BP401TSemester 43 creditsTheory
Herbal Drug Technology
Complete unit-wise syllabus for BP401T as per the PCI B.Pharm NEP 2020 curriculum (Semester 4 — Medicinal Chemistry + 1st Internship).
URL:
https://pharmacode.vercel.app/syllabus/semester-4/bp401t-herbal-drug-technology/Unit-wise Syllabus
5 Units1
WHO Guidelines and Good Agricultural Practices9 Hours- WHO guidelines for herbal medicines; global regulatory framework for herbal drugs; quality aspects
- Good Agricultural and Collection Practices (GACP): cultivation guidelines, harvesting, drying, storage, and transportation of medicinal plants
- Factors influencing quality: climate, soil, genetic factors, microbial contamination, post-harvest handling
2
Extraction Methods and Industrial Production9 Hours- Extraction methods: maceration, percolation, Soxhlet extraction, supercritical fluid extraction (CO2); selection criteria
- Industrial production of important plant drugs: opium, belladonna, digitalis, cinchona — cultivation, processing, extraction
- Downstream processing: concentration (evaporation), purification (liquid-liquid extraction, chromatography), drying of extracts
3
Herbal Formulations and Manufacturing9 Hours- Types of herbal formulations: standardised extracts, phytopharmaceuticals, nutraceuticals, cosmeceuticals
- Formulation of herbal tablets, capsules, liquids, topical preparations — excipients and considerations
- cGMP for herbal products; manufacturing process controls; documentation; WHO manufacturing practices for herbal medicinal products
4
Quality Control and Standardization9 Hours- Standardization approaches: marker-based, fingerprint-based; WHO guidelines on quality control methods
- Analytical methods: TLC, HPTLC, HPLC, GC, UV-Vis spectroscopy — fingerprinting of herbal extracts
- Physicochemical parameters: heavy metal testing, pesticide residue analysis, aflatoxin testing, microbiological testing
5
Regulatory Requirements for Herbal Drugs9 Hours- Indian regulations: AYUSH guidelines, Drugs and Cosmetics Act provisions for herbal drugs, Schedule E, FSSAI for nutraceuticals
- International regulations: European Medicines Agency (EMA) guidelines for herbal medicinal products; USFDA requirements for botanical drug products; ICH guidelines applicable to herbals
- Intellectual property in herbal drugs: traditional knowledge digital library (TKDL); biopiracy; patents on herbal formulations
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- Reference textbooks and recommended reading list
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Other subjects in Semester 4
BP402TMedicinal ChemistryBP403TPharmaceutical BiotechnologyBP404TSocial Pharmacy and Public HealthBP405TSystemic Pharmacology IBP406PHerbal Drug Technology (Practical)BP407PMedicinal Chemistry (Practical)BP408PPharmaceutical Biotechnology (Practical)BP409PSocial Pharmacy and Public Health (Practical)BP410PSystemic Pharmacology I (Practical)BP411IInternship I (Mandatory)