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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).

All Sem 4 Subjects
URL:https://pharmacode.in/syllabus/semester-4/bp401t-herbal-drug-technology/

Unit-wise Syllabus

5 Units
1
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
  • Previous year question papers (PYQ)
  • Topic-wise short notes and revision summaries
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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)
BP402T