WHO & ICH GUIDELINES FOR ASSESSMENT OF HERBAL DRUGS (PART - 1) T.Y B.PHARM | SEM VI | HERBAL DRUG TECHNOLOGY | PCI SYLLABUS | UNIT IV.

WHO & ICH GUIDELINES FOR ASSESSMENT OF HERBAL DRUGS (PART - 1)

EVALUATION OF HERBAL DRUGS/CRUDE DRUGS
QUALITY CONTROL OF HERBAL DRUGS/CRUDE DRUGS

Herbal drugs are being used as medicines from ancient period. The increased use of herbal drugs, and concerns over their safety and efficacy have certainly augmented the need of standardization of these herbal drugs.

WHO & ICH has set up guidelines for standardization of these drugs, which are used as a standard by the majority of countries..

DRUG EVALUATION:- Confirmation of its identity, determination of its quality & purity,

and detection of nature of adulteration.

IDENTITY is refer to the exact authentic biological source of the drugs can be established

by actual collection of the drug from a plant or animal which has been identified by

-A qualified, Specialized, and experienced personnel. (Botanist, Herbal specialist)

-Comparison with the standard/Authenticated sample specimen. 

QUALITY is refer to intrinsic value of crude drugs i.e nature & amount of active medicinal

principle.  The active principles may be Alkaloids, Glycosides, Carbohydrates, Tannins,

Fixed oil, Volatile oil etc.

The high grade quality of the drug can be accomplished by

• Collection of the drug from correct natural sources either wild or cultivated

• Collect the crude drug at proper time & in an appropriate manner.

• Collect the required parts of the plants

• Preparation of collected drugs by proper cleaning and drying.

• Proper preservation of the drug in order to avoid contamination microbes, fungi and

insects.

PURITY of the drugs depends upon presence and absence of foreign matter whether

organic or inorganic

NEED OF DRUG EVALUATION:- Necessary because of three main reason:-

• Biochemical variation in the drugs

• Deterioration due to treatment and storage.

• Substitution and adulteration due to carelessness, ignorance and fraud. Such as….

-Substandard commercial varieties.

-Artificially manufactured substances. – Much costlier drugs.

-Substitution  with exhausted drugs.- Volatile oil containing drug like fennel, clove etc.

-Harmful adulterant. – liquid and unorganized drugs.

TYPES OF DRUG EVALUATION

ORGANOLEPTIC EVALUATION, MORPHOLOGICAL EVALUATION, MICROSCOPIC

EVALUATION, PHYSICAL EVALUATION, CHEMICAL EVALUATION, ANALYTICAL

EVALUATION, BIOLOGICAL EVALUATION, TOXICOLOGICAL EVALUATION,

PHARMACOLOGICAL EVALUATION.

ORGANOLEPTIC EVALUATION:-

A) COLOR:-  The crude drug was kept in day light & was checked with the std crude drug.
The different parts of crude drugs may acquire a variety of color.
It is a technique of qualitative evaluation based on the study of sensory profile of whole
drug. This refers to drug evaluation by means of organs of senses like color, odor, taste, size,
shape, touch & texture.
Eg. Material derived from aerial parts of the plants is usually green color. The fruits and
seeds having a different color. Barks posses brownish grey to brownish black color.etc

                  ORGANOLEPTIC EVALUATION OF CRUDE DRUGS

B) ODOR AND TASTE:- Odor and taste of crude material are extremely sensitive criteria

based on individual perception. 

Odor:- place a small portion of the sample in the palm of the hand or a beaker of suitable

size & slowly inhale the air over the material.

• The crude drug may be odorless or pose an odor which may be Distinct and Indistinct.

• General terms for describing odor are Aromatic, Balsamic, spicy, fruity, pungent

etc.

•Eg. Aromatic odor of umbeliferus fruit.

Taste:- To achieve the taste keep the material in to the mouth over the tongue. The crude

drug may posses a characteristics taste or may be tasteless. The different term used to

defined taste are.......

                      EXAMPLES OF ORGANOLEPTIC EVALUATION OF CRUDE DRUGS

DIFFERENT TASTE OF THE CRUDE DRUGS

C) Touch & Texture:- Touch the materials to determine if it is soft or hard. Texture is best

examined by taking a small quantity of material and rubbing it between the thumb and

forefinger. It is usually described as smooth ,rough etc.

MORPHOLOGICAL EVALUATION:-

The study of the form of crude drugs is called morphology anddetermination of the form

crude drugs is called morphography. It can be considered as first step towards identity

and degree of purity of crude drugs.

Study of morphology includes visual examination of drugs like study of size and shape of

various parts of crude drugs.

Size:- The lenth, width, & Thickness of the crude material are of great importance while

evaluating. A graduated ruler in mm is adequate for measurement.

Shape:- The crude drug may be having a different shapes like cylindrical, sub cylindrical,

Conical, Ovoid, Disk etc.

Examples:-

EXAMPLES OF MORPHOLOGICAL EVALUATION OF CRUDE DRUGS

DIFFERENT SHAPES OF CRUDE DRUGS

A] Leaves and leaflet:- The study of length, width, apex, margin, venation,  the texture of

leaf and hairs in upper and lower surface. The feel of the surface describes as soft, hairy,

smooth.

MORPHOLOGICAL EVALUATION OF CRUDE DRUGS

DIFFERENT TYPES OF LEAF AND LEAFLETS

B] Bark:- Bark have two surfaces an outer and inner. The inner surface is usually lighter in

color than outer surface. The bark having a three shapes…

1.Flat or curved pieces.

2.Single quill

3.Double quill

Different shapes of bark:-

1. Flat:- When quite flat and very thick e.g. Quillaia bark

2. Curved:- When curved and slightly concave on the inner side.

e.g. Wild cherry bark.

3. Re-curved:- When the concave side is the outer one.

e.g. Pomegranate.

4. Channeled:- When deeply concave on the inner side.

e.g. Cassia bark.

5. Single quill:- When deeply concave on the inner side that the edges of the bark nearly or quite overlap. E.g. Cinchona.

6. Double quill:- When both edges are separately in rolled.

E.g. Frangula.

7. Compound quill:- When single and double quills are packed

inside one another. E.g. Cinnamon.

WHO & ICH GUIDELINES FOR ASSESSMENT OF HERBAL DRUGS (PART - 2)MICROSCOPIC EVALUATION click on link given below

https://ansaripharmaeducation.blogspot.com/2020/06/who-ich-guidelines-for-assessment-of_15.html