JNTU
JNTU B.Pharmacy IV QUALITY CONTROL AND STANDARDIZATION OF HERBALS Previous Question Paper (June/July - 2024 - R17)
Note: i) Question paper contains two parts, Part A, Part B. ii) Part A is compulsory which carries 25 marks. Answer all questions in Part A. iii) In Part B answer any one question from each unit. Each question carries 10 marks and may have a, b as sub questions.
Part A
Name various parameters for evaluation of commercial crude drugs.
Answer
The evaluation of commercial crude drugs is performed using the following parameters:
- Organoleptic evaluation: Assessment using sensory organs (color, odor, taste, size, shape, and texture).
- Microscopic evaluation: Examination of internal structures and cell contents using a microscope.
- Physical evaluation: Determination of constants such as moisture content, ash values, extractive values, and refractive index.
- Chemical evaluation: Qualitative and quantitative analysis using chemical tests and chromatography (TLC, HPTLC, HPLC).
- Biological evaluation: Assessment of pharmacological activity using bioassays or microbial assays.
What is foreign organic matter? How it is determined?
Answer
Foreign organic matter refers to any material consisting of parts of the plant other than those specified in the official monograph, or any animal matter, or any other plant material that is not part of the crude drug. This includes impurities such as soil, stones, sand, dust, or other foreign botanical contaminants like insects, molds, or excreta.
The determination of foreign organic matter is performed using the following steps:
- Weigh a specified quantity (usually 100 to 500 grams) of the air-dried, representative sample of the crude drug.
- Spread the sample in a thin layer on a clean white surface or a glass plate.
- Inspect the material under a magnifying lens or with the naked eye to identify and separate the foreign organic matter.
- Collect all identified foreign matter and weigh it accurately.
- Calculate the percentage of foreign organic matter using the formula: Percentage = (Weight of foreign matter / Weight of the sample) × 100.
Define GACP and give its importance.
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Explain role of GLP in quality assurance of Herbal drugs.
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Give a brief note about nonclinical studies relevant to herbal medicine research.
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What are important ICH guidelines for quality control of herbal Drugs?
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Difference between TLC and HPTLC requirements.
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Write a note on documentation required for new drug application.
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Give few applications of chemical markers in study of herbal medicines.
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What is the effect of light and temperature in quality control of herbal drugs?
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Part B
Describe pharmacological and toxicological evaluation of herbal drugs.
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Explain advanced methods of evaluation for quality control of herbal medicines.
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What are various physical and chemical methods for evaluation of quality of herbal drugs and write one method for each parameter.
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Give various methods for evaluating the quality of stored crude drugs.
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What is cGMP? Explain WHO guidelines of cGMP for Herbal drugs.
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Discuss factors effecting cultivation of herbal drugs as per GACP.
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Explain GAP guidelines for quality assurance of herbal medicines.
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Give clinical trial protocol for safety evaluation of herbal Drugs.
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What are ICH guidelines for the quality control of herbal medicine?
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Discuss the research guidelines for evaluating safety and efficacy of herbal products.
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What is stability testing? Explain various stability testing methods for herbal drugs.
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Write about GMP requirements for safety of herbal products.
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What about Drugs and Cosmetics Act provisions related to herbal products.
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Explain importance of HPLC and GC in standardization of herbal products.
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Write a detail note on regulatory requirements of herbal drugs as per EU.
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What are the regulatory requirements of herbal drugs in India?
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Explain the role of chemical and biological markers in standardization of herbal drugs.
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Give WHO guidelines for safety monitoring of herbal medicines.
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