FIELD OF INVENTION
This invention relates to a herbal preparation for management
of cardiovascular and neurologic disorders and to a process for the preparation
BACKGROUND OF INVENTION
The preparation of the present invention slows down the atherosclerolic changes
and hence helpful in delaying the onset of hypertension among potential hypertension
cases. The preparation also delays the development of frank diabetes mellitus and
also slows down the early cognitive decline and neurologic disorders among likely
The preparation is also helpful in increasing the general body resistance against
physical and mental stress. It helps in neurophysiological adaption following cold
stress. Such a preparation also prevents the individual from pneumonia following
Ageing is a normal physiological phenomena resulting from
intrinsic and extrinsic damage to the various organs particularly cardiovascular
and neurologic system. The magnitude of ageing process depends upon genetic as well
as environmental factors. A wide variety of disorders appear among the ageds.
Rapid atherosclerotic changes results in cerebrovascular accidents and ischaemic
heart disease similarly due to brain ageing cognitive decline and other cognitive
deficit disorders are common among the ageds. Dementia of Alzheimer's type is one
of the important cause of motility and morbidity among the ageds. Dementia of Alzheimer's
type is one of the important cause of motility and morbidity among the aged population.
The currently available drugs have shown tremendous side
effect and has no preventive role in age related disorders.
Herbal preparations for the treatment of disorders are
known from JP 2002 154978 A, JP 08 325159 A, CN 1359643 A, CN 1226405 and US 2002/0026656
A1, whereby the last mentioned US 2002/0026656 A1 discloses the use of Dioscorea
bulbifera as an anti-diabetic.
OBJECTS OF THE INVENTION
The main object of this preparation is to propose a novel
preparation for the prevention of rapid atherosclerotic changes among the individuals
showing evidence of potential hypertension.
Another object of this invention is propose a herbal preparation
to delay the onset of frank diabetes.
Still another object of this invention is to propose a
novel preparation for increasing general body immunity among those persons who have
low body resistance.
Yet another object of this invention is to propose a novel
preparation to prevent the cognitive decline among ageds.
Another object of this invention is to propose a herbal
preparation to regulate abnormal lipid profile particularly LDL-c and triglycerides
to prevent blockage of coronary, artery and vessels of brain.
DETAILED DESCRIPTION OF INVENTION
According to this invention there is provided a herebal
preparation for management of cardiovascular and neurologic disorders comprising
at least two of the following constituents, and preferably all three:
and present in the range of :
- 1. Dioscorea bulbifera
- 2. Hippophae rhamnoldes
- 3. Bacopa monnieri
for every 1000 mg of said preparation.
1. Dioscorea bulbifera
2. Hippophae rhamnoides
3. Bacopa monnieri
The preparation may also comprise known additives such
as minerals, vitamin, salts, fillers (for encapsulation) and binders, if required
and present in trace amounts.
1. Dioscorea bulbifera
2. Hippophae rhamnoides
3. Bacopa monnieri
Thus, any known additive or supplement is added to prepare
the final capsule if required, and present in trace amounts. Reference is made herein
to a capsule. However, it would be apparent that the preparation may also be in
the form of a tablet.
Preferably, the preparation comprises:
for every 1000 mg of the preparation.
1. Dioscorea, bulbifera
2. Hippophae rhamnoide
Dioscorea bulbifera belongs to the family of Dioscoreaceae,
it is a creeping plant with a bulbous root. The plant is a climber. The tuberous
bulb is about two to four inches in diameter and brown in colour. The leaves and
stem of the plant contains toxic alkaloids but the tuberous pat of the plant mainly
contains the terpenoidal glycosides, The remaining part of the bulb contains starch,
Hippophae rhamnoides commonly known as Seabuckthron is
a small genus of shrubs and trees and in native of temperate region. It belongs
to family eiaeagnaceae. Fruits and leaves are commonly used for medicinal purpose.
The fruit residue is quite rich in protein, fats, amino acids. The ripe fruits contain
many type of vitamins. The stem contains 5HT the rare occurrence in the plant kingdom.
Bacopa monnieri is commonly known as Brahmi is an annual
creeping plant found throughout India in wet, damp and marshy areas. In Ayurvedic
medicine this plant is used as a nervine tonic in the management of mental sub-normalcy,
instability and epilepsy. Total plant is used for the medicine purposes. The plant
contains contains crystalline compound and its one of the components crosses the
blood brain barrier.
The preparation containing the organic extract of Dioscorea
bulbifera was given in the dose of 100-150 mg per day did not show any action on
circadian blood pressure. Similarly in this dose no alteration was observed in the
level of post prandial glucose level. The effective dose varies from 200-500 mg
per day. The single drug therapy significantly slow downs the process of atherosclerosis
in experimental animals.
When the organic extract of Dioscorea bulbifera administered
in the dose of 200-300 mg per day along with the organic-extract of fruits of Hippophae
rhamnoide in the dose of 200-300 mg improvement was noticed in the variation of
systolic and diastolic blood pressure following circadian blood pressure changes.
Similarly when the organic extract of Dioscorea bulbifera alongwith Hippophae rhamnoide
was given in the dose of 200-300 mg per day and 150 to 400 mg per day a 1 reduction
in the level of systolic and diastolic blood pressure was observed following cold
The post prandial blood glucose level also showed significant reduction in this
particular range of combined effect of two drugs in relation placebo group.
When the organic extract of Bacopa monnieri in the dose
of 100 mg to 200 mg per day along with the organic extract of Hippophae rhamnoide
was adm in istered 200-300 mg per day and Dioscorea bulbifera in the dose of 150-200
mg per day a considerable improvement was noticed in general feeling of well being,
better sleep and good appetite. The subjects also showed better tolerance to heat
and cold. The subject developed better neurophysiological adaptation following stress.
When the organic extract of Dioscorea bulbifera was given
in the dose of 200-300 mg per day alongwith the Hippophae rhamnoide in the dose
of 200-350 mg per day alongwith the organic extract of Bacopa monnieri in the dose
of 250-400 mg per day presented good results in the form of significant reduction
in the cardiovascular reactivity and arrest the rapid decline of the cognitive function.
In this series when the organic extract of Dioscorea bulbifera
in the dose of 200-300 mg per day alongwith organic extract of Hippophae rhamnoide
in the dose of 230-350 mg and Bacopa monnieri in the dose of 250-400 mg per day
was administered simultaneously twice in a day the subject reported good sleep and
reduced systolic and diastolic blood pressure. The cardiovascular recording was
also found reduced following cold stress. About 70 percent cases reported overall
feeling of well-being.
When the organic extract of Hippophae rhamnoide in the
dose of 250 mg to 300 mg per day and the organic extract of Bacopa monnieri in the
dose of 300 to 350 mg per day the individuals showed a better tolerance to frequent
cold and cough, their body resistance towards diseases increased significantly and
thus the occurrence of pneumonia also reduced following test drug treatment.
The cases receiving the organic extract of Dioscorea bulbifera
in the dose of 200 to 250 mg per day, Hippophae rhamnoide in the dose of 150 to
200 mg and Bacopa monnieri in the dose of 200 t0 250 mg exhibited improvement in
overall mental performance particularly improvement in attention and memory performance.
An early fatigue which was a major complaint among the subjects, improved to a great
extent and a better physical fitness was reported by the subjects,
When the organic extract of Dioscorea bulbifera in the
dose of 150 to 250 mg per day and Bacopa monnieri in the dose of 250 to 300 mg per
day was administered, a significant reduction in hyperexcitability, aggressive behaviour,
anxiety and stress including depressive behaviour improved among the test drug treated
group. A regulated improved behaviour exhibited the beneficial role of this combination.
Process of extraction
The tuberous part of the Dioscorea bulbifera was properly
washed and shed dried. After cutting in pieces the tuber were initially extracted
with alcohol at 60 to 70°C for 70 hrs. The solvent was recovered at same temperature
on single distillation set of 90% concentration. The organic extract was further
separated by column chromatography method to obtain crystals. The chemical characterization
of the crystal was made by HPTLC and spectroscopic method. After chemical characterization,
the extracted material was subjected to experimental study for the evaluation of
the therapeutic potential of the extracted materials. The total extracted material
was kept between 20 to 30°C. The biological activity of the plant material
can only be sustained on this temperature.
Similarly the drug fruit of dry fruits of Hippophae rhamnoide
was initially extracted with alcohol at the temperature 60 to 70°C continuously
for 70 hours. The aqueous fraction was also obtained by using buchhi vacuum rotatory
apparatus at low temperature.
Shed dried total plant of the Bacopa monnieri was extracted
in alcohol at the temperature of 60 to 70°C to obtain extract. Further extract
was treated with column chromatography to obtain the crystals. The chemical characterization
of crystal was done by HPTLC and spectroscopic methods.
The extract in the crystalline form was subjected to animal
study for safety and efficacy profile. The whole process was performed on a particular
temperature in order to obtain various chemical constituents responsible for the
therapeutic efficacy. The therapeutic efficacy can only be obtained if all the chemical
constituents are mixed for oral consumption.
It was found that when the organic extract of Dioscorea
bulbifera alongwith the organic extract of Hippophea rhamnoide was given in the
doses described continuously for long period the subject showed marked reduction
in the level of systolic and diastolic blood pressure following cold pressure following
cold pressure test. The average variation in the level of circadian blood pressure
also reduced. Thus in potential hypertensive cases the early onset of Hypertension
can be minimized after oral administration of this formulation. Thus the anti atherosclerotic
property is proved by the oral administration of above formulation.
When the organic extract of Dioscorea bulbifera along with
extract of dry fruits of Hippophae rhamnoide was given to subjects hereinabove,
a mark reduction in the post prandial blood sugar level was observed. It indicates
that the combined effect of Dioscorea bulbifera and Hippophae rhamnoide played a
preventive role in the development of frank diabetes in the susceptible cases.
When organic extract of Bacopa monnieri particularly different
glycoside fraction alongwith the organic extract of Dioscorea bulbifera was given
(Dioscorea bulbifera 150 to 300 mg, Bacopa monnieri 150 to 450 mg), a considerable
improvement was noticed in the reduction of cognitive decline alongwith the stabilization
of systolic and diastolic blood pressure. In this particular dose the drug is beneficial
in the management of senile dementia.
When the extract of Dioscorea bulbifera 200 to 300 ing,
Hippophae rhamnoide 250 to 350 mg, Bacopa monnieri 150 to 300 mg was administered
only 60 percent cases reported general feeling of well being, reduction in anxiety
level and reduction in cardiovascular reactivity following cold stress. About 10
percent reduction in body weight was reported among obese individuals.
When the extract of Dioscorea bulbifera. 250-500 mg, Hippophae
rhamnoide 300 to 500 ing, Bacopa nmnnieri 250 to 450 mg was given, the 78 percent
cases reported general feeling of well being, reduction in anxiety level. 72 percent
cases reported reduction in cardio vascular reactivity particularly in the form
of systolic and diastolic blood pressure.
A considerable improvement was noticed in the adaptation
pattern against physical and mental stress. The 15 percent reduction in total body
weight was observed.