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JNTU B.Pharmacy IV QUALITY CONTROL AND STANDARDIZATION OF HERBALS Previous Question Paper (June/July - 2024 - R17)

B.Pharmacy | IV | IV-I | R17 | June/July - 2024

Answer PaperPaper Code: 247AHMaximum Marks: 75Time: 3 Hours

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

1.a

Name various parameters for evaluation of commercial crude drugs.

2 marks

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.
1.b

What is foreign organic matter? How it is determined?

3 marks

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:

  1. Weigh a specified quantity (usually 100 to 500 grams) of the air-dried, representative sample of the crude drug.
  2. Spread the sample in a thin layer on a clean white surface or a glass plate.
  3. Inspect the material under a magnifying lens or with the naked eye to identify and separate the foreign organic matter.
  4. Collect all identified foreign matter and weigh it accurately.
  5. Calculate the percentage of foreign organic matter using the formula: Percentage = (Weight of foreign matter / Weight of the sample) × 100.
1.c

Define GACP and give its importance.

2 marks

Answer

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1.d

Explain role of GLP in quality assurance of Herbal drugs.

3 marks

Answer

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1.e

Give a brief note about nonclinical studies relevant to herbal medicine research.

2 marks

Answer

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1.f

What are important ICH guidelines for quality control of herbal Drugs?

3 marks

Answer

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1.g

Difference between TLC and HPTLC requirements.

2 marks

Answer

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1.h

Write a note on documentation required for new drug application.

3 marks

Answer

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1.i

Give few applications of chemical markers in study of herbal medicines.

2 marks

Answer

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1.j

What is the effect of light and temperature in quality control of herbal drugs?

3 marks

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Part B

210 marks
a

Describe pharmacological and toxicological evaluation of herbal drugs.

5 marks

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b

Explain advanced methods of evaluation for quality control of herbal medicines.

5 marks

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OR
310 marks
a

What are various physical and chemical methods for evaluation of quality of herbal drugs and write one method for each parameter.

5 marks

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b

Give various methods for evaluating the quality of stored crude drugs.

5 marks

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410 marks
a

What is cGMP? Explain WHO guidelines of cGMP for Herbal drugs.

5 marks

Answer

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b

Discuss factors effecting cultivation of herbal drugs as per GACP.

5 marks

Answer

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OR
510 marks
a

Explain GAP guidelines for quality assurance of herbal medicines.

5 marks

Answer

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b

Give clinical trial protocol for safety evaluation of herbal Drugs.

5 marks

Answer

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6

What are ICH guidelines for the quality control of herbal medicine?

10 marks

Answer

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OR
7

Discuss the research guidelines for evaluating safety and efficacy of herbal products.

10 marks

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810 marks
a

What is stability testing? Explain various stability testing methods for herbal drugs.

5 marks

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b

Write about GMP requirements for safety of herbal products.

5 marks

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OR
910 marks
a

What about Drugs and Cosmetics Act provisions related to herbal products.

5 marks

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b

Explain importance of HPLC and GC in standardization of herbal products.

5 marks

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1010 marks
a

Write a detail note on regulatory requirements of herbal drugs as per EU.

5 marks

Answer

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b

What are the regulatory requirements of herbal drugs in India?

5 marks

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OR
1110 marks
a

Explain the role of chemical and biological markers in standardization of herbal drugs.

5 marks

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b

Give WHO guidelines for safety monitoring of herbal medicines.

5 marks

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This page contains the question paper of QUALITY CONTROL AND STANDARDIZATION OF HERBALS from JNTU for B.Pharmacy IV IV-I, June/July - 2024, R17.

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