From "Extracts of nerium species, methods of preparation, and use therefore". Ozel patent, USPTO number 5,135,745
See also "Extract of nerium species, pharmaceutical composition thereof and methods for preparation thereof." Patent number 6,565,897
How to make your own oleander soup: http://www.tbyil.com/oleandersoup.htm
Warning: Oleander is very poisonous. Do this at your own risk.
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Preparation of Nerium Oleander Extract
The branches, leaves and flowers of Nerium oleander were collected and sliced into pieces from about 2 to about 2.5 cm in length. Within about one week following collection and slicing of the plant material an extract was prepared from the plant material by adding approximately 2 kg of sliced plant material to about 10 kg of distilled water in an enamel container. This mixture of material was heated until it started boiling after which time the plant material was boiled for about 2.5 hours. During boiling, distilled water was added to the container to compensate for evaporation in order to maintain a constant water level in the container. At the end of about 2.5 hours of boiling the density of the aqueous phase extract should be about 1010 using a buoyancy densitometer. If the density is less than about 1010, the extract should be boiled for about another half hour until the desired density is attained through further evaporation. After boiling, the mixture is allowed to stand at room temperature for a period of about 6 to about 8 hours. Next, the mixture is processed through a coarse filter in order to remove large particulate matter should such leaves and branches. The filtrate was then subjected to a second filtration through a medical filter and decanted into 700 ml bottles with tight lids. Within about 4 hours after this last filtration step the bottles were heated to about 100.degree. C. for about 1 hour. If this second treatment does not occur within about 4 hours, the dark brown color of the extract changes to a bright yellow color and the extract should not be used. Following this second heat treatment the bottles are stored at room temperature for about 10 hours. In this form, the extract has a shelf life of about one year when stored at about 2.degree. to about 4.degree. C. This form of the extract is used to prepare pomades, powders, gargles and oral medicaments.
In order to prepare an extract for use in injection (NOI), the oral form of the extract described supra was subjected to filtration with a medical filter paper with porosity of from about 2.9 microns to about 4.8 microns and dispensed into 10 ml bottles with rubber lids and sealed aluminum covers. The sealed bottles were then sterilized at about 100.degree. C. for about 1 hour. This form of the extract is stable for about three months when stored at about 2.degree. to about 4.degree. C.
A pomade (pomade A) containing the extract of the invention was prepared using about 19% by weight NOO, about 2.5% by weight flower pollen, about 59.5% by weight Vaseline, about 7.1% by weight lanoline and about 11.9% by weight almond oil. This pomade is useful in the treatment of dermic cancers.
Another pomade of NO (pomade B) is prepared using the same ingredients and method as described for pomade A except in addition about 5% by weight salicylic acid is added to the composition.
A powder containing NO can be prepared by combining 2 ml Bepanthene (ROCHE-Turkey), 500 units of Alfasilin (FACO-Turkey), 1 ml ANTISTINE (CIBA-Turkey), 0.5 ml ethyl alcohol (70 proof pure) and 0.5 ml NOO.
A mouthwash useful for gargling comprises a mixture of water and about 5% by weight NOO.
Administration of the Extract of the Invention
Patients suspected of having a malignant cell-proliferative disease are initially screened to determine whether they will respond effectively to administration of the extract of the invention. In this initial screening test the patient is injected intramuscularly with about 0.3 ml, about 0.4 ml and about 0.5 ml of NOI on the first, second, and third days, respectively, of the test.
A positive response, which indicates that the patient will respond to the extract of the invention, is indicated by a rise in the temperature of the patient to about 38.degree. C. to about 41.degree. C. depending on the dose of extract administered. This fever takes place within about 4 hours following the intramuscular injection and continues for a period of from about 2 to about 4 hours. It has been noticed that patients often feel cold before they experience a rise in body temperature. As a general rule, the greater the rise in temperature of the patient, the shorter the length of therapy. The optimum range for fever has been found to be from about 38.degree. C. to about 39.degree. C. in order to minimize discomfort to the patient. Experimental data obtained thus far indicate that approximately 70% of those patients that present with malignant cell-proliferative diseases show a positive reaction to the screening test. The positive response, in turn, indicates that therapy with the NO extract will ameliorate the disease.
Those patients which are positive for the screening test as described supra are placed on an initial therapeutic regimen utilizing various forms of the extract of the invention. Typically, a patient is administered from about 0.3 to about 0.7 ml of NOI intramuscularly per day depending upon the rise in temperature of the patient. In cases of gastrointestinal malignancies, injections of NOI are often used in combination with oral administration of the extract (NOO). Additionally, in those patients have dermic cancers, a pomade of the extract (usually pomade A) was applied in combination with injections of NOI. The initial therapeutic regimen was performed at least until injection with NOI no longer caused a rise in the patient's body temperature. It has been found that the patient will generally receive this initial therapeutic regimen for a period from about 20 days to about one year and that this period of time depends upon the severity of the malignancy. In most cases patients can resume a normal lifestyle following completion of the initial therapeutic regimen.
Following completion of a normal therapeutic regimen a patient normally was then placed on a maintenance therapeutic regimen for a period of time ranging from about six months to about three years. Typically, during this period of time the patient receives about 0.4 ml of NOI administered about every two weeks. Usually a patient will be on maintenance therapy for a time roughly equivalent to the amount of time required for the initial therapeutic regimen. In those instances where a patient develops a fever during maintenance therapy following administration of NOI the patient is returned to an initial therapeutic regimen.
In the approximately 30% of cases where patients did not show a positive response to the screening test, even at test doses of up to about 0.8 ml NOI, no regression of malignancy nor rise in fever was seen. However, patients who elected to be administered NOI have been found to experience less pain and do not need to use any analgesic supportive drug therapy.
In patients presenting with non-malignant cell-proliferative diseases such as, for example, psoraisis, the screening test does not have to be formed and these patients do not usually experience a rise in fever. Typically, patients with psoraisis are placed on a regimen consisting of 0.3 ml of NOI administered intramuscularly every two days, 0.5 ml of NOO administered three times per day and NO pomade B applied once a day. This therapeutic regimen continues until all symptoms disappear, usually in about 20 days to about four months after initiation of therapy. No maintenance therapy is usually needed.
Those patients who present with more serious non-malignant cell-proliferative diseases such as, for example, lipid histiocytosis (Niemann-Pick disease), Behcet's syndrome and pemphigus vulgaris, are usually screened using NOI and, if positive, treated with an initial therapeutic regimen basically the same as that administered in the treatment of malignant cell-proliferative diseases. Often it is not necessary that such patients be placed on maintenance therapy.