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HERBAL DRUG TECHNOLOGY (Theory)


UNIT-I


1. Herbs as raw materials




2. Biodynamic Agriculture




3. Indian Systems of Medicine




UNIT-II



1. Nutraceuticals






UNIT-III



1. Herbal Cosmetics






Second material


Third material




UNIT-IV



1. Evaluation of Drugs


Second material



2. Patenting and Regulatory requirements of natural products:








3. Regulatory Issues –




UNIT-V



1. General Introduction to Herbal Industry




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

Biodynamic Agriculture

Good agricultural practices in 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, Lehya and Bhasma.


UNIT-II

Nutraceuticals

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 Gastro intestinal diseases. Study of 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 following drugs and their possible side effects and interactions: Hypercium, kava-kava, Ginkobiloba, Ginseng, Garlic, Pepper & Ephedra.


UNIT-III

Herbal Cosmetics

Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gums colours, perfumes, protective agents, bleaching agents, antioxidants in products such as skin care, hair care and oral hygiene products.

Herbal excipients: Herbal Excipients – Significance of substances of natural origin as excipients – colorants, sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.

Herbal formulations: Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms like phytosomes.


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, Farmers 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.


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 equipments, standard operating procedures, health and hygiene, documentation and records.


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