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Homoeopathic Pharmacy
bacillinum)
Gradual enforcement of Act &
Rules
Homoeopathic medicines were
defined in Drug Rules (Rule 2 dd) 1969
Homoeopathic pharmacopoeia
covered in the second schedule
of the act 1978
Homoeopathic drug proving (HPI
Volume 1)
1. Controlled experiment
2. On relatively healthy volunteers
3. Substances should be prepared as per general
methodology mentioned in the pharmacopoeia
4. Experiments should be in varying doses to produce the
data called ‘proving’
5. On the scheme and pattern to constitute Materia
Medica Provings are the basis of Materia Medica
6. Experiments should be carried only to extent of causing
gross temporary reversible alterations and sense
perceptible objective signs.
Unique characteristics of
homoeopathic drug standards
1. The raw material should be same as used in
the proving.
2. Method of preparation should be one
adopted by the prover.
This in turn means:
1. Go for the correct species, adopt microscopic
/ histopathological studies.
2. Fix the percentage of active & limits for
inactive constituents and aducterants.
Process has a bearing on the
quality
Trituration - particle size 10 micron at 1x level
Tincture - fresh or dry plant
- size of cut or fineness of the
powdered material
- percolator packing
- percentage of extraction
solvent
- rate of percolation
- time of maceration
Supplementary but essential
standards
Ash values
Extractive values
Saponification values
Reaction (pH) of known strength solution
Foreign matters
Moulds, fungus, bacterial, pesticide residue TLC
Rf values
Tincture, odour, taste, colour & dry residue
Triturations / tablets
Insoluble basic drug materials (1:10 or 1:100) with
lactose
Triturated by hand or machine. Particle size of the
basic drug material in the final decimal or centesimal
dilution has to be below 10 µm for 80%; no drug
particle should be more than 50 µm.
Trituration time: Minimum 1 hour.
One third of the lactose is given into the mortar, then
the basic material is added; finally the remaining
vehicle in two equal portions is added and triturated.
Triturations / tablets contd…
For tabletting permitted excipients are only
starch – concentrated up to 10 percent and
magnesium stearate in concentrations up to 2
percent.
Granulation if necessary has to be done with
saturated lactose solution, starch paste or
ethanol.
Tablets are single doses containing 250 mg of
the trituration. The weight of excipients goes
additional.
Lowest potencies – legal limits
of prescription
Name of the drug Legal position
Antim. ars. Not below 3x
Ars. Alb. Not below 3x
Ars. Iod. Not below 3x
Ars. Sul. Flv. Not below 2x
Ars. Sul. Rub. Not below 2x
Baryta carb. Not below 3x
Baryta mur. Not below 3x
Bufo rana Not below 3x
Calcarea ars. Not below 3x
Lachesis Not below 6x
Lowest potencies – legal limits
of prescription contd…
All arsenic, barium, mercury and lead – not
below 3x
All nosodes - not below 6x (3rd potency) for
trading, not below 6th potency in practice
All snake, viper, spider, toad and insect
poisons - not below 3x (exceptions in India –
Blatta orientalis Q)
Phytochemicals (HCN glyc.) etc. – not below
6x
Special storage conditions (up
to 3x)
Acidum aceticum, nitricum, Hydrastis
picrinicum and sulphuricum Iodium
Apis mellifica
Physostigma
Bromine
Rauwolfia
Creasole
Gelsemium
Secale cor.
Zincum aceticum
Stringent storage condition (up
to 3x)
Arsenic Naja
Acid fluric Nitroglycerine
(hydrofluric) Merc. Iod. Flv.
Atropine sulph Merc. Iod. Rub.
Chininum ars. Phosphorus
Lachesis
Level of testing in homoeopathic
drugs
Biochemic drugs - up to 6x; up to 12x by plasma
Triturations - up to 6x; up to 12x by plasma
Mother tinctures - up to 4x; up to 6x by HPLC
Mother tinctures - up to 2x in combinations
Combination drugs - up to 2x
Ointments, hair oils, eye drops, etc.
Dilutions - up to 6x
Level of testing in homoeopathic
drugs Contd…
Molecules are present at best up to level 12C
or 24x
But clinical response is visible even above
24x in
• Human being
• Animals
• Bacteria
• Plants
Biological response can be demonstrated on
polygraph and other sensitive equipments
used in experimental pharmacology
No. of homoeopathic drugs covered by
different materia medica & other literature
Homoeopathic 2373
pharmacopoeial list (Govt. of
India)
Maceration
II B Fresh drug + alcohol 30% 1:2
sarcodes) – 261