WO1998006383A1

WO1998006383A1 - Homeopathic composition and process for its preparation

Info

Publication number: WO1998006383A1
Application number: PCT/GB1997/002124
Authority: WO
Inventors: Rolland René CONTE; Yves Lasne
Original assignee: Dynsol Limited
Priority date: 1996-08-09
Filing date: 1997-08-05
Publication date: 1998-02-19
Also published as: JP2000516605A; BR9711051A; CA2263097A1; GB9616728D0; AU714261B2; EP0918512A1; NZ334086A; AU3704697A

Abstract

The invention relates to 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 β- radiation, including emitted β- 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 β- radiation, including emitted β- radiation in the tritium energy range. Also provided in accordance with the invention is a package comprising a storage container which is adapted to shield its contents from the effects of β- radiation, including emitted β- radiation in the tritium energy range, containing a charge of a homeopathic medicinal preparation which has been prepared by the process of the invention. The homeopathic medicinal preparation can be in the form of granules or globules containing, for example, from about 0.005 g to about 0.05 g of an inert solid carrier material, such as lactose, or can be in tablet, ointment or paste form. Concentrations as low as 30 CH appear to be effective in homeopathic treatment.

Description

HOMEOPATHIC COMPOSITION AND PROCESS FOR ITS PREPARATION

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, Simeon N. Korsakoff and involves use of a single flask. The Hahnemannian process consists in effecting dilutions in separate flasks or bottles. To make a one hundred fold dilution, 1% by volume of a starting solution (or mother tincture) of a convenient concentration, for example about 1 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 1 CH. To make a further dilution, 1% by volume of this 1 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 1 cmK) . Upon repeating the procedure with the 1 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 1 in 100, i.e. centesimal dilutions, are common, another accepted method of dilution is the decimal method in which 1 part of the mother tincture is diluted to 1/10 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 1 below. The starting concentration is a convenient concentration, such as 1 g per litre . TABLE _-

Dilution Concentration Decimal Centesimal in 1/100 in 10^"n Scale Scale

1/10 10/100 lO"¹ 1 D

1/100 1/100 10"² 2 D 1 CH

1/1000 0.1/100 lO^'3 3 D

1/10000 0.01/100 10-" 4 D 2 CH

1/100000 0.001/100 10^"5 5 D

1/1000000 0.0001/100 lO"⁶ 6 D 3 CH

₁₀-ι^β 9 CH

₁₀-60 30 CH

In his writings Hahnemann recommended that utensils used for the preparation of a homeopathic medicinal preparation 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, 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. It 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 β- radiation, including emitted β^" 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 β^" radiation, including emitted β^" 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 1 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 β^~ radiation, including emitted β- 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 shielding will also be effective to prevent penetration by α particles; it is, however, impractical to attempt to provide shielding against γ rays. The shielding step is preferably carried so as to shield from β 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 β^" 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 β^" radiation, including emitted β- 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 β^" radiation, including emitted β- radiation in the tritium energy range. Thus the 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 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 10 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. The invention further provides a storage container which is adapted to shield its contents from the effects of β^" radiation, including emitted β^~ radiation in the tritium energy range, containing a charge of a homeopathic medicinal preparation containing an agent having homeopathic efficacy, which preparation has been prepared by a process which comprises :

(c) packaging the resulting homeopathic medicinal preparation in a container adapted to protect the homeopathic medicinal composition from β^" radiation, including emitted β^~ 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 β- radiation, including emitted β- 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 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 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 β^~ radiation, including emitted β^* 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 100 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 1 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. TABLE 2

Dilution Concentration GCL in 1/100 in 10"ⁿ Scale

1/100 1/100 lO^"2 1 G

8/1000 0.8/100 8 x 10"³ 2 G

64/10000 0.64/100 64 x 10^"4 3 G

512/100000 0.512/100 512 x 10^"5 4 G

4096/1000000 0.4096/100 4096 x 10^"6 5 G

A molar solution of a substance contains, according to accepted molecular theory, 6.023 x 10²³ 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 10^"€0 molar solution (or a 30 CH solution) of a substance contains statistically less than 1 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 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 interpretation phys co-mathejπatirue de l ' effet pharmacologiqae des hautes dilutions : onde remanente apparences contoniennes (conton) by H. Berliocchi & R. R. Conte, Cahiers de Biotherapie, No. 126, pages 73 to 80 (1994) . In the accompanying drawings : -

Figure 1 is a diagram of an experimental apparatus used in Example 1 ;

Figure 2 is a diagram illustrating the inhomogeneous spread of mass in the space-time continuum. The invention is illustrated by the following Examples. E ample i

Referring to Figure 1, a Pyrex™ 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 μm thick before being placed in the water 2.

Using an NMR spectrometer the variation of the relaxation time T2 (spin-spin interaction) of *H measured at 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 μm thick.

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.

TABLE 2

Time Without aluminium shield With aluminium shield (minutes) *H Relaxation time T2 at H Relaxation time T2 37°C (milliseconds) at 37°C (milliseconds)

0 2048.80 1920.20

5 1833.00 1813.70

15 2021.40 1942.00

30 1778.90 1928.30

40 1995.20 1875.40

50 2064.60 1874.70

75 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 ^λH 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 ^λK 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 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 β" radiation, so as to retain the beneficial characteristics thereof.

Claims

CLAIMS :

1. A process for preparing a homeopathic medicinal composition which comprises:

(c) packaging the resulting homeopathic medicinal preparation in a container adapted to protect the homeopathic medicinal composition from β^~ radiation, including emitted β^" 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 β^~ radiation including emitted β^" radiation in the tritium energy range.

2. A process according to claim 1, in which the diluent comprises a solvent .

3. A process according to claim 1 or claim 2, in which the diluent comprises water.

4. A process according to any one of claims 1 to 3 , in which the dilution step (b) is repeated a plurality of times including a final dilution step and in which in the final dilution step the diluent is a solid.

5. A process according to claim 4, in which the final dilution step comprises impregnating a solid carrier material with a solution of the agent.

6. A process according to claim 5, in which the solid carrier material comprises a carbohydrate.

7. A process according to claim 6, in which the carrier material comprises lactose, sucrose, threalose or threose.

8. A process according to any one of claims 5 to 7, in which the solid carrier material comprises granules or globules weighing from about 0.005 g to about 0.05 g.

9. A process according to claim 5 or claim 6, in which the solid carrier is in the form of a tablet.

10. A process according to any one of claims 1 to 3 , in which the dilution step is repeated a plurality of times including a final dilution step and in which the final dilution step comprises formulation into an ointment or a paste .

11. A process any one of claims 1 to 10, in which the shielding step is carried so as to shield from energy in the range of up to about 19 keV.

12. A process according to claim 11, in which the shielding step is carried out so as to shield from energy in the range of from about 1 keV to about 19 keV.

13. A process according to any one of claims 1 to 12, in which the packaging step includes packaging the homeopathic medicinal preparation in a container substantially impervious to β^" radiation, including emitted β" radiation in the tritium energy range .

14. A process according to claim 13, in which the packaging step includes packaging the homeopathic medicinal preparation in a composite container comprising an inert inner container and an outer shield substantially impervious to β" radiation, including emitted β^" radiation in the tritium energy range.

15. A process according to claim 13 or claim 14, in which the storage container comprises a metal selected from aluminium, nickel and copper.

16. A homeopathic preparation which has been prepared by a process according to any one of claims 1 to 15.

17. A package comprising a storage container which is adapted to shield its contents from the effects of β' radiation, including emitted β" radiation in the tritium energy range, containing a charge of a homeopathic medicinal preparation containing an agent having homeopathic efficacy, which preparation has been prepared by a process which comprises :

(c) packaging the resulting homeopathic medicinal preparation in a container adapted to protect the homeopathic medicinal composition from β" radiation, including emitted β^" 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 β" radiation, including emitted β' radiation in the tritium energy range.