Herbal Medicine Flashcards
what are Herbal Medicinal product?
any medicinal product, exclusively containing as active ingredients one or more herbal drugs or one or more herbal drug preparations or in combination
how are herbal drug prepered?
they are homogeneous product obtained by subjecting herbal drugs to treatments such as extraction, distillation, expression, fractionation, purification, concentration
give examples of herbal drugs
extracts, essential oils, expressed juices, powered herbal drug
Definition “Herbal drug”
mainly whole, fragmented or brocken plants or part of plants in an unprecessed state, usually in dried but sometimes fresh
differences between herbal medicinal and medicinal product (API)
Herbal medicinal product: API, complex mixture of herbal ingredients e.g in herbal extract
Medicinal product:
API, defined synthetic/partial-synthetic/non-synthetic substance or mixture of synthetic/partial-synthetic/non-systhetic susstances
differences between herbal medicinal and medicinal product (defined content)
HMP: defined content of important active substances classes–> Ph.Eur.
MP: defined content of every API
what are herbal extracts?
liquid: preprations obtained by extraction
semi-solid: viscous extracts/thick extracts and oleoresins
solid: dry extracts preparations obtained from herbal drugs
standardised extracts?
are adjusted to a certain content of an igrendient(S) with kwon therapeutic efficacy (narrow content limit (+/- 10%)
Quantified extracts?
are adjusted to a defined range or one or more active lead susbtances, done by mixing batches of extracts
on what does the ratio of the ingredients in a extract depends on?
Growing conditions of the plants
the manufacturing process
the stabiliy
the extraction time and the solvent
Growing conditions of the plants
plant enviroment and genetic factors could significantly affect the biochemical components
the manufacturing process
Maceration and Percolation
the stabiliy
the extraction time and the solvent
stability: pH, temperature and light
Solvent: the extract is produced from the herbal drug and ethanl (60 -80 %)
Percolation and Maceration ?
Maceration: extraction technique that is condcuted at room temperature grind up the herb, add solvent and let it sit for a month
Percolation: grinding a dried herb, moistening it with some of the solvent, lettting is sit for 12-24 hours
Traditional use (TU)
Well-estabalished use (WEU)
Stand-alone/mixed applciation (SA/MA)
TU: must have been used for at least 30 years including at last 15 years within the EU
WEU: Establised at least 10 ears within the EU
SA/MA: Article 8(3) of directive 2011/83/EC
Efficacy of the TU, WEU and SA/MA?
TU: Plausible efficacy + safety through experience
WEU: proofed efficacy and level of safety
SA/MA: safety and efficacy data from the company’s onw development or a combination or own studesi and bibliographic data
TU: plausible efficacy and safety comes from?
through experience from bibliographic assessment no medical supervision needed--> indictaion oral, external or inhalation preparation specificfied strength and dosage regime
WEU: proofed efficacy and level of sadety is from
assessment of bibliographic safety and efficacy data
what about clinical trials in TU, WEU and SA/MA?
TU: No clinical interventional tests and trials on safety and efficacy/insufficent eveidence from clinical trials
WEU: Sufficient data are available in literature –> interventional clincial studuies post-marketing studies
SA/MA: Performance of own clincial trials
herbanl drugs used as medicines based on traditional use
it means that, eventhough there is insufficent evidence from CT the effectiveness of the HM is plausible, safe used for 15 years
herbanl drugs used as medicines based on WEU?
HMP: bibliographc data proving scientific eveidence of their effectivesses
MA for stand alone application
Full dosser (Moduel 1-5)
National procedure
decentralized procedure, mutual recongnition procedure
centralzed procedure, if obligation are fulfilled
MA for WEU
subsmission Modules 1-3, M4 and 5 are based on bibliographic assessment
NP, DP/MRP, CP
MA for TU:
simplified registration procedure–> submission modules 1-3,4 and 5 based on reference to the herbal monograph for plausible efficacy and review of safety data–> shows long term experience with safety and efficacy
NP, DP/MRP
Do the exercise
have you done it?
