant mixture in a second percola wound. Thereafter, the medicine is continuously applied but tion process using approximately 2 parts of purified in a dry form until the wound is completely healed. The 50 water under slow percolation for about 1 to about 5 hours extract medicament composition taught by Chen et al., does under a temperature in the range of about 76° to about not have any impact on AIDS itself as a systemic disease. 116° C. and allowing the mixture to cool in appropriate containers under ambient temperature conditions i.e., SUMMARY OF THE INVENTION about 16° to about 33°C., for approximately 1 to 2 days; 55 (g) repeating the extraction process a third time using a The present invention is related to a composition for treat double portion of purified water under slow percolation ing AIDS and associated conditions related to AIDS the com for about 1 to about 5 hours under a temperature in the position comprises a medicament which is an extract of at range of about 76° to about 116° C. and allowing the least one plant family. mixture to cool in appropriate containers under ambient 60 temperature conditions i.e., about 16° to about 33°C., DETAILED DESCRIPTION for approximately 1 to 2 days; (h) adding a conventional preservative system, e.g., The present invention relates to a novel extract medicament cresols, parabens, p-chlormoetaxylenol, benzoates, for use in treating AIDS, an immune deficiency or immuno alcohols, to maintain antimicrobial preservative efficacy logically compromised disease, as well as a variety of AIDS 65 of the mixed plant extract; related ailments, including recurrent and persistent fever, (i) mixing the extracts in a Suitable container, and Subject chronic diarrhea, dermatitis, generalized lymphodenpathy, ing the resulting elute repeatedly to filtration under US 7,749,544 B2 5 6 appropriate pressure and temperature conditions, to Solid product such as a tablet; or by Subjecting the result yield a pure, clean, preserved plant extract for human ant product to a filtration through a membrane filter and consumption; then a lypohilization to give powders; and then packag () fill the resultant extract through a stainless steel strainer ing the resulting mixed extracts in appropriate closure into appropriate containers for distribution; and systems for clinical use. (k) labeling the containers and presenting these for storage Typically the resultant concentrated extract contains the (The resultant concentrate may also be further concen following compounds for each plant concentrate obtained: trated into powder under reduced temperature/pressure see L. Watson and M. J. Dallwitz (1992) onwards). The conditions, e.g., by tray drying, Solvent extraction, Sol Families of Flowering Plants: Descriptions, Illustrations, vent exclusion, or spray drying, to result in a yellowish 10 Identification, and Information Retrieval. Version: 14 Dec. brown amporphous, powder for use as an injectable or 2000):

TABLE I

PLANT COMPOUNDS (1) Apocynaceae : Subclass Dicotyledonae; Tenuinucelli. cyanogenics, alkaloids Dahlgren's Superorder Gentianiflorae. Species 1500. iridoids verbascosides, Genera 164: AcOkanthera, Adenium, Aganonierion, proanthocyanidins, cyanidins Aganosma, Alafia, Allamanda, Aliomarkgrafia, delphinidins, flavonols, Allowoodsonia, Alstonia, Alyxia, Anocalyx, Ambelania, kaempferols, quercetins, Ansonia, Ancylobotrys, Anechites, Angadenia, Anodendron, elagic acid, ursolic acid, Apocyntin, Arduina, Artia, Asketanthera, Aspidosperma, Saponins, sapogenins, Baissea, Beaumonia, Boisigonia, Cabucaia, Calichia, aluminum salts, sucrose, Calocrater, Cameraria, , Carpodinus, Carruthersia, oligosaccharides, and Sugar , Catharanthus, , Cerberiopsis, alcohols Chamaecilitandra, Chilocarpus, Chonemorpha, Cleghornia, Citandra, Condylocarpon, Colina, Craspidospermin, Crioceras, Cycladenia, Cyclocotyla, Cylindropsis, Delphyodon, Dewevreila, Dictyophleba, Dipladenia, Dipiorhynchus, D-era, Ecdysanthera, Echites, Elytropits, Epigynium, Eucorymbia, Farquharia, Fernaldia, Forsteronia, Funtainia, Galactophora, Geissospermin, Gonioma, Grisseea, , Haplophyton, Himatanthus, Hoiarrhena, Hunteria, Hymenolophus, Ichnocarpus, Isonema, Ixodonerium, Kanettia, Kibatalia, Kopsia, Lacmeliea, Landolphia, Lalibertia, Laxopitimeria, Lepinia, Lepiniopsis, Leticonotis, Lochnera, Lyonsia, Maconibea, Macropharynx, Macrosiphonia, Malottetia, Mandevilia, Mascarenhasia, Meiodinus, Mesechites, Micrechtites, Microplumeria, Molongum, Mortoniella, Motandra, Mucoa, Neobracea, Neocouma, , Nouettea, Ochrosia, Odontadenia, Orthopichonia Oncinois, , Pachouria, Papuechites, Parahancornia, Parameria, Parepigynum, , Peitastes, Pentainon, Petchia, Picraima, Piectaneia, Pleiocarpa, Pleioceras, Plumeria, Pottsia, Prestonia, Pycnobotrya, Guiotania, Rauwolfia, Rhabda denia, Rhazya, Rhigospira, Rhodocalyx, Rhyncodia, Saba, Saipincies, Schizozygia, Secondatia, Sindechites, Spongiosperma Skytanthus, Spirolobium, Siennadenia, Stephanostegia, Stephanostena, Stipecoma, Sir empeiopsis, , Tabernaemoniana, , tennadenia. Thenardia, Thevetia, Tintinnabularia, Tracheiospermum, Urceola, Urnularia, Vahadenia, Vallariopsis, Vallaris, Vallesia, Vinca, Voacanga, Willughbeia, Woytkowskia, Wrightia, Xvinabaria, Xvinabariopsis. (2) Annonaceae Taxonomy - Subclass Dicotyledonae; Crassinucelli. cyanogenics, alkaloids, Dahlgren's Superorder Magnoliiflorae; Annonales. iridoids, proanthocyanidins, Cronquist's Subclass Magnoliidae: Magnoliales. APG cyanidin, flavonols, (1998) basal order: Magnoliales. Species 1200. Genera 126; quercetins, elagic acid, Afoguaiteria, Alphonsea, Ambavia, Anaxagorea, Ancana, Sucrose, oligosaccharides Annickia, Annona, Anomianthus, Anonidium, Artabotrys, Asinina, Asteranthe, Balonga, Bocagea, Bocageopsis, Boutiquea, Cananga, Cardiopetailin, Chieniodendron, Cleistochlamys, Cleistopholis, Cremastosperma, Cyathocalyx, CyathoStemma, Cymbopetailin, DaSociema, Dasymaschalon, Deeringothamnus, Dendrokingstonia, Dennettia, Desmopsis, Desmos, Dicina nona, Dielsiothamnus, Disepalum, Dickeanthus, Dugieia, Ellipeia, Ellipeiopsis, Enicosanthiim, Ephedranthus, Exelia, Fissistigma, Fitzalania, FriesOdielsia, Froesiodendron, Fusaea, Gilbertieia, Goniothalamus, Greenwayodendron, Guania, Guatteria, Guatteriella, US 7,749,544 B2 7

TABLE I-continued

PLANT COMPOUNDS Guaiteriopsis, HaploStichanthus, Heteropetailin, Hexalobus, Hornschlichia, Isolona, Letest idoxa, Lettowianihtis, Malnea, Mars-popetalum, Meiocarpidium, Meiogyne, Melodorum, Mezzettia, Mezzettiopsis, Miliusa, Mischogyne, Mitrella, Mitrephora, Mikilua, Monanthotaxis, Monocarpia, Monocyclanthus, Monodora, NeoStenanthera, Neo-tivaria, Oncodostigma, Onychopetalum, Ophrypetalum, Oreomitra, Orophea, Oxandra, Pachypodanthium, Papualithia, Petalolophus, Phaeanthus, Phoenicanthus, Piptostigma, Platymitra, Polyaithia, Polyatiax, Polyceratocarpus, Popowia, Porcelia, Pseudantabotrys, Pseudephedranthus, Pseudoxandra, Pseudu varia, Pyramidanthe, Raimondia, Reedrollinsia, Richelia, Rollinia, Ruizodendron, Sageraea, Sapranihtis, Scheferonitra, Sphaerocoryne, Steiechocarpus, Stenanoma, Tetrameranthus, Tetrapetalum, Toussaintia, Tridimeris, Trigynaea, Trivalvania, Unonopsis, Uvaria, Uvariastrum, Uvariodendron, Uvariopsis, Woodiellantha, Xylopia. (3) dichapetalaceae Taxonomy. Subclass Dicotyledonae; Crassinucelli. alkaloids, saponins, Dahlgren's Superorder Malviflorae; Euphorbiales. aluminium salts, Cronquist's Subclass Rosidae: Celastrales. APG (1998) oligosaccharides. Sucrose Eudicot; core Eudicot; Rosid: Eurosid I; Malpighiales. Species 200. Genera 3: Dichapetalum, Stephanopodium, Tapiira, (Gon-petalum, Falya) (4) Annoceae Scheferonitra subaequalis, Goniothalamus Sesquipedalis Alkaloids, cyanidins, Uvariastrum flavonols, eg. kaempferol, quercetin, and myricetin; Saponins sapogenins Sugars as sucrose, oligosaccharides or Sugar alcohols (5) Cynosuraceae Aegilopaceae, Agrostidaceae, Alopectraceae, alkaloids, arthroquinones, Andropogonaceae, Anomochloaceae, Anthoxanthaceae, proanthocyanidins, Arundinaceae, Arundineliaceae Aspereliaceae, Avenaceae cyanidins, flavonols, Banbulsaceae, Chaeti traceae, Chloridaceae, Coleanihaceae kaempferol, quercetin, Cynostiraceae, Echinariaceae, Ehrhariaceae, myricetin, ellagic acid, Eragrostidaceae, Festicaceae, Glyceriaceae, Gramineae aluminium, Sucrose and Hordeaceae, Lepittraceae, Maydaceae, Melicaceae, oligosaccharides Miliaceae, Nardaceae, Oryzaceae, Panicaceae, Pappophoraceae, Paspalaceae, Parianaceae, Phalaridaceae, Pharaceae, Saccharaceae, Spartinaceae, Sporoboiaceae, Stipaceae, Streptochaetaceae, Tristieginaceae, Triticaceae, Zeaceae (6) Asclepiadacea Taxonomy. Subclass Dicotyledonae; Tenuinucelli. alkaloids, hydrocitric acid, Dahlgren's Superorder Gentianiflorae; . L-carnitine, 3B glucuronides Cronquist's Subclass Asteridae; Gentianales. APG (1998) of different acetylated Eudicot; core Eudicot; Asterid; Euasterid I; Gentianales (as gymnemagenins, gymnemic a synonym of Apocynaceae). Species 2000. Genera 250; acid a complex mixture of at Absolmsia, AdeloStemma, Aidomene, Amblyopetailin, least 9 closely related acidic AmblyStigma, Anatropanthus, , Anisotona, glucosides, flavonols Anomotassa, Arattia, , , including kaempferol, Astephantis, Barionia, Belo.Stenna, Bidaria, Biondia, kaempferol and quercetin, , Blyttia, Brachystelma, Calotropis, aluminium, Sucrose and Campestigma, Caraitina, Ceropegia, Cibirhiza, Cionira, oligosaccharides, iridoids. Clemensiella, Cononitra, Cordylogyne, Corolonema, CosmoStigma, Costantina, Cyathostelna, Cynanchiim, Dactylostelna, Dalzielia, Decahedone, DeCanema, Decanemopsis, Dicarpophora, Diplolepis, DiploStigma, Dischidanthus, Dischidia, Ditassa, Dittoceras, Dolichopetalum, Dolichostegia, Dory.Stephania, , DrepanoStemma, Duvalia, Duvaliandra, Echidnopsis, Edithcotea, Enicocarpus, Empieciranthus, Eistegia, Fanninia, Fischeria, Fockea. Foloisia, Frerea, Funastrum, Genianthus, Glossonema, Glossostelna, , Gongronema, Gonioanthelma, GonioStemma, Gonolobits, Graphistenna, Guinnessia, , Gymnemopsis, Harmandiella, Hemipogon, HeteroStemma, Heynelia, Hickenia, HoloStemma, , X-Hoodiopsis, Hoya, Hoveila, Huernia, Huerniopsis, Hypolobus, IschnoStemma, US 7,749,544 B2 9 10

TABLE I-continued

PLANT COMPOUNDS Jacaima, Janakia, Jobinia, Kanahia, Karimbolea, Curb, Labidostelna, Lagoa, Lavrania, , Leptadenia, Lhotzkyelia, Lugonia, Ligisma, Macroditassa, Macropetalum, Macroscepis, Mahafalia, Mahawoa, Manothrix, Margaretta, , Mateliea, Meinia, Meresaldia, Merrillanthus, Metaplexis, Metastelma, Micholitzea, Microdactylon, Microloma, Microstelma, Miraglosslin, Mitostigma, Morrenia, Nationia, Nematostemma, Neoschumannia, , , Odontanthera, Odontostelma, Oncinema, OncoStemma, Ophionella, , Orbeanthus, , Oreosparte, Orihanthera, Orthosia, , , Pachycymbium, Papuastelma, Parapodium, Pectinaria, Pentalbothra, Pentacyphus, Pentarrhinum, Pentasachme, Pentastelma, , Peplonia, , Periglossum, Petaliostelna, Petopeniia, Pherotrichis, , Platykeleba, Pleurostelma, Podandra, Podostelma, Prosopostelma, Pseudolithos, Ptycanthera, Pycnoneurum, Pycnorhachis, Quaqua, Putist imbingia, Raphistemma, , Rhynchostigma, Rhyssolobium, Rhyssostelma, Rhytidocation, Riocretixia, Rojasia, , SarcoStemma, Schistogyne, Schistonema, Schizoglossum, Schubertia, Scyphostelna, Secanone, Secanonopsis, Seshagiria, Sisyranthus, , Sphaerocodon, Spirelia, Siapeia, Siapeiianthus, Stapeiopsis, Stathmostelna, SteleoStemma, Steinagoniin, Stelmatocodon, Stenomeria, Stenostelna, Stigmatorhynchus, Strohopetalum, Stuckertia, Swynnertonia, Tassadia, Tavaresia, Telminostelna, Teiosma, Tenaris, Tetractistelna, Tetraphysa, Thozetia, Toxocarpus, Treutlera, Trichocaulon, Trichosacme, Trichosandra, Tridentea, Tromotriche, Tweedia, , Tylophoropsis, Vaiia, Vincetoxicopsis, , Voharanga, Vohemaria, White-Sloanea, Widgrenia, Woodia, Xysmalobium (7) Combretaceae Taxonomy. Subclass Dicotyledonae; Crassinucelli. alkaloids, arthroquinones, Dahlgren's Superorder Myrtiflorae; Myrtales. Cronquist's proanthocyanidins, Subclass Rosidae; Myrtales. APG (1998) Eudicot; core cyanidins, flavonols, Eudicot; Rosid: Eurosid II; Myrtales. Species 600. Genera kaempferol, quercetin, about 20; Anogeissus, Bitchenavia, Bticida, Calopyxis, myricetin, ellagic acid, Calycopteris, Combrettin, Conocarpus, Danisiea, Guiera, aluminium, Sucrose and Laguncularia, Limnitzera, Macropteranthes, Meiostenon, oligosaccharides Pieleopsis, Cutisqualis, Strephonema, Terminalia, Terminaliopsis, Thiloa (8) Amaranthaceae Taxonomy. Subclass Dicotyledonae; Crassinucelli. Cyanogenics, alkaloids, Dahlgren's Superorder Caryophylliflorae: . flavonols, quercetin, elagic Cronquist's Subclass Caryophyllidae: Caryophyllales. APG acid, betalains, Saponins, (1998) Eudicot; core Eudicot; neither Rosid nor Asterid; Sapogenins, oxalates Caryophyllales. Species 850. Genera 74: Achyranthes, Achyropsis, Aerva, Allmania, Alternanthera, Amaranthus, Arthraeria, Bittaparon, Bosea, Braylinea, Caicorena, Celosia, Centena, Centenopsis, Centrostachys, Chanissoa, Charpentiera, Chionothrix, Cyathula, Dasysphaera, Dasysphaera, Deeringia, Digera, Eriostylos, Froeiichia, Gomphrena, Gossypiianthus, Guilleminea, Hebanthe, Hemichroa (~Chenopodiaceae), Henonia, Herbstia, Hermbstaedtia, Indobanaia, Irenella, Iresine, Kyphocarpa, Lagrezia, Leucosphaera, Lithophia, Lopriorea, Marcelliopsis, Mechowia, Nelsia, Neocentenna, Nothosaerva, Nototrichium, Nyssanthes, Pandiaka, Pfafia, Philoxerus, Pleuropetalum, Pleuropterantha, Polyrhabda, Pseudogomphrena, Pseudoplantago, Pseudosericocona, Psilotrichopsis, Psilotrichum, Pilotus, Pupaia, Puaternelia, Rosifax, Saitia, Sericocona, Sericocomopsis, Sericorema, Sericostachys, Siamosia, Stilbanthus, Tidestronia, Trichurieia, Volkensinia, Woehieria, Xerosipho (9) Araceae Taxonomy. Subclass Monocotyledonae. Superorder Cyanogenics, cynogenic Ariflorae; Arales. APG (1998) Monocot; non-commelinoid; constituents tyrosine-derived, Alismatales. Species 2000. Genera 106; Agiaodorum, alkaloids, proanthocyanidins, US 7,749,544 B2 11 12

TABLE I-continued

PLANT COMPOUNDS Agiaonema, Alloschemone, Aiocasia, Ambrosina, cyanidin, flavonols, Amorphophalius, Amydrium, Anadendrain, Anaphyllopsis, kaempferol, quercetin, and Anaphyllum, Anchonanes, Anthurium, Antibias, Aridarim, quercetin Ariopsis, Arisaena, Arisartin, Arophyton, Arlin, Asterostigma, Biartin, Bognera, Bucephalandra, Caladium, Calla, Callopsis, Carlephyton, Cercestis, Chlorospatha, Coiletogyne, Colocasia, Cryptocoryne, Cuicasia, Cyrtosperma, Diefenbachia, Dracontioides, Dracontium, Dracunculus, Eminium, Epipreminum, Filarum, Furtodoa, Gearum, Gonatanihtis, Gonatopus, Gorgonidium, Gymnostachys, Hapaline, Helicodiceros, Heteroaridarum, Heteropsis, Holochlamys, Homalomena, Hottarum, Jasarum, Lagenandra, Lasia, Lasimorpha, Lysichiton, Mangonia, Monstera, Montrichardia, Nephthyitis, Orontium, Pediceiiarum, Peitandra, Philodendron, Phymatarum, Pinelia, Piptospatha, Pistia, Podolasia, Pothoidium, Pothos, Protarum, Pseudodracontium, PseudohydroSme, Pycnospatha, Remusatia, Raphidophora, Rhodospatha, Satiromatiim, Scaphispatha, Schismatoglottis, Scindapsus, Spaihanthetin, Spathicarpa, Spathiphyllum, Stenospermation, Stetidinera, Stylochaeton, Sympiocarpus, Synandrospadix, Syngonium, Taccartin, Theriophonim, Tiphonium, Tiphonodorum, Ulearlin, Urospatha, Urospathelia, Xanthosoma, Zamicticas, Zantedeschia, Zonicarpa, Zomicarpella (10) Cyperaceae Taxonomy. Subclass Monocotyledonae. Superorder Alkaloids, Commeliniflorae: Cyperales. APG (1998) Monocot: proanthocyanidins, Commelinoid group: Poales. Species about 5000. Genera cyanidins, delphinidins about 120; Abildgaardia, Acritius, Actino Schoenis, flavonols, quercetins, Afrotrilepis, Ainitia, Androirichiim, Anosportin, aluminium Arthrostylis, Ascolepis, Ascopholis, Baeothryon, Baumea, Becquerelia, Bishoeckelera, Blysmopsis, Blysmus, Bolboschoentis, Bulbostylis, Calyptrocarya, Capitularina, Carex, Carpha, Calistis, Cephalocarpus, Chorizandra, Chrysitrix, Cladium, Coleochloa, Costularia, Courtoisina, Crosslandia, Cyathochaeta, Cyathocona, Cynophylliis, Cypertis, DesmoSchoentis, Didymiandrum, Dipiacrum, Diplasia, Dulichium, Egieria, Eleocharis, Eleogiton, Epischoenus, Eriophoropsis, Eriophortin, Erioscirpus, Evandra, Everardia, Exocarya, Exochogyne, Ficinia, Fimbristylis, Fuirena, Gahnia, Gymnoschoenus, Hellmuthia, Hemicarpha, Hymenochaeta, Hypolytrum, Isolepis, Kobresia, Kyllinga, Kyllingiella, Lagenocarpus, Lepidosperma, Lepironia, Lipocarpha, LophoSchoenis, Machaerina, Mapania, Mapaniopsis, Mariscus, Mesomelaena, Microdracoides, Micropapyrus, Monandrus, Morelotia, Neesenbeckia, Nemum, Nelmesia, Oreobolopsis, Oreobolus, Oxycaryum, Paramapania, Phylloscirpus, Pleurostachys, Principlina, Pseudoschoenus, Ptilanthelium, Pycretis, Pueenslandiella, Reedia, Renirea, Rhynchocladium, Rhynchospora, Rikiiella, Schoenopiectus, Schoenoxiphium, Schoenoides, Schoenus, Scirpodendron, Scirpoides, Scirpus, Scleria, Sphaerocypertis, Sumatroscirpus, Syntrinema, Tetraria, Tetrariopsis, Thoracostachyum, Torulinium, Trachystylis, Trianoptiles, Trichoschoenus, Tricostularia, Triepis, Tiviocarya, Uncinia, Vesicarex, Voikielia, Websteria. (11) Anacardiaceae Taxonomy. Subclass Dicotyledonae; Crassinucelli. Alkaloids, iridoids, Dahlgren's Superorder Rutiflorae: . Cronquist's proanthocyanidins, Subclass Rosidae: Sapindales. APG (1998) Eudicot; core delphinidins, cyanidins, Eudicot; Rosid: Eurosid II: Sapindales. Species 600. Genera flavonols, eg. kaempferol, about 70; Actinocheita, Anacardium, Androtium, quercetin, and myricetin; Antrocaryon, Apteroikarpos, Astronium, Baronia, Saponins sapogenins Sugars Bonetiella, Boltea, Buchanania, Campnosperma, as Sucrose, oligosaccharides Cardenasiodendron, Choerospondias, Conocladia, or Sugar alcohols Coint is, Cyrtocarpa, Dracontoneion, Drimycarpus, Ebandolia, Euleria, Euroschiniis, Faguetia, Fegimanra, Giulia, Haematostaphis, Hapiorhiis, Harpephyllum, Heeria, Holigarna, Koordersiodendron, Lannea, Latirophyllius, Lithrea, Loxopterigitim, Loxostylis, Mangifera, Mauria, Melanochyla, Metopium, Micronychia, Montagueia, Mosquitoxviiim, Nothopegia, Ochoter enaea, Operculicarya, Ozoroa, Pachycormus, Parishia, Pegia, Pentaspadon, US 7,749,544 B2 13 14

TABLE I-continued

PLANT COMPOUNDS Pleiogynium, Poupartia, Protorhus, Pseudoprotorhus, Pseudosmodingium, Pseudospondias, Rhodosphaera, Rhits, Schinopsis, Schinus, Sclerocarya, Senecarpits, Snodingium, Solenocarpus, Sorindeia, Spondias, Swintonia, Tapirira, Thyrsodium, Toxicodendron, Trichoscypha. (12) Bignoniaceae Taxonomy. Subclass Dicotyledonae; Tenuinucelli. Alkaloids, iridoids Dahlgren's Superorder Lamiiflorae: Scrophulariales. arthroquinones, shikimic Cronquist's Subclass Asteridae: Scrophulariales. APG acid, verbascosides, (1998) Eudicot; core Eudicot; Asterid; Euasterid I; cornosides, flavonols, . Species 650. Genera 110; Adenocalymna, quercetins, ursolic acid, Amphilophium, Amphitecna, Anemopaegna, Argylia, Saponins, Sapogenins Arrabidaea, Astianihtis, Barnettia, , Callichlamys, oligosaccharides. Sucrose, Campsidium, , Catalpa, Catophracies, Sugar Ceratophytum, Chilopsis, Clytostoma, Collea, Crescentia, Cuspidaria, Cybistax, Deiostoma, Depianchea, Digomphia, Dinklageodoxa, Distictella, Distictis, Dolichandra, Dolichandrone, Eccremocarpus, Ekmanianthe, Fernandoa, Fridericia, Gardnerodoxa, Giaziova, Godmania, Haplolophium, Haplophragma, , Hieris, Incarvillea, Jacaranda, Kigelia, Lamiodendron, Leucocaianiha, Lundia, Macfadyena, Macranihisiphon, Manaoseiia. Mansoa, Markhamia, Martinelia, Meioa. Memora, Millingtonia, Missatia, Neoiobertia, Neosepicaea, Newbouldia, Nyctealos, Ophiocolea, Oroxylum, Paianelia, , Parabiognonia, Paragonia, Paratecoma, Parmentiera, Pauldopia, Perianthomega, Periarrabidaea, Perichlaena, Phryganocydia, Phyllarthron, Phyloctenium, Piriadacus, Pithecoctenium, Pieionotona, Podranea, Potamoganos, Pseudocatalpa, Pyrostegia, Radermachera, Rhigozum, Rhodocoilea, Roentgenia, Romeroa, Saritaea, Sparattosperma, Spathicalyx, Spathodea, Sphingiphila, Spirotecoma, Stereospermin, Stizophyllum, Tabebuia, Tanaecium, , Tecomanihe, Tecomeia, tourrettia, Tynanthus, Urbanolophium, Xylophragma, Zeyheria. For discussion of classificatory problems posed by Scrophtiariaceae, impinging on Bignoniaceae, Biddleiaceae, Caliirichaceae, Plantaginaceae, Hippiiridaceae, Lentibulariaceae, and Hydrostachydaceae, and Such problem genera as Paulownia and Schiegelia, see Olmstead and Reeves (1995). (13) Bombacaceae Taxonomy. Subclass Dicotyledonae; Crassinucelli. Alkaloids, Dahlgren's Superorder Malviflorae: . Cronquist's proanthocyanidins, Subclass Dilleniidae: Malvales. APG (1998) Eudicot; core cyanidins, flavonols e.g. Eudicot; Rosid: Eurosid II; Malvales. Species 180. Genera kaempferol and quercetin; 30; Adansonia, Aguiaria, , Bombacopsis, SUCOS Bombax, Catostemma, Cavaniiliesia, Ceiba, Chorisia, Coeliostegia, Cullenia, Diirio, Eriotheca, Gyranthera, Huberodendron, Kostermansia, Matisia, Neesia, Neobuchia, Ochroma, Pachira, Patinoa, Phragmotheca, Pseudobombax, Ciaraibea, Rhodognaphaion, Rhodagnaphalopsis, Scleronema, Septotheca, Spirotheca. , Bombacaceae, Sterculiaceae and Tiliaceae (14) Anacardiaceae Taxonomy. Subclass Dicotyledonae; Crassinucelli. Alkaloids, arthroquinones, Dahlgren's Superorder Rutiflorae: Sapindales. Cronquist's proanthocyanidins, Subclass Rosidae: Sapindales. APG (1998) Eudicot; core delphinidin, cyanidin, Eudicot; Rosid: Eurosid II: Sapindales. Species 600. Genera flavonols, kaempferol, about 70; Actinocheita, Anacardium, Androtium, quercetin, myricetin, elagic Antrocaryon, Apteroikarpos, Astronium, Baronia, acid, Saponins, Sapogenins, Bonetiella, Boltea, Buchanania, Campnosperma, Sucrose, oligosaccharides, Cardenasiodendron, Choerospondias, Conocladia, Sugar alcohols Coint is, Cyrtocarpa, Dracontoneion, Drimycarpus, Ebandolia, Euleria, Euroschiniis, Faguetia, Fegimanra, Giulia, Haematostaphis, Hapiorhiis, Harpephyllum, Heeria, Holigarna, Koordersiodendron, Lannea, Latirophyllius, Lithrea, Loxopterigitim, Loxostylis, Mangifera, Mauria, Melanochyla, Metopium, Micronychia, Montagueia, Mosquitoxviiim, Nothopegia, Ochoter enaea, Operculicarya, Ozoroa, Pachycormus, Parishia, Pegia, Pentaspadon, Pleiogynium, Poupartia, Protorhus, Pseudoprotorhus, Pseudosmodingium, Pseudospondias, Rhodosphaera, Rhits, US 7,749,544 B2 15 16

TABLE I-continued

PLANT COMPOUNDS Schinopsis, Schinus, Sclerocarya, Senecarpits, Sorindeia Snodingium, Solenocarpus, , Spondias, Swintonia, Tapirira, Thyrsodium, Toxicodendron, Trichoscypha. (15) Caricaceae Taxonomy. Subclass Dicotyledonae; Crassinucelli. mustard-oils, alkaloids, Dahlgren's Superorder Violiflorae; Violales. Cronquist's Saponins sapogenins Subclass Dilleniidae; Violales. APG (1998) Eudicot; core Eudicot; Rosid: Eurosid II; . Species 55. Genera 4: Carica, Cylicomorpha, , . (16) Cynosuraceae Strophanius

Prior to the administration to a patient an extract or a extract or extract mixture is prepared in an aqueous solution mixture of extracts are typically diluted by combination with in a concentration of from about 1 to about 100 mg/ml. More a pharmecologically compatible solvent, e.g., ethanol or typically, the concentration is from about 10 to about 20 water to produce atherapeutic Solution. Typically the amount mg/ml. The formulation, which is sterile, is suitable for vari or concentration of the extract or mixed extracts in the thera ous parenteral routes including intra-dermal, intraarticular, peutic solution ranges from 0.0001 to 10.0 weight percent of intra-muscular, intravascular, and Subcutaneous. the total weight of the solution. Of course, the extract or In addition to the therapeutic extract or extract mixture the mixture of extracts is present in a therapeutically effective 25 compositions may include, depending on the formulation amount, that is, an amount Such that the extract or mixture of desired, pharmaceutically-acceptable, non-toxic carriers or extracts can be administered in a therapeutically effective diluents, which include vehicles commonly used to form amount through conventional oral, nasal, aerosol, topical, pharmaceutical compositions for animal or human adminis intravenous, peritoneal, etc. means. tration. The diluent is selected so as not to unduly affect the The term “amount’ as used herein refers to a quantity or to biological activity of the combination. Examples of such a concentration, as appropriate to the context. The amount of 30 diluents which are especially useful for injectable formula extract(s) that constitutes a therapeutically effective amount tions are water, the various Saline solutions, Ringer's solu varies according to factors such as the potency of the tion, dextrose solution, and Hank's Solution. In addition, the extract(s) the route of administration of the formulation, and pharmaceutical composition or formulation may include the mechanical system used to administer the formulation. A additives such as other carriers; adjuvants; or nontoxic, non therapeutically effective amount of a particular extract or 35 therapeutic, nonimmunogenic stabilizers and the like. mixture of extracts can be selected by those of ordinary skill Furthermore, excipients can be included in the formula in the art with due consideration of such factors. Generally a tion. Examples include cosolvents, Surfactants, oils, humec therapeutically effective amount will be from about 0.005 tants, emollients, preservatives, stabilizers and antioxidants. parts weight to about 2 parts by weight based on 100 parts by Any pharmacologically acceptable buffer may be used, e.g., weight of the therapeutic Solution, or if in Solid form, e.g., 40 tris or phosphate buffers. Effective amounts of diluents, addi tablet or capsule, 0.001 to 10 parts by weight of the weight of tives and excipients are those amounts which are effective to the tablet or capsule. obtain a pharmaceutically acceptable formulation in terms of For oral administration, either solid or fluid unit dosage solubility, biological activity, etc. forms can be prepared. For preparing solid compositions such The term “unit dosage form” refers to physically discrete as tablets, the extract or extract mixture is mixed into formu 45 units suitable as unitary dosages for human Subjects and lations with conventional ingredients, such as talc, magne animals, each unit containing a predetermined quantity of sium Stearate, dicalcium phosphate, magnesium aluminum active material calculated to produce the desired pharmaceu silicate, calcium sulfate, starch, lactose, acacia, methylcellu tical effect in association with the required pharmaceutical ose, and functionally similar materials as pharmaceutical diluent, carrier or vehicle. The specifications for the unit diluents or carriers. Capsules are prepared by mixing the dosage forms of this invention are dictated by and dependent extractor extract mixture with an inert pharmaceutical diluent 50 on (a) the unique characteristics of the active material and the and filling the mixture into a hard gelatin capsule of appro particular effect to be achieved and (b) the limitations inher priate size. Soft gelatin capsules are prepared by machine ent in the art of compounding Such an active material for use encapsulation of a slurry of the extract or extract mixture with in humans and animals. an acceptable vegetable oil, light liquid petrolatum or other Examples of unit dosage forms are tablets, capsules, pills, inert oil. 55 powderpackets, wafers, suppositories, granules, cachets, tea Fluid unit dosage forms for oral administration Such as spoonfuls, dropperfuls, ampoules, vials, aerosols with syrups, elixirs and Suspensions can be prepared. The water metered discharges, segregated multiples of any of the fore soluble forms can be dissolved in an aqueous vehicle together going, and other forms as herein described. with Sugar, aromatic flavoring agents and preservatives to Thus, a formulation of the invention includes a therapeutic form a syrup. An elixir is prepared by using a hydroalcoholic 60 extract(s) which may beformulated with conventional, phar (e.g., ethanol) vehicle with Suitable Sweeteners such as Sugar maceutically acceptable, vehicles for topical, oral or and saccharin, together with an aromatic flavoring agent. parenteral administration. Formulations may also include Suspensions can be prepared with an aqueous vehicle with the Small amounts of adjuvants such as buffers and preservatives aid of a suspending agent Such as acacia, tragacanth, methyl to maintain isotonicity, physiological and pH stability. Means cellulose and the like. 65 of preparation, formulation and administration are known to Appropriate formulations for parenteral use are apparent to those of skill. See generally Remington's Pharmaceutical the practitioner of ordinary skill. Usually, the therapeutic Science 15" ed., Mack Publishing Co., Easton, Pa. (1980). US 7,749,544 B2 17 18 Slow or extended-release delivery systems, including any II. Treatment of HIV Patients for AIDS Related Ailments of a number of biopolymers (biological-based systems), sys A total of 300 patients presenting moderate to advanced tems employing liposomes, and polymeric delivery systems, stages of AIDS, particularly with respect to debilitating ail ments, including persistent fever, chronic diarrhea, dermati can be utilized with the extracts described herein to provide a tis, generalized lymphodenapathy, persistent cough, general continuous or longterm source of therapeutic compound. pain, tuberculosis and amenorrhea, were treated with an Such slow release systems are applicable to formulations for extract mixture solution of the invention. The mixture com topical, ophthalmic, oral, and parenteral use. prised Anoceae (10 to 20 weight percent), Anarcadiaceae Delivery of the inventive therapeutic extractor extract mix (15-20 weight percent), Araceae (15 to 20 weight percent) ture is usually by oral administration as a solution. However, 10 Bombacaceae (20 weight percent), Caricaceae (15 to 20 where necessary, therapy, e.g., intra-dermal, intra-articular, weight percent), and Combretaceae (3 to 10 weight percent). The mixture was then diluted with water to give about 10 intramuscular or intravenous, is also employed. weight percent extract solution. The Solution was adminis As previously indicated, the resultant medicament extract tered to each patientata dose of 3 tablespoons three times per e.g., from a single plant or a mixture of any of the afore day. mentioned plants, has been found to be effective in treating All treated patients in this group of studies had none of the AIDS but also in treating associated conditions related to debilitating symptoms in the time periods indicated in AIDS. Such associated conditions include recurrent and per TABLE III, below: sistent fever, chronic diarrhea, dermatitis, generalized lym TABLE III phodenpathy, persistent cough, general pain, tuberculosis, and amenorrhea. Approximate Recovery Time Symptom (Average) RPFever 1 Week EXAMPLES Chronic Diarrhea 1 Week Dermatitis 3 Weeks 25 Generalizied Lymphodenpathy 4 Weeks Cough 2 Weeks 1. About 105 patients suffering from AIDS were treated General Pain 4 Weeks with mixtures of plant extracts, obtained as above described Tuberculosis 12 Weeks as approximately 10% weight percent therapeutic Solutions Amenorrhea 1 Week with the following results as reported in TABLE II, below.

TABLE II

Combinations of Plant Extract Medicaments for Treatment of AIDS Related Ailments Stage of AIDS Disease Typical Symptoms Mixture of Plant Extract Used Stage 1: Critically ill - non Significant weight loss Apocynaceae (17 weight percent) ambulatory patients Frequent and recurrent Fever Annonaceae (10 weight percent) 3–6 months duration of Chronic Diarrhea Dichapetalaceae (14 weight percent) treatinent Dermatitis Annoceae (17 weight percent) (Complete 90 to 98%) Generalized Lymphodenpathy, Cynocynaceae (21 weight percent) Cough Asclepiadaceae (14 weight percent) General Pain Combretaceae (7 weight percent) Pneumonia Diluted with Kaposi's sarcoma to give a 0.5 to 25 weight Herpes Zoster percent extracts solution Tuberculosis Amenorrhea Stage 2: Moderately ill - after going Lack of appetite Apoocynaceae (15 weight percent) through stage 1 treatment program Immune dysfunction Amaranthaceae (17 weight percent) 3–6 months duration of treatment Aroceae (17 weight percent) (Complete 95%) Cyperaceae (17 weight percent) Anacardiaceae (17 weight percent) bignoniaceae (17 weight percent) Diluted with water to give a 0.5 to 25% weight percent extract solution Stage 3: Relatively ill Restoration of immune protection Anoceae (17 weight percent) but ambulatory with good vitals Anarcadiaceae (20 weight percent) after stage 2 program Aroceae (20 weight percent) 3–6 months duration of treatment Bombacaceae (20 weight percent) Caricaceae (17 weight percent) Combretaceae (6 weight percent) Diluted with water to give a 0.5 to 25 weight percent extract solution ORAL DOSAGES: Adults 3 tablespoonsfull 3 times daily Pediatric: 2 teaspoonful 3 times daily US 7,749,544 B2 19 20 We claim: (b) Cleistopholis patens is present in the composition in an 1. A composition for treating symptoms of AIDS patients, amount of 10 weight percent; comprising a mixture of extracts from the following plants: (c) Dichapetalum madagascariense is present in the com Alstonia boomei, Cleistopholis patens, Dichapetalum position in an amount of 14 weight percent; madagascariense, Uvariastrum pierreanum, Strophan (d) Uvariastrum pierreanum is present in the composition thus gratus, Gongronema latifolium and Combretum in an amount of 17 weight percent; racenOSun, (e) is present in the composition in an wherein the symptoms of AIDS are at least one or more Selected from the group consisting of recurrent fever, amount of 21 weight percent; chronic diarrhea, general body pain, persistent cough, (f) Gongronema latifolium is present in the composition in dermatitis, and weight loss. 10 an amount of 14 weight percent; and 2. The composition according to claim 1, further compris (g) Combretum racemosum is present in the composition in ing one or more compound(s) derived from one or more of the an amount of 7 weight percent; foregoing plants, said compounds selected from the group wherein the mixture of extracts from (a), (b) or (c) of claim consisting of a glyceryl, a Saponin, an alkaloid, a protein, a 1 is further diluted with water to give a 0.5 to 25 weight fat, and a Sugar. 15 percent extracts solution. 3. The composition according to claim 1, wherein (a) Alstonia boomei is present in the composition in an amount of 17 weight percent; UNITED STATES PATENT AND TRADEMARK OFFICE CERTIFICATE OF CORRECTION

PATENT NO. 7,749,544 B2 Page 1 of 1 APPLICATION NO. : 10/902993 DATED : July 6, 2010 INVENTOR(S) : William Asiedu It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below:

Column 20, lines 13-14, in claim 3, --wherein the mixture of extracts from (a), (b) or (c) of claim 1 is further diluted-- should be changed to --wherein the mixture of extracts is further diluted--.

Signed and Sealed this Tenth Day of August, 2010

David J. Kappos Director of the United States Patent and Trademark Office