Standardization of crude drug and herbal formulation

June 1, 2011 in Pharmacognosy, Phytochemistry, Standardization by khyatimdhuwad

Definition:- Standardization of drugs means confirmation of its identity, determination of its quality, purity and detection of nature of adulterant by various parameters like morphological, microscopical, physical, chemical and biological evaluations.

Standardization of herbal formulations include:-

  1. Quality evaluation of ingredients or quality control of crude drugs, finished preparations.
  2. Assessment of Stability (Shelf life evaluation based on physico-chemical, microbial and HPTLC/HPLC finger prints)
  3. Assessment of safety (Toxicological data and documented experience)
  4. Assessment of efficacy (Pharmacological screening data and documented traditional use)

The Standardization of crude drug materials includes :-

1. Authentication: – Each and every step has to be authenticated.

a)      Stage of collection.

b)      Parts of the plant collected.

c)      Regional status.

d)     Botanical identity like phytomorphology, microscopical and

histological analysis (characteristic of cell walls, cell contents, starch

grains, calcium oxalate crystals, trichomes, fibers, vessels etc).

2. Foreign matter (herbs collected should be free from soil, insect parts or

animal excreta)

3. Organoleptic evaluation (sensory characters – taste, appearance, odor,

feel of the drug)

4. Tissues of diagnostic importance present in the drug powder.

5. Ash values and extractive values.

6. Volatile matter

7. Moisture content determination

8. Chromatographic (TLC, HPTLC, HPLC) and spectroscopic evaluation will

provide qualitative and semi quantitative information about the main

active constituents present in the crude drug as chemical markers in the

TLC fingerprint evaluation of herbals (FEH). On the basis of the

chromatographic fingerprint the quality of the drug can also be assessed.

9. Determination of heavy metals – e.g. cadmium, lead, arsenic, etc.

10. Pesticide residue – Limits of pesticides, which are usually present in the

herbs set by WHO and FAO (Food and Agricultural Organization).

Pesticides like DDT, BHC, aldrin, toxaphene are mixed with the herbs

during the time of cultivation cause serious side-effects in human beings.

11. Microbial contamination – usually medicinal plants containing bacteria

and molds are coming from soil and atmosphere. The substance known

as afflatoxins will produce serious side-effects if consumed along with the

crude drugs.

12. Radioactive contamination – Irradiation usually avoids microbial

growth in herbals. This process may sterilize the plant material but the

radioactivity hazard should be taken into account.

Herbal drug standardization includes

a)      Pharmacognostical Evaluation

  • Taxonomical
  • Morphological
  • Anatomical
  • Biological
  • Biochemical
  • Biotechnological

b)      Physico-chemical Evaluation

  • Ash Values
  • pH
  • Optical Rotation
  • Specific Gravity
  • Hardness
  • Disintegration Time
  • Elemental Composition

c)      Phytochemical protocols

  • Extractive Values
  • Chemical Profiling
  • TLC Fingerprinting
  • Markers

- Bio-active

- Biologically

- Chemical

  • HPTLC / HPLC Based Quantifications

d)      Residual analysis

  • Heavy Metals
  • Pesticides
  • Toxins
  • Radio-actives
  • Pathogens
  • Fumigants
  • Fungicides