CA2514381A1 - Improved topical preparation and method for using same to destroy herpes simplex cells - Google Patents
Improved topical preparation and method for using same to destroy herpes simplex cells Download PDFInfo
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- CA2514381A1 CA2514381A1 CA002514381A CA2514381A CA2514381A1 CA 2514381 A1 CA2514381 A1 CA 2514381A1 CA 002514381 A CA002514381 A CA 002514381A CA 2514381 A CA2514381 A CA 2514381A CA 2514381 A1 CA2514381 A1 CA 2514381A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/40—Peroxides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/075—Ethers or acetals
- A61K31/08—Ethers or acetals acyclic, e.g. paraformaldehyde
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
- A61P31/22—Antivirals for DNA viruses for herpes viruses
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Abstract
The method for treating, in vivo, an epidermal area of a human being infected with Herpes simplex virus, comprises the steps of: applying to the infected area, in an amount sufficient to cover the infected area, a topical preparation in the form of a stable emulsion having from approximately 30% by volume to approximately 50% by volume of ether in a pharmaceutically acceptable refined oil carrier of vegetable oil origin, the oil carrier being generally free of free fatty acids and essentially free of water, soaps and stabilizers, DMSO
(dimethylsulfoxide) of from approximately 10% by volume to approximately 20%
by volume for enhancing delivery of the topical preparation, 2% to 8% by volume of sodium peroxide and 2% to 8% by volume of detergent for facilitating destruction of the fatty material to unlock the cells of the virus to enable the ether to kill the cells, said emulsion having a boiling point of at least 100° F.
(dimethylsulfoxide) of from approximately 10% by volume to approximately 20%
by volume for enhancing delivery of the topical preparation, 2% to 8% by volume of sodium peroxide and 2% to 8% by volume of detergent for facilitating destruction of the fatty material to unlock the cells of the virus to enable the ether to kill the cells, said emulsion having a boiling point of at least 100° F.
Description
lMPROYED TOPICAL PREPARATION AND METHOD FOR USING
SAME TD DESTROY HERPES SIMPLEX CELLS
BACKGROUND OF THE lNYENTlON
9. Ft~eld of the Invention The present invention relates #o a method for treating Herpes simplex virus and to a topical preparation for application to areas of the human body infected by Herpes simplex virus for inactivating the virus using diethyl ether and enhancing the method by facilitating delivery of the topical preparation with DMSO and by destroying the fatty matter of the cells with a detergent to allow diethyl ether to kill the virus quicker.
SAME TD DESTROY HERPES SIMPLEX CELLS
BACKGROUND OF THE lNYENTlON
9. Ft~eld of the Invention The present invention relates #o a method for treating Herpes simplex virus and to a topical preparation for application to areas of the human body infected by Herpes simplex virus for inactivating the virus using diethyl ether and enhancing the method by facilitating delivery of the topical preparation with DMSO and by destroying the fatty matter of the cells with a detergent to allow diethyl ether to kill the virus quicker.
2. Descrlp#ion of the Related Art There are two types of Herpes simplex virus, which produce a variety of clinical manifestations. !n dal, Herpes simplex type l is associated wi#h recurrent labialis (cold sores) and Herpes simplex type 2 is associated with recurnen# vulvovagini#is.
Herpes simplex virus appears to find the spongy area around mucus membranes an a~ac~ve dace #o thrive and cause infec~ivi#~r_ Once the integrity of an area is violated by Herpes simplex virus, there seems #o be a triggering mechanism that welcomes repeated infe~ion of the same area. The reason for this phenomenon occurring is not known a# presen#.
Herpes simplex virus infectivi#y is primarily dependent upon the tntac#ness of the viral envelope and a chemical combination, which damages or removes the envelope will reduce infec#ivi#y greatly 1# is well known that ether is extremely successful in producing this effect. However, the normal body temperature is about ~.degr~. C. above the boiling point of ether' such that treatr~n# in vivo heretofore has not been successfuJ_ See for example "Topics! Ether and Herpes Simplex Labialis" by Mary E. Guinan, M.D., Ph.D., e# a!. !AMA, Mar. ?4, 9980, Vol. 243, No. ~ 0, pp, 9 D59-fi ~ . Also, due to the extreme instability of ether, particularly ether, a# room temperature or higher, diethyl ether has heretofore only been used for this type of treatment in a controlled environment such as a hospital or physician's office, and diethyl a#her has not been available in a form suitable for use outside of a controlled (e.g., hospital) envin~nmen#.
Rather, ether-, amide-, or ester-linkage compounds, atone or in nation, have been used. However, the eff~tiv~sss of such ends in treating Herpes simplex virus is far less than that of a pure ether. An example of an emutW a including such a fund is discJos~ in the Asculai et al. U.S.
Pat. No. 4,020, 983.
According to the teachings of this patent, nonionic surfactants are delivered in a non-irritating ~ such as a lotion or oil to an infected area vrith the amount of surfactant employed being between 0.5% and 20% by volume.
!t has also been proposed in Atnor U. S. Pad No 3, 949, 07 9 to use an aqueous solution including a base, fatty acids comprising primarily oleic acid, and a surface-ar~JVe agent for treating bums, scalds and other sJdn irritations.
The base is an alkali metal carbonate.
Further i# has been proposed in Grove U.S. Pat. No. 2,029, ~fi6 #o use a topical preparation of a soft soap and stearoptens in a salve for use as a Jinimen#.
Still further, i# is known from "A simp~ proof of the thermodynamic stability of materials taken up by solutions containing solubiJizers such as soap", Amer.
Chem. Soc. fit, 2855-9 0 940) that ether is thermodyrrami~aAy stable in soap.
More specifically, the colloids! solutions formed from a solution of ther and soap containing small addi~ons of silicate or hydroxide are tJ~ermodyr~amicalJy stable because the vapor p~aessur~e is signifrcan#ly less than that Of the free hydrocarbon unfit the solution is approximately saturated.
ever, i# is k~wn from SOAP I~AANUFACTURE by J. Dave, e# al.
published by lnterscience Publishers, lnc. New York, p. 495, that coconut oil soap was germicidally more active against Es'cherichia coti and Eberthella typhosa than other soaps made from natural fats and oils. Also, this test teaches a# page 5U3 that coal tar soaps earn be made by ceding wood tar #o c~conu# oil soap and at page 505 that sulphur soap can be made by adding sulphur to cxxx~nu# oil soap_ Also i# is known from U.S. Paten#s Nos. 4,fi57,933 and 4,fi57,934, #o provide a topic! preparation for treating an epidermal area of a hurr~an being affwith Herpes simplex virus comprising a stable emulsion having from approximately 3D% by volume #o approximately 50% by volume of anhydnaus ether in a pharmaceutically acceptable vegetable oil carrier having most of the free fatty acids thereof removed, said emulsion having a boiling point of a#
least 9 DO° F. These Patents also teach applying heat, e.g., wet heat, to the area where the topical prepara#ieon is app~ed for a period of between approximately three to approximately fifteen minutes.
As will be destxibed in greater detail hereinafter, the method and topical preparation of the present invention differ from the previously prod method and preparations in that according #o tl~ r~thod of the present invention a topical preparation comprising an emulsion of diethyl ether wherein the amount of diethyl ether used comprises a# !Bast 309~o by volume Of the emulsion and a vegetable oil carrier comprising at least 3Q% to 5D% by volume, together with ~ D% #0 20°.~ DMSO (dime#hylsu#oxide), 2% to 8% sodium peroxide by volume and 2% to 8% by volume detergent is applied to the infected area .
The emulsion uses a vile oil carrier preferably a lauric acid carrier having a minimum of free fatty acids. Additionally, the method preferably includes the step of subsequently applying heat to the infected area.
BRIEF SUMMARY OF THE INYE1~IT#Ot~l According to the inv~~on #here is provided a l prerpara#~n for treating an epidermal area of a human being infected with Herpes simplex virus comprising a stable solu#ion or emuls~ of from approximately 30°~6 by volume to approximately 50% by volume of diethyl ether in a pharmaceutically acceptable canter oil of vegetable origin of about C.sub_fi to C.sub_~D having roost of the free fatty aads thereof removed, DlUISC) (dimethylsulfoxide) of from approximately 10°~ by vole to apprd~dmaiely 20°~ by volume for enhancing delivery of the topical preparation, 2% to $% by volume of sodium peroxide and 296 to $% by volume of detergent for facilitating desk of the fatty material to unlock the cells of the virus to enable the diethyl ether to kill the virus cells more quickly The emulsion or solution has a boiling point of at least ~100.degr~.
F.
The oils are preferably lauric acid oils, preferably coconut oil.
Further according to the invention there is provided a method for treating in vivo an epidermal area of a human being infected with Herpes simplex virus comprising the step of applying to the infect area in an amount suit to cover the infected area, a topical preparation including a stable emulsion having from approximately 30°1o by volume to approximately 50°~ by volume of diethyl ether in a pharmaceutically acceptable vegetable oil carrier having most of the fry fatty aids remove, DIiASO {dimefhylsulfloxide) of from approximately 90°~
by volume to approximately 2I?% by volume for enhancing delivery of the topical preparation, 2°~6 to 8% by volume of sodium peroxide and 2°~ t0 $°~ by volume of detergent for facilitating destruction of the fatty material to unlock the cells of the virus to enable the diethyl ether to kill the cells. The emulsion has a boiling point of at least 100° F.
!n another embodiment of the method heat subsequently is applied to the area to which the topical preparation is applied. !n one preferred mode of this emb~iiment of the method the heat is applied approximately three minutes after the topical preparation is aand the application of heat maintained for a period of between about 3 and 9 5 minutes.
DETAlI.ED DESCRIPTION OF THE IN1IENTION
In accordance with one of the teachings of the present invention, a topical preparation including an emulsion of diethyl ether and a vegetable oil carrier, preferably a coconut oil carrier, having most of the free fatty acids removed, DMSO (dimethylsulfoxide) of from appro»mately 9 O~a by volume to approximately 20% by volume, preferably about 9 5%, for enhancing delivery of the topical preparation, 2% to 8% by volume of sodium peroxide, preferably about 5%, and 2°/fl to 8% by volume of detergent, preferably about 5%, for facilitating destnrc~ion of the fatty material to unlock the cells of the virus to enable the diethyl ether to kil! the cells more quickly, has been found to be useful in treating epidermal areas infected with Herpes simplex virus.
According to the method of the present invention a stable emulsion of at least 30°~ by volume of diethyl ether in a pharmaceutically a~eptable cocxmut oil carrier with most of the free fatty acids removed, DMSfl (dimethylsulfoxide) of from ap~oximately ~0°~ by volume to approximately 20°~, preferably about 95°.6 by volume for enhancing delivery of the topical preparation, 2% to 8% by volume of sodium peroxide, preferably about 5°~, and 2% to 8°/a by volume of ant, preferably about 5°/a, for facilitating destruction of the fatty material to unlock the cells of the virus to the diethyl ether to kill the cells more quickly, is applied to the infected area. Preferably, heat is also applied to the infected area some #ime after the application of the #op~ preparation for a period of 8 to '15 b minutes.
!t has been known for some time that ether is very helpful in trea~ng the "cold sore" lesion in an epidermal area i~ by Herpes simplex virus. In this respect, the ether damages or removes the viral envelope thereby reducing infe~ivi#y. Hc~vvever, ether, particularly di~hyJ ether, is ex#rerr~ely unstable and has a very low boiling point. Accordingly, one must be very careful in applying ether and in the past this has only been done in a controlled environment such as in a hospital outpatient ward or in a physician's ofJ'ice. Also, the ether evaporates quickly and as a result does not penetrate deeply in#o the infected area.
!n view of the rapid evaporation of ether, i# has been proposed in 1J.S. Pat.
No. 4, 020, 7 83 to apply an ether-linkage compound in a non-irritating carrier such as a lotion or oil to the infected area. !n this way the ether-linkage compound in the carrier can l~ maintain~i on the info area for a significau# period of time fo allow penetration by the ether-linkage compound. However, the ether-linkage compound is not as strong and effective as diethyl ether in destroying the viral envelope.
Thus, according to the teachings of the present invention, diethyl ether, which is a highly volatile chemical, is ui~ized. However, it must be combined with a carrier so that it will be more stable. Diethyl ether is used because it is believed #o afford deer penetration than other ewers or ether-linkage c~pounds having a higher boiling point.
Diethyl ether is a pungen#, volatile, highly flammable liquid derived from the distillation of ethyl alcohol wi#h sulfuric acid and widely used as an inhalation anesthetic. Also called ethyl ether, ethyl oxide, sulfuric a#her.
Arcarding to the teachings of the present invention, sodium peroxide in the amount of 2°I° #0 8% by volume, preferably 5°k by volume is to the emulsion. Sodium peroxide is used as an oxidizing agent that helps destroy the Herpes simplex virus.
RecentJjr i# has been found tha# the use of DMSO (dime#hylsulfo~cide) as a carrier enhances delivery of the topical preparation #o the cells of the virus.
Further, delivery of the #opical preparation appears #o be faalitated by increasing the amoun# of sodium peroxide.
Still further, the addi#ion of a ~tergen# facilita#es the oxidation process by helping #o des#roy the fatty matter in the virus cells #o libera#e or unlock the cells so #ha# #hey canno# replica#e and thus permi# the die#hyl ether #o kill the virus cells faster.
The de#ergen# can be of the type sold under the #raden~ark "Ul#ra Sunlight Lemon° or the de#ergen# sold under the #rademark "Ci#~us Burs#~. !#
is also believed #ha# any de#ergen#, which is clear or brown in color, can be used.
De#ergent~ unlike soap can des#roy the fatty matter of the Herpes simplex virus cells. The destruction of the fatty matter hinders the ability of the Herpes simplex virus cells #o be cleaved to o#her cells to make a chain for delivering other viruses to healthy cells.
Further according to the #ead~ings of the present invention, the vegetable oil, preferably, coconut oil wi#h mos# of the free fatty acids removed is used as the carrier. A!#hough o#her na#ural oils could be used, coconu# oil was found #o be the mos# sui#able for emulsification wi#h the diethyl e#her.
The vege#able oil, preferably, coconu# oil can be refined and blew or hydrogena#eci.
The other natural oils #ha# can be used comprise oils of vegetable origin, e.g., oils tlaa# have a distribution of glycerides of Cfi #o C2fJ ac~ls, it being unders#ood #ha# the percentage distribu#ion of specific glycerides varies from oil #o oil. In #his regard the oils used are generally #hose that have a pre~nderan~e of C92 #o C ~8 acid gylrerides, namely lauric acid glyceride to oleic acid glyceride. With reference #o Bailey's Jndustria! Oil and Fat Products, (3rd Ed.), 99fi4, by In#erscience Publishers, New York, N.Y., the #ex# of which is irn~rpora#ed herein by reference, it will be apprecia#ed that the oils of vegetable origin broadly encompassed by the above parameters comprise the lauric acid oils, the viable but#ers, the oleic mid oils and the liru>~C mid oils.
Represen#ative lauric acid oils having a preponderance of C 9 2 glycerides include coconut oil, palm kemal oil, #ucum oil, ouricuri oil, e#c. The oleic acid and linoleic arid oils having a preponderance of C 'l8 acid glycerides include corn oil, co##onseed oil, peanut oil, saf#lower oil, for e~sample. The sigr~ar~t considerations in selection of the oil carrier reside in an appreciation tha#
the oii must a# least be mwith the diethyl ether, and preferably soluble therein, and #ha# the oil carrier be capable of pene#rating the epidermal tissue to ensure delivery of the viricidal ether to the #rJgeminal ganglion thus d~oying the viruses hiding there. The oil carrier mus# thus also be capable of suppressing or delaying the va~poriza~on of the ether. It has been found #hat the class of oils of vegetable origin disclosed are effications. 1# is theorized tha# the violen#
ac#ivi#y of the very small ether molecules beneath the slower much larger oil molecules, aided by the breathing action of the skin, allows the ether #o penetra#e deeply #o the trigeminal ganglion. After applica#ion of the oil carrier-ether composi#ion, if after a short period of #ime #o permi# gene#ra#ion of the composi#ion, heat is applied #o the site being treated, the ether is vaporized wi#hin the tissue and as a gas #ravels #o the #rigeminal ganglion. The subsequen#ly applied hea# may be wet or dry since it does not in fad al#~ the composition of the coil-ether preparation.
The refaned and bleached or hydrogenated coconut oif carrier is obtained in the following manner:
First, coconut oil is rel~r~ecl with caustic soda (NaOH), this process also Ding known as refining of a glyceride. Here the natural oil (a glyceride) is broken down into glycerol and a soap containing most (a# least 95%) of the free fatty acids. The glycerol is retained and this process of removing free fatty acids found in the oil (i.e., palmitic, capric, oleic, linoleic and linolenic acids) makes the carrier much less irritating #o the skin. The oil now co»#ains no more than 7% free fatty acids. l# is believed that #!~e refined coconut oil carrier aids in heating #~he epiden»al area around the "cold sore" lesion, which area has been leached of moisture by the diethyl e#t~er applications, by sealing that epidermal an3a to air and water which can be de#eren#s to the heating process.
After the refining, the glycerol is ~r processed, i.e., i# can be hydrogenated, to produce stearic acid (cold cream) and the desired product, red and hydrogena#~1 ~conu# oil, the carrier used in the emulsion with the diethyl ether. )t has been found empirically that the most suitable refractive index of hydrogenation for the carver is 1.4540±0.0002 at 25° C. and an iodine value of 4.5±0.5.
Refining and hydrogenation of oils are well known processes and the manner in which these processes are card out is described in the text entitled:
Off~ciat and Tentative Methods of the American Oit Chemist's Society (3rd Ed.
) X976, published by the n Oil Chemist's Society, Champaign, tlt., the disc;Jasure of which is incorporated herein by reference. )n this text, refining of oil tectmiqt~s are described in A.O.C.S. Qfl~ia! N)e~Od Cc 8d-55 pages 9-3 and hydrogenation of oi! techniques are described in A.O.C.S. Recommended Prac#iC$ Ca 17-7fi pages 9-~_ This hydrogenation process is betiev~l to slow down the development of rancidity of the oil, a common problem of oil based ends and thus allows a )anger shelf and use life.
Refined and bleached or hydrogenated coconut oil which has an iodine value of 4.5±0.5, which has no more than 7% free fatty acids (FFA as oleic) and which has a refractive index of ~.454~±0.0002 at 25° C. is commercially available from:
CPC l#ic~nal International Plaza P.C. Box 5th Englewood Cliffs, ~LJ., from its subsidiary Best Foods CPC l~tional 2849 S. Kilboume Chicago, l11.
and from:
Capi~l City Products ~ 200 Route 48 W. N~nr York, N.J.
One preferred partially hardened refined and bleached (or hydrogenated) coconut Oil had the folk~unr~g maul spe~cifca#ions:
Color (Lovibond): Max. 4.0 Red F. F.A (aS Oleic): N~c. 7.0%
M.1. U. (A9oisture Inert: Dist): Max. ~ , 0%
SapDnifrcatiOn value: Min. 254 ( ~ ) Polyunsaturated Acids: Max. 0.40%
Iodine Value: 4.5±0.5 Odor: Usual charectaistic odor Refractive index: 1.4540±0.0002 {1 ) To be determined by using AO.C.S. Method Cd 7 58 !n the refining of the coconut oil, the free fatty acids are taken off, i.e., the fry falfy acids are conversed ~o soap which se#tles and are taken off as "foots'.
with glycerols of other fatty acids retained, i.e., the glycerols C6 to C18_ The hydrogenation thus changes the unstable gtyc~ols, e.g., oleic (unstable) to stearic (stable}.
Coconut oil is a mixture of fatty acids of even number molecultes Cfi through Cl8-1. The amounts of C6 and C20 are nil.
The % distribution is as follows:
Fatty Acid °I°
C6 (Caproic) Nil C8 (Caprylic) s ±1 Cl0 (Capric}
7 ± 1 Cl2 (Lauric) 48.5 ± 1.5 Cl4 (Myrystic) 9 9.0 .~'-_ 9.0 Clfi (Palmitic) 8.75 ± 0.75 C98 ~Stearic) 5.25 ± D.75 C ~ 8-9 (Oleic) 3.00 ± 0.50 The free fatty acids in the coconut oi! will saponify under certain conditions during the refining of the crude coconut oil while the other comets wt!! not.
!=or example, in one refining process, 500 gm of crude coconut oi! is put into a water bath with a rnect~anic;a! stirrer at a temperature between 30.d~ree.-35° C. at 250 RPM. Next an amount of 20° 8aume NaOH is added to eff~tively saponify the free fatty acids, e.g., C a 7 H33 COOH
oleic acid+NaOH=C97 H33 COONa+H2 O. the molecular weight of the oleic acid is 282.4 and the molecular weight of the sodium hydroxide is 40.
After the amount of NaOH is determined by conventional calculations, it is added to the water bath which is then stirn~ fnr 5 minutes. Next, decrease speed to 70 RPM and raise the temperature of the water bath quickly to 50°-53.c~gree. C. Stir for 90-95 minutes more or until the "foots" (bottom soap) appear to be ready to settle out. Let sit in bath anti! oil is relatively clear before removing the refined oil.
!n bleaching the refined coconut oil, a fi0 mesh screen, bleaching earth as per Arr~erican Oil Chemists Society standards, ice- paper (Sargent Welch Grade S 32915-J or equivalent) and rolled cotton are used: The screen is lined with thin layers of rolled and 300 gm of refined oil are allowed to flJ#er into a stainless steel cup which is then placed under a mechanical stirrer. Then, 9 grams of bleaching earth are and stirred at a temperature of ~00°
#0 7 90° C_ The speed of stirring is fast enough #o keep the bleach in suspension for five minuses. Next the solution is filtered through a steel funnel having the filter paper therein and the l~ltra#e of refined and bleached coconut oi!
is collected in a beaker.
The emulsion of diethyl e#h~r and the hydrolyzed and hydrogenated cxxonu# oil or the reined and t>~Ched coc~nu# oil is cx~mbined in a ratio of from 1:2 to 1: 9 , diethyl ether by volume to coconut oiJ by volume with a ratio of 2:3 being pnefen~l.
From numerous tests it was found that by combining the coconut oil wi#h the diethyl ether in a ratio of 3:2 by volume, forming thereby a supersaturated emulsion, the normal boiling point of the emulsified diethyl ether is raised to approxirna#ely 9 9 9. degr~. F. This numerical ratio ration of the oi! and ether was also observed to produce the Least amount of damage, i.e., necrosis, of the viable tissue surrounding the herpetic lesion, while still providing a highly effective agent in destroying the viral envelope.
The emulsion is applied as a topical preparation #o the ink area or areas in an amount sufficient to cover the infected area or areas once a day for a period of from one week up to ninety days, if necessary. Empirical measurements indicate that the amount applied is approximately one cubic c~n#ime#er ( ~ cc) for approxirna#ety each 9 /4 square inch {4.4 square c~n~me#er) of infected surtace area. More specifically, the preparation is applied daily until the "cold sore" lesions in the infec.#er! area are no kmger visible.
Preferably, heat is also applied to the infected area, and it has been obsenr~! that the heat application appears #o speed up and assist the healing process, i.e., the disappearance of the "cold sore" Lesions.
Two #ypes of heat have been used with goods results. One is n~diant, infrared or dry hea# and the other is wet heat applied with a ho#, wet #owel.
The radiant, infrar~i heat is applied a# a #emperature as high as the pa#ien# can withstand for a period of 9 5 #0 20 minutes on the morning af#er the prepara#ion is applied. The infrared source is positi~ed 98 inches or more from the infected area on the pa#ien#'s face wi#h a mask provided over the adjacent fascia! area, par#icularly over the eyes, #o protect thin. Tt~ radian# hea#
appears #o assis# in drying the lesions and was found #o be very effective in drying multiple erup#ions_ !# is also believed #ha# the applica#ion of hea# increases the blood supply #o the area of ink and increases o~rgenation of the tissue in that area so as to aid healing fur#her. Also, increased blood flow caused by application of hea#
is believed to promote a more rapid removal of the debris left behind as the lion is destroyed.
As an al#emative #o infra-red head wet hea# in the form of hot, wet towels can be applied to the infected area at a tempera#ure as high as the paa#ient can withs#and, for a period of ~ 5 to 2D minutes each morning and each evening with the topical preparation being applied only once a day in the evening.
For individuals subjec# to multiple infections at regular in#ervals, the #opical prepara#~n is apl three #imes daily for the first fwe days fotby applica#ion of the #opical prepare#ion three times a day for the next five days with each such applk;a#ion being ~ by appJir~#ion of a ho#, we# towel (as hot as the individual can s#and~ for 3 to 20 minu#es #hree times a day.
Jn one me#hod of trea#men#, abou# 2 cc of the preparation is applied to the intact area around, for example, the lips. After #hree minu#es, a we#
towel, as ho# as is bearable by the patient, is applied to the area for about three minutes.
It is believed that without heat the ether penetrates the infected area as d~pJy as possible in about three minu#es. Then i# is believed the hea# from the vve# #o~rel causes the ether that has penetrated #o vaporize allowing it to propel or move up the "#rr~r~al canal", killing the viruses #ha# hide );here in a dcxman#
s#a#e and become active la#er causing t~umen# infections. Again, i# is believed tha# abou# #hree minu#es is a suf~en# #irr~e #o keep the vapors wing in the canal a# a sufficient pressure and v~ume to des#roy the virus.
Empirical studies sf~r #ha# one prod of #reatmen# is to apply the l preparation at leas# once (preferably twice) a day #or #hree days. Then, on the #hird day. even if the "cold sore" appears to be "cured", the prepara#ion and heat as described above are applied three times a day for at least #hree days. t#
is believed #ha# after this period the m~Cation has "won the fight" in killing the virus at the site of infection and the body's immune system can take over the "ba#tle" forcing the virus to escape via the #rigemi»a! carnal.
1# will be appreciated that with the topical preparation of the present invention, a safe means of delivering diethyl ether #o an epidermal area infect with F simplex virus is made possible. !n #his respect, the diethyl ether is emulsif~~d in the reined and bleached coconu# oil carries- as described above so #ha# the heat instability of the diethyl ether is coon#eracted by the high boiling poin# of the co~nut oil carer. )n this way, the boiling poin# of the overall emulsion is raised from the normal boiling poin# of diethyl ether a#
34.8°
C. {approxirr~#ety 87.degn~_ F.} up #o approximately 54.4° C.
{approximately 9 ~)9° F.). This increase in the boiling poin# of die#hyl e#her in the emu~On enables #t~ die#hyl e#her in the emulsion #o be s#ored more ,e~a~ly and more safely #hereby to permi# its use outside of the con#rolted environment of a hospital ou#pa#ien# clinic or a physi~an's office. Further, the use of DMSO
{dime#hylsutfoxide} facilitates delivery of the topical prepara#ion #o the virus cells lb and the de#ergent facili#ates the destruction of the fa#y mater to liberate or unlock the cells better to enable the diethyl ether #o kill the virus cells.
Also it will be appreciated that by utilizing applications of heat to the infected area in addition #o the application of the topical preparation healing of the "cold sore" lesions is entranced and expedi#ed. As sta#ed above, i# is believed this is caused by the increase in bt~d flow #o the infected area as a result of the bat applied thereto.
Another important feature of the presen# invention is that by using at leas#
30% by volume of die#hyl ether in a n3trned and bleached co~nu# oil carrier , as opposed to an ether-linkage compound, a stronger agen# is used in the treatment of Herpes simplex virus thereby #o provide a more effet~ive #reatment. In #his respect, the diethyl ether is more effective than the ether-linkage compounds in destroying the viral envelope of Herpes simplex virus thereby to provide a more effective treatmen#. !n this respect, the diethyl ether is more effective than the ether-linkage compounds in destroying the viral envelope and the emulsion enables one #o apply a sufficient volume of diethyl ether to the infected area.
ever, by using diethyl ether, virtually no wa#er is placed in contact with the infected area when the ether is applied thereby to aid further the healing process.
Ano#her advan#age of the topical pr~aration of the presen# invis the use of refined and bleach~d coconu# oil u~rhich has much of the skin irri#ating free fatty aids removed #herefrom. Moreover, #b rs~ned and bleact~d cu#
oil carrier serves to pro#ect the infected area during irea#men# iher~sof from air and water, which are often deterents to #b baling prods.
According #o one preferr~ embodimen# of the topical preparation of the presen# invention comprised_ Diethyl ether 3S cc 1?
DMSO 7 5 cc Sodium peroxide 5 cc Oit Gamier 40 cx Detergent 5 cc t# has been found through empirical #~es#s #ha# the oxida#ian process of the detergen# helps to destroy the fatty matter in the cells #o libera#e the abiti#y to unlock the cells. The damaged cue!! #hen canno# replica#e and are hamntess.
f=rom the foregoing descrip#ion i# will be apparer~# that the rne#hod and #preparation for #rea#ing Herpes simplex virus of the presen# inven#ion have a number of advan#ages some of which are described above and others of which are inheren# in the inven#ion. f=or example, i# has been observed #ha# in #rea#ing a cad sore virus according #o the teachings of the method of the presen#
inven#ion and utilizing the topical prepara#ion of the presen# invention, local recurrence of cold sores is greasy minimized if not al#ogether etimina#ed, and such preven#ion of recurrence is grea#!y desired when treating Herpes simplex virus infec#ivi#y.
tlltoreover, from empirical tests it has been found that the #opica!
prepara#ion applied ceding #o the me#hods of the present inven#i<ua is effective in #rea#ing in vivo Herpes J, Herpes !t, "athlete's foot" fungus, "jock i#ch"
fungus and yeast infers and may be eff~tive in #rea#ing Chicken Pox, Acne, F~zema, occlusions and infections of pores (pimples and blackheads), skin rand canker sores_ t# has been found, generally by in vivo experimentation, tha# the disclosed oils of vege#abte origin have the requisite prod to deliver an etive amoun# of ether #o the lrigeminal ganglion. In a sense, the topical prepara#ion of the present invention thus comb lafentiat~ ether by virtue of effecting delivery of the viricidal ether to the site of the virus, i.e., the trigeminal ganglion.
Herpes simplex virus appears to find the spongy area around mucus membranes an a~ac~ve dace #o thrive and cause infec~ivi#~r_ Once the integrity of an area is violated by Herpes simplex virus, there seems #o be a triggering mechanism that welcomes repeated infe~ion of the same area. The reason for this phenomenon occurring is not known a# presen#.
Herpes simplex virus infectivi#y is primarily dependent upon the tntac#ness of the viral envelope and a chemical combination, which damages or removes the envelope will reduce infec#ivi#y greatly 1# is well known that ether is extremely successful in producing this effect. However, the normal body temperature is about ~.degr~. C. above the boiling point of ether' such that treatr~n# in vivo heretofore has not been successfuJ_ See for example "Topics! Ether and Herpes Simplex Labialis" by Mary E. Guinan, M.D., Ph.D., e# a!. !AMA, Mar. ?4, 9980, Vol. 243, No. ~ 0, pp, 9 D59-fi ~ . Also, due to the extreme instability of ether, particularly ether, a# room temperature or higher, diethyl ether has heretofore only been used for this type of treatment in a controlled environment such as a hospital or physician's office, and diethyl a#her has not been available in a form suitable for use outside of a controlled (e.g., hospital) envin~nmen#.
Rather, ether-, amide-, or ester-linkage compounds, atone or in nation, have been used. However, the eff~tiv~sss of such ends in treating Herpes simplex virus is far less than that of a pure ether. An example of an emutW a including such a fund is discJos~ in the Asculai et al. U.S.
Pat. No. 4,020, 983.
According to the teachings of this patent, nonionic surfactants are delivered in a non-irritating ~ such as a lotion or oil to an infected area vrith the amount of surfactant employed being between 0.5% and 20% by volume.
!t has also been proposed in Atnor U. S. Pad No 3, 949, 07 9 to use an aqueous solution including a base, fatty acids comprising primarily oleic acid, and a surface-ar~JVe agent for treating bums, scalds and other sJdn irritations.
The base is an alkali metal carbonate.
Further i# has been proposed in Grove U.S. Pat. No. 2,029, ~fi6 #o use a topical preparation of a soft soap and stearoptens in a salve for use as a Jinimen#.
Still further, i# is known from "A simp~ proof of the thermodynamic stability of materials taken up by solutions containing solubiJizers such as soap", Amer.
Chem. Soc. fit, 2855-9 0 940) that ether is thermodyrrami~aAy stable in soap.
More specifically, the colloids! solutions formed from a solution of ther and soap containing small addi~ons of silicate or hydroxide are tJ~ermodyr~amicalJy stable because the vapor p~aessur~e is signifrcan#ly less than that Of the free hydrocarbon unfit the solution is approximately saturated.
ever, i# is k~wn from SOAP I~AANUFACTURE by J. Dave, e# al.
published by lnterscience Publishers, lnc. New York, p. 495, that coconut oil soap was germicidally more active against Es'cherichia coti and Eberthella typhosa than other soaps made from natural fats and oils. Also, this test teaches a# page 5U3 that coal tar soaps earn be made by ceding wood tar #o c~conu# oil soap and at page 505 that sulphur soap can be made by adding sulphur to cxxx~nu# oil soap_ Also i# is known from U.S. Paten#s Nos. 4,fi57,933 and 4,fi57,934, #o provide a topic! preparation for treating an epidermal area of a hurr~an being affwith Herpes simplex virus comprising a stable emulsion having from approximately 3D% by volume #o approximately 50% by volume of anhydnaus ether in a pharmaceutically acceptable vegetable oil carrier having most of the free fatty acids thereof removed, said emulsion having a boiling point of a#
least 9 DO° F. These Patents also teach applying heat, e.g., wet heat, to the area where the topical prepara#ieon is app~ed for a period of between approximately three to approximately fifteen minutes.
As will be destxibed in greater detail hereinafter, the method and topical preparation of the present invention differ from the previously prod method and preparations in that according #o tl~ r~thod of the present invention a topical preparation comprising an emulsion of diethyl ether wherein the amount of diethyl ether used comprises a# !Bast 309~o by volume Of the emulsion and a vegetable oil carrier comprising at least 3Q% to 5D% by volume, together with ~ D% #0 20°.~ DMSO (dime#hylsu#oxide), 2% to 8% sodium peroxide by volume and 2% to 8% by volume detergent is applied to the infected area .
The emulsion uses a vile oil carrier preferably a lauric acid carrier having a minimum of free fatty acids. Additionally, the method preferably includes the step of subsequently applying heat to the infected area.
BRIEF SUMMARY OF THE INYE1~IT#Ot~l According to the inv~~on #here is provided a l prerpara#~n for treating an epidermal area of a human being infected with Herpes simplex virus comprising a stable solu#ion or emuls~ of from approximately 30°~6 by volume to approximately 50% by volume of diethyl ether in a pharmaceutically acceptable canter oil of vegetable origin of about C.sub_fi to C.sub_~D having roost of the free fatty aads thereof removed, DlUISC) (dimethylsulfoxide) of from approximately 10°~ by vole to apprd~dmaiely 20°~ by volume for enhancing delivery of the topical preparation, 2% to $% by volume of sodium peroxide and 296 to $% by volume of detergent for facilitating desk of the fatty material to unlock the cells of the virus to enable the diethyl ether to kill the virus cells more quickly The emulsion or solution has a boiling point of at least ~100.degr~.
F.
The oils are preferably lauric acid oils, preferably coconut oil.
Further according to the invention there is provided a method for treating in vivo an epidermal area of a human being infected with Herpes simplex virus comprising the step of applying to the infect area in an amount suit to cover the infected area, a topical preparation including a stable emulsion having from approximately 30°1o by volume to approximately 50°~ by volume of diethyl ether in a pharmaceutically acceptable vegetable oil carrier having most of the fry fatty aids remove, DIiASO {dimefhylsulfloxide) of from approximately 90°~
by volume to approximately 2I?% by volume for enhancing delivery of the topical preparation, 2°~6 to 8% by volume of sodium peroxide and 2°~ t0 $°~ by volume of detergent for facilitating destruction of the fatty material to unlock the cells of the virus to enable the diethyl ether to kill the cells. The emulsion has a boiling point of at least 100° F.
!n another embodiment of the method heat subsequently is applied to the area to which the topical preparation is applied. !n one preferred mode of this emb~iiment of the method the heat is applied approximately three minutes after the topical preparation is aand the application of heat maintained for a period of between about 3 and 9 5 minutes.
DETAlI.ED DESCRIPTION OF THE IN1IENTION
In accordance with one of the teachings of the present invention, a topical preparation including an emulsion of diethyl ether and a vegetable oil carrier, preferably a coconut oil carrier, having most of the free fatty acids removed, DMSO (dimethylsulfoxide) of from appro»mately 9 O~a by volume to approximately 20% by volume, preferably about 9 5%, for enhancing delivery of the topical preparation, 2% to 8% by volume of sodium peroxide, preferably about 5%, and 2°/fl to 8% by volume of detergent, preferably about 5%, for facilitating destnrc~ion of the fatty material to unlock the cells of the virus to enable the diethyl ether to kil! the cells more quickly, has been found to be useful in treating epidermal areas infected with Herpes simplex virus.
According to the method of the present invention a stable emulsion of at least 30°~ by volume of diethyl ether in a pharmaceutically a~eptable cocxmut oil carrier with most of the free fatty acids removed, DMSfl (dimethylsulfoxide) of from ap~oximately ~0°~ by volume to approximately 20°~, preferably about 95°.6 by volume for enhancing delivery of the topical preparation, 2% to 8% by volume of sodium peroxide, preferably about 5°~, and 2% to 8°/a by volume of ant, preferably about 5°/a, for facilitating destruction of the fatty material to unlock the cells of the virus to the diethyl ether to kill the cells more quickly, is applied to the infected area. Preferably, heat is also applied to the infected area some #ime after the application of the #op~ preparation for a period of 8 to '15 b minutes.
!t has been known for some time that ether is very helpful in trea~ng the "cold sore" lesion in an epidermal area i~ by Herpes simplex virus. In this respect, the ether damages or removes the viral envelope thereby reducing infe~ivi#y. Hc~vvever, ether, particularly di~hyJ ether, is ex#rerr~ely unstable and has a very low boiling point. Accordingly, one must be very careful in applying ether and in the past this has only been done in a controlled environment such as in a hospital outpatient ward or in a physician's ofJ'ice. Also, the ether evaporates quickly and as a result does not penetrate deeply in#o the infected area.
!n view of the rapid evaporation of ether, i# has been proposed in 1J.S. Pat.
No. 4, 020, 7 83 to apply an ether-linkage compound in a non-irritating carrier such as a lotion or oil to the infected area. !n this way the ether-linkage compound in the carrier can l~ maintain~i on the info area for a significau# period of time fo allow penetration by the ether-linkage compound. However, the ether-linkage compound is not as strong and effective as diethyl ether in destroying the viral envelope.
Thus, according to the teachings of the present invention, diethyl ether, which is a highly volatile chemical, is ui~ized. However, it must be combined with a carrier so that it will be more stable. Diethyl ether is used because it is believed #o afford deer penetration than other ewers or ether-linkage c~pounds having a higher boiling point.
Diethyl ether is a pungen#, volatile, highly flammable liquid derived from the distillation of ethyl alcohol wi#h sulfuric acid and widely used as an inhalation anesthetic. Also called ethyl ether, ethyl oxide, sulfuric a#her.
Arcarding to the teachings of the present invention, sodium peroxide in the amount of 2°I° #0 8% by volume, preferably 5°k by volume is to the emulsion. Sodium peroxide is used as an oxidizing agent that helps destroy the Herpes simplex virus.
RecentJjr i# has been found tha# the use of DMSO (dime#hylsulfo~cide) as a carrier enhances delivery of the topical preparation #o the cells of the virus.
Further, delivery of the #opical preparation appears #o be faalitated by increasing the amoun# of sodium peroxide.
Still further, the addi#ion of a ~tergen# facilita#es the oxidation process by helping #o des#roy the fatty matter in the virus cells #o libera#e or unlock the cells so #ha# #hey canno# replica#e and thus permi# the die#hyl ether #o kill the virus cells faster.
The de#ergen# can be of the type sold under the #raden~ark "Ul#ra Sunlight Lemon° or the de#ergen# sold under the #rademark "Ci#~us Burs#~. !#
is also believed #ha# any de#ergen#, which is clear or brown in color, can be used.
De#ergent~ unlike soap can des#roy the fatty matter of the Herpes simplex virus cells. The destruction of the fatty matter hinders the ability of the Herpes simplex virus cells #o be cleaved to o#her cells to make a chain for delivering other viruses to healthy cells.
Further according to the #ead~ings of the present invention, the vegetable oil, preferably, coconut oil wi#h mos# of the free fatty acids removed is used as the carrier. A!#hough o#her na#ural oils could be used, coconu# oil was found #o be the mos# sui#able for emulsification wi#h the diethyl e#her.
The vege#able oil, preferably, coconu# oil can be refined and blew or hydrogena#eci.
The other natural oils #ha# can be used comprise oils of vegetable origin, e.g., oils tlaa# have a distribution of glycerides of Cfi #o C2fJ ac~ls, it being unders#ood #ha# the percentage distribu#ion of specific glycerides varies from oil #o oil. In #his regard the oils used are generally #hose that have a pre~nderan~e of C92 #o C ~8 acid gylrerides, namely lauric acid glyceride to oleic acid glyceride. With reference #o Bailey's Jndustria! Oil and Fat Products, (3rd Ed.), 99fi4, by In#erscience Publishers, New York, N.Y., the #ex# of which is irn~rpora#ed herein by reference, it will be apprecia#ed that the oils of vegetable origin broadly encompassed by the above parameters comprise the lauric acid oils, the viable but#ers, the oleic mid oils and the liru>~C mid oils.
Represen#ative lauric acid oils having a preponderance of C 9 2 glycerides include coconut oil, palm kemal oil, #ucum oil, ouricuri oil, e#c. The oleic acid and linoleic arid oils having a preponderance of C 'l8 acid glycerides include corn oil, co##onseed oil, peanut oil, saf#lower oil, for e~sample. The sigr~ar~t considerations in selection of the oil carrier reside in an appreciation tha#
the oii must a# least be mwith the diethyl ether, and preferably soluble therein, and #ha# the oil carrier be capable of pene#rating the epidermal tissue to ensure delivery of the viricidal ether to the #rJgeminal ganglion thus d~oying the viruses hiding there. The oil carrier mus# thus also be capable of suppressing or delaying the va~poriza~on of the ether. It has been found #hat the class of oils of vegetable origin disclosed are effications. 1# is theorized tha# the violen#
ac#ivi#y of the very small ether molecules beneath the slower much larger oil molecules, aided by the breathing action of the skin, allows the ether #o penetra#e deeply #o the trigeminal ganglion. After applica#ion of the oil carrier-ether composi#ion, if after a short period of #ime #o permi# gene#ra#ion of the composi#ion, heat is applied #o the site being treated, the ether is vaporized wi#hin the tissue and as a gas #ravels #o the #rigeminal ganglion. The subsequen#ly applied hea# may be wet or dry since it does not in fad al#~ the composition of the coil-ether preparation.
The refaned and bleached or hydrogenated coconut oif carrier is obtained in the following manner:
First, coconut oil is rel~r~ecl with caustic soda (NaOH), this process also Ding known as refining of a glyceride. Here the natural oil (a glyceride) is broken down into glycerol and a soap containing most (a# least 95%) of the free fatty acids. The glycerol is retained and this process of removing free fatty acids found in the oil (i.e., palmitic, capric, oleic, linoleic and linolenic acids) makes the carrier much less irritating #o the skin. The oil now co»#ains no more than 7% free fatty acids. l# is believed that #!~e refined coconut oil carrier aids in heating #~he epiden»al area around the "cold sore" lesion, which area has been leached of moisture by the diethyl e#t~er applications, by sealing that epidermal an3a to air and water which can be de#eren#s to the heating process.
After the refining, the glycerol is ~r processed, i.e., i# can be hydrogenated, to produce stearic acid (cold cream) and the desired product, red and hydrogena#~1 ~conu# oil, the carrier used in the emulsion with the diethyl ether. )t has been found empirically that the most suitable refractive index of hydrogenation for the carver is 1.4540±0.0002 at 25° C. and an iodine value of 4.5±0.5.
Refining and hydrogenation of oils are well known processes and the manner in which these processes are card out is described in the text entitled:
Off~ciat and Tentative Methods of the American Oit Chemist's Society (3rd Ed.
) X976, published by the n Oil Chemist's Society, Champaign, tlt., the disc;Jasure of which is incorporated herein by reference. )n this text, refining of oil tectmiqt~s are described in A.O.C.S. Qfl~ia! N)e~Od Cc 8d-55 pages 9-3 and hydrogenation of oi! techniques are described in A.O.C.S. Recommended Prac#iC$ Ca 17-7fi pages 9-~_ This hydrogenation process is betiev~l to slow down the development of rancidity of the oil, a common problem of oil based ends and thus allows a )anger shelf and use life.
Refined and bleached or hydrogenated coconut oil which has an iodine value of 4.5±0.5, which has no more than 7% free fatty acids (FFA as oleic) and which has a refractive index of ~.454~±0.0002 at 25° C. is commercially available from:
CPC l#ic~nal International Plaza P.C. Box 5th Englewood Cliffs, ~LJ., from its subsidiary Best Foods CPC l~tional 2849 S. Kilboume Chicago, l11.
and from:
Capi~l City Products ~ 200 Route 48 W. N~nr York, N.J.
One preferred partially hardened refined and bleached (or hydrogenated) coconut Oil had the folk~unr~g maul spe~cifca#ions:
Color (Lovibond): Max. 4.0 Red F. F.A (aS Oleic): N~c. 7.0%
M.1. U. (A9oisture Inert: Dist): Max. ~ , 0%
SapDnifrcatiOn value: Min. 254 ( ~ ) Polyunsaturated Acids: Max. 0.40%
Iodine Value: 4.5±0.5 Odor: Usual charectaistic odor Refractive index: 1.4540±0.0002 {1 ) To be determined by using AO.C.S. Method Cd 7 58 !n the refining of the coconut oil, the free fatty acids are taken off, i.e., the fry falfy acids are conversed ~o soap which se#tles and are taken off as "foots'.
with glycerols of other fatty acids retained, i.e., the glycerols C6 to C18_ The hydrogenation thus changes the unstable gtyc~ols, e.g., oleic (unstable) to stearic (stable}.
Coconut oil is a mixture of fatty acids of even number molecultes Cfi through Cl8-1. The amounts of C6 and C20 are nil.
The % distribution is as follows:
Fatty Acid °I°
C6 (Caproic) Nil C8 (Caprylic) s ±1 Cl0 (Capric}
7 ± 1 Cl2 (Lauric) 48.5 ± 1.5 Cl4 (Myrystic) 9 9.0 .~'-_ 9.0 Clfi (Palmitic) 8.75 ± 0.75 C98 ~Stearic) 5.25 ± D.75 C ~ 8-9 (Oleic) 3.00 ± 0.50 The free fatty acids in the coconut oi! will saponify under certain conditions during the refining of the crude coconut oil while the other comets wt!! not.
!=or example, in one refining process, 500 gm of crude coconut oi! is put into a water bath with a rnect~anic;a! stirrer at a temperature between 30.d~ree.-35° C. at 250 RPM. Next an amount of 20° 8aume NaOH is added to eff~tively saponify the free fatty acids, e.g., C a 7 H33 COOH
oleic acid+NaOH=C97 H33 COONa+H2 O. the molecular weight of the oleic acid is 282.4 and the molecular weight of the sodium hydroxide is 40.
After the amount of NaOH is determined by conventional calculations, it is added to the water bath which is then stirn~ fnr 5 minutes. Next, decrease speed to 70 RPM and raise the temperature of the water bath quickly to 50°-53.c~gree. C. Stir for 90-95 minutes more or until the "foots" (bottom soap) appear to be ready to settle out. Let sit in bath anti! oil is relatively clear before removing the refined oil.
!n bleaching the refined coconut oil, a fi0 mesh screen, bleaching earth as per Arr~erican Oil Chemists Society standards, ice- paper (Sargent Welch Grade S 32915-J or equivalent) and rolled cotton are used: The screen is lined with thin layers of rolled and 300 gm of refined oil are allowed to flJ#er into a stainless steel cup which is then placed under a mechanical stirrer. Then, 9 grams of bleaching earth are and stirred at a temperature of ~00°
#0 7 90° C_ The speed of stirring is fast enough #o keep the bleach in suspension for five minuses. Next the solution is filtered through a steel funnel having the filter paper therein and the l~ltra#e of refined and bleached coconut oi!
is collected in a beaker.
The emulsion of diethyl e#h~r and the hydrolyzed and hydrogenated cxxonu# oil or the reined and t>~Ched coc~nu# oil is cx~mbined in a ratio of from 1:2 to 1: 9 , diethyl ether by volume to coconut oiJ by volume with a ratio of 2:3 being pnefen~l.
From numerous tests it was found that by combining the coconut oil wi#h the diethyl ether in a ratio of 3:2 by volume, forming thereby a supersaturated emulsion, the normal boiling point of the emulsified diethyl ether is raised to approxirna#ely 9 9 9. degr~. F. This numerical ratio ration of the oi! and ether was also observed to produce the Least amount of damage, i.e., necrosis, of the viable tissue surrounding the herpetic lesion, while still providing a highly effective agent in destroying the viral envelope.
The emulsion is applied as a topical preparation #o the ink area or areas in an amount sufficient to cover the infected area or areas once a day for a period of from one week up to ninety days, if necessary. Empirical measurements indicate that the amount applied is approximately one cubic c~n#ime#er ( ~ cc) for approxirna#ety each 9 /4 square inch {4.4 square c~n~me#er) of infected surtace area. More specifically, the preparation is applied daily until the "cold sore" lesions in the infec.#er! area are no kmger visible.
Preferably, heat is also applied to the infected area, and it has been obsenr~! that the heat application appears #o speed up and assist the healing process, i.e., the disappearance of the "cold sore" Lesions.
Two #ypes of heat have been used with goods results. One is n~diant, infrared or dry hea# and the other is wet heat applied with a ho#, wet #owel.
The radiant, infrar~i heat is applied a# a #emperature as high as the pa#ien# can withstand for a period of 9 5 #0 20 minutes on the morning af#er the prepara#ion is applied. The infrared source is positi~ed 98 inches or more from the infected area on the pa#ien#'s face wi#h a mask provided over the adjacent fascia! area, par#icularly over the eyes, #o protect thin. Tt~ radian# hea#
appears #o assis# in drying the lesions and was found #o be very effective in drying multiple erup#ions_ !# is also believed #ha# the applica#ion of hea# increases the blood supply #o the area of ink and increases o~rgenation of the tissue in that area so as to aid healing fur#her. Also, increased blood flow caused by application of hea#
is believed to promote a more rapid removal of the debris left behind as the lion is destroyed.
As an al#emative #o infra-red head wet hea# in the form of hot, wet towels can be applied to the infected area at a tempera#ure as high as the paa#ient can withs#and, for a period of ~ 5 to 2D minutes each morning and each evening with the topical preparation being applied only once a day in the evening.
For individuals subjec# to multiple infections at regular in#ervals, the #opical prepara#~n is apl three #imes daily for the first fwe days fotby applica#ion of the #opical prepare#ion three times a day for the next five days with each such applk;a#ion being ~ by appJir~#ion of a ho#, we# towel (as hot as the individual can s#and~ for 3 to 20 minu#es #hree times a day.
Jn one me#hod of trea#men#, abou# 2 cc of the preparation is applied to the intact area around, for example, the lips. After #hree minu#es, a we#
towel, as ho# as is bearable by the patient, is applied to the area for about three minutes.
It is believed that without heat the ether penetrates the infected area as d~pJy as possible in about three minu#es. Then i# is believed the hea# from the vve# #o~rel causes the ether that has penetrated #o vaporize allowing it to propel or move up the "#rr~r~al canal", killing the viruses #ha# hide );here in a dcxman#
s#a#e and become active la#er causing t~umen# infections. Again, i# is believed tha# abou# #hree minu#es is a suf~en# #irr~e #o keep the vapors wing in the canal a# a sufficient pressure and v~ume to des#roy the virus.
Empirical studies sf~r #ha# one prod of #reatmen# is to apply the l preparation at leas# once (preferably twice) a day #or #hree days. Then, on the #hird day. even if the "cold sore" appears to be "cured", the prepara#ion and heat as described above are applied three times a day for at least #hree days. t#
is believed #ha# after this period the m~Cation has "won the fight" in killing the virus at the site of infection and the body's immune system can take over the "ba#tle" forcing the virus to escape via the #rigemi»a! carnal.
1# will be appreciated that with the topical preparation of the present invention, a safe means of delivering diethyl ether #o an epidermal area infect with F simplex virus is made possible. !n #his respect, the diethyl ether is emulsif~~d in the reined and bleached coconu# oil carries- as described above so #ha# the heat instability of the diethyl ether is coon#eracted by the high boiling poin# of the co~nut oil carer. )n this way, the boiling poin# of the overall emulsion is raised from the normal boiling poin# of diethyl ether a#
34.8°
C. {approxirr~#ety 87.degn~_ F.} up #o approximately 54.4° C.
{approximately 9 ~)9° F.). This increase in the boiling poin# of die#hyl e#her in the emu~On enables #t~ die#hyl e#her in the emulsion #o be s#ored more ,e~a~ly and more safely #hereby to permi# its use outside of the con#rolted environment of a hospital ou#pa#ien# clinic or a physi~an's office. Further, the use of DMSO
{dime#hylsutfoxide} facilitates delivery of the topical prepara#ion #o the virus cells lb and the de#ergent facili#ates the destruction of the fa#y mater to liberate or unlock the cells better to enable the diethyl ether #o kill the virus cells.
Also it will be appreciated that by utilizing applications of heat to the infected area in addition #o the application of the topical preparation healing of the "cold sore" lesions is entranced and expedi#ed. As sta#ed above, i# is believed this is caused by the increase in bt~d flow #o the infected area as a result of the bat applied thereto.
Another important feature of the presen# invention is that by using at leas#
30% by volume of die#hyl ether in a n3trned and bleached co~nu# oil carrier , as opposed to an ether-linkage compound, a stronger agen# is used in the treatment of Herpes simplex virus thereby #o provide a more effet~ive #reatment. In #his respect, the diethyl ether is more effective than the ether-linkage compounds in destroying the viral envelope of Herpes simplex virus thereby to provide a more effective treatmen#. !n this respect, the diethyl ether is more effective than the ether-linkage compounds in destroying the viral envelope and the emulsion enables one #o apply a sufficient volume of diethyl ether to the infected area.
ever, by using diethyl ether, virtually no wa#er is placed in contact with the infected area when the ether is applied thereby to aid further the healing process.
Ano#her advan#age of the topical pr~aration of the presen# invis the use of refined and bleach~d coconu# oil u~rhich has much of the skin irri#ating free fatty aids removed #herefrom. Moreover, #b rs~ned and bleact~d cu#
oil carrier serves to pro#ect the infected area during irea#men# iher~sof from air and water, which are often deterents to #b baling prods.
According #o one preferr~ embodimen# of the topical preparation of the presen# invention comprised_ Diethyl ether 3S cc 1?
DMSO 7 5 cc Sodium peroxide 5 cc Oit Gamier 40 cx Detergent 5 cc t# has been found through empirical #~es#s #ha# the oxida#ian process of the detergen# helps to destroy the fatty matter in the cells #o libera#e the abiti#y to unlock the cells. The damaged cue!! #hen canno# replica#e and are hamntess.
f=rom the foregoing descrip#ion i# will be apparer~# that the rne#hod and #preparation for #rea#ing Herpes simplex virus of the presen# inven#ion have a number of advan#ages some of which are described above and others of which are inheren# in the inven#ion. f=or example, i# has been observed #ha# in #rea#ing a cad sore virus according #o the teachings of the method of the presen#
inven#ion and utilizing the topical prepara#ion of the presen# invention, local recurrence of cold sores is greasy minimized if not al#ogether etimina#ed, and such preven#ion of recurrence is grea#!y desired when treating Herpes simplex virus infec#ivi#y.
tlltoreover, from empirical tests it has been found that the #opica!
prepara#ion applied ceding #o the me#hods of the present inven#i<ua is effective in #rea#ing in vivo Herpes J, Herpes !t, "athlete's foot" fungus, "jock i#ch"
fungus and yeast infers and may be eff~tive in #rea#ing Chicken Pox, Acne, F~zema, occlusions and infections of pores (pimples and blackheads), skin rand canker sores_ t# has been found, generally by in vivo experimentation, tha# the disclosed oils of vege#abte origin have the requisite prod to deliver an etive amoun# of ether #o the lrigeminal ganglion. In a sense, the topical prepara#ion of the present invention thus comb lafentiat~ ether by virtue of effecting delivery of the viricidal ether to the site of the virus, i.e., the trigeminal ganglion.
Claims (5)
1. A method for treating, in vivo, an epidermal area of a human being infected with Herpes simplex virus, comprising the steps of: applying to the infected area, in an amount sufficient to cover the infected area, a topical preparation in the form of a stable emulsion having from approximately 30% by volume to approximately 50% by volume of ether in a pharmaceutically acceptable refined oil carrier of vegetable oil origin, said oil carrier being generally free of free fatty acids and essentially free of water, soaps and stabilizers, DMSO (dimethylsulfoxide) of from approximately 10% by volume to approximately 20% by volume for enhancing delivery of the topical preparation,
2 to 8% by volume of sodium peroxide and 2% to 8% by volume of detergent for facilitating destruction of the fatty material to unlock the cells of the virus to enable the diethyl ether to kill the cells, said emulsion having a boiling point of at least 100° F.
2. The method of claim 1 wherein said topical preparation is applied to the infected area in the evening at the time the patient retires for the night.
2. The method of claim 1 wherein said topical preparation is applied to the infected area in the evening at the time the patient retires for the night.
3. The method of claim 1 wherein said refined oil is coconut oil refined to have no more than 7% free fatty acids.
4. The method of claim 3 wherein said coconut oil is hydrogenated.
5. The method of claim 4 wherein the refractive index of said hydrogenated coconut oil is 1.4540±0.0002 at 25° C.
5. The method of claim 4 wherein the iodine value of said hydrogenated coconut oil is 4.5±0.5.
7. The method of claim 1 wherein said sufficient amount of topical preparation to be applied to the infected area is approximately 1 cubic centimeter of the topical preparation for approximately each 0.4 square centimeter of infected area.
8. The method of Claim 1 wherein said refined oil is refined and bleached coconut oil.
9. The method of claim 1 wherein the numerical ratio of said refined oil by volume to said diethyl ether by volume in said emulsion is 3:2.
10. The method of claim 9 wherein said emulsion has a boiling point of approximately 119° F.
11. The method of claim 9 wherein said emulsion is supersaturated.
12. The method of claim 1 wherein the amount of DMSO in the emulsion is about 15% by volume.
13. The method of claim 1 wherein the amount of sodium peroxide in the emulsion is about 5% by volume.
14. the method of claim 1 wherein the amount of detergent in the emulsion is about 5% by volume.
15. The method of claim 1 wherein the detergent is a common household detergent that is clear or brown in color.
16. A topical preparation for treating an epidermal area of a human being infected with Herpes simplex virus in the form of a stable emulsion having from approximately 30% by volume to approximately 50% by volume of di-diethyl ether in a pharmaceutically acceptable refined oil carrier of vegetable oil origin, said oil carrier being generally free of free fatty acids and essentially free of water, soaps and stabilizers, DMSO (dimethylsulfoxide) of from approximately 10% by volume to approximately 20% by volume for enhancing delivery of the topical preparation, 2% to 8% by volume of sodium peroxide and 2% to 8% by volume of detergent for facilitating destruction of the fatty material to unlock the cells of the virus to enable the ether to kill the cells, said emulsion having a boiling point of at least 100° F.
17. The topical preparation of claim 16 wherein said refined oil in coconut oil refined to have no more than 7% free fatty acids.
18. The topical preparation of claim 17 wherein said coconut oil is refined and bleached coconut oil.
19. The topical preparation of claim 17 wherein the numerical ratio of said coconut oil by volume to said diethyl ether by volume is 3:2.
21. The topical preparation of claim 17 wherein said coconut oil is hydrogenated.
22. The topical preparation of claim 18 wherein the iodine value of said hydrogenated coconut oil is 4.5 +-Ø5.
23. The topical preparation of claim 18 wherein the refractive index of said hydrogenated coconut oil is 1.4540±0.0002 at 25° C.
24. The topical preparation of claim 16 having a boiling point of approximately 119° F.
25. The topical preparation of claim 16 wherein said emulsion is supersaturated.
26. The topical preparation of claim 16 wherein the amount of DMSO in the emulsion is about 15% by volume.
27. The topical preparation of claim 16 wherein the amount of sodium peroxide in the emulsion is about 5% by volume.
28. The topical preparation of claim 16 wherein the amount of detergent in the emulsion is about 5% by volume.
29. The topical preparation of claim 16 wherein the detergent is a common household detergent that is clear or brown in color.
5. The method of claim 4 wherein the iodine value of said hydrogenated coconut oil is 4.5±0.5.
7. The method of claim 1 wherein said sufficient amount of topical preparation to be applied to the infected area is approximately 1 cubic centimeter of the topical preparation for approximately each 0.4 square centimeter of infected area.
8. The method of Claim 1 wherein said refined oil is refined and bleached coconut oil.
9. The method of claim 1 wherein the numerical ratio of said refined oil by volume to said diethyl ether by volume in said emulsion is 3:2.
10. The method of claim 9 wherein said emulsion has a boiling point of approximately 119° F.
11. The method of claim 9 wherein said emulsion is supersaturated.
12. The method of claim 1 wherein the amount of DMSO in the emulsion is about 15% by volume.
13. The method of claim 1 wherein the amount of sodium peroxide in the emulsion is about 5% by volume.
14. the method of claim 1 wherein the amount of detergent in the emulsion is about 5% by volume.
15. The method of claim 1 wherein the detergent is a common household detergent that is clear or brown in color.
16. A topical preparation for treating an epidermal area of a human being infected with Herpes simplex virus in the form of a stable emulsion having from approximately 30% by volume to approximately 50% by volume of di-diethyl ether in a pharmaceutically acceptable refined oil carrier of vegetable oil origin, said oil carrier being generally free of free fatty acids and essentially free of water, soaps and stabilizers, DMSO (dimethylsulfoxide) of from approximately 10% by volume to approximately 20% by volume for enhancing delivery of the topical preparation, 2% to 8% by volume of sodium peroxide and 2% to 8% by volume of detergent for facilitating destruction of the fatty material to unlock the cells of the virus to enable the ether to kill the cells, said emulsion having a boiling point of at least 100° F.
17. The topical preparation of claim 16 wherein said refined oil in coconut oil refined to have no more than 7% free fatty acids.
18. The topical preparation of claim 17 wherein said coconut oil is refined and bleached coconut oil.
19. The topical preparation of claim 17 wherein the numerical ratio of said coconut oil by volume to said diethyl ether by volume is 3:2.
21. The topical preparation of claim 17 wherein said coconut oil is hydrogenated.
22. The topical preparation of claim 18 wherein the iodine value of said hydrogenated coconut oil is 4.5 +-Ø5.
23. The topical preparation of claim 18 wherein the refractive index of said hydrogenated coconut oil is 1.4540±0.0002 at 25° C.
24. The topical preparation of claim 16 having a boiling point of approximately 119° F.
25. The topical preparation of claim 16 wherein said emulsion is supersaturated.
26. The topical preparation of claim 16 wherein the amount of DMSO in the emulsion is about 15% by volume.
27. The topical preparation of claim 16 wherein the amount of sodium peroxide in the emulsion is about 5% by volume.
28. The topical preparation of claim 16 wherein the amount of detergent in the emulsion is about 5% by volume.
29. The topical preparation of claim 16 wherein the detergent is a common household detergent that is clear or brown in color.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002514381A CA2514381A1 (en) | 2005-07-29 | 2005-07-29 | Improved topical preparation and method for using same to destroy herpes simplex cells |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002514381A CA2514381A1 (en) | 2005-07-29 | 2005-07-29 | Improved topical preparation and method for using same to destroy herpes simplex cells |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2514381A1 true CA2514381A1 (en) | 2007-01-29 |
Family
ID=37696166
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002514381A Abandoned CA2514381A1 (en) | 2005-07-29 | 2005-07-29 | Improved topical preparation and method for using same to destroy herpes simplex cells |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2514381A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2954701A1 (en) * | 2009-12-24 | 2011-07-01 | Carilene Lab | DERMATOLOGICAL COMPOSITIONS COMPRISING AN ASSOCIATION OF PEROXIDE LIPIDS AND ZINC AND THEIR USES IN PARTICULAR IN THE TREATMENT OF HERPES |
-
2005
- 2005-07-29 CA CA002514381A patent/CA2514381A1/en not_active Abandoned
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2954701A1 (en) * | 2009-12-24 | 2011-07-01 | Carilene Lab | DERMATOLOGICAL COMPOSITIONS COMPRISING AN ASSOCIATION OF PEROXIDE LIPIDS AND ZINC AND THEIR USES IN PARTICULAR IN THE TREATMENT OF HERPES |
| EP2343038A1 (en) * | 2009-12-24 | 2011-07-13 | Laboratoires Carilene | Dermatological compositions comprising a combination of peroxidized lipids and zinc for use amongst others in the treatment of herpes |
| US9144612B2 (en) | 2009-12-24 | 2015-09-29 | Laboratoires Carilene | Dermatological compositions containing an association of peroxide lipids and zinc, and uses thereof in particular in the treatment of labial and/or genital herpes |
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