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A QUICK  REVIEW IN HOMOEOPATHIC PHARMACY

Dr.Ram Jyothis

BHMS,MD(Hom) Pharmacy

Lecturer. Fr.Muller’s Homeopathic Medical College. Mangalore

 

  Previous Page 

22.   Semi – Solid Vehicles - Vehicles that are in the semisolid state at room temperature.

 

Paraffin hard (Paraffinum durum; Paraffin wax)

Source: Petroleum

It is used, mainly to increase the consistency of ointments.

It is an ingredient of paraffin ointment, simple ointment and wool alcohol ointment.

Yellow soft paraffin (petrolatum; Amber petrolatum; Yellow petrolatum; Petroleum jelly; Paraffin jelly; Paraffinum molle flavum)

It is used as a base for ointments. It is highly occlusive and a good emollient.

White Soft Paraffin (white petrolatum; white petroleum jelly; paraffinum molle album)

The utility of white petrolatum is similar to yellow petrolatum, but is often preferred because of its freedom from color. It is employed as a protective, a base for ointments and cerates and forms the basis for burn dressings.

Liquid Paraffin (Mineral oil; Liquid petrolatum; white mineral oil; Heavy liquid petrolatum)

It is used in the preparation of eye ointment.

 Yellow Bee Wax (Cera flava)

Source: wax from honeycomb or the hive bee of Apis mellifica                      

It is used in the preparation of cerates and ointments and used for hardening of soft ointment.                    

White Bee Wax (Cera alba)

It is used as a component of cerates and ointments.

Lanolin (wool fat, Adeps lanae)

Source: from the wool of sheep, Ovis aries                                  

It is used as a base in water-absorbable ointment, increases the absorption of the drug from the skin. It is used also as an emollient.

Spermaceti (Cetaceum, Esperma de Ballena)

Source    : from head and blubber of sperm whale, Physeter macrocephalus and bottle- nosed whale Hyperoodon rostratus.                                            

It is one of the solid fatty substances employed to give consistency to cerates and ointments.

 

Prepared Lard (Adeps lard)

Source: purified internal fat known as ‘flare’, of the abdomen of hog, Sus scrofa or Sus domestica                           

It is used as an ingredient in ointments.

Isinglass (Russian Isinglass, Ichthyocolla)

Source    : collagen derived from the thin, inner, silver shiny layer of the air bladder of some fishes, particularly Sturgeon, Acipenser huso.                                      

It is an important component of plasters.

Soft soap (Sapo mollis)

Source   :  interaction of potassium hydroxide or sodium hydroxide with a suitable vegetable oil or oils or with fatty acids derived there from.                                 

It is used in soap liniment.

Hard Soap (Sapo durus)

Source: it is prepared from fats or oils, with sodium hydroxide and it consists of the sodium salts of the fatty acids.

Curd soap (Sapo animalis)

Source    : Soap made with soda and purified animal fat consisting principally of stearin.

It usually constitutes the bar laundry soap.

It is a component of opodeldocs.

Starch (Amylum)

Source    : grain of maize; grain of wheat tubers of potato; rice

It is a component of glycerol of starch.

It has absorbent and demulcent properties.

 

23.     Glass mortar - for mercurial preparations, ointments.

 

24.     According to HPI, the sieves are specified as sieve numbers 6, 8, 10,

22, 25, 30, 36, 44, 60, 85, 100 and 200.

           

25.      For drying at a very high temperature, crucible made of silica is used.

 

26.   Dessicator is used for removing moisture or dehydration of substances at moderate temperature. The air inside the desiccator is always kept dry by placing some drying agent like fused calcium chloride or Conc. sulphuric acid.

 

27.  Pycnometer (specific gravity bottle) is used for determination of specific   gravity & Hydrometer is used or rapid detection of specific gravity & relative density of liquid.

28.  Alcoholometer - Used for estimating the strength of alcohol.

Markings are in actual percentage of alcohol.

 

29. Decantation is a process of slowly and carefully pouring out liquids from one vessel to another without disturbing the sediments that have been accumulated at the bottom of the liquid.

30.  Filtration is a physical process of separation of a liquid from substances insoluble in that liquid with the help of a filtering medium through which only the liquid can pass but not the other substances insoluble in that liquid.

31.   Evaporation is the simple process of removing a liquid slowly from a solution.

32.  Distillation is a process of converting a liquid into a gas and condensing the gas back into a liquid.

33.  Fractional distillation is the method used for separating a mixture of several liquids of different boiling points, as in the case of organic liquids.

34.    Sublimation is the process of distilling a solid; of converting the solid into a vapor and condensing the vapor back to a solid. Sublimation is a method of obtaining crystals.

35.  Desiccation is a process of removing water from a substance at moderate temperature, differing from exsiccation, which means removing the water from a substance at high temperatures.

36.  Precipitation is the process of separating a solid from its solution by the aid of physical or chemical action.

37. Crystallization is the process of separating substances in forms possessing definite geometric shapes.

 

38.      Sifting is a process of separating finer portions of comminuted drugs from the coarser particles by the use of a sieve. This is determining particle size.

 

 

Class 1      

Class 2

Class 3

Class 4

Source

Most Juicy Plants

Moderately Juicy Plants

 

Less Juicy Plants

Dried vegetable,

Dried and fresh

animal substances

Nature of Drug

Non- Mucilagenous,

No resins,terpins or volatile oils

 

Non- Mucilagenous,

But with resins,terpins or volatile oils

 

Mucilagenous drug Substances

Dried drug substances

Fundamental rule

Belladonna

Thuja

Scilla

Spigelia & Stapysagria

Drug: Menstrum

1 : 1 ( by weight)

3 : 2 ( by weight)

1 : 2 (by weight)

1 : 5 (by weight)

Duration

8 days

8 days

8 days

15 days

Decimal – 1X

Tincture : Vehicle

2 :8

2: 8

6 : 4

Drug strength 1/10

Centesimal – 1C

Tincture : Vehicle

2 : 98

2 : 98

6: 94

10 : 90

Organon Reference

Aphorism - 267

 

Footnote to

Aphorism - 267

 

Drug Strength

1/2

1/2

1/6

1/10

Examples

Arum triphyllum

Bryonia, Calendula,

Chamomilla, Ruta

Euphrasia, Mezereum, Vinca

Abrotanum,Aesculus

Arnica,Baptisia,Puls,

Rhus tox.

Aloe, Apis

Cantharis, Cina, Ignatia

 

 

Class 5A

Class 5B

Class 6A

Class 6B

Source

Substances soluble

in less quantity of

Water.

Substances soluble

in greater quantity of

Water.

Substances soluble

in less quantity of

alcohol.

Substances soluble

in greater quantity of  alcohol.

 

Drug : Vehicle

1 : 9 ( by weight)

1 : 99 ( by weight)

1: 9 ( by weight)

1 : 99( by weight)

Drug Strength

1/10

1/100

1/10

1/100

Preparation – 1X

Preparation corresponds to 1X

Not possible – first potency is 2X

 

Preparation corresponds to 1X

Not possible – first potency is 2X

 

Preparation - !C

10 parts of solution : 90 parts of purified water

Preparation corresponds to 1C

10 parts of solution : 90 parts of purified alcohol

Preparation corresponds to 1C

Examples

Nitric acid, Ammo. Carb, Baryta mur

Acid phos, Bromium,Antim tart

Guaiacum, Camphor

 Iodum, Croton - tig

 

 

Class - 7

Class - 8

Class - 9

Source

Trituration of dried

 medicinal substances.

Trituration of liquid

medicinal substances.

Trituration of fresh

Vegetable & animal

Substances.

Fundamental Rule

Ars alb (M.M.Pura)

Petroleum (Chronic diseases)

Agaricus (Chronic diseases)

Drug : Vehicle

1 : 9  ( by weight)

           decimal

1 :99 ( by weight)

         centesimal

1 : 9  ( by weight)

           decimal

1 :99 ( by weight)

         centesimal

2 : 9  ( by weight)

           decimal

2 :99 ( by weight)

         centesimal

Examples

Sepia, Spongia, Kali carb, Graphitis, Silicea

Crotalus, Elaps,Lachasis

Anacardium, Blatta,  Fel tauri

 

40. As per Pharmacopoeia, preparations of mother tinctures, solutions and triturates have been standardized in decimal scale and have uniform drug strength of 1/10.

 

41. Tinctures and solutions other than 1/10 or 1/100 drug strength

 

Bufo rana                 1/1000
Cactus grandiflorus    -         1/20

Causticum                  -        1/2

Chlorinum                -        1/1000

Moschus                    -         1/20

Phosphorus    -         1/667

Sulphur θ                -          1/5000

 

42. Determination of moisture content:

 

Gravimetric method - Loss on Drying [as per HPI]      

Separation and Measurement of Moisture - Distillation Method

Gas Chromatography Method

Chemical Method - Karl Fischer Titration

Spectroscopic Methods

 

43. Maceration

It is the process of removing the active principles from a drug by allowing the latter to remain at room temperature in contact with the solvent for several days, with frequent agitation.

Gummy and mucilaginous substances with viscid juice.

     Time required is 2 - 4 weeks.

44. Percolation

It is a process of extracting the soluble constituents of a drug and preparing the mother tincture by the passage of a solvent through the powdered drug contained in a suitable vessel called percolator for a definite period of time as per directions specified in Pharmacopoeia.

Percolation is adopted for extraction of dry vegetable and animal substances.

Percolation usually requires 24 hours of extraction.

In preparation of liquid potencies, scales used are Centesimal, Decimal, and Fifty millesimal. In preparation of solid potencies, decimal and centesimal scales are used. When trituration attains 6X potency; then it is converted into liquid potency and potentized.

 

45. Centesimal   scale - This scale was introduced by Hahnemann in 5th edition of Organon of Medicine, Aphorism 270, designated by ‘C’ or ‘CH’. Ratio – 1: 99.

 

46. Decimal   scale

Dr. Constantine Hering of Philadelphia was the first who introduced the decimal scale. Dr. Vehsemeyer of Berlin, in 1836, in a precise manner, set forth the principles, therein involved. The decimal potency is denoted by suffixing the letter 'X' or 'D' to the number indicating the potency. Ratio – 1: 9

 

47. Fifty millesimal potencies are based on the principle enunciated by Hahnemann

in his sixth edition of Organon of Medicine - Aphorism 270. Fifty millesimal potencies were termed by Dr. Pierre Schmidt.

 

Preparation of LM potencies (HPI)            

Triturate drug with the sugar of milk to prepare 3C potency. One grain of the 3C potency is dissolved (by shaking) in 500 drops of a mixture of one part of dispensing alcohol and four parts of purified water. Thus, the dry trituration is converted into liquid form. It is called as mother potency of LM potency. One drop of mother potency is put in a suitable vial of neutral glass and 100 drops of pure alcohol are added so that the vial is filled 2/3rd full. This is to be succussed 100 times. This makes the first LM potency-  ‘ 0/1 ’. For preparation of each subsequent potency, soak few globules (100 globules weighing 65 mg and such 500 globules can hardly absorb one drop for their saturation are taken.) of nearly uniform size in a drop of the preceding potency, dry them. Take one globule and dissolve it in a drop of Purified Water in new phial. Add 100 drops of dispensing alcohol to it and give 100 strong succussions. All subsequent potencies are prepared    by succussing 1 globule (equivalent to  1 / 500 th part of a drop) with 100 parts  of alcohol,  decreasing  the  material quantity by 50000 times at each potency.

Fifty millesimal potencies are designated by

0/1, 0/2, 0/3, … 0/30

LM 1, LM 2, LM 3 … LM 30

LM I, LM II, LM III … LM XXX

0/I, 0/II, 0/III … 0/XXX

Drug strength of 0/1 potency is 1/5x1010.

48. In triturating Plumbum, pestle has to be used softly.

49. In making the first trituration of Mercury, Graphites and Plumbum, double time is required.

50. In triturating Ferrum metallicum, the moisture has to be driven out by keeping the mortar warm.

51. Trituration –

Drug and sugar of milk are taken according to scale. Drug is taken in an unglazed porcelain mortar. Sugar of milk is divided into three parts in a definite ratio, on a measuring tile. The process of trituration consumes one hour time. Each stage consumes twenty minutes. In each stage, one part of sugar of milk is added. Each stage consumes twenty minutes. In each stage, one part of sugar of milk is added. Each stage is divided into two sub-stages that consume ten minutes each. The process carried out in the first ten minutes of each stage is repeated for the next ten minutes. Each sub-stage of ten minutes consists of – grinding or pulverizing for six minutes; and scraping and mixing for four minutes.(Organon – Ratio is 3:3:3, HPI – 1:3:5).

52. Conversion of trituration to succussion in decimal scale -Jumping Potency (Fluxion Potency)

All medicinal substances triturated to 6X trituration are soluble in water and alcohol.

Dissolve one part of 6X trituration in 50 parts of water and 50 parts of dispensing alcohol. Give 10 succussions to this liquid mixture. Number 7X dilution from 6X trituration is not possible. The first potency prepared from 6X trituration is 8X. The 7X cannot be prepared in the proportion of one to nine. To get 7X potency from 6X, 5 parts of water and 5 parts of alcohol are required to succuss 1 part of 6X potency. This quantity is not sufficient to dissolve the solute. Thus, 50 parts each by volume of water and alcohol is required for the dissolution of 1 part of 6X potency. After succussion, the solute is found to be reduced 100 times, giving drug strength of 8X potency.

 

53. Modified Potentization Techniques

Korsakoff Potencies - General Korsakoff of Russia was the real originator of high potencies. He believed that one single medicated globule when placed among many non- medicated globules communicated its medicinal power to the non-medicated globules.

Jenichen Potencies -Jenichen of Wismar pursued the idea that further attenuation is not necessary for dynamization of medicine, but continuous succussion without dilution is sufficient.  He advocated that the degree of strength was directly proportional to the number of strokes given.

Dunham potencies - Carroll Dunham was one of the early people to mechanize the process of potentization. He used an abandoned oil-mill for preparing potencies. His potencies were suffixed by letter ‘D”.

Fincke’s continuous fluxion Potency - Bernhard Fincke used a spring as a model of power for his succussions. A one drachm vial filled with a hand - made 30C potency is subjected to a continuous water flow.  When one drachm of water has flowed through the vial, the potency was considered to have been raised by one degree. The important concept in this process is that the walls of the glass vial have adsorbed the medicinal substance.

Skinner's discontinuous fluxion Potencies - Skinner's potencies were prepared by a process of discontinuous fluxion in contrast to the continuous fluxion of Fincke. Thomas Skinner developed 'Skinner Fluxion Centesimal Attenuator'. This device was designed to mount above a small to mount above a small sink in the office or home. The motive power was water pressure. The potencies are labeled 'F.C.' (Fluxion Centesimal).

Swan’s Potencies - Samuel Swan used fractional part of potencies and attenuated from them. He suggested that if one drop of tincture were used to make 1M potency, then 1/10th of a drop of the 1M would be used to make the 10M. This method had more to do with the dilution of the final potency rather than the serial dilution of each potency along the way.

Multiple or Single vial Potencies- Hahnemannian method of potentization requires a new vial to be used for every stage of potentization, which is the original method developed by Hahnemann. It is known as Hahnemann's Multiple Vial method.

Single vial potencies are easier and cheaper to produce. They are also called Korsakoff potencies.

 

54. Mother tincture for external use-

When a mother tincture is to be used for the purpose of preparing external applications, it needs to undergo a modification. Normally, except otherwise specified, 10% mixture of mother tincture for external application and suitable base is used.

If the mother tincture is prepared according to New method, equal weight of mother tincture and ethyl alcohol are to be taken and this mother tincture will be used for external application.

According to Old Hahnemannian method, Tincture of Class I and II, 1 part by weight of mother tincture and 1.5 parts by weight of ethyl alcohol (45%) are to be mixed. For tincture of Class III, 1.5 parts by weight of mother tincture and 1 part by weight of ethyl alcohol (60%) are to be mixed. For tincture of Class IV, 1 part by weight of mother tincture and 1 part by weight of ethyl alcohol that was used for the preparation of the mother tinctures are to be mixed

 

55. External Applications (Apho- 284 -285, 6th edition)

Liniments are liquid preparations, applied with or without friction, by rubbing, anointing or painting. Liniments may be alcoholic solutions, oily solutions or emulsions, prepared with tincture of soap or olive oil. Liniments are prepared by mixing one part of the required drug with four parts of olive oil or tincture of soap (according to HPI).

Lotions are aqueous solutions, suspensions or dispersions for application to the skin surface. If they contain insoluble solids in suspension, they are sometimes suspension; they are sometimes referred to as 'Shake Lotions'. Lotions may be prepared by diluting medicine with water in proportion of 1 to 10 or 100 or by adding 1 part of glycerole with 4 or 9 parts of water.

Glyceroles are mixtures of solutions of mother tincture in glycerin. They are usually viscous with jelly like consistency.Glyceroles are made by adding mother tincture of a drug to glycerin in various proportions. All glyceroles (except of starch) are prepared by mixing one part of the required drug with four parts of glycerin. Glyceroles are anti-fungal, anti-pruritic and used in cases of stomatitis and gingivitis.

Glycerole of starch - 1 part of starch + 8 parts of glycerin. Transfer the mixture to porcelain dish. Apply heat, stir till starch particles are completely broken and a jelly like preparation is made.

Ointments are semi-solid preparations used for application to the skin. They are used for emollient, protective or other surface effects.

Fusion method - When wax, spermaceti or other hard fusible bodies are to be incorporated with soft, oleaginous materials, fusion method is employed. The insoluble solid medicament is finely powdered.

Mechanical incorporation or   trituration method: This method is used when the base is soft and the medicament is either a solid insoluble in the base or a liquid present in small quantity. Mechanical incorporation is performed by trituration in a mortar or a glass slab with a spatula.

Opodeldocs are semi-solid liniments prepared by mixing specified quantities of white curd soap and purified water are heated gently till the solution becomes transparent. Strong alcohol is then added gradually. The mother tincture of the drug is then added and it is stirred well.

Cerates are oily substances containing cera or wax. Mix spermaceti 3 parts, white wax 6 parts and olive oil 14 parts. 1 part of mother tincture is mixed 9 parts of simple cerate. It is used as dressings for inflamed areas.

Poultices (Cataplasms) are soft, semi – sold external applications that either stimulate the body surface or alleviate an inflamed area by applying medicated substances in the presence of heat and moisture. It helps in drawing infective material from the affected area due to its hygroscopic and absorptive properties of the ingredients.

Fomentations are one method of external applications. They do not contain any medicament. They act firmly on thermal principle. Two types – Hot & Cold.

 

56. The term Posology originates from the Greek posos meaning how much and logos meaning study or discourse.

The terminology of dose originates from the word dosis, which means the quantity of a drug.

 Minimum Dose- It is the amount of medicine which is though smallest in quantity produces the least possible excitation of the vital force, yet sufficient to effect the necessary changes in it. It is that dose which is sufficient to overpower and annihilate the disease and capable o producing slight homoeopathic aggravation scarcely observable after its ingestion. 

Maximum Dose – it is the maximum or largest possible amount of medicine, which can be taken at a time by an adult, not harmful to human life.

Lethal of Fatal Dose – it is also known as toxicological or narcotic dose. It is such amount of dose which can cause death of living being.

Booster Dose – A subsequent dose given to enhance the action of initial dose.

 Fractional or refractive Dose – It is the fraction of a full dose which is to be taken at sort intervals.

Physiological Dose - Dose which stimulates the normal physiology or function of the different organs or systems of our body and the symptoms thus appearing are known as physiological symptoms.

 

57. ‘Prescription’ is derived from the Latin word ‘prescripto’ (pre - before; scripto – write).

A prescription is a written document (order) given by a physician to the dispenser for preparation of required medication as well as instructions about the mode of intake, for a particular patient, at a particular time.

Superscription - Name of the patient, age and sex with address. The word 'For' is

written before the name of the patient.

The symbol ‘Rx’- This sign was originally employed as the sign of Jupiter. It is now used as an abbreviation for the Latin word 'recipe' - 'receive'

Inscription - Name of the remedy, its potency and its quantity.  Nature and quantity of various vehicles.

Subscription - Instructions and directions for the dispenser.

Signature - Directions to the patient such as mode of intake, route of administration and the time of intake of the medicine, when to report, advice regarding diet and regimen and any other instructions or caution to   the patient. Signature of the physician with date and registration number.

 

Abbreviation commonly used in Prescription.

a.c – before food

ad lib. – At pleasure

ad us. Exter. – For external use

adhib. – To be administered

b.d. – Twice daily

b.i.d – Twice in a day

capiend. – To be taken

cochl.ampl. – A Table spoonful

cochl.med. – A dessert spoonful

cochl.parv. – A teaspoonful

collyr. -  An eye lotion

cont.rem. – Continue the medicine

 dieb. Alt. – On alternate days

 dos. – A dose

 freq. – Frequently

 gr. – A grain

 gtt. – A drop

 h.s.s. – To be taken at bed time

 m. - Mix

 mane. -  In the morning

 min. – A minim

 mist. – A mixture

 n.m. – Night and morning

 noct. – At night

o.d. – Every day

o.h. – Every hour

omn. Man. – Every morning

 omn. Noct. – Every night

p.a. – To the affected part

p.c. – After food.

q.i.d – Four times a day.

s.o.s – if necessary.

t .i. d. - Thrice daily.

trit. – Triturate.

Vac. Ven – On empty stomach.

 

58. Pharmaconomy is the subject that deals with the route of administration of       medications.

 Various route of administrating drugs are oral route, olfaction, and application to skin (epidermic), Enepidermic (drugs are simply kept in contact with the unbroken skin without friction or rubbing), eye, ear, rectal route, vagina, urethra, placental route and via milk of mother.

59. Placebo is a term used for a pharmacologically and pharmacodynamically inactive substance administered to a patient during the course of therapy when no active drug treatment is indicated. (Placere - to please; Placebo - I shall please).

Second best remedy - placebo.

The label should carry an identity of Placebo like 'phytum', rubrum', 'nihilinum', 'lactopen', 'p pills', 'S.L., etc

60. Homoeopathic Pharmacodynamics is that branch of homoeopathic pharmacy that helps us to acquire knowledge about the dynamic actions and effects of drugs on healthy organisms and constitutes the fundamental aspects of homoeo-therapeutics

 

61. Albrecht von Haller advocates the necessity of drug proving before Hahnemann.

62. The three basic components of a drug proving are the Test Substance, the Proving Team, the Methodology.

 

63  The drug proving team consists of Project Director / Master Prover, Advisor / Expert, Proving    Supervisors / Panel of Investigators and Provers.

Methodology of proving consists the Pre-proving Protocol, the Proving and Post Proving Protocol.

Recording of proving are done in Initial Medical Report Proforma, Prover’s Daybook / Logbook and Response Monitoring Proforma.

Criteria for including symptoms -new symptoms unfamiliar to the prover, usual or current symptoms those are intensified, current symptoms modified or altered, old symptoms that have not occurred for at least one year, present symptoms that have disappeared during the proving. If a symptom is in doubt, it is included in brackets; if another prover experienced the same symptom it could be valid. If not, it is excluded.

Extraction - The observations and experiences of all the provers have to be analyzed compared with their Initial Medical Report Proforma and finally comparison of the control, test and crossover groups is done.

Collation - All the prover's separate sheets are put together. Symptoms with a common denominator are grouped together under each section.

 

64. In India, Drugs and Cosmetics Act 1940 controls quality of homoeopathic medicines.

The Homoeopathic Pharmacopoeia Laboratory (HPL) was established in 1975 under the Ministry of Health and Family Welfare, Government of India as a quality monitoring apex body.

Evaluation of crude, raw products of plant origin is carried out by, organoleptic evaluation, microscopic evaluation, physical evaluation, chemical evaluation and biological evaluation.

Organoleptic evaluation - It refers to evaluation by means of organs of senses such as external morphology (Shape and Size), External colour, external markings, fracture, odour and taste.

Microscopic examination of drugs helps for searching adulterants in powdered drugs and also in the identification of drugs. It consists of histology, microchemistry, micro-sublimation and crystallography.

Physical evaluation consists of Chromatographic study of drugs, Fluorescence test, Solubility, Specific gravity, Melting point, Congealing point, Refractive index, Optical rotation and Water content or loss on drying.

Chemical methods of evaluation cover isolation, identification, purification and characteristic determination of drugs having active principles. Quantitative analysis may be gravimetric, volumetric, gasometric and colorimetric analysis.

The chemical assays include: Color reaction test, Acid value, Iodine value, Saponification value, Ester value, Ash value, Sulphated ash value, Determination of acid insoluble ash and Determination of water soluble ash.

Biological evaluation - The assays on living animals and on their intact or cut-off organs to indicate the strength of the drug or their preparation.

Mother tinctures are subjected to a qualitative and quantitative analysis such as Alcohol content determination, Weight per ml, pH value, Total solids, λ Max , Fluorescence analysis,

Chromatography is a separation process based upon the differential distribution of a mixture between two phases, one of which is percolated through other. There are various methods of chromatography study – paper, thin layer, columnar, gas, HPLC, HPTLC etc.

 

 

65. The drugs and cosmetic rules, 1945

The drugs and cosmetics act, 1940 (23 of 1940 - 10th April, 1940)

 

Import – Part IV
30-AA : Import of New Homoeopathic medicines
32-A : Packing and labelling of Homoeopathic medicine
 
Sale of Homoeopathic medicines - Part VI A
 
67-A
67-B
67-C : Forms of licenses to sell drugs
67-D : Sale at more than one place
67-E : Duration of licenses
67-EE : Certificate of renewal
67-F : Conditions to be satisfied before a license in Form 20-C or Form 20- D is granted
67-G : Conditions of license
67-GG : Additional information to be furnished by an applicant for license or a licensee to the licensing authority
67-H : Cancellation and suspension of licenses
 
Manufacture for sale or for distribution of Homoeopathic medicines - Part VII A
 
85-A : Manufacture on more than one set of premises
85-B : Application for license to manufacture Homoeopathic medicines
85-C : Application to manufacture 'New Homoeopathic medicines'
 85-E : Conditions for the grant or renewal of a license in Form 25 - C
85-EA : Inspection before grant or renewal of license
85-EB : Report by Inspector
85-EC : Grant or refusal of license
85-ED : Further application after rejection
85-EE : Appeal to the State Government
85-F : Duration of license
85-G : Certificate of renewal
85-H : Conditions of license
85-HH : Additional information to be furnished by an applicant for license or a licensee to the licensing authority
85-I : Cancellation and suspension of licenses
 
Labelling & packing of homoeopathic medicines - Part IX A
 
106-A : Manner of labelling of Homoeopathic medicines
106-B : Prohibition of quantity and percentage
 
Standards - Part XII
 
126-A : Standards of ophthalmic preparations including Homoeopathic Ophthalmic preparations
 
Schedules

Schedule A  : Forms

Schedule FF : Standards for ophthalmic preparations

Schedules M-I       : Good manufacturing practices and requirements of premises,   plant and equipment

                                           

66.  The Drugs and Magic Remedies Act (Objectionable advertisement)

 (21 of 1954) and the rules (1955)

These act and rules thereunder are intended to protect the consumer and prevent the practice of misleading and extravagant claims made in respect of many medicines and especially those claiming as remedies for many diseases considered at present as incurable.

 

67.  Medicinal and Toilet Preparation (Excise Duties) Act, 1955

 (No.16 of 1955)

It provides for the levy and collection of duty of excise on medicinal and toilet preparations containing alcohol, opium, Indian hemp, or other narcotic drugs.

 

68.  Dangerous Drugs Act – 1930 and Rules – 1957

This legislation relates to medicines containing opium, morphine, pethadine etc which are considered addition – forming, dependence – producing drugs and regulates their manufacture, sales, possession etc.

 

69.   Name of Drug                           Synonyms                        Family                   

 

Aconite napellus                           Monk’s hood                  Ranunculaceae

Aesculus hippocastanum              Horse chestnut                Sapindaceae

Aethusa cynapium                        Garden hemlock/Fool’s Umbelliferae

                                                       Parsley                                       

Cicuta virosa                                 Water hemlock               Umbelliferae

Cina                                               Worm seed                    Compositeae

Conium maculatum                       Poison hemlock             Umbelliferae

Agaricus muscarius                      Toad stool                      Agaricaceae

Andrographis paniculata               Kalmegh                        Acanthaceae    

Arnica montana                             Leopard’s bane              Compositae     

Asafaetida                                     Devil’s dung                   Umbelliferae

Baptisia tintora                              Wild indigo                    Leguminosae     

     Belladonna                                    Deadly night shade         Solanaceae

     Phytolacca decandra                     American night shade     Phytolaccaceae

     Bovista                                          Puff ball                          Lycoperdaceae

     Actea racemosa                             Black cohosh                  Ranunculaceae

     Caulophyllum                                Blue cohosh                   Beriberidaceae

     Cinchona                                       Peruvian bark                  Rubiaceae

     Colocynthis                                   Bitter gourd                     Cucurbitaceae     

     Convallaria majalis                       Lilly of valley                  Liliaceae

     Crocus sativus                               Saffron                             Iridaceae

     Drosera                                          Sundew                            Drosceraceae

     Helleborus niger                            Black hellebore               Ranunculaceae   

     Holarrhena antidysentrica              Kurchi                             Apocynaceae    

     Hypericum perfoliatum                    St.John’s wort                 Hypericaceae

     Ignatia amara                                 St. Ignatius bean              Loganniaceae

     Lycopodium                                  Club moss /wolf foot        Lycopodiaceae

     Millifolium                                     Yarrow                            Compositae

     Nux moschata                                 Nut – meg                       Myristicaceae

     Podophyllum                                   May apple                       Beriberidaceae

     Psoralea corylifolia                         Babchi                             Leguminosae

     Rhus tox                                          Poison ivy                       Anacardiaceae

     Sanguinaria canadensis                   Blood root                       Papaveraceaea

                  Stramonium                                     Thorn apple                     Solanaceae

     Thuja                                               Arbor vitae                      Cupressaceae

     Veratrum album                              White hellebore                Liliaceae

     Withania somnifera                         Ashvagandha                   Solanaceae

 

 

70. Pharmacognosy – It is the science which deals with the history, source, cultivation, collection, preparation, distribution, identification, composition, purity, preservation and commerce of crude drugs of vegetable and animal origin.

71. Drug strength is the power or strength of drug in proportion to its solvent.

72. Drug is a therapeutic agent, prepared pharmaceutically from standardised drug substance according to the rules and regulations of pharmacopoeia, which is sufficiently capable of affecting the sensations and functions, even the structural change and may cause of death, if continued for a sufficient time and dose.

     The word ‘drug’ is derived from the French word ‘drogue’ means ‘a dry herb’.

73.Medicine – when a drug has been potentised homoeopathically and proved on healthy human beings – in both sexes, all ages and in different constitutions, producing abnormal signs and symptoms ( both subjective & objective) is called medicine.

74. Remedy – when a particular medicine is prescribed for a particular diseased condition, according to symptom similarity and when the diseased condition is cured totally, the medicine is called a remedy.

75. Doctrine of Signature – The relation between the drug source and drug symptoms. (advocated by Paracelsus).

     Examples

Belladonna grows in a soil rich in calcium carbonate. Hence, Calcarea carb is complementary to Belladonna.                   

Tarantula hispanica is a spider that comes out when drums are beaten. Tarantula patient is sensitive to music.

Digitalis may be of use in blood diseases, as its flowers are adorned to with blood colored dots.

Euphrasia is a good remedy for eyes, as it had a black spot in corolla that looked like a pupil.

Hypericum having red juice maybe of use in hemorrhages.     

Rhus tox plants are collected in damp weather, rainy season, in evening, as it possesses more medicinal properties. These are also its modalities.

Bryonia is prepared from root, which is fleshy, yellowish white in color, rough with acidic and bitter taste. Bryonia patient is also fleshy, with yellowish white coated tongue, rough irritating temperament and possessing bitter taste in mouth.         

 

76. Important Families and Drugs –

      Compositae

     Arnica, Chamomilla, Cina, Artemisia vulgaris, Absinthium, Millifolium, Eup.perf, Taraxacum.

     Ranunculaceae

     Aconite, Helloborous, Clematis, Paeonia, Pulsatilla, Hydrastis, Staphysagria, Actea recemosa, Ranunculus bulbosa.

     Liliaceae

     Allium cepa, Allium sativum, Aloe socotrina, Colchicum, Convallaria, Sabadilla, Veratrum album.

     Solanaceae

     Belladonna, Hyoscyamus, Stramonium, Dulcamera.

     Loganiaceae

     Gelsemium, Nux vomica, Ignatia, Curare, Spigelia.

     Cucurbitaceae

     Colocynthis, Bryonia, Mamordica.

    Anacardiaceae

    Anacardium, Rhus tox.

     Coniferae

     Abis nigra, Sabina, Thuja, Terebinthina.

     Rubiaceae

     Cinchona, Ipecacuanha, Coffea.

     Umbelliferae

     Conium, Cicuta, Phellandrium, Petroselinum.

77. Gulta – purcha bottles is used for the preservation of Acid flour.

78. 1 grain powder is equal to 65mg.

79. 1 ml equal to 17 drops (appro – 17 minims).

80. Solubility – means how much of a substance dissolves in a given solvent.

      Descriptive Terms.      Relative quantities of solvent for 1part of solute.

       Very soluble                    Less than 1 part.

       Freely soluble                  From 1 to 10 parts

       Soluble                            From 10 to 30 parts

       Sparingly soluble                        From 30 to 100 parts

       Slightly soluble                           From 100 to 1000 parts

       Very slightly soluble                    From 1000 to 10000 parts

       Practically insoluble                     More than 10000 

 

 

81. The degree of coarseness or fineness of a powder is differentiated and expressed by the size of the mesh of sieve through which the powder is able to pass.

       Coarse powder (10/44) – a powder which all the particles pass through a no.10 sieve and not more than 40% through a no.44 sieve.

       Moderately coarse powder (22/60) – a powder of which all the particles pass through a no.22 sieve and more than 40% through a no.60 sieve.

       Moderately fine powder (44/85) - a powder of which all the particles pass through a no.44 sieve and more than 40% through a no.85 sieve.

       Fine powder (85) – a powder of which all the particles pass through a no 85 sieve.

       Very fine powder – a powder of which all the particles pass through a silk sieve in which not less than 120 meshes are included in a length of 2.54 cm in each transverse direction parallel to the threads.

 

Recognised Homoeopathic Pharmacopoeias

Homoeopathic Pharmacopoeias recognised by Drugs and Cosmetics Act:

lHomoeopathic Pharmacopoeia of India (HPI)

lBritish Homoeopathic Pharmacopoeia (BHP)

lHomoeopathic Pharmacopoeia of United States (HPUS)

lGerman Homoeopathic Pharmacopoeia (GHP)

French homoeopathic pharmacopoeia is not recognised, but it has valuable information on nosodes and organotherapies (sarcodes)

 

Standardisation

Standardisation is a process to fix certain confirmity to acceptable standards.

To minimise  variation due to individual, group or commercial houses influence, the government or other statutory bodies notify the acceptable standards.

Standardisation…

 

As a result the pharmacopoeia that is followed have details like:

Genera & species

Synonym & common names

Description & data about percentage of active ingredient / TLC / chemical identification tests

Macroscopic and microscopic details

Methods of preparation / formulation / 2x & higher methods

Minimum potency permitted for prescribing in case of toxic substances

Storage condition

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

 

Sources of homoeopathic drugs

Sources…

Nosodes – methods of preparation

N1 for the lysate of bacteria producing endotoxins (e.g.. Typhoid, paratyphoid, e.coli)

N2 for bacteria producing exotoxins (e.g.. dphtheria)

N3 for pure organisms (e.g. tuberculinum pure culture)

N4 for preparations from tissues (e.g. psorinum, bacillinum)

 

Homoeopathic drug proving (HPI Volume 1)

Controlled experiment

On relatively healthy volunteers

Substances should be prepared as per general methodology mentioned in the pharmacopoeia

Experiments should be in varying doses to produce the data called ‘proving’

On the scheme and pattern to constitute Materia Medica Provings are the basis of Materia Medica

Experiments should be carried only to extent of causing gross temporary reversible alterations and sense perceptible objective signs.

Unique characteristics of homoeopathic drug standards

The raw material should be same as used in the proving.

Method of preparation should be one adopted by the prover.

 

This in turn means:

Go for the correct species, adopt microscopic / histopathological studies.

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

 

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

Lowest potencies – legal limits of prescription                                  

 

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, picrinicum and sulphuricum

lApis mellifica

lBromine

lCreasole

lGelsemium

lHydrastis

lIodium

lPhysostigma

lRauwolfia

lSecale cor.

lZincum aceticum

 

Stringent storage condition (up to 3x)

Arsenic

Acid fluric (hydrofluric)

Atropine sulph

Chininum ars.

Lachesis

Naja

Nitroglycerine

Merc. Iod. Flv.

Merc. Iod. Rub.

Phosphorus

 

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

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

lBiological 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 – large number is a problem for pharmacopoeia

No. of homoeopathic drugs covered by different materia medica & other literature    

                                            

Simplification has been done: Hahnemannian classification of mother tincture preparation

Quotation from HPI Vol II

“The old Hanemannian method of preparation has been discarded in favour of a new uniform method with specific drug strength which takes in to consideration the moisture content of the drug, thus eliminating the variation in standards. This method (the new uniform method of preparation of tincture as mentioned in the General Instructions for preparation in Homoeopathic Pharmacopoeia) is applicable to most* of the drugs and has been accepted  by the committee

*A few exceptions have been taken care in the individual monograph”

On uniform drug strength…

Materia Medica Pura Vol II pg 30 or Chronic Diseases pg 182

“In order to make alcoholic medicinal substances of uniform strength and to obtain from them determinable dilution follow….”

 

BHP part I pg 11 & 12

“In every substance the dry crude substance is to be taken as starting point for calculation of strength.”

German Homoeopathic Pharmacopoeia

Changing face of German Homoeopathic Pharmacopoeia

German Homoeopathic Pharmacopoeia                                  contd…

German Homoeopathic Pharmacopoeia                                  contd…

French Homoeopathic Pharmacopoeia

Gemmotherapie (extraction in glycerine) – 56

Organotherapie (parts of the body – similar to sarcodes) – 261

Lithotherapie (from crude minerals) - 43

 

From HPUS

In many homoeopathic texts the words “potency” and “potentisation”, “dilution” or “solution” are synonymous with the terms “attenuation” or “trituration” the later terms, by decision of the Pharmacopoeia Convention, have become the official designations, i.e., “attenuation” for liquids and “trituration” for solids. In plant products, plant moisture was equated to purified water. Most of the mother tinctures were simplified to drug strength 1/10, exception those not soluble like Iodine or those poisonous in nature like Arsenic where 1/100 is used.

Guidelines in evaluating the merit of a drug for inclusion in pharmacopoeia

lIt should be a published data

lIt should be a proved drug

lThe raw material should be commercially available of identifiable characters and of definite composition

lIt should have a demand to establish professional recognition

Other facts which are considered

lAbsence of abnormal toxicity

lNon addict forming in the dosage form

lStability of the product during production and storage

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