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Test for active pharmaceutical raw materials
in herbal drugs
Introduction
The term “herbal drugs” denotes plants or plant parts
that have been converted into phytopharmaceuticals
by means of simple processes involving harvesting,
drying, and storage.
Pharmacognostic analysis
Qualitative and quantitative tests in order to verify or to establish the
drugs -
Identity
Purity
Quality
Parameters
Identity parameters:
Qualitative chemical analysis:
Chromatographic analysis
Purity parameters:
Foreign matter.
macroscopic examination
microscopic examination
CONTD..
• Quality parameters: loss on drying; soluble-substances; total
ash and ash insoluble in hydrochloric acid; heavy metals; assay
of active principles;
• Microbiological examination (bacteria, yeasts and moulds,
specified microorganisms);
• Pesticide residues; aflatoxins; ochratoxins.
Macroscopic examination
Methodology
• Morphological characters and the colour may be examination with
the naked eye or by using a magnifying glass.
• The size can be determined by using a ruler or a caliper.
• The odour can be determined by shattering the drug between two
fingers and smell, or using an extractive solution.
• The taste can be determined by putting a piece of drug or an
extractive solution in the mouth.
Determination of morphological characters
Microscopic examination
It is carried out on the powdered drug.
common reagent:
Other reagents are:
Determination of the anatomic characteristics
Lactic reagent
Ruthenium red solution
Glycerol
Chloral hydrate
Evaluation of results
Phloroglucinol is used to identify
the presence of lignin.
Ruthenium red solution is used to
show the presence of mucilage.
Glycerol is used to show the
presence of starch and inulin.
Qualitative chemical analysis
Evaluation of results
Confirm the presence of a chemical compound
Qualitative chromatography
Techniques:
TLC: Each compound has a characteristic spot, with a definite Rf-value,
colour and / or fluorescence.
Gc & hplc: this technique is used both for identification and for assay.
TLC
HPLCGC
Foreign matter
Methodology
• A macroscopic examination, microscopic examination, reactions or
chromatography are used to identify foreign matters.
Evaluation of results
• All results are compared with pure herbal drugs.
• The content of foreign matter is expressed as %.
Limits:
• Not more than 2%
Heavy metals
Methodology
Atomic absorption spectrometry (AAS).
Limits
• cadmium – max. 1.0 ppm
• lead – max. 5.0 ppm
• mercury – max. 0.1 ppm.
Express the pollution
Thank You

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Test for active pharmaceutical raw materials in herbal drugs, Pharmacognostic analysis

  • 1. Test for active pharmaceutical raw materials in herbal drugs
  • 2. Introduction The term “herbal drugs” denotes plants or plant parts that have been converted into phytopharmaceuticals by means of simple processes involving harvesting, drying, and storage.
  • 3. Pharmacognostic analysis Qualitative and quantitative tests in order to verify or to establish the drugs - Identity Purity Quality
  • 4. Parameters Identity parameters: Qualitative chemical analysis: Chromatographic analysis Purity parameters: Foreign matter. macroscopic examination microscopic examination
  • 5. CONTD.. • Quality parameters: loss on drying; soluble-substances; total ash and ash insoluble in hydrochloric acid; heavy metals; assay of active principles; • Microbiological examination (bacteria, yeasts and moulds, specified microorganisms); • Pesticide residues; aflatoxins; ochratoxins.
  • 6. Macroscopic examination Methodology • Morphological characters and the colour may be examination with the naked eye or by using a magnifying glass. • The size can be determined by using a ruler or a caliper. • The odour can be determined by shattering the drug between two fingers and smell, or using an extractive solution. • The taste can be determined by putting a piece of drug or an extractive solution in the mouth. Determination of morphological characters
  • 7. Microscopic examination It is carried out on the powdered drug. common reagent: Other reagents are: Determination of the anatomic characteristics Lactic reagent Ruthenium red solution Glycerol Chloral hydrate
  • 8. Evaluation of results Phloroglucinol is used to identify the presence of lignin. Ruthenium red solution is used to show the presence of mucilage. Glycerol is used to show the presence of starch and inulin.
  • 9. Qualitative chemical analysis Evaluation of results Confirm the presence of a chemical compound
  • 10. Qualitative chromatography Techniques: TLC: Each compound has a characteristic spot, with a definite Rf-value, colour and / or fluorescence. Gc & hplc: this technique is used both for identification and for assay. TLC HPLCGC
  • 11. Foreign matter Methodology • A macroscopic examination, microscopic examination, reactions or chromatography are used to identify foreign matters. Evaluation of results • All results are compared with pure herbal drugs. • The content of foreign matter is expressed as %. Limits: • Not more than 2%
  • 12. Heavy metals Methodology Atomic absorption spectrometry (AAS). Limits • cadmium – max. 1.0 ppm • lead – max. 5.0 ppm • mercury – max. 0.1 ppm. Express the pollution

Editor's Notes

  1. Since ancient times humanity has depended on the diversity of plant resources for food, clothing, shelter, and traditional medicine to cure myriads of ailments.
  2. Aflatoxins are poisonous carcinogens that are produced by certain molds which grow in soil Ochratoxins are a group of mycotoxins produced by some Aspergillus species and some Penicillium species
  3. It gives details concerning the drug aspect, size, colour, odour and taste.
  4. only reactions in an extractive solution apply.
  5. Fluorescence is the emission of light by a substance that has absorbed light or other electromagnetic radiation.