Course program
PROGRAM
The syllabus (10 CFU; 80 h) is divided into two main macromodules: Pharmacognosy (Module 1) and Phytotherapy (Module 2), which are each one further divided into two submodules a and b. In the Module 1a (20 h), the general aspects of Pharmacognosy and issues related to natural products are addressed, with particular focus on factors affecting the variability of natural products, preparation of herbal drugs, quality control, and bioequivalence. Module 1b (20 h) covers the characteristics of the phytochemicals of herbal drugs, their pharmacological properties, and risks of toxicity, with examples of medicinal plants containing them. Module 2a (32 h) describes different merchandising categories of natural products (e.g., herbal medicines, plant-based supplements, herbal products, medical devices), with references to regulatory aspects governing their marketing and their application in phytotherapy for specific mild/moderate pathologies. Lastly, Module 2b (8 h) addresses general issues related to the safety of using herbal drugs and natural products, potential adverse reactions associated with their use in phytotherapy, and in combination with drugs or food.
Module 1. Pharmacognosy
Module 1a (20 h)
History of Pharmacognosy and principles of unconventional medicines. Basic concepts of Pharmacognosy (medicinal plant, crude drug, herbal drug, active principle, phytocomplex, balsamic time, herbal medicine, botanicals). Principles of animal and mineral Pharmacognosy. Advantages and disadvantages of phytocomplex compared to purified principles.
Spontaneous and cultivated medicinal plants. Introduction to biotechnologies applied to medicinal plants. Collection of medicinal plants. Methods of post-harvest conservation (drying, freeze-drying). Extractive methods for preparing an herbal drug (maceration, percolation, infusion, decoction).
Quality control of herbal drugs (definition and objectives according to the Official Pharmacopoeia). Quality of herbal drugs: variability factors and causes of alteration (adulteration, sophistication, deterioration, substitution). Operational phases of quality control: identification of herbal drugs (macroscopic and microscopic analysis), organoleptic examination, purity tests, and physicochemical analysis.
Module 1b (20 h)
Classes of phytoconstituents of herbal drugs: chemical and biosynthetic characteristics, properties and mechanisms of action, distribution in nature and examples of herbal drugs.
Main medicinal plants containing carbohydrates (monosaccharides, oligosaccharides, polysaccharides), lipids, glycosides (anthraquinones, cardiotonics, phenolics, flavonoids, and sulfates) and saponins, polyphenols and tannins, terpenes (monoterpenes, sesquiterpenes, diterpenes, triterpenes, tetraterpenes) and alkaloids (this part of the program requires, in particular, knowledge of the physiology of the central and autonomic nervous system).
Module 2. Phytotherapy
Module 2a (34 h)
Issues related to the use of herbal preparations: variability and bioequivalence. Standardization and titration. Merchandising categories. Herbal medicines of consolidated and traditional use and EMA Monographs.
Preparations based on herbal drugs and their derivatives: evidence-based use. Methods for evaluating the clinical efficacy of preparations: systematic reviews and meta-analyses.
Herbal drugs and their preparations in Phytotherapy for anxiety and stress disorders, mild and moderate depression, urinary tract and upper respiratory tract infections, immune system, benign prostatic hyperplasia, menopause, premenstrual syndrome, dysmenorrhea, skin inflammations, wounds, burns, bruises, weight control, digestive disorders, constipation, lipid metabolism disorders, and venous circulation alterations.
Module 2b (6 h)
Safety of using herbal drugs.
Introduction to Phytovigilance. Causes of adverse reactions to natural products. Pharmacological interactions between herbal drugs and medications. Surveillance of adverse events from natural products: case reports and causality assessment.
Prerequisites
To effectively follow and understand the topics covered in the course and to achieve the learning objectives, or to begin the study of the topics provided by the module of Pharmacognostic biotechnology, the students should possess key competences of general biology, plant biology, in particular with regard to the structure and physiology of vegetable cell and plant, inorganic and organic chemistry, biochemistry and physiology. Knowledge of the principles of general pharmacology is recommended.
Books
- Farmacognosia e Fitoterapia. Basi farmacologiche e aspetti applicativi. Mazzanti G., Dell'Agli M., Izzo A.A. Ed. Piccin (2020).
- Farmacognosia – Botanica, chimica e farmacologia della piante medicinali. Capasso F. II° Ed. Springer-Verlag (2011).
- Fitoterapia – Impiego razionale delle droghe vegetali. Capasso F., Grandolini G., Izzo A.A. Ed. Springer (2006).
In order to help the student in terms of method and continuity in the study, the distribution of the recommended texts along the duration of the course could be hypothesized as follows:
Text 1 is useful for carrying out the entire program of the course and can be effectively integrated with the notes taken in class and with the sitography and / or other specific bibliography, recommended by the teacher (see sites and references reported in the "Reference Bibliography" section)
The texts 2 and 3 are useful if they are integrated with each other. Text 2 for the general part of the program (see points 1 and 2 of the same, in the appropriate section "teaching program"). Text 3 is more useful for the special part (see point 3 of the program) relating to the phytotherapy of specific mild / moderate diseases.
Teaching mode
The adopted teaching method provides (for the greater number of hours), in accordance with any measures relating to the management of emergencies, lectures. However, exercises, related to the analysis of case reports of Phytovigilance and the simulations of bibliographic research in the drafting of papers, through the use of telematic supports (specific to the field of pharmacognosy and phytotherapy) are also foreseen. The course will in any case depend on the teaching method, allowed by the COVID19 emergency.
The teaching methods, chosen by the teacher, contribute not only to the achievement of the planned training objectives, but are also methods easily usable in the real working life, as they provide quick and free access to databases and websites of the medicinal plants sector and its uses and warnings.
Frequency
Course attendance is mandatory. The teacher will check the presence in the way it deems most appropriate. The frequency is useful as it allows to obtain updated information, not necessarily available in textbooks and, above all, helps to achieve a valid method of approach to the study of the subject.
Exam mode
The actual achievement of the expected learning outcomes by the student, in accordance with the training objectives, is evaluated through an oral exam. Among the aspects that contribute to the formation of the final judgment, beyond the specific preparation of the student on exam topics, is also evaluated the reasoning ability and the study that has conducted in an autonomous way, not based only on the mnemonic abilities.
The duration of the test, as an oral one, is difficult to define and depends essentially on the degree of preparation and the student's exhibition skills. An average duration of about 20 minutes is conceivable.
The teaching, as established by Manifesto, does not provide intermediate tests but only tests at the end of the teaching course. These tests have pre-established dates and are communicated annually to the Secretariats and published via e-learning and via Infostud.
To pass the exam it is necessary to achieve a grade of not less than 18/30. The student must demonstrate that he has acquired sufficient knowledge of the general and special topics and that he is able to provide useful application advice concerning the use modalities, warnings, undesired effects, interactions of the products containing medicinal plants. To achieve a score of 30/30 cum laude, the student must instead demonstrate that he has acquired excellent knowledge of all the topics covered during the course (including the most recent ones covered during the course), being able to link them in a way logical and consistent.
Bibliography
The reference bibliography reported below can be used in the part related to the in-depth analysis (point 4) and/or more current topics. It should however be specified that the preparation of the student should not be sectorialized, but must provide the reasoned capacity for the integration between the different parts of the program, in the different sources of information.
Website list
hhttp://www.salute.gov.it/
http://www.epicentro.iss.it/focus/erbe/sorv_reaz-avv.asp
https://www.ncbi.nlm.nih.gov/pubmed/
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/herbal_search.jsp&mid=WC0b01ac058001fa1d
https://www.farmacovigilanzasif.org/topics/aggiornamenti/
Photocopies delivered in class and/or included on the course website (http://elearning2.uniroma1.it/).
Lesson mode
The adopted teaching method provides (for the greater number of hours), in accordance with any measures relating to the management of emergencies, lectures. However, exercises, related to the analysis of case reports of Phytovigilance and the simulations of bibliographic research in the drafting of papers, through the use of telematic supports (specific to the field of pharmacognosy and phytotherapy) are also foreseen. The course will in any case depend on the teaching method, allowed by the COVID19 emergency.
The teaching methods, chosen by the teacher, contribute not only to the achievement of the planned training objectives, but are also methods easily usable in the real working life, as they provide quick and free access to databases and websites of the medicinal plants sector and its uses and warnings.