Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2001-01-02
2003-04-29
Azpuru, Carlos (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S451000, C424S456000, C424S463000, C424S464000, C424S422000, C514S552000, C514S011400, C514S783000
Reexamination Certificate
active
06555126
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a method that can be used to treat, control, cure, and prevent Diabetes Mellitus, of all types, through the administration of Linalool, alone, in any form, and possibly with other hypoglycemic additives in several forms, and by various means. The method does not cause any harmful or unpleasant side effects.
BACKGROUND OF THE INVENTION
Diabetes Mellitus is a feared and complex disorder. It has been a most distressing disease that can develop to a seriously life threatening condition. For ages, society was resigned to accepting various methods and medications that became a standard with no real hope for a cure, or drastic eradication of the disease. In fact, many of the drugs used cause serious side effects.
A most important indicator of the ability of the body to deal with the complications of diabetes is the glycated hemoglobin HbAlc, that gives an integrated reading of the level of blood glucose. While all other known methods and medications help lower the glucose level at limited periods of the day or night time, the HbAlC remains higher than the normal 4.3 to 6.7 range regardless of the insulin dosage and other medicines. No full cure is expected or hoped for by the present regimens. The described method herein is new and unique, and actually reduces the HbAlc reading to the normal levels and for all patients. This method has actually cured some patients of both types I and II diabetes to such a degree that they stopped taking any medication while leading normal lives.
The knowledge gained by the inventors through years of research, testing, and development work on tens of ancient folk herbs and methods, gave an incentive to aim to identify active beneficial components and ingredients, in dealing with various diseases. The result of the work of the inventors indicated that Pelargonium Graveolens contains substances that are beneficial and helpful in treating several diabetic complications. Our continuing studies and experiments on animals, mice, rats, and rabbits, and later tests on human volunteers, enabled the inventors to identify and effectively employ Linalool for treating and preventing, and in some cases, curing Diabetes Mellitus.
Numerous tests were conducted on various types of animals using:
Water extract of Pelargonium Graveolens plant.
Crude oil of the extract of the plant (Geranium Oil) which contains mainly Linalool, Geraniol, Citronellol, Eugenol.
Linalool oil
Each of the components above was tested alone, and in combination with other substances, such as Vitamin E, and observations were made regarding contribution to hypoglycemic effects. It became ultimately evident and clear to us, that Linalool is a potent, effective, and active hypoglycemic ingredient.
Linalool can be obtained naturally from the labiate family plants, or could be chemically synthesized, maintaining the same hypoglycemic effect. Our further work and tests led us to perfect a method for utilizing Linalool in several forms for curing, treatment, control, and prevention of Diabetes Mellitus.
PRIOR ART
The present invention has not been found in prior art, nor does prior art suggest or teach anything resembling this invention. The search regarding the usage of Linalool in all available electronic and published literature, led us to the followings:
Linalool, Cironnellol, and Eugenol have been found to have many pharmacological activities and as listed below:
Pet Kov et al—Hypotensive effects of Geranium
Dube et al—Antibacterial effects of Geranium
Husson et al—Anti viral effects of Geranium
Yaoxuo Xubao—Anti Tumor effect of Pelargonium Greveolens
Weischer et al—Treat Diabetes by R-Alpha Lipoic acid in mammal animals
However, no prior art exists or suggests the use of Linalool alone or with other ingredients as a hypoglycemic element. In this respect, our findings are unique and establish the novelty and much more effective benefits obtainable by this invention in dealing with Diabetes Mellitus.
OBJECTS OF THE INVENTION
It is among the objects of this invention to provide a method for treating and lowering the hyperglycemia of diabetic patients.
It is another object of this invention to lower the HbAlc readings to normal levels. To enable the body to deal and control the complications of Diabetes Mellitus.
To cure diabetic patients from this disease by lowering blood sugar to normal levels permanently.
To prevent the onslaught of Diabetes Mellitus in vulnerable patients, with family history of the disease.
DETAILS OF THE INVENTION
In arriving to the conclusive results, indicated, many experiments were conducted, including:
Animal Studies
Limited clinical studies
ANIMAL STUDIES
The following study was carried out and controlled by Pharmacy College, Jordan University.
1. LD 50: For this determination, 59 rats (Rattus rattus) of both sexes were used with body weights of 200-240 grams to determine the LD50. The rats were divided into groups consisting of 5-6 rats each.
The rats were fed standard laboratory pellet diet and water ad libitum. Linalool was given as one single dose subcutaneously to rats in gradually increasing doses of 0.2 ml/kg body weight, 0.25 ml/hgkg, 0.3 ml/kg, 0.35 ml/kg, 0.40 ml/kg, 0.45 ml/kg, 0.50 ml/kg, 0.55 ml/kg, 0.60 ml/kg, 0.65 ml/kg.
LD 50 was determined to be 0.63 ml/kg body weight.
2. Hypoglycemic studies of Linalool effect on Normal and Diabetic rats:
Preparation of Animals: For each experiment, eight (8) overnight fasted normoglycemic and diabetic rats were used. The animals were kept in the experimental animal laboratory for three days with free access to food and water.
Hyperglycemia was induced in the diabetic group of rats by a single intraperitoneal injection of Streptozocin (Upjohn Co, Kalamazoo, Mich., USA). 6 mg/kg body weight-freshly dissolved in citrate phosphate buffer with pH adjusted to 4.5.
Diabetes was confirmed one week after administration of Streptozocin by determining the fasting blood glucose concentration. Most of the rats exhibited blood glucose concentration in the range of 400-500 mg/dl. The fasting blood glucose concentration in normal rats is 90-120 mg/dl.
On the day of the experiment, blood samples were collected at zero time before IP injection of the test substance (Riedel De Hein—Germany), and at intervals as given in Table 1 and 2. Blood samples were drawn from the ear vein in 100 micro millimeter heparinized capillary tubes.
Blood glucose concentrations were determined according to glucose oxidase method, using glucose enzymatic kits (Biomerioux France).
The percentage change in glycaemia was calculated.
For control animals, sterile saline solution was used instead of Linalool.
STATISTICAL ANALYSIS
Data are expressed as means and standard error of the mean (S.E.M.) statistical analysis were performed using student's t test. The values were considered to be significantly different when P-value was less than 0.05.
Our results show that Linalool (Tables #1 and #2) has significant hypoglycemic activity in normoglycemic and hyperglycemic rats. For these normoglycemic rats, the highest activity was observed at four hours after the intraperitoneal injection of Linalool. For hyperglycemic rats the highest activity was observed at 24 hours after the Linalool injection.
TABLE 1
Short term hypoglycemic effect of a single intraperitoneal injection
of Linalool (0.2 ml/kg) on blood glucose concentration of normal and
Streptozocin diabetic rats
Change in blood glucose
Pretreatment glu-
% at
cose (mg/100 ml)
15 min.
1 h.
Normoglycemic
rats:
Saline
108
± 10.2
3.2
± 1.7
1.4
± 0.6
Linalool
116.5
± 8.7
−36.1
± 7.7*
−35.2
± 6.2*
Hyperglycemic rats:
Saline
519
± 58.8
2.1
± 0.5
−2.4
± 0.8
Linalool
443.6
± 28.9
−32.1
± 3.6*
−35
± 3.4*
*Significant to pretreatment values at P < 0.05
Tabular values represent the mean S. E. M.
TABLE 2
Effect of a single intraperitoneal injection of Linalool (0.2 ml/kg) on
blood concentration of normal Streptozocin diabetic rats within 24 hours
Pretre
Farouqi Hafez Taji
Murad Osama Mansour
Seir Husni Abu
Azpuru Carlos
Di Nola-Baron Liliana
Diabex, Inc.
Ladas & Parry
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