Herbal Drug Technology – B. Pharma 6th Semester Notes Pdf
Scope: This subject gives the student the knowledge of basic understanding of the herbal drug industry, the quality of raw materials, guidelines for the quality of herbal drugs, herbal cosmetics, natural sweeteners, nutraceuticals etc. The subject also emphasizes on Good Manufacturing Practices (GMP), patenting and regulatory issues of herbal drugs
Objectives: Upon completion of this course the student should be able to:
1. Understand raw material as a source of herbal drugs from cultivation to herbal drug product
2. Know the WHO and ICH guidelines for the evaluation of herbal drugs
3. Know the herbal cosmetics, natural sweeteners, nutraceuticals
4. Appreciate patenting of herbal drugs, GMP.
Herbal Drug Technology UNIT-I
Herbs as raw materials
Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation
Source of Herbs
Selection, identification, and authentication of herbal materials
Processing of herbal raw material
Good agricultural practices in the cultivation of medicinal plants including Organic farming.
Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.
Indian Systems of Medicine
a) Basic principles involved in Ayurveda, Siddha, Unani, and Homeopathy
b) Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas, Ghutika, Churna, and Bhasma, Avleha, and Taila..
Herbal Drug Technology UNIT-II
General aspects, Market, growth, scope, and types of products available in the market. Health benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable bowel syndrome, and various Gastrointestinal diseases.
Study of the following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic, Honey, Amla, Ginseng, Ashwagandha, Spirulina
Herbal-Drug and Herb-Food Interactions: General Introduction to Interaction and Classification. Study of the following drugs and their possible side effects and interactions: Hypercium, kava-kava, Ginkgo Biloba, Ginseng, Garlic, Pepper & Ephedra.
Herbal Drug Technology UNIT-III
Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gums colors, perfumes, protective agents, bleaching agents, and antioxidants in products such as skin care, hair care, and oral hygiene products.
Herbal Excipients – Significance of substances of natural origin as excipients – colorants, sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.
Conventional herbal formulations like syrups, mixtures, and tablets and Novel dosage forms like phytosomes.
Herbal Drug Technology UNIT- IV
Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs
Stability testing of herbal drugs.
Patenting and Regulatory Requirements of natural products:
a) Definition of the terms: Patent, IPR, Farmer’s right, Breeder’s right, Bioprospecting, and Biopiracy
b) Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma & Neem.
Regulatory Issues – Regulations in India (ASU DTAB, ASU DCC), Regulation of manufacture of ASU drugs – Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Herbal Drug Technology UNIT-V
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant-based industries and institutions involved in work on medicinal and aromatic plants in India.
Schedule T – Good Manufacturing Practice of Indian Systems of Medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipment, standard operating procedures, health and hygiene, documentation, and records.
Herbal Drug Technology (Practical)
1. To perform preliminary phytochemical screening of crude drugs.
2. Determination of the alcohol content of Asava and Arista
3. Evaluation of excipients of natural origin
4. Incorporation of a prepared and standardized extract in cosmetic formulations like creams, lotions and shampoos and their evaluation.
5. Incorporation of a prepared and standardized extract in formulations like syrups, mixtures, and tablets and their evaluation as per Pharmacopoeial requirements.
6. Monograph analysis of herbal drugs from recent Pharmacopoeias
7. Determination of Aldehyde content
8. Determination of Phenol content
9. Determination of total alkaloids
Herbal Drug Technology Recommended Books: (Latest Editions)
1. Textbook of Pharmacognosy by Trease & Evans.
2. Textbook of Pharmacognosy by Tyler, Brady & Robber.
3. Pharmacognosy by Kokate, Purohit and Gokhale
4. Essential of Pharmacognosy by Dr.S.H.Ansari
5. Pharmacognosy & Phytochemistry by V.D.Rangari
6. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian Medicine & Homeopathy)
7. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers, New Delhi, India, 2002.