Note: Descriptions are shown in the official language in which they were submitted.
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HOMEOPATHIC COMPOSlTlON AND PROCESS FOR lTS PREPARAT~ON
This invention relates to a process for the production
of a homeopathic medicinal composition, the product of such a
process, and a package containing such a product.
Homeopathic medicine is a system of healing which has
been in existence since 1796. The word homeopathy comes from
the Greek language and may be translated as "similar
suffering". In other words an agent which can cause disease
in a healthy person can be used to therapeutic advantage in a
person who is sick and whose symptoms resemble those of the
agent. Normally the agent is administered to a patient in
minute amount and in very high dilution, in contrast to the
practice in allopathic medicine in which the therapeutic
agent is normally administered to a patient in much higher
amount and at a much higher concentration.
The agent can be administered in the form of a solution,
as an ointment or paste, as tablets, or in the form of
pellets or globules of a carrier, such as lactose, which has
been impregnated with a dilute solution of the agent.
Alternatively it is possible to triturate the agent with a
solid carrier. A typical size for pellets is around 200 per
gram, while globules typically come in a size of about 20 per
gram. Tablets may be of any suitable size which are
convenient for swallowing, for example about 0.2 g to about 1
g-
Two principal methods are used for dilution of a
substance so as to lower its concentration in a given
product, whether liquid or solid. In the first method, which
was developed by the German physician and experimental
pharmacologist Samuel Hahnemann (1755-1843), multiple flasks
are used. The second method is one developed by Hahnemann's
contemporary, Siméon N. Korsakoff and involves use of a
single flask.
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The Hahnemannian process consists in effecting dilutions
in separate flasks or bottles. To make a one hundred fold
dilution, l~ by vo~ume of a starting solution (or mother
tincture) of a convenient concentration, for example about l
g per litre, is placed in a flask and mixed with 99~ by
volume of diluent. The resulting diluted mixture has a
Hahnemannian Concentration which, for convenience, can be
designated l CH. To make a further dilution, l~ by volume of
this l CH solution is again mixed with 99~ by volume of
diluent. The resulting diluted solution can be designated 2
CH. These operations can be carried out N times to obtain a
solution of the Nth CH.
The Korsakovian process is undertaken in a single bottle
or flask. In this case 99~ of a starting solution (or mother
tincture) is drained or aspirated from the bottle or flask
and the remaining 1% by volume is diluted by pouring in 99
by volume of the diluent. After mixing the resulting
solution can, for convenience, be designated the first
Korsakovian centesimal (or l cmK). Upon repeating the
procedure with the l cmK solution a further diluted solution,
i.e. the 2 cmK solution, is obtained. By carrying out the
procedure N times the Nth cmK solution can be obtained.
Whilst dilutions of l in lO0, i.e. centesimal dilutions,
are common, another accepted method of dilution is the
decimal method in which l part of the mother tincture is
diluted to l/lO of its original strength.
The number of operations that require to be carried out
in order to reach a desired level of dilution can be
summarised as shown in Table l below. The starting
concentration is a convenient concentration, such as l g per
litre.
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T~RT,F, 1
Dilution ConcentrationDecimal Centesimal
in 1/100 in lO~n Scale Scale
1/lO 10/100 lo-l 1 D
1/100 1/100 lo-2 2 D 1 CH
1/1000 0.1/100 10-3 3 D
1/10000 0.01/lOO 10-4 4 D 2 CH
1/100000 0.001/100 10-5 5 D
1/1000000 0.0001/100 lo-6 6 D 3 CH
1O-le 9 CH
10-~~ 30 CH
In his writings Hahnemann recommended that utensils used
for the preparation of a homeopathic medicinal preparation
lS should be sterilised in boiling water. He also recommended
that, in order to have a correct succussion effect in
diluting a solution, the bottle should be large enough to be
only two thirds filled up. In order to develop the dynamic
pharmaceutical virtues of the preparations, the bottle should
be submitted to a series of strong succussions. Typically
this should involve pounding the bottle filled to 75~ or 50
with the solution on a thick book having a leather cover 100
times at the frequency of the heart's beat. Furthermore the
prepared solutions should be stored and protected from the
sun and the daylight in a well sealed bottle.
Although the homeopathic preparations produced by the
dilution methods of Hahnemann and Korsakoff can produce
effective homeopathic medicinal preparations, their
effectiveness is variable. It would accordingly be desirable
to provide a process for preparing homeopathic medicinal
preparations which can enable the reliable production,
. _ . . ... .
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preferably on an industrial scale, of homeopathic medicinal
preparations with reproducible effects. It would further be
desirable to provide a homeopathic medicinal product in a
form which, it can be ensured, will reach the patient in
optimal condition and with its efficacy undiminished.
It is accordingly an object of the present invention to
provide a process for the production of homeopathic medicinal
preparations which results in such preparations yielding
reliable and reproducible results. ~t is a further object of
the present invention to provide a process for the production
of a homeopathic medicinal preparation which yields a
preparation which, it can be ensured, will reach the patient
after transport and storage with its homeopathic efficacy
undiminished from that at the time of its production.
According to the present invention there is provided a
process for preparing a homeopathic medicinal composition
which comprises:
(a) providing an initial solution containing a
predetermined starting concentration of a selected compound
having homeopathic efficacy;
(b) diluting the initial solution using at least one
dilution step by addition of diluent so as to produce
following the or each dilution step a diluted preparation
having a lower concentration of the selected compound than
the concentration of the selected compound in the solution
being diluted; and
(c) packaging the resulting homeopathic medicinal
preparation in a container adapted to protect the homeopathic
medicinal composition from ~~ radiation, including emitted ~~
radiation in the tritium energy range, until required for
consumption by a patient;
wherein the dilution, succussion and packaging steps are
carried out within an environment shielded from ~~ radiation,
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including emitted ~~ radiation in the tritium energy range.
The compound having homeopathic efficacy may be any
agent conventionally used in homeopathic medicine.
In the process of the invention, at least in the initial
dilution step, the diluent generally comprises a solvent,
such as water, ethyl alcohol, or a mixture thereof. The
diluent preferably comprises water.
In one form of the process the dilution step (b) is
repeated a plurality of times including a final dilution step
and in the final dilution step the diluent is a solid. In
such a process all dilution steps preceding the final
dilution step the diluent is preferably a solvent.
Conveniently the final dilution step comprises
impregnating granules or globules of a solid carrier material
with a solution of the agent. A typical solid carrier
material comprises a carbohydrate, such as a saccharose, for
example lactose, sucrose, threalose, threose, or the like. A
mixture of saccharoses can be used. The solid carrier
material may, for example, comprise particles weighing from
about 0.005 g to about 0.05 g. The solid carrier can
alternatively be formed into tablets weighing, for example,
from about 0.2 g up to about l g or more, e.g. up to about
2 g.
The final dilution step may alternatively comprise
formulation as an ointment or paste using a conventional
excipient or excipients.
The shielding step is effected so as to shield from ~~
radiation, including emitted ~~ radiation in the tritium
energy range. In other words the shielding should be
effective to prevent penetration of ~~particles. In order to
provide the necessary shielding during the dilution,
succussion step, and the packaging step these operations can
be carried out inside a Faraday cage. Normally such
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shielding will also be effective to prevent penetration by ~
particles; it is, however, impractical to attempt to provide
shielding against y rays. The shielding step is preferably
carried so as to shield from ~~ radiation having energy in the
range of up to about 19 keV. In particular, the shielding
step can be carried out so as to shield from ~~ radiation
energy in the range of from about 1 keV to about 19 keV.
The packaging step includes packaging the homeopathic
medicinal preparation in a container substantially impervious
to ~~ radiation, including emitted ~~ radiation in the tritium
energy range. Such a container may comprise a composite
container comprising an inert inner container and an outer
shield substantially impervious to ~~ radiation, including
emitted ~~ radiation in the tritium energy range. Thus the
1~ storage container may, for example, comprise a metal selected
from aluminium, nickel and copper.
The dilution step (b) preferably includes a succussion
step. Succussion can be imparted manually; in this case the
succussion should preferably be carried using a gloved hand
so as not to supply heat to the flask or other container
during succussion. Alternatively the flask or other
container can be succussed mechanically. It is desirable to
avoid stirring the solution during succussion in such a way
as to produce a vortex. A suitable succussion regimen
2~ involves shaking the flask or other container mechanically at
a frequency in the range of from about 0.1 Hz to about 60 Hz
with an amplitude of about 40 mm for a period of about lO
seconds. Whilst succussion is desirable, it should not be so
vigorous as to impart energy to the solution of more than
about 85000 kJ/mole.
In another aspect the invention provides a homeopathic
medicinal preparation which has been prepared according to
the process of the invention.
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The invention further provides a storage container which
is adapted to shield its contents from the effects of ~~
radiation, including emitted ~~ radiation in the tritium
energy range, containing a charge of a homeopathic medicinal
S preparation containing an agent having homeopathic efficacy,
which preparation has been prepared by a process which
comprises:
(a) providing an initial solution containing a
predetermined starting concentration of a selected compound
having homeopathic efficacy;
(b) diluting the initial solution using at least one
dilution step by addition of diluent so as to produce
following the or each dilution step a diluted preparation
having a lower concentration of the selected compound than
the concentration of the selected compound in the solution
being diluted; and
(c) packaging the resulting homeopathic medicinal
preparation in a container adapted to protect the homeopathic
medicinal composition from ~~ radiation, including emitted ~~
radiation in the tritium energy range, until required for
consumption by a patient;
wherein the dilution, succussion and packaging steps are
carried out within an environment shielded from ~~ radiation,
including emitted ~~ radiation in the tritium energy range.
conveniently the storage container is adapted to contain
a unit dosage of the homeopathic medicinal composition, for
example about 1 g of granules or globules, one or more
tablets, or a suitable amount of a liquid, an ointment or
paste. This means that, when the patient opens the container~ 30 in readiness for taking the unit dosage, there is no risk of
any subsequent dosage being exposed to the effects of
radiation such as would occur if the container contained more
than one unit dosage of the homeopathic medicinal composition
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and were opened by the patient. There is also no risk of the
contents of the container, in this case, being influenced by
the contents of another container with a homeopathic
preparation of another strength or containing a different
homeopathic agent. Such a container can be a screw capped
container, a container with a childproof cap, a container
with a slide-off cap, a sealed ampoule with a frangible tip,
or a bag made of a metallised plastics material. The
container may be provided with a tamperproof seal of
conventional design so as to indicate to the patient that the
homeopathic medicinal preparation contained therein has
remained shielded from ~~ radiation, including emitted ~~
radiation in the tritium energy range, since packaging was
effected.
In the dilution step the conventional dilution methods
of Hahnemann or of Korsakoff can be used in which the initial
solution, which is of any convenient strength, is diluted by
a factor of one hundred or ten at each dilution stage.
Alternatively the initial solution can be diluted by a method
(which we have termed the GCL method) which involves dilution
in a first dilution step by a factor of lO0 and mixing by
succussion. In such a succussion step the flask should be
shaken a number of times in the same direction, e.g.
horizontally or vertically, in order to introduce into the
diluted solution energy in the range of, for example, from
about 10-3 to about 200 J/g. This solution can be termed a
G solution. Then the succussed diluted solution resulting
from such a first dilution step is diluted by discarding one
fifth of its volume and replacing the discarded volume with
further diluent and again succussing the resulting solution.
This resulting solution can be termed a 2 G solution. The
concentrations in the resulting solution are set out in Table
2 below.
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T~T,~ 2
Dilution Concentration GCL
in l/lO0 in lO~n Scale
- l/lO0 l/lO0 lo-2 l G
8/lO00 0.8/lO0 8 x 10-3 2 G
564/lO000 0.64/lO0 64 x 10-4 3 G
512/lO0000 0.512/lO0 512 x 10-5 4 G
4096/lO00000 0.4096/lO0 4096 x 10-6 5 G
A molar solution of a substance contains, according to
accepted molecular theory, 6.023 x lO23 molecules (i.e.
Avogadro's number of molecules) of that substance per litre.
Hence conventional scientific wisdom would suggest that, even
if one were to commence with an initial solution of molar
strength, a lO-60 molar solution (or a 30 CH solution) of a
substance contains statistically less than l molecule per
litre of that substance. Nonetheless there is evidence to
suggest that a beneficial homeopathic effect can be observed
in a patient, in a suitable case, who has been treated with
a 30 CH solution of a given homeopathic agent.
The applicants postulate that, in contrast to the
usually accepted theory which suggests that mass is uniformly
distributed in the space-time continuum, in fact mass is non-
uniformly spread in the space-time continuum and so non-
existing in the cone of the future of a point. Within this
theoretical framework it can be calculated mathematically (by
use of so-called contonian statistics) that, in the cone of
the future where a particle disappears, a non-trivial
physical field appears; this can be termed the remanent wave.
A remanent wave is always created when a particle disappears
and leaves what can be termed a "white hole". It is further
postulated that, at any Hahnemannian dilution, remanent waves
,. . ,. , _ , . . . .. .
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and so-called hyperprotons are created which take over and
reorganise the structure of the diluent.
For further information regarding the mathematical
calculations involved in contonian statistics reference may
be made to interprétation physico-mathématique de l'effet
pharmacologique des hautes dilutions: onde rémanente
apparences contoniennes (conton) by H. Berliocchi & R. R.
Conte, Cahiers de Biothérapie, No. 126, pages 73 to 80
(1994).
In the accompanying drawings:-
Figure 1 is a diagram of an experimental apparatus used
in Example l;
Figure 2 is a diagram illustrating the inhomogeneous
spread of mass in the space-time continuum.
lS The invention is illustrated by the following Examples.
Fxam~le 1
Referring to Figure 1, a Pyrex'M vessel 1 which was 10 cm
in diameter was filled to a depth of approximately 8 cm with
500 ml of de-ionised water 2. A tube 3 which was 18 cm in
length was filled to a depth of about 3.5 cm with 2 ml of a D
5 thyroxine solution 4 produced by dilution and succussion.
This tube 3 was placed in the flask 1. In this way the ratio
of the volume of water 2 in the flask 1 to the volume of
solution 4 was 500:2 or 250:1.
The flask 1 and tube 3 was protected from direct or
indirect sunlight and from any extraneous source of
ultraviolet radiation.
In one series of experiments the tube 3 was placed
directly in the water 2. In a second series of experiments
the tube 3 was wrapped with aluminium foil 13 ~m thick before
being placed in the water 2.
Using an NMR spectrometer the variation of the
relaxation time T2 (spin-spin interaction) of lH measured at
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20 MHZ of 2 ml samples of the water 2 withdrawn at given time
intervals from flask 1 was measured at 37~C both (a) with the
tube 3 unwrapped and (b) with the tube 3 wrapped in aluminium
foil 13 ~m thick.
S The results are summarised in Table 2 below. The
results at time zero are those obtained before introduction
of the tube 3 into flask 1.
. , _ ,.
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T~RLE 2
Time Without aluminium shield With aluminium shield
(minutes)lH Relaxation time T2 atlH Relaxation time T2
37~C (milliseconds) at 37DC (milliseconds)
0 2048.80 1920.20
1833.00 1813.70
2021.40 1942.00
1778.90 1928.30
1995.20 1875.40
2064.60 1874.70
1803.50 1968.80
105 1918.50 1879.60
1440 2046.00 1933.80
Average 1932.64 1902.04
With the aluminium shield around tube 3 the average lH
relaxation time T2 of the water 2 was 1902.4 milliseconds.
It remained, within the experimental error (0.95~), identical
to the value measured before the introduction of the shielded
tube 3 (1920.02 milliseconds). On the other hand, without
the aluminium shielding, the lH relaxation time T2 of the
water 2 decreased by 5.95%. It thus appears that the
environment is affected by the introduction of the tube 3
containing the sample of thyroxine but without the aluminium
shield. Thus it seems that a very small volume of the
diluted-succussed thyroxine solution can affect a very much
greater volume of water; in this Example the thyroxine
solution affected 250 times its volume of water. On the
other hand, shielding the thyroxine solution by means of an
aluminium shield from all influence of radiation has the
effect that the surrounding water is not affected by the
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thyroxine solution. This suggests that during production,
transport and storage of a homeopathic medicine comprising
thyroxine it is necessary to shield the homeopathic medicine
from all influence of visible, ultraviolet and other
radiation, including ~- radiation, so as to retain the
beneficial characteristics thereof.
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