Patent Application: US-60442403-A

Abstract:
disclosed is a topical preparation for the treatment of topical itch in humans and animals . the said composition consists of opuntia , propolis , stearic acid , beeswax , vegetable oil and β - sitosterol . itch includes scratch reaction itch , anal itch , or irritant itch due to plants , insect bite , sunburn , chemical itch , eczema , pruritis dermatitis , diabetic skin itch , aging skin itch , foot - itch , chickenpox , jock itch , hives , itch of healing burns and wounds , dry winter skin itch , and stress - related scalp itch , etc

Description:
in this invention , a combination of herbs and other natural substances is described consisting of cactus ( opuntia ficus indica ), feng jiao ( apis mellifera ligustica spin ) ( also known as bee propolis ), β - sitosterol , and stearic acid in which each of the ingredients is preferably in an amount in the range of 1 . 0 to 20 % of the final amount of preparation . in this preparation , soybean concentrates ( containing 40 % β - sitosterol used . ), and propolis dilution ( 5 : 1 ) is used . in the foregoing assertion , efforts have been made to find a suitable palliative and / or curative agent for the treatment of various types of skin itch . each component of preparation whether used in its raw form or as an extract is standardized according to its marker compound ( s ) and factored into final calculation of the amount of extract used for the manufacturing of final preparation . for example , if an extract is used which is 1 : 10 extract ( such as the cactus extract ), meaning that 10 g of the component yields 1 g of extract then the required quantity of the extract for a 5 % of original component will be provided by a quantity of 0 . 50 g extract in the preparation . in the case of soybean , a standardized 40 % extract is used ( catalog # s 5753 minimum 40 % soybean , sigma - aldrich , st . louis , mo .). in this case , a 2 % final concentration of β - sitosterol is provided by 5 g of the above 40 % soybean . in the case of propolis , a 5 : 1 dilution in ethanol provides a 1 % or original propolis by adding 5 g of the diluted propolis . note that whereas in the case of extracts the yield is more concentrated but in the case of propolis it is a diluted form . the extracts and dilutions corresponding to about 1 - 15 %, are mixed together in a stainless steel tank with vacuum and heating implementation and then an amount of vegetable oil , preferably canola oil , is mixed for 10 minutes . vacuum is then applied while heating the preparation to 40 ° c . to remove alcohol ( such as from propolis dilution and cactus extract ), leaving a residue of alcohol not more than one percent in the final preparation . this , however , is not a critical step . the oil mixture is then filtered through muslin cloth to remove any suspended particles . further the while the preparation is still warm , pharmaceutical grade beeswax in the amount equivalent to final preparation composition of 8 %, ranging from 5 - 12 %, is added and the mixture stirred gently for about 5 minutes at elevated temperature and then allowed to cool in appropriate containers such as laminated plastic tubes or laminated aluminum tubes or jars ( laminated plastic , laminated metal or glass ). the quantity of wax added is also not critical and can be adjusted to provide a consistency of ointment suitable for topical administration . different amounts of wax can be added to produce preparations that may be useful for different purposes . as is described in propolis in natural therapeutics ( 1983 ), 2nd revised edition , published by librairie maloine s . a . editeur , paris , france , fragrance journal , no . 83 , pp . 20 - 28 and pp . 36 - 43 ( 1987 ), and apidologie , vol . 22 , pp . 155 - 162 ( 1991 ), propolis is a resin - like product , stored by bees in beehives , containing resins , beeswaxes , essential oils , pollens and flavonoids and having been used in a variety of folk medicines for a long time . it has been known that the main activities of propolis are antiseptic activity , antioxidation activity , anti - inflammatory activity , local anesthesia , virus growth - inhibitory activity , immunoregulatory activity , and macrophage activating activity , and that the main ingredients of propolis are flavonoids , aromatic carboxylic acids , and aromatic aldehydes . honey bees collect the sap or resin from trees , such as poplar or birch , combine it with their own enzymes , and create propolis . raw propolis is composed of 50 - 70 % resins and balsams , 30 - 50 % wax , 5 - 10 % pollen and 10 % essential oils . it contains vitamin b1 , 0 . 20 mg / 100 g ; vitamin b2 0 . 60 mg / 100 g , vitamin b6 0 . 16 mg / g , vitamin e 3 . 80 mg / 100 g , folic acid 7 mg / 100 g , pantothenic cid 0 . 08 mg / 100 g , inositol 6 mg / 100 g . it is rich in trace minerals . and in its raw state , has 500 times more bioflavonoids than oranges . propolis acts as a natural antibiotic , creating one of the most sterile environments in the animal kingdom has shown it offers antiseptic , antibiotic , antibacterial , antifungal , and even antiviral properties . propolis is manufactured by collecting from the frames and boxes of the beehives and collectors place in the hives . propolis is macerated and dissolved in pure ethyl alcohol and the mixture agitated and matured until a proportion of 20 % dilution is achieved . ( see : ceschel g c , maffei p , sforzini a , lombardi borgia s , yasin a , ronchi c . in vitro permeation through porcine buccal mucosa of caffeic acid phenetyl ester ( cape ) from a topical mucoadhesive gel containing propolis . fitoterapia . 2002 november ; 73 suppl 1 : s44 - 52 . ; kiderman a , torten r , furst a l , reinus k . bi - lateral eosinophilic ulcers in an infant treated with propolis . j dermatolog treat . 2001 march ; 12 ( 1 ): 29 - 31 . ; totan y , aydin e , cekic o , cihan dagloglu m , borazan m , daglioglu k , gultek a . effect of caffeic acid phenethyl ester on corneal neovascularization in rats . curr eye res . 2001 october ; 23 ( 4 ): 291 - 7 ; bauer a , geier j , elsner p . allergic contact dermatitis in patients with anogenital complaints . j reprod med . 2000 august ; 45 ( 8 ): 649 - 54 . ; ozturk f , kurt e , cerci m , emiroglu l , inan u , turker m , ilker s . the effect of propolis extract in experimental chemical corneal injury . ophthalmic res . 2000 january - february ; 32 ( 1 ): 13 - 8 . ; ilhan a , koltuksuz u , ozen s , uz e , ciralik h , akyol o . the effects of caffeic acid phenethyl ester ( cape ) on spinal cord ischemia / reperfusion injury in rabbits . eur j cardiothorac surg . 1999 october ; 16 ( 4 ): 458 - 63 . ; ozturk f , kurt e , inan u u , emiroglu l , ilker s s , sobaci g . effect of propolis on endotoxin - induced uveitis in rabbits . jpn j ophthalmol . 1999 july - august ; 43 ( 4 ): 285 - 9 . ; hepsen i f , er h , cekic o . topically applied water extract of propolis to suppress corneal neovascularization in rabbits . ophthalmic res . 1999 ; 31 ( 6 ): 426 - 31 . ; ozturk f , kurt e , inan u u , emiroglu l , ilker s s . the effects of acetylcholine and propolis extract on corneal epithelial wound healing in rats . cornea . 1999 july ; 18 ( 4 ): 466 - 71 . ; gallenkemper g , rabe e , bauer r . contact sensitization in chronic venous insufficiency : modern wound dressings . contact dermatitis . 1998 may ; 38 ( 5 ): 274 - 8 . ; fernandez de corres l , diez j m , audicana m , garcia m , munoz d , fernandez e , etxenagusia m . photodermatitis from plant derivatives in topical and oral medicaments . contact dermatitis . 1996 september ; 35 ( 3 ): 184 - 5 . ; basnet p , matsushige k , hase k , kadota s , namba t . potent antihepatotoxic activity of dicaffeoyl quinic acids from propolis . biol pharm bull . 1996 april ; 19 ( 4 ): 655 - 7 . huang m t , ma w , yen p , xie j g , han j , frenkel k , grunberger d , conney a h . inhibitory effects of caffeic acid phenethyl ester ( cape ) on 12 - o - tetradecanoylphorbol - 13 - acetate - induced tumor promotion in mouse skin and the synthesis of dna , rna and protein in hela cells . carcinogenesis . 1996 april ; 17 ( 4 ): 761 - 5 . ; maichuk iuf , orlovskaia l e , andreev v p . [ the use of ocular drug films of propolis in the sequelae of ophthalmic herpes ] voen med zh . 1995 december ;( 12 ): 36 - 9 , 80 . russian . ; magro - filho o , de carvalho a c . topical effect of propolis in the repair of sulcoplasties by the modified kazanjian technique . cytological and clinical evaluation . j nihon univ sch dent . 1994 june ; 36 ( 2 ): 102 - 11 . ; frenkel k , wei h , bhimani r , ye j , zadunaisky j a , huang m t , ferraro t , conney a h , grunberger d . inhibition of tumor promoter - mediated processes in mouse skin and bovine lens by caffeic acid phenethyl ester . cancer res . 1993 mar . 15 ; 53 ( 6 ): 1255 - 61 . ; magro filho o , de carvalho a c . application of propolis to dental sockets and skin wounds . j nihon univ sch dent . 1990 march ; 32 ( 1 ): 4 - 13 . ; machackova j . the incidence of allergy to propolis in 605 consecutive patients patch tested in prague . contact dermatitis . 1988 april ; 18 ( 4 ): 210 - 2 . ; frosch p j . [ current contact allergens ] z hautkr . 1987 dec . 1 ; 62 ( 23 ): 1631 - 4 , 1637 - 8 . german . ; hausen b m , wollenweber e , senff h , post b . propolis allergy . ( ii ). the sensitizing properties of 1 , 1 - dimethylallyl caffeic acid ester . contact dermatitis . 1987 september ; 17 ( 3 ): 171 - 7 . ; trevisan g , kokelj f . contact dermatitis from propolis : role of gastrointestinal absorption . contact dermatitis . 1987 january ; 16 ( 1 ): 48 . no abstract available . ; savova i . [ results of treating varicose ulcer patients with propolis ] vestn dermatol venerol . 1987 ;( 1 ): 56 - 7 ; valsecchi r , cainelli t . dermatitis from propolis . contact dermatitis . 1984 november ; 11 ( 5 ): 317 . no abstract available . ; takahashi m , matsuo i , ohkido m . contact dermatitis due to honeybee royal jelly . contact dermatitis . 1983 november ; 9 ( 6 ): 452 - 5 . ; lutsenko s m , pisarenko a s . [ use of water - soluble propolis for trophic ulcers of the lower extremities in arteriosclerosis obliterans ] klin khir . 1980 july ;( 7 ): 74 . russian . ; zambor m , martanova h , matel i . [ uses of 5 % alcohol solution of propolis in the treatment of dermatomycoses ( author &# 39 ; s transl )] cesk dermatol . 1977 august ; 52 ( 4 ): 243 - 6 . slovak .). opuntia comprises mainly the whole plant of opuntia ficus indica ( cactacea family ) as the main constituents . other species and varieties of opuntia genus of the cactaceae family are included here by reference . the reported pharmacologic properties of opuntia include : analgesia , antiinflmmatory , antiulcerogenic , antioxidative , affecting activity of aromatase and reductase , free radical scavenger , antiviral , lowering ldl cholesterol levels , glucose - 6 - phosphatase and fructose - 1 , 6 - diphosphatase activity , antidiabetic , a rich source of biologically active alkaloids and other nutritional elements often considered essential for tissue growth . optunia ficus - indica ( mission cactus , yellow tuna , prickly pear , indian fig , nopal ) comprises mainly the whole plant of opuntia ficus indica ( cactacea family ) as the main constituents . it is indigenous to the americas as well as south asia , southeast asia and the middle east . other species and varieties of optunia genus of the cactaceae family are included here by reference . the reported pharmacologic properties of optunia include : analgesia , antiinflmmatory , antiulcerogenic , antioxidative , affecting activity of aromatase and reductase , free radical scavenger , antiviral , lowering ldl cholesterol levels , glucose - 6 - phosphatase and fructose - 1 , 6 - diphosphatase activity , antidiabetic , a rich source of biologically active alkaloids and other nutritional elements often considered essential for tissue growth . it is also an excellent source of beta - sitosterol . i contains mescaline , tyramine , n - methyltyramine . ( see : park e , kahng j , lee s h , shin k . an anti - inflammatory principle from cactus . fitoterapia 2001 march ; 72 ( 3 ): 288 - 90 ., college of pharmacy , sookmyung women &# 39 ; s university , 140 - 742 , seoul , south korea ; bwititi p , musabayane c t , and nhachi c f : effects of opuntia megacantha on blood glucose and kidney function in streptozotocin diabetic rats . j ethnopharmacol 2000 march ; 69 ( 3 ): 247 - 52 ; gurrieri s , miceli l , lanza c m , tomaselli f , bonomo r p , rizzarelli e : chemical characterization of sicilian prickly pear ( opuntia ficus indica ) and perspectives for the storage of its juice . j agric food chem 2000 nov . 20 ; 48 ( 11 ): 5424 - 5431 ; mtambo m m , mushi e j , kinabo l d , maeda - machang &# 39 ; u a , mwamengele g l , yongolo m g , temu r p : evaluation of the efficacy of the crude extracts of capsicum frutescens , citrus limon and opuntia vulgaris against newcastle disease in domestic fowl in tanzania . j ethnopharmacol 1999 dec . 15 ; 68 ( 1 - 3 ): 55 - 61 ; loro j f , del rio i , perez - santana l : preliminary studies of analgesic and anti - inflammatory properties of opuntia dillenii aqueous extract . j ethnopharmacol 1999 nov . 1 ; 67 ( 2 ): 213 - 8 ; loro j f , del rio i , perez - santana l : preliminary studies of analgesic and anti - inflammatory properties of opuntia dillenii aqueous extract . j ethnopharmacol 1999 nov . 1 ; 67 ( 2 ): 213 - 8 ; park e h , kahng j h , paek e a : studies on the pharmacological action of cactus : identification of its anti - inflammatory effect . arch pharm res 1998 february ; 21 ( 1 ): 30 - 4 ; uchoa a f , souza p a , zarate r m , gomes - filho e , campos f a : isolation and characterization of a reserve protein from the seeds of opuntia ficus - indica ( cactaceae ). braz j med biol res 1998 june ; 31 ( 6 ): 757 - 61 ; jonas a , rosenblat g , krapf d , bitterman w , neeman i : urol res 1998 ; 26 ( 4 ): 265 - 70 ; el kossori r l , villaume c , el boustani e , sauvaire y , mejean : composition of pulp , skin and seeds of prickly pears fruit ( opuntia ficus indica sp .) plant foods hum nutr 1998 ; 52 ( 3 ): 263 - 70 ; ahmad a , davies j , randall s , skinner g r : antiviral properties of extract of opuntia streptacantha . antiviral res 1996 may ; 30 ( 2 - 3 ): 75 - 85 ; trejo - gonzalez a , gabriel - ortiz g , puebla - perez a m , huizar - contreras m d , munguia - mazariegos m r , mejia - arreguin s , calva e : a purified extract from prickly pear cactus ( opuntia fuliginosa ) controls experimentally induced diabetes in rats . j ethnopharmacol 1996 december ; 55 ( 1 ): 27 - 33 ; roman - ramos r , flores - saenz j l , alarcon - aguilar f j : anti - hyperglycemic effect of some edible plants . j ethnopharmacol 1995 aug . 11 ; 48 ( 1 ): 25 - 32 ; rosado j l , diaz m : physico - chemical properties related to gastrointestinal function of 6 sources of dietary fiber . rev invest clin 1995 july - august ; 47 ( 4 ): 283 - 9 ; fernandez m l , lin e c , trejo a , mcnamara d j : prickly pear ( opuntia sp .) pectin alters hepatic cholesterol metabolism without affecting cholesterol absorption in guinea pigs fed a hypercholesterolemic diet . j nutr 1994 june ; 124 ( 6 ): 817 - 24 ; fernandez m l , lin e c , trejo a , mcnamara d j : prickly pear ( opuntia sp .) pectin reverses low - density lipoprotein receptor suppression induced by a hypercholesterolemic diet in guinea pigs . j nutr 1992 december ; 122 ( 12 ): 2330 - 40 ; frati a c , xilotl diaz n , altamirano p , ariza r , lopez - ledesma r : the effect of two sequential doses of opuntia streptacantha upon glycemia . arch invest med ( mex ) 1991 july - december ; 22 ( 3 - 4 ): 333 - 6 ; roman - ramos r , flores - saenz j l , partida - hernandez g , lara - lemus a , alarcon - aguilar f : experimental study of the hypoglycemic effect of some antidiabetic plants . arch invest med ( mex ) 1991 january - march ; 22 ( 1 ): 87 - 93 ; fernandez m l , trejo a , mcnamara d j : pectin isolated from prickly pear ( opuntia sp .) modifies low - density lipoprotein metabolism in cholesterol - fed guinea pigs . j nutr 1990 november ; 120 ( 11 ): 1283 - 90 ; frati - munari a c , licona - quesada r , araiza - andraca c r , lopez - ledesma r , chavez - negrete a : activity of opuntia streptacantha in healthy individuals with induced hyperglycemia . arch invest med ( mex ) 1990 april - june ; 21 ( 2 ): 99 - 102 ; frati - munari a c , altamirano - bustamante e , rodriguez - barcenas n , ariza - andraca r , lopez - ledesma r : hypoglycemic action of opuntia streptacantha lemaire : study using raw extracts . arch invest med ( mex ) 1989 october - december ; 20 ( 4 ): 321 - 5 ; frati - munari a c , de leon c , ariza - andraca r , banales - ham m b , lopez - ledesma r , lozoya x : effect of a dehydrated extract of nopal ( opuntia ficus indica mill .) on blood glucose . arch invest med ( mex ) 1989 july - september ; 20 ( 3 ): 211 - 6 ; rodriguez - felix a , cantwell m : developmental changes in composition and quality of prickly pear cactus cladodes ( nopalitos ). plant foods hum nutr 1988 ; 38 ( 1 ): 83 - 93 ; frati munari a c , quiroz lazaro j l , altamirano bustamante p , banales ham m , islas andrade s , ariza andraca c r : the effect of various doses of nopal ( opuntia streptacantha lemaire ) on the glucose tolerance test in healthy individuals . arch invest med ( mex ) 1988 april - june ; 19 ( 2 ): 143 - 8 ; frati - munari a c , gordillo b e , altamirano p , ariza c r : hypoglycemic effect of opuntia streptacantha lemaire in niddm . diabetes care 1988 january ; 11 ( 1 ): 63 - 6 ; frati - munari a c , yever - garces a , islas - andrade s , ariza - andraca c r , chavez - negrete a : studies on the mechanism of “ hypoglycemic ” effect of nopal ( opuntia sp .). arch invest med ( mex ) 1987 january - march ; 18 ( 1 ): 7 - 12 ; ma w w , jiang x y , cooks r g , mclaughlin j l , gibson a c , zeylemaker f , ostolaza c n : j nat prod 1986 july - august ; 49 ( 4 ): 735 - 7 ; ibanez - camacho r , meckes - lozoya m : effect of a semipurified product obtained from opuntia streptacantha l . ( a cactus ) on glycemia and triglyceridemia of rabbit . arch invest med ( mex ) 1983 october - december ; 14 ( 4 ): 437 - 43 ; frati - munari a c , fernandez - harp j a , de la riva h , ariza - andraca r , del carmen torres m : effects of nopal ( opuntia sp .) on serum lipids , glycemia and body weight . arch invest med ( mex ) 1983 april - june ; 14 ( 2 ): 117 - 25 ; ibanez - camacho r , meckes - lozoya m , mellado - campos v : the hypoglucemic effect of opuntia streptacantha studied in different animal experimental models . j ethnopharmacol 1983 march ; 7 ( 2 ): 175 - 81 ; ibanez - camacho r , roman - ramos r : hypoglycemic effect of opuntia cactus . arch invest med ( mex ) 1979 ; 10 ( 4 ): 223 - 30 ; woodard r w , craig j c , bruhn j g : acta chem scand b 1978 ; b32 ( 8 ): 619 - 20 ; the absolute configuration of the cactus alkaloid (−)- calipamine . mukerji s k , ting i p : malic dehydrogenase isoenzymes in green stem tissue of opuntia : isolation and characterization . arch biochem biophys 1969 may ; 131 ( 2 ): 336 - 51 ; mukerji s k , ting i p : malate dehydrogenase ( decarboxylating ) ( nadp ) isoenzymes of opuntia stem tissue . mitochondrial , chloroplast , and soluble forms . biochim biophys acta 1968 oct . 8 ; 167 ( 2 ): 239 - 49 ; satta m a , sisini a : glucose - 6 - phosphatase and fructose - 1 , 6 - diphosphatase activity in opuntia ficus indica . boll soc ltal biol sper 1964 sep . 30 ; 40 ( 18 ): 1109 - 10 .) soybean extract containing a minimum of 40 % β - sitosterol as used in this invention ( sigma chemicals catalog s5753 ), which also contains campesterol , dihy dro - brassicacasterol prepared according to the method of n . kozumi , et al ., chem . pharm . bull ., 27 : 38 , 1979 . the source of β - sitosterol however is not relevant . it could be obtained from natural sources or from synthetic sources . β - sitosterol ( c29h50o , molecular weight 414 . 72 ) is a common sterol in plants . it is generally isolated from wheat germ , soybean or corn oil . sterols are important cyclized triterpenoids that perform many critical functions in cells . phytosterols such as campesterol , stigmasterol and β - sitosterol in plants , ergosterol in fungi and cholesterol in animals are each primary components of the cellular and sub - cellular membranes in their respective cell types . the dietary source of phytosterols in humans comes from vegetables and plant oils . the estimated daily phytosterol content in the conventional western - type diet is approximately 250 mg in contrast to a vegetable diet , which would provide double that amount . although having no nutritional value to humans , phytosterols have recently received a great deal of attention due to their possible anti - cancer properties and their ability to decrease cholesterol levels when fed to a number of mammalian species , including humans . phytosterols aid in limiting cholesterol absorption , enhance biliary cholesterol excretion and shift cholesterol from atherosclerotic plaque . while many of the mechanisms of action remain unknown , the relationship between cholesterol and phytosterols is apparent . this is perhaps not surprising given that chemically , phytosterols closely resemble cholesterol in structure . the major phytosterols are β - sitosterol , campesterol and stigmasterol . others include stigmastanol ( β - sitostanol ), sitostanol , desmosterol , chalinasterol , poriferasterol , clionasterol and brassicasterol . ( gould r . g ., jones r . j ., leroyu g . v ., wissler r . w ., taylor c . b . ; absorbability of b - sitosterol in humans ; metabolism , ( august ) 1969 ; 18 ( 8 ): 652 - 662 . tabata t ., tanaka m ., lio t . ; hypocholesterolemic activity of phytosterol . ii ; yakugaku zasshi , 1980 ; 100 ( 5 ): 546 - 552 . hepistall r . h ., porter k . a . ; the effect of β - sitosterol on cholesterol - induced atheroma in rabbits with high blood pressure ; br . j . experimental pathology , 1957 ; 38 : 49 - 54 .). the role of phytosterols , particularly , β - sitosterol in stimulating human stem cells and particularly promoting hair growth has not been reported yet . several novel applications of phytosterols including β - sitosterol have been reported . the u . s . pat . no . 5 , 965 , 449 to novak describes a method of assessing risk for cardiovascular disease and other disorders and phytosterol - based compositions useful in preventing and treating cardiovascular disease and other disorders . the level of serum campesterol and β - sitosterol are determined and their ratio is correlated with the risk of cardiovascular or a related disorder . the u . s . pat . no . 5 , 523 , 087 to shlyankevich is for a pharmaceutical composition for the treatment of diabetic male sexual dysfunction ; it contains physosterogens , phosphatidyl choline , β - sitosterol , damiana leaf extract and vitamins and minerals . the u . s . pat . no . 5 , 486 , 510 to bouic , et al ., is for a mixture of β - sitosterol glucoside and β - sitosterol is administered to persons for the modulation or control of immune responses . the u . s . pat . no . 5 , 747 , 464 to see is for a composition for inhibiting absorption of fat and cholesterol from the gut and a method for making and using the composition . the composition comprises β - sitosterol bound irreversibly to pectin to form a β - sitosterol and pectin complex . the u . s . pat . no . 5 , 118 , 671 to bombardelli , et al ., is for complexes formed between aescin , cholesterol or β - sitosterol and phospholipids and a method for producing an anti - inflammatory effect is also described . olive oil is a complex compound made of fatty acids , vitamins , volatile components , water - soluble components and microscopic bits of olive . primary fatty acids are oleic and linoleic acid . oleic acid is monosaturated and makes up 55 - 85 % of olive oil . linoleic is polyunsaturated and makes up about 9 %. linolenic , which is polyunsaturated , makes up 0 - 1 . 5 %. vitamins are vitamin e and carotene . the levels of these acids ( actually bound to glycerol as triglycerides ) varies during the different maturation stages of the olive , varies with the variety and the growing conditions . it is generally accepted that cooler areas ( e . g ., tuscany ) will give oil with higher oleic acid than warmer climates . most of the research however has be reported as individual studies so that comparisons are like apples and oranges . however there is a major trial underway in all the major mediterranean producing countries with some 10 or so varieties . this study will give more definitive information . regarding the poly - unsaturated fatty acids ( pufas ) there is a wide range acceptable for evo , however the linolenic has to be less than 0 . 9 %. there is no problem if the levels are higher e . g ., 1 . 5 % regarding the olive oils nutritional value . but the linolenic acid level is used to establish the authenticity of the olive oil . seed oils like canola have higher levels of linolenic acid . also the higher the level of unsaturation ie more pufas leads to a less stable oil , however this has to be counterbalanced by the levels of antioxidants that protect the oil ( these will also vary by similar factors to the fatty acid profile as well as stress e . g ., drought . a higher linolenic than the iooc may actually be of benefit nutritionally for reasons other than those associated with oleic acid . other constituants : phenols , free fatty acids , peroxide , triacylglycerols ( tag ), diacylglycerols ( dag ), and monoacylglycerols ( mag ), thiobarbituric acid reactive substances ( tbars ), pheophytin a andand many other substances make up olive oil . the flavenoid polyphenols in olive oil are natural anti - oxidants , which have been shown to have a host of beneficial effects from healing sunburn to lowering cholesterol , blood pressure , and risk of coronary disease . there are as many as 5 mg of antioxidant polyphenols in every 10 grams of olive oil . many other nut and seed oils have no polyphenols . ( see also : essential fatty acid deficiency in renal failure : can supplements really help ? j am diet assoc . 1997 october ; 97 ( 10 suppl 2 ): s150 - 3 ; peck l w , monsen e r , ahmad s . effect of three sources of long - chain fatty acids on the plasma fatty acid profile , plasma prostaglandin e2 oncentrations , and pruritus symptoms in hemodialysis patients . am j clin nutr . 1996 august ; 64 ( 2 ): 210 - 4 ; benitez del castillo j m , del aguila c , duran s , hernandez j , garcia sanchez j . influence of topically applied cyclosporine a in olive oil on corneal epithelium permeability . cornea . 1994 march ; 13 ( 2 ): 136 - 40 ; bond r , lloyd d h . a double - blind comparison of olive oil and a combination of evening primrose oil and fish oil in the management of canine atopy . ( vet rec . 1992 dec . 12 ; 131 ( 24 ): 558 - 60 .) natural beeswax contains many still yet unidentified components that have for centuries provided healing properties for many ailments . propolis is just one such example . the isolation of d - 002 series of alcohols provides the clue to its anti - inflammatory activity ; flavolins and other minor components provide impart many pharmacologic properties to beeswax . ( see : carbajal d , molina v , valdes s , arruzazabala m l , mas r , magraner j : anti - inflammatory activity of d - 002 : an active product isolated from beeswax . prostaglandins leukot essent fatty acids 1998 october ; 59 ( 4 ): 235 - 8 . ; tsigouri a , menkissoglu - spiroudi u , thrasyvoulou a t , diamantidis g c : determination of fluvalinate residues in beeswax by gas chromatography with electron - capture detection . j aoac int 2000 september - october ; 83 ( 5 ): 1225 - 8 ; carbajal d , molina v , noa m , valdes s , arruzazabala m l , aguilar c , mas r : effect of d - 002 on gastric mucus composition in ethanol - induced ulcer . pharmacol res 2000 october ; 42 ( 4 ): 329 - 32 ; aichholz r , lorbeer e : investigation of combwax of honeybees with high - temperature gas chromatography and high - temperature gas chromatography - chemical ionization mass spectrometry . ii : high - temperature gas chromatography - chemical ionization mass spectrometry . j chromatogr a 2000 jun . 23 ; 883 ( 1 - 2 ): 75 - 88 ; noa m , carbajal d , molina v , valdes s , mas r : comparative study of d - 002 versus sulfasalazine on acetic acid - induced colitis in rats . drugs exp clin res 2000 ; 26 ( 1 ): 13 - 7 ; noa m , mas r , carbajal d , valdes s : effect of d - 002 on acetic acid - induced colitis in rats at single and repeated doses . pharmacol res 2000 april ; 41 ( 4 ): 391 - 5 ; aichholz r , lorbeer e : investigation of combwax of honeybees with high - temperature gas chromatography and high - temperature gas chromatography - chemical ionization mass spectrometry . i . high - temperature gas chromatography . j chromatogr a 1999 sep . 10 ; 855 ( 2 ): 601 - 15 ; turi m s , matray e s : determination of acrinathrin residues in honey and beeswax . acta vet hung 1999 ; 47 ( 2 ): 173 - 9 ; rodriguez m d , gamez r , sanchez m , garcia h : developmental toxicity of d - 002 ( a mixture of aliphatic primary alcohols ) in rats and rabbits . j appl toxicol 1998 september - october ; 18 ( 5 ): 313 - 6 ; carbajal d , molina v , valdes s , arruzazabala l , mas r : anti - ulcer activity of higher primary alcohols of beeswax . j pharm pharmacol 1995 september ; 47 ( 9 ): 731 - 3 ; carbajal d , molina v , valdes s , arruzazabala m l , mas r , magraner j : anti - inflammatory activity of d - 002 : an active product isolated from beeswax . prostaglandins leukot essent fatty acids 1998 october ; 59 ( 4 ): 235 - 8 . ; noa m , mas r : effect of d - 002 on the pre - ulcerative phase of carrageenan - induced colonic ulceration in the guinea pig . j pharm pharmacol 1998 may ; 50 ( 5 ): 549 - 53 . ; rodriguez m d , gamez r , sanchez m , garcia h : developmental toxicity of d - 002 ( a mixture of aliphatic primary alcohols ) in rats and rabbits . j appl toxicol 1998 september - october ; 18 ( 5 ): 313 - 6 ; liu f , sun d : active constituents lowering blood - lipid in beeswax . zhongguo zhong yao za zhi 1996 september ; 21 ( 9 ): 553 - 4 , 576 ; carbajal d , molina v , valdes s , arruzazabala l , rodeiro i , mas r , magraner j : possible cytoprotective mechanism in rats of d - 002 , an antiulcerogenic product isolated from beeswax . j pharm pharmacol 1996 august ; 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91 ( 3 ): 581 - 3 ; chlorazak t , szaflarski j , seferowicz e , scheller s : preliminary evaluation of clinical usefulness of propolis ( beeswax ) preparations . przegl lek 1971 ; 2 8 ( 12 ): 828 - 31 . ingredient percentage propolis 1 opuntia 5 β - sitosterol 2 stearic acid 3 olive oil to 100 alcohol qs the preparation described above was applied to itching surface in different situations , chemical itch , wound - healing itch , anal itch , vaginal itch , irritant itch , nervous itch and in all instances an immediate relief was observed . it will be appreciated by those skilled in this art that the above approximate weight percentages are dependent on generally expected potencies of the components , whereby the relative weight percentages will vary sometimes substantially from the above individual amounts . it will be within the skilled person &# 39 ; s knowledge with this disclosure that the objects of the present invention require the inclusion of each of the components in relative approximate weight percentages above .