Regulatorni status i kontrola kakvoće fitopreparata s ginkom

professional thesis

• Title (english): Regulatory status and quality control of ginkgo preparations
• Author: Ružica Jagić
• Mentor: Sanda Vladimir-Knežević (mentor)
• Committee member: Maja Bival Štefan (predsjednik povjerenstva)
• Committee member: Sanda Vladimir-Knežević (član povjerenstva)
• Committee member: Donatella Verbanac (član povjerenstva); MBZ: 133213
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmacognosy); Zagreb
• Defense date and country: 2017, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Cilj istraživanja
Cilj ovog rada je dati sveobuhvatan pregled stručnih i znanstvenih spoznaja o kontroli kakvoće i regulatornim zahtjevima za komercijalne pripravke koji sadrže ginko.
Materijal i metode
Istraživanje u okviru ovog rada je teorijskog karaktera i uključuje pregled dostupne literature o predloženoj temi. U pretraživanju su korištene dostupne elektronske bibliografske baze podataka (Current Contents, ScienceDirect, Scopus, PubMed) te mrežne stranice relevantnih hrvatskih i europskih institucija (Agencija za lijekove i medicinske proizvode, Ministarstvo zdravstva, Europska Agencija za lijekove i medicinske proizvode i Europska agencije za sigurnost hrane).
Rezultati
Fitopreparati s ginkom se široko primjenjuju za ublažavanje simptoma oslabljenih kognitivnih funkcija povezanim sa starenjem, od blagog gubitka pamćenja i cerebralne insuficijencije do demencije. Da bi se osigurala učinkovitost i sigurnost primjene, za izradu fitopreparata koriste se standardizirani ginkovi ekstrakti. Postoji značajna razlika u regulatornim zahtjevima komercijalnih pripravaka koji sadrže ginko u statusu lijeka i dodatka prehrani. Biljni lijekovi koji sadrže ginko mogu se registrirati kao lijekovi za kojeg je dostupna cjelovita dokumentacija, lijekovi s provjerenom medicinskom uporabom ili tradicionalni biljni lijekovi. Nadležno tijelo za lijekove u Republici Hrvatskoj je Agencija za lijekove i medicinske proizvode. Dodaci prehrani su regulirani zakonodavstvom o hrani, a u nadležnosti su Ministarstva zdravstva.
Zaključci
Iako nije propisano zakonskom regulativom, dodatke prehrane s ginkom trebalo bi, po uzoru na biljne lijekove, podvrgavati zahtjevnijim ispitivanjima kakvoće prije stavljanja u promet, postrožiti nadzor i prijavljivati neželjene učinke u praksi.

Abstract (english)

Objectives
The aim of this work was to give a comprehensive overview of professional-related and scientific aspects of quality control and regulatory requirements for commercial products containing ginkgo.
Material and methods
This work is a theoretical investigation of the available literature on the topic. Targeted literature search was conducted using online scientific databases (Current Contents, ScienceDirect, Scopus, PubMed) and web pages of the relevant Croatian and European institutions (Agency for Medicinal Products and Medical Devices, Ministry of Health, European Agency for Medicinal Products and European Food Safety Authority).
Results
Ginkgo biloba products are widely used to ameliorate the symptoms of age-related cognitive decline in conditions ranging from mild memory impairment and cerebral insufficiency to dementia. In order to ensure the efficiency and safety of ginkgo preparations, standardized extracts are used. There are significant differences in the regulatory requirements between dietary supplements and medicinal products of commercial preparations containing ginkgo. Ginkgo medicinal products can be regulated as a traditional herbal medicinal product or a herbal medicinal product with a well-established use. The Agency for Medicinal Products and Medical Devices is the competent Croatian authority for medicinal products. Dietary supplements are regulated by food legislation under the responsibility of the Ministry of Health.
Conclusion
Although not required by legislation, Ginkgo biloba dietary supplements should be subjected to demanding quality and safety tests before they are marketed. Furthermore, monitoring of dietary supplements must be tightened up and side effects should be reported.

• Keywords: ginko; kontrola kakvoće
• Keywords (english): ginkgo; quality control
• Language: croatian
• URN:NBN: urn:nbn:hr:163:916637
• Study programme: Title: Drug development; Study programme type: university; Study level: postgraduate specialist; Academic / professional title: sveučilišni magistar/sveučilišna magistra razvoja lijekova (sveučilišni magistar/sveučilišna magistra razvoja lijekova)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2017-09-15 11:03:57