Nosodes

by Robert Müntz

List of Nosodes you can buy at Remedia.

As long as there exists homeopathy we do know homeopathic remedies of which the material origin lies in the disease itself. As a result of diseases like AIDS and BSE (mad cow disease) the conditions have been tightened for producing remedies from blood and tissues of animal or human origin -- the subject of drug safety is seen in today's times much different than it was seen in Constantin Hering's times.

Here is an example of the production of one of the first nosodes, as it was done 170 years ago by the pioneer of American homeopathy Constantin Hering under risk of his own life:

Constantin Hering about "Hydrophobin":

"I have looked in vain, as expected, for the experiments which one would do in Germany with the saliva of the rabid dog. Four years have gone by since I talked about it and even in the newest journals (archive XIV.1.Zeitung 4 Nr.2) nothing has been reported. Instead that those who should be the first to get the rabid dog saliva would have attempted it, this ‘Abortivmol' (derogatory ?), the ‘Isopathik‘, without a single experiment, was published. Likewise nothing was contained in the ‘Zooiasis', which I regret *).Therefore I also had to do the experiments with respect to hydrophobin myself. It wasn't possible in Surinam, because there were no rabid dogs. Therefore I couldn't do anything before last summer when I was here. Through continued serious efforts, which we doubled, since for a child with hydrophobia all praised medications showed to be totally ineffective, it was finally possible to get a rabid dog in August 1833. After we had put the dog beneath a barrel, its muzzle emerged - searching for air, and while the dog was lying in convulsions I have put the foam from his teeth into a glass. As much as possible to get a clear drop to potentize and to poison it with the other vaccination needles, which had to serve in further experiments.

... The old [1], temporary enclosed in a box, raged terribly, and before I had the potencies ready, in order to give her those at first, she was dead.

.... Of the same hydrophobin I have sent potencies to Stapf, Mühlenbein and the apothecary Lappe. 2  "

The desire for an optimal drug safety - as after all the basic materials of nosodes are mostly infectious material - lead to the general regulations for production, which go too far in that they present only a sub-optimal regulation in the sense of homeopathy.

Due to lacking understanding of the essence of homeopathic potentizing the legislator introduced safety measures in the homeopathic pharmacopoeia which correspond exclusively to the standards of conventional medicine but do not take the essence of homeopathic potentizing into consideration. The decision finding process in respect to formulation of production rules was facilitated and it required that every form of remedy preparation had to correspond to the state of art of conventional medicine.

In the following the general production regulations of nosodes are discussed as well as the process of sterilization is presented.

 

Production of nosodes 3

Nosodes are preparations from disease products from humans or animals; from disease-causing agents or their metabolic products or from decay products of animal organs. Their production is regulated in pharmacopoeia HAB 2006 - these regulations do have official validity for all drug manufacturers all over Europe.

Nosodes should be exclusively produced after regulations 43, 44, 58a and 58b, with the exception of ointments which are produced according to regulation 6.

Basic materials for nosodes after regulations 6 and 43 are operatively removed, pathologically altered organs or organ parts of humans and animals.

Basic materials for nosodes after regulation 44 are dead cultures of micro organisms or decay products of animal organs or body fluids, which contain disease-causing agents or rather disease products that contain for instance blood, spinal fluid or aspiration fluid.

Basic materials for nosodes after regulations 58a and 58b are dead cultures from suitable bacteria or protozoa or inactivated influenza-virus preparations.

The identity of the basic materials has to be verified by the findings (of the operation material) of a medical specialist or by the findings of an appropriately designed and specialized laboratory.

Basic materials have to meet the requirements of the European pharmacopoeia as well as the requirements of the German pharmacopoeia with regard to the production of drugs from materials of animal or human origin or from microorganisms. Further they have to comply to the monographies

  1. Homeopathic preparations (Ph.Eur.) as well as
  2. Products with the risk of transmission of disease-causing agents of the spongiform encephalopathy of animal origin. (Ph.Eur.)

Moreover they have to meet the regulations of other guidelines by the relevant authorities and the European union.

If the medicine is produced as auto-nosode, which means the medicine is taken from the organism and has been administered to the same in potentized form, this is called isopathy (ISOS=the same); because the same is treated with the same this is not homeopathy in its proper sense, which is rather described by the law of similars.

If a nosode is produced from disease-causing agents and is applied, after the law of similars, to other patients, this can be called homeopathic therapy.

 

Procedure

The basic materials, if required suspended in 85 % glycerol, have to be sterilized for 20 minutes in saturated water vapour at a pressure of 3 . 107 kPa and a core temperature of 133°C.

Before further processing one has to verify that the previous mentioned basic materials meet the requirements „checking of sterility" (2.6.1) in the European pharmacopoeia.

Before sterilisation cultures of microorganisms have to be adjusted at 133 °C to 107 microorganisms (KBE) per gram, if not given otherwise in the monography; in the case of virus preparations the adjustment has to be done differently from that at a certain titre (ZKID50/ml or HA Unit).

 

Regulation 43:

Mother tinctures and fluid dilutions (nosodes)

Mother tinctures after regulation 43 are produced from altered organs or part of organs of human or animal origin.

For the production of the mother tincture 1 part of the crushed basic material is mixed with 10 parts of 85 % glycerol. This mixture will be put aside for 5 days and after this time it will be filtered. The filtered mixture is the mother tincture.

 

Potentizing

The mother tincture corresponds to the 1.  decimal dilution

Ø = D 1
1T Ø + 9T EtOH 30% = D2
1T Ø + 9T EtOH 43% = D3

The 1. Centesimal dilution (C 1) is made from
10 T D1 + 90T EtOH 30 % = C1

1T C1 + 99T EtOH 43% = C2,

provided that no other fluid carrier substance has been prescribed. The procedure for further dilutions is carried out correspondingly.

 

Regulation 44:

Mother tinctures and fluid dilutions (nosodes)

Mother tinctures after regulation 44 are produced from dead cultures of microorganisms or from decay products of animal organis or from body fluids, which contain disease causing agents or disease products.

Before sterilisation cultures of microorganisms have to be adjusted at 133 °C (H 5.2.5) to 107 Mikroorganismen (KBE) per gram, if not given otherwise in the monography, or

in the case of virus preparations the adjustment has to be done differently from that at a certain titre (ZKID 50/ml or HA Unit).

The mixture has to meet the requirements „checking of sterility" (2.6.1) in the European pharmacopoeia.

For the production of the mother tincture 1 part of the previous mentioned basic material is mixed and succussed with 9 parts of 85 % glycerol. This mixture will be put aside for 5 days and after this time it will be filtered. The filtered mixture is the mother tincture.

 

Potentizing

The mother tincture corresponds to the 1.  decimal dilution
Ø = D 1
1T Ø + 9T EtOH 30% = D2
1T Ø + 9T EtOH 43% = D3

The 1. Centesimal dilution (C 1) is made from
10T  D1 + 90T EtOH 30 % = C1
1T C1 + 99T EtOH 43% = C2

provided that no other fluid carrier substance has been prescribed. The procedure for further dilutions is carried out correspondingly.

 

Sterilisation

Methods of Sterilisation

Sterility is the absence of viable micro-organisms. The sterility of a product cannot be guaranteed by testing; it has to be assured by the application of a suitably validated production process. It is essential that the effect of the chosen sterilisation procedure on the product (including its final container or package) is investigated to ensure effectiveness and the integrity of the product and that the procedure is validated before being applied in practice. It is recommended that the choice of the container is such as to allow the optimum sterilisation to be applied. Failure to follow meticulously a validated process involves the risk of a non-sterile product or of a deteriorated product. Revalidation is carried out whenever major changes in the sterilisation procedure, including changes in the load, take place. It is expected that the principles of good manufacturing practice (as described in, for example, the European Community Guide to GMP) will have been observed in the design of the process including, in particular, the use of:

  • qualified personnel with appropriate training,
  • adequate premises,
  • suitable production equipment, designed for easy cleaning and sterilisation,
  • adequate precautions to minimise the bioburden prior to sterilisation,
  • validated procedures for all critical production steps,
  • environmental monitoring and in-process testing procedures.

The precautions necessary to minimise the pre-sterilisation bioburden include the use of components with an acceptable low degree of microbial contamination. Microbiological monitoring and setting of suitable action limits may be advisable for ingredients which are liable to be contaminated because of their origin, nature or method of preparation. For biological products of animal or human origin or in cases where such material has been used in the production process, it is necessary during validation to demonstrate that the process is capable of the removal or inactivation of relevant viral contamination. Guidance on this aspect is provided in, for example, the appropriate European Community Notes for Guidance.

 

Sterility Assurance Level (SAL)

Where appropriate reference is made within the methods described below, to a "sterility assurance level" or "SAL". The achievement of sterility within any one item in a population of items submitted to a sterilisation process cannot be guaranteed nor can it be demonstrated. The inactivation of micro-organisms by physical or chemical means follows an exponential law; thus there is always a finite statistical probability that a micro-organism may survive the sterilising process. For a given process, the probability of survival is determined by the number, types and resistance of the micro-organisms present and by the environment in which the organisms exist during treatment. The SAL of a sterilising process is the degree of assurance with which the process in question renders a population of items sterile. The SAL for a given process is expressed as the probability of a non-sterile item in that population. An SAL of 10-6, for example, denotes a probability of not more than one viable micro-organism in 1 × 106 sterilised items of the final product. The SAL of a process for a given product is established by appropriate validation studies.

 


Methods and conditions of sterilisation

Sterilisation has to be carried out by steam sterilisation described below.

 

Terminal sterilisation

For terminal sterilisation it is essential to take into account the non-uniformity of the physical and, where relevant, chemical conditions within the sterilising chamber. The location within the sterilising chamber that is least accessible to the sterilising agent is determined for each loading configuration of each type and size of container or package (for example, the coolest location in an autoclave). The minimum lethality delivered by the sterilising cycle and the reproducibility of the cycle are also determined in order to ensure that all loads will consistently receive the specified treatment. Having established a terminal sterilisation process, knowledge of its performance in routine use is gained wherever possible, by monitoring and suitably recording the physical and, where relevant, chemical conditions achieved within the load in the chamber throughout each sterilising cycle.

Steam sterilisation for Nosodes (Heating in an autoclave)

Sterilisation by saturated steam under pressure is preferred, wherever applicable, especially for aqueous preparations. For this method of terminal sterilisation the reference conditions for aqueous preparations are heating at a minimum of 133 °C for 20 min.

The procedures and precautions employed are such, as to give an SAL of 10- 6 or better. Guidance concerning validation by means of the F0 concept is provided below (5.1.5). Knowledge of the physical conditions (temperature and pressure) within the autoclave chamber during the sterilisation procedure is obtained. The temperature is usually measured by means of temperature-sensing elements inserted into representative containers together with additional elements at the previously established coolest part of the loaded chamber. The conditions throughout each cycle are suitably recorded, for example, as a temperature-time chart, or by any other suitable means. Where a biological assessment is carried out, this is obtained using a suitable biological indicator.

Biological indicators of sterilisation

(Ph. Eur. method 5.1.2)

Biological indicators are standardised preparations of selected micro-organisms used to assess the effectiveness of a sterilisation procedure. They usually consist of a population of bacterial spores placed on an inert carrier, for example a strip of filter paper, a glass slide or a plastic tube.

The inoculated carrier is covered in such a way that it is protected from any deterioration or contamination, while allowing the sterilising agent to enter into contact with the micro-organisms.

Spore suspensions may be presented in sealed ampoules.

Biological indicators are prepared in such a way that they can be stored under defined conditions; an expiry date is set.

Micro-organisms of the same bacterial species as the bacteria used to manufacture the biological indicators may be inoculated directly into a liquid product to be sterilised or into a liquid product similar to that to be sterilised. In this case, it must be demonstrated that the liquid product has no inhibiting effect on the spores used, especially as regards their germination.

A biological indicator is characterised by the name of the species of bacterium used as the reference micro-organism, the number of the strain in the original collection, the number of viable spores per carrier and the D-value. The D-value is the value of a parameter of sterilisation (duration or absorbed dose) required to reduce the number of viable organisms to 10 per cent of the original number. It is of significance only under precisely defined experimental conditions. Only the stated micro-organisms are present. Biological indicators consisting of more than one species of bacteria on the same carrier may be used. Information on the culture medium and the incubation conditions is supplied. It is recommended that the indicator organisms are placed at the locations presumed, or wherever possible, found by previous physical measurement to be least accessible to the sterilising agent.

After exposure to the sterilising agent, aseptic technique is used to transfer carriers of spores to the culture media, so that no contamination is present at the time of examination. Biological indicators that include an ampoule of culture medium placed directly in the packaging protecting the inoculated carrier may be used.

A choice of indicator organisms is made such that:

  • the resistance of the test strain to the particular sterilisation method is great compared to the resistance of all pathogenic micro-organisms and to that of micro-organisms potentially contaminating the product,
  • the test strain is non-pathogenic,
  • the test strain is easy to culture.

After incubation, growth of the reference micro-organisms subjected to a sterilisation procedure demonstrates that the procedure has been unsatisfactory.

 

Final considerations

In recent years there have been increasing tendencies, which strive to restrict the variety of remedies in homeopathy, particularly animal remedies and nosodes of human pathogenic origin; this all happens under the justification of "drug safety".

Naturally there is some understanding for meaningful and comprehensible requirements on drug safety, however there should be - above a certain appropriate remedy potency - an exemption from safety regulations with regards to basic materials. This would be justified at last at a potency of 10-23 (C12/D23) and higher.

It would be very easy, and at the same time it would correspond to a high standard of safety, to name a harmless level of potency, above which it would be possible to put homeopathic mono-preparations into circulation without further harm.

Further, for homeopathica, especially for nosodes, the requirements of the legislator - to have the basic material „free from pathogenic agencies" - should be replaced by a „rational risk assessment" of the final product.

The drug safety of nosodes is solely warranted by the method of homeopathic potentizing with the multiple test tube method.

The hereby occurring dilution of pathogenic germs is the safest method to exclude infectivity; - the dilution in the multiple test tube method is mathematically clearly comprehensible and hereby scientifically well-founded with regard to its safety risk in respective to the production of nosodes. The clarity of the results of calculation also allows statements without experimental proof of apathogenity.

Denaturing treatments before, during or after the production of preparations will not improve the safety but rather will most probably diminish the effectivity of the medication; therefore they should be removed from the regulations of production.

Nosodes of human pathogenic origin are an integral part of homeopathic cure; therefore they should not be expelled from the market due to inadequate legislation.

List of Nosodes you can buy at Remedia.

 


[1] Female dog (translator's remark)
2 Constantin Hering: Medizinische Schriften in drei Bänden; Klaus-Henning Gypser, 1988, Bd II, S.504 ff
3 HAB 2006, allgemeine Vorschriften (general regulations)
4 Ph. Eur. general texts 5.1.1, 5.1.2 and 5.1.5

 

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